PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Dilcardia SR 60 mg Prolonged-release capsules, hard Dilcardia SR 90 mg Prolonged-release capsules, hard Dilcardia SR 120 mg Prolonged-release capsules, hard (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.

•    ivabradine to treat angina;

•    medicines used to treat a heart rhythm condition e.g. digoxin, amiodarone;

•    cilostazol to treat intermittent claudication (a condition that causes leg pain due to a restriction in blood supply to the muscles);

•    beta-blockers, water tablets (diuretics) or ACE inhibitors, used to treat high blood pressure and heart conditions e.g. propranolol, furosemide or lisinopril;

•    rifampicin, used to treat an infection;

•    ciclosporin, tacrolimus or sirolimus, usually used after an organ or bone

marrow transplant;

•    a specific type of medicine known as a protease inhibitor to treat HIV (examples include atazanavir or ritonavir);

•    theophylline (to prevent shortness of breath or difficulty breathing);

•    barbiturates e.g. phenobarbital or primidone, carbamazepine or phenytoin (antiepileptics, to treat seizures, fits

or convulsions);

•    cimetidine or ranitidine, for heartburn or stomach ulcers;

•    benzodiazepines, used to treat anxiety or sleep disturbances e.g. midazolam

or triazolam;

•    methylprednisolone, a corticosteroid (normally used to treat inflammation or allergy);

•    statins, used to lower blood cholesterol levels e.g. simvastatin.

If you need to have an operation and will require an anaesthetic, tell your doctor or dentist you are taking this medicine.

Dilcardia SR with alcohol

Do not take Dilcardia SR at the same time as an alcoholic drink.

Pregnancy and breast-feeding

Do not take Dilcardia SR if you are pregnant or planning to become pregnant.

If you are a woman of child bearing age or have not gone through the menopause, and your doctor recommends you take this medicine, you must use an effective form of contraception

Dilcardia should not be taken if you are breast-feeding.

Driving and using machines

Dilcardia SR may cause side effects such as dizziness or feeling generally unwell. If you are affected you should not drive or use machines.

Dilcardia SR contains sucrose

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

3. How to take Dilcardia SR

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

•    This medicine should not be sucked or chewed

•    Swallow the capsule whole with a glass of water

•    Allow 12 hours between each dose Angina

Adults: the recommended dose is 90 mg twice daily. If necessary, your doctor may be gradually increased to a dose of 180 mg twice daily.

Hypertension

Adults: the recommended dose is 120 mg once or twice daily. Your doctor may give you a lower starting dose and gradually increase the dosage.

Older people or patients with liver or kidney problems

Angina

Your doctor may prescribe a lower dose of 60 mg twice daily which may be increased as required.

Hypertension

Your doctor may prescribe a lower dose of 60 mg twice a day which may be increased to up to a maximum of 90 mg twice a day if required.

Use in children and adolescents

Dilcardia SR is not suitable for children and adolescents.

If you take more Dilcardia SR than you should

Contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining capsules with you. Signs of overdose include low blood pressure possibly leading to collapse, slow heart beat or changes in heart rhythm and/or abnormal blood sugar levels.

If you forget to take Dilcardia SR

If you have forgotten to take a dose at the scheduled time, take it as soon as possible.

If it is less than 6 hours until you are due to take your next dose, do not double the dose, just carry on as before. Do not take a double dose to make up for forgotten individual doses.

If you stop taking Dilcardia SR

Take the medicine for as long as the doctor has prescribed it. Do not discontinue treatment without prior discussion with your doctor or pharmacist.

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

4. Possible side effects

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

If any of the following happen, stop taking Dilcardia SR and tell your doctor immediately or go to your nearest hospital emergency department:

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

•    allergic reactions such as swollen skin or swelling of the face, lips, tongue and/or throat which may cause difficulty breathing or swallowing

•    liver problems which may cause dark urine, pale stools, yellowing of the skin or whites of the eyes

•    severe skin reactions including blistering of the skin, mouth, eyes and genitals, and swollen blood vessels in the skin.

These side effects are serious. You may need medical attention.

Tell your doctor straight away if you notice any of the following side effects:

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

•    mood changes, including depression

•    uncontrollable movements, including trembling or shaking of the hands and fingers

•    trembling, muscle stiffness or spasms, slowing of movement (Parkinsonian syndrome)

•    shortness of breath, swelling of the feet or legs (congestive heart failure)

•    abnormal heart rhythm, slow or uneven heartbeat (sinoatrial block).

Other side effects include:

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

•    swelling of the ankles, feet and fingers

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

•    abnormal heart rhythm (AV block)

•    headache

•    feeling dizzy

•    palpitations

•    flushing

•    constipation

•    indigestion

•    stomach pain

•    feeling sick

•    redness of the skin

•    feeling generally unwell

•    tiredness

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

•    feeling nervous

•    difficulty sleeping

•    slower heart beat

•    dizziness, light-headedness or fainting on standing up

•    being sick

•    diarrhoea

•    increase in liver enzymes (these may show up in blood tests)

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

•    dry mouth

•    a nettle-like rash or hives

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

•    reduction in blood platelets which increase risk of bleeding or bruising

•    loss of appetite

•    pins and needles or tingling

•    bleeding, tender or enlarged gums

•    skin problems such as an increased sensitivity to light, rash, dark areas, severe flaking or peeling

•    sweating

•    breast enlargement in men

•    inflammation of blood vessels (often with skin rash)

•    gastrointestinal disorders (e.g. upset stomach)

•    low blood pressure

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.

5.    How to store Dilcardia SR

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label after eXp. The expiry date refers to the last day of that month.

Store below 25^oC. 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 dispose of medicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other information

What Dilcardia SR contains

The active substance is diltiazem hydrochloride. Each prolonged-release capsule contains 60 mg, 90 mg or 120 mg diltiazem hydrochloride.

The other ingredients are sucrose (see section 2, 'Dilcardia SR contains sucrose'), maize starch, povidone, methacrylic acid - ethyl acrylate copolymer, ethylcellulose, diethyl phthalate, and talc. The capsule also contains gelatin, titanium dioxide (El71), red iron oxide (E172) and the 90 mg and 120 mg capsules also contain yellow iron oxide (E172). The printing ink contains shellac, black iron oxide (E172), propylene glycol, ammonium hydroxide/strong ammonia solution and may also contain potassium hydroxide.

What Dilcardia SR looks like and contents of the pack

Your medicine comes in the form of a capsule.

Dilcardia SR 60 mg Prolonged-release Capsules, Hard

Hard gelatin capsules with pink cap and white body, printed with "G" and "DT60 SR".

They are supplied in blister packs containing 56 or 100 capsules or in plastic containers containing 100 capsules.

Dilcardia SR 90 mg Prolonged-release Capsules, Hard

Hard gelatin capsules with pink cap and yellow body, printed with "G" and "DT90 SR". They are supplied in blister packs containing 56 capsules or in plastic containers containing 100 capsules.

Dilcardia SR 120 mg Prolonged-release Capsules, Hard

Hard gelatin capsules with pink cap and orange body, printed with "G" and "DT120 SR". They are supplied in blister packs containing 56 capsules or in plastic containers containing 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Manufacturers

Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland

This leaflet was last revised in 11/2015.