Trangina XL 60mg tablets (isosorbide mononitrate)

Read all of this leaflet carefully before

you start taking this medicine.

•    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If you have any of the side effects, or if you notice any not listed, please tell your doctor or pharmacist.

•    have heart problems caused by an inflammation of the heart, abnormal pressure around the heart or narrowing of the aortic or mirtal valve.

•    have suffered from a heart attack

•    have angina that is caused by an enlarged heart muscle

•    have suffered from shock or vascular collapse

(collapse of the blood vesels)

•    have sever anaemia

•    have suffered from a head injury or bleeding in the brain

•    have suffered from closed-angle glaucoma

•    suffer from very low blood pressure

In this leaflet:

j What Trangina XL tablets are and what they are used for

^1 Before you take Trangina XL tablets

3j How to take Trangina XL tablets

4 Possible side effects How to store Trangina XL tablets

4 Further information

Check with your doctor or pharmacist before

taking Trangina XL tablets if you:

•    are having an angina attack. Trangina XL tablets are not suitable for treating sudden angina attacks.

•    have recently suffered a heart attack, or are suffering from an under active thyroid gland, low body temperature (hypothermia), malnutrition (undernourishment from a poorly balanced diet)

•    have severe liver or kidney disease

Q What Trangina XL tablets are and what they are used for

Isosorbide Mononitrate belongs to a group of medicines called nitrate vasodilators. These work by relaxing the blood vessels of the heart, reducing the strain on the heart making it easier to pump blood.

Trangina XL tablets may be used to:

•    prevent angina pectoris (chest pain).

12 Before you take Trangina XL tablets

Do not take Trangina XL tablets if you:

•    are allergic (hypersensitive) to isosorbide mononitrate, isosorbide dinitrate, other nitrates or any of the ingredients in the tablet (see section 6). An allergic reaction may include a rash, itching or difficulty breathing

•    have any condition where your blood pressure is very low or your blood is not circulating properly (such as shock)

Taking other medicines

Please tell your doctor or pharmacist if you are taking

or have recently taken any other medicines, including

medicines obtained without a prescription. Especially:

•    noradrenaline (norepinephrine) - to treat high blood pressure or heart attack

•    acetylcholine - used in some operations

•    medicines to treat high blood pressure such as ACE inhibitors, beta blockers, alphablockers, angiotensin-II receptor agonists, clonidine, diazoxide, diuretics (water tablets), methyldopa, moxonidine,

•    histamine - to treat allergic reactions

•    sildenafil , tadalafil and vardenafil, used to treat male erection dysfunction, should not be taken if taking nitrate preparations such as Isosorbide Mononitrate tablets because a severe and possibly dangerous fall in blood pressure can occur. This would result in collapse, unconsciousness and could be fatal.

Continued over page

Pregnancy and breastfeeding

If you are pregnant, planning to become pregnant or breastfeeding speak to a doctor before taking Trangina XL tablets.

Driving and using machines

Trangina XL tablets may make you feel dizzy. Make sure you are not affected before you drive or operate machinery.

Sugar intolerance

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains lactose.

Taking Trangina XL tablets with alcohol

You are advised not to drink alcohol with this medicine as it may increase the blood pressure lowering affect of the tablets.

If you see another doctor or go into hospital, let them know what medicines you are taking.

^ How to take Trangina XL tablets

Always take Trangina XL tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Swallow the tablets whole with water. Do not crush or chew them.

The usual doses are:

•    Adults - one tablet in the morning, the dose may be increased to two tablets (120mg) in the morning. To reduce the possibility of headaches you may initially be given half a tablet (30mg) once daily for the first 2-4 days.

•    Children - not recommended.

•    Elderly patients with low blood pressure or liver or kidney disease - your doctor may prescribe you a smaller dose.

If you take more Trangina XL tablets then you should

If you (or someone else) swallow's a lot of tablets at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately.

If you forget to take Trangina XL tablets

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.

If you stop taking the tablets

Do not stop taking the tablets without talking to your

doctor and follow their advice.

4| Possible side effects

Like all medicines, Trangina XL tablets can cause side effects, although not everybody gets them. Please tell your doctor or pharmacist if you notice any of the following effects or any not listed.

Contact your doctor at once if you experience symptoms of an allergic reaction skin rash, swelling of the skin of the extremities or face, swelling of lips, tongue, or the mucous membranes in mouth, throat, or airways, resulting in shortness of breath or difficulty to swallow.

Tell your doctor if you notice any of the following side

effects or notice any other effects not listed:

•    headaches, which can be relieved with painkillers and usually get better after 1-3 weeks of treatment.

•    dry or flaky skin rash

•    being sick, heartburn

•    glaucoma (pressure within the eye)

•    flushing, dizziness, weakness, low blood pressure including fainting on standing, fast or slow heart rate, temporary low levels of oxygen in the blood, fainting or passing out and heartburn.

•    slow or fast heart beat

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 Trangina XL tablets

Keep out of the reach and sight of children.

Do not store above 25°C.

Do not use Trangina XL tablets after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of that month.

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.

Further information

What Trangina XL tablets contain

•    The active substance (the ingredient that makes the tablets work) is isosorbide mononitrate. Each tablet contains 60mg of the active ingredient.

•    The other ingredients are lactose, hypromellose (E464), glyceryl palmitostearate, maize starch, magnesium stearate.

What Trangina XL tablets look like and contents of the pack

Trangina XL tablets are white, oval shaped prolonged release tablets.

Pack sizes are 28 tablets

Marketing Authorisation holder and manufacturer

Actavis, Barnstaple, EX32 8NS, UK Date of last revision: June 2014

^actavis

Actavis, Barnstaple, EX32 8NS, UK