¹ On the receptacle for delivery (box, bottle, ointment tube and tablets, etc.) shall be shown:

A.

For medicinal products for human use, the denomination, if any, with indication of the dosage; the galenic form and the indication of the quantity contained in each packaging;

B.

For veterinary medicinal products, in addition to the indications according to the whistle. A, the animal species to be treated and the indication " ad us. " As well as, where applicable, the waiting period;

C.

The qualitative and quantitative indication of the active ingredients; the concentration is indicated in uniform measurement units internationally, for example in milligrams per millilitre; the concentration per cent is renounced, except Where necessary, for example for complementary medicinal products; the Institute may require that an active principle be declared under a given name;

D.

The holder of the authorization (name and seat, in accordance with the extract from the register of commerce);

E.

The distinguishing sign of each batch (lot number);

F.

Medical information essential to the use of the product (instructions for use, warnings, waiting period, etc.);

G.

The clear expiry date;

H.

Storage instructions (storage instructions) and, if necessary, the time limit for use after the first opening of the container;

I.

The authorization number;

J.

The warning about children and the reference to the instructions in the package insert.

² On the authorisation of the Institute, indications may exceptionally be renounced according to para. 1, let. C, d, f, h, i and j, where all the above indications cannot be mentioned on technical grounds (p. Ex. In the case of small containers); this rule also applies to the indication of the waiting period according to the let. B.

³ If the drug is placed on the market with outside packaging (p. Ex. (cartonnage), it must be provided with the information required by para. 1, whatever the container; in this case, it is possible to waive the indication of the authorization number on the container.

⁴ On the outer packaging of medicinal products for human use containing up to three active ingredients, the name of the active ingredients according to the usual international names (INN) must appear directly under the trade name; in the case of Generic drugs, it must be mentioned before the company's trade name or corporate name. The Institute may authorize exceptions for generic drugs if circumstances warrant. In addition, the exceptions set by the Institute for complementary medicinal products and phytomedicaments are reserved for medicinal products containing a combination of active principles of complementary medicine or Phytotherapeutic and other active ingredients.

⁵ The characters used for the indication of active ingredients must be at least half the size of those used for the business name or business name.

⁶ On the outer packaging of medicinal products for human use, the characters used for the indication of the dosage must be at least twice as large as those used for the indication of the quantity contained in each packaging; their Size must be at least the size of the characters used to indicate the active ingredients. In addition, the indication of the dosage and the quantity contained in each packaging must be separated from each other.

⁷ On the alveolar plate ( Blister ) Must include at least the name, expiry date, lot number and, where multiple dosages are permitted, the dosage.

⁸ Any other indication or illustration is permitted only on condition that it is in direct relation to the use of the medicinal product, that it is essential for the health of the patient and that it is not inconsistent with the provisions of the Annexes 4, 5.1, 5.2, 5.3 and 6.

¹ The holder of the authorization shall be designated by the words "holder of the authorization:". If, due to a lack of space, it is not possible to affix this statement, the abbreviation "tit" shall be used. AMM: ".

² Manufacturer's reference is not mandatory. However, if the holder of the authorisation wishes the name of the manufacturer to be mentioned, then it should be clearly designated as such ('fabricant: ',' manufactured by: 'or' fabrication: '). If a company performs all the manufacturing steps (including quality controls), it can be mentioned as a manufacturer. If the various stages of manufacture are carried out by several undertakings, only the undertaking which establishes the batch certificate may be mentioned as a manufacturer.

³ If the holder of the authorization and the manufacturer are identical, and if the holder of the authorization wishes to mention the name of the manufacturer, then the manufacturer must be designated as such ("holder of the authorization and manufacturer:").

⁴ Where the information to be shown on containers for the purpose of being given to the patient cannot be included in extenso for technical reasons, an outer packaging should be provided (p. Ex. Cartonnage) with all the information required by c. 1, para. 1.

⁵ Easily detachable labels or perforated labels whose detachable part contains information required by c. 1, para. 1, are prohibited.

⁶ Packages whose contents are intended for several patients must be subdivided into individual packages. The exception is packaging intended exclusively for hospitals and private pharmacies for veterinary use. Individual packagings shall meet the requirements set out in c. 1 and 2, para. 5. Veterinary drugs with the smallest licensed processing unit that is too large for the treatment of a single animal must meet the requirements set out in c. 1, let. A, b, d, f, g, and 2, al. 5.

¹ On the label of parenteral drugs for human use must be at least:

A.

The name;

B.

The route of administration (i.v., s.c., etc.);

C.

The total volume;

D.

The expiration date;

E.

The lot number.

² For drugs containing no more than two active ingredients, in addition to the data according to para. 1, at least:

A.

IUU active principles;

B.

The total quantity of the active principle (s); and

C.

Concentration.

³ The name of the holder of the authorisation and the indications of conservation, provided that it does not deviate from the standards (15 -25 ° C), shall be mentioned only if the legibility of the data and, if applicable, the identification code, is not Assigned. For parenteral drugs intended for the hospital setting, the reference to the instructions in the package insert should be waived in principle.

⁴ The legibility of the data on the label must be guaranteed. In particular, the characters of the data must be of a minimum size of 1.4 mm, and the font should not contain an impatment. You should not be forced to turn the container to easily read the data on a line. The data should not be printed directly on the container.

⁵ The Institute may admit exceptions to the provisions of paras. 1 to 4:

A.

Whether they are complementary drugs and phytomedicines;

B.

If the supply of important drugs is threatened; or

C. If necessary for readability reasons.

¹ The category of rebate granted by the Institute shall be duly indicated on the packaging or, failing that, on the receptacle.

² The discount category must appear on each individual package.

On the receptacle for delivery (box, vial, bulb, pommade tube, etc.) and on the packaging material (cartonnage, etc.) must be shown:

A.

The name for which the following criteria will be met:

1.

For the units, use exclusively the common name of the active principle in the sector concerned (nomenclature according to specialised homeopathic or anthroposophical publications recognised with, in the case of divergence, mention in parentheses of Designation according to HAB, Ph. F. or pharmacopoeia) and the corresponding dilution,

2.

For complexes, use only the common name in the sector concerned of at least one main component, followed by a complement such as "comp." Or "complex"; it is forbidden to use an identical designation to that of another complex Same therapeutic (homeopathy or anthroposophical medicine) but different composition,

3.

For the salts of Schüssler (biochemical salts), the Latin name of the raw material shall be used exclusively, including the number of the salt concerned according to the list of salts of Schüssler (list SC, annex 5 OAMédcophy ² ) Which may be the subject of an advertisement, and the corresponding dilution;

B.

The words "homeopathic medicine" or "homeopathic medicine-spagyrique/spagyric", "anthroposophical drug "or" drug based on anthroposophical knowledge "," biochemical salt "," biochemical salt according to D ^R Schüssler "or" biochemical mineral salt of D ^R Schüssler ";

C.

The galenic form and the quantity contained in the unit package;

D.

The target animal species or "ad us". " For veterinary medicinal products, in order to distinguish them from medicinal products for human use, and, where appropriate, the waiting period;

E.

The composition of the medicinal product: the qualitative and quantitative declaration of all active ingredients; the concentration of the homeopathic active ingredients must be expressed by the corresponding dilution (or as a mother-of-mother) Indicate the quantities of each final dilution present in the finished product; the reference pharmacopoeia, the manufacturing process followed and, where appropriate, a more detailed specification of the Raw material (p. Ex. Part of the plant) in addition (p. Ex. Aralia racemosa e radice 3CH Ph. F, Anthoxantum odoratum e planta tota D4 HAB 3a); if, for the units, these data are already contained in the name of the preparation, it is not necessary to recall them in the heading "Composition"; if the active component is based on a Product Monograph for HAB or Ph. F., it is sufficient to specify the name of the Pharmacopoeia; for homeo-spagyric or spagyric drugs, the spagyric manufacturing process must be indicated in addition to the HAB or a manufacturing process recognized by the Institute (p. Ex. Spagyric according to Zimpel, spagyric according to Krauss, spagyric according to Pekana); the declaration of excipients according to Annex 3 OEMEd or as a complete declaration of all excipients, taking into account the provisions listed in Annex 3 EMO; Medicinal products containing alcohol and administered orally, the provisions laid down in Annex 2, c. 2 EMO;

F.

The holder of the authorization (name and seat according to the extract from the register of commerce);

G.

The distinguishing sign of each batch (lot number);

H.

The mandatory text: "intended for individual therapy, application and dosage according to the instructions of the consultant", on an optional basis;

I.

Medical information essential for proper use (p. Ex. "For external use", "to be swallowed", "for injection");

J.

The substances listed in the list of eligible homeopathic and anthroposophic substances (SHA list, Annex 4 OAMédcophy) and any other known employment limitations or warnings; to the exclusion of data The recommended scope or dosages;

K.

The clear expiry date, the storage instructions (storage instructions) and, if necessary, the time limit for use after the first opening of the container;

L.

The authorization number.

¹ The holder of the authorization shall be designated by the words "holder of the authorization:". If, due to a lack of space, it is not possible to affix this statement, the abbreviation "tit" shall be used. AMM: ".

² Manufacturer's reference is not mandatory. However, if the holder of the authorisation wishes the name of the manufacturer to be mentioned, then it should be clearly designated as such ('fabricant: ',' manufactured by: 'or' fabrication: '). If a company performs all the manufacturing steps (including quality controls), it can be mentioned as a manufacturer. If the various stages of manufacture are carried out by several undertakings, only the undertaking which establishes the batch certificate may be mentioned as a manufacturer.

³ If the holder of the authorization and the manufacturer are identical, and if the holder of the authorization wishes to mention the name of the manufacturer, then the manufacturer must be designated as such ("holder of the authorization and manufacturer:").

⁴ Where the information referred to in c. 1 may not appear in extenso on the container for the purpose of being given to the patient for technical reasons, it is possible to waive the indications given in the let. C to e, h to j and l; in this case, however, it is appropriate to indicate all the information according to the let. A to l on an outer packaging (p. Ex. A cartonnage).

⁵ If all the information referred to in c. 1, let. He may be placed on the receptacles intended for delivery, it is possible to renounce an outer packaging.

⁶ Easily detachable labels or perforated labels whose detachable part contains information required by c. 1 is prohibited.

⁷ Packages whose contents are intended for several patients must be subdivided into individual packages. The exception is packaging intended exclusively for hospitals. Individual packagings shall meet the requirements set out in c. 1 and 2, para. 1 to 6.

⁸ If several homeopathic or anthroposophical drugs intended for individual therapy without an indication are allowed and packed together for delivery (p. Ex. As a homeopathic medicine for travel), the secondary packaging shall not contain any mention which may provide an indication or an scope. The statement must then contain the data set out in the c. 1, let. B, and the labelling of all drugs must meet the requirements set out in c. 1, let. A, d to g and i to l and 2, al. 1 to 3 and 6. If the indication referred to in c. 1, let. H, cannot be applied to all drugs contained in the packaging, it must then be permanently displayed on the secondary packaging (p. Ex. On the case).

¹ The category of discount assigned by the Institute shall be duly indicated on the outer packaging or, failing that, on the receptacle.

² The discount category must appear on each individual package.

On the container to be delivered (box, vial, sachet, etc.) and on the packaging material (cartonnage, etc.) must be shown:

A.

The name for which the following criteria will be met:

1.

For preparations containing only one active ingredient, the name of the preparation shall correspond to its pharmaceutical designation and to the common name in the relevant field of the active principle (p. Ex. Pinyin name for Chinese medicines),

2.

For fixed associations of medicinal products, the common name used in the specialised publications and in the standard works as cited in Annex 3 OAMédcophy ² (p. Ex. "Chai Ling Tang"),

3.

No indication of possible scope;

B.

The mandatory text: "Medicine from traditional Chinese medicine (or <Tibetan > or <ayurveque>)";

C.

The target animal species or "ad us". " For veterinary medicinal products, in order to distinguish them from medicinal products for human use, and, where appropriate, the waiting period;

D.

The composition of the medicinal product: statement, both qualitative and quantitative, of all active ingredients (complete declaration) using the pharmaceutical designation, supplemented, if applicable, by the name pinyin; the declaration of the Must comply with the rules laid down in Annex 3 OEMEd or take the form of a complete declaration in the light of Annex 3 EMO; concerning medicinal products containing alcohol and designed for oral administration, they Comply with the provisions laid down in Annex 2, c. 2, EMO; in the case of preparations, the indication of the drug-native extract (DER) ratio is recommended;

E.

The galenic form and the quantity contained in the unit package;

F.

The holder of the authorization (name and seat according to the extract from the register of commerce);

G.

The distinguishing sign of each batch (lot number);

H.

Medical information essential to the use, however, limited to the necessary employment restrictions and caveats (p. Ex. "Intended for external use"); a possible indication of a maximum dose if it is included in the list of traditional Asian substances documented as such or if it is necessary for safety reasons; if no maximum dose Is required, the mandatory text: "intended for individual therapy, application and dosage according to the instructions of the consultant", on an optional basis;

I.

The clear expiry date, the storage instructions (storage instructions) and, if necessary, the time limit for use after the first opening of the container;

J.

The authorization number.

¹ The holder of the authorization shall be designated by the words "holder of the authorization:". If, due to a lack of space, it is not possible to affix this statement, the abbreviation "tit" shall be used. AMM: ".

² Manufacturer's reference is not mandatory. However, if the holder of the authorisation wishes the name of the manufacturer to be mentioned, then it should be clearly designated as such ('fabricant: ',' manufactured by: 'or' fabrication: '). If a company performs all the manufacturing steps (including quality controls), it can be mentioned as a manufacturer. If the various stages of manufacture are carried out by several undertakings, only the undertaking which establishes the batch certificate may be mentioned as a manufacturer.

³ If the holder of the authorization and the manufacturer are identical, and if the holder of the authorization wishes to mention the name of the manufacturer, then the manufacturer must be designated as such ("holder of the authorization and manufacturer:").

⁴ Where the information referred to in c. 1 may not appear in extenso on the container intended to be given to the patient for lack of space, it is exceptionally possible to waive the indications set out in paragraphs b, d, e, h and j; in this case, however, it is necessary to indicate All information on an outer packaging.

⁵ If all the information referred to in c. 1 may appear in a typeface easily legible on the container intended to be delivered, then it is possible to renounce an outer packaging.

⁶ Easily detachable labels or perforated labels whose detachable part contains information required by c. 1 is prohibited.

⁷ Packages whose contents are intended for several patients must be subdivided into individual packages. The exception is packaging intended exclusively for hospitals. Individual packagings shall meet the requirements set out in c. 1 and 2.

¹ The category of discount assigned by the Institute shall be duly indicated on the outer packaging or, failing that, on the receptacle.

² The discount category must appear on each individual package.

¹ These provisions shall apply in the context of the marketing authorisation

A.

Medicinal products for oral administration, having an alcohol content of more than 0.7 % vol.;

B.

Drugs for parenteral administration, with an alcohol content of more than 0.5 g per dose.

² Also considered to be medicinal products within the meaning of para. 1, let. A, preparations for both internal and external use.

¹ Preparations packaged in bottles:

A.

Alcohol content: must be limited to the minimum galenically justified, but must in any case be less than 16 % vol. (in the drug-ready drug);

B.

Bottle contents: 750 ml maximum;

C.

Measuring prescription: a graduated spoon or a graduated container;

D.

Multiple packagings: maximum 750 ml per multiple packaging.

E.

Mandatory labelling: the statement " Contains ... % vol. Alcohol. Must not be used in the child and the young person " shall be in clearly legible characters on the package, container and package insert;

F.

Declaration of composition: the alcohol content must also be included in the declaration of composition (in % vol.);

G.

Dosage: in ml.

² Preparations packaged in dropper bottles or in graduated pipette bottles:

A.

Alcohol content: must be limited to the minimum galenically justified;

B.

Bottle contents: maximum 200 ml

C.

Presentation: dropper bottles or graduated pipette bottles.

D.

Mandatory labelling: the statement " Contains ... % vol. Of alcohol must be clearly legible on the packaging, the container and the package insert.

E.

Declaration of composition: the alcohol content must also be included in the declaration of composition (% vol.).

F.

Dosage:

-

Dropper bottles: number of drops

-

Graduated pipette vials: ... ml.

³ Preparations packaged in blisters:

A.

Alcohol content: must be limited to the minimum galenically justified.

B.

The contents of the drinkable light bulb for ready-to-use drugs with an alcohol content of less than 16 % vol.: 10 ml maximum. The total contents of the blisters must not exceed 750 ml per package.

C.

The contents of the drinkable light bulb for ready-to-use drugs with an alcohol content greater than 16 % vol.: 3 ml maximum. The total contents of the blisters must not exceed 200 ml per package.

D.

Mandatory labelling: the statement " Contains ... % vol. Alcohol. Not to be used in the child and the adolescent " shall be marked in legible characters on the package, container and package insert.

E.

Declaration of composition: the alcohol content must also be included in the declaration of composition (% vol.).

⁴ Any additional requirements, in particular by virtue of c. 22 (warnings) and 23 (note concerning preparations without alcohol), is reserved.

In addition, the following caveats must be posted:

¹ For preparations whose maximum single dose contains, according to the dosage, between 0.5 and 3.0 g of ethanol:

A.

On the outer packaging and the container: "observe the instructions in the package insert";

B.

On the package insert under the heading "Precautions": " This medicine contains ... % vol. Alcohol. By observing the recommended dosage, a dose of alcohol up to ... g (for children, up to ... g) will be absorbed by each administration. In particular, there is a risk of harm to health in the liver, alcoholics, epilepsy, or head trauma, as well as in pregnant or nursing mothers, as well as in children when the dose Children's special is exceeded. The effect of other drugs may be reduced or strengthened. ";

C.

If there is no package insert, the warnings in the box. B shall be affixed to the container;

D.

In cases where the occupational information is attached to the medicinal product, the quantity of alcohol absorbed per dose will be indicated in g under the heading "Special remarks".

² For preparations whose single highest dose contains, according to the dosage, more than 3.0 g of ethanol:

A.

On the outer packaging and the container: "observe the instructions in the package insert";

B.

On the package insert under the heading "Precautions": " This medicine contains ... % vol. Alcohol. By observing the recommended dosage, a dose of alcohol up to ... g will be absorbed by each administration. Use only with caution. This drug should not be used in liver, alcohol, epileptic or head injury subjects, as well as in pregnant or nursing mothers and in children. The effect of other drugs can be reduced or strengthened. Reflexes can be reduced, especially for drivers and machinists. ";

C.

If there is no package insert, the warnings in the box. B shall be affixed to the container;

D.

In cases where the occupational information is attached to the medicinal product, the quantity of alcohol absorbed per dose will be indicated in g under the heading "Special remarks".

If the drug is also available in an alcohol-free form, it will be mentioned on the package insert and on the outer packaging or, failing that, on the container (p. Ex. "Preparation ... also exists without alcohol").

The alcohol content must be included in the declaration of the composition; it shall be indicated in g or mg in relation to the total contents of the container.

For parenteral preparations, the amount of alcohol administered per dose will be indicated in g under the heading "Special Considerations".

¹ Must be reported on container, outer packaging and drug information:

A.

All curators ("conserv.:");

B.

All antigens ("antiox.:").

² In addition, it must be stated:

A.

Dyes ("color.:") According to let. C of the table

B.

Flavours, sweeteners and flavour enhancers according to let. D of the table;

C.

Other excipients as per-let. E of the table.

³ Where such indications cannot be mentioned for technical reasons (p. Ex. In the case of small light bulbs), the Institute may grant exceptions.

¹

^{With the exception of ascorbic acid and tocopherols, and their derivatives.}

²

^{To c. 17.4 Drug products of the Pharmacopoea Helvetica.}

³

^{The low amounts of acids or bases used to adjust the pH of injectable solutions will not be reported.}

-

Aspartame

-

Essence of bergamot

-

Cyclamate (acid and all salts)

-

Ethylvanillin

-

Glutamate (acid and all salts)

-

Saccharin (acid and all salts)

-

Vanillin

-

Wool and derivatives (lanolin and derivatives)

-

Laurylsulfate (all salts)

-

Macrogols of molecular weight up to 900

-

Propylene glycol

¹ The draft texts will be written with an interline of 1.5 and will be submitted to the institute in French or German. The right margin must remain free for references.

² Change requests must be highlighted and referenced.

³ Where a medicinal product has several galenical forms, it is possible to draw up a common text provided that the clarity of the information is guaranteed.

⁴ If, pursuant to s. 14, para. 2, the information for patients is replaced by the professional information, it must be written in French and German. The font must not be less than 7 points.

⁵ In the case of an application for a second applicant an Art. 12 LPTh, the text under headings 4 to 15 must be identical to that of the original preparation; however, the Institute may grant derogations in duly substantiated cases.

⁶ The Explanatory Notes to the headings referred to in c. 3 are authorised only if they are in direct contact with the use of the medicinal product, are essential for the health of the patient and not be in contradiction with other information.

To the extent that the Institute does not publish the professional information itself, it is the responsibility of the applicant to publish it and to confirm it to the Institute with reference to the place and the date.

¹ The draft texts will be drawn up with an interline of 1.5 and will be submitted to the Institute in one of the three official languages.

² Patient information must be written in all three official languages. The font must not be less than 8 points.

³ When a medicinal product has several galenical forms, it is possible to draw up a common text as long as the clarity of the information is guaranteed for patients.

⁴ The order of listing of items 1 and 2 may be reversed upon request.

⁵ Section 14 can also be added as a result of the versions in the three languages of patient information.

⁶ In the case of an application for a second applicant an Art. 12 LPTh, the text under headings 3 to 9 must be identical to that of the original preparation; however, the Institute may grant derogations in duly substantiated cases.

⁷ The Explanatory Notes to the headings referred to in c. 3 are authorised only if they are in direct contact with the use of the medicinal product, are essential for the health of the patient and not be in contradiction with other information.

To the extent that the Institute does not itself publish the information intended for patients, it is the applicant's responsibility to ensure publication of the information and to confirm it to the Institute with reference to the place and date.

¹ The draft texts will be drawn up with an interline of 1.5 and will be submitted to the Institute in one of the three official languages.

² Patient information must be written in all three official languages. The font must not be less than 8 points.

³ When a medicinal product has several galenical forms, it is possible to draw up common texts, provided that the clarity of the information is guaranteed for patients.

⁴ The order of listing of headings 1 and 2a to 2b may be reversed upon request.

⁵ Section 14 can also be added as a result of the versions in the three languages of patient information.

⁶ The Explanatory Notes to the headings referred to in c. 3 are authorised only if they are in direct contact with the use of the medicinal product, are essential for the health of the patient and not be in contradiction with other information.

To the extent that the Institute does not itself publish the information intended for patients, it is the applicant's responsibility to ensure publication of the information and to confirm it to the Institute with reference to the place and date.

¹ The draft texts will be drawn up with an interline of 1.5 and will be submitted to the Institute in one of the three official languages.

² Patient information must be written in all three official languages. The font must not be less than 8 points.

³ When a medicinal product has several galenical forms, it is possible to draw up common texts, provided that the clarity of the information is guaranteed for patients.

⁴ The order of listing of headings 1 and 2a to 2b may be reversed upon request.

⁵ Section 14 can also be added as a result of the versions in the three languages of patient information.

⁶ The Explanatory Notes to the headings referred to in c. 4 are only authorised provided that they are in direct contact with the use of the medicinal product, that they are essential for the health of the patient and that they do not conflict with other information.

Information for patients is not required for teas, teas mixtures and tea preparations, when all requirements under s. 14, para. 3, or 15, para. 2, are completed.

To the extent that the Institute does not itself publish the information intended for patients, it is the applicant's responsibility to ensure publication of the information and to confirm it to the Institute with reference to the place and date.

Information for patients of Asian drugs without any indication that is reported in accordance with s. 27 OAMédcophy ² Must be in accordance with the mandatory text referred to in c. 2, available in all three official languages and be attached to the package in all three languages, or delivered to the patient in the language required by the person authorized to do so. The information font for patients should not be less than 8 points.

Mandatory text content:

Patient Information

Medicine from traditional Chinese medicine ( Or Tibetan or Ayurvedic ), to be used according to the therapeutic principles of Chinese medicine ( Or tib é Taine or Ayurvedic ); its employment and security are based exclusively on traditional experience and have not been subject to any State control. The drug must therefore be used only on the prescription or recommendation of a professional trained in Chinese medicine [ Or Tibetan or Ayurved I That ].

When should this drug be used?

This medicine has been given to you on the prescription or recommendation of your doctor or therapist specially trained in Chinese medicine [or tib é Taine or Ayurvedic] Be sure to use it in strict accordance with the information provided by the specialist (doctor, therapist, pharmacist or drugist) who has prescribed or delivered to you.

What should be taken into account when it is used?

Interactions with other drugs cannot be excluded. Please inform the specialist who follows you or who has given you the medicine if you are taking or using other medications, whether on prescription or in self-medication, or if you are suffering from another disease or allergy.

When should this drug not be used or only with care?

In children, the use of this drug requires a specially adapted individual dosage regimen, defined by a physician or therapist experienced and specialized in Chinese medicine [or Tibetan or Ayurvedic] And paediatrics, which will take into account the efficacy of the drug, but also the age and weight of the child. In addition, to the extent that the children's body is sensitive to the administration of medication and where changes-particularly in the direction of an aggravation of the disease-can take place quickly, the doctor or therapist must Subject the child to constant monitoring throughout the course of treatment, in order to be able to respond quickly if necessary.

Relatively mild adverse effects in adults, such as vomiting or diarrhea, can have serious consequences for children and should be immediately reported to your doctor or therapist.

If there are new symptoms or sudden worsening of the disease, inform your doctor or therapist without delay.

If you have allergies, use this medicine only after talking to your doctor or therapist. In the case of liver or kidney problems, it is advisable to take this medicine only under medical supervision. Before any surgery, inform your doctor that you are currently taking a medicine from Chinese medicine [or Tibetan or Ayurvedic] .

Can this drug be used during pregnancy or breastfeeding?

As a precautionary measure, you should quit if you can take medication during pregnancy and breastfeeding. No systematic scientific studies have been carried out to date to demonstrate the safety of medicines derived from traditional Asian medicine (Chinese, Tibetan or Ayurvedic) during pregnancy or lactation. In the same way, if you are pregnant, inform your doctor or therapist, who will adapt your treatment accordingly. Some plants must not be prescribed or recommended during this period.

How do I use this medicine?

The dosage set specifically for you by your doctor or therapist is listed separately on the packaging texts of this medicine. Respectfully respect the prescribed or recommended dosage and inform your doctor or therapist if you feel that the drug's efficacy is too low or too high.

Follow the instructions provided by your doctor or therapist regarding the use of different preparations.

What are the possible side effects of this drug?

The use of medicines, even from Chinese medicine [or Tibetan or Ayurvedic] , can cause side effects. To date, in the case of use in accordance with the one to which they are intended, it has been observed that certain medicinal products have the following side effects: nausea, loss of appetite, heavy stomach, referrals, constipation or diarrhea, allergies, eruptions Skin and headache. The correct use of the medicinal product and compliance with the precautionary measures required, however, generally allow for the avoidance of serious secondary effects. Be sure to report any side effects you may see to the specialist who is following you or who has given you the medication.

What else needs to be paid attention to?

As long as your doctor or therapist has not decided otherwise, this drug is intended for immediate use and should not be retained for further treatment. All drugs, including granules and plants, must be stored in a dry, light-sheltered location at room temperature (15 to 25 ° C) and out of reach of children.

This medicine must not be used beyond the date shown after the entry "EXP" on the container. [This statement is deleted when the indication " to util I Ser to " figure on all containers].

For more information, consult the specialist who follows you or who has given you the medicine.

Owner of the authorization

[name and seat of the holder of the authorization]

¹ The draft texts will be submitted to the Institute in one of the three official languages. Change requests must be highlighted and referenced. Where a medicinal product has several galenical forms, it is possible to draw up a common text provided that the clarity of the information is guaranteed.

² Original prints of package inserts must be submitted to the Institute in the following languages:

A.

In German and French for Category A and B drugs;

B.

In the three official languages for drugs in categories C, D and E.

The font must not be less than 7 points.

³ Heading 10 (waiting times) should be completed only for medicinal products intended for use in food producing animals.

⁴ Upon authorisation by the Institute, certain headings may be waived where they are superfluous (5. Pharmacokinetics, 8. Employment limitations, 9. Adverse Reactions and 11. Interactions).

⁵ If a marketing authorisation has been granted in a Member State of the EU or EFTA, the Institute may approve the form of information also valid for the marketing of the veterinary medicinal product in Switzerland.

¹ A bundle is an application for a single amendment involving multiple drugs and supported by identical documentation for all the drugs concerned.

² A multiple application means a request for different modifications to one or more drugs at the same time.

³ Common texts refer to texts of professional information, or, failing that, information to patients or information on the medicinal product for veterinary use, which are established by the holder of an authorisation and which are common to several Galenical forms of the same active principle.

¹ Are deemed amendments submitted for approval that require scientific expertise:

1.

Any change in the quality of a drug, provided that it is not an amendment that is required to be announced under Schedule 8;

2.

Any changes to professional information or patient information, or information about the veterinary drug, for which documentation is to be submitted;

3.

Any changes to professional information or information intended for patients, or information about the veterinary drug, related to the safety of the drug;

4. To 6. ...

7.

Any change in the waiting period;

8.

Any extension of the additional protection of the first applicant from 3 to 5 years.

² It is permissible to file a consolidated application for the amendments referred to in points 1, 2 and 3; however, collective applications for the amendments referred to in points 2 and 3 shall be allowed only if they relate to common texts.

¹ Are deemed amendments submitted for approval that do not require scientific expertise:

1.

Any changes in professional information or information to patients, or information about the veterinary drug, for which no documentation is to be submitted, provided that it is not an amendment Subject to the obligation to advertise in accordance with Annex 8;

2.

Any adaptation of professional information or information to patients, or information on the medicinal product for veterinary use, accompanying a generic to the one accompanying the original preparation, provided that it is not An amendment subject to the obligation to advertise in accordance with Annex 8;

3.

Any change in the designation of the preparation;

4.

Any removal of a packaging size, provided that it is not an amendment subject to the obligation to advertise in accordance with Annex 8;

5.

Any announcement of a new packaging size without quality documentation;

6.

Any modification of a packaging size without quality documentation;

7.

Any marketing authorisation only for the export of a medicinal product previously authorised for distribution in Switzerland;

8.

Any marketing authorisation for the distribution in Switzerland of a medicinal product previously authorised only for export;

9.

Any transfer of the authorization and any change in the name, headquarters or domicile of the holder of the authorization;

10.

Any modification of the packaging material, provided that it is not an amendment subject to the obligation to advertise in accordance with Annex 8;

11.

Any adaptation of the category of drug submission to the list of substances.

² Grouped applications shall be accepted; in the case of the amendments referred to in points 1 and 2, collective applications shall be allowed only if they relate to common texts.

¹ A group announcement means an announcement concerning a single amendment involving multiple drugs simultaneously and supported by identical documentation for all the medicinal products concerned.

² Multiple announcement means an advertisement for different changes to one or more drugs simultaneously.

³ Common texts refer to texts of professional information, or, failing that, information to patients or information on the medicinal product for veterinary use, which are established by the holder of an authorisation and which are common to several Galenical forms of the same active principle.

¹ The following are deemed amendments to the obligation to announce the following amendments:

Regulatory Requirements Amendment

1.

Amending the mandatory text of the shelf life on the packaging elements ("EXP" instead of "to use to" or vice versa);

2.

New graphics, for example for all packaging of other preparations of the same authorisation holder ( Corporate Identity ) After the first package has been approved on the basis of an application submitted for approval;

3.

Removal of a packaging provided that there is no elimination of an entire sequence;

4.

Adaptation of professional information and information to patients of a generic medicinal product with the information accompanying the original preparation with identical text, except in the case of amendments relating to the protection of the first applicant For the original preparation;

5.

Adaptation of professional information and information to patients of a drug imported within the meaning of s. 14, para. 2, LPTh, to the information accompanying the original preparation with identical text;

6.

Adaptation of a drug in co-marketing to its basic preparation (p. Ex. As a result of changes to the drug or quality texts);

7.

Removal, recording or modification of the name of the dispatcher on the packaging elements;

8.

ATC code change/code change ATCvet;

Change in name/name

9.

Change in the name of the active principle

10.

Change in the name of the manufacturer of the active ingredient;

11.

A change in the name or home of the manufacturer of a drug-ready drug;

12.

A change in the social or home reason of a quality control laboratory or manufacturer responsible for the release of lots of drug-ready drugs;

Manufacturer/Laboratory Change of Analysis

13.

Site, new or additional, of primary or secondary conditioning or repackaging of a drug-ready drug, are excluded from the primary packaging of sterile ready-to-use drugs, vaccines, serums, allergens, Blood products, plasma-based products, immunological drugs, drugs produced using recombinant technologies, hybridomas and monoclonal antibodies, as well as drugs for innovative therapies On gene transfer methods (gene therapy medicinal products);

14.

Testing laboratory, new or supplementary, responsible for quality control or manufacturer, new or additional, responsible for the release of lots of the drug ready for employment; s. 5 is reserved;

15.

Removal of a production site;

Change in Active Principles

16.

Manufacturer, new or additional, of an active ingredient if that manufacturer may submit a certificate of conformity to the European Pharmacopoeia; para. 5 is reserved;

17.

Manufacturer, new or additional, of an intermediate product necessary for the manufacture of an active ingredient; s. 5 is reserved;

18.

Minor modification of the manufacturing process of the active ingredient, with the exception of modifications to the last stage of manufacture; para. 5 is reserved;

19.

Modification of the size of the lots of an active ingredient or an intermediate product necessary for the manufacture of an active ingredient; s. 5 is reserved;

20.

Modification of the specifications or addition of an analysis to the specifications of a raw material or intermediate material necessary for the manufacture of an active ingredient; s. 5 is reserved;

21.

Restriction of specifications or addition of an analysis to the specifications of an active principle; in the case of the addition of an analysis, para. 5 is reserved;

22.

Minor modification of an active ingredient analysis process or an approved analytical process for a raw material, intermediate or reagent necessary for the manufacture of an active ingredient; s. 5 is reserved;

23.

Presentation of a new or updated certificate of conformity to the European Pharmacopoeia for an active ingredient of an approved manufacturer at the time of presentation of the certificate;

24.

Presentation of a new or updated certificate of conformity to the European Pharmacopoeia concerning the risk of transmission of TSE for an active ingredient or raw material/intermediate product/reagent necessary for the manufacture of a Active ingredient, for a manufacturer or manufacturing process approved at the time of presentation of the certificate;

25.

Modification of the retest period or storage conditions of an active principle; s. 5 is reserved;

Change in excipients

26.

Restriction of specifications or addition of an analysis to the specifications of an excipient of the drug;

27.

Minor modification of the procedure for the analysis of non-pharmacopoeial excipients;

28.

Presentation of a new or updated certificate of conformity to the European Pharmacopoeia on the risk of TSE transmission for an excipient;

29.

Modification of the source of an excipient or reagent: the abandonment of substances with TSE risks for plant or synthetic substances;

30.

Minor modification in the manufacture of nonpharmacopoeial excipients that have been described in the original literature;

Pharmacopoeia Modification

31.

Modification of active principles in order to comply with the European Pharmacopoeia, the Swiss Pharmacopoeia or any other recognised pharmacopoeia, in the case of the use of new active or actuarial principles;

32.

Modification of excipients to comply with the European Pharmacopoeia, the Swiss Pharmacopoeia or other recognised pharmacopoeia, in the case of the use of new excipients;

Change in a drug ready for use

33.

Restriction of specifications or addition of an analysis to the specifications of the primary packaging of a drug;

34.

Modifying the primary packaging analysis procedure;

35.

Modification of a component of the packaging material that does not come into contact with the drug (p. Ex. Colour of the removable cap, colour code rings on bulbs or needle guards [different synthetic material]);

36.

Modification of the qualitative or quantitative composition of the material of the primary packaging, provided that it is not a sterile product or semi-solid or liquid form, that the material is equivalent to the permitted material In respect of at least its significant properties and that the amendment relates only to the same packaging type and packaging material; s. 5 is reserved;

37.

Restriction of specifications or addition of an analysis to the drug specifications;

38.

Restriction of specifications or addition of an analysis to the specifications for the current drug manufacturing control;

39.

Modification of the batch size of the drug; s. 5 is reserved;

40.

Change the weight of the coating of the tablets or the weight of the capsule shells for fast-release oral dosage forms;

41.

Modification of the shape or size of the primary receptacle or closure system;

42.

Minor modification of a drug analysis procedure; s. 5 is reserved;

43.

Modification or addition of printing or other markings (other than grooves) of tablets or capsules, including changes or modifications to inks used for markings;

44.

Modification of the dimensions of tablets, capsules, suppositories or pessaries without changes in the quantitative composition or the average content; are excluded from the galenic forms with modified/delayed or gastro-resistant release;

45.

Modification of the procedure for analysis of drug administration devices;

46.

Addition or replacement of a device for measuring or applying a drug that does not count among the components of the primary packaging (except for the tips of the inhalation devices);

Amendment to a veterinary medicinal product

47.

Modification of specifications for a device for measuring or administering a veterinary drug;

48.

Modification of the procedure for analysing a device for measuring or administering a veterinary medicinal product.

² When an amendment is made subject to the obligation to announce which has the direct consequence of other amendments subject to the obligation to announce, all amendments are discussed in a group. The joint announcement must establish why the other amendments subject to the obligation to announce are a direct consequence of the first amendment subject to the obligation to announce.

³ If a change results in a review of the drug information, this revision is part of the amendment.

⁴ Grouped ads are allowed, but only if they are common texts in the case of the changes referred to in c. 4, 5 and 6, or only if the manufacturer is not mentioned on the packaging elements for those referred to in paragraph 11.

⁵ Amendments referred to in c. 14, 16 to 22, 25, 36, 39 and 42 exclude vaccines, serums, allergens, blood products, plasma-based products, immunological drugs, drugs produced by genetic engineering, hybridomas and monoclonal antibodies, and Drugs for innovative therapies based on gene transfer methods (gene therapy drugs).

The following are deemed essential changes requiring a new authorisation procedure for the medicinal product:

1.

Any change in active policy;

2.

Any changes in the galenic form;

3.

Any modification of a genetically modified organism in a drug or active ingredients manufactured using recombinant technology or process;

4.

Any modification of the dosages or addition of data;

5.

Any change in the mode of administration or addition of data.

6.

Any change or addition of an indication;

7.

Any modification or addition of a dosing recommendation;

8.

Any change in the animal species to be treated or any addition of data concerning the animal species.