Tildiem La 200mg Prolonged-Release Capsules
1. What Tildiem LA is and what it is used for
PACKAGE LEAFLET: INFORMATION FOR THE USER Tildiem® LA 200mg Prolonged Release Capsules
(diltiazem hydrochloride)
Your medicine is known as the above but will be referred to as Tildiem LA throughout the remainder of this leaflet.
This product is available in multiple strengths and all strengths will be referred to throughout this leaflet.
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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
In this leaflet:
1. What Tildiem LA is and what it is used for
2. Before you take Tildiem LA
3. How to take Tildiem LA
4. Possible side effects
5. How to store Tildiem LA
6. Further information
Tildiem LA contains a medicine called diltiazem hydrochloride. This belongs to a group of medicines called 'calcium-channel blockers'.
It works by making your blood vessels wider.
This helps to lower your blood pressure.
It also makes it easier for your heart to pump blood around the body. This helps to prevent the chest pain caused by angina.
• Medicines used for high levels of cholesterol such as simvastatin, fluvastatin and atorvastatin
• Ciclosporin used to stop the rejection of organs after a transplant
• Phenytoin used for epilepsy
• Aspirin used for relieving pain and reducing fever
• Iodinated contrast media (used for tests involving X-rays)
• Carbamazepine used for epilepsy
• Theophylline used for breathing problems
• Lithium used for some types of mental illness
• Medicines used for sleeplessness and anxiety, such as triazolam and midazolam
• Methylprednisolone used for inflammation and allergic reactions
Tildiem LA may make the following medicine work less well:
• Rifampicin used for tuberculosis
The following medicines can increase the effect of Tildiem LA:
• Medicines for stomach ulcers such as cimetidine and ranitidine
Tildiem LA with food and drink
It is advisable to limit the amount of grapefruit juice you drink while taking Tildiem LA as it can increase the blood levels of the active ingredient diltiazem and may increase your chance of getting side effects. If you are concerned you should stop drinking grapefruit juice and consult your doctor.
Pregnancy and breast-feeding
• You should not take Tildiem LA if you are pregnant, might become pregnant or think you may be pregnant. This is because Tildiem LA can cause problems for your baby. Talk to your doctor if you might be pregnant.
• Do not breast-feed if you are taking Tildiem LA. This is because small amounts may pass into mothers' milk. If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking any medicine
Tildiem LA is used for:
• High blood pressure
• Angina (chest pain)
Driving and using machines
You may feel dizzy while taking this medicine.
If this happens, do not drive or use any tools or machines.
Do not take this medicine and tell your doctor if:
x You are allergic (hypersensitive) to diltiazem hydrochloride or any of the other ingredients of Tildiem LA (listed in Section 6 below) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
x You are breast-feeding or planning to breast-feed (see Section below: 'Pregnancy and breastfeeding') x You are having a medicine called dantrolene used for severe muscle spasms or severe fever (see Section below: 'Taking other medicines')
x You have a very slow heartbeat - less than 50 beats per minute x You are already taking a medicine containing ivabradine for the treatment of certain heart diseases x You have heart failure and problems with blood flow to your lungs. With these illnesses, you may feel out of breath and have swollen ankles
x You have any other serious problems with your heart. This includes having an uneven heartbeat (unless you have a pacemaker)
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Tildiem LA.
Take special care with Tildiem LA
Check with your doctor or pharmacist before taking your medicine if:
▲ You have any other problem with your heart, apart from angina or those described in the previous section
▲ You are going to have an operation
▲ You are at risk of mood changes, including depression
▲ You are at risk of gut problems
Your doctor will check you more closely particularly when you first start taking the capsules if:
▲ You are over 65 years old
▲ You have liver or kidney problems
▲ You have diabetes
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Tildiem LA.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
This includes medicines you buy without a prescription, including herbal medicines. This is because Tildiem La can affect the way some other medicines work. Also some medicines can affect the way Tildiem LA works.
In particular, do not take this medicine and tell your doctor if you are taking:
• Dantrolene (an infusion) used for severe muscle spasms or severe fever (called 'malignant hyperthermia')
• Medicines containing ivabradine used for the treatment of certain heart diseases
Always take Tildiem LA exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Please find below a translation of the days of the week printed on the blister.
Taking this medicine
• Take this medicine by mouth
• Do not break, crush or chew your capsules
• Swallow the capsules whole with a drink of water
• Take before or during a meal
• If you feel the effect of your medicine is too weak or too strong do not change the dose yourself, but ask your doctor
How much to take Adults:
Angina and high blood pressure:
• The usual starting dose is one Tildiem LA 200mg capsule a day. If necessary, your doctor may increase this to:
• One Tildiem LA 300mg capsule a day or
• Two Tildiem LA 200mg capsules a day.
• One Tildiem LA 300mg capsule and one LA Tildiem 200mg capsule a day.
Over 65 years or adults with liver or kidney problems:
Angina and high blood pressure
• The usual starting dose is one Tildiem LA 200mg capsule a day. If necessary, your doctor may increase this dose to:
• One Tildiem LA 300mg capsule a day.
Children:
Tildiem LA should not be given to children.
If you take more Tildiem LA than you should
If you take more capsules than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. The following effects may happen: feeling dizzy or weak, blurred vision, chest pain, shortness of breath, fainting, an unusually fast or slow heartbeat, slurred speech, confusion, coma and sudden death.
If, in an emergency situation, the patient is treated quickly sudden death is not only the potential outcome.
If you forget to take Tildiem LA
If you forget a dose, take it as soon as you remember it. 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 stop taking Tildiem LA
Keep taking Tildiem LA until your doctor tells you to stop. Do not stop taking them just because you feel better. If you stop, your illness may get worse.
Tests
Your doctor may do regular tests while you are taking this medicine. These might include a check on your heart and blood tests to check on your liver and kidneys.
Tildiem LA may increase the effect of the following medicines:
• Medicines for high blood pressure such as doxazosin, tamsulosin, atenolol, propranolol or acebutolol
• Medicines used for an uneven heartbeat such as amiodarone
If you have any further questions on the use of this product, ask your doctor or pharmacist.
and digoxin
• Medicines used for angina such as glyceryl trinitrate or isosorbide trinitrate