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ANGITIL XL 300

Active substance(s): DILTIAZEM HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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
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.
Dosage
• 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 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 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 and Manufacturer:

The Marketing Authorisation holder and manufacturer is Chiesi Limited, 333 Styal Road, Manchester,
M22 5LG, UK.

Is this leaflet hard to see or read? Phone 0161 488 5555 for help.
This leaflet was last revised in February 2016

CP0018/6

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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