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ANGIVERT 75 MG DISPERSIBLE TABLETS, DISPERSIBLE ASPIRIN TABLETS BP 75 MG - patient leaflet, side effects, dosage

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Patient leaflet - ANGIVERT 75 MG DISPERSIBLE TABLETS, DISPERSIBLE ASPIRIN TABLETS BP 75 MG

2. what you need to know before you take dispersible aspirin tablets

If you are taking this medicine for the first time or if you are going to take this medicine in order to prevent blood clots, you should seek advice from your doctor before you commence therapy to make sure it is suitable for you.

This medicine can be taken by adults. However, some people should not take this medicine or should seek advice from their doctor or pharmacist before taking it.

Do NOT take Dispersible Aspirin Tablets if you:

! Are allergic to aspirin, other non-steroidal antiinflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6)

! Are under 16 years of age. 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 should not be given to children under 16 years unless on the advice of a doctor

! Have a history of allergic reactions to aspirin (you may have had asthma, itchy skin or a runny nose after taking medicines containing aspirin)

! Have a stomach ulcer, or have had one in the past

! Have gout or have a history of gout

! Are in your last 3 months of pregnancy (unless advised by your doctor)

! Have a disease associated with an increased tendency to bleed (e.g. haemorrhagic disease)

! Have a blood clotting disorder (e.g. haemophilia or thrombocytopenia) or are taking medicines to thin your blood

! Have severe kidney or liver problems

! Are taking methotrexate (a cancer drug which can also be used to treat psoriasis) at doses higher than 15mg per week.

nogen Pharma

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Dispersible Aspirin Tablets if you:

! Are elderly as your dose may be reduced

! Have asthma or suffer from other allergies

! Are diabetic as aspirin may alter your insulin requirements

! Have high blood pressure (hypertension), your doctor will want to monitor you while taking this medicine

! Are dehydrated

! Have a condition called glucose-6-phosphate dehydrogenase deficiency

! Suffer from liver or kidney disease

! Are breast-feeding

! Have heavy menstrual periods.

If you experience any unusual symptoms or side effects such as abnormal bleeding, passing blood in your faeces (stools/motions), passing black tarry stools, or vomit any blood or dark particles that look like coffee granules, seek immediate medical help as these may be signs of a bleed in the stomach or intestines.

Tell your doctor or dentist if you are planning to have an operation as aspirin may cause an increased risk of bleeding.

This medicine is not suitable to use for the treatment of inflammation, pain or fever.

Children

This medicine should not be given to children aged under 16 years unless advised by a doctor.

Other medicines and Dispersible Aspirin Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular tell your doctor if you are taking any of the following:

! Medicines to thin your blood and prevent blood clots e.g. warfarin, heparin, coumarin, phenindione

! Other NSAIDs to treat pain e.g. ibuprofen, diclofenac sodium

! Medicines called corticosteroids which are used to treat many conditions such as eczema, rheumatoid arthritis and inflammatory conditions e.g. hydrocortisone, prednisolone

! Medicines used to treat glaucoma e.g. acetazolamide

! Medicines used to treat indigestion e.g. alkali hydroxides and antacids

! A medicine called methotrexate which is used to treat psoriasis, rheumatoid arthritis and certain cancers

! Medicines used to treat high blood pressure such as diuretics e.g. spironolactone and ACE inhibitors e.g. captopril

! Medicines used to treat epilepsy e.g. phenytoin and sodium valproate

! Medicines used to treat gout e.g. probenecid and sulfinpyrazone

! Medicines used to treat diabetes e.g. insulin, metformin, glibenclamide

! Alcohol enhances some of the effects of aspirin ! Selective serotonin re-uptake inhibitors (SSRIs) e.g. sertraline or paroxetine used to treat depression

! Digoxin for heart problems

! Lithium for mental illness

! Ciclosporin and tacrolimus to prevent rejection after organ transplant

! Iron salts (to treat iron deficiency anaemia)

! Deferasirox to treat iron overload

! Metamizole (substance to decrease pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells sticking together and forming a blood clot), when taken concomitantly. Therefore, this combination should be used with caution in patients taking low dose aspirin for cardioprotection.

Dispersible Aspirin Tablets with alcohol Avoid alcohol while taking this medicine.

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.

If you are in the late stages of pregnancy and you take aspirin, it may prolong your labour and cause bleeding in you or your baby.

Driving and using machines

These tablets are not known to cause any side effects that will affect your ability to drive or use machinery. However, if you feel like you are affected do not drive or operate machinery.

Dispersible Aspirin Tablets contain lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. how to take dispersible aspirin tablets

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.

For oral administration. The tablets can be swallowed with some water. If you prefer, you can also disperse the tablet in a glass of water before being swallowed.

Adults, elderly and children over 16 years For long term use. One to two tablets (75–150mg) may be taken once daily.

A higher dose of up to four tablets (300mg) daily may be taken. This is for a short period of time and only on the instruction of your doctor.

Use in children under 16 years

These tablets are NOT for use in children under 16 years of age unless specifically advised by a doctor.

If you take more Dispersible Aspirin Tablets than you should

If you take too many tablets by mistake contact your nearest hospital casualty department or tell your doctor immediately. Take with you any remaining tablets and the pack so that the medicine can be identified.

If you forget to take Dispersible Aspirin Tablets If you have forgotten to take a dose, take a dose as soon as you remember. If the next dose is due within 2 hours, take a single dose now and skip the next. Do not take a double dose to make up for a forgotten dose. If you have trouble remembering to take the tablets, tell your doctor or pharmacist.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

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

If any of these occur STOP taking the medicine and contact a doctor immediately.

! Unusual or abnormal bleeding such as bleeding more or bleeding for longer

! Pass blood in your faeces (stools/motions), pass black tarry stools, or vomit blood or dark particles that look like coffee granules (these may be signs of a bleed in the stomach or intestines)

! Difficulty in breathing, wheezing, swelling of your face, lips, throat or body

! Allergic skin reactions such as a rash, itching, nettle rash/hives, blistering or peeling.

If you experience any of the following other side effects contact your doctor or pharmacist:

Common (may affect up to 1 in 10 people)

! Increased tendency for bleeding

! Indigestion.

Uncommon (may affect up to 1 in 100 people)

! Hives (itchy red weals on the skin)

! Swelling and irritation inside the nose

! Shortness of breath.

Rare (may affect up to 1 in 1,000 people)

! Blood disorders which may cause bruising and sometimes abnormal bleeding or makes infections more likely

! Bleeding within the skull

! Bleeding under the skin due to inflammation and damage to blood vessels

! Asthma attacks

! Feeling or being sick

! Abnormally heavy or prolonged menstrual

periods.

Not known (frequency cannot be estimated from the available data)

! Bleeding with prolonged bleeding time such as nosebleed or bleeding from your gums

! High level of uric acid in the blood

! Headache, feeling of dizziness or spinning

! Reduced hearing ability or ringing in your ears

! Ulcers or perforation in the stomach or small

intestine, diarrhoea

! Impaired liver or kidney function, salt and water retention.

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: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store dispersible aspirin tablets

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

Do not use this medicine after the expiry date which is stated on the label or carton. The expiry date refers to the last day of that month.

Protect from heat, light and moisture. Do not use this medicine if you notice any visible signs of deterioration.

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 Dispersible Aspirin Tablets contain

The active substance is aspirin. Each tablet contains 75mg aspirin.

The other ingredients are maize starch, sodium saccharin, lactose granules (see section 2), anhydrous citric acid, calcium carbonate, purified talc and sodium lauryl sulfate.

What Dispersible Aspirin Tablets look like and contents of the pack

Dispersible Aspirin Tablets are white, flat, circular tablets with a bevelled edge and are 8mm in diameter.

Dispersible Aspirin Tablets are supplied in packs of 24, 25, 50 and 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Ennogen Pharma Limited

Unit G4, Riverside Industrial Estate, Riverside Way, Dartford, DA1 5BS, UK.

Manufacturer

Clonmel Healthcare Limited, Waterford Road, Clonmel Co Tipperary, Ireland.

This leaflet was last revised in December 2019.