Document: leaflet MAH BRAND_PL 24581-0010 change

• leaflet MAH BRAND_PL 11311-0538
• leaflet MAH BRAND_PL 24581-0010

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PATIENT INFORMATION LEAFLET

Mezatil SR 60mg, 90mg & 120mg Capsules

(Sustained-release capsules containing diltiazem hydrochloride)

|1| What Mezatil 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. These relax the muscles around the blood vessels and make it easier for the heart to do its work.

Your medicine is used for the following:

■    to treat high blood pressure

■    to prevent attacks of chest pain (angina)

Before you take Mezatil

Do not take Mezatil:

■    if you are allergic to diltiazem or any of the other ingredients in Mezatil (see list in Section 6, under 'What Mezatil contains')

■    if you are pregnant, planning to become pregnant, could become pregnant or you are breast-feeding (see Section 2, 'Pregnancy and breast-feeding')

■    if you have heart problems, such as:

-    very slow heart beat (severe bradycardia with less than 40 beats per minute)

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

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

-    heart failure after a heart attack

-    left ventricular failure with lung congestion (symptoms include breathlessness, excessive sweating, anxiety and pale skin)

■    if you are being treated with dantrolene infusion.

Medicine used as a muscle relaxant (see 'Taking other medicines', Section 2)

■    if you suffer from porphyria (a rare disease of the blood pigment). Mezatil should not be taken unless told to do so by your doctor

Take special care and speak to your doctor before taking if:

■    you are diabetic as your doctor may need to change the dosage of your medication.

■    you have liver or kidney problems or you are elderly. You should be closely monitored by your doctor at the beginning of treatment, in particular your heart rate

■    you have with problems with your heart such as:

-    reduced left ventricular function

-    slow heart beat (mild bradycardia), as it may become worse

-    first degree heart block (symptoms may include skipped beats)

-    prolonged PR interval (detected on an electrocardiogram ECG). Your doctor will monitor your treatment

■    you are to have a general anaesthesia as you must tell the anaesthetist that you are taking Mezatil

■    you are at risk of developing a blockage of the bowel, which may cause stomach pain, constipation, diarrhoea or wind

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any medicines, including medicines obtained without a prescription, in particular, you should tell your doctor if you are taking the following:

Mezatil should not be taken with the following:

■ Dantrolene infusion, used to relieve muscle spasm for conditions such as cerebral palsy, multiple sclerosis or spinal cord injury

Other medicines which may interact include:

■    Medicines used to treat high blood pressure or chest pain (angina), such as nifedipine, beta blockers (e.g. propranalol), ACE inhibitors (e.g. enalapril), alpha blockers (e.g. doxazosin) and diuretics (e.g. bendrofluazide)

■    Medicines used for the treatment of irregular heart beat (e.g. amiodarone) or heart failure (e.g. digoxin) Particular care is needed if you are taking amiodarone or digoxin with Mezatil and you are elderly or you are taking a high dose

■    Medicines used to treat stomach ulcers

(e.g. cimetidine or ranitidine). You should be carefully monitored when starting or stopping treatment with such medicines and your dose of Mezatil may need to be adjusted

■    Medicines to treat epilepsy (e.g. phenytoin, carbamazepine, phenobarbital or primidone)

■    Medicines to prevent rejection of transplant organs (e.g. ciclosporin, tacrolimus, or sirolimus)

■    Theophylline, used to treat bronchial asthma

■    Warfarin, used to thin the blood (anti-coagulant)

■    Lithium, used to treat depression or mania

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

■    Atazanivir, efavirenz, amprenavir or ritonavir, used to treat HIV infection and AIDS

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

■    Buspirone, used to treat anxiety

■    Dutasteride, used to treat men with an enlarged prostate

■    Imipramine, used to treat the symptoms of depression (tricyclic antidepressant)

■    Eplerenone, used to control blood pressure and heart function

■    Atorvastatin or simvastatin, used to lower lipids known as cholesterol and triglycerides in the blood (statins)

■    Alfentanil, a short-acting painkiller used for surgical procedures

■    Cilostazol, used to treat cramping pain in the leg when walking, due to poor circulation (intermittent claudication)

■    Ivabradine, used to treat stable chest pain (angina)

■    Methylprednisolone, used for inflammation and allergic reactions

If you are not sure of the medicines you are taking ask your doctor or a pharmacist.

Pregnancy and breast-feeding

Pregnancy

You must not take this medicine if you are pregnant, might become pregnant or think you may be pregnant.

If it is at all possible that you could become pregnant, you must only take this medicine if you are using effective contraception. You may wish to discuss this with your doctor.

Breast-feeding

As the active ingredient diltiazem passes into breast milk, you must not breast-feed whilst taking this medicine.

Driving or using machines

You may feel dizzy or generally unwell. If affected you should not drive or operate machinery.

Important information about some of the ingredients of Mezatil Capsules

Mezatil 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 Mezatil

Always take Mezatil exactly as your doctor has told you. Read and follow the instructions on the pharmacist's label. You should check with your doctor or pharmacist if you are not sure about anything.

Your medicine comes in a sustained-release capsule which means the drug is released over a longer period of time.

■    Mezatil capsules are for oral use

■    The capsules should be taken whole with some water

■    Do not suck or chew the capsules

■    Do not stop taking the medicine without speaking to your doctor first

Adults

The initial dose is normally 90mg taken twice a day. Your doctor may decide to increase this to 180mg twice a day.

Elderly people and patients with liver or kidney problems

The initial dose should be 60mg taken twice a day. Your doctor may increase the dose slowly to achieve the required level of control. The daily dose should not exceed 90mg twice a day.

Children

Children should not take this medicine.

If you take more Mezatil than you should

Do not exceed the dose prescribed to you by your doctor. If a child takes any capsules or if you accidentally take more than the prescribed dose, seek medical advice immediately and take your medicine and this leaflet with you. 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. It may also cause an increase in blood sugar levels (hyperglycaemia).

If you forget to take Mezatil

Try and take your Mezatil Capsules at the same time each day. If you forget to take a dose, take it as soon as you remember. If it is near the time for your next dose, do not take your missed dose but take your next dose at your normal time. Never take a double dose to make up for the one you have missed.

|4 Possible side effects

Like all medicines, Mezatil can sometimes cause side effects,

although not everybody gets them.

Contact your doctor immediately if you experience the

following:

■    Severe slowing of the heart, which may cause fainting or dizziness

■    Allergic reaction which may cause swelling to the face or throat

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

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

■    Swelling of the ankles

Common side effects (affects less than 1 in 10 people)

■    Headache

■    Dizziness

■    Feeling your heart beat (palpitations)

■    Hot flushes or flushing of the skin

■    Minor stomach problems such as, indigestion, stomach pain, feeling sick, constipation

■    General feeling of not being well

Uncommon side effects (affects less than 1 in 100 people)

■    Nervousness

■    Difficulty sleeping

■    Slower heart beat

■    Feeling dizzy, light-headed or faint when you stand or sit up quickly (low blood pressure)

■    Being sick

■    Diarrhoea

■    Increase in liver enzymes (detected through blood tests)

Rare side effects (affects less than 1 in 1,000 people)

■    Dry mouth

■    Itchy rash

Other possible side effects (frequency not known)

■    Increased risk of bleeding or bruising due to a reduction in blood platelets (thrombocytopenia)

■    Swollen or tender lumps in the underarm, groin, neck, chest, and abdomen due to swelling of the lymph nodes

■    Wheezing, breathlessness, abdominal pain, diarrhoea, fever, cough & rashes due to an increase in a certain type of white blood cells (eosinophilia -diagnosed through blood test)

■    Mood changes including depression, seeing or hearing things that are not real (hallucination) or personality change

■    Involuntary movements, and uncontrollable speech

■    Fainting

■    Memory loss

■    Tingling or numbness in the hands or feet

■    Sleepiness

■    Shaking

■    Feeling of dizziness, weakness or confusion due to heart block

■    Severe tiredness or shortness of breath due to congestive heart failure

■    Chest pain (angina)

■    Irregular heart beat

■    Inflammation of blood vessels, often with skin rash

■    Low blood pressure

■    Enlarged, swollen gums

■    Loss of appetite

■    High temperature, feeling tired, loss of appetite, stomach pain, feeling sick. These can be signs of inflammation of the liver (hepatitis)

■    Increased sensitivity of the skin to sunlight

■    Skin rashes, redness of the skin or itchy rash

■    Red patches on the skin and/or scaling of the skin, with or without fever

■    Sweating

■    Boil-like inflammation of the skin

■    Enlargement of breasts (in men)

■    Problems having sex

■    Unusual or uncontrollable movements when walking

■    Increase in weight

■    Increase in CK (Creatine Kinase) blood levels (detected through blood test)

■    Poor sight ('lazy eye')

■    Ringing in the ears (tinnitus)

■    Breathlessness

■    Nosebleed

■    Blocked nose

■    High blood sugar (glucose) level which can cause increased thirst, urination and tiredness

■    Need to urinate during the night or more often

■    Muscle or joint pain

If any of the side-effects become serious or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist.

Hi How to store Mezatil

Keep out of the reach and sight of children

Do not use Mezatil after the expiry date, which appears after 'EXP' on the carton. The expiry date refers to the last day of the month.

Do not store above 25°C

Store in original package.

If you have any medicine left which you do not need, return it to your pharmacist. Only keep them if your doctor tells you to. 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.

© Further information

What Mezatil Capsules contain

The active ingredient in Mezatil 60mg, 90mg and 120mg sustained-release capsules is diltiazem hydrochloride.

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

The hard gelatine capsules contain, titanium oxide (E171), red iron oxide (E172), yellow iron oxide (E172). (Mezatil 120mg does not include iron oxide yellow).

What Mezatil Capsules look like and contents of the pack

Mezatil 60mg: Opaque pink and white capsule Mezatil 90mg: Opaque pink and yellow capsule Mezatil 120mg: Opaque pink and orange capsule

The capsules are available in blister packs containing 14, 28, 42, 56 or 84 capsules or containers with 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

ZeCare Ltd.

Unit 5 Blenheim Court,

Brownfields, Welwyn Garden City,

Hertfordshire, AL7 1AN UK

Manufacturer

Ethypharm Industries,

Zone Industrielle de Saint Arnoult,

28170 Chateauneuf-en-Thymerais,

France

Product Licence Numbers

Mezatil SR 60mg Capsules: PL 24581/0010 Mezatil SR 90mg Capsules: PL 24581/0011 Mezatil SR 120mg Capsules: PL 24581/0012

Date of Revision: May 2011

Zc-Ver.6.6s