Flegamina Classic expectorant syrup with raspberry flavor 120 ml

Oral administration.

Dosage and method of administration:
Unless a doctor prescribes a specific dosage, the drug is most commonly used:
Age Children aged 7 to 12 years / Dosage 5 ml 3 times daily.
Age Adults and children over 12 years / Dosage 10 ml 3 times a day

5 ml = one measuring spoon

For further information, see the leaflet

Read the leaflet before using the drug.
Storage: Store at ambient temperature
Package: Box

5 ml of syrup contains 4 mg bromohexine hydrochloride and excipients: glucose monohydrate, glycerol, propyl parahydroxybenzoate, ethanol 96% and others

Teva Pharmaceuticals Polska Sp. z o.o.

Manufacturer
Teva Operations Poland Sp. z o.o,
Mogilska 80 street,
31-546 Kraków

Keep the drug out of sight and reach of children.

Do not use after expiration date.

Do not use in children under 7 years of age due to alcohol content.

Recommended: 7 years/years/years

Read the leaflet carefully before taking this medication, as it contains important information for the patient.
Always take this medication exactly as described in the patient leaflet, or as directed by your doctor, pharmacist or nurse.
- Keep this leaflet so that you can read it again if necessary.
- If you need advice or additional information, ask your pharmacist.
- If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor, pharmacist or nurse. See section 4.
- If there is no improvement or the patient feels worse, contact your doctor.

Table of contents of the leaflet:
1. what is the drug Flegamina Classic raspberry flavor and for what purpose it is used.
2. important information before using Flegamina Classic raspberry flavor.
3. how to use the drug Flegamina Classic with raspberry taste
4 Possible side effects
5. how to store Flegamina Classic raspberry flavored medicine
6. package contents and other information

1.What is the drug Flegamina Classic with raspberry flavor and for what purpose it is used.

Flegamina Classic raspberry-flavored syrup contains as an active substance bromohexine hydrochloride, which has an expectorant effect, liquefies secretions from the respiratory tract. The drug facilitates expectoration and bronchial clearance.

The drug Flegamina Classic with raspberry flavor is indicated in acute and chronic diseases of the respiratory tract, which proceed with disorders of expectoration and mucus clearance.

3.How to use the drug Flegamina Classic with raspberry flavor.

This drug should always be used exactly as described in the leaflet for the patient or as prescribed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Drug for oral use.

The recommended dose of the drug is:
Children aged 7 to 12 years: 5 ml (1 measuring spoon of syrup) 3 times a day.
Adults and children over 12 years of age: 10 ml (2 measuring spoons of syrup) 3 times a day.

Do not take the drug immediately before bedtime.

Use of a larger-than-recommended dose of the drug Flegamina Classic with raspberry flavor.
So far, no symptoms of bromohexine overdose have been described.
In case of overdose, active charcoal should be administered. If necessary, the doctor will recommend gastric lavage and administer symptomatic treatment.
If you take more than the recommended dose of the drug, contact your doctor or pharmacist immediately.

Omission of use of the drug Flegamina Classic with raspberry flavor.
If you miss a dose of the drug, take it as soon as possible. When the time for taking the next dose is approaching, take it at the appointed time.
Do not use a double dose to make up for a missed dose.

If you have any further doubts about the use of this drug, ask your doctor or pharmacist.

5 How to store the drug Flegamina Classic with raspberry flavor.

Store out of sight and reach of children.
Store at a temperature below 30°C.

Shelf life after the first opening of the bottle: 28 days.

Do not use this drug after the expiration date placed on the cardboard box and bottle after the marking "Expiration date (EXP):" or "EXP:". Expiration date means the last day of the month stated. The batch number on the package is located after the abbreviation "Lot".

Medicines should not be disposed of in sewage or household waste containers. Ask your pharmacist how to dispose of medicines that you no longer use. Such treatment will help protect the environment.

4 Possible side effects

Like any drug, this medication may cause undesirable effects, although they will not occur in everyone.

During the use of the drug Flegamina Classic with raspberry flavor may occur:

Uncommon (may occur in no more than 1 in 100 people):
- Upper abdominal pain, nausea, vomiting, diarrhea

Rare (may occur in not more than 1 in 1000 people):
- hypersensitivity reactions, rash, urticaria

Frequency unknown (frequency cannot be determined from available data):
- headache, dizziness, drowsiness,
- bronchospasm,
- indigestion,
- excessive sweating,
- increased liver enzymes,
- decreased blood pressure,
- Anaphylactic reactions, including anaphylactic shock, angioedema (rapidly progressive swelling of the skin, subcutaneous tissue, mucous membrane or submucosal tissue) and pruritus,
- severe skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalized pustulosis).

Reporting side effects
If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Adverse Drug Reactions Monitoring Department of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Jerozolimskie Avenue 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 responsible party.
By reporting side effects, it will be possible to gather more information on the safety of the drug.

6 Contents of the package and other information

What does the drug Flegamina Classic with raspberry flavor contain?
- The active substance of the drug is bromohexine hydrochloride. 5 ml of syrup contains 4 mg of bromohexine hydrochloride.
- The other ingredients are: citric acid monohydrate, glucose monohydrate, glycerol, propyl parahydroxybenzoate (E216), liquid carmine dye (contains, among others, carminic acid (E120) and propylene glycol (E1520)), liquid raspberry flavor (contains, among others, propylene glycol (E1520) and benzyl alcohol), ethanol 96%, purified water.

What the drug Flegamina Classic raspberry flavor looks like and what the package contains.
Flegamina Classic with raspberry flavor is a bright red, clear syrup with raspberry smell and taste in a brown glass bottle containing 120 ml or 200 ml of syrup. The bottle closes

is with an aluminum or polypropylene cap with a foam seal and a guarantee ring made of polyethylene, placed together with a measuring spoon in a cardboard box.

2 Important information before using Flegamina Classic raspberry flavor.

When not to use the drug Flegamina Classic with raspberry flavor
- if the patient is allergic to bromohexine hydrochloride or any of the other components of this drug (listed in section 6).
- In children under 7 years of age, because the drug contains alcohol.

Warnings and precautions
Discuss with your doctor before taking Flegamina Classic raspberry flavor:
- if the patient has inflammation of the respiratory tract with an accompanying bacterial infection. Flegamina Classic raspberry-flavored should be taken at the same time as antibiotics and airway dilators prescribed by the doctor. During treatment, drink a lot, especially when there is a fever. Adequate hydration of the body increases the thinning of bronchial secretions and facilitates expectoration.
- if the patient has a history of peptic ulcer disease or active peptic ulcer disease of the stomach and duodenum, as the drug may exacerbate its symptoms.
- If the patient has severe hepatic impairment.
- if the patient has severe renal impairment.
- if the patient has intolerance to certain sugars (see also "The drug Flegamina Classic raspberry flavor contains glucose").

Cases of severe skin reactions associated with the use of bromohexine hydrochloride have been reported. If a rash develops (including lesions on mucous membranes, such as the mouth, throat, nose, eyes, genitals), discontinue use of Flegamina Classic raspberry flavor and contact your doctor immediately.

Children
Due to the alcohol content, do not use Flegamina Classic raspberry flavor in children under 7 years old.

Flegamina Classic raspberry flavor medicine and other drugs.
Tell your doctor or pharmacist about all the medicines you are currently or recently taking, as well as the medicines you plan to take, including those that are dispensed without a prescription.

Flegamina Classic raspberry flavor should not be used with:
- antitussive drugs, such as those containing codeine and its derivatives, as they may weaken the cough reflex and cause retention of secretions in the airways.

The drug Flegamina Classic with raspberry flavor should be used with caution in case of concomitant use:
- atropine and other cholinolytics, as they cause dryness of the mucous membranes.
- salicylates and other non-steroidal anti-inflammatory drugs, as the drug may increase the irritant effect on the mucosa of the gastrointestinal tract.
- Antibiotics, such as oxytetracycline, erythromycin, ampicillin, doxycycline, cefuroxime, amoxicillin, since the simultaneous use of the drug with these antibiotics increases their concentration in the pulmonary parenchyma.

Use of the drug Flegamina Classic with raspberry flavor with food and drink.
The drug should be used after a meal.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect that you may be pregnant, or if you are planning to have a baby, you should consult your doctor or pharmacist before taking this medication.

Pregnancy:
It is not recommended to use the drug during the first three months of pregnancy.
During the remainder of pregnancy, the drug may be used only if, in the opinion of the doctor, the benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding:
Do not use the drug during breastfeeding.

Driving and operating machinery
Caution should be exercised, as the drug may cause headaches and dizziness or drowsiness. The drug contains ethanol, so it may impair the ability to drive and operate machinery.

The drug Flegamina Classic with raspberry flavor contains 96% ethanol.
The drug contains about 160 mg of alcohol (96% ethanol) in 5 ml of syrup (one measuring spoon). The amount of alcohol in 5 ml of this drug is equivalent to less than 4 ml of beer or 1.67 ml of wine. A small amount of alcohol in this drug will not cause noticeable effects.

The drug Flegamina Classic with raspberry flavor contains propyl parahydroxybenzoate (E216).
The drug contains propyl parahydroxybenzoate and may cause allergic reactions (possible late type reactions).

The drug Flegamina Classic with raspberry flavor contains glucose
5 ml (1 measuring spoon) of the syrup contains 1.75 g of glucose. This should be taken into account in patients with diabetes. If you have previously been diagnosed with intolerance to certain sugars, you should contact your doctor before taking the drug.

The drug Flegamina Classic raspberry flavor contains benzyl alcohol 5 ml of syrup (one measuring spoon) contains 0.625 µg of benzyl alcohol. Benzyl alcohol may cause allergic reactions. Pregnant or breastfeeding women should consult a doctor before taking the drug, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse reactions (known as metabolic acidosis). Patients with liver or kidney disease should contact their doctor before taking the drug, as a large amount of benzyl alcohol can accumulate in their body and cause side effects (known as metabolic acidosis).

Flegamina Classic with raspberry flavor, 4 mg/5 ml, syrup
Bromhexini hydrochloridum