Flegtac Kashel

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Flegtac Cough, 1.6 mg/ml, syrup

Bromhexine hydrochloride

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Flegtac Cough and what is it used for
• 2. Important information before taking Flegtac Cough
• 3. How to take Flegtac Cough
• 4. Possible side effects
• 5. How to store Flegtac Cough
• 6. Contents of the pack and other information

1. What is Flegtac Cough and what is it used for

Flegtac Cough contains the active substance bromhexine hydrochloride, which acts as an expectorant, thinning the secretion of the respiratory tract. This facilitates the transport of bronchial secretion by the cilia (small hairs lining the respiratory tract) and its removal from the lungs. Bromhexine facilitates coughing up and alleviates cough. The medicine is used in acute and chronic respiratory diseases with impaired expectoration and sputum removal. If after 7 days there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before taking Flegtac Cough

When not to take Flegtac Cough

• if the patient is allergic (hypersensitive) to bromhexine or any of the other ingredients of the medicine (listed in section 6).
• if the patient has stomach or duodenal ulcer disease.
• in patients with congenital fructose intolerance.
• in children under 2 years of age.

Warnings and precautions

Before starting treatment with Flegtac Cough, the patient should discuss it with their doctor or pharmacist if:

• the patient has inflammatory respiratory diseases with accompanying bacterial infection; Flegtac Cough should be taken together with antibiotics and bronchodilators prescribed by the doctor. During treatment, the patient should drink plenty of fluids, especially if they have a fever. Proper hydration helps to thin the bronchial secretion and facilitates expectoration.

fever. Proper hydration helps to thin the bronchial secretion and facilitates expectoration.

• the patient is at risk of stomach or duodenal ulcer disease.
• the patient has asthma,
• the patient has impaired motor function of the bronchi, e.g. a disease called ciliary dyskinesia,
• the patient has impaired liver or kidney function,
• the patient has difficulty expectorating,
• there have been reports of severe skin reactions associated with the use of bromhexine. If a rash occurs (including blisters or changes in the mucous membranes, e.g. in the mouth, throat, nose, eyes, genitals), the patient should stop taking Flegtac Cough and immediately consult their doctor.

Children and adolescents

Flegtac Cough should not be used in children under 2 years of age. Before starting treatment with Flegtac Cough in children and adolescents, they should consult their doctor or pharmacist.

Flegtac Cough and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Flegtac Cough should be used with caution with atropine and other anticholinergic medicines, as they can cause dryness of the mucous membranes. Flegtac Cough should not be taken together with cough suppressants, as this may lead to dangerous accumulation of bronchial secretion due to weakened cough reflex. Bromhexine may enhance the irritating effect of salicylates and other non-steroidal anti-inflammatory drugs on the mucous membrane of the gastrointestinal tract. Concurrent use of bromhexine and antibiotics (medicines used to treat infections: amoxicillin, cefuroxime, erythromycin, doxycycline, oxytetracycline, ampicillin) may lead to increased antibiotic concentration in the lungs.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Flegtac Cough is not recommended during the first trimester of pregnancy. In the remaining period of pregnancy, the medicine may be used only if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus. If the patient is breastfeeding, they should consult their doctor before taking this medicine. Bromhexine passes into breast milk. There is insufficient information on the effect of bromhexine on newborns/children. Considering the benefits of breastfeeding for the child and the benefits of treatment for the mother, the doctor will decide whether the patient should stop breastfeeding or stop taking Flegtac Cough.

Driving and using machines

No studies have been conducted on the effect of bromhexine on the ability to drive and use machines. The patient should be cautious, as dizziness, headache, or drowsiness may occur.

Flegtac Cough contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216).

This medicine may cause allergic reactions (possible late reactions). The medicine contains sorbitol (E 420), 1 ml of syrup contains 760 mg of sorbitol. The energy value of sorbitol is 2.6 kcal/g. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or has a rare genetic disease, hereditary fructose intolerance, in which the patient's body does not break down fructose, the patient should consult their doctor before taking the medicine or giving it to their child. Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect. The medicine contains propylene glycolin an amount of 40 mg per 1 ml of syrup.

3. How to take Flegtac Cough

This medicine should always be used exactly as described in this patient leaflet or as directed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. Flegtac Cough is ready to use and should not be diluted. The recommended dose of the medicine should be measured using the enclosed measuring spoon.

Route of administration

Oral administration. The medicine should be taken at equal intervals, after meals.

The medicine should not be taken directly before bedtime.

If after 7 days there is no improvement or the patient feels worse, they should consult their doctor.

Recommended dose

Adults, including the elderly: 5 ml (1 full measuring spoon) 3 times a day. At the beginning of treatment, it may be necessary to increase the dose to 30 ml/day (maximum dose), (2 measuring spoons, 3 times a day) which corresponds to 48 mg of bromhexine. Adolescents over 12 years of age: 5 ml (1 full measuring spoon), 3 times a day, up to a maximum of 30 ml per day (which corresponds to 48 mg of bromhexine). Children from 6 to 12 years of age: 2.5 ml (1 measuring spoon filled to the 1/2 mark), 3 times a day, up to a maximum of 10 ml per day (which corresponds to 16 mg of bromhexine). Children from 2 to 6 years of age: 1.25 ml (1 measuring spoon filled to the 1/4 mark), 3 times a day, up to a maximum of 5 ml per day (which corresponds to 8 mg of bromhexine). Children under 2 years of age should not be given Flegtac Cough.

Taking a higher dose of Flegtac Cough than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor. The symptoms observed in case of unintentional overdose are the same as the side effects of bromhexine at the recommended doses and require symptomatic treatment. Excessive increase in the amount of secretion may occur. In case of overdose, the doctor will perform gastric lavage, administer activated charcoal, and provide symptomatic treatment.

Missing a dose of Flegtac Cough

If the patient forgets to take a dose of the medicine, they should take it as soon as possible, unless it is almost time for the next dose. In this case, the patient should skip the missed dose and continue taking the medicine as directed. The patient should not take a double dose to make up for the missed dose. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Flegtac Cough can cause side effects, although not everybody gets them. In case of severe side effects, such as severe skin reactions (including polymorphic rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis) or allergic reactions (including rash, facial, lip, tongue, and/or throat swelling, which may cause difficulty breathing or swallowing), or other severe side effects, the patient should stop taking the medicine and immediately consult their doctor or the Emergency Department of the nearest hospital. Rarely(occurring in less than 1 in 1000 patients): Nausea, abdominal pain (especially pain in the upper abdomen), vomiting, diarrhea, rash, urticaria, hypersensitivity reactions. Very rarely(occurring in less than 1 in 10,000 patients): Headache, dizziness, drowsiness. Frequency not known(frequency cannot be estimated from the available data): Indigestion, excessive sweating, severe skin reactions (including polymorphic rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis), anaphylactic reactions, including anaphylactic shock, angioedema, and itching, decreased blood pressure, increased activity of liver enzymes AST and ALT.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C 02-222 Warsaw Tel.: +48 22 49 21 301 Fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl By reporting side effects, more information can be collected on the safety of the medicine. Side effects can also be reported to the marketing authorization holder.

5. How to store Flegtac Cough

The medicine should be stored out of sight and reach of children. There are no special recommendations for the storage temperature of this medicine. The medicine should be stored in its original packaging to protect it from light. Shelf life after first opening the bottle: 3 months. Flegtac Cough is a clear, colorless liquid. The patient should not use the syrup if it becomes cloudy. The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Flegtac Cough contains

• The active substance of the medicine is bromhexine hydrochloride. 1 ml of syrup contains 1.6 mg of bromhexine hydrochloride.
• The other ingredients of the medicine are: liquid, non-crystallizing sorbitol (E 420), propylene glycol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sodium saccharin (E 954), purified water, cherry flavor (composition: propylene glycol, benzyl alcohol, triethyl citrate, lactic acid, 4-methoxyacetophenone, 3-hydroxy-2-methyl-4-pyrone (maltol), anise aldehyde, benzoic acid).

What Flegtac Cough looks like and contents of the pack

Flegtac Cough is a clear, colorless syrup with a characteristic cherry flavor. The bottle is made of orange glass type III, with a PE cap and a protective ring, in a cardboard box. A measuring spoon made of PP with a scale: 1.25 ml; 2.5 ml; 3.75 ml, and 5 ml is attached to the bottle. The pack contains: 125 ml, 200 ml, or 250 ml of syrup.

Marketing authorization holder and manufacturer

Marketing authorization holder

Tactica Pharmaceuticals Sp. z o.o. ul. Królowej Jadwigi 148a/1a 30-212 Kraków tel.: +48 889 388 538 {logo of the marketing authorization holder}

Manufacturer

Laboratórios Basi – Indústria Farmacêutica, S.A Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15 e16, Mortágua, 3450-232 Portugal

Date of last revision of the leaflet: