Read all of this leaflet carefully before you start taking this

medicine because it contains important information for you.

* Keep this leaflet. You may need to read it again.

* If you have any further questions, ask your doctor or

pharmacist.

* This medicine has been prescribed for you only.

Do not pass it on to others. It may harm them, even if their

signs of illness are the same as yours.

* If you get any side effects talk to your doctor or pharmacist.

100 ml.

2-COMPOSITION

Each 5ml of SOLVAMUC contains 30mg ambroxol hydrochloride

solution.

Excipients: sodium benzoate, glycerin, sorbitol 70%,propylene glycol,

HEC, citric acid, sodium citrate, sucralose, menthol, strawberry flavor,

purified water

3-THERAPEUTIC INDICATIONS

SOLVAMUC cough syrup 30 mg/5 ml is a medicine used to thin

mucus in respiratory tract diseases where tenacious mucus is a

pharmacist if you are not sure.

The recommended dose is:

Children up to 2 years of age: on medical advice only 1.25 ml of

solution should be taken twice daily (equivalent to 15 mg ambroxol

hydrochloride per day).

Children from 2 to 5 years of age: 1.25 ml of solution should be taken

three times daily (equivalent to 22.5 mg ambroxol hydrochloride per

day).

Children from 6 to 12 years of age: 2.5 ml of solution should be taken

two to three times daily (equivalent to 30 - 45 mg ambroxol

For adults and adolescents from 12 years of age, the therapeutic

effect may be enhanced by increasing the dosage to 10 ml twice daily

(equivalent to 120 mg ambroxol hydrochloride per day).

Method of administration and duration of treatment

SOLVAMUC cough syrup 30 mg/5 ml is an oral solution.

SOLVAMUC cough syrup 30 mg/5 ml can be taken with or without food

and is dispensed with the aid of the measuring cup provided. Please

clean the measuring cup after each use by rinsing with warm water.

You must talk to a doctor if you feel worse or if you do not feel better

after 4 - 5 days. If you feel that the effect of SOLVAMUC cough syrup 30

recommended doses (see section 6). In case of overdose, please

consult a doctor as symptomatic treatment may be required.

If you forget to take SOLVAMUC cough syrup 30 mg/5 m

If you forget to take SOLVAMUC cough syrup 30 mg/5 ml or take too

small a dose, wait until it is time to take your next dose and then

continue taking SOLVAMUC cough syrup 30 mg/5 ml as described in

the dosage instructions above.

If you stop taking SOLVAMUC cough syrup 30 mg/5 ml

If you stop treatment early, your symptoms may get worse.

5-ADVERSE REACTIONS

Vomiting, diarrhea, indigestion, abdominal pain, dry mouth, Fever,

mucous membrane reactions

Rare (may affect up to 1 in 1,000 treated patients)

Hypersensitivity reactions, Rash, urticaria, Dry throat

Very rare (may affect up to 1 in 10,000 treated patients)

Increased salivation

Not known(frequency cannot be estimated from the available data)

Anaphylactic reactions including anaphylactic shock, angioedema

(rapidly developing swelling of the skin, subcutaneous, mucosa or

submucosal tissues) and pruritus, severe cutaneous adverse

cough syrup 30 mg/5 ml

6-WARNINGS AND PRECAUTIONS:

Contraindications:

Do not take SOLVAMUC cough syrup 30 mg/5 ml:

• if you are allergic to the active substance, ambroxol hydrochloride,

or any of the other ingredients of this medicine (listed in section 2).

Appropriate precautions for use; special warnings:

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine.

There have been reports of severe skin reactions associated with the

must not take SOLVAMUC cough syrup 30 mg/5 ml except on

medical advice. With ambroxol, as with any medicine which is

broken down in the liver and then eliminated via the kidneys,

accumulation of the breakdown products (metabolites) of ambroxol

which are formed in the liver can be expected to occur in patients

with severely impaired kidney function.

In some rare bronchial diseases which are associated with

excessive accumulation of secretions (such as primary ciliary

dyskinesia), SOLVAMUC cough syrup 30 mg/5 ml should only be used

under medical supervision because of the risk that secretions may

taken/used or might take/use any other medicines.

Ambroxol/antitussives

If SOLVAMUC is used in combination with antitussives in patients with

pre-existing respiratory diseases such as cystic fibrosis or

bronchiectasis who are affected by mucus hypersecretion, a

reduced cough reflex may lead to (serious) accumulation of mucus.

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.

Animal studies have shown that the active

substance ambroxol passes into breast milk.

Even though no harmful effects to the child

are to be expected, use during

breastfeeding is not recommended.

Fertility

Non-clinical studies have produced no

evidence of any harmful effects on fertility.

Driving and using machines

There is no evidence of any effect on the

ability to drive or use machines. No relevant

studies have been performed.

SOLVAMUC cough syrup 30 mg/5 ml

REACH OF CHILDREN

Do not use this medicine after the expiry

date which is stated on the label and carton

after EXP. The expiry date refers to the last

day of that month.

Store below 30° C.

Shelf life after first opening the bottle.

The shelf life after first opening the bottle is 6

months.