1.3.1    SPC, LABELLING AND PACKAGE LEAFLET.

1.3 PRODUCT INFORMATION.

PACKAGE LEAFLET : INFORMATION FOR THE USER Paracetamol and Caffeine, 500mg & 65mg Tablets Paracetamol / Caffeine

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to take Paracetamol and Caffeine, 500mg & 65mg Tablets carefully to get the best results from it.

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

•    Ask your pharmacist if you need more information or advice.

•    You must contact a doctor if your symptoms worsen or do not improve within 3 days for fever and 5 days for pain.

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

In this leaflet:

1.    What Paracetamol and Caffeine, 500mg & 65mg Tablets is and what it is used for.

2.    Before you take Paracetamol and Caffeine, 500mg & 65mg Tablets.

3.    How to take Paracetamol and Caffeine, 500mg & 65mg Tablets.

4.    Possible side effects.

5.    How to Store Paracetamol and Caffeine, 500mg & 65mg Tablets.

6.    Further information.

1.    WHAT PARACETAMOL AND CAFFEINE, 500MG & 65MG TABLETS IS AND WHAT IT IS USED FOR.

Paracetamol and Caffeine, 500mg & 65mg Tablets contain paracetamol which is a pain reliever (analgesic) and helps reduce your temperature when you have a fever and caffeine which helps to increase the pain relief from paracetamol and makes you more alert.

This medicine is for the symptomatic treatment of mild to moderate pain and fever in conditions such as headache, toothache and period pains.

2.    BEFORE YOU TAKE PARACETAMOL AND CAFFEINE, 500MG & 65MG TABLETS

Do not take Paracetamol and Caffeine, 500mg & 65mg Tablets if:

•    You are allergic to paracetamol, caffeine or any of the other ingredients.

•    If you are under 15 years of age or weigh less than 50kg.

DO NOT TAKE ANYTHING ELSE CONTAINING PARACETAMOL WHILE TAKING THIS MEDICINE.

Take special care with Paracetamol and Caffeine, 500mg & 65mg Tablets. Check with your doctor before taking this medicine:

•    If you suffer from kidney or liver problems (including Gilbert’s syndrome) as the dose you need to take may need to be reduced

•    If you have hepatitis

•    If you suffer from Glucose-6-phosphatehydrogenase enzyme deficiency,

•    If you suffer from haemolytic anaemia (a form of anaemia caused by a breakdown of red blood cells)

•    If you are an alcoholic or are recovering from alcoholism

•    If you suffer from asthma and are sensitive to aspirin

•    If you are dehydrated or suffer from chronic malnutrition

•    If you have gout

•    If you suffer from hyperthyroidism

•    If you have arrhythmia.

Do not use Paracetamol and Caffeine, 500mg & 65mg Tablets without a doctor’s prescription if you have alcohol problems or a liver damage and do not use Paracetamol and Caffeine, 500mg & 65mg Tablets and alcohol concomitantly. The effect of alcohol is not enhanced by the addition of Paracetamol and Caffeine, 500mg & 65mg Tablets.

Taking other medicines

Talk to your pharmacist or doctor before you take Paracetamol and Caffeine, 500mg & 65mg Tablets if you are taking any medication, especially:

•    Clozapine (used to treat e.g. schizophrenia)

•    Beta-blockers such as atenolol, metoprolol, oxeprenolol or propranolol (used to treat high blood pressure and heart conditions)

•    Disulfiram (used in the treatment of alcoholism)

•    Fluvoxamin, monoamine oxidase inhibitors and litium (used to treat anxiety, depression and other psychological conditions) Diazepam (used to treat anxiety or as a sedative)

•    St John’s wort (used to treat mild forms of depression)

•    Phenylpropanolamine and ephedrine (decongestants) or theophylline (for asthma)

•    Other medicines containing paracetamol

•    Colestyramine (used to treat high cholesterol levels and reduce the amount of fat in the blood)

•    Metoclopramide and domperidone (used to control feeling sick or being sick).

•    Anticoagulants taken by mouth (used to prevent the blood from clotting) Dipyridamole (often used during hospital tests for heart conditions)

•    Methoxsalen (used to treat the skin condition psoriasis)

•    Carbamazapine, phenobarbitol, phenytoin, stiripentol and lamotrigine (used to treat epilepsy)

•    Levothyroxine (used to treat thyroid conditions)

•    Pipermidic acid (used to treat infections)

•    Probenecid (used to treat gout)

•    Salicylamide (used to treat fever or mild pain)

•    Isoniazid (used to treat tuberculosis)

•    Zidovudine (used to treat HIV).

•    Mexiletine (used to treat heart arrhythmias)

Chloramphenicol, ciprofloxacin, norfloxacin, enoxacin, rifampicin (antibiotics)

The results of tests on uric acid and blood sugar may be affected by paracetamol.

Taking Paracetamol and Caffeine, 500mg & 65mg Tablets with food and drink:

Do not take this product with alcoholic drinks.

Paracetamol and Caffeine, 500mg & 65mg Tablets contains caffeine. To avoid consuming too much caffeine, you should limit drinking liquids containing caffeine (coffee, tea, cola drinks) during treatment with Paracetamol and Caffeine, 500mg & 65mg Tablets .

Pregnancy and Breast feeding

Talk to your doctor before taking Paracetamol and Caffeine, 500mg & 65mg Tablets if you are pregnant or are breastfeeding. The caffeine in Paracetamol and Caffeine, 500mg & 65mg Tablets may affect your child.

3. HOW TO TAKE PARACETAMOL AND CAFFEINE, 500MG & 65MG TABLETS

Swallow the tablets whole, preferably with a drink of water.

For short term use only.

Age	Dose and how often to take
Adults, the elderly and adolescents (over 15 years) who weigh more than 60kg	Take 1-2 tablets every 4-6 hours as required. Do not take more than 6 tablets in any 24 hour period. Do not take more often than every 4 hours.
Adults, the elderly and adolescents (over 15 years) who weigh between 50kg and 60kg	Take 1 tablet every 4-6 hours as required. Do not take more than 4 tablets in any 24 hour period. Do not take more often than every 4 hours.
Do not give Paracetamol and Caffeine, 500mg & 65mg Tablets to children under 15 years or to adults or adolescents weighing less than 50kg.
Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor. If fever persists for more than 3 days or pain for more than 5 days or gets worse or other symptoms appear, stop taking this medicine and consult a doctor.

If you take more Paracetamol and Caffeine, 500mg & 65mg Tablets than you should

Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.

If you forget to take the medicine

You should only take this medicine as required following the dosage instructions carefully. If you forget to take a dose, take a dose as soon as you remember. Do not take a double dose to make up for a forgotten dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Paracetamol and Caffeine, 500mg & 65mg Tablets can sometimes have side effects, although not everybody gets them.

The following side effects have been reported in post marketing experience. The frequencies are defined as such: (common: 1 patient out of 100 to 1 out of 10, uncommon: 1 out of 1,000 to 1 out of 100, rare: 1 out of 10,000 to 1 out of 1,000, very rare: less than 1 out of 10,000) and not known (cannot be estimated from available data).

Blood and lymphatic system disorders

Very rare: Thrombocytopenia (low levels of blood platelets), agranulocytosis (low levels of white blod cells)

Immune system disorders

Rare: Anaphylactic reaction, allergic dermatitis, rash, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis Psychiatric disorders:

Common: Insomnia, restlessness, anxiety Nervous system disorders Common: Nervousness, dizziness, headache Cardiac disorders

Not known: Palpitations, tachycardia (heart beating too fast)

Respiratory, thoracic and mediastinal disorders Very rare: Bronchospasm Gastrointestinal disorders Common: Gastrointestinal disorder Hepatobiliary disorders

Very rare: Hepatic function abnormal, increased transaminases (symptoms of liver damage)

General disorders and administration site conditions Not known: Irritability

When the recommended dosage is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeine-related side effects such as nervousness, dizziness, insomnia, restlessness, anxiety, irritability, headache, gastrointestinal disorder and palpitations.

If you develop one of the side effects described above, please inform your doctor. At the first signs of a hypersensitivity reaction, stop taking Paracetamol and Caffeine, 500mg & 65mg Tablets . Your doctor will then assess the severity and decide on any further measures that may be necessary.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE PARACETAMOL AND CAFFEINE, 500MG & 65MG TABLETS Keep out of the sight and reach of children.

Do not store above 25°C. Keep the blister in the outer carton in order to protect from light.

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

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 to protect the environment.

6.    FURTHER INFORMATION What is in this medicine:

The active ingredients are: Paracetamol 500mg and Caffeine 65mg per tablet.

The other ingredients are: Maize Starch, Maize Starch, Pregelatinised, Povidone, Stearic Acid and Talc.

What this medicine looks like and contents of the pack

Paracetamol and Caffeine, 500mg & 65mg Tablets are white, capsule-shaped, tablets.

This pack contains 10, 12, 20, 24 or 30 Tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder: Galpharm Healthcare Limited, Wrafton, Braunton, Devon, EX33 2DL, United Kingdom.

Manufacturer: Wrafton Laboratories Limited, Wrafton, Braunton, Devon, EX33 2DL, United Kingdom.

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

Czech Republic ; Paracetamol/Caffeine Galpharm 500mg/65mg Tablets Denmark: Paracetamol/Caffeine ‘Orion’

France: Paracetamol/Cafeine Galpharm 500mg/65mg, Comprime Finland: Paracetamol / Coffein Galpharm 500mg/65mg Tabletti Germany: Paracetamol + Coffein Galpharm 500mg / 65 mg Tabletten Hungary: Paracetamol/Koffein APC 500mg/ 65mg tabletta Ireland: Paracetamol & Caffeine Galpharm Italy: Paracetamolo e Caffeina Galpharm

The Netherlands: Paracetamol/Coffeine Galpharm 500mg / 65 mg, tabletten

Norway: Paracetamol-Koffein Orion

Poland: Paracetamol + Caffeine Galpharm

Sweden: Paracetamol/Caffeine Galpharm

Slovakia: Paracetamol/Caffeine Galpharm 500mg/65mg tablety

This leaflet was revised in May 2016.

Paracetamol 500mg and Caffeine 65mg Tablets / Module 1.3.1 / May 2016