PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USERS Flavamed 30 mg tablets Ambroxoli hydrochloridum

The leaflet should be read carefully because it contains information important for the patient. The drug is available over the counter, to enable the patients to treat some diseases without consulting a doctor. However, Flavamed should be used with caution to obtain a good result. - The leaflet should be kept to be read again if necessary. - A doctor or a pharmacist should be consulted if advice or additional information is required. - If the symptoms aggravate or fail to subside after 4 to 5 days, a doctor should be consulted. - If any adverse effect aggravates, or adverse effects not mentioned in the leaflet occur, a doctor or a pharmacist should be consulted.

Table of contents: 1. What is Flavamed and what it is used for 2. Information important before Flavamed is taken 3. How Flavamed should be used 4. Potential adverse effects 5. How Flavamed should be stored 6. Other information 1. WHAT IS FLAVAMED AND WHAT IT IS USED FOR Flavamed is a mucolytic agent used in respiratory tract disorders. Flavamed is used in pulmonary and bronchial diseases associated with production of thick mucus. Owing to the effect of Flavamed, thick mucus becomes more liquid and easier to expectorate. 2. INFORMATION IMPORTANT BEFORE FLAVAMED IS TAKEN Flavamed should not be used in the following cases - if the patient is found to be allergic (hypersensitive to the active substance of Flavamed (ambroxol hydrochloride) or any of the other components of the drug, see section 6 „What Flavamed contains”). - in children below 6 years of age. Flavamed should be used with particular caution - if the patient had in the past severe allergic skin reactions (Stevens-Johnson syndrome, Lyell syndrome). • Stevens-Johnson syndrome is a condition characterized by high fever and vesicular skin eruptions on the skin and mucous membranes. • life-threatening Lyell syndrom is also known as burnt skin syndrome. The symptoms include severe skin lesions in the form of vesicles similar to those observed in scalds and burns.

Therefore, if the patient develops any lesions on the skin or mucous membranes, Flavamed should be discontinued immediately. A physician should be consulted! - if the patient has impaired renal function or a severe liver disease. In such cases, Flavamed should be used with particular caution (i.e. longer intervals between the consecutive doses or lower doses of the drug – a physician should be consulted). In severe renal failure the metabolites of Flavamed may ccumulate in the organism. - if the patient suffers from a bronchial condition associated with increased mucus production (e.g. ciliary immobility syndrome). In such a case, the mucus cannot be removed from the lungs. Flavamed should be used only under the supervision of a doctor. - in patients with a history of gastric and/or duodenal ulcers, a physician should be consulted how to use Flavamed, because mucolytic agents can damage the gastric mucosa. Before the use of Flavame a doctor must be consulted. Children Flavamed can be used only in children above 6 years of age. Co-administration of Flavamed with other drugs The doctor should be informed about all current and recent medications, also those available over the counter. Cough inhibitors No drugs inhibiting the cough reflex (so-called cough inhibitors) should be used during the treatment with Flavamed. The cough reflex is important for elimination of liquefied mucus and its removal from the lungs. Pregnancy and lactation Before the use of any drug a physician or a pharmacist should be consulted. During pregnancy and breastfeeding, Flavamed can be used only if prescribed by a doctor! There are no available data concerning the use of the drug during pregnancy and breastfeeding. However, animal tests indicate that the active substance is excreted with milk. Driving and machine operation Flavamed exerts no effect, or insignificant effect, on the ability to drive and to operate mechanical devices. Important information concerning some components of Flavamed The drug contains lactose (a saccharide occurring in milk). If the patient has been diagnosed with intolerance of some saccharides, a doctor should be consulted before the drug is used. 3. HOW FLAVAMED SHOULD BE USED Flavamed should always be used according to the instructions provided in the patient information leaflet. In case of any doubts, a physician or a pharmacist should be consulted. The information provided below is applicable if the doctor recommends no other dosage. The instructions should be followed because otherwise Flavamed will not act correctly. If not indicated otherwise by the doctor, the usual doses are as follows: Age Single dose Maximum daily dose ½ tablet 2 to 3 times daily 1½ tablets Children aged 6 - 12 (corresponding to 15 mg of (corresponding to 45 mg years ambroxol hydrochloride 2 – 3 of ambroxol times daily). hydrochloride).

Adults and adolescents above 12 years of age

During the first 2 – 3 days, 1 tablet 3 times daily (corresponding to 30 mg of ambroxol hydrochloride 3 times daily); then 1 tablet of the drug twice daily (corresponding to 30 mg of ambroxol hydrochloride twice daily).

3 tablets (corresponding to 90 mg of ambroxol hydrochloride).

Note: In adults the dose can be increased to 2 tablets twice a day. Administration Flavamed tablets should preferably be swallowed whole, followed by an appropriate amount of liquid (e.g. water, tea or fruit juice). The tablet can be divided into two halves. Duration of treatment If no physician has been consulted, Flavamed should not be taken longer than 4 – 5 days. If after 4 – 5 days the symptoms fail to subside, or even aggravate, a doctor should be consulted immediately! In case of an impression that the effect of Flavamed is too potent or too weak, a physician or a pharmacist should be consulted. Overdose of Flavamed No severe poisoning symptoms have been observed. Transient agitation and diarrhea may occur. In case of significant overdose, increased salivation may occur, as well as nausea, vomiting and hypotension. A doctor should be consulted. Usually immediate intervention such as induction of vomiting and gastric lavage is unnecessary; such management can be considered in case of acute overdose. Treatment dependent on the observed symptoms of overdose is recommended. Missing a dose of Flavamed In case of a missed dose, or too low dose of the drug taken, the next prescribed dose should be taken at the usual time. No double dose to compensate for the missed one should be used. In case of any doubts associated with dosage of the drug, a physician or a pharmacist should be consulted. 4. POTENTIAL ADVERSE EFFECTS Like any other drug, Flavamed may cause adverse effects, although they are not observed in all patients. Adverse effects are assessed according to the following frequency criteria: Very frequent

In more than 1 out of 10 treated patients

Frequent

In fewer than 1 out of 10, but more than 1 out of 100 treated patients

Infrequent

In fewer than 1 out of 100, but more than 1 out of 1 000 treated patients

Rare

In fewer than 1 out of 1 000, but more than 1 out of 10 000 treated patients

Very rare

In fewer than 1 out of 10 000 treated patients Unknown (the frequency cannot be estimated on the basis of available data).

Adverse effects Gastrointestinal: Infrequent: Stomachache, nausea, vomiting Skin and subcutaneous tissue: Very rare: Severe dermal reactions, such as Lyell syndrome and Stevens-Johnson syndrome (see section 2 „When Flavamed should be used with particular caution”) Systemic disorders and local conditions: Infrequent: Hypersensitivity reactions such as rash, facial edema, respiratory disturbances, pruritus, fever Very rare: Severe allergic reactions (anaphylaxia), including anaphylactic shock Management In case of one or more of the aforementioned adverse effects, treatment with Flavamed should be discontinued. If any adverse effect aggravates, or adverse effects not mentioned in the leaflet occur, a doctor or a pharmacist should be consulted. . 5. HOW FLAVAMED SHOULD BE STORED The drug should be stored out of the reach and sight of children. Flavamed should not be used after the expiry date indicated on the blister and cardboard box after the abbreviation EXP. The expiry date is the last day of the given month. The drug should not be stored at temperatures exceeding 25°C. The drug should not be disposed of in the sewage system or home waste bins. A pharmacist should be consulted what to do with unwanted drugs. Such disposal method will help to protect the environment. 6. OTHER INFORMATION What Flavamed contains: The active substance – ambroxol hydrochloride. One tablet contains 30 mg of ambroxol hydrochloride. Other components of the drug include: lactose monohydrate, corn starch, cellulose (powder), sodium croscaramellose, povidon K 30, magnesium stearate. Appearance of the drug and package content White, round tablets, flat on both sides, with beveled edges and a division groove on one side. Flavamed is available in packages containing 10, 20 and 50 tablets. Responsible entity and manufacturer: Berlin-Chemie AG Glienicker Weg 125 12489 Berlin, Germany

This medicinal product has been approved for sale in the territories of European Economic Community Member States under the following names: Bulgaria: Flavamed Cough Tablets Czech Republic: Flavamed tablety Estonia: Flavamed 30 mg Finland: Flavamed 30 mg Tablets Hungary: Flavamed Cough Tablets Latvia: Flavamed Cough Tablets Lithuania: Flavamed Cough Tablets Poland: Flavamed Romania: Flavamed Comprimate Republic of Slovakia: Flavamed Cough Tablets Slovenia: Flavamed 30 mg Tablets Leaflet approval date: 29.02.2008