Isotard 50xl Capsules
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Isib 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 Isib 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 any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Isib is and what it is used for
2. Before you take Isib Capsules
3. How to take Isib Capsules
4. Possible side effects
5. How to store Isib Capsules
6. Further information
1. WHAT ISIB IS AND WHAT IT IS USED FOR
Isib 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 ISIB CAPSULES Do not take Isib Capsules
- if you are allergic (hypersensitive) to isosorbide-5-mononitrate or any of the other ingredients (listed in section 6) of Isib
- 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 Isib 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 Isib and they will decide what to do. It may still be safe for you to take Isib.
Taking other medicines
Do not take Viagra (sildenafil - for male erectile dysfunction) while you are taking Isib. Taking Viagra while you are taking Isib 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 Isib Capsules with alcohol
Do not drink alcohol while taking Isib Capsules.
Pregnancy and breast-feeding
You should not use Isib 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
Isib 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 Isib 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 ISIB 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 Isib 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 Isib 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 Isib 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 Isib 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 Isib Capsules
Do not stop taking Isib 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 Isib Capsules, your doctor will supply you with another medicine for this. Do not stop taking your Isib 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, Isib 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.
If you consider any of these side effects to be serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE ISIB CAPSULES Keep out of the reach and sight of children.
Do not use Isib 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 Isib 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 Isib Capsules contain
The active substance is called isosorbide-5-mononitrate. Isib 50XL Capsules 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 contain 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 Isib capsules look like and the contents of the pack
Isib 50XL Capsules are hard gelatin capsules, which have a brown cap and a red
body, with “ISM 50” overprinted in white ink.
Isib 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 approved in September 2012.
The following date should be inserted below the in-house PX code on the mock-up:
1.3.1 Package Leaflet 5
Date of revision: 26 October 2012