PARACETAMOL AND CAFFEINE 500MG/65MG TABLETS

Active substance: CAFFEINE

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1.3

PRODUCT INFORMATION.

1.3.1

SPC, LABELLING AND PACKAGE LEAFLET.

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.
2.
3.
4.
5.
6.

What Paracetamol and Caffeine, 500mg & 65mg Tablets is and what it is used for.
Before you take Paracetamol and Caffeine, 500mg & 65mg Tablets.
How to take Paracetamol and Caffeine, 500mg & 65mg Tablets.
Possible side effects.
How to Store Paracetamol and Caffeine, 500mg & 65mg Tablets.
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
Paracetamol 500mg and Caffeine 65mg Tablets / Module 1.3.1 / February 2014

1.3

PRODUCT INFORMATION.

1.3.1

SPC, LABELLING AND PACKAGE LEAFLET.







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

Paracetamol 500mg and Caffeine 65mg Tablets / Module 1.3.1 / February 2014

1.3

PRODUCT INFORMATION.

1.3.1

SPC, LABELLING AND PACKAGE LEAFLET.

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
Adults, the elderly and adolescents (over 15
years) who weigh more than 60kg

Dose and how often to take
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 Take 1 tablet every 4-6 hours as required.
years) who weigh between 50kg and 60kg
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:
Paracetamol 500mg and Caffeine 65mg Tablets / Module 1.3.1 / February 2014

1.3

PRODUCT INFORMATION.

1.3.1

SPC, LABELLING AND PACKAGE LEAFLET.

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.
If you think you have any side effects not mentioned in this leaflet, please inform your doctor or
pharmacist.
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, Hugh House, Upper Cliffe Road,
Dodworth Business Park, Dodworth, Barnsley, South Yorkshire, S75 3SP, UK.
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
Paracetamol 500mg and Caffeine 65mg Tablets / Module 1.3.1 / February 2014

1.3

PRODUCT INFORMATION.

1.3.1

SPC, LABELLING AND PACKAGE LEAFLET.

Denmark: Paracetamol/Caffeine ‘Orion’
France: Paracetamol/Cafeine Galpharm 500mg/65mg, Comprimé
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/Coffeïne 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 February 2014.

Paracetamol 500mg and Caffeine 65mg Tablets / Module 1.3.1 / February 2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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