Isosorbidmononitrat Mylan

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PACKAGE LEAFLET

Package leaflet: Information for the patient

Isosorbidmononitrat Mylan 60 mg Prolonged-release Tablets

(isosorbidemononitrate)

Read all of this leaflet carefully before you start taking this medicinebecause it contains important information for you.

Keep this leaflet. You may need to read it again.
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 their signs of illness are the same as yours.
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.

What is inthis leaflet

1. What Isosorbidmononitrat Mylan is and what it is used for

2. What you need to know before you take Isosorbidmononitrat Mylan

3. How to take Isosorbidmononitrat Mylan

4. Possible side effects

5. How to store Isosorbidmononitrat Mylan

6. Contents of the pack and other information

1. What Isosorbidmononitrat Mylan is and what it is used for

Isosorbidmononitrat Mylan contains isosorbide mononitrate which belongs to a family of medicines known as nitrates. These medicines allow the blood vessels around the heart to relax and widen, allowing more blood to flow to the heart and around the body. Your medicine is in the form of a ‘prolonged-release’ tablet, which slowly releases the medicine into your body.

Isosorbidmononitrat Mylan can be used to help prevent angina (a muscle cramp of the heart). However, Isosorbidmononitrat Mylan is nota suitable treatment for the relief of acute angina. If you suffer from an acute attack of angina, a more suitable medicine should be taken. Do not stop taking Isosorbidmononitrat Mylan without first consulting your doctor or pharmacist.

2. What you need to know before you take Isosorbidmononitrat Mylan

Do not take Isosorbidmononitrat Mylan:

if you are allergic to isosorbide mononitrate, other nitrates, or any of the other ingredients of this medicine (listed in section 6).
if you have heart conditions such as swelling of the lining that surrounds the heart, problems with your heart muscle or valves.
if you are taking sildenafil or similar medicines called “phosphodiesterase type-5 inhibitors” normally used to treat male impotence (erectile dysfunction).
if you have very low blood pressure or problems with blood flow to the brain which may be due to blood pressure or blood vessel problems e.g. a stroke or a brain injury.
if you have a condition called “cardiogenic shock” which may occur after a heart attack when the body cannot pump enough blood around the body.

Warnings and precautions

Talk to your doctor or pharmacist before taking Isosorbidmononitrat Mylan

if you have severe anaemia.
if you have hypothyroidism (underactive thyroid).
if you have raised pressure in the head (intra-cranial pressure).
if you have severe liver or kidney problems.
if you are malnourished or are unable to regulate body temperature (hypothermia) or develop these during treatment.
if you have hypoxaemia (low oxygen level in your blood, due to lung disease for example).

Other medicines and Isosorbidmononitrat Mylan

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines obtained without a prescription. Do not take Isosorbidmononitrat Mylan with sildenafil or other phosphodiesterase type-5 inhibitors normally used to treat male impotence. If you take one of these medicines for erectile dysfunction, taking Isosorbidmononitrat Mylan as well can cause a severe and possibly dangerous fall in blood pressure. This could result in fainting, or even a heart attack.

If you are taking any of the following medicines it is important you talk to you doctor or pharmacist.

medicines for heart problems such as beta-blockers e.g. sotalol, carvedilol
diuretics, used to increase urination e.g. furosemide, hydrochlorothiazide
medicines for depression (called tricyclic antidepressants) e.g. mirtazapine, trimipramine
medicines used to treat anxiety and mental health conditions e.g. tranquillisers
alprostadil (a prostaglandin), another drug used for the treatment of male impotence
dihydroergotamine (used to treat migraines)
medicines that lower the blood pressure as their effect may become more pronounced (including vasodilators, antihypertensives, calcium channel blockers and angiotensin II receptor antagonists)
aldesleukin, a medicine used for the treatment of cancer

Isosorbidmononitrat Mylan with alcohol

Alcohol may increase the effect of reducing your blood pressure and may also make you drowsy. The use of alcohol should therefore be avoided.

Pregnancy and breast-feeding

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.

Driving and using machines

Do not drive or operate machines if you feel dizzy or weak.

Isosorbidmononitrat Mylan 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.

3. How to take Isosorbidmononitrat Mylan

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 starting dose is half a tablet (30 mg) a day for the first two to four days.

The tablet can be divided into equal doses.

After this, the recommended dose is one tablet (60 mg) a day, taken in the morning. When necessary, the dose may be increased to two tablets (120 mg) a day, taken together in the morning.

Swallow the tablets with half a glass of water, in the morning.

Do not crush or chew the tablets, although you can divide them into equal doses if required.

During treatment

When you are taking this medicine, you may notice the remains of the tablet in your faeces. This is not a sign that this medicine is less effective. The medicine is released from the tablet leaving behind part of the tablet which you may pass in faeces.

Use in children and adolescents

Do not give these tablets to children and adolescents.

If you take more Isosorbidmononitrat Mylan than you should

The signs of an overdose may include headache, excitation, flushing, cold sweat, feeling sick (nausea), vomiting, fast heart rate, palpitations, confusion, dizziness and fainting which may be due to low blood pressure. Very rarely, a large amount of this medicine may cause a ‘blurring’ of the skin e.g. lips. If you suddenly experience any of the above, lie down with your legs raised slightly as this may help to ease the symptoms.

Contact your doctor or pharmacist immediately or go to the accident and emergency department of your local hospital at once. Take the carton or container of medicine with you, even if it is empty.

If you forget to take Isosorbidmononitrat Mylan

Do not take a double dose to make up for a forgotten dose. If it is almost time for your next dose simply carry on as before.

If you stop taking Isosorbidmononitrat Mylan

Do not stop taking these tablets without consulting your doctor or pharmacist as your chest pains may re-occur or get worse.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Side effects due to Isosorbidmononitrat Mylan are more likely to occur at the start of treatment.

Very common (may affect more than 1 in 10 people)

headache

Common (may affect up to 1 in 10 people)

dizziness
low blood pressure
fast heart beat
feeling sick (nausea)

Uncommon (may affect up to 1 in 100 people)

vomiting
diarrhoea

Rare (may affect up to 1 in 1,000 people)

fainting
skin rash or itching

Very rare (may affect up to 1 in 10,000 people)

aching muscles, muscle tenderness or weakness, not caused by exercise (myalgia)

Reporting of side effects

If you getany side effects, talk to your doctor or pharmacist. This includes any possible side effectsnot listed in this leaflet.

You can also report side effects directly via [to be completed nationally]. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Isosorbidmononitrat Mylan

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the blister and the carton after “EXP”. The expiry date refers to the last day of that month.

Do not throw away any medicine 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 Isosorbidmononitrat Mylancontains

Each tablet contains 60 mg of Isosorbide mononitrate.
The other ingredients are cellulose microcrystalline, kaolin heavy, magnesium stearate, silica colloidal anhydrous, synthetic paraffin wax and hard paraffin wax. The coating contains hypromellose, titanium dioxide (E171), lactose monohydrate (see section 2 “Isosorbidmononitrate Mylan contains lactose”), macrogol, iron oxide yellow (E172), iron oxide black (E172) and iron oxide red (E172)

What Isosorbidmononitrat Mylanlooks like and contents of the pack

Isosorbidmononitrat Mylan are pale yellow, elliptical, film-coated tablets, marked with ‘IM’ breakline ‘60’ on one side and a break line on the reverse..

Isosorbidmononitrat Mylan are available in plastic containers with an optional plastic spacer at the top of the pack and blister packs of 7, 14, 28, 30, 60, 90, 98, 100, 100x1, 250 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

[To be completed nationally]

Manufacturer

McDermott Laboratories Limited trading as Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

Mylan B.V, Dieselweg 25, 3752 LB Bunschoten, Netherlands [NL only]

This medicinal product is authorised in the Member States of the EEA under the following names:

Denmark Fem-Mono Retard, depottabletter 60 mg

Iceland Fem-Mono Retard

Ireland Sormon 60 mg prolonged-release tablets

Netherlands Isosorbide Mononitraat Retard Mylan 60 mg

Portugal Mononitrato de Isossorbido Mylan 60 mg comprimidos de liberacao prolongada

Sweden Isosorbidmononitrat Mylan 60 mg depottablett

United Kingdom Monigen XL 60

This leaflet was last revised in 2015-01-12.

[To be completed nationally]