Ofcram 100 CC

Si7«- 160 x ?7fi mm

Package Leaflet: Information for the patient Ofcram PR 200mg iProlonged Release Capsules, Hard |Dipyridamole

Read all of this leaflet carefully before you Istart taking this medicine because it contains _ important information for you.

I* Keep this leaflet. You may need to read it again, i* If you have any further questions, ask your doctor or pharmacist.

I* This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if I their signs of illness are the same as yours, i* If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not | listed in this leaflet.

What is in this leaflet:

n .What Ofcram Prolonged Release Capsules are and i what they are used for

2. What you need to know before you take Ofcram | Prolonged Release Capsules

3. Howto take Ofcram Prolonged Release Capsules k. Possible side effects

|5.How to store Ofcram Prolonged Release Capsules 6.Contents of the pack and other information

I-<Dll.What Ofcram Prolonged Release Capsules . are and what they are used for

You must talk to your doctor if you do not feel better or |if you feel worse after a few days.

Ofcram PR 200mg Prolonged Release Capsules (called Ofcram Prolonged Release Capsules throughout the rest of this leaflet) contain a medicine called dipyridamole. Ofcram belongs to a group of |medicines called antithrombotic agents which are used to stop blood clots forming, bfcram Prolonged Release Capsules are used: p After a stroke to prevent blood clots in the brain;

- To prevent blood clots forming after having a heart I valve replaced.

i-0-

What you need to know before you take | Ofcram Prolonged Release Capsules Do not use Ofcram Prolonged Release Capsules:

!• if you are allergic (hypersensitive) to dipyridamole, or I any of the other ingredients in this medicine (listed in Section 6).

IWarnings and Precautions

,• Talk to your doctor or pharmacist before taking ' Ofcram Prolonged Release Capsules.

|Take special care with Ofcram Prolonged Release Capsules:

fcheck with your doctor or pharmacist before taking .your medicine if you have: • Angina or other heart problems (including heart | valve or circulation problems) or have recently had a heart attack;

I* Myasthenia gravis (a rare muscle problem);

|* Bleeding problems;

• Or if you are pregnant, planning to become I pregnant or breast-feeding.

Always tell your doctor that you are taking Ofcram Prolonged Release Capsules before having a test of |your heart function (myocardial imaging). Treatment with Ofcram Prolonged Release Capsules may affect [the results. You may need to stop taking Ofcram Prolonged Release Capsules before you have the test.

Please tell your doctor or pharmacist if you are taking| or have recently taken or might take any other medicines. This includes medicines obtained without d prescription, for example herbal medicine, strong vitamins and minerals.

Tell your doctor or pharmacist if you are taking medicines for:

•    high blood pressure    I

•    heart problems or irregular heartbeat (e.g₁

adenosine)    '

•    blood clots (e.g. warfarin, aspirin)    |

•    myasthenia gravis, a disease which causes muscle

weakness (e.g. cholinesterase inhibitors).    I

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.

Pregnancy    .

If you are pregnant you are not recommended to take Ofcram Prolonged Release Capsules. Ask your doctor| for advice.

Breast-feeding    I

If you are breast-feeding, do not take Ofcram Prolonged Release Capsules, as Ofcram is excreted into breast milk. Talk to your doctor.

Fertility

No data are available.

Driving and using machines

You may experience dizziness whilst taking Ofcram Prolonged Release Capsules. If this occurs you should not drive or operate machinery.    ,

3. How to take Ofcram Prolonged Release    I

Capsules    i

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:    '

Use in adults    |

The recommended dose is one capsule twice daily, usually one in the morning and one in the evening. I The capsules should be swallowed whole without, chewing.    ¹

Use in children    |

Ofcram Prolonged Release Capsules are not recommended in children.    I

If you take more Ofcram Prolonged Release Capsulesj than you should

Tell your doctor, hospital or pharmacist straight away if| you have taken more Ofcram Prolonged Release Capsules than listed here or more than the doctor hasl prescribed and you feel unwell.    |

If you forget to take Ofcram Prolonged Release Capsules If you forget a dose, take it as soon as you remember itj However, if it is 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 Ofcram Prolonged Release Capsules If you have any further questions on the use of thisl medicine, ask your doctor or pharmacist.

Ofcram Prolonged Release Capsules with food, drink and alcohol    |

The capsules should be taken with food.

You should avoid alcohol when taking the capsules. I

(continued overleaf)!

14. Possible side effects

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

|lf you experience any of the following side effects after you have taken your medicine, see your doctor limmediately. These side effects are rare but serious: i- Severe allergic reaction which may include a red ¹ and lumpy skin rash, difficulty breathing, swelling of | face, mouth, lips or eyelids, unexplained high temperature (fever) and feeling faint. If the swelling | affects your throat and makes breathing and swallowing difficult, stop taking your medicine and I go to hospital straight away.

[Very common (affects more than 1 in 10 patients)

-    Headache;

I- Feeling dizzy; i- Diarrhoea;

-    Feeling sick.

ICommon (affects less than 1 in 10 patients to more than 1 in 100 patients)

-    Worsening of the symptoms of heart disease such as | chest pain;

-    Being sick;

L Muscle pain.

|Not known

-    Increased heart rate;

L Lowering of blood pressure; i- Hot flushes;

-    Tightening of the chest;

I- Pale, raised, itchy areas of skin with red edges; i- A blood problem called “thrombocytopenia" which ¹ can cause bruising and prolong bleeding from | wounds or during and after surgery;

-    Gallstone pain (in the centre or right of your I stomach).

iReporting of side effects

If you get any side effects, talk to your doctor or Ipharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: iwww.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the [safety of this medicine.

¹-CD

's. How to store Ofcram Prolonged Release I Capsules

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

|Do not store above 25°C.

Keep the container tightly closed in order to protect from moisture.

|Do not open the container until your are ready to start taking the capsules. If you have any capsules left after bix weeks, these should not be taken. iDo not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last iday of that month.

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 will help protect the environment.

-®-

6. Contents of the pack and other information

.What Ofcram Prolonged Release Capsules contain

The active substance is dipyridamole. Each capsule [contains dipyridamole 200mg.

The other ingredients are: tartaric acid pellets, Hypromellose, talc, acacia, spray-dried, triacetin, Povidone, simeticone emulsion (30 % W/V), methacrylic acid - ethyj acrylate copolymer, hypromellose phthalate P55.    |

Capsule shells: gelatin, titanium dioxide (El 71), red and yellow iron oxides (El 72).    I

What Ofcram Prolonged Release Capsules| look like and contents of the pack Hard gelatin capsules consisting of a red capl and an orange body. Dimension 7,66 mm x_ — 23,1 mm.    I

The capsule contains yellow coloured slow release] pellets.

HDPE bottle with polypropylene child resistant closurej containing a desiccant in a pillow pouch.    ,

Packs contain 60 capsules.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is:    |

Focus Pharmaceuticals Limited, Capital House,

1st Floor, 85 King William Street, London EC4N 7BL, UK I Tel: 00 44 (0)1283 495 280    ,

Fax: 00 44 (0)1283 495 290    ¹

Email: medinfo@focuspharma.co.uk    |

The Manufacturer is:

Geryon Pharma Limited, 18 Owen Drive, Liverpool, I L24 1YL, UK    |

For any information about this medicinal product, please contact the Marketing Authorisation Holder] details provided above.    ,

Other sources of information

For information in large print, audio CD or Braille please telephone    I

00 44 (0)1283 495 280 or    |

email medinfo@focuspharma.co.uk.    ,

This leaflet was last revised in 09/2016.

103461 /LF/249/05