PACKAGE LEAFLET Package leaflet: Information for the user

Flamasacard® 162.5 mg prolonged release hard capsules

aspirin

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 pharmacist has told you.

-    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 before you start taking this medicine.

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

In this leaflet

1.    What Flamasacard® is and what it is used for

2.    What you need to know before you take Flamasacard®

3.    How to take Flamasacard®

4.    Possible side effects

5.    How to store Flamasacard®

6.    Contents of the pack and other information

1. What Flamasacard® is and what it is used for

The name of your medicine is Flamasacard® 162.5 mg prolonged release hard capsules (called Flamasacard® in this leaflet). Flamasacard® contains the active substance aspirin (acetylsalicylic acid).

Flamasacard® is used in patients who have already suffered a heart attack, a stroke or have had coronary artery bypass surgery. It is used to prevent further:

•    Heart attacks

•    Strokes including mini strokes

•    Stable and unstable angina (chest pain due to reduced oxygen supply to the heart).

•    Problems following coronary angioplasty (procedure used to treat narrowed (diseased) coronoary

arteries to improve the blood flow to the heart muscle).

Flamasacard® affects ‘platelets’, which are tiny cells in your blood that make your blood clot. Flamasacard® works by helping to stop the platelets in your blood fron sticking together and making a clot.

Do not take Flamasacard® for headaches or other pains. This is because the amount of aspirin in Flamasacard® is too low for pain-relief.

There is a special coating around the small particles in Flamasacard®. This helps to stop the aspirin in Flamasacard® from irritating your stomach, but means that the capsule should not be used if an immediate effect is required such as during a heart or angina attack.

2. What you need to know before you take Flamasacard®

Do not take Flamasacard® if:

- You are allergic (hypersensitive) to aspirin or any of the other ingredients of Flamasacard® (listed in section 6). An allergic reaction may include a rash or a runny or blocked nose. Asthma patients may experience an asthma attack or faint.

-    You are allergic (hypersensitive) to medicines like aspirin -called “Non-steroidal anti-inflammatory drugs” or NSAIDs. These include amongst others ibuprofen and naproxen.

-    You have a stomach ulcer or bleeding in the stomach (gastrointestinal hemorrhages).

-    You suffer from stomach problems or have suffered stomach pain when taking this medicine before.

-    You are taking methotrexate, used in the treatment of cancer and rheumatoid arthritis at does higher than 15 mg per week.

-    You have had a stroke with bleeding in your head.

-    You have a severe problem with your kidneys or your liver.

-    You have a blood problem that makes you bleed or bruise easily or if you bleed easily for any other reason.

-    You are in the last three months of pregnancy or breast feeding (see ‘Pregnancy and breastfeeding’ below).

Do not take Flamasacard® if any of the above apply to you. If you are not sure, talk to your doctor or

pharmacist before taking Flamasacard®.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Flamasacard® if:

-    You    have    gout

-    You    have    asthma

-    You    have    high blood pressure

-    You    have    kidney or liver problems

-    You    have    any bleeding problems

-    You    have    heavy monthly periods

-    You have been told that your blood does not have enough of something called ‘glucose-6-phosphate

dehydrogenase’ enzyme

-    You have a rash or a runny nose

-    You have a history of peptic ulcer disease

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Flamasacard®.

Children and adolescents

Flamasacard® should not be given to children under 16 years of age, unless on the advice of a doctor..

Other medicines and Flamasacard®

Tell your doctor or your pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Flamasacard® can affect the way some other medicines work. Also some other medicines can affect the way Flamasacard® works.

In particular tell your doctor or pharmacist if you are taking any of the following medicines, before taking Flamasacard®

-    Medicines to treat cancer, certain skin diseases or rheumatoid arthritis - such as methotrexate.

Patients taking methotrexate at doses higher than 15 mg per week cannot use Flamasacard® capsules. Those on lower doses of methotrexate can use Flamasacard® but will need regular (weekly) monitoring of their blood.

-    Medicines for high blood pressure - such as diuretics or ACE-inhibitors.

-    Medicines for rejection of organ after transplantation -such as ciclosporin, tacrolimus.

-    Medicines for pain and inflammation - such as steroids or anti-inflammatory medicines.

-    Medicines for epilepsy - such as phenytoin or valproic acid and sodium valproate.

-    Medicines for gout -such as benzbromarone, probenecid or suphinpyrazone.

-    Medicines for blood clot -such as warfarin, ticlopidin, clopidogrel, tirofiban, eptifibatide or heparin,

hirudine, fondaparinux.

-    Medicines for diabetes - such as suphonylureas and insulin (your blood sugar might become too low).

-    Medicines for too much acid in your stomach -called antacids. They may make Flamasacard® work

less well.

-    Non-steroidal anti-inflammatory medicines or NSAIDs - like ibuprofen or naproxen.

Operations or tests

Tell your doctor that youare taking Flamasacard® if you have to have an operation, including dental procedures such as having a tooth removed. You may need to stop taking the medicine prior to your operation to reduce the risk of bleeding problems.

Taking Flamasacard® with food and drink

Take the capsules in the morning, 15 minutes before breakfast.

If you drink alcohol while taking Flamasacard® this may make stomach irritation worse. Alcohol can also affect how your blood clots. Talk to your doctor or pharmacist if you are not sure.

Pregnancy, breast-feeding and fertility

Do not take Flamasacard® in the last three months of pregnancy. The capsules should only be taken in the first six months of pregnancy if the doctor decides it is necessary.

Do not breast-feed if you are taking Flamasacard®.

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.

Driving and using machines

Flamasacard® is not likely to affect you being able to drive or use an tools or machines.

3. How to take Flamasacard®

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.

Take one capsule every morning, 15 minutes before breakfast.

-    Swallow the capsule whole with a drink of water.

-    Do not crush or chew the capsules or their contents.

This could affect the way the medicine is absorbed into your body.

-    Take this medicine as long as your doctor tells you to do so.

Use in children and adolescents

There is a possible association between the aspirin in Flamasacard® and ‘Reye’s syndrome’ when it is given to children.

-    Reye’s syndrome is a very rare disease,which can be fatal.

-    For this reason, Flamasacard® should not be given to children under 16 years unless on the advice of

a doctor.

If you take more Flamasacard® than you should

If you take more Flamasacard® than you should, talk to a doctor or go to a hospital straight away. The following effects may happen: headache, feeling dizzy, feeling drowsy, having buzzing in the ears, feeling sick (nausea), being sick (vomiting), stomach ache, difficulty breathing, feeling hot, sweating, convulsions.

If you forget to take Flamasacard®

-    If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next

dose, skip the missed dose.

-    Do not take a double dose (2 capsules at once) to make up for a forgotten dose.

If you stop taking Flamasacard®

-    Ask your doctor for advice before your stop taking this medicine.

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

4. Possible side effects

Like all medicines, Flamasacard® can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Allergic reactions

If you have any signs of an allergic reaction, stop taking Flamasacard® and see a doctor straight away.

The signs may include

-    Severe rash, itching or hives on the skin

-    Swelling of the face, lips, tongue or other parts of the body (oedema).

-    Shortness of breath, wheezing or difficulty breathing.

These side effects are uncommon (affects less than 1 in 100 users) or even very rare (affects less than 1 in 1,000 users).

Tell your doctor straight away if you notice any of the following serious side effects:

-    Confusion, a headache that won’t go away or feeling of being sick. These could be signs of bleeding

inside your head (intracranial bleeding) which is uncommon (affects less than 1 in 100 users).

-    Abdominal pain, fever or chills. These could be signs of a hole in your stomach, small intestine or

bowel (gastrointestinal perforation) which is very rare (affects less than 1 in 10,000 users).

-    Being sick with blood or having blood in your stools (they will look black). This is rare (affects less

than 1 in 1,000 users). However, these could be signs of bleeding in your stomach (gastric bleeding) which is uncommon (affects less than 1 in 100 users).

Other possible side effects:

•    Very common (affects more than 1 in 10 users)

-    Stomach problems such as heartburn or feeling sick (nausea).

•    Common (affects less than 1 in 10 users)

-    Being sick (vomiting),

-    Inflamed stomach (gastritis). This may cause pain, feeling or being sick, or being sick with blood, or

having blood in your stools (they will look black),

-    Mild to moderate blood loss in your digestive tract,

-    Diarrhoea

-    Y our blood taking longer to clot.

•    Uncommon (affects less than 1 in 100 users):

-    Stomach ulcers

-    Blood in your urine

•    Rare (affects less than 1 in 1,000 users):

-    Feeling dizzy

-    Headache

-    Ringing in your ears (tinnitus),

-    Bleeding (hemorrhages) such as bleeding in your nose or gums, or increase menstrual bleeding.

•    Very rare (affects less than 1 in 10,000) users including isolated reports

-    Fainting

-    Worsening of food allergy signs

-    Lowering of blood    sugar levels (hypoglycaemia)

- Liver or kidney problems, or too much uric acid in your blood (this can cause gout in pre-disposed patients): this is shown in blood tests.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any 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 Flamasacard®

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

Do not store above 25°C. Store in the original packaging.

Do not use Flamasacard® after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.

Do not use Flamasacard® if you notice that the colour of the capsules has changed.

Do not throw any medicines away via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information What Flamasacard® 162.5 mg Capsules contain

-    The active substance is aspirin (acetylsalicylic acid) Each prolonged release hard capsule contains 162.5 mg of aspirin.

-    The other ingredients are: ethylcellulose, povidone, castor oil, magnesium stearate, colloidal anhydrous silica, tartaric acid and talc. The capsule shell contains gelatin and colours called titanium dioxide (E171) , erythrosine (E127) and indigotine (E132).

What Flamasacard® 162.5 mg capsules look like and contents of the pack

-    The capsules have a white body and a red cap and are sealed into a blister.

-    The packs contain blister strips of 4, 10, 28, 30 or 100 capsules in a carton.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

New Haven Pharma (UK) Limited

1 Park Row

Leeds

LS1 5AB

UK

Manufacturer

FLAMEL TECHNOLOGIES S.A Flamel Technologies Parc Industriel Bersol 1 11, Avenue Gustave Eiffel F 33608 Pessac Cedex France

Tel: 33(0)5 57 25 07 70

Fax: 33 (0)5 56 36 58 91 Email: info@flamel.com

This medicinal product is authorised in the Member States of the EEA under the following names:

Denmark: Asacard® 162,5 mg dopotkapsler, harde Ireland:    Asacard® 162.5 mg prolonged release hard capsules

Netherlands: Asacard® 162,5 mg harde capsules met verlengde afgigte United Kingdom: Flamasacard® 162.5 mg prolonged release hard capsules

This leaflet was last approved in 2016

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