Flegamina classic raspberry flavored

Package leaflet: Information for the user

Flegamina Classic raspberry-flavoured, 4 mg/5 ml, syrup
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, pharmacist or nurse.

• Keep this leaflet. You may need to read it again.
• If you need advice or more information, ask your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
• If your symptoms do not improve or if you feel worse, you should consult your doctor.

Contents of the leaflet:

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

1. What Flegamina Classic raspberry-flavoured is and what it is used for

Flegamina Classic raspberry-flavoured syrup contains bromhexine hydrochloride as the active substance, which acts as an expectorant and liquefies respiratory secretions. The medicine facilitates expectoration and clears the bronchi.
Flegamina Classic raspberry-flavoured is indicated in acute and chronic respiratory diseases associated with impaired mucus expectoration and clearance.

2. Important information before using Flegamina Classic o smaku malinowym

When not to use Flegamina Classic o smaku malinowym

• if the patient is allergic to bromhexine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• in children under 7 years of age.

Warnings and precautions
Before starting treatment with Flegamina Classic o smaku malinowym, discuss with your doctor:

• if the patient has inflammatory respiratory conditions associated with bacterial infection. Flegamina Classic o smaku malinowym should be taken simultaneously with antibiotics and bronchodilators prescribed by the doctor. During treatment, it is important to drink plenty of fluids, especially when fever is present. Adequate hydration enhances the liquefaction of bronchial secretions and facilitates expectoration.
• if the patient has a history of peptic ulcer disease of the stomach and duodenum or active peptic ulcer disease, as the medicine may exacerbate its symptoms.
• if the patient has severe liver function disorders.
• if the patient has severe kidney function disorders.
• if the patient has intolerance to certain sugars (see also section "Flegamina Classic o smaku malinowym contains maltitol liquid (E965)").

Severe skin reactions associated with the use of bromhexine hydrochloride have been reported. If a rash occurs (including lesions on mucous membranes, e.g. in the mouth, throat, nose, eyes, genital organs), discontinue use of Flegamina Classic o smaku malinowym immediately and contact your doctor without delay.

Children
Flegamina Classic o smaku malinowym must not be used in children under 7 years of age.

Flegamina Classic o smaku malinowym and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient intends to take, including those available without a prescription.

Do not use Flegamina Classic o smaku malinowym 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 respiratory tract.

Use Flegamina Classic o smaku malinowym with caution when used concomitantly with:

• atropine and other anticholinergic drugs, as they may cause dryness of mucous membranes.
• salicylates and other non-steroidal anti-inflammatory drugs (NSAIDs), as Flegamina Classic o smaku malinowym may enhance their irritating effect on the gastrointestinal mucosa.
• antibiotics such as oxytetracycline, erythromycin, ampicillin, doxycycline, cefuroxime, amoxicillin, as concomitant use increases their concentration in lung tissue.

Taking Flegamina Classic o smaku malinowym with food and drink
The medicine should be taken after meals.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy:
Use of this medicine is not recommended 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.

Breastfeeding:
The medicine should not be used during breastfeeding.

Driving and operating machinery
Exercise caution, as the medicine may cause headache, dizziness, or drowsiness.

Flegamina Classic o smaku malinowym contains benzoic acid (E 210)
The medicine contains 1.5 mg of benzoic acid in 5 ml of syrup.

Flegamina Classic o smaku malinowym contains benzyl alcohol
The medicine contains 0.875 micrograms of benzyl alcohol in 5 ml of syrup. Benzyl alcohol may cause allergic reactions. Pregnant or breastfeeding women should consult their doctor before using the medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis). Patients with liver or kidney disease should consult their doctor before using the medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).

Flegamina Classic o smaku malinowym contains maltitol liquid (E965)
5 ml of syrup contains 1500 mg of maltitol liquid. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Flegamina Classic raspberry-flavoured

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
For oral use.
The recommended dose is:
Children aged 7 to 12 years: 5 ml three times daily.
Adults and adolescents over 12 years of age: 10 ml three times daily.
Do not take the medicine immediately before going to sleep.

Taking more Flegamina Classic raspberry-flavoured than recommended
Symptoms of bromohexine overdose have not been described so far.
In case of overdose, activated charcoal should be administered. If necessary, a doctor may recommend gastric lavage and symptomatic treatment.
If you have taken more than the recommended dose of this medicine, seek medical advice immediately from a doctor or pharmacist.

If you forget to take Flegamina Classic raspberry-flavoured
If you miss a dose, take it as soon as possible. However, if it is almost time for the next dose, take the next dose at the scheduled time.
Do not take a double dose to make up for a missed dose.

If you have any further doubts concerning 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 everyone will experience them.
When using Flegamina Classic o smaku malinowym, the following may occur:
Not common (may affect up to 1 in 100 people):

• pain in the upper abdomen, nausea, vomiting, diarrhoea

Rare (may affect up to 1 in 1,000 people):

• hypersensitivity reactions, rash, urticaria

Frequency unknown (frequency cannot be determined from available data):

• headache, dizziness, drowsiness,
• bronchospasm,
• dyspepsia,
• excessive sweating,
• increased liver enzyme activity,
• hypotension,
• anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissue, mucous membranes or submucosal tissues), and itching,
• severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalised exanthematous pustulosis).

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Phone: +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 helps to provide more information on the safety of the medicine.

5. How to store Flegamina Classic raspberry-flavoured medicine

Keep out of the sight and reach of children.
Store below 30°C.
Keep the medicine for up to 28 days after first opening the bottle.
Do not use this medicine after the expiry date stated on the carton and on the bottle after the words “Expiry date (EXP):” or “EXP:”. The expiry date refers to the last day of that month. The batch number on the packaging follows the abbreviation “Lot”.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Flegamina Classic raspberry-flavoured medicine contains

• The active substance is bromhexine hydrochloride. 5 ml of syrup contains 4 mg of bromhexine hydrochloride.
• The other ingredients are: citric acid monohydrate, hydroxyethylcellulose (E 1525), maltitol liquid (E 965), sucralose (E 955), benzoic acid (E 210), raspberry flavouring liquid (containing, among others, propylene glycol (E 1520) and benzyl alcohol), purified water.

What Flegamina Classic raspberry-flavoured looks like and contents of the pack
Flegamina Classic raspberry-flavoured is a clear syrup with raspberry odour and taste,
contained in a brown or coloured glass bottle with an aluminium or polypropylene cap,
with a polyethylene (LDPE or HDPE) foam seal and an LDPE tamper-evident ring,
together with a measuring cup made of polystyrene or polypropylene, packed in a cardboard box.
Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, Poland, tel.: (22) 345 93 00
Manufacturer
Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków, Poland
Teva Czech Industries s.r.o., Ostravská 305/29, Komárov, 747 70 Opava, Czech Republic