Zemtard 300 Xl
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Zemtard* 120XL, 180XL, 240XL and 300XL
(Diltiazem Hydrochloride Modified Release Capsules)
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 Zemtard is and what it is used for
2. Before you take Zemtard
3. How to take Zemtard
4. Possible side effects
5. How to store Zemtard
6. Further information
1. WHAT ZEMTARD IS AND WHAT IT IS USED FOR
Zemtard contains diltiazem hydrochloride as the active substance. Diltiazem hydrochloride belongs to a group of medicines known as calcium channel blockers.
Zemtard is used to treat high blood pressure (hypertension). It can also be used to prevent and treat a certain type of chest pain known as angina. Zemtard works by opening up blood vessels so that blood passes through them more easily, and so reduces blood pressure and chest pain in angina.
2. BEFORE YOU TAKE ZEMTARD
Zemtard is not suitable for use in children.
Do not take Zemtard
- if you are allergic (hypersensitive) to diltiazem hydrochloride or any of the other ingredients of Zemtard (see Section 6 for a full list of ingredients)
- if you are pregnant or could become pregnant
- if you are breast-feeding
- if you have a very slow heart rate, less than 50 beats per minute (marked bradycardia)
- if you have a condition called sick sinus syndrome (an abnormality of heart rate or heart rhythm)
- if you suffer from left-sided heart failure (left ventricular failure), with symptoms such as shortness of breath and swelling of the ankles
- if you suffer from second or third degree heart block (this is a problem with the electrical impulses of the heart) unless you have a working pacemaker fitted
- if you are due to have an operation where you might be given a muscle relaxant called dantrolene (most likely to be administered in hospital under general anaesthesia)
Talk to your doctor before taking this product if any of the above apply to you.
Take special care with Zemtard
- if you have any liver or kidney problems
- if you have a slow heart rate (mild bradycardia)
- if you have any heart problems such as heart failure or first degree heart block (a problem with the electrical impulses of the heart)
If any of the above apply to you, it is important that you tell your doctor or pharmacist before taking Zemtard and they will decide what to do. It may still be safe for you to take Zemtard.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any of the following medicines, including those medicines obtained without a prescription:
- alpha-blockers, such as doxazosin or prazosin (medicines used for high blood pressure or prostate enlargement in men)
- amiodarone (used to treat abnormal heart rhythms)
- rifampicin (used to treat bacterial infections)
- carbamazepine, phenytoin or primidone (used in epilepsy)
- atazanavir or ritonavir (used to treat viral infections)
- sleeping tablets or sedatives
- beta-blockers, such as propranolol or atenolol (medicines used to treat high blood pressure or other heart conditions)
- digoxin (used to treat heart failure and abnormal heart rhythms)
- ciclosporin, sirolimus or tacrolimus (used to prevent rejection of a transplanted organ)
- cilostazol (used to improve blood circulation to the legs)
- theophylline (used to treat breathing problems)
- general anaesthetics
- tricyclic antidepressants, such as imipramine
- antidepressants known as monoamine oxidase inhibitors/MAOIs, such as moclobemide or phenelzine
- itraconazole (used to treat fungal infections)
- mefloquine (used for treating and preventing malaria)
- corticosteroids, sometimes simply referred to as steroids, such as hydrocortisone or prednisolone (they may be prescribed in many different illnesses but their main action is in controlling inflammation)
- simvastatin, atorvastatin or lovastatin (medicines for lowering cholesterol)
- nifedipine (used to treat high blood pressure and angina)
- lithium (used in cases of marked mood changes or mania)
- nitrate medicines, such as glyceryl trinitrate or isosorbide mononitrate (used to treat angina)
- ulcer-healing medicines, such as cimetidine.
It may still be safe for you to take Zemtard; your doctor or pharmacist will be able to advise you further.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Zemtard with food and drink
Taking Zemtard with food and drink does not affect the way the product works.
Pregnancy and breast-feeding
Do not take Zemtard if you are pregnant, trying to become pregnant or if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or while breast-feeding.
Driving and using machines
It is safe to drive while taking this medicine, however it may make you feel faint or dizzy. If you find that you are affected you should not drive or operate machinery.
Important information for patients with an intolerance to some sugars
These capsules contain sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE ZEMTARD
Always take Zemtard 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 between 180mg and 300mg of diltiazem given once a day. This dose may be reduced to 120mg once a day, for elderly patients, or patients with kidney or liver disease.
The label on the carton will tell you how many capsules you should take and when. This product should be taken orally (by mouth). Swallow the capsules whole with a drink of water. Do not crush or chew the capsules.
If you take more Zemtard than you should
If you take too many capsules, contact your nearest hospital casualty department or doctor immediately. Take this leaflet and any remaining capsules with you to show the doctor.
If you forget to take Zemtard
If you miss a dose but remember within 12 hours of the usual time, take it when you remember. If you remember more than 12 hours after your usual time, leave out this dose completely and carry on with the next dose when it is due. Do not take a double dose to make up for a forgotten dose.
If you stop taking Zemtard
Do not stop taking Zemtard without consulting your doctor. Stopping suddenly might make your angina worse.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Zemtard can cause side effects, although not everybody gets them.
If you notice:
- slowing of the heart rate (bradycardia)
- irregular heart rate
- severe skin rashes with skin flaking
Stop taking Zemtard and contact your doctor immediately.
The following side effects have also been reported:
|
swelling of the legs, (this is |
- change in the way things taste |
|
more common in elderly |
- feeling sick (nausea) |
|
patients and may be worse |
- loss of appetite |
|
with higher doses) |
- being sick (vomiting) |
|
headache |
- constipation |
|
low blood pressure |
- diarrhoea |
|
dizziness |
- weight gain |
|
flushing (when your face, |
- skin rash |
|
ears, neck and, occasionally, |
- sensitivity to sunlight |
|
your upper chest, becomes |
- enlargement of breast |
|
red in colour) |
tissue in men |
|
palpitations |
- jaundice (yellowing of the |
|
tiredness/weakness |
skin and the whites of the |
|
generally feeling unwell |
eyes) |
|
depression |
- hepatitis (inflammation of |
|
swollen gums |
the liver) |
If you consider any of the side effects to be serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE ZEMTARD
Keep out of the reach and sight of children.
Do not use Zemtard after the expiry date which is stated on the carton and blister foil. The expiry date refers to the last day of that month.
Do not store your capsules above 25‘C. Store in the original packaging in order to protect the capsules from light and moisture.
Do not use Zemtard if you notice that the packaging or any of the capsules are damaged.
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.
6. FURTHER INFORMATION
What Zemtard contains
The active substance is diltiazem hydrochloride.
Zemtard comes in four different strengths of capsule:
- Zemtard 120XL which contains 120mg of diltiazem hydrochloride per capsule.
- Zemtard 180XL which contains 180mg of diltiazem hydrochloride per capsule.
- Zemtard 240XL which contains 240mg of diltiazem hydrochloride per capsule.
- Zemtard 300XL which contains 300mg of diltiazem hydrochloride per capsule.
The beads in the capsule shells also contain other ingredients: ammonio methacrylate copolymer types A and B, paraffin, talc, sucrose and starch.
The capsule shells are made of gelatin and may contain, depending on the strength of the capsule, the following colouring agents: erythrosine (E127), indigotine (E132), titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172) and yellow iron oxide (E172).
The ink on the capsule shells contains shellac, black iron oxide (E172) and propylene glycol.
What Zemtard capsules look like and the contents of the pack
- Zemtard 120XL are hard gelatin capsules, with a brownish-red cap and an orange body, with "DIL 120" overprinted in black ink.
- Zemtard 180XL are hard gelatin capsules, with a pink cap and a grey body, with "DIL 180" overprinted in black ink.
- Zemtard 240XL are hard gelatin capsules, with a light blue cap and body, with "DIL 240" overprinted in black ink.
- Zemtard 300XL are hard gelatin capsules, with a light blue cap and a white body, with "DIL 300" overprinted in black ink.
Zemtard 120XL, 180XL, 240XL and 300XL are packaged in blister packs containing 28 capsules.
Marketing Authorisation Holder
Galen Limited
Seagoe Industrial Estate
Craigavon
BT63 5UA
UK
Manufacturer
Almac Pharma Services Limited Almac House
20 Seagoe Industrial Estate
Craigavon
BT63 5QD
UK
This leaflet was last approved in February 2010.
Zemtard is a trade mark.
PX654/A
05/11/08