DILZEM XL 120 mg, 180 mg, 240 mg
Prolonged-release
Hard Capsules
(Diltiazem hydrochloride)
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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What DILZEM XL is and what it is used for.
- 2. Before you take DILZEM XL.
- 3. How to take DILZEM XL.
- 4. Possible side effects.
- 5. How to store DILZEM XL.
- 6. Further information.
What Dilzem Xl Is And What It Is Used For
DILZEM XL contains the active ingredient, diltiazem hydrochloride.
Diltiazem belongs to a group of medicines called calcium channel blockers. These medicines work to lower blood pressure and ease anginal chest pain by preventing the narrowing of blood vessels.
DILZEM XL is designed to release the active ingredient, diltiazem, in a controlled manner throughout the whole day so that blood pressure and angina are treated for a full 24 hour period.
DILZEM XL is used to treat and control mild to moderately high blood pressure and to prevent and treat chest pain due to the narrowing of blood vessels in the heart.
Before You Take Dilzem Xl
Do not take DILZEM XL if you:
- Are allergic to diltiazem hydrochloride or any of the other ingredients of DILZEM XL.
- Are a woman able to have children and not using contraception.
- Are pregnant or think you may be pregnant or are breast-feeding.
- Are currently in shock (reduced blood flow to vital organs).
- Suffer from any serious heart problems such as heart failure with shortness of breath and abnormal heart rhythm which may result in palpitation.
- Have a very low pulse rate or low blood pressure.
- Are currently receiving an infusion of a muscle relaxant called dantrolene (this is only given in hospitals).
Take special care with DILZEM XL if you have:
- Diabetes.
- Any liver or kidney problems.
- Any heart problems such as heart failure with shortness of breath, low pulse rate and abnormal heart rhythm which may result in palpitation.
- A rare disease of the blood pigment called ‘porphyria’, or anyone in your family has it.
If any of the above apply to you, please tell your doctor before taking DILZEM XL.
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. This is especially important if you are taking any of the following medicines:
- Digoxin, beta-blockers (such as propanolol), ACE inhibitors (such as enalapril), warfarin, amiodarone or any other medicines used to treat heart problems.
- Methyldopa, nifedipine, diuretics (such as bendrofluazide), alpha blockers such as hytrin and doxazosin.
- Simvastatin or atorvastatin (used to treat high cholesterol).
- Phenobarbital or carbamazepine (used to treat epilepsy).
- Rifampicin to treat tuberculosis.
- Theophylline used to treat asthma.
- Ciclosporin (a corticosteroid).
- Lithium (used to treat mental problems).
If you are due to have surgery, or visit your dentist, tell the doctor or dentist that you are taking DILZEM XL as it may interact with anaesthetics.
Pregnancy and breast-feeding
Do not take DILZEM XL if you are pregnant, think you may be pregnant, or if you are breast-feeding.
Driving and using machines
DILZEM XL should not affect your ability to drive or use machines. However, if you feel faint or dizzy, do not drive or operate any machines.
Important information about some of the ingredients of DILZEM XL
DILZEM XL contains sucrose. If you have been told that you have an intolerance to some sugars, contact your doctor before taking DILZEM XL.
How To Take Dilzem Xl
Always take DILZEM XL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual dose for adults is one 180 mg capsule a day.
Always swallow the capsules whole with water.
Do not suck or chew the capsule or remove the contents as this will affect the special release properties of the product.
Your doctor may increase the dose of DILZEM XL, depending on your response to the drug.
Elderly patients and those with kidney or liver problems may be started on a lower dose of 120 mg a day.
DILZEM XL is not recommended for children.
If you take more DILZEM XL than you should
If you accidentally take too many DILZEM XL capsules, tell your doctor immediately or go to the nearest hospital accident and emergency department. Take along any capsules that are left, the container and the label so that the hospital staff can easily tell what medicine you have taken.
If you forget to take DILZEM XL
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose (up to eight hours before), do not take the missed dose but take your next dose at your normal time. Do not take a double dose to make up for the forgotten one.
Dilzem XL Side Effects
Like all medicines, DILZEM XL can cause side effects, although not everybody gets them.
If you notice any of the following, stop taking DILZEM XL and contact your doctor immediately:
- Swelling of the face, lips, tongue or glands.
- Skin rash, blistering affecting the skin, mouth, eyes, genitals or anus.
- Sore throat and fever.
As these may be signs of an allergic reaction.
If you notice any of the following, stop taking DILZEM XL and contact your doctor immediately:
- Darkening of your urine.
- Pale stools.
- Yellowing of your skin or eyes.
As these may be signs of liver problems.
The most common side effects of DILZEM XL (affecting between 1 in 10 and 1 in 100 people) are:
- Headache, dizziness, weakness.
- Slow or irregular heart rate, changes in the hearts electrical impulses.
- Flushing, feeling sick.
Other side effects of DILZEM XL include:
- Chest pain, heart failure, low blood pressure, palpitations, fainting, numbness.
- Memory loss, depression, nervousness, change in personality.
- Problems sleeping, tiredness, hallucinations, shaking, ringing in ears, staggering.
- Rash, itching, increased skin sensitivity to sunlight.
- Loss of appetite, constipation, diarrhoea, indigestion, being sick, weight gain, inflammation or overgrowth of the gums.
- Eye irritation, lazy eye, blocked nose, nose bleed, shortness of breath.
- Pain in muscles, bones or joints.
- Increased need to pass urine or an increased volume of urine, especially at night.
- Swelling of breast tissue in men, loss of ability to have, or loss of interest in sex.
- Reduction in blood platelets which increases the risk of bruising or bleeding, increased blood sugar levels.
If any of these side effects become serious or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
How To Store Dilzem Xl
Do not store above 25°C. Store in the original package.
Keep out of the reach and sight of children.
Do not use DILZEM XL after the last day of the month shown in the expiry date printed on the carton and on the blister strips.
If your doctor tells you to stop your treatment, return any left over capsules to the pharmacist.
Further Information
What DILZEM XL contains
Each DILZEM XL capsule contains 120 mg, 180 mg or 240 mg of the active ingredient diltiazem hydrochloride. The other ingredients are: fumaric acid, talc, povidone, sugar spheres (containing sucrose and maize starch), ammonio methacrylate copolymer Type A, ammonio methacrylate copolymer Type B. The capsule shell contains gelatin, titanium dioxide (E171), black iron oxide (E172), shellac and propylene glycol (E1520).
What DILZEM XL looks like and contents of the pack
DILZEM XL capsules are white coloured capsules printed with e120, e180 or e240. They are supplied in blister packs of 28 capsules.
Marketing Authorisation Holder
Manufacturer
This leaflet was last approved in September 2009
For more information in the UK please call free on 0800 783 4869 or e-mail: UKMedInfo@cephalon.com
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