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BI-CARZEM SR 60 MG PROLONGED-RELEASE CAPSULES - patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - BI-CARZEM SR 60 MG PROLONGED-RELEASE CAPSULES

What Bi-Carzem SR is and what it is used for

The active ingredient in this medicine is 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.

Bi-Carzem SR is used to treat: ■ Chest pain (angina) ■ High blood pressure

What you need to know before you take Bi-Carzem SR

Do not take Bi-Carzem SR if:

  • ■ You are allergic (hypersensitive) to diltiazem hydrochloride or any of the ingredients of this medicine (listed in section 6)

  • ■ You are breast-feeding or planning to breast-feed (see „Pregnancy and breast-feeding“ section)

  • ■ You have heart problems, such as:

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

o dizziness, fainting, chest pain, light-headedness 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)

  • ■ You are already taking a medicine containing ivabradine for the treatment of certain heart diseases (see „Other medicines and Bi-Carzem SR“ section)

  • ■ You are being treated with dantrolene injection (for severe muscle spasm or severe fever) (see „Other medicines and Bi-Carzem SR“ 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

  • ■ you are going to have an operation and will have anaesthesia

  • ■ 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 elderly

  • ■ you have liver or kidney problems

  • ■ you have diabetes

  • ■ you have or ever had asthma

Other medicines and Bi-Carzem SR:

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.

Bi-Carzem SR 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 Bi-Carzem SR:

  • ■ Medicines used to treat high blood pressure such as doxazosin, tamsulosin, atenolol, propranolol or acebutol

  • ■ Medicines used for the treatment of irregular heartbeat (e.g. amiodarone) or heart failure (e.g. digoxin)

  • ■ Medicines for chest pain (angina) such as glyceryl trinitrate or isosorbide dinitrate (nitrates)

  • ■ Carbamazepine, phenytoin, used to treat epilepsy

  • ■ Iodinated contrast media (used for tests involving X-rays)

  • ■ Theophylline, used to treat bronchial asthma

  • ■ Ciclosporin, used to prevent rejection of transplant organs

  • ■ Medicines used to treat stomach ulcers (e.g. cimetidine or ranitidine)

  • ■ Lithium, used to treat depression or mania

  • ■ Rifampicin, an antibiotic used to treat various infections, in particular tuberculosis

  • ■ Antiplatelet medicines used to reduce the chance of blood clots forming, such as aspirin or clopidogrel

  • ■ Midazolam, triazolam, used to induce sleepiness or drowsiness before an operation, during minor surgery or as a premedication

  • ■ Statins, used to treat high cholesterol e.g. atorvastatin, fluvastatin or simvastatin

  • ■ Methylprednisolone (corticosteroid), used to treat inflammation

  • ■ Cilostazol, used to treat intermittent cramp-like leg pain when walking caused by insufficient blood supply

Bi-Carzem SR with food and drink

It is advisable to limit the amount of grapefruit juice you drink while taking Bi-Carzem SR 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 whilst 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, breast feeding must be stopped whilst taking this medicine.

Driving and using machines

Bi-Carzem SR 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.

Bi-Carzem SR 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.

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How to take Bi-Carzem SR


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 prolonged release hard gelatin capsule which means the medicine is released over a longer period of time.

Continued…

  • ■ This medicine is for oral use

  • ■ You should swallow the capsule whole, with a little water.

  • ■ Do not chew or crush 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

Angina and high blood pressure:

The usual starting dose is one 60mg capsule three times a day (180mg per day) or one 90mg capsule twice a day (180mg per day) or 120mg capsule twice a day (240mg per day).

If necessary, your doctor may increase this to 360mg per day or 480mg per day, given in divided doses.

Older people or adults with liver or kidney problems Angina:

The recommended starting dose is one 60mg capsule twice a day (120mg per day).

If necessary, your doctor may increase this to one 90mg capsule twice a day (180mg per day) or one 120mg capsule twice a day (240mg per day).

High blood pressure:

The usual starting dose is one 120mg capsule a day.

If necessary, your doctor may increase this to one 90mg capsule twice a day (180mg per day) or one 120mg capsule twice a day (240mg per day).

Use in children

This medicine is not recommended for use in children.

If you take more Bi-Carzem SR 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 Bi-Carzem SR

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 Bi-Carzem SR

It is important that you keep taking Bi-Carzem SR 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

  • ■ Abnormal heart rhythm where the heart beats too slowly (AV block, sinoatrial block, congestive heart failure) or stops beating (sinus arrest, cardiac arrest)

  • ■ Swelling of the deeper layers of the skin caused by a build-up of fluid (angioneurotic oedema)

  • ■ Severe blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome, toxic epidermal necrolysis)

  • ■ Difficulty breathing or wheezing (bronchospasm, aggravation of asthma)

Other possible side effects

Very common side effect (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

  • ■ Flushing of the skin

  • ■ Feeling your heartbeat (palpitations)

  • ■ Generally feeling unwell

  • ■ Indigestion, stomach pain, feeling sick, constipation

  • ■ Skin rashes (erythema)

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

  • ■ Difficulty sleeping

  • ■ Nervousness

  • ■ 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

  • ■ Being sick

  • ■ Diarrhoea

  • ■ 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)

  • ■ Sweating

  • ■ Reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)

  • ■ Mood changes including depression

  • ■ Medicine-induced movement disorders (Extrapyramidal Syndrome)

  • ■ Swollen gums

  • ■ Increased blood sugar levels (hyperglycaemia)

  • ■ Excessive development of the male breast

  • ■ 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)

  • ■ Inflammation of blood vessels (vasculitis)

  • ■ Incresaed sensitivity of the skin to sunlight (photosensitivity)

  • ■ Inflammation of the liver (hepatitis)

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.

15

How to store Bi-Carzem SR


  • ■ 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 below 25°C in a dry place away from heat.

  • ■ Store in the original package in order to protect from moisture.

  • ■ 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 Bi-Carzem SR contains

  • ■ Each Bi-Carzem 60mg prolonged release capsule contains 60mg of active substance diltiazem hydrochloride in sustained release sugar beads

  • ■ Each Bi-Carzem 90mg prolonged release capsule contains 90mg of active substance diltiazem hydrochloride in sustained release sugar beads

  • ■ Each Bi-Carzem120mg prolonged release capsule contains 120mg of active substance diltiazem hydrochloride in sustained release sugar beads

The other ingredients are: sucrose, corn starch, povidone, methacrylic acid copolymer, ethylcellulose, talc, diethyl phthalate, gelatin.

The capsules also contain titanium dioxide (E171), iron oxide red (E172) and iron oxide yellow (E172). (Bi-Carzem 120mg does not contain iron oxide yellow).

What Bi-Carzem SR looks like and contents of the pack

  • ■ Bi-Carzem SR 60mg: opaque pink and white capsule

  • ■ Bi-Carzem SR 90mg: opaque pink and yellow capsule

  • ■ Bi-Carzem SR 120mg: opaque pink and orange capsule

The capsules are available in blister packs or containers containing 56 or 100 capsules.

Not all pack sizes or types may be marketed.

Product Licence Numbers:

  • ■ Bi-Carzem SR 60mg Capsules: PL 11311/0468

  • ■ Bi-Carzem SR 90mg Capsules: PL 11311/0469

  • ■ Bi-Carzem SR 120mg Capsules: PL 11311/0470

Sources: Original (products.mhra.gov.uk)