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PACKAGE LEAFLET: INFORMATION FOR THE USER

Svelux 200 mg/25 mg Modified-release Capsules, hard

dipyridamole and aspirin

Read all of this leaflet carefully before you start taking

this medicine because it contains important

information for you.

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

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    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.

What is in this leaflet

1.    What Svelux is and what it is used for

2.    What you need to know before you take Svelux

3.    How to take Svelux

4.    Possible side effects

5.    How to store Svelux

6.    Contents of the pack and other information

1. What Svelux is and what it is used for

The name of your medicine is Svelux. It contains two different medicines called dipyridamole and aspirin. Both belong to a group of medicines called ‘anti-thrombotic medicines’. Aspirin is also a type of medicine called a ‘Non-Steroidal Anti-inflammatory Drug’ (NSAID).

Svelux belongs to a group of medicines called ‘anti-thrombotic agents’. They are used to stop blood clots forming. Svelux is used for people who have had a

•    Stroke

•    Transient Ischaemic Attack (TIA)

which are caused by a clot in the brain. This medicine reduces the risk of them happening again.

2. What you need to know before you take Svelux

Do not take Svelux if you:

•    are allergic to dipyridamole, aspirin or any other medicines containing substances similar to aspirin (also called ‘salicylates’) or to any of the other ingredients of this medicine (listed in section 6: )

•    are allergic to peanut or soya

•    have any bleeding problems

•    have ever had an ulcer in your stomach or gut (duodenum)

•    have severe kidney or liver problems

•    are taking methotrexate at doses higher than 15 mg/week

•    have something called ‘glucose-6-phosphate dehydrogenase deficiency'. This is a problem of the red blood cells which can cause anaemia

•    have ever had abnormal bleeding in the brain

•    have had stomach pain when previously taking this medicine.

Do not take this medicine if any of the above apply to you.

If you are not sure, talk to your doctor or pharmacist before taking Svelux.

Warnings and precautions

Talk to your doctor or pharmacist before taking svelux if you:

•    have an increased risk of bleeding as you might require careful follow up by your doctor

•    have angina or other heart problems (including a recent heart attack, heart failure, heart valve or circulation problems), as this medicine can cause widening of your blood vessels

•    have myasthenia gravis (a rare muscle problem). The dose of medicine you take for myasthenia gravis may need to be adjusted, especially when the dose of Svelux is changed

•    have asthma, hay fever or nasal polyps (a type of growth in the nose)

•    have kidney or liver problems. If these are severe, do

not take this medicine

•    are allergic to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen

•    are taking medicines that increase the risk of bleeding such as anti-platelet medicines (e.g. clopidogrel) or some antidepressants (SSRIs e.g. paroxetine, sertraline, fluoxetine)

•    have long-term or recurring stomach or intestine problems, causing your stools to be darker in colour

•    are about to have surgery such as having a tooth removed. Your doctor may want you to stop taking this medicine up to 7 days before.

If you get a severe migraine-like headache at the start of your treatment tell your doctor. DO NOT take painkillers containing aspirin to treat your headache.

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

Children and adolescents

Svelux should not be given to children and adolescents.

Other medicines and Svelux

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes herbal medicines. This is because Svelux can affect the way some other medicines work. Also some other medicines can affect the way Svelux works.

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

•    aspirin or medicines containing aspirin (or planning to for any condition)

•    medicines for high blood pressure. The blood pressure lowing effects of these medicines could be increased

•    medicines to thin the blood such as warfarin, heparin, coumarins, clopidogrel and ticlopidine. The effect of these medicines could be increased, increasing the risk of bleeding. If you attend an anticoagulant clinic tell them at your next visit

•    medicines for depression called ‘selective serotonin reuptake inhibitors' such as fluoxetine, paroxetine or sertraline. The risk of bleeding could be increased

•    other Non-Steroidal Anti-inflammatory Drugs (such as ibuprofen) for another condition , or steroids (such as prednisolone). The risk of side effects of your stomach and intestines could be increased

•    methotrexate - used for joint problems or cancer. The risk of side effects may be increased. Your doctor may want to do some blood tests. Do not take this medicine if your dose of methotrexate is higher than 15 mg/week

•    medicines to lower your blood sugar. The effect of these medicines may be increased

•    adenosine - used for heart problems or tests on the heart. Your doctor may want to change the amount of adenosine you are taking

•    spironolactone - a water tablet. The effect of this medicine may be reduced

•    uricosuric medicines used to treat gout, such as probenecid or sulphinpyrazone. The effect of these medicines may be reduced

•    valproic acid - used for treating epilepsy or during the manic episodes) in people with bipolar disorder. The risk of side effects could be increased

•    phenytoin - used to treat epilepsy (seizures). The risk of side effects could be increased

•    cholinesterase inhibitors. The effect of these medicines could be reduced leading to a worsening of myasthenia gravis.

If you are having heart tests

Svelux contains dipyridamole. Dipyridamole is also sometimes given as an injection during tests to see if the heart is working properly (also called ‘myocardial imaging’). This means that the test and your medicine may contain the same substance. If you are going to have an injection of dipyridamole, tell the doctor that you are taking Svelux.

Svelux with alcohol

Do not take Svelux capsules at the same time as an alcoholic drink. Avoid drinking excessive amount of alcohol because the risk of side effects to your stomach and intestines could be increased.

Pregnancy and breast-feeding

Svelux is not recommended during 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.

Driving and using machines

Svelux is not likely to affect your ability to drive or use machines.

Svelux contains lactose.

If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.

Svelux contains parahydroxybenzoate

Svelux contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (possibly delayed).

Svelux contains the colouring ponceau 4R (E124) and sunset yellow (E110)

May cause allergic reactions.

3. How to take Svelux

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is

• One capsule twice a day usually one in the morning and one in the evening.

•    Swallow the capsule whole with a glass of water.

•    Do not crush or chew it.

If you get a severe migraine-like headache at the start of your treatment tell your doctor as they may need to change your dose for a short period of time. DO NOT take painkillers containing aspirin to treat your headache.

Use in children and adolescents

This medicine should not be given to children and adolescents (see also section 2 “Warnings and precautions”).

If you take more Svelux than you should

If you take more of this medicine than you should, talk to a doctor or go to a hospital straight away. You may experience symptoms of dizziness, confusion, tinnitus (ringing in your ears), breathing too fast, feeling sick, being sick, loss of hearing, warm feeling, flushing of the face, sweating, restlessness, weakness or heart problems. Take the medicine pack with you, even if there are no capsules left.

If you forget to take Svelux

If you forget a dose, take it as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for the forgotten dose.

If you stop taking Svelux

Do not stop treatment without talking to your doctor first.

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. The following side effects may happen with this medicine.

Bleeding

Bleeding at different sites within the body can occur which in some cases may be serious.

In such cases stop taking your medicine and seek urgent medical advice.

If you have any of the following side effects, stop taking your medicine and see a doctor straight away.

Common, may affect up to 1 in 10 people

•    allergic reactions. The signs may include difficulty breathing, rash of the skin which may be severe with itching, or swelling of the throat or face.

•    bleeding in the brain

•    bleeding in the stomach or gut

•    nosebleeds

Uncommon, may affect up to 1 in 100 people

•    bleeding in the eye

•    stomach ulcers. Signs may be continuous heartburn, black tarry stools, abdominal discomfort.

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

•    reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)

•    anaemia due to internal bleeding into the stomach

Frequency not known, frequency cannot be estimated from the available data

•    prolonged bleeding from wounds including during or after surgery or other medical procedures, skin bleeding

•    bruising or swellings where blood has collected (haematoma)

•    blood in the stools or vomiting blood

•    inflammation of the pancreas, which causes severe pain in the abdomen and back

•    inflammation of the liver (hepatitis)

•    abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis)

•    kidney failure and other kidney problems

•    convulsions (fits) or swelling of the brain

•    deafness or ringing in the ears

•    Reye‘s syndrome, a rare disease which affects major organs and can be fatal. It especially occurs if acetylsalicylic acid* is given to children.

•    swelling in the throat

Other side effects that have been reported for Svelux

Very common, may affect more than 1 in 10 people

•    headache. This is more common at the start of treatment and usually goes away as treatment continues. If this occurs, tell your doctor. DO NOT take painkillers containing aspirin to treat your headache

•    feeling dizzy

•    feeling sick (nausea)

•    stomach ache

•    indigestion or diarrhoea

Common, may affect up to 1 in 10 people

•    reduction in red blood cells which can make the skin pale and cause weakness or breathlessness (anaemia)

•    worsening of the symptoms of heart disease

•    migraine

•    being sick (vomiting)

•    muscle pain

•    fainting

Uncommon, may affect up to 1 in 100 people

•    faster heart beat

•    lowering of blood pressure

•    hot flushes

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

•    inflammation of the stomach

In addition, there are other side effects that are known for the active ingredients dipyridamole and aspirin when taken on their own. These are listed below. However they have not been reported for Svelux.

Dipyridamole

In people who have gallstones, dipyridamole can be absorbed into the gallstones.

Aspirin

•    blood clotting problems and bleeding gums

•    severe allergic reactions especially in patients who have asthma

•    high or low blood sugar levels

•    increased uric acid in the blood, which may cause gout, or other changes in the composition of the blood

•    feeling thirsty or becoming dehydrated

•    feeling confused or restless

•    feeling less alert

•    irregular heart beats

•    difficulty breathing or fast or shallow breathing

•    excess fluid in the lungs

•    rash with blisters

•    possible effect on liver test results

•    prolonged pregnancy or labour, bleeding before or after birth, small baby or stillbirth

•    fever or low body temperature (hypothermia)

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: 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 Svelux

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

Store in the original package in order to protect from moisture. Keep the bottle tightly closed.

This medicine does not require any special temperature storage conditions.

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

Do not open the bottle until you are ready to start taking the capsules. If you have any capsules left in the bottle after 30 days, these should not be taken.

Do not throw away any medicines via wastewater. 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 Svelux contains

•    The active substances are dipyridamole and aspirin. Each capsule contains dipyridamole 200 mg in modified release form and 25 mg aspirin in standard release form.

•    The other ingredients are: Dipyridamole pellets - tartaric acid, hypromellose, acacia, talc, povidone, methacrylic acid-methyl methacrylate copolymer (1:2), hypromellose phthalate, dimethicone 350, triacetin, stearic acid; Aspirin tablet - microcrystalline cellulose, lactose anhydrous, pre-gelatinised corn starch, colloidal anhydrous silica, stearic acid, polyvinyl alcohol-part hydrolysed, titanium dioxide (E171), talc, quinoline yellow aluminium lake (E104), soya lecithin (E322), xanthan gum (E415); Capsule shells - gelatine, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ponceau 4R (E124), patent blue V (E131), quinoline yellow (E104), sunset yellow (E110), titanium dioxide (E171);

What Svelux looks like and contents of the pack

The capsules have an orange cap and white to off-white body.

Svelux 200 mg/25 mg modified-release capsules, hard is available in bottles containing 30, 50, 60 (2x30) and 100 (2x50) capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder

Sandoz Ltd,

Frimley Business Park, Frimley,

Camberley, Surrey, GU16 7SR, UK.

Manufacturer

Dr. Reddy’s Laboratories (UK) Ltd, 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD, UK.

This leaflet was last revised in 01/2016.

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