PACKAGE LEAFLET: INFORMATION FOR THE USER

Molita 200 mg/25 mg Modified-Release Capsules, Hard

Dipyridamole and aspirin

Read all of this leaflet carefully before you start taking

this medicine.

-    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet

1.    What Molita is and what it is used for

2.    Before you take Molita

3.    How to take Molita

4.    Possible side effects

5.    How to store Molita

6.    Further information

1. What Molita is and what it is used for

The name of your medicine is Molita. 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).

Molita belongs to a group of medicines called 'antithrombotic agents'. They are used to stop blood clots forming. Molita is used for people who have had a

•    Stroke

•    T ransient Ischaemic Attack (TIA)

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

2. Before you take Molita

Do not take Molita if you:

•    are allergic (hypersensitive) to dipyridamole, aspirin or any other medicines containing aspirin (also called 'salicylates') or to any of the other ingredients of Molita (see section 6: Further information)

•    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 Molita.

Take special care with Molita

Check with your doctor or pharmacist before taking

your medicine 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 Molita is changed

•    have asthma, hayfever 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.

Molita should not be given to children.

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

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because Molita can affect the way some other medicines work. Also some other medicines can affect the way Molita 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

Molita 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 Molita.

Taking Molita with alcohol

Do not take Molita 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

Molita is not recommended during pregnancy and breastfeeding. If you are pregnant, likely to get pregnant or are breast-feeding, talk to your doctor before taking this medicine

Driving and using machines

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

Important information about some of the ingredients of Molita

Molita 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. Molita also contains methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216) and colourings ponceau 4R (E124) and sunset yellow (E110), which may cause allergic reactions.

3. How to take Molita

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

The usual 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

This medicine should not be given to children (see also section 2 Take special care with Molita).

If you take more Molita 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 T ake the medicine pack with you, even if there are no capsules left.

If you forget to take Molita

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 Molita

Do not stop treatment without talking to your doctor first.

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

4. Possible side effects

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

Allergic reactions

Allergic reactions are common. If you have an allergic reaction, stop taking your medicine and see a doctor straight away. The signs may include difficulty breathing, rash which may be severe with itching, or swelling of the throat or face.

If any of the following side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Bleeding

Bleeding at different sites within the body can occur which in some cases may be serious. The following have been seen with Molita.

Common (affects less than 1 in 10 people but more than 1 in 100 people)

•    bleeding in the brain

•    bleeding in the stomach or gut

•    nosebleeds

Uncommon (affects less than 1 in 100 people but more than 1 in 1,000 people)

•    bleeding in the eye

Unknown (incidence cannot be estimated)

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

•    bruising or swellings where blood has collected (haematoma)

Other side effects that have been reported for Molita

Very Common (affects 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 (affects less than 1 in 10 people but more than 1 in 100 people)

•    anaemia

•    worsening of the symptoms of heart disease

•    migraine

•    being sick (vomiting)

•    muscle pain

•    fainting

Uncommon (affects less than 1 in 100 people but more than    1 in 1,000 people)

•    increased heart beat

•    lowering of blood pressure

•    hot flushes

•    stomach ulcers

Rare (affects less than 1 in 1,000 people but more than 1 in 10,000 people)

•    a blood problem called 'thrombocytopenia' which can cause bruising or prolonged bleeding

•    inflammation of the stomach

•    anaemia due to internal bleeding into 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 Molita.

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, convulsions (fits) or swelling of the brain

•    deafness or ringing in the ears

•    irregular heart beats

•    difficulty breathing or fast or shallow breathing

•    swelling in the throat or excess fluid in the lungs

•    perforated ulcers in the stomach

•    blood in the stools or vomiting blood

•    inflammation of the pancreas

•    inflammation of the liver (hepatitis)

•    Reye's syndrome - a rare disease which can be fatal especially if aspirin is given to children

•    rash with blisters

•    muscle breakdown

•    kidney failure and other kidney problems

•    possible affect 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, 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.

By reporting side effects you can help provide more infomation on the safety of this medicine

5. How to store Molita

Keep out of the sight and reach of children.

This medicinal product does not require any special temperature storage conditions.

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

Do not use Molita 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Further information

What Molita 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, hypromellose phthalate, dimethicone, triacetin, stearic acid; Aspirin tablet - microcrystalline cellulose, anhydrous lactose, corn starch, colloidal anhydrous silica, stearic acid, polyvinyl alcohol, titanium dioxide, talc, quinoline yellow (E104), soya lecithin (E322), xanthan gum (E415); Capsule shells - gelatine, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ponceau 4R (E124), patent blue (E131), quinoline yellow (E104), sunset yellow (E110), titanium dioxide (E171).

What Molita looks like and contents of the pack

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

Molita is available in plastic bottles with child-proof closure containing 30, 50 or 60 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Dr. Reddy's Laboratories (UK) Ltd., 6 Riverview Road, Beverley, HU17 0LD, United Kingdom

This leaflet was last revised in 07/2016