Patient Leaflet Updated 21-Oct-2019 | Dexcel Pharma Ltd
Tardisc XL 60 Prolonged Release Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Tardisc® XL 60 Prolonged Release Tablets
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.
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’.
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.
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
Talk to your doctor or pharmacist before taking Tardisc XL 60:
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:
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:
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
How much to take
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.
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 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:
The above problems usually disappear with time.
Other possible side effects:
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Very rare (may affect up to 1 in 10,000 people)
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
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Tardisc XL 60 contains
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:
This leaflet was last revised in August 2019.
7, Sopwith Way, Drayton Fields, Daventry, Northamptonshire, NN11 8PB, UK
+44 (0)1327 312 266
+44 (0)1327 312 262
+44 (0) 1748 828 784
+44 (0) 1748 828 784