What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL14017/0096 .


Tardisc XL 60 Prolonged Release Tablets

Package leaflet: Information for the user

Tardisc® XL 60 Prolonged Release Tablets

(Isosorbide Mononitrate)

Read all of this leaflet carefully before you start taking Tardisc XL 60 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.

What is in this leaflet:

1. What Tardisc XL 60 is and what it is used for
2. What you need to know before you take Tardisc XL 60
3. How to take Tardisc XL 60
4. Possible side effects
5. How to store Tardisc XL 60
6. Contents of the pack and other information

1. WHAT TARDISC XL 60 IS AND WHAT IT IS USED FOR

Tardisc XL 60 Prolonged Release Tablets (referred to as Tardisc XL 60 throughout this leaflet) contains an active substance called Isosorbide Mononitrate. This belongs to a group of medicines called ‘nitrates’.

  • It is used to prevent chest pain (angina). Angina is a crushing pain or tightness in the chest, although the pain may also be felt in the neck or arm. The pain happens when the muscle in the heart does not receive enough oxygen for the work it has to do. Tardisc 60 XL works by improving the supply of blood and oxygen to the heart muscle. The tablets will release your medicine slowly and will treat your condition throughout the day.
  • It works by making the blood vessels relaxed and widen. This makes it easier for the heart to pump blood around the body.

The tablets are made so that they release the medicine slowly over a number of hours.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TARDISC XL 60

Do not take Tardisc XL 60:

DO NOT use these tablets to treat sudden chest pain (acute angina). Instead seek immediate medical attention. These tablets work too slowly to treat this and are only used to prevent symptoms of angina from happening.

  • If you are allergic (hypersensitive) to isosorbide mononitrate or any of the other ingredients of Tardisc XL 60 (listed in Section 6: Further information).
  • If you have ever had a stroke.
  • If you have very low blood pressure.
  • If you have severe anaemia.
  • If you have a heart problem called 'cardiomyopathy' or 'pericarditis' or you have narrow heart valves.
  • If you are taking sildenafil or similar medicines called Phosphodiesterase Type 5 inhibitors, (used for male impotence). See the section "Other medicines and Tardisc XL 60".

Do not take Tardisc XL 60 if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Tardisc XL 60.

Warnings and precautions

  • if you have labile (unsteady) circulation. Speak with your doctor as treatment may be started with a 30mg dose.
  • If you suffer from an under-active thyroid gland.
  • If you have hypoxaemia (low oxygen level in your blood, due to lung disease for example).
  • If you suffer from hypothermia (symptoms include shiver, abnormal drowsiness, confusion).
  • If you suffer from malnutrition
  • If you suffer from severe liver or renal disease

Talk to your doctor or pharmacist before taking Tardisc XL 60 if:

  • You have ever had any serious damage to your heart, such as a heart attack or operation.

If any of the above apply to you, or you are not sure, talk to your doctor or pharmacist before taking Tardisc XL 60.

Other medicines and Tardisc XL 60

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines.

This is because Tardisc XL 60 can affect the way some medicines work and some medicines can have an effect on Tardisc XL 60.

Do not take Tardisc XL 60 if you are taking the following medicines:

  • Sildenafil or similar medicines called Phosphodiesterase Type 5 inhibitors, (used for male impotence).

If you take one of these drugs for erectile dysfunction, taking nitrate preparations such as Tardisc 60 XL as well can cause a severe and possible dangerous fall in blood pressure. This could result in fainting, or even worse, in a heart attack.

Do not take Tardisc 60 XL if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Tardisc 60 XL.

The following medicines may interfere with the way Tardisc 60 XL works:

  • noradrenaline (norepinephrine) (used to treat sharp and severe drop in blood pressure)
  • acetylcholine (used to shrink the pupil of the eye during cataract surgery and other types of eye surgery)
  • histamine (used mostly as a diagnostic agent in some medical conditions)
  • any drugs used to treat high blood pressure (e.g. beta-blockers, calcium channel blockers, vasodilators, angiotensin II receptor antagonists, ACE inhibitors).

Taking Tardisc 60 XL with alcohol

Avoid drinking alcohol while taking Tardisc 60 XL, as the side-effect of low blood pressure may be worse than normal and you may feel dizzy or faint.

Pregnancy, breast-feeding and fertility

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

You may get headache or feel dizzy after taking Tardisc 60 XL. If this happens, do not drive or use any tools or machines.

Tardisc XL 60 contains lactose and sucrose

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE TARDISC XL 60

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine

  • The tablets can be divided into equal doses.
  • Take the tablets with half a glass of water.
  • Do not crush or chew the tablets.

How much to take

  • The recommended dose is one or two tablets a day.
  • Take the medicine in the morning.
  • Your doctor may ask you to start with a low dose so that you are less likely to have a reaction to starting Tardisc XL 60.

You must not take Tardisc XL 60 for a sudden attack of angina. If you have a sudden attack, take a glyceryl trinitrate tablet (follow the instructions given on the label).

Use in Children

Do not give these tablets to children.

Elderly

If you are an elderly person, your dosage should be the same as above, unless you suffer from low blood pressure or have a severe liver or kidney disorder – in any case you should follow your doctor's instructions. If you are already taking medication such as beta-blockers or calcium channel blockers, let your doctor or pharmacist know, as he/she may need to adjust your dose of Tardisc 60 XL or existing treatment (see Section 2 "Other medicines and Tardisc 60 XL").

If you take more Tardisc XL 60 than you should

If you take more Tardisc XL 60 than you should, talk to your doctor or go to a hospital straight away. Take the medicine pack with you so the tablets can be identified.

Symptoms of an overdose can include: pounding headache, excitation, cold sweat, nausea (feeling sick), vomiting (being sick), vertigo (a feeling of dizziness or "spinning"), fainting, racing pulse.

If you forget to take Tardisc XL 60

  • If you forget a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose.
  • Do not take a double dose to make up for a forgotten dose.

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

If you stop taking Tardisc XL 60

Do not suddenly stop taking Tardisc XL 60 tablets, as this could make your angina worse.

If your treatment is to be stopped this should be done gradually. Be sure to follow your doctor's instructions. Ask your doctor or pharmacist any further questions you may have.

4. POSSIBLE SIDE EFFECTS

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

The following side effects may happen with this medicine:

  • Headaches
  • Feeling sick (nausea).
  • Feeling dizzy

The above problems usually disappear with time.

Other possible side effects:

Common (may affect up to 1 in 10 people)

  • Low blood pressure. This may make you feel faint and dizzy especially when getting up from a lying or sitting position, but this usually disappears in time on continued use.
  • Tachycardia (fast heart beat).
  • Headache
  • Feeling dizzy
  • Feeling sick (nausea).

Uncommon (may affect up to 1 in 100 people)

  • Being sick (vomiting).
  • Diarrhoea

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

  • Fainting
  • Rash
  • Itchy skin

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

  • Pain in muscles.

Reporting 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE TARDISC XL 60

  • Keep this medicine out of the sight and reach of children.
  • Do not store above 25°C.
  • Do not transfer them to another container. 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 dispose of medicines you no longer use. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Tardisc XL 60 contains

  • The active substance is isosorbide mononitrate. Each tablet contains 60mg of the active substance.
  • The other ingredients are Hydroxypropyl methylcellulose 2208, lactose, compressible sugar (composed of sucrose and maltodextrin), magnesium stearate, silica colloidal anhydrous, ferric oxide yellow E-172.

What Tardisc XL 60 looks like and contents of the pack

Tardisc XL 60 tablets are light yellow, biconvex, oval-shaped, scored on both sides and marked "DX 31" on one side.

Tardisc XL 60 is available in packs of 28 tablets in foil blister strips (2 blister packs of 14 tablets); 30 tablets in foil blister strips (3 blister packs of 10 tablets). Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Dexcel®-Pharma Ltd.
7 Sopwith Way
Drayton Fields
Daventry
Northamptonshire
NN11 8PB
UK

This leaflet was last revised in December 2017.

V-1351