Ambroxol EG 15 mg/5 ml Mucolytic Syrup 200 ml

Syrup for oral suspension based on ambroxol hydrochloride .

Therapeutic indications

Ambroxol EG is indicated for the treatment of cough in case of diseases of the bronchi and lungs (acute and chronic bronchopulmonary diseases). This medicine contains the active substance ambroxol hydrochloride, which belongs to a group of medicines called mucolytics, used to help clear mucus from the airways.

Dosage and posology

Take Ambroxol STADA after meals and avoid taking it for prolonged periods.

• Adults: The recommended dose for adults is 10 ml (30 mg) 3 times a day.
• Children over 5 years of age: the recommended dose is 5 ml (15 mg) 3 times a day.
• Children 2 to 5 years of age: the recommended dose is 2.5 ml (7.5 mg) 3 times a day.

Overdose

No cases of overdose have been reported. Symptoms of an overdose may correspond to undesirable effects that can occur at recommended doses. If you accidentally take an overdose of this medicine, notify your doctor immediately or go to the nearest hospital.

Contraindications

Do not take Ambroxol STADA:

• if you are allergic to ambroxol hydrochloride or any of the other ingredients of this medicine
• if you have severe liver or kidney problems (severe liver and / or kidney problems)
• if the person who is to take this medicine is a child under 2 years of age

Side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur:

• Common (which may affect up to 1 in 10 people) altered sense of taste (dysgeusia); loss of sensation in the mouth and pharynx (hypoesthesia); nausea.
• Uncommon (which may affect up to 1 in 100 people) vomiting, diarrhea, digestive difficulties (dyspepsia) and abdominal pain; dry mouth.
• Rare (may affect up to 1 in 1,000 people) headache (headache); increased mucus production, runny nose (runny nose); heartburn and heartburn (heartburn); constipation (constipation); skin irritation (rash, hives, contact dermatitis); difficulty passing urine (dysuria); tiredness.
• Not known (frequency of which cannot be estimated from the available data) allergic reactions (anaphylactic shock, angioedema, pruritus and other hypersensitivity reactions); occlusion of the bronchi (bronchial obstruction); dry throat.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• Pregnancy

It is not recommended to use Ambroxol STADA during pregnancy especially during the first three months. If you are pregnant, take it only in cases of absolute necessity and under the direct supervision of your doctor.

• Feeding time

It is not recommended to use Ambroxol STADA while breastfeeding.

Special warnings

Talk to your doctor or pharmacist before taking Ambroxol Stada. Take this medicine with caution and tell your doctor:

• if you have a stomach or bowel problem called a peptic ulcer;
• if you have kidney problems (severe kidney failure).

Rare cases of skin lesions (Stevens Johnson syndrome or toxic epidermal necrolysis) have been reported during treatment with this medicine. Particularly in the early stages of such illnesses, you may experience flu-like symptoms, such as fever, pain, cold (rhinitis), cough and sore throat. If you experience any skin or mucosal lesions, consult your doctor and stop taking Ambroxol STADA.

Ambroxol STADA should not be given to children under 2 years of age as it can block the bronchi and prevent normal breathing. Contains sorbitol and glycerol This medicine contains sorbitol, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This medicine contains glycerol, a type of alcohol, which can cause headache, stomach upset and diarrhea.

Expiration and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. After first opening the syrup bottle, the medicine should be used within 30 days; after this period the residual medicinal product must be discarded.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

100 ml of Ambroxol EG syrup contains:

Active principle

300 mg of ambroxol hydrochloride.

Excipients

Hydroxyethylcellulose, 70% sorbitol solution, glycerol, benzoic acid, black cherry flavor, propylene glycol, tartaric acid. purified water.