Flegamina Fast

Package Leaflet: Information for the Patient

Flegamina Fast, 8 mg, Orodispersible Tablets

Bromhexine Hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet or as directed by a doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If after 5 days of treatment in adults or after 3 days of treatment in adolescents over 12 years of age, there is no improvement or the patient feels worse, consult a doctor.

Table of Contents of the Package Leaflet:

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

1. What is Flegamina Fast and what is it used for

Flegamina Fast 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 expectoration and alleviates cough. The medicine is used in acute and chronic respiratory diseases with impaired expectoration and sputum removal in adults and adolescents over 12 years of age. If after 5 days of treatment in adults or after 3 days of treatment in adolescents over 12 years of age, there is no improvement or the patient feels worse, consult a doctor.

2. Important information before taking Flegamina Fast

When not to take Flegamina Fast

• if the patient is hypersensitive (allergic) to bromhexine or any of the other ingredients of this medicine (listed in section 6),
• in children under 12 years of age.

Warnings and precautions

Before starting treatment with Flegamina Fast, discuss it with your doctor or pharmacist if:

• the patient has inflammatory respiratory diseases with accompanying bacterial infection

Flegamina Fast should be taken together with antibiotics and bronchodilators prescribed by the doctor. During treatment, drink plenty of fluids, especially if there is a fever. Proper hydration of the body helps to thin the bronchial secretion and facilitates expectoration.

• if the patient has a history of gastric or duodenal ulcer, as well as active gastric or duodenal ulcer, because bromhexine may exacerbate its symptoms.
• if the patient has asthma.
• if the patient has impaired motor function of the bronchi, e.g., a disease called ciliary dyskinesia.
• if the patient has impaired liver or kidney function.
• if the patient has difficulty expectorating.
• severe skin reactions associated with the use of bromhexine have been reported. If a rash occurs (including blisters or changes in the mucous membranes, e.g., in the mouth, throat, nose, eyes, genitals), discontinue the use of Flegamina Fast and consult a doctor immediately (see section 4).

Children

Do not use in children under 12 years of age. Before starting treatment with Flegamina Fast, consult a doctor or pharmacist. For children between 2 and 12 years of age, it is recommended to use Flegamina Fast Junior at a dose of 4 mg.

Flegamina Fast and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. Flegamina Fast should be used with caution with atropine and other anticholinergic medicines, as they cause dryness of the mucous membranes. Do not take Flegamina Fast with cough medicines, e.g., those containing codeine or its derivatives, as this may lead to a dangerous accumulation of bronchial secretion due to a weakened cough reflex. Bromhexine may enhance the irritating effect of salicylates and other non-steroidal anti-inflammatory drugs on the gastrointestinal mucosa. Concurrent use of bromhexine and antibiotics (medicines used to treat infections: erythromycin, doxycycline, amoxicillin, cefuroxime) may lead to increased antibiotic concentrations in the lungs.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine. Flegamina Fast 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 you are breastfeeding, consult your doctor before taking this medicine. Bromhexine passes into breast milk. There is insufficient information on the effect of bromhexine on newborns and children. Flegamina Fast is not recommended during breastfeeding. There are no data on the effect of bromhexine on human fertility.

Driving and using machines

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

Flegamina Fast contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Flegamina Fast

This medicine should always be taken exactly as described in this package leaflet or as directed by a doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Adults, including the elderly

1 tablet 3 times a day. At the beginning of treatment, it may be necessary to increase the dose to 48 mg (maximum dose) (2 tablets 3 times a day, equivalent to 48 mg of bromhexine).

Children and adolescents

Adolescents over 12 years of age: 1 tablet 3 times a day, up to a maximum of 6 tablets per day (equivalent to 48 mg of bromhexine). For children between 2 and 12 years of age, it is recommended to use Flegamina Fast Junior at a dose of 4 mg.

Method of administration

Oral use. Flegamina Fast tablets should not be touched with wet hands, as they may disintegrate. Place the orodispersible tablet in the mouth, where it will disintegrate in saliva within 30 seconds and can be easily swallowed. Immediately before administration, the tablet can be dissolved in a small amount of drinking water on a spoon. The dose should be taken immediately after opening the blister. Do not use the medicine for more than 7 days without consulting a doctor. If symptoms worsen or do not improve after 5 days of treatment in adults or after 3 days in adolescents over 12 years of age, consult a doctor. The medicine should be taken at equal intervals, after a meal. Do not take the medicine directly before bedtime.

Use in patients with liver or kidney impairment

There are no data on the use of bromhexine hydrochloride in patients with liver or kidney impairment. The excretion of bromhexine or its metabolites is reduced in these patients. Before taking the medicine, consult your doctor.

Overdose of Flegamina Fast

In case of overdose, consult a doctor immediately. The symptoms observed in case of accidental overdose are similar to the adverse effects of bromhexine at recommended doses and require symptomatic treatment. Excessive secretion may occur. In case of overdose, the doctor will perform gastric lavage, administer activated charcoal, and provide symptomatic treatment.

Missed dose of Flegamina Fast

If you forget to take a dose, take it as soon as possible, unless it is almost time for the next dose. In this case, skip the missed dose and continue with the recommended schedule. Do not take a double dose to make up for the missed dose. If you have any further questions on the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Flegamina Fast can cause side effects, although not everybody gets them.

Seek immediate medical attention if you experience:

• severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis)
• allergic reactions (including rash, facial, lip, tongue, and/or throat swelling, which may cause difficulty breathing or swallowing).

The following side effects may occur:
Uncommon(may affect up to 1 in 100 people):
upper abdominal pain, nausea, vomiting, diarrhea
Rare(may affect up to 1 in 1,000 people):
skin rash, urticaria, hypersensitivity reactions.
Frequency not known(frequency cannot be estimated from the available data):
indigestion, 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 itching, low blood pressure, increased liver enzyme activity, headache, dizziness, drowsiness, bronchospasm.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Flegamina Fast

Keep the medicine out of the sight and reach of children. There are no special storage instructions. Store in the original packaging to protect from light and moisture. Do not use this medicine after the expiry date stated on the carton or blister after "Expiry Date" or "EXP". The expiry date refers to the last day of the month. Medicines should 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 pack and other information

What Flegamina Fast contains

The active substance is bromhexine hydrochloride. One orodispersible tablet contains 8 mg of bromhexine hydrochloride. The other ingredients are: Mannitol, Crospovidone (type B), Sucralose, Colloidal anhydrous silica, Magnesium stearate, Strawberry flavor PHS-455920 of composition: Natural flavoring substances, flavoring preparations, Corn maltodextrin, Sodium octenyl succinate starch (E 1450).

What Flegamina Fast looks like and contents of the pack

Flegamina Fast orodispersible tablets: are white, round, flat with a beveled edge, 9 mm in diameter. The pack contains 10, 20, or 40 orodispersible tablets.

Marketing authorization holder

Teva B.V., Swensweg 5, 2031 GA Haarlem, Netherlands

Manufacturer

Mako Pharma Sp. z o.o., ul. Władysława Reymonta 2, 05-092 Dziekanów Leśny

Date of last revision of the package leaflet: March 2025