AMBROLAN (AMBROXOL) TABLETTEN 30MG N20

ATC code: R05CB06 

Active substances: Ambroxoli Hydrochloridum

Vendor, principal: Gl Pharma. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

AMBROLAN 30MG N20

Package leaflet: Information for the user

Ambrolan 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 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, pharmacist or nurse. 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 4-5 days.

What is in this leaflet

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

1. What Ambrolan is and what it is used for

The active substance of the Ambrolan tablets is the active metabolite of bromhexine, ambroxol hydrochloride. It dissolves the viscous secretion accumulated in bronchi and accelerates its excretion by ciliary activation. In addition ambroxol dilutes excessively thick mucus and facilitates its excretion.

Indications

Mucolysis in case of productive cough accompanying diseases of lungs and bronchi.

2. What you need to know before you use Ambrolan

Do not take Ambrolan:

-   if you are allergic to ambroxol or any of other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Ambrolan:
-   if you have bronchial disease accompanied by excretion of large amount of secretions (risk of mucus stasis),
-   if you have renal impairment,
-   if you have severe liver disease,
-   if you are prone to developing ulcerative diseases of gastrointestinal tract,
-   due to high content of the active substance Ambrolan 30 mg tablets should not be administered to children under 6 years of age,
-   serious skin reactions have been reported in association with ambroxol; stop the treatment with Ambrolan and contact your doctor immediately if skin rash (including sores on mucous membranes, e.g. in mouth, nose, eyes, genitals) develops.

Other medicines and Ambrolan

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Talk to your doctor or pharmacist before taking Ambrolan if take simultaneously other cough medicines. Taking Ambrolan with other cough medicines may cause a dangerus obstruction of mucus movement in airways due to impairment of cough reflex.
Higher penetration of antibiotics amoxicillin, cefuroxime, doxycycline, and erythromycin into bronchial secretion has been noted during concomitant administration of ambroxol.

Pregnancy and breast-feeding

Talk to your doctor or pharmacist before using this medicine.
Ambroxol may be used during pregnancy (especially during the first trimester) and breast-feeding only with the doctor’s prescription.

Driving and using machines

Ambrolan has no effect on the ability to drive and use machines.

Ambrolan contains lactose (milk sugar).

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Ambrolan

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if
you are not sure.

Take the tablet after meal with liquid (e.g. a glass of water).

Mucolytic effect increases with liquid consumption.
Talk to your doctor if symptoms become worse or do not improve within 4-5 days of starting the
treatment.
If not prescribed otherwise, the recommended dose is:
-   adults and adolescents over 12 years: 1 tablet twice a day. After consulting with a doctor and in severe cases the dose may be increased to 1 tablet three times a day.
-   children 6-12 years of age: 54 tablets twice a day. After consulting with a doctor and in severe cases the dose may be increased to 54 tablet three times a day.
-   children under 6 years of age: Due to high content of the active substance Ambrolan tablets should not be administered to children under 6 years of age.
-   patients with renal and (or) liver impairment: in case of renal or liver impairment you should talk to the doctor before taking Ambrolan. The dose should be reduced or the time between doses prolonged if required.

If you take more Ambrolan than you should

If overdosage is suspected, contact a doctor immediately.

If you forget to take Ambrolan

Do not take a double dose to make up for a forgotten tablet.
If you feel that the effect of Ambrolan is too strong or too weak, talk to your doctor or pharmacist.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

4.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Ambrolan immediately and talk to your doctor if the next symptoms develop during treatment with Ambrolan: severe allergic reaction, for example extensive rash, accompanied by itching, fever, chills, lymph node disease, joint pain, skin detachment and changes in blood tests.
The frequency of side effects is determined as follows: very common (occurs in more than 1 user out of 10), common (occurs in 1-10 users out of 100), uncommon (occurs in 1-10 users out of 1,000), rare (occurs in 1-10 users out of 10,000), very rare (occurs in lesss than 1 user out of 10,000), not known (cannot be estimated from the available data).

The next side effects may occur:

Gastrointestinal disorders
Common: diarrhea Uncommon: nausea, vomiting Rare: heartburn Very rare: dyspepsia
Skin and subcutaneous tissue disorders
Rare: rash, urticaria
Unknown: serious skin reactions (incl. erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalized exanthematous pustulosis).
Immune system disorders Rare: hypersensitivity reactions
Unknown: anaphylactic reactions, incl. anaphylactic shock, angioedema (rapidly developing edema of skin, subcutaneous tissues, mucous membranes and submucosal tissues) and pruritus.

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 Ambrolan

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Store in the original package in order to protect from light.
Do not use this medicine after the expiry date which is stated on the carton. 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 Ambrolan contains

-   The active substance is ambroxol hydrochloride. 1 tablet contains 30 mg of ambroxol hydrochloride.
-   The other ingredients are lactose monohydrate, potato starch, povidone (K=22.5-27.0), microcrystalline cellulose, magnesium stearate.

What Ambrolan looks like and contents of the pack

White, round, biconvex and scored tablet.
The tablet may be divided into equal doses.
20 tablets in blister package.

Marketing Authorisation Holder and Manufacturer

G.L. Pharma Ges.m.b.H., Schlossplatz 1, A-8502 Lannach, Austria
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Covalent OÜ
Pämu mnt 102c, Tallinn 11312, Estonia Tel: +3726600945, fax: +3726600946

This leaflet was last revised in May 2016.

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