Sopharma – Ambrolitin syrup against wet cough 15 mg/5 ml (100 ml)
| SKU | 30019035 |
|---|---|
| Form | SYRUP |
| Weight | 0.15 kg |
€6,39
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Sopharma's Ambrolytin syrup is a product that relieves a wet cough. It is a mucolytic, suitable for use in acute and chronic diseases of the upper and lower respiratory tract, accompanied by increased viscous secretion and impaired mucus transport. The syrup relieves a wet cough, liquefies bronchial secretions and facilitates expectoration. Ambrolitin is a non-prescription medicine intended for adults and children over 2 years of age. No sugar, no dyes. With a pleasant raspberry taste.
It is available in a 100 ml package.
| Composition | |
| Ambroxol hydrochloride | 15 mg/5 ml |
| Excipients: sorbitol (E420), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), glycerol, propylene glycol, saccharin sodium, citric acid monohydrate, raspberry essence, purified water. | |
Usage
Dosage:
- Adults and children over 12 years: 10 ml, 3 times a day during the first 2-3 days. After that – 10 ml, 2 times a day.
- Children from 6 to 12 years: 5 ml, 2-3 daily.
- Children from 2 to 6 years: 2.5 ml, 3 times a day.
- Children under 2 years: 2.5 ml, 2 times a day, after consultation with a doctor or pharmacist.
Application: orally, during meals.
The duration of treatment should not exceed 4-5 days without consulting a doctor!
Non-prescription medicinal product intended for adults and children over 2 years of age. For children under 2 years of age – consult a doctor or pharmacist
Patient Leaflet
AMBROLITIN syrup 15 mg / 5 ml 100 ml
Package leaflet: patient
information Ambrolytin 15 mg/5 ml syrup
Ambrolytin®® 15 mg/5 ml syrup
ambroxol hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may have to read it again.
- If you need further information or advice, ask your pharmacist.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
- If after 5 days you do not feel better or your condition worsens, you should seek medical attention.
What is in this leaflet:
1. What Ambrolitin is and what it is used
for 2. What you need to know before you take Ambrolitin
3. How to take Ambrolitin
4. Possible side effects
5. How to store Ambrolitin
6. Contents of the pack and other information
1. What Ambrolitin is and what it is used for
Ambrolitin syrup contains the active substance ambroxol hydrochloride, which liquefies the dense secretion in the bronchi, formed in various diseases of the respiratory tract. It is used to facilitate expectoration, relieve cough and improve breathing in acute and chronic diseases of the respiratory system, which are associated with the formation of dense secretions in the respiratory tract.
2. What you need to know before you take Ambrolitin
Do not take Ambrolitin
- • if you are allergic (hypersensitive) to the active substance or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Ambrolitin:
- if you are allergic to certain medicines or foods;
- if you have kidney or liver disease;
- if serious skin and mucosal damage occurs during treatment.
Severe skin reactions related to the use of ambroxol have been reported. If you get a skin rash (including lesions of the mucous membranes, such as the mouth, throat, nose, eyes, genitals), stop using Ambrolitin and call your doctor immediately.
Other medicines and Ambrolitin
Tell your doctor or pharmacist if you are taking, have recently taken or might use any other medicines.
It is not recommended to use ambroxol simultaneously with cough suppressant drugs.
Pregnancy, breast-feeding and fertility
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. The safety of the use of this drug during pregnancy has not been proven. Therefore, it is not recommended to use the product during pregnancy, especially in the first trimester.
Ambroxol passes into breast milk. Although no adverse effects on the infant are expected, the use of the medicinal product during breast-feeding is not recommended.
Driving and using machines
There are no data on the influence of Ambrolitin on motor reactions and attention in drivers and machine operators.
Ambrolithin contains as excipients:
- sorbitol – if you have been told by your doctor that you have an intolerance to some sugars, ask your doctor for advice before taking this product;
- methyl- and propyl parahydroxybenzoate – can cause allergic reactions (it is possible that they are of a delayed type);
- glycerol – in high doses (10 g / dose) can cause headache, stomach irritation and diarrhea;
- Sodium – This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially sodium free.
3. How to take Ambrolitin
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Adults and adolescents over 12 years: 10 ml 3 times a day for the first 2-3 days, after which the dose can be reduced — 10 ml 2 times a day.
The
dosage in the elderly does not differ from that in adults.
Patients with hepatic and renal impairment
This category of patients is given half a dose of that recommended for adults.
Use in children
- from 6 to 12 years – 5 ml 2-3 times a day
- from 2 to 6 years – 2.5 ml 3 times a day
- under 2 years – 2.5 ml 2 times a day
Ambrolitin syrup should be used in children under 2 years of age in consultation with a doctor or pharmacist.
Ambrolitin syrup is taken orally, with meals.
Do not use the drug for more than 5 days without a doctor’s recommendation.
If you feel that the effect of the drug is very strong or too weak, consult your doctor.
If you take more Ambrolitin than you should
If you take a dose greater than necessary, ask your doctor for advice.
If you forget to take Ambrolitin
In case you miss a dose, take it as soon as possible. If it’s time for your next dose, take it as usual. Do not take a double dose to make up for a forgotten dose. Continue to take the medicine as recommended in the information.
If you have any further questions on the use of this product, please ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Adverse reactions are classified by frequency:
- Common (affects 1 to 10 patients): decreased sensitivity in the oral cavity and throat, nausea, change of taste.
- Uncommon (affects 1 to 100 patients): dry mouth, vomiting, diarrhoea, dyspepsia (stomach discomfort, belching after meals) and stomach pain.
- Rare (affects 1 to 1000 patients): hypersensitivity reactions, dry throat, rash, hives.
- Not known (frequency cannot be estimated from the available data): anaphylactic reactions, including anaphylactic shock, angioedema (rapidly developing edema of the skin, subcutaneous tissue, mucous membranes or submucosal layer) and pruritus; severe skin side effects (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalised exanthema pustulost).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. This allows continued monitoring of the benefit-risk balance of the medicinal product.
5. How to store Ambrolitin
Store in the original package at a temperature below 25°C.Keep out of the reach of children.
The medicine should not be used after the expiry date which is stated on the package. The expiry date refers to the last day of that month. The syrup can be used up to 1 month after opening the bottle.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unnecessary medicines. These measures will help to protect the environment.
6. Contents of the pack and other information
What Ambrolitin contains
- The active substance is ambroxol hydrochloride 15 mg in 5 ml syrup.
- The other ingredients are: sorbitol (E420), methyl parahydroxybenzoate (E218), propyl parahydroxybeisoate (E216), glycerol, propylene glycol, saccharin sodium, citric acid monohydrate, raspberry essence, purified water.
What Ambrolitin looks like and contents of the pack
Clear, syrupy liquid, pale yellow to slightly brownish in color, with the smell of raspberry.
Syrup 100 ml in a dark glass bottle or polyethylene terephthalate in a cardboard box, together with a measuring cup and a leaflet.
Marketing Authorisation Holder and Manufacturer
SOPHARMA AD, Bulgaria
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