Flegamina Classic o smaku miemtovim bez cukru

Package Leaflet: Information for the User

Flegamina Classic Mint Flavor Sugar-Free, 4 mg/5 ml, Syrup

Bromhexine Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains

Important Information for the Patient.
This medication should always be taken exactly as described in the patient leaflet or as directed by a doctor, pharmacist, or nurse.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. See section 4.
• If there is no improvement or the patient feels worse, a doctor should be contacted.

Table of Contents of the Leaflet:

• 1. What is Flegamina Classic Mint Flavor Sugar-Free and what is it used for
• 2. Important Information Before Taking Flegamina Classic Mint Flavor Sugar-Free
• 3. How to Take Flegamina Classic Mint Flavor Sugar-Free
• 4. Possible Side Effects
• 5. How to Store Flegamina Classic Mint Flavor Sugar-Free
• 6. Package Contents and Other Information

1. What is Flegamina Classic Mint Flavor Sugar-Free and what is it used for

Flegamina Classic Mint Flavor Sugar-Free Syrup contains the active substance bromhexine hydrochloride, which has an expectorant effect, thinning the secretion of the respiratory tract.
The medication facilitates coughing up and cleansing of the bronchi. The medication does not contain sugar.
Flegamina Classic Mint Flavor Sugar-Free is indicated for acute and chronic respiratory diseases, accompanied by impaired expectoration and sputum clearance.

2. Important Information Before Taking Flegamina Classic Mint Flavor Sugar-Free

Sugar-Free

When Not to Take Flegamina Classic Mint Flavor Sugar-Free

• if the patient is allergic to bromhexine hydrochloride or any of the other ingredients of this medication (listed in section 6);
• in children under 7 years of age, as the medication contains alcohol.

Warnings and Precautions

Before taking Flegamina Classic Mint Flavor Sugar-Free, the patient should discuss with their doctor:

• if the patient has inflammatory respiratory diseases with accompanying bacterial infection. Flegamina Classic Mint Flavor Sugar-Free should be taken simultaneously with antibiotics and bronchodilators prescribed by the doctor. During treatment, the patient should drink plenty of fluids, especially if they have a fever. Proper hydration increases the thinning of bronchial secretion and facilitates expectoration.
• if the patient has a history of stomach or duodenal ulcers or active stomach or duodenal ulcers, as the medication may exacerbate their 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 "Flegamina Classic Mint Flavor Sugar-Free contains sorbitol").

There have been reports of severe skin reactions associated with the use of bromhexine hydrochloride. If a rash occurs (including changes in the mucous membranes, e.g., mouth, throat, nose, eyes, genitals), the patient should stop taking Flegamina Classic Mint Flavor Sugar-Free and contact their doctor immediately.

Children

Due to the presence of alcohol, Flegamina Classic Mint Flavor Sugar-Free should not be taken by children under 7 years of age.

Flegamina Classic Mint Flavor Sugar-Free and Other Medications

The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take, including those available without a prescription.
Flegamina Classic Mint Flavor Sugar-Free should not be taken with:

• cough suppressants, such as those containing codeine and its derivatives, as they may weaken the cough reflex and cause retention of secretions in the respiratory tract.

Flegamina Classic Mint Flavor Sugar-Free should be taken with caution when used concurrently with:

• atropine and other anticholinergic medications, as they cause dryness of the mucous membranes.
• salicylates and other nonsteroidal anti-inflammatory medications, as the medication may enhance their irritating effect on the gastrointestinal mucosa.
• antibiotics such as oxytetracycline, erythromycin, ampicillin, doxycycline, cefuroxime, amoxicillin, as concurrent use of the medication with these antibiotics increases their concentration in lung tissue.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication.
Pregnancy:
The medication is not recommended during the first three months of pregnancy. In the remaining period of pregnancy, the medication may be taken only if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus.
Breastfeeding:
The medication should not be taken during breastfeeding.

Driving and Operating Machinery

Cautiousness is advised, as the medication may cause headaches, dizziness, or drowsiness. The medication contains ethanol, which may impair the ability to drive vehicles and operate machinery.

Flegamina Classic Mint Flavor Sugar-Free Contains Ethanol

The medication contains 200 mg of alcohol (ethanol) per 5 ml of syrup. The amount of alcohol in 5 ml of this medication is equivalent to less than 5 ml of beer or 2 ml of wine. The small amount of alcohol in this medication will not have noticeable effects.

Flegamina Classic Mint Flavor Sugar-Free Contains Propyl Parahydroxybenzoate (E 216)

The medication contains propyl parahydroxybenzoate and may cause allergic reactions (possible late reactions).

Flegamina Classic Mint Flavor Sugar-Free Contains Sorbitol

The medication contains sorbitol (5 ml of syrup contains 2.1 g of sorbitol). Sorbitol is a source of fructose. If hereditary fructose intolerance has been previously diagnosed in the patient, they should consult their doctor before taking the medication. Sorbitol may cause gastrointestinal discomfort and has a mild laxative effect. The energy value is 2.6 kcal/g of sorbitol.

Flegamina Classic Mint Flavor Sugar-Free Contains Patent Blue (E 131)

The medication may cause allergic reactions.

Flegamina Classic Mint Flavor Sugar-Free Contains Sodium

The medication contains less than 1 mmol (23 mg) of sodium per 5 ml of syrup, which means the medication is considered "sodium-free".

3. How to Take Flegamina Classic Mint Flavor Sugar-Free

This medication should always be taken as directed by the doctor or pharmacist. If there are any doubts, the doctor or pharmacist should be consulted.
The medication is for oral use.
The volume of syrup should be measured using the enclosed measuring spoon or cup, according to the patient's age.
If the doctor does not recommend a special dosage, the medication is usually taken:

Children from 7 to 12 years of age:5 ml of syrup – 3 times a day.
Adults and children over 12 years of age:10 ml of syrup – 3 times a day.
The medication should not be taken directly before bedtime.

Overdose of Flegamina Classic Mint Flavor Sugar-Free

No symptoms of overdose of bromhexine have been reported.
In case of overdose, activated charcoal should be administered. If necessary, the doctor will prescribe gastric lavage and symptomatic treatment.
In case of taking a higher dose of the medication than recommended, the patient should immediately consult their doctor or pharmacist.

Missed Dose of Flegamina Classic Mint Flavor Sugar-Free

If a dose of the medication is missed, it should be taken as soon as possible. If it is almost time for the next dose, the missed dose should be skipped.
A double dose should not be taken to make up for the missed dose.
If there are any further doubts about taking the medication, the doctor or pharmacist should be consulted.

4. Possible Side Effects

Like all medications, Flegamina Classic Mint Flavor Sugar-Free can cause side effects, although not everybody gets them.
During treatment with Flegamina Classic Mint Flavor Sugar-Free, the following side effects may occur:

Uncommon(may affect up to 1 in 100 people):

• upper abdominal pain, nausea, vomiting, diarrhea

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

• -hypersensitivity reactions, rash, urticaria

Frequency Not Known(frequency cannot be estimated from the available data):

• headaches, dizziness, drowsiness,
• bronchospasm,
• indigestion,
• excessive sweating,
• increased liver enzyme activity,
• decreased blood pressure,
• anaphylactic reactions, including anaphylactic shock, angioedema (rapidly progressing swelling of the skin, subcutaneous tissue, mucous membranes, or submucosal tissue) and itching,
• severe skin reactions (including polymorphic erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).

Reporting Side Effects

If any side effects occur, including those not listed in this leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Medicinal Product Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medication.

5. How to Store Flegamina Classic Mint Flavor Sugar-Free

Store out of sight and reach of children.
Store in the original packaging to protect from light.
Shelf life after opening the bottle: 28 days.
Do not take this medication after the expiration date stated on the carton and bottle after the label "Expiration Date (EXP):" or "EXP:". The expiration date refers to the last day of the month.
Medications should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of unused medications. This will help protect the environment.

6. Package Contents and Other Information

What Flegamina Classic Mint Flavor Sugar-Free Contains

• The active substance of the medication is bromhexine hydrochloride. 5 ml of syrup contains 4 mg of bromhexine hydrochloride.
• The other ingredients are: liquid sorbitol, non-crystallizing, glycerol, ethanol 96%, propyl parahydroxybenzoate (E 216), levomenthol, eucalyptus-mint flavor (contains, among others, ethanol), concentrated hydrochloric acid, patent blue (E 131), turmeric (turmeric (E 100), polysorbate 80 (E 433), propylene glycol (E 1520)), purified water.

What Flegamina Classic Mint Flavor Sugar-Free Looks Like and What the Package Contains

Flegamina Classic Mint Flavor Sugar-Free is a light green, clear syrup with a minty smell and taste, in an orange glass bottle containing 120 ml or 200 ml of syrup, in a carton. The bottle is closed with a polypropylene cap with a foam LDPE/HDPE seal and a guarantee ring LDPE. A polystyrene measuring spoon with a scale of 1 ml; 1.25 ml; 2 ml; 2.5 ml; 3 ml; 4 ml; 5 ml or a polypropylene measuring cup with a scale of 1.25 ml; 2.5 ml; 5 ml; 7.5 ml; 10 ml is attached to the package.

Marketing Authorization 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 Krakow
Teva Czech Industries s.r.o., Ostravská 305/29, Komárov 747 70 Opava, Czech Republic

Date of Last Revision of the Leaflet: