Isodur 50xl Capsules
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Isodur 25XL and 50XL Capsules
(Isosorbide-5-mononitrate)
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take Isodur carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your symptoms worsen or do not improve.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
In this leaflet:
1. What Isodur is and what it is used for
2. Before you take Isodur Capsules
3. How to take Isodur Capsules
4. Possible side effects
5. How to store Isodur Capsules
6. Further information
1. WHAT ISODUR IS AND WHAT IT IS USED FOR
Isodur Capsules are one of a group of medicines known as nitrates. They are used to help prevent an attack of angina (chest pain). They are not suitable for the relief of an angina attack.
2. BEFORE YOU TAKE ISODUR CAPSULES Do not take Isodur Capsules
- if you are allergic (hypersensitive) to isosorbide-5-mononitrate or any of the other ingredients (listed in section 6) of Isodur
- if you are suffering a heart attack or have recently had a heart attack
- if you suffer from severe anaemia (severe reduction in red blood cells)
- if you are suffering from a head injury
- if you are suffering from bleeding in the brain (brain haemorrhage)
- if you suffer from very low blood pressure (severe hypotension)
- if you suffer from low circulating blood volume (hypovolaemia)
Talk to your doctor before taking this product if any of the above apply to you.
Take special care with Isodur Capsules
- if you are pregnant
- if there is a chance you might become pregnant
- if you are breast-feeding
- if you suffer from liver problems
- if you suffer from kidney problems
- if you suffer from glaucoma (glaucoma is the name given to a group of eye conditions that affect vision)
- if you suffer from an under-active thyroid gland (a condition known as hypothyroidism)
- if you suffer from hypothermia (very low body temperature)
- if you suffer from malnutrition (severe lack of food)
If any of the above apply to you, it is important that you tell your doctor or pharmacist before taking Isodur and they will decide what to do. It may still be safe for you to take Isodur.
Taking other medicines
Do not take Viagra (sildenafil - for male erectile dysfunction) while you are taking Isodur. Taking Viagra while you are taking Isodur could cause a severe and possibly dangerous fall in blood pressure. This could result in collapse, unconsciousness and could be fatal.
It is important that you inform your doctor or pharmacist if you are taking medicines that can lower your blood pressure.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Isodur Capsules with alcohol
Do not drink alcohol while taking Isodur Capsules.
Pregnancy and breast-feeding
You should not use Isodur Capsules during pregnancy or while breast-feeding unless your doctor thinks it is essential. Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or while breast-feeding.
Driving and using machines
Isodur Capsules may make you feel faint or dizzy. You should not drive or operate machinery until you know how they affect you.
Important information about some of the ingredients of Isodur Capsules
These capsules contain sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE ISODUR CAPSULES
This product should be taken orally (by mouth). You must swallow the capsules whole with a drink of water. The capsules must not be crushed or chewed.
The usual dose of Isodur for adults is one or two capsules to be taken in the morning.
If this product has been prescribed by your doctor the label on the carton will tell you how many capsules you should take and when. Always take Isodur Capsules exactly
as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Elderly patients or patients with low blood pressure, kidney or liver disease may be advised to take a lower dose.
The capsules should not be given to children.
If you take more Isodur Capsules than you should
If you take too many capsules, contact your nearest hospital casualty department or doctor immediately. Take this leaflet and any remaining capsules with you.
If you forget to take Isodur Capsules
If you forget to take your capsule(s), take your recommended dose as soon as you remember and then carry on as normal. Do not take a double dose to make up for a forgotten dose.
If you stop Isodur Capsules
Do not stop taking Isodur Capsules without consulting your doctor. Stopping your medicine suddenly may lead to your condition getting worse.
If you have an angina attack (chest pain) despite taking Isodur Capsules, your doctor will supply you with another medicine for this. Do not stop taking your Isodur Capsules.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Isodur Capsules can cause side effects, although not everybody gets them.
In rare cases, some patients feel faint and collapse after taking their first dose of the medicine. If this occurs, tell your doctor immediately.
Headaches may occur when this treatment is first started, but these usually disappear after 1-2 weeks. Dizziness, tiredness, nausea (feeling sick), vomiting, stomach upsets, flushing (when your face, ears, neck and, occasionally, your upper chest, becomes red in colour), uneven heart beat and a fast heart beat may also occasionally occur.
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 information on the safety of this medicine.
HOW TO STORE ISODUR CAPSULES
5.
Keep out of the reach and sight of children.
Do not use Isodur Capsules after the expiry date, which is stated on the carton and blister foil. The expiry date refers to the last day of that month.
Do not use Isodur Capsules if you notice that the packaging or any of the capsules are damaged.
This product does not require any special storage conditions.
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 to protect the environment.
6. FURTHER INFORMATION
What Isodur Capsules contain
The active substance is called isosorbide-5-mononitrate.
Isodur Capsules come in two different strengths of capsule:
- Isodur 25XL Capsules, which contain 25mg of isosorbide-5-mononitrate per modified-release capsule.
- Isodur 50XL Capsules, which contain 50mg of isosorbide-5-mononitrate per modified-release capsule.
As well as the active substance the pellets inside the capsule shells also contain other ingredients: sucrose, maize starch, shellac, povidone, poly (-o-ethyl) cellulose and talc.
The capsule shells are made of gelatin and may contain, depending on the strength of the capsule, the following colourings: titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172) and erythrosine (E127).
The ink on the capsule shells contains: shellac, propylene glycol, strong ammonia solution, potassium hydroxide, titanium dioxide (E171), povidone and sodium hydroxide.
What Isodur capsules look like and the contents of the pack
- Isodur 25XL Capsules are hard gelatin capsules, which have a brown cap and a white body, with “ISM 25” overprinted in white ink.
- Isodur 50XL Capsules are hard gelatin capsules, which have a brown cap and a red body, with “ISM 50” overprinted in white ink.
Isodur 25XL and 50XL Capsules are packaged in calendar/blister packs containing 28 capsules.
Marketing Authorisation Holder
Galen Limited
Seagoe Industrial Estate
Craigavon
BT63 5UA UK
Manufacturer
Almac Pharma Services Limited
Almac House
20 Seagoe Industrial Estate
Craigavon
BT63 5QD
UK
This leaflet was last revised in 02/2015.
The following date should be inserted below the in-house PX code on the mock-up: “02/02/2015"
1.3.1 Package Leaflet 5