Sopharma – Ambrolitin 30 mg (20 tablets)
| Form | TABLETS |
|---|---|
| Content | 20 tablets |
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Ambrolytin tablets of Sopharma 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 product relieves wet coughs by liquefying bronchial secretions and facilitating expectoration. Ambrolitin is a non-prescription drug intended for adults and children over 6 years of age. Available in a pack of 20 tablets.
| Composition | in 1 tablet: |
| Ambroxol hydrochloride | 30 mg |
| Excipients: lactose monohydrate, corn starch, colloidal anhydrous silicon dioxide, magnesium stearate. | |
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, ask your doctor or pharmacist.
Daily dose:
- Adults: 1 tablet (30 mg ambroxol) 3 times a day for the first 2-3 days, then 1 tablet (30 mg ambroxol) 2 times a day.
The daily dose can be increased to 2 tablets (60 mg ambroxol) 2 times a day. - Adolescents over 12 years: 1 tablet (30 mg ambroxol) 3 times a day for the first 2-3 days, then 1 tablet (30 mg ambroxol) 2 times a day.
- Children from 6 to 12 years: 1/2 tablet (15 mg ambroxol) 2-3 times a day.
This dosage is suitable for the treatment of acute diseases of the respiratory tract and for the initial therapy of chronic conditions for up to 14 days.
The duration of treatment should not exceed 4-5 days without consulting a doctor.
Ambrolitin tablets are taken after a meal, with a sufficient amount of liquid (eg water, tea or fruit juice).
More Information
Warnings and precautions
Talk to your doctor or pharmacist before taking Ambrolitin:
What you should know before taking Ambrolitin
Do not use Ambrolitin
if you are allergic to ambroxol hydrochloride or to any of the other ingredients of this medicine;
in children under 6 years of age.
if you have impaired kidney function or severely impaired liver function;
if you have had a peptic ulcer in the past;
if you have impaired bronchomotor function and large amounts of secretion (eg in a condition known as primary ciliary dyskinesia).
There have been reports of severe skin reactions associated with the administration of ambroxol hydrochloride. If you develop a skin rash (including mucosal lesions 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.
Concomitant use of ambroxol hydrochloride with cough suppressants is not recommended.
No clinically significant side effects have been reported with simultaneous use with other medicinal products.
Pregnancy and breast-feeding
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.
Pregnancy
It is not recommended to use Ambrolitin during pregnancy, especially in the first trimester.
Breast-feeding
It is not recommended to use Ambrolitin during breast-feeding, as ambroxol hydrochloride passes into breast milk.
Driving and using machines
There is no evidence from post-marketing data regarding the effect of the drug on the ability to drive and use machines.
No studies have been conducted on the effect on the ability to drive and use machines.
Ambrolitin contains lactose monohydrate
If your doctor has told you that you have an intolerance to some sugars, contact him before taking this medicinal product.
If you take more Ambrolitin than you should
If you take more than you should, talk to your doctor or pharmacist. No specific symptoms of overdose in humans have been reported so far. Symptoms observed in reports of accidental overdose or misuse are consistent with known side effects when using 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 missed dose. Continue to take subsequent doses as usual.
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.
Common (may affect up to 1 in 10 patients):
– nausea.
Uncommon (may affect up to 1 in 100 patients):
– vomiting, diarrhoea, indigestion, stomach pain.
Rare (may affect up to 1 in 1,000 patients):
– hypersensitivity reactions;
– 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 itching;
– severe skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalized exanthematous pustulosis).
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 and blister after EXP. The expiry date corresponds to the last day of the month indicated.
To be stored below 25°C.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
Patient Leaflet
AMBROLITIN tablets 30 mg * 20
Package leaflet: patient
information Ambrolytin 30 mg tablets Ambrolytin 30 mg tablets
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 you need to know before you take Ambrolitin
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 tablets contain the active substance ambroxol hydrochloride, which liquefies the dense secretion in the bronchi, formed in various diseases of the respiratory tract.
It is used in children over 6 years, adolescents and adults to facilitate expectoration and relieve cough in acute and chronic diseases of the bronchi and lungs, which are associated with the formation of dense secretions in the respiratory tract.
Talk to your doctor if after 4-5 days you do not feel better or your condition worsens.
2. What you need to know before you take Ambrolitin
Do not use Ambrolitin
- if you are allergic to ambroxol hydrochloride or any of the other ingredients of this medicine (listed in section 6);
- in children under 6 years.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ambrolitin:
- if you have impaired kidney function or severely impaired liver function;
- if you have had peptic ulcer in the past;
- • if you have impaired bronchomotor function and high amounts of secretion (for example, in a condition known as primary ciliary dyskinesia).
Severe skin reactions associated with the use of ambroxol hydrochloride have been reported. If you experience a skin rash (including lesions of the mucous membranes of 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 significant adverse reactions have been reported with concomitant use with other medicinal products.
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 post-marketing data on the effect of the medicine on the ability to drive and use machines.
No studies have been conducted regarding the effect on the ability to drive and use machines.
Ambrolithin contains lactose monohydrate
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Ambrolitin
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has said. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Adults:
1 tablet (30 mg ambroxol) 3 times a day for the first 2-3 days, then 1 tablet (30 mg ambroxol) 2 times a day.
The daily dose can be increased to 2 tablets (60 mg ambroxol) 2 times a day.
Adolescents over 12 years
On 1 tablet (30 mg ambroxol) 3 times a day for the first 2-3 days, then 1 tablet (30 mg ambroxol) 2 times a day.
Children from 6 to 12 years
1/2 tablet (15 mg ambroxol) 2-3 times a day.
This dosage is suitable for the treatment of acute respiratory diseases and for the initial therapy of chronic conditions up to 14 days.
The duration of treatment should not exceed 4 – 5 days without consulting a doctor.
Ambrolitin tablets are taken after meals, with a sufficient amount of fluid (e.g. water, tea or fruit juice).
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. Continue to take the following doses as usual.
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.
Common (may affect up to 1 in 10 people):
- nausea.
Uncommon (may affect up to 1 in 100 people):
- 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 adverse reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalised exanthemal pustullosis).
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 and blister after EXP. The expiry date refers to the last day of that month.
Store below 25°C.
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. Each tablet contains 30 mg ambroxol hydrochloride.
The other ingredients are lactose monohydrate, cornstarch, colloidal anhydrous silica, magnesium stearate.
What Ambrolitin looks like and contents of the pack
White to off-white, round flat tablets, with double-sided veneer and score, 9 mm in diameter. The tablet can be divided into two equal doses.
10 (ten) tablets in a blister of PVC/Al or PVC/PVdC/Al foil. 2 (two), 3 (three) or 5 (five) blisters in a cardboard box, together with a leaflet.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
SOPHARMA AD, Bulgaria
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