“Composition
The active substance is ambroxol hydrochloride. 5 ml of syrup contains 30 mg of ambroxol hydrochloride.
The other ingredients are: liquid, non-crystallizing sorbitol; glycerol 85%; benzoic acid (E 210); propionic acid; banana essence (contains, among others: propylene glycol (E 1520), methylheptine-carbonate, eugenol, citral, isoeugenol, sulfites); Purified Water.
Dosage
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.
Children aged
1 to 2 years: 1.25 ml of syrup (7.5 mg ambroxol) – 2 times a day;
2 to 5 years: 1.25 ml of syrup (7.5 mg ambroxol) – 3 times a day;
6 to 12 years: 2.5 ml of syrup (15 mg of ambroxol) – 2 to 3 times a day.
Children over 12 years of age and adults
5 ml of syrup (30 mg of ambroxol) up to 3 times a day for the first 2 to 3 days, then 5 ml of syrup 2 times a day.
Action
A drug that stimulates the secretion of bronchial mucus and reduces its viscosity.
Indications
Ambroksol Orifarm is used in acute and chronic respiratory diseases causing difficulty in expectorating viscous secretions in the respiratory tract, such as: acute and chronic bronchitis, inflammation of the nose and throat, cystic fibrosis.
Contraindications
When not to use Ambroksol Orifarm
– If you are allergic to the active substance or any of the other ingredients of this medicine.
– If you suffer from bronchospasm.
Side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare (may affect up to 1 in 1,000 people):
– hypersensitivity reactions;
– allergic reactions such as: skin reactions, redness and/or burning of mucous membranes, facial swelling, shortness of breath, chills;
– rash, hives;
– abdominal pain, constipation, heartburn, indigestion, nausea and vomiting.
Not known (frequency cannot be estimated from the available data):
– anaphylactic reactions, including anaphylactic shock, angioedema (rapidly progressive swelling of the skin, subcutaneous tissue, mucosa or submucosal tissue) and pruritus;
– serious skin side effects (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalized pustulosis).
During long-term use, in rare cases, the following may occur: dryness of the oral mucosa and respiratory tract, watery nose, increased salivation, and urination disorders.
Occasionally, fatigue and/or fatigue have also been reported in patients receiving ambroxol 60-120 mg daily.
Warnings and precautions
Before you start using Ambroksol Orifarm, talk to your doctor or pharmacist.
The drug should be used with particular caution in patients with a weakened cough reflex or impaired ciliary clearance of the bronchi.
In patients with bronchial asthma, the drug may initially worsen cough.
The drug should be used with caution in patients with severe liver failure, gastric or duodenal ulcer and intestinal ulceration.
In patients with renal failure, the doctor will recommend reducing the daily dose depending on the degree of kidney function or extending the interval between doses.
It is not recommended to administer the drug immediately before bedtime.
Store at temperatures below 25°C. Do not freeze. Protect from light.
After opening the bottle, do not store the medicine for longer than 3 months.
Keep the medicine out of the sight and reach of children
Taking other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Ambroksol Orifarm should not be used simultaneously with antitussive drugs (e.g. codeine) due to their effect on inhibiting the cough reflex.
Ambroxol Orifarm administered simultaneously with antibiotics (e.g. amoxicillin, ampicillin, cefuroxime, doxycycline, erythromycin) increases their penetration into the lungs and intensifies their action.
Orifarm ambroxol and theophylline mutually intensify their effects.
Pregnancy and breastfeeding
For pregnant or breastfeeding women, consult your doctor before using the medicine.
The medicine can be used by pregnant and breastfeeding women only when clearly necessary.
This is medicine. For safety, use it according to the leaflet included in the package. Pay attention to contraindications. If in doubt, consult your doctor or pharmacist.”
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