1. What Dipyridamole is and what it is used for

2. What you need to know before you take Dipyridamole

3. How to take Dipyridamole 4. Possible side effects

5. How to store Dipyridamole 6. Contents of the pack and other information

1. what dipyridamole is and what it is used for

Dipyridamole belongs to a group of medicines called ‘anti-thrombotic agents’, which are used to help stop blood clots forming.

Dipyridamole helps stop blood clots which may occur if you have had your heart valves replaced.

2. what you need to know before you take dipyridamole

Do not take Dipyridamole if:

► You are allergic (hypersensitive) to dipyridamole or any of the other ingredients of this medicine (listed in section 6: Contents of the pack and other information).

Warnings and precautions

Talk to your doctor or pharmacist before taking Dipyridamole if: ► you have angina or other heart problems (including heart valve or circulation problems) or have had a recent heart attack

► you have myasthenia gravis (a rare muscle problem)

► you have any bleeding problems ► you are pregnant or planning to become pregnant or are breast feeding

► you have been told by your doctor that you have an intolerance to some sugars.

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

Other medicines and Dipyridamole

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicine. This includes medicines obtained without a prescription and herbal medicines. Dipyridamole may affect or be affected by other medicines.

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

► Medicines for high blood pressure

► Medicines for muscle weakness such as something called a ‘cholinesterase inhibitor’

► Antacids – for indigestion ► Aspirin (or planning to take aspirin for any condition) or other anti-platelet agents which are used to prevent blood clot formation

► Adenosine injection – used for heart problems or tests on the heart

► Warfarin or other medicines to stop blood clots forming. If so, tell them at your next visit to the anticoagulant clinic that you are now taking Dipyridamole.

If you are having heart tests 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 Dipyridamole.

► If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

► Tell your doctor if you are breast-feeding or about to start breast-feeding as Dipyridamole should only be used during breast-feeding if your doctor considers it essential.

Driving and using machines You may feel dizzy while taking Dipyridamole. If this happens do not drive or use any tools or machines.

3 Dipyridamole contains: Liquid maltitol (E965): If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Methyl (E218) and propyl parahydroxyben­zoates (E216): May cause allergic reactions (possibly delayed).

Dipyridamole also contains 545.20mg/5ml propylene glycol (E1520) as an ingredient necessary for the medicine to work properly.

3. how to take dipyridamole ,

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

The usual dose is:

• ► The usual dose is 300–600mg each day.

• ► This is taken in three or four separate doses.

• ► The most you can take in a day is 600mg (which is a total of 15 mls per day).

• ► It is best to take the Dipyridamole before meals.

Do not give to children.

Route and Method of administration

This medicinal product must be taken orally.

This product may settle during storage. Shake well before use.

► Use only the dosing spoon supplied with the pack (see figure below).

► Measure the exact quantity of dipyridamole using the dosing spoon, 2.5ml (small end) contains 100mg of dipyridamole, and 5ml (large end) contains 200mg of dipyridamole.

• ► Swallow the suspension.

• ► Wash the spoon with clean water after taking every dose.

• 2.5–5ml double-ended spoon

  5ml

  (Large end)

  
  

  2.5ml

  
  

(Small end)

If you take more Dipyridamole than you should

Call your doctor or go to your nearest hospital casualty department straight away. Take the medicine pack with you, even if there is no Dipyridamole left.

If you forget to take Dipyridamole

• ► If you forget a dose, take it as soon as you remember.

• ► However, if it is nearly time for the next dose, skip the missed dose.

• ► Do not take a double dose to make up for a forgotten dose.

If you stop taking Dipyridamole

Do not stop taking Dipyridamole unless your doctor tells you to.

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.

Allergic reactions:

If you have an allergic reaction, stop taking your medicine and see a doctor straight away. The signs may include feeling breathless, runny nose, severe rash with itching, swelling and swelling around the eyes.

Other side effects that have been reported for Dipyridamole are:

Very common (affects more than 1 in 10 people)

• ► Headache

• ► Feeling dizzy

• ► Feeling sick (nausea)

• ► Diarrhoea

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

• ► Muscle pain

• ► Being sick (vomiting)

• ► Worsening of the symptoms of heart disease such as chest pain and shortness of breath

Not known

• ► Hot flushes

• ► Lowering of blood pressure

• ► A blood problem called ‘thrombocytopenia’ which can cause bruising and prolonged bleeding from wounds, including during or after surgery

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

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

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 Website 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 dipyridamole

• ► Keep out of the sight and reach of children.

• ► Do not use after the expiry date which is printed on the carton and bottle label after ‘Exp’. The expiry date refers to the last day of that month.

• ► Do not store above 25°C.

• ► Discard after 60 days of first opening.

• ► Do not use this medicine if you notice that the suspension becomes discoloured or shows any signs of deterioration. Seek the advice of your pharmacist.

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

/---------------------------------------------

What Dipyridamole contains

The active substance is dipyridamole.

Each 5ml of oral suspension contains 200mg dipyridamole.

The other ingredients are methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), polysorbate 80 (E433), simeticone emulsion 30% (containing polydimethylsi­loxane, sorbitan monostearate, polyoxyethylene 20 sorbitan, silicon dioxide, xanthan gum, benzoic acid, sorbic acid, potassium hydroxide, hydrogen chloride and deionised water), liquid maltitol (E965), xanthan gum (E415), aluminium magnesium silicate (E553a), citric acid monohydrate (E330), disodium phosphate anhydrous (E339), ammonium glycyrrhizinate, propylene glycol (E1520), orange flavour [containing propylene glycol (E1520)] and purified water.

What Dipyridamole looks like and contents of the pack

1. What Dipyridamole is and what it is used for

2. What you need to know before you take Dipyridamole

3. How to take Dipyridamole 4. Possible side effects

5. How to store Dipyridamole 6. Contents of the pack and other information

1. what dipyridamole is and what it is used for

k____________­________________________­_______/

Dipyridamole belongs to a group of medicines called ‘anti-thrombotic agents’, which are used to help stop blood clots forming.

Dipyridamole helps stop blood clots which may occur if you have had your heart valves replaced.

2. what you need to know before you take dipyridamole

Do not take Dipyridamole if:

► You are allergic (hypersensitive) to dipyridamole or any of the other ingredients of this medicine (listed in section 6: Contents of the pack and other information).

Warnings and precautions

Talk to your doctor or pharmacist before taking Dipyridamole if: ► you have angina or other heart problems (including heart valve or circulation problems) or have had a recent heart attack

► you have myasthenia gravis (a rare muscle problem)

► you have any bleeding problems ► you are pregnant or planning to become pregnant or are breast feeding

► you have been told by your doctor that you have an intolerance to some sugars.

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

Other medicines and Dipyridamole

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicine. This includes medicines obtained without a prescription and herbal medicines. Dipyridamole may affect or be affected by other medicines.

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

► Medicines for high blood pressure

► Medicines for muscle weakness such as something called a ‘cholinesterase inhibitor’

► Antacids – for indigestion ► Aspirin (or planning to take aspirin for any condition) or other anti-platelet agents which are used to prevent blood clot formation

► Adenosine injection – used for heart problems or tests on the heart

► Warfarin or other medicines to stop blood clots forming. If so, tell them at your next visit to the anticoagulant clinic that you are now taking Dipyridamole.

If you are having heart tests 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 Dipyridamole.

Jg” Jfk Pregnancy and vik Breast-feeding

► If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

► Tell your doctor if you are breastfeeding or about to start breastfeeding as Dipyridamole should only be used during breast-feeding if your doctor considers it essential.

Driving and using machines

You may feel dizzy while taking Dipyridamole. If this happens do not drive or use any tools or machines.

^7 Dipyridamole contains: Liquid maltitol (E965): If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Methyl (E218) and propyl parahydroxyben­zoates (E216):

May cause allergic reactions (possibly delayed).

Dipyridamole also contains 545.20mg/5ml propylene glycol (E1520) as an ingredient necessary for the medicine to work properly.

3. how to take dipyridamole.

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

The usual dose is:

• ► The usual dose is 300–600mg each day.

• ► This is taken in three or four separate doses.

• ► The most you can take in a day is 600mg (which is a total of 15 mls per day).

• ► It is best to take the Dipyridamole before meals.

Do not give to children.

Route and Method of administration

This medicinal product must be taken orally.

This product may settle during storage. Shake well before use.

► Use only the dosing spoon supplied with the pack (see figure below).

► Measure the exact quantity of dipyridamole using the dosing spoon, 2.5ml (small end) contains 100mg of dipyridamole, and 5ml (large end) contains 200mg of dipyridamole.

• ► Swallow the suspension.

• ► Wash the spoon with clean water after taking every dose.

• 2.5–5ml double-ended spoon

  5ml

  (Large end)

  
  

  2.5ml

  
  

(Small end)

If you take more Dipyridamole than you should

Call your doctor or go to your nearest hospital casualty department straight away. Take the medicine pack with you, even if there is no Dipyridamole left.

If you forget to take Dipyridamole

• ► If you forget a dose, take it as soon as you remember.

• ► However, if it is nearly time for the next dose, skip the missed dose.

• ► Do not take a double dose to make up for a forgotten dose.

If you stop taking Dipyridamole

• ► Do not stop taking Dipyridamole unless your doctor tells you to.

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.

Allergic reactions:

If you have an allergic reaction, stop taking your medicine and see a doctor straight away. The signs may include feeling breathless, runny nose, severe rash with itching, swelling and swelling around the eyes.

Other side effects that have been reported for Dipyridamole are:

Very common (affects more than 1 in 10 people)

• ► Headache

• ► Feeling dizzy

• ► Feeling sick (nausea)

• ► Diarrhoea

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

• ► Muscle pain

• ► Being sick (vomiting)

• ► Worsening of the symptoms of heart disease such as chest pain and shortness of breath

Not known

• ► Hot flushes

• ► Lowering of blood pressure

• ► A blood problem called ‘thrombocytopenia’ which can cause bruising and prolonged bleeding from wounds, including during or after surgery

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

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

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2;

Tel: +353 1 6764971; Fax: +353 1 6762517. Web­site: ;

E-mail: for Ireland. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store dipyridamole

• ► Keep out of the sight and reach of children.

• ► Do not use after the expiry date which is printed on the carton and bottle label after ‘Exp’. The expiry date refers to the last day of that month.

• ► Do not store above 25°C.

• ► Discard after 60 days of first opening.

• ► Do not use this medicine if you notice that the suspension becomes discoloured or shows any signs of deterioration. Seek the advice of your pharmacist.

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

/---------------------------------------------

What Dipyridamole contains

The active substance is dipyridamole.

Each 5ml of oral suspension contains 200mg dipyridamole.

The other ingredients are methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), polysorbate 80 (E433), simeticone emulsion 30% (containing polydimethylsi­loxane, sorbitan monostearate, polyoxyethylene 20 sorbitan, silicon dioxide, xanthan gum, benzoic acid, sorbic acid, potassium hydroxide, hydrogen chloride and deionised water), liquid maltitol (E965), xanthan gum (E415), aluminium magnesium silicate (E553a), citric acid monohydrate (E330), disodium phosphate anhydrous (E339), ammonium glycyrrhizinate, propylene glycol (E1520), orange flavour [containing propylene glycol (E1520)] and purified water.

What Dipyridamole looks like and contents of the pack

Dipyridamole is a uniform yellow coloured suspension with orange flavour supplied in an amber glass bottle with a tamper evident child resistant plastic cap and a 2.5ml-5ml double-ended plastic spoon for measuring and administering the dose.

Dipyridamole is supplied in bottles containing 150ml and 300ml of oral suspension.

Not all pack sizes may be marketed.

POM

Marketing Authorisation

Holder and Manufacturer:

Thame Laboratories,

Unit 4, Bradfield Road,

Ruislip, Middlesex

HA4 0NU, UK.

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

UK and IE: Dipyridamole 200mg/5ml Oral Suspension

This leaflet was last revised in 03/2020.

Thame Laboratories

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.

The name of your medicine is Dipyridamole 200mg/5ml Oral Suspension but it will be referred to as Dipyridamole throughout this leaflet.

What is in this leaflet:

• 1. What Dipyridamole is and what it is used for

• 2. What you need to know before you take Dipyridamole

• 3. How to take Dipyridamole 4. Possible side effects

5. How to store Dipyridamole 6. Contents of the pack and other information

1. what dipyridamole is and what it is used for

k____________­________________________­_______/

Dipyridamole belongs to a group of medicines called ‘anti-thrombotic agents’, which are used to help stop blood clots forming.

Dipyridamole helps stop blood clots which may occur if you have had your heart valves replaced.

2. what you need to know before you take dipyridamole

Do not take Dipyridamole if:

► You are allergic (hypersensitive) to dipyridamole or any of the other ingredients of this medicine (listed in section 6: Contents of the pack and other information).

Warnings and precautions

Talk to your doctor or pharmacist before taking Dipyridamole if: ► you have angina or other heart problems (including heart valve or circulation problems) or have had a recent heart attack

► you have myasthenia gravis (a rare muscle problem)

► you have any bleeding problems ► you are pregnant or planning to become pregnant or are breast feeding

► you have been told by your doctor that you have an intolerance to some sugars.

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

Other medicines and Dipyridamole

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicine. This includes medicines obtained without a prescription and herbal medicines. Dipyridamole may affect or be affected by other medicines.

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

► Medicines for high blood pressure

► Medicines for muscle weakness such as something called a ‘cholinesterase inhibitor’

► Antacids – for indigestion ► Aspirin (or planning to take aspirin for any condition) or other anti-platelet agents which are used to prevent blood clot formation

► Adenosine injection – used for heart problems or tests on the heart

► Warfarin or other medicines to stop blood clots forming. If so, tell them at your next visit to the anticoagulant clinic that you are now taking Dipyridamole.

If you are having heart tests 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 Dipyridamole.

Jg” Jfk Pregnancy and vik Breast-feeding

► If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

► Tell your doctor if you are breastfeeding or about to start breastfeeding as Dipyridamole should only be used during breast-feeding if your doctor considers it essential.

Driving and using machines

You may feel dizzy while taking Dipyridamole. If this happens do not drive or use any tools or machines.

^7 Dipyridamole contains: Liquid maltitol (E965): If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Methyl (E218) and propyl parahydroxyben­zoates (E216):

May cause allergic reactions (possibly delayed).

Dipyridamole also contains 545.20mg/5ml propylene glycol (E1520) as an ingredient necessary for the medicine to work properly.

3. how to take dipyridamole.

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

The usual dose is:

• ► The usual dose is 300–600mg each day.

• ► This is taken in three or four separate doses.

• ► The most you can take in a day is 600mg (which is a total of 15 mls per day).

• ► It is best to take the Dipyridamole before meals.

Do not give to children.

Route and Method of administration

This medicinal product must be taken orally.

This product may settle during storage. Shake well before use.

► Use only the dosing spoon supplied with the pack (see figure below).

► Measure the exact quantity of dipyridamole using the dosing spoon, 2.5ml (small end) contains 100mg of dipyridamole, and 5ml (large end) contains 200mg of dipyridamole.

• ► Swallow the suspension.

• ► Wash the spoon with clean water after taking every dose.

• 2.5–5ml double-ended spoon

  5ml

  (Large end)

  
  

  2.5ml

  
  

(Small end)

If you take more Dipyridamole than you should

Call your doctor or go to your nearest hospital casualty department straight away. Take the medicine pack with you, even if there is no Dipyridamole left.

If you forget to take Dipyridamole

• ► If you forget a dose, take it as soon as you remember.

• ► However, if it is nearly time for the next dose, skip the missed dose.

• ► Do not take a double dose to make up for a forgotten dose.

If you stop taking Dipyridamole

• ► Do not stop taking Dipyridamole unless your doctor tells you to.

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.

Allergic reactions:

If you have an allergic reaction, stop taking your medicine and see a doctor straight away. The signs may include feeling breathless, runny nose, severe rash with itching, swelling and swelling around the eyes.

Other side effects that have been reported for Dipyridamole are:

Very common (affects more than 1 in 10 people)

• ► Headache

• ► Feeling dizzy

• ► Feeling sick (nausea)

• ► Diarrhoea

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

• ► Muscle pain

• ► Being sick (vomiting)

• ► Worsening of the symptoms of heart disease such as chest pain and shortness of breath

Not known

• ► Hot flushes

• ► Lowering of blood pressure

• ► A blood problem called ‘thrombocytopenia’ which can cause bruising and prolonged bleeding from wounds, including during or after surgery

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

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

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2;

Tel: +353 1 6764971; Fax: +353 1 6762517. Web­site: ;

E-mail: for Ireland. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store dipyridamole

• ► Keep out of the sight and reach of children.

• ► Do not use after the expiry date which is printed on the carton and bottle label after ‘Exp’. The expiry date refers to the last day of that month.

• ► Do not store above 25°C.

• ► Discard after 60 days of first opening.

• ► Do not use this medicine if you notice that the suspension becomes discoloured or shows any signs of deterioration. Seek the advice of your pharmacist.

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