Package Leaflet: Information for the patient

BI-CARZEM SR 60mg, 90mg and 120mg prolonged release hard capsules

(Each hard gelatine capsule contains 60mg, 90mg or 120mg diltiazem hydrochloride in sustained release sugar beads)

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, "Contents of the pack and other information”). Diltiazem can cause allergic reactions including rash, itching, shortness of breath, swelling of your lips, face throat or tongue

■    You are breast-feeding

■    You have heart problems, such as:

-    very slow heart beat - less than 50 beats per minute (severe bradycardia)

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

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

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

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

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

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.

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

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 heart beat (e.g. amiodarone) or heart failure (e.g. digoxin)

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

■    Carbamazepine, used to treat epilepsy

■    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

■    Midazolam, used for sleepiness or drowsiness before an operation, during minor surgery or as a premedication

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

■    Methylprednisolone (corticosteroid), used to treat inflammation

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist.

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, 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.

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 drug is released over a longer period of time.

continued..

■    This medicine is for oral use

■    You should swallow the whole capsule, preferably with a glass of water.

■    Do not chew or crush the capsules

The recommended dose is:

Adults

Angina and high blood pressure:

The usual dose is one 60mg capsule three times a day or one 90mg or 120mg capsule twice a day.

If necessary, your doctor may increase this to:

■    Two Bi-Carzem SR 60mg capsules three times a day or

■    Two Bi-Carzem SR 90mg capsules twice a day or

■    Two Bi-Carzem SR 120mg capsules twice a day

Older people or adults with liver or kidney problems Angina

The usual starting dose is one 60mg capsule twice a day.

If necessary, your doctor may increase your dose to:

■    One Bi-Carzem SR 90mg capsule twice a day or

■    One Bi-Carzem SR 120mg capsule twice a day

High blood pressure

The usual starting dose is one Bi-Carzem SR 120mg capsule a day.

If necessary, your doctor may increase your dose to:

■    One Bi-Carzem SR 90mg capsule twice a day or

■    One Bi-Carzem SR 120mg capsule twice a day

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:

Exceeding the correct dose may cause your blood pressure to become too low, which may lead to collapse, slow heart beat and/or an irregular heart beat.

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.

Stop taking your medicine and seek medical advice immediately if you develop the following symptoms:

■    Dizziness, fainting, chest pain, light-headedness, severe tiredness or shortness of breath (symptoms of artrioventricular block, sinoatrial block or congestive heart failure)

■    Allergic reaction which may cause swelling to the face or throat (angioneurotic oedema)

■    Blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome) or severe blistering of the skin (toxic epidermal necrolysis)

Other possible side effects

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

■    Swelling of the lower legs

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

■    Headache

■    Dizziness

■    Hot flushes or flushing of the skin

■    Feeling your heart beat (palpitations)

■    General feeling of not being well

■    Indigestion, stomach pain, feeling sick, constipation

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

■    Difficulty sleeping

■    Nervousness

■    Slower heart beat

■    A fall in blood pressure on standing up which causes dizziness, light-headedness or fainting

■    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

■    Itchy rash

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

■    Unusual movements of the tongue, muscle spasms in your face, rolling eyes and trembling

■    Swollen gums

■    Passing large amounts of urine, excessive thirst and having a dry mouth or skin. These may be signs of high blood sugar (hyperglycemia)

■    Breast enlargement in men

■    Red patches on the skin

■    Rash, scaling of the skin (with or without fever),

■    Boil like inflammation of the skin

■    Inflammation of blood vessels often with a skin rash (vasculitis)

■    Increased sensitivity of the skin to sunlight

■    Inflammation of the liver (hepatitis), which may cause tiredness, stomach pain, muscle and joint pain

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: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

51 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.

6 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, gelatine.

The hard gelatine capsules contain titanium dioxide (E171), iron oxide red (E172) and iron oxide yellow (E172) (Bi-Carzem 60mg 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 may be marketed.

Marketing Authorisation Holder and Manufacturer

Tillomed Laboratories Ltd,

3 Howard Road, Eaton Socon, St Neots, Cambridgeshire PE19 8ET, UK

Product Licence Numbers:

Bi-Carzem SR 60mg Capsules: Bi-Carzem SR 90mg Capsules: Bi-Carzem SR 120mg Capsules:

Date of Revision: June 2015

Hard to Read? Phone 0800 970 6115 for help

Till-Ver.6.2s