Flegamina fast junior

Package leaflet: Information for the patient

Flegamina Fast Junior, 4 mg, orodispersible tablets
Bromhexini hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken 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 contact your pharmacist.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 5 days of treatment in adults or after 3 days of treatment in adolescents and children aged 2 years and older, or if the patient feels worse, consult a doctor.

Contents of the leaflet:

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

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

Flegamina Fast Junior contains bromhexine hydrochloride as the active substance, which acts as an expectorant by liquefying respiratory tract secretions. This facilitates the movement of bronchial mucus by cilia (tiny hair-like structures lining the airways) and its removal from the lungs.
Bromhexine facilitates expectoration and relieves cough.
This medicine is used in acute and chronic respiratory conditions associated with impaired mucus clearance and expectoration in adults, adolescents, and children aged 2 years and older.
If there is no improvement after 5 days of treatment in adults or after 3 days of treatment in adolescents and children aged 2 years and older, or if the patient feels worse, consult a doctor.

2. Important information before taking Flegamina Fast Junior

When not to use Flegamina Fast Junior

• if the patient is allergic (hypersensitive) to bromhexine hydrochloride or any of the other ingredients of this medicine (listed in section 6)
• in children under 2 years of age.

Warnings and precautions
Before starting treatment with Flegamina Fast Junior, consult a doctor or
pharmacist if:

• the patient has inflammatory conditions of the respiratory tract associated with bacterial infection; Flegamina Fast Junior should be taken simultaneously with antibiotics and bronchodilators prescribed by a doctor. During treatment, it is important to drink plenty of fluids, especially when fever is present. Adequate hydration helps to liquefy bronchial secretions and facilitates expectoration.
• the patient has a history of peptic ulcer disease of the stomach and duodenum, or currently has active peptic ulcer disease of the stomach and duodenum, as bromhexine may exacerbate symptoms.
• the patient has asthma.
• the patient has impaired bronchial motility, e.g. a condition known as ciliary dyskinesia.
• the patient has impaired liver or kidney function.
• the patient has difficulty expectorating.
• severe skin reactions associated with the use of bromhexine 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 Flegamina Fast Junior and contact a doctor immediately (see section 4).

Children
Do not use in children under 2 years of age.
Before starting treatment with Flegamina Fast Junior in children, consult a doctor
or pharmacist.
Flegamina Fast Junior and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines you plan to take.
Flegamina Fast Junior should be used with caution together with atropine and other anticholinergic drugs, as they may cause dryness of mucous membranes.
Flegamina Fast Junior should not be administered simultaneously with antitussive medicines, e.g. those containing codeine or its derivatives, as this may lead to dangerous accumulation of bronchial secretions due to suppressed cough reflex.
Bromhexine may enhance the irritating effect of salicylates and other nonsteroidal anti-inflammatory drugs (NSAIDs) on the gastrointestinal mucosa.
Concomitant use of bromhexine and antibiotics (medicines used to treat infections: erythromycin, doxycycline, amoxicillin, cefuroxime) may lead to increased antibiotic concentration in the lungs.
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 using this medicine.
Use of Flegamina Fast Junior 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 using this medicine.
Bromhexine passes into human milk. There is insufficient information on the effects of bromhexine on newborns and infants. Use of the medicine is not recommended during breastfeeding.
There are no data available on the effect of bromhexine on human fertility.
Driving and operating machinery
No studies have been conducted on the effects of bromhexine on the ability to drive or operate machinery. Caution is advised, as headache, dizziness or drowsiness may occur.
Flegamina Fast Junior contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 1 tablet, meaning the medicine is considered "sodium-free".

3. How to take Flegamina Fast Junior

This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults, including elderly people
2 tablets three times a day.
At the beginning of treatment, the dose may need to be increased to the maximum dose of 48 mg
(4 tablets three times a day, corresponding to 48 mg of bromhexine).
Children and adolescents
Adolescents over 12 years of age: 2 tablets three times a day, up to a maximum of 12 tablets per day (corresponding to 48 mg of bromhexine).
Children aged 6 to 12 years: 1 tablet three times a day, up to a maximum of 4 tablets per day (corresponding to 16 mg of bromhexine).
Children aged 2 to 6 years: half a tablet three times a day, up to a maximum of 2 tablets per day (corresponding to 8 mg of bromhexine).
Method of administration
Oral use.
Do not handle Flegamina Fast Junior tablets with wet hands, as they may disintegrate.
The Flegamina Fast Junior tablet, which disperses in the oral cavity, should be placed in the mouth, where it will disperse in saliva within approximately 30 seconds and can then be easily swallowed. Exercise caution when administering the medicine to young children due to the risk of choking. Immediately before administration, the tablet may be dissolved on a spoon in a small amount of drinking water. The dose should be taken immediately after opening the blister.
The tablet may be divided into equal doses.
The remaining half tablet should be stored in the opened blister and used no later than the following day.
Do not use this medicine for longer than 7 days without consulting a doctor. If symptoms worsen or do not improve after 5 days of use in adults or after 3 days in adolescents and children aged 2 years and older, consult a doctor.
The medicine should be taken at regular intervals, after meals.
Do not administer the medicine immediately before bedtime.
Use in patients with hepatic or renal impairment
There is a lack of data regarding the use of bromhexine hydrochloride in patients with hepatic or renal impairment. Elimination of bromhexine or its metabolites is reduced in these patients. Patients should consult their doctor before using this medicine.
Overdose of Flegamina Fast Junior
In case of accidental overdose, seek medical advice immediately.
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 secretions may occur.
In case of overdose, the doctor may perform gastric lavage, administer activated charcoal, and provide symptomatic treatment.
Missed dose of Flegamina Fast Junior
If a dose is missed, take it as soon as possible, unless it is almost time for the next dose. In that case, skip the missed dose and continue with the regular dosing schedule. Do not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
You should immediately inform your doctor or go to the nearest hospital if the following occur:

• severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalized exanthematous pustulosis)
• allergic reactions (including rash, swelling of the face, lips, tongue and (or) throat, which may cause difficulty in breathing or swallowing). The following adverse reactions may also occur.

Not common (may affect up to 1 in 100 people):
upper abdominal pain, nausea, vomiting, diarrhoea
Rare (may affect up to 1 in 1000 people):
skin rash, urticaria, hypersensitivity reactions.
Frequency unknown (frequency cannot be estimated from the 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, pruritus, hypotension, increased liver enzyme activity, headache, dizziness, somnolence, bronchospasm.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, please inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 .
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Flegamina Fast Junior

Keep the medicine out of the sight and reach of children.
There are no special requirements regarding storage temperature.
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 pack after
"Expiry date (EXP)" or "EXP". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste bins. Ask your
pharmacist how to dispose of medicines no longer in use. This practice helps protect
the environment.

6. Contents of the packaging and other information

What Flegamina Fast Junior contains
The active substance is bromhexine hydrochloride. One orodispersible tablet contains 4 mg of bromhexine hydrochloride.
The other ingredients are: Mannitol, Crospovidone (type B), Sucralose, Colloidal anhydrous silica, Magnesium stearate, Strawberry flavor PHS-455920 containing: Natural flavoring substances, flavoring preparations, Corn maltodextrin, Sodium octenyl succinate starch (E 1450).

What Flegamina Fast Junior looks like and contents of the pack
Flegamina Fast Junior orodispersible tablets are white, round, biconvex tablets with a score line, flat on both sides and beveled edges, 7 mm in diameter. The tablet can be divided into equal doses.
The pack contains 10, 20 or 40 orodispersible tablets.

Marketing Authorisation Holder
Teva B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands

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