Angitil Xl 240

Document: leaflet MAH BRAND_PL 06934-0198 change

567 0108002545 ANGITIL 567 0108002545 04/11/16 15:03 Pagel

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^ Angitil SR 90 mg, 120 mg & 180 mg Capsules Angitil® XL 240 mg & 300 mg Capsules

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 or nurse.

-    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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Angitil is and what it is used for

2.    What you need to know before you take Angitil

3.    How to take Angitil

4.    Possible side effects

5.    How to store Angitil

6.    Contents of the pack and other information

1. What Angitil is and what it is used for

Angitil SR and XL Modified-release Capsules contain diltiazem hydrochloride which belongs to a group of medicines called calcium-channel blockers that act on the cardiovascular system (the heart and blood vessels). Angitil has been prescribed by your doctor to treat your high blood pressure or to reduce the frequency of your anginal attacks. They are called modified-release capsules because they are manufactured in a way that allows the diltiazem hydrochloride to be released and slowly absorbed by your body over a period of several hours.

In high blood pressure, diltiazem hydrochloride works by widening the blood vessels. This creates less resistance to the blood flow, and results in lower blood pressure, which in turn reduces the strain on your heart.

In angina, diltiazem hydrochloride works by opening up the arteries supplying the heart muscle and this allows more blood and oxygen to reach the muscle, decreasing the chances of angina (chest pains) occuring when extra strain is placed upon the heart.

2. What you need to know before you take Angitil

Do not take Angitil:

   if you are allergic to diltiazem hydrochloride, other calcium-channel blockers (e.g. amlodipine, nisoldipine or nifedipine) or the other ingredients in Angitil

   if you have been told that you have a very slow heart rate of less than 40 beats per minute

   if you have been told that you have other problems with your heart. Ask your doctor if you are not sure if this applies to you.

   if you are receiving dantrolene by intravenous injection to treat muscle spasms.

•    if you are already taking a medicine containing ivabradine for the treatment of certain heart diseases.

Warnings and precautions:

Take special care with Angitil and always tell your doctor if:

   you suffer from a poorly functioning left ventricle of the heart

   you have a slower heart rate

   you have an irregular heart beat

   you suffer from porphyria, an inherited blood disorder that can cause increased sensitivity to light

   you have liver or kidney problems or if you are elderly

   you are going to have an anaesthetic

•    you suffer from constipation.

In some patients this medicine has caused mood changes, including depression. If you think you are affected in this way talk to your doctor.

Other medicines and Angitil

Before starting treatment, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

If you have to go to a doctor, dentist or hospital for any reason, tell them that you are taking Angitil. This is especially important if you are likely to have an anaesthetic or an operation.

Do not take this medicine and talk to your doctor or pharmacist if you are currently receiving an infusion of a muscle relaxant called dantrolene (this is only given in hospital).

In particular, tell your doctor if you are taking:

   medicines to control abnormal heart rhythms, such as amiodarone or digoxin

•    water tablets, such as frusemide

•    carbamazepine, to treat epilepsy

•    ciclosporin, to treat psoriasis or to prevent rejection of an organ following a transplant

•    theophylline, to treat breathing problems

•    lithium, to treat depression or a manic-depressive disorder

   rifampicin, an antibiotic to treat turberculosis

   medicines to treat stomach ulcers, such as cimetidine or ranitidine

   medicines to help lower cholesterol, such as atorvastatin or simvastatin

   medicines to treat angina, high blood pressure or heart failure, such as prazosin, atenolol, timolol, captopril, cilazapril, isosorbide mononitrate, glyceryl trinitrate or isosorbide dinitrate

   midazolam or triazolam

   methylprednisolone, a corticosteroid.

Taking Angitil with alcohol

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

Pregnancy and breast-feeding

Do not take Angitil if you are pregnant, trying to become pregnant or are breast-feeding. Driving and using machines

If you feel dizzy or extremely tired after taking Angitil, then do not drive or operate machinery.

Important information about some of the ingredients of Angitil

Angitil contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Please read the back of this leaflet

3.    How to take Angitil

Always take Angitil exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.


   Angitil is formulated so that you only have to take your capsules once or twice a day. This depends on which strength capsule you are taking. The label on the carton will tell you how many capsules you should take and when.

   Take your capsules at the same time each day.

   Swallow your capsule whole with a glass of water. Do not break or chew your capsules.

•    Do not stop treatment even if you feel better unless told to do so by your doctor. Adults: the usual starting dose is 90 mg twice a day.

If you are taking your capsules twice a day, it is important that the second dose is taken 12 hours after the first dose and that no more than 2 capsules are taken in any 24 hour period.

Your doctor may decide to increase your dose to:

   120 mg or 180 mg twice a day or

   240 mg or 300 mg once a day.

Elderly patients and people who suffer from liver or kidney disease: your doctor will prescribe a lower dose for you to take. Your doctor will also want to check your condition regularly and may gradually increase your dose.

Children must not take this medicine.

If you take more Angitil than you should

If you accidentally take more Angitil than you should, contact your nearest casualty department or tell your doctor or pharmacist immediately. Remember to take the pack and any remaining capsules with you.

If you forget to take Angitil

Do not worry. Simply leave out that dose completely and then take your next dose at the right time. Do not take a double dose to make up for a missed dose.

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

4.    Possible side effects

Like all medicines, Angitil can cause side effects, although not everyone gets them.

Allergic reactions, although serious, have been reported occasionally. If you experience any of the following, contact your doctor or casualty department immediately:

•    skin rashes including irritation or itchiness, unusual bruising, peeling and scaling, or a serious illness with blistering of the skin, mouth, eyes and genitals (Steven-Johnson Syndrome)

•    fever

•    swelling of the face, throat, lips, tongue or glands

Talk to your doctor straightaway if you notice any of the following:

•    any mood changes, including depression

•    difficulty controlling movements and restlessness

•    irregular heart beat

•    low blood pressure

The following other side effects have also been reported:

Very common (affects more than 1 in 10 people):

• swelling of the ankles, feet or fingers

Common (affects less than 1 in 10 people):

•    headache, dizziness • flushing

•    skin redness    • tiredness

•    a heart problem called ‘atrioventricular block’ palpitations (feeling your heart beat)

•    constipation, indigestion, stomach pain, feeling sick (nausea)

Uncommon (affects less than 1 in 100 people):

•    nervousness, difficulty in sleeping

•    slow heart rate

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

•    vomiting (being sick), diarrhoea

•    blood tests which show changes in the way the liver is working

Rare (affects less than 1 in 1000 people):

•    dry mouth, hives (lumpy, red, itchy skin)

Frequency not known:

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

•    heart failure

•    inflammation of blood vessels, often with skin rash

•    swollen, enlarged or bleeding gums

•    inflammation of liver causing yellowing of skin or eyes

•    increased sensitivity to sunlight, sweating

•    swelling of breast tissue in men

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 By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Angitil

•    Keep this medicine out of the sight and reach of children.

•    Do not store above 30°C. Store in the original packaging.

•    Do not use Angitil after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month.

•    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 protect the environment.

6.    Contents of the pack and other information

What Angitil contains:

•    The active substance in your capsules is diltiazem hydrochloride. Each capsule contains 90 mg, 120 mg, 180 mg, 240 mg or 300 mg of diltiazem hydrochloride.

•    The other ingredients are sucrose, maize starch, povidone, ethylcellulose, talc, sodium lauryl sulfate, cetyl alcohol, dibutyl sebacate, gelatine, titanium dioxide (E171), red iron oxide (E172) [120mg and 180mg capsules only], yellow iron oxide (E172) [120mg, 180mg and 300mg capsules only], black iron oxide (E172), indigotine (E132) [120mg capsules only], shellac, propylene glycol, ammonium hydroxide and potassium hydroxide.

What Angitil look like and the contents of the pack:

Each strength of Angitil SR and XL capsules can be identified by its colour and marking.

90 mg capsules are transparent and white marked with "90 mg”

120 mg capsules are transparent and brown marked with "120 mg”

180 mg capsules are transparent and pale brown marked with "180 mg”

240 mg capsules are white marked with "240 mg”

300 mg capsules are transparent and yellow marked with "300 mg”

Angitil SR 90 mg, 120 mg and 180 mg are avaliable in blister packs of 56 capsules.

Angitil XL 240 mg and 300 mg are avaliable in blister packs of 28 capsules.

Marketing Authorisation Holder: Ethypharm, 194, Bureaux de la Colline - Batiment D,

92213 Saint-Cloud Cedex, France.

Manufacturer: Ethypharm, Chemin de la Poudriere, 76120 Grand-Quevilly, France.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: United Kingdom: Ethypharm UK Ltd. Medical information tel: +44(0)1483662805

This leaflet was last revised in October 2016