Paracetamol Adipharm 500 mg

Dear patients,

 

Please, read carefully the information included in the present leaflet. It contains important information for you about the medicinal product and its correct and safe use. In case that after reading this information, you still have additional questions, please do not hesitate to contact your physician or pharmacist.

 

Patients leaflet

 

NAME OF THE MEDICINAL PRODUCT

 

PARACETAMOL ADIPHARM

 

ACTIVE INGREDIENT

 

Each tablet contains:

 

 Paracetamol                                                          500 mg

 

LIST OF EXCIPIENTS

     

 Each tablet contains:

     

Carboximethylcellulose sodium type A  - 15 mg

     

Lactose monohydrate -  61 mg

     

Copovidone - 23 mg

     

Cellulose microcrystalline  - 25 mg

     

Magnesium stearate -   6 mg

     

Talcum  - 10 mg

 

PHARMACEUTICAL FORM

     

Tablets

 

MANUFACTURER AND MARKETING AUTHORISATION HOLDER

  

Adipharm Ltd., 1700 Sofia, 130 Simeonovsko shosse blvd.

 

PROPERTIES

 

Symptomatic treatment of mild to moderate: headache, toothache, mild to moderate postoperative or posttraumatic pain, increased body temperature due to influenza or cold.

 

CONTRAINDICATIONS

 

Paracetamol is contraindicated in cases of hypersensibility to paracetamol or any other substance from the list of excipients, in severe liver diseases.

 

SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE

 

Do not take other medicines containing paracetamol (combination products for treatment of cold) at the same time with this medicinal product in order to avoid the risk of overdose.

 

You must consult a physician in case:

 

- You take anti-convulsive agents, izoniazide or other medicines (prescribed by a physician or given without prescription) together with paracetamol.

 

- You suffer from liver or kidney diseases.

 

- Patients using more than 90 ml of concentrated alcohol daily must consult a physician before taking paracetamol.

 

 

ATTENTION!

 

You have to consult your physician if your symptoms continue for more than 5 days or these symptoms are accompanied by high temperature, headache, rash, nausea and vomiting for more than 3 days.

 

If you plan to undergo an operation even if it is a dentist procedure, you have to inform the physician that you take paracetamol.

 

If you know that you suffer from intolerability towards some kinds of saccharides /e.g. lactose, galactose, etc./, you have to consult your physician before starting the intake of this medicinal product.

 

Paracetamol do not cause languishing or dizziness and may be used by drivers and users of machines.

 

INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

 

The concomitant use of paracetamol may increase the effect of the drugs for suppression of blood clotting (anti-coagulant and fibrinolytic agents) but the clinical significance of this interaction is not known. Cholestyramine, antacids and the presence of food in the stomach reduce the paracetamol resorption. Metoclopramide and domperidon increase the extent of paracetamol resorption and enhance its effects. The concomitant use of paracetamol and some drugs like phenytoin, carbamazepine, phenobarbital, and izoniazide may increase the risk of liver toxicity when using paracetamol.

 

Paracetamol must not be used together with alcohol since it may increase liver toxicity of paracetamol. Patients using more than 90 ml of concentrated alcohol daily must consult a physician before taking paracetamol.

 

In order to avoid possible interactions between several medicinal products, always inform your physician or pharmacist when you take other drugs as well.

 

PREGNANCY AND LACTATION

 

During pregnancy and lactation paracetamol may be taken only consultation with a physician.

 

DURING PREGNANCY AND LACTATION ALWAYS CONSULT YOUR PHYSICIAN OR PHARMACIST BEFORE TAKING ANY KIND OF MEDICINAL PRODUCT.

 

POSOLOGY AND METHOD OF ADMINISTRATION

 

Adults and children more than 12 years of age:

 

1-2 tablets every 4-6 hours but no more than 6 tablets daily.

 

Children from 6 to 12 years of age:

 

½-1 tablet every 4-6 hours but no more than 4 tablets daily.

 

The treatment duration without consultation with a physician should not exceed 5 days for adults and 3 days for children

 

UNDESIRABLE EFFECTS

 

Often the following undesirable effects can be observed: increased hypersensitivity of the skin towards sunlight, nausea and vomiting, sleep disturbances and nightmares, increased pulse rate, nervousness and irritability, fast tiredness, excitation in children. In these cases the intake of paracetamol may be continued or to shift to other similar products.

 

Rarely blood formation disturbances including also the risk of hemorrhages are observed.

 

Rarely allergic reaction (heavy breathing, tightness of throat, swelling of lips, tongue, face) are observed.

 

Liver impairment (yellow skin and eyes, nausea, abdominal pain, fast tiredness or discomfort) is observed at the toxic dosage.

 

DO NOT HESITATE TO ASK YOUR PHYSICIAN OR PHARMACIST FOR AN ADVICE. INFORM THEM FOR ANY UNDESIRABLE OR UNPLEASANT EFFECT WHICH YOU HAVE NOTICED AND IT IS NOT MENTIONED IN THIS LEAFLET.

 

OVERDOSE

 

In case of overdose, liver impairment may occur including severe liver insufficiency. In every case of overdose, both on purpose or occasionally, seek immediately for medical aid!

 

STORAGE

 

Shelf life: 3 years.

 

DO NOT USE THIS PRODUCT AFTER THE DATE INDICATED ON THE OUTER PACKAGE!

 

SPECIAL PRECAUTIONS FOR STORAGE

 

Store under 25^о С in a dry and protected from sunlight place, far from the reach of children.

 

NATURE AND CONTENTS OF THE PACK

      

Secondary pack – card box containing 1 blister of 10 tablets.

     

Secondary pack – card box containing 2 blister, each of 10 tablet .

 

DEAR PATIENTS, YOU CANNOT FIND THE COMPLETE INFORMATION FOR THIS DRUG IN THIS LEAFLET. IF YOU HAVE ANY QUESTIONS AFTER READING IT, CONSULT YOUR PHYSICIAN OR PHARMACIST.

 

DATE OF LAST REVISION OF THE TEXT

 

February 2005.