PEP

(Caffeine and Glucose Monohydrate)

PATIENT INFORMATION LEAFLET

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

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

» Ask your pharmacist if you need more information or advice, k You should contact a doctor if your symptoms worsen or do not improve within 24 hours.

IN THIS LEAFLET:

1.    What this medicine is for

2.    Before you take the medicine

3.    How to take the medicine

4.    Possible side effects

5.    Storing the medicine

6.    Further information

WHAT THIS MEDICINE IS FOR

PEP tablets contain caffeine and glucose. They are used to relieve mental and muscular tiredness. Caffeine makes you feel more awake and enhances muscle performance. Glucose provides a quick source of energy.

VX BEFORE YOU TAKE THE MEDICINE

Check with your doctor before taking this medicine if:

•    You have or have had a stomach ulcer.

If you are taking other medicines:

You must not take these tablets if you are taking certain other medicines - see sectionl 2 ‘Do not take this medicine if:'.

Talk to your pharmacist or doctor before you take the tablets if you are taking any other regular medication, especially:

•    aspirin

•    indomethacin or phenylbutazone (used in the treatment of arthritis)

•    ergot alkaloids (such as ergotamine used in the treatment of migraine)

•    phenytoin (used in the treatment of epilepsy)

•    levothyroxine (used to treat underactive thyroid)

•    methoxsalen (used to treat psoriasis and eczema)

•    pipemidic acid (used to treat bacterial infections).

•    medicines that contain caffeine, in particular cough and cold remedies.

You may need to reduce the number of PEP tablets you take in a day.

You should stop taking these tablets at least 24 hours before you have a heart scan which involves drugs like adenosine and dipyramidole.

Do not take this medicine if:

•    You are allergic to any of the ingredients listed in Section 6

•    You have high blood pressure

•    You have a history of anxiety or have had a heart rhythm disorder (e.g. rapid or irregular heart beat)

•    You are taking any of the following medicines: ° decongestants containing

phenylpropanolamine, ephedrine or pseudoephedrine

° antidepressants or mood stabilisers (e.g. Mono-amine Oxidase Inhibitors (MAOIs) or lithium carbonate)

° anxiolytics or sedatives (e.g. diazepam) ° theophylline (used to treat asthma)

° disulfiram (used to treat longstanding alcoholism)

° antipsychotic medicines (e.g. clozapine) ° medicines to treat high blood pressure such as beta-blockers (e.g. atenolol or propranolol)

•    You are pregnant or breastfeeding

|_ (unless instructed by your doctor). _

Each PEP tablet contains 30mg of caffeine and up to 6 tablets may be taken per day (a maximum daily dose of 180mg of caffeine). If you are also consuming food that contains caffeine (coffee, tea, cola drinks, chocolate) reduce the number of tablets you take in a day.

The amount of caffeine in a drink of coffee or tea depends on how they are made, but you can use the table below as a guide:

100ml is about the same as a small

_ Further information overleaf!

Important information about some of the ingredients of this medicine.

This product contains glucose (also known as dextrose). If you have been told by your doctor that you have an intolerance to home sugars, contact your doctor before taking this medicinal product.

HOW TO TAKE THE MEDICINE

Adults, the elderly and children over

12 years

How to take:

The tablets should be swallowed whole

with a drink of water.

Dose and how often to take:

Take 2 tablets up to three times a day,

as required.

•    Do not give to children under 12 years of age.

•    Avoid taking the tablets close to bedtime as the stimulant may prevent you from falling asleep.

•    Do not take more than 6 tablets in any 24 hours.

•    DO NOT EXCEED THE STATED DOSE

IF YOU TAKE TOO MUCH: If you take more tablets than you should, tell your doctor or pharmacist.

[] POSSIBLE SIDE EFFECTS

bide effects do not usually occur with Caffeine or Glucose Monohydrate.

Most people take the tablets without any problems, but as with all medicines, side effects may occur occasionally.

Allergic reaction:

Stop taking the medicine and contact your doctor immediately if you notice:

• skin rashes or other signs of allergic reaction such as itching, swelling of the lips, tongue or throat, or difficulty in breathing.

Other side effects are:

•    nausea (feeling sick), headaches and insomnia (sleeplessness)

,• nervousness, anxiety, restlessness, irritability, tinnitus (ringing in the ears), tremors, irregular or rapid heart beat, breathing fast and increased sensitivity of the skin

•    diuresis (increased urine production) stomach discomfort

stomach acicTproduction may be increased which can cause stomach ulceration (symptoms include stomach pain particularly! when eating, vomiting and diarrhoea).

If you stop taking caffeine after regular use:

There are some people who may experience unwanted side effects when they stop taking tablets or foods containing caffeine after regular] use. The most common effect is headache but also tiredness and feeling less alert can occur. These effects are temporary and may last up to a week but to minimise these effects it is best to gradually reduce caffeine intake.

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 Cardi Scheme at: www.mhra.gov.uk/yellowcard.

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

El STORING THE MEDICINE

Do not store above 25°C. Store in the original packaging.

Do not use the tablets after the expiry date shown on the pack.

Keep all medicines out of the reach and sight of children.

H FURTHER INFORMATION

What is in this medicine:

The active ingredients in the tablets are: Caffeine 30mg and Glucose Monohydrate 150mg.

The other ingredients in the tablets are:

Dextrin, Maize Starch and Magnesium Stearate.

What this medicine looks like and the contents of the pack:

PEP are white, circular flat tablets with no markings.

This pack contains 8, 12, 20, 24, 36, 48,

60 or 100 tablets (not all pack sizes may be marketed).

Marketing Authorisation Holder:

Galpharm Healthcare Ltd, Wrafton, Braunton, Devon, EX33 2DL, United Kingdom. Manufacturer:

Galpharm International Ltd, Elmhirst Park, Middle Field Road, Barnsley, South Yorkshire, S75 4LS, United Kingdom.

Text revised: September 2013. ooooooo 4oo42sg