h PATIENT INFORMATION LEAFLET

IDILTIAZEM MODIFIED RELEASE

Tablets 60mg

Please read all of this leaflet carefully before you start taking this medicine.

Keep the leaflet; you may need to read it again. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4._

In this leaflet:

1.    What Diltiazem Tablets are and what they are used for

2.    Before you take Diltiazem Tablets

3.    How to take Diltiazem Tablets

4.    Possible side effects

5.    How to store Diltiazem Tablets

6.    Further information

1.    What Diltiazem Tablets are and what they are used for

The name of your medicine is Diltiazem Modified Release Tablets 60mg.

Diltiazem belongs to a group of drugs known as calcium channel blockers, which help blood vessels to relax and widen, allowing more blood to flow to the heart.

This medicine is used for the treatment and prevention of angina pectoris (chest pain).

2.    Before you take Diltiazem Tablets Do not take these tablets if:

•    you are allergic to diltiazem or to any of the other ingredients (see section 6)

•    you have a very slow heartbeat i.e. less than 40 beats per minute (severe bradycardia)

•    you have second or third degree heart block without a pacemaker fitted (the electrical impulses which make the heart beat are affected, causing your heart to miss a beat or your heartbeat being very slow), or have heart failure and problems with blood flow to your lungs, or sick sinus syndrome (heart rhythm disorders that cause slow and fast heart rates) without a pacemaker fitted.

•    you are pregnant, planning to become pregnant or breastfeeding

•    you are of child bearing age

•    you are having a medicine called dantrolene used for severe muscle spasms or severe fever.

Check with your doctor before taking these tablets if:

•    you have first degree heart block (the electrical impulses which make the heart beat are slower than normal although this does not cause your heartbeat to slow), impaired left ventricular function, slow heartbeat (bradycardia)

•    you are at risk of developing an obstruction in your intestines

•    you are elderly or you have impaired liver or kidney function (as your dose may need to be reduced).

Taking other medicines:

Check with your doctor or pharmacist before taking these tablets if you are taking any other medicines, including any that you can buy without a prescription. This is especially important if you are taking:

•    drugs to treat heart problems or high blood pressure such as beta blockers e.g. atenolol, alpha blockers e.g. prazosin, ACE inhibitors e.g. enalapril, nitrates e.g. glyceryl trinitrate, angiotensin-ll antagonists e.g. eprosartan, diuretics e.g. furosemide, or the drugs amiodarone, nifedipine, digoxin

•    carbamazepine, phenytoin or phenobarbital (used in epilepsy)

•    lithium (to treat some types of mental illnesses), imipramine or other tricyclic anti-depressants e.g. amitriptyline or MAOIs (monoamine oxidase inhibitors e.g. phenelzine)

•    drugs to treat ulcers e.g cimetidine, ranitidine

•    antipsychotic drugs e.g. chlorpromazine (used for sedation in psychotic disorders such as schizophrenia, mania, severe anxiety)

•    benzodiazepines to treat anxiety or help you sleep e.g. midazolam, triazolam

•    corticosteroids e.g. methylprednisolone used to suppress the symptoms of inflammatory and allergic disorders

•    rifampicin (an antibiotic) or drugs to treat viral infections e.g. ritonavir, amprenavir

•    tacrolimus, sirolimus or ciclosporin (used to prevent organ transplant rejection)

•    cilostazol or moxisylate (used to improve blood circulation in the legs), theophylline (used for asthma), aldesleukin (used for cancer), alprostadil (used for erectile dysfunction), mefloquine (used to treat or prevent malaria), statins e.g. atorvastatin, fluvastatin and simvastatin (used to lower blood cholesterol)

Other special warnings:

If you need to have an anaesthetic or are going to have an operation or a liver function test tell the doctor you are taking this medicine. Tell your doctor if you notice any mood changes or feel depressed.

Important information about one of the ingredients of this medicine.

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, check with your doctor before taking this medicine.

Driving or using machinery

Some people may feel dizzy or generally unwell when they are taking these tablets. Do not drive or operate machinery if this happens to you.

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant, planning to become pregnant or breastfeeding.

3.    How to take Diltiazem Tablets

Swallow the tablets whole with water (the tablets should not be crushed or chewed).

Adults:

The usual dose for adults is 1 tablet three times a day.

Dependent on your response the dose may be increased up to a maximum of 6 tablets a day, taken in divided doses. Higher doses of 8 tablets a day have been used in some patients with unstable angina.

Elderly:

If you are elderly or have impaired liver or kidney function, your doctor may reduce your initial dose to 1 tablet twice a day. Your doctor will probably want to monitor your heart rate.

Children:

Not recommended.

Your doctor will decide the dose that is best for you. The pharmacist's label will also tell you how many tablets to take and how often. If you are not sure about anything, ask your doctor or pharmacist.

Remember, this medicine is for YOU. Do not give it to someone else, even if their symptoms are the same as yours. This medicine may harm them.

If you forget to take a dose:

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and continue with the regular dosing schedule. DO NOT DOUBLE THE DOSE.

If you have taken too many tablets:

If you think you have taken too many tablets, contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining tablets and the pack so that the medicine can be identified.

4.    Possible side effects

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

If any of the following occur STOP TAKING the tablets and contact your doctor IMMEDIATELY:

•    allergic reaction such as rash, difficulty swallowing or breathing problems, swelling of the face, lips, tongue or throat.

Tell your doctor STRAIGHTAWAY if you notice any of the following effects:

•    skin reactions such as peeling or shedding of the skin, blistering of the skin, mouth, eyes and genitals, rashes or pink/red lesions

•    inflammation of blood vessels (symptoms include skin rashes or red/purplish spots on the skin)

•    slow or irregular heartbeat, feeling your heartbeat (palpitations)

•    shortness of breath, tiredness, swollen ankles and legs (signs of heart failure)

•    liver problems (symptoms may include yellowing of the skin or whites of the eyes, dark urine, pale stools, loss of appetite or stomach discomfort)

•    increased sensitivity to sunlight.

The following other effects have been reported. If you notice any of these tell your doctor or pharmacist.

Very common effects that may happen to more than 1 in 10 people:

•    swollen legs or ankles.

Common effects that may happen to less than 1 in 10 people:

•    headache, dizziness

•    flushing, redness of the skin

•    feeling sick, constipation, indigestion, stomach pain

•    generally feel unwell, weak or tired.

Uncommon effects that may happen to less than 1 in 100 people:

•    nervousness, difficulty in sleeping

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

•    vomiting, diarrhoea

•    change in the levels of liver enzymes shown up in blood tests. This can mean that your liver is not working properly.

Rare effects that may happen to less than 1 in 1000 people:

•    dry mouth.

Other effects:

•    low blood pressure which may make you feel faint or light-headed

•    reduction in blood platelets, which increases risk of bleeding or bruising

•    mood changes (including depression)

•    changes in muscle tone and/or abnormal body movement

•    swollen gums

•    sweating

•    swelling of breast tissue in males.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 .aov .uk/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Diltiazem Tablets

Keep this medicine in the original package and protect from light.

Do not take the tablets if the expiry date on the pack has passed. If you have any medicines that are out of date, return them to your pharmacist for safe disposal.

KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN

6.    Further information Ingredients:

Each modified release tablet contains 60mg of diltiazem hydrochloride as the active ingredient. The tablets also contain the inactive ingredients: lactose, hydrogenated castor oil, macrogol 6000 and magnesium stearate.

What the medicine looks like:

The tablets are white, round and engraved with the company logo on one side and C/066 on the other side.

This medicine is available in pack sizes of 28, 30, 50, 56, 60, 84, 90, 100, 112, 250 and 1000 tablets. (Not all pack sizes may be marketed). Who makes this medicine and holds the Product Licence:

Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED Date leaflet revised April 2016

If you would like this leaflet in a different format please contact the licence holder at the above address.