Package leaflet: Information for the patient

MANDANOL® PLUS

(Paracetamol 500mg/Caffeine 65mg)

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 doctor or pharmacist if you need more information or advice.

WHAT IS IN THIS LEAFLET

1.    What Mandanol Plus is and what it is used for

2.    What you need to know before you take Mandanol Plus

3.    How to take Mandanol Plus

4.    Possible side effects

5.    How to store Mandanol Plus

6.    Contents of the pack and other i nformation

1.    WHAT MANDANOL PLUS IS AND WHAT IT IS USED FOR

Mandanol Plus tablets contain paracetamol, which is used to reduce pain and fever, and caffeine, which acts to increase the effectiveness of paracetamol.

Mandanol Plus is used in the treatment of painful and feverish conditions such as headache, migraine, toothache, colds, influenza, sore throat, period pains, muscular aches and pains, nerve pain and rheumatic pain.

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE MANDANOL PLUS

Do NOT take Mandanol Plus if:

•    you are allergic (hypersensitive) to paracetamol, caffeine or any of the other ingredients of this medicine (listed in section 6).

•    you have high blood pressure or are taking medicines to treat high blood pressure

•    you have a history of anxiety or are taking anxiolytics (tranquillisers)

•    you are pregnant or breast feeding

•    you have ever had heart rhythm disorders e.g. rapid or irregular heartbeat

•    you are taking any of the following medicines:

-    decongestants containing ephedrine

-    antidepressants e.g. Monoamine oxidase inhibitors or lithium

-    antipsychotic medicines such as clozapine

-    sedatives such as diazepam

-    theophylline used to treat asthma

-    disulfiram used to treat chronic alcoholism.

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

Warnings and precautions

Talk to your doctor or pharmacist before you take this medicine if:

•    you have severe kidney or liver disease, including alcoholic liver disease

•    you are trying to become pregnant

Other medicines and Mandanol Plus

Talk to your doctor or pharmacist before you take this medicine if you are taking any of the following:

•    methoxselan used to treat psoriasis

•    phenytoin used to treat epilepsy

•    pipedemic acid used occasionally to treat bladder infections

•    levothyroxine used to treat thyroid problems

•    adenosine and dipyridamole used during hospital tests for heart conditions

•    beta-blockers used to lower blood pressure e.g. atenolol, oxprenolol, propranolol

•    medicines for nausea or sickness, such as metoclopramide or domperidone

•    colestyramine for high cholesterol or high blood fats

•    warfarin or other medicines used to thin the blood and reduce the risk of clotting

•    phenylpropanolamine (found in some cough medicines)

•    any other tablets or medicines including any not prescribed by your doctor.

Mandanol Plus with food and drink

This medicine contains caffeine, which is also found in tea, coffee, some fizzy drinks and chocolate. Avoid excessive intake of caffeine while taking these tablets.

Pregnancy and breast-feeding

Due to the caffeine content of this product it should not be used if you are pregnant or breast-feeding.

3. HOW TO TAKE MANDANOL PLUS

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.

The tablets should be swallowed, preferably with a drink of water. Avoid drinking too much coffee or tea when taking

these tablets.    „ „    , ,

Continued overleaf

Adults and children over 12 years of age:

•    Take 1 or 2 tablets up to four times a day, as required.

•    Do not take more often than every 4 hours.

•    Do not take more than 8 tablets in any 24-hour period.

•    Do not give to children under 12 years.

Do not take more medicine than the label tells you to.

If you do not get better, talk to your doctor.

If your symptoms continue or your headache becomes persistent, see your doctor.

If you forget to take Mandanol Plus

Take it as soon as you remember unless it is nearly time for your next dose. Do not take a double dose to make up for a forgotten dose.

IF YOU OR ANYONE ELSE TAKES TOO MUCH MANDANOL PLUS:

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 an overdose has been taken contact your doctor immediately or go to your local hospital casualty department. Please take this leaflet, any remaining tablets and the container with you.

4. POSSIBLE SIDE EFFECTS

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

These are rare with Mandanol Plus and may include:

•    Signs of an allergic reaction such as skin rash, swelling of the lips, tongue or throat or difficulty breathing.

•    Breathing problems. These are more likely if you have experienced them before when taking other painkillers such as ibuprofen and aspirin.

If you experience any symptoms of an allergic reaction or breathing problems see your doctor or go to the nearest hospital immediately.

Seek medical advice as soon as possible if you experience:

•    Unexpected bruising or bleeding, or an increased number of infections e.g. sore throats, may indicate changes in your blood.

Other side effects reported are:

Nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin.

Mandanol Plus tablets contain caffeine and some people are more sensitive and can get side effects at lower doses especially if they have not taken caffeine before. These side effects may include tremor, insomnia, nervousness, irritability, anxiety, restlessness, headache, ringing in the ears and stomach problems (e.g. nausea, vomiting, diarrhoea). You may also notice palpitations, changes in your heart beat, rapid breathing and an increased need to pass water.

Some people may experience effects when they stop taking the tablets. These may include headache, tiredness and decreased alertness. These effects are temporary and may last a week.

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 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 MANDANOL PLUS Keep out of the sight and reach of children.

Do not store above 25°C. Keep in the original container.

Do not use after the expiry date printed on the pack. 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 protect the environment.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION What Mandanol Plus contains:

•    The active ingredients in each tablet are paracetamol 500mg and caffeine 65mg.

•    The other ingredients are maize starch, colloidal anhydrous silica, sodium starch glycollate, povidone, potassium sorbate (E202), magnesium stearate, talc, hypiomellose and macrogol 4000.

What Mandanol Plus looks like and contents of the pack:

•    The tablets are white, capsule-shaped with 'MANDA+' embossed on one side.

•    They are available in packs of 16 tablets.

Marketing Authorisation Holder and Manufacturer:

M & A Pharmachem Ltd, Bolton BL5 2AL, UK.

This leaflet was last revised in March 2014

PP2396

100    95    75    50    25    5

0