Package leaflet: Information for the user Toptabs Tablets

(Aspirin, Caffeine)

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 have told you.

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

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

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

-You must talk to a doctor if you do not feel better or if you feel worse .

What is in this leaflet

1.    What Toptabs are and what they are used for

2.    What you need to know before you take Toptabs

3.    How to take Toptabs

4.    Possible side effects

5.    How to store Toptabs

6.    Contents of the pack and other information

1.    What Toptabs are and what they are used for

Toptabs contains the active ingredients Aspirin and Caffeine. Aspirin belongs to a group of medicines called the non-steroidal anti-inflammatory drugs (NSAIDS). Caffeine acts as a mild stimulant.

Toptabs provide relief from cold and flu symptoms, including sore throat pain, headache, feverishness and aches and pains.

It also provides relief of mild to moderate pain including migraine, neuralgia, toothache, sore throat, period pain and rheumatic pain.

2.    What you need to know before you take Toptabs Do not take Toptabs if you:

•    Are allergic to aspirin or salicylates, caffeine, any other medicines known as NSAIDs or to any other ingredient (listed in Section 6);

•    Have had an allergic reaction after taking ibuprofen or aspirin;

•    Have had asthma or shortness of breath in response to aspirin before;

•    Suffer from high blood pressure or heart disease;

•    Have ever had a stomach ulcer, perforation or bleeding of the stomach;

•    Have blood clotting disorders (e.g. Haemophilia) or have ever had gout;

•    Have liver or kidney disease;

If any of the above applies to you, speak to your doctor before taking these tablets.

Warnings and precautions

Talk to your doctor or pharmacist before taking Toptabs if:

•    You suffer from asthma, high blood pressure or allergic disease;

•    You suffer from any kidney or liver disorder;

•    You have haemolytic anaemia (reduction in red blood cells which can make the skin pale yellow and cause weakness or breathlessness) with a G6PDH deficiency;

•    You experience any unusual bleeding (Aspirin may cause bleeding);

•    You think you are dehydrated (you may feel thirsty with a dry mouth).

Children and adolescents

Do not give to children under 16 years of age unless your doctor tells you to.

Aspirin can cause Reye’s syndrome when it is given to children. This is a very rare disease but it can be fatal. Do not give aspirin to children under 16 of age unless your doctor tells you to.

Other medicines and Toptabs

Tell your doctor or pharmacist if you are taking, have recently taken or might take any of the following medicines:

•    Medicines to thin your blood/prevent clotting (e.g. warfarin, heparin, phenindione);

•    Medicines to treat gout (e.g. probenecid, sulfinpyrazone);

•    Medicines to prevent organ rejection after transplantation (e.g. ciclosporin, tacrolimus);

•    Medicines to treat high blood pressure (e.g.ACE-inhibitors such as captopril,carbonic anhydrous inhibitors such as acetazolamide, beta-blockers such as atenolol);

•    Medicines for the treatment of pain and inflammation (e.g. anti-inflammatory medicines such as ibuprofen, diclofenac or steroids);

•    Medicines for cancer or rheumatoid arthritis (e.g. methotrexate);

•    Medicines to treat peptic ulcers and reflux (e.g. pantoprazole, rabeprazole);

•    Medicines used to treat depression (e.g. fluoxetine and paroxetine);

•    Medicines to treat epilepsy (e.g. Phenytoin or sodium valproate);

•    Medicines to treat diabetes (e.g. Insulin or sulfonylurea hypoglycaemic agents);

•    Medicines used to pass water (e.g. furosemide, bendroflumethiazide);

Toptabs with food, drink and alcohol

Drinking alcohol at the same time as taking aspirin increases the risk of bleeding.

Avoid excessive intake of caffeine (e.g. coffee, tea and some canned drinks) while taking this product.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Toptabs are best avoided in late pregnancy and during breastfeeding as they may prolong labour and cause bleeding in the newborn. Ask your doctor or pharmacist for advice before taking any medicine.

Toptabs contain Lactose

Toptabs contain small amount of a sugar called lactose. If you have been told by your doctor that you have intolerance to lactose or any other sugars, contact your doctor before taking this medicinal product.

3.    How to take Toptabs

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults and children aged 16 years and over:

For adults and children over 16 years old one or two tablets should be swallowed with a drink of water, preferably after food. The dose may be repeated every 4 to 6 hours. Do not exceed 8 tablets in any 24 hour period.

Children and adolescents (under 16 years old):

Do not give to children aged under 16 years old, unless specifically indicated by your doctor.

Duration of treatment:

Stop taking this medicine if pain gets worse or lasts more than 10 days or if you have a fever for more than 3 days.

If you take more Toptabs than you should

Do not exceed the stated dose. If you take too much medicine or someone else accidentally takes your medicine, contact your doctor, pharmacist or local hospital straight away. Symptoms of an overdose include effects on the stomach and intestines such as feeling or being sick, feeling dehydrated, ringing in ears, sweating, warm extremities with racing pulse, increased breathing rate, problem with the rate or rhythm of the heartbeat, and fits.

If you forget to take Toptabs

If you forget to take one dose simply continue with the following dose when it is due. Do not take a double dose to make up for a forgotten dose.

4.    Possible side effects

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

Stop taking this medicine and tell your doctor immediately or go to the casualty department of the nearest hospital if you get any of the side effects:

Not known: frequency cannot be estimated from the available data

•    Stomach ulceration or perforation: Symptoms could include severe abdominal pain, nausea and vomiting. People with sensitive stomachs may suffer stomach irritation and may experience bleeding (you may pass blood in your stools, or vomit blood or dark particles that look like coffee grounds);

•    Severe allergic reactions: Symptoms could include difficulty breathing, skin rash or swollen facial features, or tightening of the chest or asthma attacks in those sensitive to aspirin;

•    Kidney problems: Symptoms include fatigue and weakness, sleep problems and may experience changes in the urine output.

•    Occasionally a decrease in the number of blood cells needed for clotting (thrombocytopenia), the blood does not clot well, which may result in bruising or bleeding, or yellowing of the skin and eyes may occur.

Other side effects may include weakness, shortness of breath, and generalised swelling or water retention, abnormal liver function tests (aminotransferase), high levels of uric acid in your blood, ringing in your ears or temporary hearing loss, nervousness and dizziness;

High caffeine intake can result in sleeplessness, restlessness, anxiety, irritability, headache, gastrointestinal problems and irregular heart rhythms.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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 Toptabs

•    Keep this medicine out of the sight and reach of children.

•    The tablets should be stored in a dry place below 25°C.

•    Do not use this medicine after the expiry date which is stated on the label 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 protect the environment.

6.    Contents of the pack and other information What Toptabs contains

•    The active ingredients are: Aspirin and Caffeine.

•    The other ingredients are: Lactose and Maize starch.

What Toptabs look like and contents of the pack

•    Toptabs are white bi-convex tablets with logo on one face.

• This medical product come in blister packs of 24, 30 or 48 tablets, in paper strips of 50 tablets or in glass bottles of 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Name and address: Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road Berkhamsted, Hertfordshire,

United Kingdom, HP4 1EG Telephone: 0044 (0)1442 200922 Fax: 0044 (0)1442 873717 E-mail: info@bristol-labs.co.uk

This leaflet was last revised in July 2016.

Toptabs Tablets; PL 17907/0452

To request a copy of this leaflet in Braille, large print or audio please contact the licence holder at the address (or telephone, fax, email) above.