Flegamina baby
Poland
Table of Contents
Patient Information Leaflet
Flegamina Baby, 2 mg/ml, oral drops, solution
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
the 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 any adverse reactions occur, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If there is no improvement after 3 to 5 days, or if the patient feels worse, consult a doctor.
Table of contents
- What Flegamina Baby is and what it is used for
- Important information before taking Flegamina Baby
- How to take Flegamina Baby
- Possible side effects
- How to store Flegamina Baby
- Contents of the pack and other information
1. What Flegamina Baby is and what it is used for
Flegamina Baby contains bromhexine hydrochloride as the active substance, which is an expectorant
medication that liquefies secretions from the respiratory tract. The medicine facilitates expectoration and clearance of the bronchi.
Flegamina Baby is indicated for the treatment of acute and chronic respiratory tract diseases associated with impaired expectoration and mucus clearance.
Flegamina Baby is intended for use in children aged 2 to 6 years.
Flegamina Baby should not be used for longer than 3 to 5 days without medical supervision.
2. Important information before using Flegamina Baby
When not to use Flegamina Baby:
- if the patient is allergic 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 Baby, discuss with your doctor or pharmacist:
- if the patient has inflammatory respiratory conditions accompanied by bacterial infection, because Flegamina Baby should then be administered together with antibiotics and bronchodilators prescribed by the doctor.
- if the patient has fever, adequate hydration is important. Proper hydration enhances the liquefaction of bronchial secretions and facilitates expectoration.
- if the patient currently has or has had in the past gastric or duodenal ulcer disease, because the medicine may exacerbate symptoms.
- if the patient has severe impairment of liver or kidney function.
Severe skin reactions associated with bromhexine hydrochloride have been reported.
If rash occurs (including mucosal lesions, e.g. in the oral cavity, throat, nose, eyes, genital organs), discontinue use of Flegamina Baby immediately and contact your doctor without delay.
Flegamina Baby with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
Bromhexine should be used with caution with atropine and other anticholinergic drugs, as they may cause dryness of mucous membranes.
Bromhexine should not be used simultaneously with antitussive medicines (e.g. those containing codeine and its derivatives), as they may suppress the cough reflex and lead to accumulation of secretions in the airways.
Bromhexine may intensify the irritating effect of salicylates and other non-steroidal anti-inflammatory drugs (NSAIDs) on the gastrointestinal mucosa.
Concomitant administration of Flegamina Baby with antibiotics (oxytetracycline, erythromycin, ampicillin, doxycycline, cefuroxime, amoxicillin) increases their concentration in lung tissue.
Flegamina Baby with food and drink
This medicine should be taken after meals.
Pregnancy and breastfeeding
This section does not apply to Flegamina Baby, as it is intended for use in children aged 2 to 6 years. However, the following information is relevant regarding the active substance, bromhexine hydrochloride.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
This medicine should not be used during the first three months 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.
Use of this medicine during breastfeeding is not recommended.
Driving and operating machinery
Exercise caution, as headache, dizziness or drowsiness may occur.
This medicine contains ethanol and may therefore impair the ability to drive or operate machinery.
Flegamina Baby contains ethanol 96% as well as methyl parahydroxybenzoate and propyl parahydroxybenzoate
1 ml of solution contains 40 mg of 96% ethanol.
This medicine contains 50 mg of alcohol (96% ethanol) in the maximum single dose (25 drops). The amount of alcohol in the maximum single dose (25 drops) of this medicine is equivalent to 1.25 ml of 5% vol. beer or 0.5 ml of 12.5% vol. wine.
The small amount of alcohol in this medicine will not cause noticeable effects.
This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (including delayed-type reactions).
3. How to use Flegamina Baby
This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is for oral use.
Recommended dose:
children aged 2 to 6 years: 20 to 25 drops 3 times daily.
The maximum recommended duration of treatment with Flegamina Baby without medical supervision is 3 to 5 days.
Flegamina Baby should not be used in children under 2 years of age.
The medicine should be administered at regular intervals, after meals.
Do not administer the medicine immediately before bedtime.
If you feel that the effect of the medicine is too strong or too weak, consult a doctor.
Use of a higher than recommended dose of Flegamina Baby
In case of overdose, seek immediate advice from a doctor or pharmacist.
Symptoms of overdose have not been reported so far.
In the event of overdose, activated charcoal should be administered. If necessary, the doctor may recommend gastric lavage and symptomatic treatment.
Missed dose of Flegamina Baby
Give the missed dose to the child as soon as possible. If it is almost time for the next dose, give the next dose at the scheduled time. Do not use a double dose to make up for the missed dose.
If you have any further questions about the use of this medicine, consult a doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Not common (may occur in up to 1 in 100 people):
- upper abdominal pain, nausea, vomiting, diarrhoea.
Rare (may occur in up to 1 in 1,000 people):
- hypersensitivity reactions,
- rash, urticaria.
Frequency unknown (frequency cannot be estimated from the available data):
- anaphylactic reactions, including anaphylactic shock, angioedema (rapidly developing swelling of the skin, subcutaneous tissue, mucous membranes or submucosal tissues), and itching,
- severe skin-related adverse reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalised exanthematous pustulosis),
- headache, dizziness,
- bronchospasm,
- excessive sweating,
- dyspepsia,
- increased liver enzyme activity.
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 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 authorisation holder.
Reporting adverse reactions enables further information on the safety of the medicine to be collected.
5. How to store Flegamina Baby
Keep this medicine out of sight and reach of children.
Store below 25°C.
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.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.
6. Contents of the pack and other information
What Flegamina Baby contains
- The active substance is bromhexine hydrochloride. 1 ml of solution (20 drops) contains 2 mg of bromhexine hydrochloride.
- The other ingredients are: propyl parahydroxybenzoate, methyl parahydroxybenzoate, ethanol 96%, hydrochloric acid 0.1 N, purified water.
What Flegamina Baby looks like and contents of the pack
Flegamina Baby is a clear, colourless and odourless solution.
The medicine is packed in an amber or brown bottle containing 30 ml of solution, closed with a dropper cap used for measuring and/or administering the dose, and a polypropylene or polyethylene screw cap.
The pack is placed in a cardboard carton.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel.: (22) 345 93 00
Manufacturer
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
Teva Czech Industries s.r.o.
Ostravská 305/29 Komárov
747 70 Opava
Czech Republic