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Flavamed forte effervescent tablets 60 mg No. 10 No. 1

Name

Flavamed forte effervescent tablets tab.spike. 60 mg in tubes No. 10 per pack. No. 1

Description

Round white tablets with a scoring line on one side and a bevel on both sides.

Main active ingredient

Ambroxol hydrochloride

Dosage

60mg

special instructions

This medicine contains lactose (milk sugar), sorbitol (a sweetener) and sodium. If your doctor has warned you that you have an intolerance to certain types of sugar, consult with him before starting to take this medicine. Each tablet of this drug contains 5.5 mmol (126.5 mg) sodium. This should be taken into account in patients who control their intake of sodium salts.

Indications for use

Flavamed forte effervescent tablets contain ambroxol hydrochloride as an active substance and belong to the group of medicines used for coughs and colds. Mucolytic agents. Ambroxol hydrochloride is used to treat cough caused by acute or chronic diseases of the lungs and bronchi. Under the influence of Flavamed forte effervescent tablets, mucus becomes more liquid and is easier to clear from the respiratory tract when coughing. Flavamed forte effervescent tablets are indicated for use in adults and adolescents over 12 years of age. Diseases of the upper respiratory tract and lungs are often accompanied by the formation of viscous sputum, the removal of which is difficult. Viscous sputum and microorganisms present in it are retained in the bronchi. Respiratory function may decrease. Ambroxol (the active ingredient in Flavamed forte effervescent tablets) causes mucus liquefaction and promotes its elimination, although the exact mechanism of action has yet to be fully studied. Along with easily coughed up sputum, pathogenic microorganisms and their decay products are removed from the body. Under the influence of ambroxol, the motor activity of microscopic cilia of the bronchial epithelium increases. The movements of the cilia mechanically remove mucus and phlegm and promote cleansing and drainage of the bronchi. The combined effect of Flavamed forte effervescent tablets helps cleanse the respiratory tract of mucus. In addition to the mucolytic effect (coughing up sputum), ambroxol stimulates the synthesis of surfactant (a special surfactant) in the lungs, which prevents the collapse of lung tissue. The results of experimental studies confirmed the antioxidant and anti-inflammatory effects of ambroxol. In addition, ambroxol therapy leads to an increase in the concentration of certain antibiotics (amoxicillin, cefuroxime, erythromycin) in the lung tissue.

Directions for use and doses

Always take Flavamed forte effervescent tablets exactly as directed in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. When taking Flavamed forte effervescent tablets, you should follow the instructions below, unless your doctor has given you other instructions. To avoid errors when using Flavamed forte effervescent tablets, it is recommended to save the instructions for later use. Unless otherwise prescribed by a doctor, the recommended dosage is as follows: Age Adolescents over 12 years of age and adults Single dose During the first 2-3 days, ? effervescent tablet 3 times a day (equivalent to 30 mg ambroxol hydrochloride 3 times a day), then ? effervescent tablet twice daily (equivalent to 30 mg ambroxol hydrochloride twice daily) Max. daily dose 1? effervescent tablet (equivalent to 90 mg ambroxol hydrochloride) Note: For adults, the dose can be increased to 1 tablet twice daily. Directions for use When administered orally, effervescent tablets should be dissolved in a glass of water and the resulting solution should be drunk after meals. Effervescent tablets can be divided into two equal halves. Duration of use Flavamed forte effervescent tablets should not be taken for longer than 4-5 days without a doctor’s prescription. If your complaints still persist after 4-5 days of using the drug and even worsen, you should immediately consult a doctor. If you feel that the effect of Flavamed forte effervescent tablets is too intense or, conversely, insufficient, please inform your doctor or pharmacist. What should you do in case of overdose of Flavamed forte effervescent tablets? Based on data on cases of overdose and/or application errors, it can be stated that the observed symptoms correspond to the described side effects of Flavamed, which are possible when used in recommended doses. In case of overdose, consult your doctor, who will determine the necessary treatment according to your symptoms. If you forget to take Flavamed forte effervescent tablets or take too small a dose, at your next dose, simply take your usual dose of the drug. Do not take a double dose of the drug to make up for a missed dose. If you have any additional questions about the use of this drug, contact your doctor or pharmacist.

Use during pregnancy and lactation

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice about taking this drug. During pregnancy and breastfeeding, take Flavamed forte effervescent tablets only after receiving clear instructions from your doctor! Especially during the first trimester of pregnancy, the use of Flavamed forte effervescent tablets is not recommended. Studies have shown that the active ingredient in Flavamed forte effervescent tablets can pass into breast milk. Flavamed forte effervescent tablets are not recommended for use during breastfeeding. Animal studies have shown no negative effects of ambroxol hydrochloride on fertility.

Precautionary measures

Contact your doctor or pharmacist before using Flavamed forte effervescent tablets - If you have experienced acute allergic skin reactions (Stevens-Johnson syndrome, Lyell's syndrome). — Stevens-Johnson syndrome is a disease accompanied by high fever in which the skin and mucous membranes become covered with a rash and blisters. — Life-threatening Lyell's syndrome is also known as toxic epidermal necrolysis. Its sign is blisters forming on the skin, similar to a burn. There have been reports of cases of severe skin reactions associated with the use of ambroxol hydrochloride. If you notice changes in the skin (including damage to the mucous membranes of the mouth, throat, nose, eyes, genitals), stop taking Flavamed forte effervescent tablets immediately and contact your doctor immediately. — If you suffer from histamine intolerance, you should avoid long-term use of Flavamed forte effervescent tablets, since the active substance of the drug affects the metabolism of histamine and can cause intolerance/allergy symptoms (such as headache, nasal congestion, itching, etc. .). - If you suffer from impaired renal function or liver disease, you should take Flavamed forte effervescent tablets, taking special precautions (for more complete information, consult your doctor). In case of severe impairment of renal function, the accumulation of products of transformation of the active substance of the drug "Flavamed forte effervescent tablets" in the body is possible. — If you suffer from a rare bronchial disease accompanied by increased mucus production (for example, primary ciliary dyskinesia syndrome), in which mucus cannot be removed from the lungs, Flavamed forte effervescent tablets should only be taken under medical supervision. — If you suffer from a peptic ulcer, you need to consult a doctor about taking Flavamed forte effervescent tablets, since mucolytic drugs can destroy the mucosal barrier of the gastric mucosa. Consult your doctor before taking Flavamed forte effervescent tablets. Children and adolescents Flavamed forte effervescent tablets are allowed to be used only by adolescents over 12 years of age. Elderly persons No dosage adjustment is required in elderly persons

Interaction with other drugs

Please consult your doctor or pharmacist if you are taking or have recently taken other medications, including over-the-counter medications. Medicines that suppress cough (antitussives) When taking Flavamed forte effervescent tablets, you should not take any medicines that suppress the cough reflex (so-called antitussives). The cough reflex is important for coughing up liquefied mucus and clearing it from the lungs.

Contraindications

- If you have hypersensitivity (allergic reactions) to the active substance (ambroxol hydrochloride) or other ingredients of Flavamed forte effervescent tablets (see section “Composition”). — Children under 12 years of age.

Compound

Active ingredient: ambroxol hydrochloride. One effervescent tablet contains 60 mg of ambroxol hydrochloride. Other Ingredients: Citric acid anhydrous, sodium bicarbonate, sodium carbonate anhydrous, saccharin sodium salt, sodium cyclamate, sodium chloride, sodium citrate, lactose anhydrous, mannitol, sorbitol, cherry flavor, simethicone.

Side effect

Like other medicines, this medicine may cause side effects in some cases. Side effects Common (affects 1 in 10 people) - Dysgeusia (for example, changes in taste perception) - Nausea, oral and pharyngeal hyposthesia Uncommon (affects 1 in 100 people) - vomiting, diarrhea, dyspepsia, abdominal pain and dry mouth . - fever - mucous membrane reactions Rare (affects 1 in 1,000 people) - hypersensitivity reactions - rash, urticaria Very rare (affects 1 in 10,000 people) - sialorrhea Not known (frequency cannot be estimated from available data) - anaphylactic reactions, including anaphylactic shock, angioedema (rapidly developing swelling of the skin, subcutaneous tissues, mucous membranes), pruritus - severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis) - dry throat - dyspnea (as a symptom of hypersensitivity reactions) Reports of side effects If you notice the development of side effects, contact your doctor or pharmacist immediately. This also applies to side effects not listed in this leaflet. By reporting side effects, you help gather more information about the safety of the drug.

Storage conditions

Keep out of the reach of children. Do not use Flavamed forte effervescent tablets after the expiration date indicated on the bottom of the tube and on the folding cardboard box. The expiration date is the last day of the specified month. Store at a temperature not exceeding 30 °C. To protect effervescent tablets from exposure to light and moisture, keep the tubes tightly closed.

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