Flegamina Classic Tablets 40 pcs.

Read the leaflet before using the drug.

Oral administration.

Dosage and method of administration:
Age Children 3 to 6 years / Dosage ½ tablet 2 times daily.
Age Children aged 6 to 12 years / Dosage ½ tablet 3 times daily.
Age Adults and children over 12 years / Dosage 1 tablet 3 times daily

For further information, see the leaflet.
Storage: Store at ambient temperature
Packaging: box

One tablet contains 8 mg bromohexine hydrochloride and excipients, including lactose monohydrate

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.

Number of units: 40

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 or 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 or 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 Flegamina Classic drug and for what purpose it is used.
2 Information important before using Flegamina Classic.
3. how to use Flegamina Classic drug
4 Possible side effects
5. how to store Flegamina Classic drug
6. package contents and other information

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

The drug Flegamina Classic contains as an active substance bromohexine hydrochloride, which is an expectorant drug that liquefies secretions from the respiratory tract. The drug facilitates expectoration and bronchial clearance.

The indication for the use of Flegamina Classic is acute and chronic diseases of the respiratory tract with disorders of expectoration and mucus clearance.

3 How to use the drug Flegamina Classic

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

Drug for oral use.

The recommended dose is:
Adults and children over 12 years of age: 1 tablet 3 times a day.
Children aged 6 to 12 years: half a tablet 3 times a day.
Children aged 3 to 6 years: half a tablet 2 times a day.

It is not advisable to use Flegamina Classic in tablet form in children aged 3 to 6 years who are unable to swallow tablets; in these patients, it is recommended to use the drug in the form of Flegamina Classic Junior strawberry-flavored syrup.

The drug should be taken at equal intervals, after a meal.
Do not use the drug immediately before bedtime.

The drug is usually used for 7 to 10 days.
If symptoms worsen or do not resolve, contact your doctor.

If you feel that the effect of the drug is too strong or too weak, contact your doctor.

Use of a larger than recommended dose of Flegamina Classic.
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
Take the drug as soon as possible. When it is nearing the time to take the next dose, 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 medication, ask your doctor or pharmacist.

5 How to store the drug Flegamina Classic.

Store the drug out of sight and reach of children.
Store at a temperature below 25ºC, in a dry place.

Do not use this medicine after the expiration date on the label after "Expiration date:" or "EXP". Expiration date means the last day of the month stated.

Medicines should not be disposed of down the drain or in household waste containers. Ask your pharmacist how to dispose of medicines you no longer use. This treatment will help protect the environment. The batch number on the package is located after the abbreviation "Lot".

4 Possible side effects

Like any drug, this medication can cause adverse reactions, although they will not occur in everyone.

During the use of the drug Flegamina Classic may occur:

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

Rare (may occur in no 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 or pharmacist.
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, more information on the safety of the drug can be gathered.

6 Contents of the package and other information

What the drug Flegamina Classic contains
- The active substance of the drug is: bromohexine hydrochloride. One tablet contains 8 mg of bromohexine hydrochloride.
- The other ingredients are: lactose monohydrate, sodium carboxymethyl starch (see section 2 "The drug Flegamina Classic contains sodium"), magnesium stearate.

What Flegamina Classic drug looks like and what the packaging contains.
Flegamina Classic tablets are round, bilaterally flat with truncated edges, with a dividing line on one side. The package contains 20, 40 or 60 tablets.

2 Information important before using Flegamina Classic.

When not to use the drug Flegamina Classic
- if the patient is allergic to bromohexine hydrochloride or any of the other components of this drug (listed in section 6).
- In children aged 3 to 6 years who are unable to swallow the tablet.
- In children under 2 years of age due to the content of bromohexine.

Warnings and precautions
Discuss with your doctor before taking Flegamina Classic:
- if the patient has inflammation of the respiratory tract with an accompanying bacterial infection. Flegamina Classic tablets 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 gastric and duodenal ulcers, or active gastric and duodenal ulcers, as the drug may exacerbate their 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 contains lactose").

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 and contact your doctor immediately.

Children
The drug Flegamina Classic in tablet form should not be used in children aged 3 to 6 years who are unable to swallow a tablet. In these patients, it is recommended to use bromohexine in the form of Flegamina Classic Junior strawberry-flavored syrup.
The drug Flegamina Classic tablets, due to the content of bromohexine, should not be given to children under the age of 2 years.

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

The drug Flegamina Classic tablets 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 tablets 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 tablets with food and drink.
The drug should be taken 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 child, you should consult your doctor or pharmacist before taking this medication.

Pregnancy
Do not 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
It is not recommended to use the drug during breastfeeding.

Driving and operating machinery
Caution should be exercised, as headaches and dizziness or drowsiness may occur.

The drug Flegamina Classic contains lactose.
If you have previously been diagnosed with intolerance to certain sugars, you should contact your doctor before taking the drug.

The drug Flegamina Classic contains sodium
The drug contains less than 1 mmol (23 mg) of sodium per tablet, that is, the drug is considered "sodium free."

Flegamina Classic, 8 mg, tablets
Bromhexini hydrochloridum