PACKAGE LEAFLET: INFORMATION FOR THE USER

Paracetamol Nordic 500 mg Granules

Read all of this leaflet carefully before you start taking this medicine.

This medicine is available without prescription. However, you still need to take Paracetamol Nordic 500 mg Granules carefully to get the best results from it.

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

-    If you have any further questions ask your pharmacist.

-    This product should only be used for a short period of time without consulting a doctor.

-    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What paracetamol is and what it is used for

2.    Before you take paracetamol

3.    How to take paracetamol

4.    Possible side effects

5.    How to store paracetamol

6.    Further information

1.    WHAT PARACETAMOL IS AND WHAT IT IS USED FOR

Paracetamol reduces pain and fever. It may be used in adults and children aged 12 years and older to treat mild to moderate pain and/or fever.

2.    BEFORE YOU TAKE PARACETAMOL Do not take Paracetamol Nordic 500 mg Granules

-    if you are allergic (hypersensitive) to paracetamol or any of the other ingredients of Paracetamol Nordic 500 mg Granules.

Take special care with paracetamol

You should not take Paracetamol Nordic 500 mg Granules without first consulting a doctor, if you:

-    Are suffering from liver problems including liver problems due to excessive alcohol consumption.

- Have an excessive alcohol consumption

-    Are suffering from Gilbert's syndrome (a mild form of Jaundice)

-    Are suffering from kidney problems

-    Are suffering from dehydration and chronic malnutrition

-    Are an asthma patient and also sensitive to aspirin.

-    Use other painkillers which contain paracetamol

-    Have fever that does not disappear within 3 days even after paracetamol therapy

-    Have glucose-6-phosphatedehydrogenase deficiency (enzyme deficiency)

-    Have hemolytic anemia (abnormal breakdown of red blood cells].

Stop using this medicine and consult a doctor:

-    If the pain persists for longer than 5 days.

-    If the fever persists for longer than 3 days.

-    If the pain and/or fever become more serious.

-    If other symptoms develop.

Never take more paracetamol than recommended. Taking a higher dose than recommended has no extra pain-killing or fever-reducing effect but may seriously damage your liver. The symptoms of liver damage normally don't appear until after a few days. After an overdose, it is therefore very important to seek medical advice as soon as possible, even if you feel well.

Using other medicines

Please see your doctor before you take paracetamol in case you use one of the following medicines:

-    metoclopramide or domperidone ( medicines used to treat nausea and vomiting);

-    colestyramine (used to lower your cholesterol);

-    anti-coagulants (medicines to thin the blood, e.g. warfarin), in case you need to take a painkiller on a daily basis over a long period.

-    salicylamide (a pain killer)

-    probenecide (a medicine used to treat gout)

-    isoniazid (a medicine used to treat tuberculosis)

-    lamotrigine, phenytoin, phenobarbital and carbamazepine (medicines used to treat epilepsy)

-    rifampicin (a medicine used to treat tuberculosis)

Please tell your doctor pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

If you are going to have any laboratory tests (such as a blood test, urine analysis, skin allergy test, etc.), you should tell your doctor that you are taking this medicine as it could affect the results of these tests.

Taking paracetamol with food and drink

During use of paracetamol you should not drink alcohol.

Pregnancy

Studies with paracetamol do not indicate that there are adverse effects on the pregnancy or on the health of the unborn child. You may take paracetamol in the recommended doses during pregnancy.

During pregnancy, paracetamol should not be taken for long periods, at high doses or in combination with other medicinal products.

Breast-feeding

Although paracetamol is excreted in the breast milk in small amounts it has no unwanted effects on the child that is breast fed. Paracetamol may be used by breastfeeding women as long as the recommended dosage is not exceeded. In case of long term use caution should be exercised.

Driving and using machines

Using paracetamol does not influence your ability to drive or use machines.

Important information about some of the ingredients of Paracetamol Nordic 500 mg Granules

Paracetamol Nordic 500 mg Granules contains aspartame, which is a source of phenylalanine. Phenylalanine may be harmful to people suffering from the rare disorder phenylketonuria.

3. HOW TO TAKE PARACETAMOL

Always take paracetamol exactly as stated in the package information leaflet. You should check with your doctor or pharmacist if you are not sure.

Paracetamol Nordic 500 mg Granules may only be used by adults and by children aged 12 years and above.

The usual dose is:

Children aged 12-15 years and weighing 41 to 50 kg:

1 sachet (500 mg) a time, with a maximum of 4 sachets (2000 mg) per 24 hours, and with intervals of at least 4 hours.

Adults and children aged 16 years and older and weighing more than 50 kg:

1-2 sachets (500-1000 mg) at a time, with a maximum of 6 sachets (3000 mg) per 24 hours, and with intervals of at least 4 hours.

Do not exceed the stated dose.

Method of administration:

Paracetamol Nordic 500 mg Granules can be swallowed without water or other fluid.

Tear or cut the sachet open on the end where the notch is. Empty the sachet directly on your tongue and swallow the granules. If required, any remaining granules can be swallowed with water.

If you take more paracetamol than you should

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, paracetamol can cause side effects, although not everybody gets them.

The frequency using the following convention:

common: affects 1 to 10 users in 100;

uncommon: affects 1 to 10 users in 1.000;

rare: affects 1 to 10 users in 10.000;

very rare: affects less than 1 user in 10.000

not known: frequency cannot be estimated from the available data.

Rare:

oedema (abnormal accumulation of fluid under the skin), abnormal vision, simple skin rash or urticaria (dark red rash on the skin),bleeding in the gastrointestinal tract, abdominal pain, diarrhoea, nausea, vomiting, dizziness, fever, sedation, uneasiness, platelet disorders (clotting disorders), problems with the blood forming cell in the bone marrow, liver problems, poisoning (after an overdose), tremor, headache, depression, confusion, hallucinations, sweating, itching, angioedema. You should stop taking paracetamol and see your doctor immediately if you experience symptoms of angioneurotic oedema, such as: swollen face, tongue or pharynx, difficulty in swallowing, hives and difficulties in breathing.

Very rare:

damage caused to the liver due to chemicals (hepatotoxicity), hypersensitivity reaction requiring discontinuation of treatment (immediate severe allergic reaction), thrombocytopenia (reduced platelet count), leucopenia (decrease in white blood cells), neutropenia (reduced neutrophil count in blood), agranulocytosis (decrease in granulocytes in the blood), haemolytic anemia (abnormal breakdown of red blood cells), hypoglycaemia (low levels of blood glucose in the blood), cloudy urine, kidney disorders.

Adverse reactions of paracetamol whose frequency is unknown, are: epidermal necrolysis (life-threatening skin disorder), erythema multiforme (allergic reaction or infection of skin), Stevens-Johnson syndrome (a severe life-threatening skin disorder), accumulation of fluid in the larynx, anaphylactic shock (severe allergic reaction), anaemia (decrease in red blood cells), kidney problems, blood in urine,problems with urinating, gastrointestinal effects (stomach ulcers and bleeding), vertigo, hepatitis.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    HOW TO STORE PARACETAMOL

Keep out of the reach and sight of children and adolescents.

Do not use Paracetamol Nordic 500 mg Granules after the expiry date which is stated on the carton or sachet after “EXP.”.

The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Paracetamol Nordic 500 mg Granules contains

The active substance is paracetamol. Each sachet contains 500 mg of paracetamol.

The other ingredients are: basic butylated methacrylate copolymer, colloidal hydrated silica (E551), stearic acid, sodium laurilsulfate, xylitol (E967), saccharin sodium (E954), aspartame (E951) and grapefruit flavour (containing potato maltodextrin, acacia gum (E414), buthylhydroxyanisol (E320)).

What Paracetamol Nordic 500 mg Granules looks like and contents of the pack

Paracetamol Nordic 500 mg Granules consists of white to off-white granules.

Paracetamol Nordic 500 mg Granules are available in sachets packed in cartons of 5, 10, or 20 sachets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder

Imgroma B.V.

Verrijn Stuartweg 60 1112 AX Diemen The Netherlands

This medicinal product is authorised in the Member States of the EEA under the following names:

This leaflet was last approved in { 03/2013}

Version Feb/2013 Page 5 of 5