Jenapri Pr 200 Mg Prolonged-Release Capsules Hard
Jenapri 100 CC Pack Insert Size: 160 x 270 mm
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MercuryPharma
Package Leaflet: Information for the patient
Ijenapri PR 200mg Prolonged-release capsules, hard
Dipyridamole
Read all of this leaflet carefully before you Mart 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.
|® 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
I pharmacist. This includes any possible side effects | not listed in this leaflet.
What is in this leaflet:
II .What Jenapri Prolonged-release capsules are and I what they are used for
2. What you need to know before you take Jenapri | Prolonged-release capsules
3. How to take Jenapri Prolonged-release capsules k. Possible side effects p.How to store Jenapri Prolonged-release capsules 6.Contents of the pack and other information
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1. WHAT JENAPRI PROLONGED-RELEASE CAPSULES ARE AND WHAT THEY ARE USED FOR
You must talk to your doctor if you do not feel better ior if you feel worse after a few days.
Jenapri PR 200mg Prolonged-release capsules, hard l(called Jenapri Prolonged-release capsules .throughout the rest of this leaflet) contain a medicine called dipyridamole. Jenapri belongs to a group of medicines called antithrombotic agents which are used to stop blood clots forming.
Llenapri 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 | valve replaced.
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WHAT YOU NEED TO KNOW BEFORE YOU TAKE | JENAPRI PROLONGED-RELEASE CAPSULES Do not use Jenapri Prolonged-release capsules:
I® If you are allergic (hypersensitive) to dipyridamole,
I or any of the other ingredients in this medicine (listed 1 in Section 6).
^Warnings and Precautions
• Talk to your doctor or pharmacist before taking I Jenapri Prolonged-release capsules.
Take special care with Jenapri Prolonged-release capsules:
Check 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);
I® Bleeding problems;
• Or if you are pregnant, planning to become I pregnant or breast-feeding.
Always tell your doctor that you are taking Jenapri Prolonged-release capsules before having a test of iyour heart function (myocardial imaging). Treatment with Jenapri Prolonged-release capsules may affect [the results. You may need to stop taking Jenapri Prolonged-release capsules before you have the test.
Other medicines and Jenapri Prolonged-release i
capsules
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 al prescription, for example herbal medicine, strong vitamins and minerals. '
Tell your doctor or pharmacist if you are taking |
medicines for:
• Heart problems or irregular heartbeat (e.g. ,
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 i
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. I
Pregnancy i
If you are pregnant you are not recommended to take Jenapri Prolonged-release capsules. Ask your doctor for advice.
Breast-feeding
If you are breast-feeding, do not take Jenapri i
Prolonged-release capsules, as Jenapri is excreted into breast milk. Talk to your doctor.
Fertility
You may experience dizziness whilst taking Jenapri Prolonged-release capsules. If this occurs you should I not drive or operate machinery. ,
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3. HOW TO TAKE JENAPRI PROLONGED-RELEASE I
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or I pharmacist if you are not sure. .
The recommended dose is;
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 i
chewing.
Jenapri Prolonged-release capsules are not recommended in children. '
If you take more Jenapri Prolonged-release capsules | than you should
Tell your doctor, hospital or pharmacist straight away ifl you have taken more Jenapri Prolonged-release capsules than listed here or more than the doctor has' prescribed and you feel unwell. i
If you forget to take Jenapri Prolonged-release capsules If you forget a dose, take it as soon as you remember I it. 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. i
If you stop taking Jenapri Prolonged-release capsules If you have any further questions on the use of this I medicine, ask your doctor or pharmacist.
Jenapri 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)
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4. POSSIBLE SIDE EFFECTS
.Like all medicines, this medicine can cause side effects, although not everybody gets them, ilf you experience any of the following side effects after you have taken your medicine, see your doctor |immediately. These side effects are rare but serious:
- Severe allergic reaction which may include a red
I and lumpy skin rash, difficulty breathing, swelling of I face, mouth, lips or eyelids, unexplained high 1 temperature (fever) and feeling faint. If the swelling | affects your throat and makes breathing and swallowing difficult, stop taking your medicine and | go to hospital straight away.
.Other side effects that have been reported for Uenapri Prolonged-release capsules are described ■below. They are listed as either very common, common, or not known.
kery common (affects more than 1 in 10 patients)
,- Headache;
Feeling dizzy;
|- Diarrhoea;
- Feeling sick.
Common (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; p Hot flushes;
- Tightening of the chest;
I- Pale, raised, itchy areas of skin with red edges;
,- A blood problem called "thrombocytopenia” which ' can cause bruising and prolong bleeding from I wounds or during and after surgery;
- Gallstone pain (in the centre or right of your | stomach).
■Reporting of side effects
If you get any side effects, talk to your doctor or 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: lvww.mhra.gov.uk/yellowcard
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6.CONTENTS OF THE PACK AND OTHER if INFORMATION I 1
What Jenapri Prolonged-release capsules i contain
The active substance is dipyridamole. Each | capsule contains dipyridamole 200mg.
The other ingredients are: Tartaric acid,
Sucrose, Povidone, Hypromellose, Talc, — — n
Acacia, spray-dried Triacetin, Simethicone, Cetostearyl alcohol and Ethoxylate, Sodium benzoate, Methacrylic | acid - ethyl acrylate copolymer, Hypromellose phthalate P55, Capsule shells: Gelatin, Titanium dioxide (El 71), Red I and yellow iron oxides(El 72)
What Jenapri Prolonged-release capsules look like 1 and contents of the pack i
Hard gelatin capsules consisting of a red cap and an orange body. Dimension 7,66 mm x 23,1 mm. The capsule contains yellow coloured slow release pellets., HDPE bottle with polypropylene child resistant closure, containing 2 desiccants. Packs contain 60 capsules, i Marketing Authorisation Holder:
Mercury Pharmaceuticals Ltd.
85 King William Street,
UK
organisations in formats appropriate for the blind and partially-sighted. I
This leaflet was last revised in October 2015. |
By reporting side effects you can help provide more
■information on the safety of this medicine.
5.HOW TO STORE JENAPRI PROLONGED-RELEASE | CAPSULES
Keep this medicine out of the sight and reach of Ichildren.
Do not store above 25°C. Keep the container tightly closed in order to protect from moisture.
|Do not open the container until you are ready to start taking the capsules. If you have any capsules left after six weeks, these should not be taken. Do not use ■this medicine after the expiry date which is stated on The carton.
[The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or house hold waste. Ask your pharmacist how to throw ,a way medicines you no longer use. These measures will help protect the environment.