Menisor Xl 60mg Prolonged-Release Tablets
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MENISOR XL 60 mg PROLONGED-RELEASE TABLETS
ISOSORBIDE MONONITRATE
Read all of this leaflet carefully before you start' taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- 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.
- You must talk to a doctor if you do not feel better or if you feel worse.
1. What Menisor XL is for
2. Before you take Menisor XL
3. How to take Menisor XL
4. Possible side effects
5. How to store Menisor XL
6. Further Information
The name of your medicine is Menisor XL 60 mg Prolonged-Release Tablets, (referred to as Menisor XL throughout this leaflet).
It contains the active ingredient isosorbide mononitrate, which belongs to a group of medicines called 'nitrates'. These work by relaxing and widening the blood vessels of the heart, making it easier for the heart to pump blood around the body.
Menisor XL tablets are used to prevent angina, (chest pain). They have been made so that they release the medicine slowly over a number of hours.
- pericarditis, (inflammation of the lining of the heart)
- cardiac tamponade, (fluid build-up in the lining of the heart)
- aortic stenosis or mitral stenosis, (a narrowing of the main artery of the heart or of the heart valves)
• are taking phosphodiesterase type 5 inhibitors, such as sildenafil, (for male impotence), see 'other medicines and Menisor XL' below
Do not take Menisor XL if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Menisor XL.
Warnings and precautions
Menisor XL are used for the prevention of angina, and should not be used for the relief of a sudden angina attack.
Talk to your doctor or pharmacist before taking Menisor XL, if you;
• have ever had any serious damage to your heart, such as a heart attack or an operation
If the above applies to you, or if you are unsure, talk to your doctor or pharmacist before taking Menisor XL.
Other medicines and Menisor XL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines bought without a prescription.
This is because Menisor XL can affect the way some medicines work, and some medicines can affect the way Menisor XL works, especially;
• medicines called phosphodiesterase type 5 inhibitors, such as sildenafil, for male impotence
Do not take Menisor XL if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Menisor XL.
Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant or are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine
Driving and using machines
You may experience dizziness after first taking Menisor XL.
If this happens, do not drive or use any tools or machines.
Menisor XL contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
DO NOT take Menisor XL, if you;
• are allergic to isosorbide mononitrate, or any of the other ingredients of these tablets (listed in section 6)
• have ever suffered a reduced supply of blood to the brain, which may have lead to a stroke
• have low blood pressure, (hypotension)
• have severe anaemia
• suffer from a heart problem such as;
- cardiomyopathy, (heart muscle disease)
Always take this medicine exactly as described in this leaflet, or as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Swallow the tablets whole (or broken in half if this is easier to swallow) with half a glass of water. Do not crush or chew the tablets.
Recommended dose:
Adults (including the elderly):
The usual dose is one tablet a day, taken in the morning. This may be increased to two tablets on the advice of your doctor, if so both tablets should be taken in the morning.
To reduce the possibility of getting headaches, you may start on half a tablet once a day for the first 2-4 days.
The blister strips are marked with the days of the week. If you are taking two tablets a day, make sure you take one tablet from each strip marked with the same day of the week.
You must not take Menisor XL for a sudden attack of angina. If you have a sudden attack, take a glyceryl trinitrate tablet (follow the instructions given on the label).
These tablets are not recommended for use in children.
If you take more Menisor XL than you should
If you take more of this medicine than you should, contact your doctor or go to the nearest hospital casualty department immediately. Take this leaflet and the package with you so they know what has been taken.
The symptoms of an overdose include:
• excitation, pulsing headache or fainting
• vertigo, (a feeling of dizziness or "spinning”)
• a faster heart beat or a fall in blood pressure
• flushing (sudden reddening of skin) or cold sweat
• nausea or vomiting
If you forget to take Menisor XL
If you forget to take a dose, take it as soon as you remember. However, if it is less than 12 hours to the next dose, skip the missed dose and take the next dose when it is due. Do not take a 'double dose' (two doses at the same time), to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
These usually occur at the start of treatment, but disappear with time during continued treatment.
Very rare side effects (may affect up to 1 in 10,000 people)
• muscle pain
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 at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
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 household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get the following side effects, STOP TAKING Menisor XL and tell your doctor or go to the nearest hospital emergency department immediately:
• an allergic reaction to isosorbide mononitrate, the signs of which can include rashes, itching, swelling of the hands, feet, face, lips, tongue or throat which may cause difficulty in swallowing or breathing
The following side effects may also happen with this medicine:
Rare side effects (may affect up to 1 in 1,000 people)
• headache
• low blood pressure (hypotension), which may cause you to feel sick (nausea) or dizzy
What Menisor XL contains
The active substance (the ingredient that makes the tablets work) is isosorbide mononitrate. Each tablet contains 60 mg of isosorbide mononitrate.
The other ingredients are; lactose monohydrate, hydroxy-propylmethylcellulose, glyceryl palmitostearate, maize starch and magnesium stearate.
What Menisor XL looks like and contents of the pack
Menisor XL are white capsule-shaped prolonged-release tablets with MP86 imprinted on one side and scored on the other side.
Menisor XL are available in blister packs of 28 tablets.
Marketing Authorisation Holder
Metwest Pharmaceuticals Limited
15 Runnelfield, Harrow on the Hill, Middlesex, HA1 3NY
Manufacturer
Edmond Pharma S.R.L.
Via Dei Giovi, 131, 20037 Paderno Dugnano (MI)
For any information about this medicine, please contact the Marketing Authorisation Holder.
This leaflet was last revised in 03/2014
M0086/P/PIL-Br/M1