ZEMRET 240 XL CAPSULES - patient leaflet, side effects, dosage

Patient leaflet - ZEMRET 240 XL CAPSULES

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Zemret 180, 240 and 300 XL Capsules

Modified Release Capsules, Diltiazem Hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
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.

What is in this leaflet:

□ What Zemret XL is and what it is used for 0 Possible side effects

B What you need to know before you take Zemret XL 0 How to store Zemret XL

0 How to take Zemret XL 0 Contents of the pack and other information

What Zemret XL is and what it is used for

The active ingredient in this medicine is called diltiazem hydrochloride. It 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.

Zemret XL is used to treat: ■ High blood pressure ■ Chest pain (angina)

What you need to know before you take Zemret XL

Do not take Zemret XL if:

■ If you are allergic (hypersensitive) to diltiazem hydrochloride or any of the other ingredients of this medicine (listed in section 6)
■ If you have heart problems, such as:

o dizziness, fainting, chest pain, lightheadedness or shortness of breath, unless you have a pacemaker (second or third degree heart block)

o dizziness, fainting, confusion, palpitations, shortness of breath or tiredness, unless you have a pacemaker (sick sinus syndrome)

o shortness of breath, excessive sweating, anxiety and pale skin (left ventricular failure with lung congestion)

o very slow heartbeat – less than 50 beats per minute (severe bradycardia)

■ If you are already taking a medicine containing ivabradine for the treatment of certain heart diseases (see „Other medicines and Zemret XL“ section)
■ If you are breast-feeding or planning to breast-feed (see „Pregnancy and breast-feeding“ section)
■ If you are being treated with dantrolene injection (for severe muscle spasms or severe fever) (see „Other medicines and Zemret XL“ section)

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

■ If you have any other problems with your heart rhythm or reduced heart function
■ If you are going to have an operation and will have anaesthesia
■ If you are at risk of mood changes, including depression
■ If 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 elderly
■ If you have liver or kidney problems
■ If you have diabetes
■ If you have or ever had asthma

Other medicines and Zemret XL

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including those obtained without a prescription.

This includes herbal medicines.

Zemret XL should not be taken with the following:

■ Dantrolene infusion, used to relieve severe muscle spasm or severe fever (called malignant hyperthermia) for conditions such as cerebral palsy, multiple sclerosis or spinal cord injury
■ Ivabradine, used for the management of stable heart-related chest pain and heart failure

Other medicines which may interact with or be affected by Zemret XL:

■ Lithium, used to treat depression or mania
■ Nitrates, such as glyceryl trinitrate (GTN) or isosorbide trinitrate, used to treat angina
■ Rifampicin, an antibiotic used to treat various infections, in particular tuberculosis
■ Carbamezepine, phenytoin, used to treat epilepsy
■ Iodinated contrast media (used for tests involving X-rays)
■ Ciclosporin, used to treat severe psoriasis (type of skin disease) or to prevent rejection of an organ following a transplant
■ Antiplatelet medicines used to reduce the chance of blood clots forming, such as aspirin or clopidogrel
■ Theophylline, used to treat breathing problems
■ Digoxin and other medicines such as amiodarone, used to treat irregular heartbeat and heart failure Particular care is needed if you are taking amiodarone or digoxin with Zemret XL and you are elderly or you are taking a high dose
■ Medicines used to treat indigestion and stomach ulcers e.g. cimetidine and ranitidine. You should be carefully monitored when starting or stopping treatment with such medicines and your dose of Zemret XL may need to be adjusted
■ Medicines for high blood pressure such as doxazosin, tamsulosin, atenolol, propranolol or acebutolol
■ Midazolam, triazolam, used to induce sleepiness or drowsiness before an operation or during minor surgery
■ Methylprednisolone, used for inflammation and allergic reactions
■ Statins, used to lower lipids known as cholesterol and triglycerides in the blood e.g. atorvastatin, fluvastatin or simvastatin
■ Cilostazol, used to treat intermittent cramp-like leg pain when walking caused by insufficient blood supply

Zemret XL with food and drink

It is advisable to limit the amount of grapefruit juice you drink while taking Zemret XL 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

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking any medicine.

Pregnancy

You should not take this medicine if you are pregnant or think you may be pregnant. If it is at all possible that you could become pregnant while taking this medicine you should use suitable contraception. You may wish to discuss this with your doctor.

Breast-feeding

As low amounts of diltiazem pass into breast milk, breastfeeding must be stopped while taking this medicine.

Driving and using machines

Zemret XL should not affect your ability to drive or operate machinery. However, common side effects of this medicine are feeling dizzy or unwell. If affected you should not drive or operate machinery.

Zemret XL contains sucrose

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

How to take Zemret XL

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

■ Your medicine comes in a modified release gelatin capsule which means the medicine is released over a longer period of time.

Continued…

■ These capsules are to be taken orally, before or during a meal
■ You should swallow the capsule whole, with a little water
■ Do not crush or chew the capsules
■ You may notice remains of the medication (the capsule shell) in your stools. This has no clinical relevance as your body has already absorbed the medicine.

The recommended dose is:

Adults

The usual starting dose is one Zemret XL 180mg capsule a day.

If necessary, your doctor may increase your dose up to:

■ One Zemret XL 300mg capsule a day or
■ Two Zemret XL 180mg capsules a day.
■ One Zemret XL 300mg capsule and one 180mg capsule a day.

Older people or adults with liver or kidney problems Angina and high blood pressure:

The recommended starting dose is one Zemret XL 180mg capsule a day.

If necessary, your doctor may increase this dose to one Zemret XL 300mg capsule a day.

Use in children

This medicine is not recommended for use in children.

If you take more Zemret XL than you should

If you accidentally take too many capsules, contact your doctor or go to your nearest hospital emergency department immediately. Remember to take this leaflet and any remaining capsules with you.

Symptoms of an overdose include: low blood pressure, which may lead to collapse, slow heartbeat and/or an irregular heartbeat. There is a possibility of kidney impairment in patients following an overdose of diltiazem.

If you forget to take Zemret XL

Take it as soon as you remember unless it is nearly time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose.

If you stop taking Zemret XL

It is important that you keep taking Zemret XL for as long as your doctor has told you to.

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

Possible side effects

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

Seek medical advice immediately if you develop the following symptoms:

■ Allergic reactions: swelling of the face, throat or tongue, fever, difficulty in breathing, dizziness
■ Swelling of the deeper layers of the skin caused by a build-up of fluid (angioneurotic oedema)
■ Difficulty breathing or wheezing (bronchospasm, aggravation of asthma)
■ Severe blistering of the skin, mouth, eyes and genitals (Stevens-Johnson Syndrome) or severe blistering of the skin (toxic epidermal necrolysis)
■ Abnormal heart rhythm where the heart beats too slowly (AV block, sinoatrial block, congestive heart failure) or stops beating (sinus arrest, cardiac arrest)

Other possible side effects

Very common side effects (may affect more than 1 in 10 people)

■ Swelling of the calves, ankles or feet

Common side effects (may affect up to 1 in 10 people)

■ Headache
■ Dizziness
■ Feeling your heartbeat (palpitations)
■ Flushing of the skin
■ Indigestion, stomach pain, feeling sick, constipation
■ Generally feeling unwell
■ Skin rashes (erythema)

Uncommon side effects (may affect up to 1 in 100 people)

■ Nervousness
■ Difficulty sleeping
■ Being sick
■ Diarrhoea
■ Slower heartbeat
■ Low blood pressure causing dizziness or lightheadedness after a change in position i.e. when standing up from a lying or sitting position
■ Increase in liver enzymes (detected through a blood test)

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

■ Dry mouth
■ Skin rash rashes with the formation of wheals (urticaria)

Not known (frequency cannot be estimated from the available data)

■ Reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)
■ Mood changes including depression
■ Medicine-induced movement disorders

(Extrapyramidal Syndrome)

■ Inflammation of blood vessels (vasculitis)
■ Swollen gums
■ Increased blood sugar levels (hyperglycaemia)
■ Inflammation of the liver (hepatitis)
■ Increased sensitivity of the skin to sunlight (photosensitivity)
■ Peeling of the skin over large areas of the body (exfoliative dermatitis)
■ Small raised bumps on the skin that fill with fluid or pus caused by a hypersensitivity (allergy) to medicine (Acute Generalised Exanthematous Pustulosis (AGEP))
■ Rash, scaling of the skin (with or without fever)
■ Sweating
■ Excessive development of the male breast

Reporting of 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: 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.

How to store Zemret XL

■ Keep this medicine out of the sight and reach of children.
■ Do not use this medicine after the expiry date, which is stated on the carton/blister after ‚EXP‘. The expiry date refers to the last day of that month.
■ Store in a dry place below 25°C. Store in the original package in order to protect from light.
■ Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

□

Contents of the pack and other information

What Zemret XL contains

■ Each Zemret 180 XL modified release capsule contains 180mg of active substance diltiazem hydrochloride.
■ Each Zemret 240 XL modified release capsule contains 240mg of active substance diltiazem hydrochloride.
■ Each Zemret 300 XL modified release capsule contains 300mg of active substance diltiazem hydrochloride.

The other ingredients are: acetone, ammonio methacrylate copolymer (Types A and B), gelatin, methylene chloride, paraffin, sugar spheres (sucrose and starch), talc and titanium dioxide (E171),

Zemret 180 XL also contains: erythrosine (E127), black and red iron oxides (E172).

also contains: indigotine (E132).

What Zemret XL looks like and contents of the pack

■ Zemret 180 XL: opaque grey body, pink cap, marked

180, containing white and whitish pellets

■ Zemret 240 XL: light blue body and cap, marked 240, containing white and whitish pellets
■ Zemret 300 XL: white body, light blue cap, marked 300, containing white and whitish pellets

The capsules are available in blister packs containing 28, 30, 56, 60 or 100 capsules.

Not all pack sizes may be marketed.

Product Licence Numbers:

■ Zemret 180 XL capsules – PL 11311/0449
■ Zemret 240 XL capsules – PL 11311/0450
■ Zemret 300 XL capsules – PL 11311/0451