Package leaflet: Information for the user

Supofen 200 mg/5ml Oral suspension

Paracetamol

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 or pharmacist. This includes any possible side effects not listed in this leaflet.

You must talk to a doctor if you do not feel better or if you feel worse after 2 days.

What is in this leaflet

1.    What Supofen is and what it is used for

2.    What you need to know before you take Supofen

3.    How to take Supofen

4.    Possible side effects

5.    How to store Supofen

6.    Contents of the pack and other information

1. What Supofen is and what it is used for

Supofen belongs to a group of drugs called analgesics (painkillers) and antipyretics that relieve mild to moderate pain and reduce fever.

Supofen can be used for the short-term symptomatic treatment of mild to moderate pain (e.g. headache, toothache, and period pain) and/or fever (high temperature).

Supofen is used to treat mild to moderate pain and/or fever in infants (older than 3 months), children, adolescents and adults (including elderly).

You must talk to your doctor if you do not feel better or if you feel worse after 2 days.

2. What you need to know before you take Supofen Do not take Supofen

-    if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6);

Warnings and precautions

Talk to your doctor or pharmacist before taking Supofen:

-    if you have liver problems (including Gilbert’s syndrome or hepatitis);

-    if you have kidney problems;

-    if you have haemolytic anaemia (abnormal breakdown of red blood cells);

-    if you are suffering from dehydration or and chronic malnutrition;

-    if you have a deficiency of a certain enzyme called glucose-6-phosphatedehydrogenase;

-    if you are using other medicines that are known to affect the liver;

-    if you are using other paracetamol containing medicines, as it may severely damage the liver ;

-    if you are asthmatic sensitive to acetylsalicylic acid.

Taking pain relieving medicines frequently for a long period of time can cause headaches or make them worse. You should not increase your dose of the pain relieving medicine, but contact your doctor for advice.

Warning: Ingestion of higher doses than the recommended does not give better pain-relief, but involves risk of serious liver damage. The maximal daily dose of paracetamol must therefore not be exceeded. Ask a doctor or pharmacist before concurrent use of other medicinal products also containing paracetamol. The symptoms of liver damage normally occur first after a couple of days. It is therefore important to seek medical advice immediately if you have taken more than recommended. See also section 3 “If you take more Supofen than you should”.

In case of high fever (>39°C), signs of infection or persistence of symptoms for more than 2 days you should contact a doctor.

Other medicines and Supofen

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is especially important in case of:

-    other medicines containing paracetamol, such as, for example, some medicines for flu;

-    warfarin or acenocoumarol (oral anticoagulant medicines used to thin the blood);glycopyrronium and propantheline (anticholinergic drugs that may reduce the absorption of paracetamol);

-    oral contraceptives;

-    phenytoin, phenobarbital, primidone and lamotrigine (medicines used in epilepsy);

-    chloramphenicol (an antibiotic);

-    isoniazid and rifampicin (medicines used to treat tuberculosis);metoclopramide and domperidone (medicines that accelerate the food emptying from the stomach);

-    probenecid (a medicine used to treat high levels of uric acid in the blood stream (gout));

-    propranolol (a medicine used to treat hypertension);

-    cholestyramine (a medicine used to lower the cholesterol levels);

-    zidovudine (a medicine used in the treatment of AIDS).

Effects of paracetamol on laboratory tests Uric acid and blood sugar tests may be affected.

Supofen with food, drink and alcohol

Supofen is a ready to use medicine and can be taken with food and drinks (except alcoholic drinks). If you usually drink large quantities of alcoholic drinks, you should take Supofen with special care and, during treatment with Supofen, you cannot drink alcoholic beverages. The administration of food did not show influence on the effect of the medicine but if you take this medicine after meals its effects may be delayed.

Pregnancy and breast-feeding

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.

Supofen should be used in pregnancy only after carefully assessment of the benefit-risk ratio. In this case, the recommended dosage and duration of use should be accurately followed.

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

Supofen in recommended doses may be used during breast-feeding.

Driving and using machines

Usually Supofen does not interfere with the ability of driving or using machines. However, if you experience mild drowsiness and dizziness as side effects, you should neither drive, nor use machines.

Supofen contains sucrose, methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216)

This medicine contains sucrose. If your doctor tells you that you have intolerance to certain types of sugar, contact your doctor before taking this medicine. Doses over 10 ml of oral suspension contain more than 5 g of sucrose per dose which should be taken into account in patients with diabetes mellitus. Sucrose may be harmful to the teeth.

This medicine contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (possibly delayed).

3. How to take Supofen

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Instructions for use:

-    Supofen is to be taken orally;

-    Shake well before use ;

-    The bottle cap is child proof. To open it, you must press the cap and at the same time turn it in a clockwise direction;

-    The oral suspension should not be diluted or mixed with other drinks;

-    Do not exceed the stated dose. Please observe that higher doses than those recommended may result in a risk of very serious liver damage.

This oral suspension should be given as follows:

Child’s Age	How Much	How often (in 24 hours)
3 - 6 months	1.5 ml	4 times
6 - 24 months	3 ml	4 times
2 - 3 years	4.5 ml	4 times
4 - 6 years	6 ml	4 times
7 - 9 years	9 ml	4 times
10 - 12 years	12.5 ml	4 times

Supofen must not be used in children under the age of 3 months unless advised by a doctor.

The exact quantity of Supofen should be delivered using the 5 ml oral syringe (graduated every 0.25 ml) provided in the cardboard box. The dosing syringe should be rinsed after use under the tap by hand operating several times (filling in with water).

In case of high fever (>39°C), signs of infection or persistence of symptoms for more than 2 days you must contact a doctor.

Patients with impaired liver or kidney function

In patients with mild to moderate hepatic insufficiency, or with Gilbert syndrome (familial nonhaemolytic jaundice) the daily effective dose should not exceed 60 mg/kg/day (up to maximum of 2 g/day).

In patients with impaired kidney function the dose has to be reduced or the dosing interval prolonged. In patients with severely impaired kidney function the dosing interval of Supofen has to be at least 8 hours.

Ask your doctor or pharmacist for advice.

For infants weighing less than 7 kg of body weight (6 month), the use of suppositories, if available, should be considered except in the case where the administration of this pharmaceutical form is not possible for clinical reasons (e.g. diarrhoea).

For children weighing more than 41 kg (older than 12 years), adolescents and adults other paracetamol dosage forms are available which may be considered more appropriate.

If you take more Supofen than you should

Talk to a doctor at once if your child takes too much of this medicine even if they seem well. This is because too much paracetamol can cause delayed, serious liver damage. Take the bottle or the empty box for easy identification. To avoid possible liver damage it is important that an antidote is given by a doctor as soon as possible. Symptoms of liver damage normally do not appear until after a few days. Symptoms of an overdose may include nausea, vomiting, anorexia (loss of appetite), paleness and abdominal pain and these symptoms usually occur within 24 hours after intake.

If you forget to take Supofen

Do not take a double dose to make up for a forgotten dose and take again Supofen according to the usual time.

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

4. Possible side effects

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

Stop the treatment and contact your doctor immediately in case of allergic reactions (hypersensivity) to paracetamol manifested by: Quincke’s oedema (swelling of the face, neck and genitals), dyspnoea (shortness of breath), sudation episodes (sweating), nausea, or low blood pressure.

Common (may affect up to 1 in 10 people):

-    mild drowsiness;

-    nausea;

-    vomiting.

Uncommon (may affect up to 1 in 100 people):

-    dizziness;

-    drowsiness;

-    nervousness;

-    burning sensation in the throat;

-    diarrhoea;

-    abdominal pain (including cramps and heartburn);

-    constipation;

-    headache;

-    sweating / sudation;

-    hypothermia (shivering).

Rare (may affect up to 1 in 1,000 people):

-    redness of the skin.

Very rare (may affect up to 1 in 10,000 people):

-    disorders of the blood development (thrombocytopenia, leukopenia, isolated cases of agranulocytosis, pancytopenia);

- in predisposed patients, bronchospasm.

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

5. How to store Supofen

This medicinal product does not require any special temperature storage conditions.

Store in the original package in order to protect from light.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the bottle label after EXP. The expiry date refers to the last day of that month.

After first-opening the bottle, the oral suspension should be used in the next 6 months.

Do not use this medicine if you notice visible signs of deterioration.

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 Supofen contains

-    The active substance is paracetamol.

-    The other ingredients are:

- citric acid monohydrate, sodium citrate, sucrose, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), orange flavour [natural flavouring substance(s), artificial flavouring substance(s), ethanol, butylated hydroxyanisole (E320)], xanthan gum and purified water.

What Supofen looks like and contents of the pack

Supofen is a white to almost white liquid with uniform appearance and orange flavour. Supofen is supplied in a cardboard box containing a glass bottle with 85 ml of oral suspension with a child-resistant closure and also a 5 ml oral syringe (graduated every 0.25 ml).

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorios Basi - Industria Farmaceutica, S.A.

Rua do Padrao, 98 3000-312 Coimbra - Portugal Tel.: +351 239 827 021 Fax.: +351 239 492 845 e-mail: basi@basi.pt

Manufacturer

Laboratorios Basi - Industria Farmaceutica, S.A.

Rua do Padrao, 98

3000-312 Coimbra - Portugal

This leaflet was last revised in 11/2012