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MAXIMUM STRENGTH

ASPRO

Clear®

Aspirin 500mg

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

This medicine is available without prescription.

However, you still need to use Maximum Strength Aspro Clear 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.

•    If you have any unusual effects after using this product, tell your doctor or pharmacist.

IN THIS LEAFLET:

1.    What is Maximum Strength Aspro Clear and what is it used for?

2.    Before you take Maximum Strength Aspro Clear

3.    How to take Maximum Strength Aspro Clear

4.    Possible side effects

5.    How to store Maximum Strength Aspro Clear

6.    Further information

1. WHAT IS MAXIMUM STRENGTH ASPRO CLEAR® AND WHAT IS IT USED FOR?

Maximum Strength Aspro Clear are effervescent tablets which contain aspirin (acetylsalicylic acid). They dissolve in water to form a sparkling, lemon-tasting solution which is absorbed quickly into the bloodstream.

Aspirin belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDS). It is used for the treatment of pain and reduction of fever and also has antiinflammatory properties.

Maximum Strength Aspro Clear can be used for the:

•    Treatment of mild to moderate pain including headache, migraine, backache (including lumbago), nerve pain (neuralgia and sciatica), period pain, toothache and sore throat.

•    Symptomatic relief of colds and influenza.

•    Relief of rheumatic pain (arthritis), fibrositis, muscular aches and pains, the pain of joint swelling and stiffness, strains and sprains.

•    Effective reduction of high temperature.

2. BEFORE YOU TAKE MAXIMUM STRENGTH ASPRO CLEAR®

DO NOT take Maximum Strength Aspro Clear if you:

•    Are allergic (hypersensitive) to aspirin, any other salicylates (eg aloxiprin) or any of the other ingredients of Maximum Strength Aspro Clear (see Section 6, Further Information).

•    Have history of hypersensitivity reactions (eg asthma, rhinitis, urticaria) induced by pain relieving or anti-inflammatory medicines (eg NSAIDS or salicylates).

•    Have severe kidney or liver problems.

•    Have severe heart problems.

•    Are on a high dose of methotrexate (15mg per week or more). If you are not sure check with your doctor. Also see ‘Using other medicines ’.

•    Have a disorder which causes excessive bleeding such as haemophilia.

•    Have, or have had, a stomach or duodenal ulcer.

•    Are pregnant or breast-feeding, unless advised by a doctor.

Speak to your doctor before taking Maximum Strength Aspro Clear if you:

•    Are allergic (hypersensitive) to any other pain relieving, anti-rheumatic or antiinflammatory medicines (eg NSAIDS). For more information see section 4 ‘Possible Side Effects’.

•    Suffer from tightness in the chest or asthma.

•    Have low uric acid excretion, which is commonly associated with gout.

•    Have a history of gastrointestinal disorders (regular stomach upsets).

•    Have a deficiency in glucose-6-phosphate dehydrogenase (G6PD), since you may experience anaemia.

•    Have kidney, liver, heart or blood circulation problems.

•    Are about to have surgery. Before the operation tell the doctor or surgeon that you are taking aspirin.

If you are not sure whether any of the above apply to you, speak to a doctor or pharmacist before taking Maximum Strength Aspro Clear.

Important information about some of the ingredients:

Each Maximum Strength Aspro Clear tablet contains 298mg sodium. This should be taken into consideration by people on a controlled sodium diet.

Use in children:

There is a possible association between aspirin and Reye’s Syndrome when given to children. Reye’s Syndrome is a very rare disease which can be fatal. For this reason aspirin must not be given to children under 16 years, unless on the advice of a doctor.

Using other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Aspirin can affect the way in which some medicines work. These medicines include:

•    Any pain relieving or anti-inflammatory medicines.

•    Medication to prevent blood clotting (eg warfarin, heparin, ticlopidine).

•    Medication to treat heart problems or to lower blood pressure (eg ACE inhibitors or digoxin).

•    Medication to treat gout.

•    Diuretics (to treat water retention).

•    Medication to treat epilepsy (eg sodium valproate, phenytoin).

•    Medication to lower blood sugar if you are diabetic.

•    Methotrexate (to treat psoriasis, rheumatoid arthritis, Crohn’s disease and some types of cancer).

•    Some antidepressants known as SSRIs (eg fluoxetine, paroxetine).

•    Medication to treat Addison’s disease (eg corticosteroids except hydrocortisone).

2. BEFORE YOU TAKE MAXIMUM STRENGTH ASPRO CLEAR® (cont.)

You should avoid taking other medicines containing aspirin or other non-steroidal antiinflammatory drugs (NSAIDS), such as ibruprofen or ketoprofen, when taking these tablets .

Taking with food and drink:

Avoid taking alcohol while taking Maximum Strength Aspro Clear.

Pregnancy and breast-feeding:

Do not use Maximum Strength Aspro Clear if you are pregnant, breast feeding or trying for a baby unless directed by your doctor. Aspirin can prolong labour and affect blood clotting in the mother or baby.

Always ask your doctor or pharmacist for advice before taking any medicine.

3. HOW TO TAKE MAXIMUM STRENGTH ASPRO CLEAR®

Follow the directions below closely. You should ask your doctor or pharmacist if you are unsure how to use this medicine.

Maximum Strength Aspro Clear tablets must always be dissolved in water before use. Adults and children over 16:

One or two tablets dissolved in half a glass (100ml) of water may be taken every 4 hours as required. Drink when effervescence subsides.

You should not take more than 8 tablets in 24 hours.

Not recommended in children under 16.

Make sure you follow the dosage instructions and do not take more than the stated dose.

If symptoms persist speak to your doctor or pharmacist.

If you take more Maximum Strength Aspro Clear than you should:

If you think you have taken too many tablets you should go to your nearest Accident and Emergency Department or contact your doctor immediately. Take this leaflet with you and any packaging to show what you have taken.

4. POSSIBLE SIDE EFFECTS

Like all medicines Maximum Strength Aspro Clear can cause side effects although not everybody gets them.

If you experience any of the following side effects, stop taking Maximum Strength Aspro Clear and go to your nearest Accident and Emergency Department or doctor immediately:

•    An allergic reaction. Signs of allergic reaction may include: difficulty in breathing or swallowing, swelling of the face, lips, throat or tongue, skin rashes or itching, large or itchy wheals on the skin, attacks of sneezing, runny nose and itching eyes or water retention, heart racing.

•    Mild stomach pain and heartburn. These are the most common side effects but can usually be avoided if aspirin is taken with food.

•    Stomach ulcer or perforation, stomach bleeding, which may result in black or tarry stools.

•    Increased bleeding/blood thinning (if you cut or injure yourself) including bruises, nose bleeds, bleeding gums.

•    Internal bleeding which may result in anaemia causing weakness, increased tiredness and pale skin.

•    An asthma attack if you are asthmatic and sensitive to aspirin.

•    Dizziness or ringing in the ears.

•    Changes in normal liver activity in blood tests (very rare).

•    Runny nose, blocked nose.

•    Kidney problems.

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 MAXIMUM STRENGTH ASPRO CLEAR®

Keep out of the reach and sight of children.

Do not store above 25 °C. Store in a dry place. This product should be stored in its original carton.

The tablets are packaged in individual foil pouches. If the pouch is opened and a tablet is not used immediately, dispose of the tablet. If the pouch is damaged or if a tablet is powdery or discoloured, do not use the tablet.

Do not use Maximum Strength Aspro Clear after the expiry date which is stated on the carton and on the foil pouch. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    FURTHER INFORMATION

What Maximum Strength Aspro Clear contains:

The active substance is aspirin (acetylsalicylic acid) (500mg per tablet).

The other ingredients are citric acid, dioctyl sodium sulphosuccinate, lemon flavour, malic acid, mannitol, povidone, saccharin sodium, sodium hydrogen carbonate, sodium carbonate.

What Maximum Strength Aspro Clear looks like and contents of the pack:

Maximum Strength Aspro Clear comes in cartons containing 8, 12, 16, or 20 white effervescent tablets packaged in foil pouches.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Bayer plc

Consumer Care Division Bayer House, Strawberry Hill Newbury, Berkshire RG14 1JA United Kingdom

Manufacturer:

Delpharm Gaillard 33, Rue de l’Industrie 74240 Gaillard France

This leaflet was last revised in July 2015.

Aspro^® and Aspro Clear^® are registered trademarks.

Bayer