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AMBROXOL SANDOZ SYR. 15MG/5ML 100ML

Attention: Information on this site is provided for informational purposes and is not meant to substitute for the advice provided by your own physician or other medical professional. You should not use the information contained herein for treating a health problem or disease, or prescribing any medication. iDrugs24.com is not responsible for any damage to your health as the result of self treatment.

# On 2024-Mar-28
AMBROXOL-drug/medicine aproximate price on "AMBROXOL SANDOZ SYR. 15MG/5ML 100ML" in Riga city, Latvia is:
  • 3.47€  3.75$  2.98£  401Rub  39.9SEK  15PLN  13.73₪ 


Maximum allowed state defined price ( from ZVA webpage) Euro:State defined maximum allowed price indicated on the picture on drug/medicine  AMBROXOL SANDOZ SYR. 15MG/5ML 100ML     Recheck

ATC codeR05CB06 

Active substances: Ambroxolum

 


Vendor, principal: Hexal Ag/salutas Pharma Gmbh
No prescription needed/Patient care products, dressings, gloves, medical devices,...

 .

AMBROXOL SOPHARMA 3MG/1ML 100ML

Package leaflet: information for the user

Ambroxol Sopharma, 3 mg/ml syrup

Ambroxol hydrochloride

Read all of this leaflet carefully before you start using 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 need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   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.
-   You must talk to a doctor if you do not feel better or if you feel worse after 5 days.

What is in this leaflet

1.   What Ambroxol Sopharma is and what it is used for
2.   What you need to know before you take Ambroxol Sopharma
3.   How to take Ambroxol Sopharma
4.   Possible side effects
5.   How to store Ambroxol Sopharma
6.   Contents of the pack and other information

1. What Ambroxol Sopharma is and what it is used for

Ambroxol Sopharma contains ambroxol hydrochloride as an active substance, which liquefies dense bronchial secretions accumulating during several respiratory diseases.
Mucus becomes more fluid and can easily be expelled through coughing, alleviating the cough and improving the respiratory function.
Ambroxol Sopharma is used to treat productive cough associated with diseases affecting bronchi of the lungs.
This medicine is intended for use for children aged 6 and older and for adults.
You must talk to a doctor if you do not feel better or if you feel worse after 5 days.

2. What you need to know before you take Ambroxol Sopharma Do not use Ambroxol Sopharma:

-   if you are allergic to ambroxol or any of the other ingredients of this medicine (listed in section 6);
in children under 6 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ambroxol Sopharma
-   If you are allergic to some medicines or food substances.
-   If you have a kidney or liver disease.
-   There have been reports of serious skin reactions in association with ambroxol use. If you develop skin rash (including ulcers on mucosal linings, such as in the mouth, throat, nose, eyes, or on the genitals), stop taking Ambroxol Sopharma and contact your doctor immediately.
-   Consult your doctor if you feel that your cough or condition has not become any better after 5 days.

Other medicines and Ambroxol Sopharma

Tell your pharmacist if you are taking, have recently taken or might take any other medicines.
- Ambroxol may be administered with antibiotics, but the concomitant use of ambroxol and medicines that suppress cough (such as codeine) is not recommended.

Ambroxol Sopharma with food, drink and alcohol

Take the Ambroxol Sopharma syrup orally during meals.

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.
The safe use of this medicine during pregnancy has not been confirmed. Therefore, it is not recommended to use this medicine during the pregnancy, especially during the first trimester. Ambroxol is excreted into breast-milk. Although no harmful effects to the breast-fed baby are expected, the use of this medicine is not recommended during breast-feeding.

Driving and using machines

There is no information on ambroxol affecting the ability to drive or work with machines.

Ambroxol Sopharma contains sorbitol.

If your doctor has told you that you do not tolerate certain sugars, consult your doctor before taking this medicine.
-   Methyl and propyl parahydroxybenzoates added to Ambroxol Sopharma may cause allergic reactions (possibly, delayed reactions).
-   One dose of the medicine contains less than 1 mmol of sodium (23 mg), which essentially means that it is sodium-free.

3. How to take Ambroxol Sopharma

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. You should check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Adults and adolescents over 12 years old
The initial treatment of acute or chronic diseases should start with the dose of 10 ml of syrup 3 times a day (equivalent to 90 mg ambroxol hydrochloride a day) for the first 2 to 3 days. Then, the dose may be decreased to 10 ml 2 times a day, corresponding to 60 mg ambroxol hydrochloride a day.
Elderly patients
Dosing in elderly patients is not different from adults.
Patients with liver and/or kidney impairment
In patients with liver and/or kidney impairment, the dose is '/2 of the recommended adult dose.

Use in children and adolescents

3 times a day (corresponds to 22.5 mg ambroxol 3 times a day (corresponds to 30 to 45 mg ambroxol
-   Children aged 2 to 5 years - 2.5 ml hydrochloride a day).
-   Children aged 6 to 12 years - 5 ml 2 to hydrochloride a day).
If the medicine is used in children aged 2 to 6 years, a doctor should be consulted before the start of
the treatment.
The secretolytic effect of ambroxol is enhanced if used with fluids; therefore, it is especially necessary to drink large amount of fluids during the treatment.
Do not use Ambroxol Sopharma over 5 days without consulting a doctor.
If you feel that the effect of this medicines is either too strong or too weak, consult your doctor.

If you take more Ambroxol Sopharma than you should

If you have taken more than you should, consult a doctor.

If you forget to take Ambroxol Sopharma

If you miss a dose, then take it as soon as possible. If the time of your next dose is near, take it as usual. Do not take a double dose to make up for a forgotten dose. Continue taking the medicine as instructed on the package leaflet.
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.
Ambroxol may cause serious hypersensitivity reactions. If you notice that you have suddenly developed the signs of allergy, such as skin rash, itching, or hives, the swelling of the skin somewhere on your body, breathlessness, wheezing, the swelling of your face, lips, tongue, or throat, difficulties in breathing or swallowing, stop taking Ambroxol Sopharma immediately and seek medical help.

Side effects have been classified according to frequency:

Common (may affect up to 1 person in 10):
-   decreased sensitivity in oral cavity and throat;
-   nausea;
-   taste disturbances or loss of taste.
Uncommon (may affect up to 1 person in 100):
-   dry mouth, vomiting, diarrhoea, dyspepsia (abdominal discomfort, postprandial belching), and abdominal pain.
Rare (may affect up to 1 person in 1,000):
-   hypersensitivity reactions;
-   rash, urticaria.
Unknown (frequency cannot be estimated from the available data):
-   anaphylactic reactions, including anaphylactic shock, angioedema (rapidly developing swelling of skin, subcutaneous tissue, mucosal membranes, or submucosal tissue) and itching;
-   sever skin reactions (including multiform erythema, Stevens-Johnson’s syndrome / toxic epidermal necrolysis, and acute generalised exanthematous pustulosis);
-   dry throat.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ambroxol Sopharma

Keep this medicine out of sight and reach of children.
This medicinal product does not require any special storage precautions.
Syrup may be used for 1 month after the initial opening of the bottle.
Do not use this medicine after the expiry date, which is stated on the inner and outer packages after the phrase ‘Use by’. The expiry date refers to the last day of that month.
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 protect the environment.

6. Contents of the pack and other information What Ambroxol Sopharma contains

-   The active substance is 15 mg ambroxol hydrochloride in 5 ml of syrup (3 mg/ml).
-   The other excipients are: sorbitol (E 420), methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), glycerol, propylene glycol, sodium saccharine, citric acid monohydrate, raspberry flavouring, purified water.

What Ambroxol Sopharma looks like and contents of the pack

Pale yellow to brownish clear raspberry-flavoured syrup.
100 ml syrup in a dark glass or polyethylene terephtalate bottle that is packaged in to a carton box with a measuring cap and a package leaflet. The volume of the measuring cap is 20 ml; the cap has been marked with increments of 2.5 ml, 5 ml, 7.5 ml, 10 ml, 15 ml and 20 ml.
Marketing Authorisation Holder and manufacturer SOPHARMA AD 16 Iliensko Shosse Str.
Sofia 1220 Bulgaria
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
VIP Pharma Eesti OÜ Uusaru 5 76505 Saue Estonia
Tel: +372 56 480 207.
E-mail: [email protected]
This leaflet was last revised in August 2017.





  Instruction, annotation source for medicine: State Agency of Medicines, Estonia




[*1]

DDD. Information source: WHO Collaborating Centre for Drug Statistics Methodology. Norwegian Institute of Public Health


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