PACKAGE LEAFLET

Read this entire leaflet carefully before you start using this medicine.
-Keep this leaflet. You may need to read it again.
-If you have further questions, please ask your doctor or your pharmacist.
-This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

In this leaflet:

1. What PARAMAX-COD-tablets are and what they are used for
2. Before you take PARAMAX-COD-tablets
3. How to take PARAMAX-COD-tablets
4. Possible side effects
5. Storing PARAMAX-COD-tablets

 

PARAMAX-COD-tablet

Light blue, capsule-shaped tablet with score. Width is 7.5 mm and length is 18 mm.

The active substances are paracetamol 500 mg and codeine phosphate hemihydrate 30 mg in one tablet. The other ingredients are microcrystalline cellulose, pregelatinised starch, sodium starch glycolate, povidone, stearic acid, magnesiumstearate and colour substance (indigo carmine E132).

PARAMAX-COD tablets are lactose free and sugar free.

 

Marketing authorisation holder and manufacturer

Vitabalans Oy, Varastokatu 8, 13500 Hämeenlinna

 

1. WHAT PARAMAX-COD-TABLETS ARE AND WHAT THEY ARE USED FOR

PARAMAX-COD-tablets are used in different pain conditions. PARAMAX-COD-tablets are meant for temporary use.

 

2. BEFORE YOU TAKE PARAMAX-COD-TABLETS

Pregnancy and breast-feeding

Long-term use of PARAMAX-COD during pregnancy is not recommended. Consult with your doctor before taking PARAMAX-COD.

The active substance passes into breast milk. Long-term use during nursing is not recommended. Consult with your doctor before taking PARAMAX-COD.

Driving and using machines

Codeine produces tiredness. PARAMAX-COD may hence affect harmfully ability to drive and use machines.

Taking other medicines

Carbamazepine, phenytoin, phenobarbital, rifampicin and isoniazid can increase the liver toxicity of paracetamol.

Overdose

The first symptoms in overdose are nausea, vomiting and pain in stomach. Liver insufficiency is possible when taken in high quantities.

In the case of overdose or poisoning, contact you doctor immediately.

Take special care with PARAMAX-COD-tablets

Concomitant use of PARAMAX-COD with alcohol should be avoided because of the increased risk of possible respiratory depression and liver toxicity.

 

3. HOW TO TAKE PARAMAX-COD-TABLETS

The dose of PARAMAX-COD should be adjusted according to physician´s advice.

The tablets should be taken with plenty of liquid.

 

4. POSSIBLE SIDE EFFECTS

Paracetamol: With recommended dosage, side effects are minimal. As rare side effects paracetamol may cause allergic reactions.
In long-term use liver damage is possible.
Codeine: Codeine can cause tiredness, nausea, constipation and biliousness. Side effects are dose-dependent. Risk of dependence caused by codeine must be taken into account.
If other side effects occur, or if side effects, which are mentioned above are strong, contact your doctor.

 

5. STORING PARAMAX-COD-TABLETS

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
Store the tablets under 25 ° C. Do not use after expiry date stated on the carton.

The last update of the package leaflet

10.3.2009