Sopharma – Ambrolitin 30 mg/5 ml Anti-cough syrup (120 ml)
| SKU | 30022715 |
|---|---|
| Form | SYRUP |
| Weight | 0.15 kg |
€7,29
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Sopharma's Ambrolytin syrup 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 liquefies bronchial secretions, facilitates expectoration and relieves cough. Ambrolitin is a non-prescription medicine intended for adults and adolescents over 12 years of age. No sugar, no dyes. With a pleasant raspberry taste.
It is available in a 120 ml package.
| Composition | in 5 ml: |
| Ambroxol hydrochloride | 30 mg |
| Other ingredients: sorbitol (E420), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), glycerol, propylene glycol, saccharin sodium, citric acid monohydrate, raspberry essence, purified water. | |
Usage
How to take Ambrolitin:
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure about something, ask your doctor or pharmacist.
Dosage:
Adults and adolescents over 12 years: 5 ml 3 times a day during the first 2 days; then – 5 ml 2 times a day.
Ambrolitin syrup is taken orally, during meals.
Do not use the medicine for more than 5 days without a doctor’s recommendation.
If you have the feeling that the effect of the drug is too strong or too weak, consult your doctor.
Do not take Ambrolitin:
if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine.
More Information
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.
There have been reports of severe skin reactions associated with the administration of ambroxol. If you develop a skin rash (including mucosal lesions, eg 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.
The simultaneous use of ambroxol with cough suppressants is not recommended.
Pregnancy, breast-feeding and fertility:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using 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 adverse effects on the infant are not expected, the use of the medicinal product during breastfeeding is not recommended.
Driving and using machines:
There are no data on the influence of Ambrolitin on motor reactions and attention in drivers of vehicles and machine operators.
Ambrolitin contains as excipients:
sorbitol – if your doctor has told you that you have an intolerance to some sugars, consult him before taking this product;
methyl- and propyl parahydroxybenzoate – can cause allergic reactions (possibly 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. practically no sodium.
If you have taken more Ambrolitin than you should:
If you have taken more than you should, consult your doctor.
If you forget to take Ambrolitin:
In case you miss a dose, take it as soon as possible. If it is almost time for the next dose, take it as usual. Do not take a double dose to make up for a missed dose. Continue to take the medicine as recommended in the information.
If you have any further questions related to the use of this product, please ask your doctor or pharmacist.
Possible side effects:
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Adverse drug reactions are classified by frequency:
– Common (affects 1 to 10 patients): reduced sensitivity in the oral cavity and throat, nausea, change in taste.
– Uncommon (affects 1 to 100 patients): dry mouth, vomiting, diarrhoea, dyspepsia (stomach discomfort, belching after eating) and stomach pain.
– Rare (affects 1 to 1,000 patients): hypersensitivity reactions, dry throat, rash, urticaria.
– With an unknown frequency (an estimate cannot be made from the available data): anaphylactic reactions, including anaphylactic shock, angioedema (rapidly developing swelling of the skin, subcutaneous tissue, mucous membranes or submucosal layer) and pruritus; severe skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis).
If any of the side effects become serious or you notice other side effects not described in this leaflet, please tell your doctor or pharmacist.
How to store Ambrolitin:
Store in the original packaging, at a temperature below 25°C.
Keep out of the reach of children.
The medicine should not be used after the expiration date marked on the package. The expiration date corresponds to the last day of the specified month. The syrup can be used up to 1 month after opening the bottle.
Medicines should not be disposed of down the drain or in the household waste container. Ask your pharmacist how to dispose of your unwanted medicines. These measures will help protect the environment.
Patient Leaflet
AMBROLITIN syrup 30 mg / 5 ml 120 ml
Package leaflet: patient
information Ambrolytin 30 mg/5 ml syrup
Ambrolytin 30 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 4-5 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
Ambrolithin syrup contains the active substance ambroxol hydrochloride, which liquefies the thick bronchial secretion formed in various diseases of the respiratory tract.
Ambrolitin syrup is used in adults and adolescents over 12 years of age to facilitate expectoration and relieve coughing in acute and chronic diseases of the lung associated with the formation of dense secretions in the respiratory tract.
If after 4-5 days you do not feel better or your condition worsens, you should seek medical attention.
2. What you need to know before you take Ambrolitin
Do not take Ambrolitin
- • if you are allergic to amberoxol hydrochloride 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 have impaired kidney function or severely impaired liver function.
Severe skin reactions associated with the use of ambroxol hydrochloride 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 hydrochloride at the same time with cough suppressant drugs.
No clinically relevant adverse interactions with other medicinal products have been reported.
Pregnancy and breast-feeding
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 Ambrolitin during pregnancy, especially in the first trimester.
Breastfeeding
It is not recommended to use Ambrolitin during lactation, since ambroxol hydrochloride passes into breast milk.
Driving and using machines
There is no evidence from the post-marketing data concerning the influence on the ability to drive and use machines. No studies have been conducted regarding the effects on the ability to drive and use machines.
Ambrolithine contains sorbitol (E 420), methylparahydroxybenzoate (E 218) and propylparahydroxybenzoate (E 216), propylene glycol (E 1520) and sodium.
This medicine contains 1.75 g of sorbitol in every 5 ml of syrup, which is equivalent to 350 mg/ml. If you have been told by your doctor that you have an intolerance to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic condition in which people cannot break down fructose, talk to your doctor before taking or being given this medicine.
The excipients methylparahydroxybenzoate and propylparahydroxybenzoate may cause allergic reactions (possibly of the delayed type).
This medicine contains 100 mg propylene glycol in 5 ml, which is equivalent to 20 mg/ml.
This medicine contains less than 1 mmol sodium (23 mg) in 5 ml, that is, it can be said that it is practically 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:
5 ml of syrup 3 times a day (equivalent to 90 mg amberoxol hydrochloride) for the first 2 to 3 days, subsequently 5 ml of syrup 2 times a day (equivalent to 60 mg ambroxol hydrochloride daily).
In adults, the dose may be increased, if necessary, to 60 mg ambroxol hydrochloride twice daily (equivalent to 120 mg ambroxol hydrochloride daily).
This dosage is suitable for the treatment of acute respiratory diseases and for the initial therapy of chronic conditions.
If in case of acute respiratory disease, symptoms do not improve within 4 – 5 days, a doctor should be consulted.
Elderly patients
The dosage in elderly patients does not differ from the dosage in adults.
Patients with hepatic or renal impairment
In patients with hepatic or renal impairment, a doctor should be consulted before starting treatment.
Ambrolithin can be taken with or without food.
If you take more Ambrolitin than you should
If you take a dose greater than necessary, ask your doctor or pharmacist for advice. So far, no specific symptoms of overdose have been reported in humans. The symptoms observed in reports of accidental overdose or misuse are consistent with known adverse reactions with the use of Ambrolitin at recommended doses and may require symptomatic treatment.
If you forget to take Ambrolitin
In case you miss a dose, take it as soon as possible. Do not take a double dose to make up for a forgotten dose. Take the next dose as usual.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people):
- taste change, nausea, decreased sensitivity in the mouth, tongue and throat.
Uncommon (may affect up to 1 in 100 people):
- dry mouth, vomiting, diarrhoea, digestive disorders, stomach pain.
Rare (may affect up to 1 in 1000,<> patients):
- hypersensitivity reactions; rash, urticaria.
Not known (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 itching;
- severe skin side effects (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalised exanthemal pustullosis);
- dryness in the throat.
Reporting suspected adverse reactions
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Ambrolitin
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light.
Shelf life after opening the bottle: 6 months.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Ambrolitin contains
The active substance is ambrooxol hydrochloride.
1 ml contains 6 mg ambroxol hydrochloride. 5 ml of syrup contains 30 mg ambroxol hydrochloride.
The other ingredients are: sorbitol (E420), methylparahydroxybenzoate (E218), propylparahydroxybenzoate (E216), glycerol (E 422), propylene glycol (E 1520), saccharin sodium (E 954), citric acid monohydrate (E 330), Tutti Frutti essence (flavouring part: orange oil, ethyl butyrate, isoamyl butyrate, isoamyl acetate, vanillin; a-tocopherol racemate (E 307)),
purified water.
What Ambrolitin looks like and contents of the pack
Clear, colourless syrupy liquid, with a specific odour, pH 2,20-3,20.
120 ml syrup in a brown glass bottle of 125 ml capacity, closed with a polypropylene, child-resistant stopper
Or
200 ml syrup in a brown glass bottle of 200 ml capacity, closed with a polypropylene, child-resistant stopper.
1 (one) bottle, together with a graduated measuring cup with 2.5 ml, 3 ml, 5 ml, 7.5 ml, 10 ml, 12.5 ml, 15 ml and 20 ml and a leaflet are placed in a cardboard box.
Not all packs may be marketed.
Marketing Authorisation Holder and Manufacturer
SOPHARMA AD, Bulgaria
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