Flegtac for cough

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Flegtac Cough, 1.6 mg/ml, syrup
Bromhexini hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because 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.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if your condition worsens, consult your doctor.

Table of contents of the leaflet:

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

Flegtac Cough contains bromhexine hydrochloride as the active substance, which acts as an expectorant by liquefying respiratory secretions. This facilitates the movement of mucus by the cilia (tiny hair-like structures lining the respiratory tract) and helps remove bronchial secretions from the lungs.
Bromhexine facilitates expectoration and relieves cough.
This medicine is used in acute and chronic respiratory conditions associated with impaired expectoration and mucus clearance.
If there is no improvement after 7 days, or if the patient feels worse, medical advice should be sought.

2. Important information before taking Flegtac Cough

When not to use 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 been diagnosed with peptic ulcer disease of the stomach or duodenum,
• in patients with hereditary fructose intolerance,
• in children under 2 years of age.

Warnings and precautions
Before starting treatment with Flegtac Cough, consult a doctor or
pharmacist if:

• the patient suffers from inflammatory respiratory conditions associated with bacterial infection; Flegtac Cough should then be taken concurrently with antibiotics and bronchodilators prescribed by the doctor. During treatment, it is important to drink plenty of fluids, especially if fever occurs. Adequate hydration supports the thinning of bronchial secretions
  and facilitates expectoration.

• the patient is at risk of developing peptic ulcer disease of the stomach or duodenum,

• the patient has asthma,

• the patient has impaired bronchial motility, e.g. a condition called ciliary dyskinesia,

• the patient has impaired liver or kidney function,

• the patient has difficulty expectorating,

• severe skin reactions associated with bromhexine use have been reported. If a rash occurs (including blisters or mucosal lesions, e.g. in the mouth, throat, nose, eyes, or genital organs), discontinue use of Flegtac Cough immediately and contact a doctor without delay.

Children and adolescents
Do not use in children under 2 years of age.
Before starting treatment with Flegtac Cough in children and adolescents, consult a
doctor or pharmacist.

Flegtac Cough and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient intends to take.
Flegtac Cough should be used cautiously with atropine and other anticholinergic drugs, as they may cause dryness of mucous membranes.
Flegtac Cough should not be administered simultaneously with antitussive (cough suppressant) medicines, as this may lead to dangerous accumulation of bronchial secretions due to suppressed cough reflex.
Bromhexine may enhance the irritating effects of salicylates and other non-steroidal anti-inflammatory drugs (NSAIDs) on the gastrointestinal mucosa.
Concomitant use of bromhexine and antibiotics (medicines used to treat infections: amoxicillin, cefuroxime, erythromycin, doxycycline, oxytetracycline, ampicillin) may increase antibiotic concentrations in lung tissue.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before taking this medicine.
Use of Flegtac Cough is not recommended during the first trimester of pregnancy. During the remainder of pregnancy, the medicine may be used only if, in the opinion of the doctor, the benefit to the mother outweighs the potential risk to the fetus.
If the patient is breastfeeding, she should consult a doctor before taking this medicine.
Bromhexine passes into human milk. There is insufficient information on the effects of bromhexine on newborns or infants. Taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother, the doctor will decide whether the patient should discontinue breastfeeding or discontinue use of Flegtac Cough.

Driving and operating machinery
No studies have been conducted on the effects of bromhexine on the ability to drive vehicles or operate machinery. Caution is advised, as headache, dizziness or drowsiness may occur.

Flegtac Cough contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216).
This medicine may cause allergic reactions (including delayed-type reactions).

The medicine contains sorbitol (E 420); 1 ml of syrup contains 760 mg of sorbitol. The caloric value of sorbitol is 2.6 kcal/g. Sorbitol is a source of fructose. If intolerance to certain sugars has previously been diagnosed in the patient (or their child), or if hereditary fructose intolerance—a rare genetic disorder in which the patient's body cannot metabolize fructose—has been diagnosed, the patient should consult a doctor before taking the medicine or giving it to a child. Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.

The medicine contains propylene glycol at a dose of 40 mg per 1 ml of syrup.

3. How to use Flegtac Cough

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Flegtac Cough is ready for use and should not be diluted.
The recommended volume of the medicine should be measured using the provided measuring spoon.
Route of administration
Oral administration.
The medicine should be taken at regular intervals, after meals.
Do not administer the medicine immediately before going to sleep.
If there is no improvement after 7 days of treatment, or if the patient feels worse, consult a doctor.
Recommended dose of the medicine
Adults, including elderly people: 5 ml (1 full measuring spoon) three times daily.
At the beginning of treatment, it may be necessary to increase the dose up to 30 ml/day (maximum dose), (2 measuring spoons, three times daily), corresponding to 48 mg of bromhexine.
Adolescents over 12 years of age: 5 ml (1 full measuring spoon), three times daily, up to a maximum of 30 ml per day (corresponding to 48 mg of bromhexine).
Children aged 6 to 12 years: 2.5 ml (1 measuring spoon filled up to the 1/2 mark), three times daily, up to a maximum of 10 ml per day (corresponding to 16 mg of bromhexine).
Children aged 2 to 6 years: 1.25 ml (1 measuring spoon filled up to the 1/4 mark), three times daily, up to a maximum of 5 ml per day (corresponding to 8 mg of bromhexine).
Flegtac Cough must not be given to children under 2 years of age.
Taking more than the recommended dose of Flegtac Cough
In case of accidental overdose, seek immediate medical advice.
Symptoms observed in cases of accidental overdose are similar to the adverse effects of bromhexine at recommended doses and require symptomatic treatment. Excessive increase in secretion may occur.
In case of overdose, the doctor may perform gastric lavage, administer activated charcoal, and apply symptomatic treatment.
Missed dose of Flegtac Cough
If the patient forgets to take a dose, it should be taken as soon as remembered, unless it is almost time for the next dose. In that case, the missed dose should be skipped and the medicine taken according to the prescribed schedule. Do not take a double dose to make up for a missed dose.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Flegtac Kaszel may cause adverse reactions, although not everyone experiences them.
If severe adverse reactions occur, such as severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis) or allergic reactions (including rash, swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing or swallowing), or any other serious adverse reactions, treatment with the medicine should be discontinued immediately and medical advice should be sought urgently from a doctor or the nearest hospital Emergency Department.

Rare (occurs in fewer than 1 in 1,000 patients):
Nausea, abdominal pain (particularly epigastric pain), vomiting, diarrhoea, rash, urticaria, hypersensitivity reactions.

Very rare (occurs in fewer than 1 in 10,000 patients):
Headache, dizziness, drowsiness.

Frequency not known (frequency cannot be estimated from available data):
Dyspepsia, excessive sweating, severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalized exanthematous pustulosis), anaphylactic reactions including anaphylactic shock, angioedema and pruritus, hypotension, increased hepatic enzyme activity (AST and ALT).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 4921301
Fax: +48 22 4921309
Website: https://smz.ezdrowie.gov.pl

Reporting adverse reactions enables better assessment of the safety profile of the medicine.
Adverse reactions may also be reported to the Marketing Authorisation Holder.

5. How to store Flegtac Kaszel

Keep this medicine out of sight and reach of children.
There are no special requirements regarding storage temperature for this medicine. Store in the original packaging to protect from light.
Shelf life after first opening the bottle: 3 months.
Flegtac Kaszel is a clear, colourless liquid. Do not use the syrup if it becomes cloudy.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Flegtac Cough contains

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

What Flegtac Cough looks like and contents of the pack
Flegtac Cough is a clear, colourless syrup with a characteristic cherry odour.
The bottle is made of amber glass type III, with a polyethylene (PE) child-resistant cap. It comes in a cardboard box. A polypropylene (PP) measuring spoon with graduations at 1.25 ml, 2.5 ml, 3.75 ml and 5 ml is included.
Pack sizes: 125 ml, 200 ml or 250 ml of syrup.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Tactica Pharmaceuticals Sp. z o.o.
Królowej Jadwigi 148a/1a
30-212 Kraków
Poland
Tel.: +48 889 388 538
{marketing authorisation holder's logo}

Manufacturer
Laboratórios Basi – Indústria Farmacêutica, S.A
Parque Industrial Manuel Lourenço Ferreira,
Lotes 8, 15 and 16, Mortágua,
3450-232 Portugal