Patient leaflet - Dispersible Aspirin tablets BP 300 mg

1. WHAT DISPERSIBLE ASPIRIN TABLETS ARE AND WHAT THEY ARE USED FOR

This medicine contains aspirin. Aspirin belongs to a group of medicines called anti-platelet agents that help prevent your blood cells sticking together and forming a blood clot.

Dispersible Aspirin Tablets 300mg are used in:

Treatment of mild to moderate pain including headache,
migraine, neuralgia (nerve pain), toothache, sore throat, period pains, aches and pains, sprains, strains, rheumatic pain, sciatica (nerve pain of the leg/back), lumbago (lower back pain), fibrositis (muscular rheumatism), muscular aches and pains, joint swelling and stiffness · The symptomatic relief of colds and flu.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DISPERSIBLE ASPIRIN TABLETS

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) · Have a stomach ulcer or a history of ulcers or
indigestion
Have gout or have a history of gout
Have bleeding in the stomach and/or intestines, or
other kinds of bleeding such as bleeding from the blood vessels of the brain
Have nasal polyps associated with asthma · Have haemophilia or other blood clotting disorder or
are taking medicines to thin the blood
Have severe liver, kidney or heart failure
Are in the third trimester of pregnancy
Are taking methotrexate (more than 15mg a week) · Are a child under 16 years old.

Important warning:

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 aged under 16 years, unless on the advice of a doctor.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking this medicine if you:

Have asthma, chronic respiratory disease or allergies · Experience heavy periods
Have hypertension (high blood pressure)
Have a history of stomach ulcers or excessive bleeding · Have heart, liver or kidney problems or gout · Have severe skin rash with flushing, fever, blisters or
ulcers (Stevens Johnson syndrome).
Treatment should be stopped immediately. · Have an overactive thyroid gland
Have dehydration
- Have anaemia or suffer from a deficiency of the enzyme
  glucose-6-phosphate dehydrogenase (G6PD) this can cause episodes of anaemia after eating certain foods such as fava beans (favism)
- Have systemic lupus erythematosus (SLE) or other
  connective tissue disease.
- Are elderly
- Have had any disorders affecting blood vessels in the
  brain
- Have received a varicella (chickenpox) vaccination
  within the last 6 weeks.

When taking acetylsalicylic acid, serious allergic reactions which may include chest pain and even heart attack (Kounis syndrome) have been reported (see section 4). Seek medical care immediately when you notice chest pain with allergic reactions (such as skin rashes, shortness of breath).

Other important warnings:

Taking painkillers for headaches too often or for too long
can make them worse.

Other medicines and Dispersible Aspirin Tablets 300mg

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 prevent blood clotting such as warfarin,
dipyridamole, clopidogrel and heparin
Deferasirox (for patients with excessive iron levels
following blood transfusion)
Digoxin (for heart problems)
Metoclopramide or domperidone (to prevent sickness) · Diuretics “water tablets” acetazolamide (to treat high
blood pressure)
Medicines which make your urine more alkaline such as
antacids, citrates
Probenecid (to treat gout)
Methotrexate (to treat some cancers, psoriasis and
rheumatic disease)
Medicines to treat diabetes
Phenytoin or sodium valproate (to treat epilepsy) · Corticosteroids, tacrolimus and ciclosporin (to suppress
the immune system)
Mifepristone (to induce abortion)
Other non-steroidal anti-inflammatory drugs – NSAIDs
used for pain (eg ibuprofen or naproxen)
Medicines which can cause hearing problems
(vancomycin)
Medicines to treat high blood pressure (ACE inhibitors,
Calcium channel blockers)
Medicines to treat depression such as lithium or SSRIs
(e.g. paroxetine)
Varicella (chickenpox) vaccine. Aspirin should be avoided
for 6 weeks after vaccination
Herbal medicines containing ginkgo biloba. · 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 drinking alcohol while taking aspirin.

Pregnancy, breast-feeding and fertility

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.

Avoid taking Dispersible Aspirin Tablets during pregnancy especially in the last 3 months of pregnancy or whilst breast-feeding. Ask your doctor or pharmacist for advice before taking this medicine.

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 your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Dispersible Aspirin Tablets should be dissolved in a glass of water before being swallowed.

Adults, the elderly and children over 16 years:

300mg to 900mg (1 to 3 tablets) every 4 hours if necessary. A maximum of 3.6g (12 tablets) a day in divided doses.

Use in children and adolescents

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

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 your pack with you. Symptoms of an overdose include ringing in the ears, hearing problems, headache, dizziness, confusion, feeling or being sick, stomach pain, high temperature, dehydration, sweating, feeling restless, fits, hallucinations, low blood sugar, severe chest pain, difficulty breathing, unconsciousness.

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, pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS

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

If you experience the following side effects while taking your medicine, you should stop taking your tablets and tell your doctor straight away:

Severe allergic reactions (blistered skin, swelling of the
face, lips, throat or tongue, difficulty breathing, shock) · Itchy skin rash caused by allergic reaction- pale or red
irregular raised patches with severe itching (hives/urticaria)
Severe rash involving reddening, peeling and swelling of
the skin that resembles severe burns (Lyells syndrome) or severe rash, blisters, or red patches on the skin (Stevens-Johnson syndrome), irregular red patches on the skin of the hands and arms (erythema multiforme) · Bleeding on the brain (sudden severe headache, fit,
changes in vision, speaking, understanding or coordination, weakness in an arm or leg
Stomach ulcers or bleeding which can be severe (you
may develop bloody or black tarry stools, severe stomach pain and vomit blood), stomach irritation (mild stomach pain, heartburn and feeling or being sick). Fatalities have occurred.

Tell your doctor, pharmacist or nurse if you notice any of the following effects or any effects not listed:

Common: may affect up to 1 in 10 people

increased bleeding tendencies,
indigestion

Uncommon: may affect up to 1 in 100 people

runny nose

Rare: may affect up to 1 in 1,000 people

anaemia, changes in numbers and types of blood cells as
seen in blood tests
difficulty breathing or wheezing, asthma attacks. · heavy periods
feeling or being sick
disorder characterised by blood spots, bruising and
discolouring to skin (hemorrhagic vasculitis or purpura) · red tender lumps developing under the skin (Erythema
nodosum)

Not known: frequency cannot be estimated from the available data

nosebleeds, bleeding of the gums, which may be
prolonged. (Please advise doctor or dentist if surgery is planned)
reduction in red blood cells which cause pale yellow skin
and weakness or breathlessness
low levels of protein in the blood (can be caused by
nephritic syndrome)
- reduced number of red and white blood cells, increased blood enzyme levels (as seen in blood test).
- Gout (high levels of uric acid in the blood)- causing crystals to deposit in joints of
  hands/feet causing pain (Hyperuricemia)
- Headache
- feeling of dizziness or spinning (vertigo)
- hearing loss, Ringing or buzzing in the ears · swelling of blood vessels resulting from loss of blood. (characterised by rash, fever, sweating, fatigue, weight loss) worsening of asthma
- liver problems including hepatitis (inflammation of the liver causing yellowing of the skin or eyes or tiredness, pain in abdomen, joint or muscles)
- reduced kidney function
- Salicylism - if you take large doses for a long time you may develop symptoms of salicylism, these include: dizziness, ringing or buzzing in the ear, deafness, sweating, feeling or being sick, headache and confusion. · Acute myocardial ischemia (painful heart condition caused by lack of blood flow to the heart) with or without myocardial infarction (heart attack) occurring as part of an allergic reaction (Kounis syndrome).

Additional side effects in children

Aspirin may be associated with the development of a condition called Reye's Syndrome, which causes severe liver and brain damage.

Gastrointestinal system and inflammation of the liver. Deaths have occurred.

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 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. The expiry date refers to the last day of that month.

Store in a cool dry place. Protect from light.

In case of any visible signs of deterioration, you should discard the package.

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 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 300mg aspirin.

The other ingredients are: maize starch, sodium saccharin, lactose, anhydrous citric acid, calcium carbonate, talc and sodium lauryl sulphate.

What Dispersible Aspirin Tablets look like and contents of the pack

Dispersible Aspirin Tablets 300mg are white, flat, circular tablets with a bevel edge. Engraved 'A9' on one side.

Dispersible Aspirin Tablets 300mg are supplied in packs of 24 or 25 tablets.

Marketing Authorisation Holder

Ennogen IP Ltd

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK

Manufacturer

Ennogen Pharma Limited