DILTIAZEM HCL 200MG PROLONGED RELEASE CAPSULES HARD

Active substance: DILTIAZEM HYDROCHLORIDE

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Company name
Product name Diltiazem HCl 200 mg and 300 mg
prolonged-release capsules, hard
1.3.1.3

Module 1.3.1.3
Package Leaflet

Package Leaflet

Package leaflet: Information for the user
Diltiazem HCl 200 mg and Diltiazem HCl 300 mg
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.
What is in this leaflet:
1.
What Diltiazem HCl is and what it is used for
2.
What you need to know before you use Diltiazem HCl
3.
How to take Diltiazem HCl
4.
Possible side effects
5.
How to store Diltiazem HCl
6.
Contents of t he pack and other information

1.
What Diltiazem HCl is and what it is used for
Diltiazem HCl contains a medicine called diltiazem. This belongs to a group of medicines called
‘calcium-channel blockers’.
Diltiazem HCl is used for:

High blood pressure

Angina (chest pain).
It works by making your blood vessels wider. This helps to lower your blood pressure. It also
makes it easier for your heart to pump blood around your body. This helps to prevent the chest
pain caused by angina.
2.

What you need to know before you take Diltiazem HCl

Do not take Diltiazem HCl:

if you are allergic to diltiazem or any of the other ingredients of this medicine (listed in
Section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue

if you have a very slow heartbeat – less than 50 beats per minute

if you have heart failure and problems with blood flow to your lungs. With these illnesses,
you may feel out of breath and have swollen ankles

if you have any other serious problems with your heart. This includes having an uneven
heartbeat (unless you have a pacemaker).

if you are taking a dantrolene infusion used for severe muscle spasm or serious fever
(called “malignant hyperthermia”).
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Company name
Product name Diltiazem HCl 200 mg and 300 mg
prolonged-release capsules, hard

Module 1.3.1.3
Package Leaflet

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor
or pharmacist before taking Diltiazem HCl.
Warnings and precautions
Talk to your doctor or pharmacist before taking Diltiazem HCl:

if you have any other problem with your heart, apart from angina or those described in the
Section above ‘Do not take Diltiazem HCl’

if you are going to have an operation

if your are at risk of mood changes, including depression

if you are at risk of gut problems.

if you have liver problems

if you have kidney problems

if you are elderly
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before
taking Diltiazem HCl.
Other medicines and Diltiazem HCl
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. This includes medicines you buy without a prescription, including herbal medicines.
This is because Diltiazem HCl can affect the way some other medicines work. Also some
medicines can affect the way Diltiazem HCl works.
In particular, do not take this medicine and tell your doctor if you are taking:

Dantrolene (an infusion) used for severe muscle spasms or serious fever (called
‘malignant hyperthermia’).

Nifedipine

Ergot derivatives (ergotamine, dihydroergotamine)

Cisapride

Sertindole

Pimozide
The use of Diltiazem HCl concomitantly with the following medicine is not
recommended:

Ivabradine
Take special care with the concomitant use of Diltiazem HCl with the following
medicine:

medicinal products inducing torsades de pointes, such as phenothiazines, bepridil,
certain oral macrolides (such as erythromycin), terfenadine and Calss I and III
antiarrhythmics, methadone.
Diltiazem HCl may increase the effect of the following medicines:

Medicines for high blood pressure such as doxazosin, tamsulosin, atenolol, propranolol
or acebutolol

Medicines used for an uneven heartbeat such as amiodarone, digoxin and dronedarone

Medicines used for angina such as glyceryl trinitrate or isosorbide trinitrate

Medicines used for high levels of cholesterol such as simvastatin, fluvastatin and
atorvastatin

Medicines used for sleeplessness and anxiety, such as triazolam and midazolam

Carbamazepine - used for epilepsy

Theophylline - used for breathing problems
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Company name
Product name Diltiazem HCl 200 mg and 300 mg
prolonged-release capsules, hard




Module 1.3.1.3
Package Leaflet

Lithium - used for some types of mental illness
Methylprednisolone - used for inflammation and allergic reactions
Immunosuppressants (ciclosporine, tacrolimus, sirolimus, everolimus) - used to stop the
rejection of organs after a transplant.

Diltiazem HCl may make the following medicine work less well:

Rifampicin - used for tuberculosis.
The following medicines can increase the effect of Diltiazem HCl

Medicines for stomach ulcers such as cimetidine and ranitidine.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before
taking Diltiazem HCl.
Pregnancy, breast-feeding and fertility

Diltiazem HCl may impair fecundation and cause fetal abnormalities.

If you are pregnant or breast-feeding, think you may be pregnant or planning to have a
baby, Diltiazem HCl is not recommended. This is because Diltiazem HCl can cause
problems for your baby.

Breast-feeding during the use of Diltiazem HCl is not recommended, since small amounts
may pass into the mother’s milk. .
Driving and using machines
You may feel dizzy while taking this medicine. If this happens, do not drive or use any tools or
machines.
3.

How to take Diltiazem HCl

Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure. Also ask your doctor if you feel the effect of your medicine is too
weak or too strong. Do not change the dose yourself.
Taking this medicine:

Take this medicine by mouth.

Do not break, crush or chew your capsules.

Swallow the capsules whole with a drink of water.

Take before or during a meal.
How much to take
Adults:

The usual starting dose is one Diltiazem HCl 200 mg capsule a day.
If necessary, your doctor may increase your dose. Possible doses are:

One Diltiazem HCl 300 mg capsule a day

Two Diltiazem HCl 200 mg capsules a day

One Diltiazem HCl 300 mg capsule and one Diltiazem HCl 200 mg capsule a day.
Over 65 years or adults with liver or kidney problems

Your doctor will check you more closely particularly when you first start taking the
capsules.

The usual starting dose is one Diltiazem HCl 200 mg capsule a day.
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Company name
Product name Diltiazem HCl 200 mg and 300 mg
prolonged-release capsules, hard

Module 1.3.1.3
Package Leaflet

If necessary, your doctor may increase this to:

One Diltiazem HCl 300 mg capsule a day.
Children:
Diltiazem HCl should not be given to children.
Sun protection
You should use sun protection whilst taking this medicine.
Tests
Your doctor may do regular tests while you are taking this medicine. These might include a check
on your heart. It may also include blood tests to check your liver and kidneys.
If you take more Diltiazem HCl than you should
If you take more capsules than you should, tell a doctor or go to a hospital casualty department
straight away. Take the medicine pack with you. This is so the doctor knows what you have
taken. The following effects may happen: feeling dizzy or weak, blurred vision, chest pain, being
short of breath, fainting, an unusually fast or slow heartbeat, coma, slurred speech and confusion.
If you forget to take Diltiazem HCl
If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next
dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Diltiazem HCl
Keep taking Diltiazem HCl until your doctor tells you to stop. Do not stop taking Diltiazem HCl
just because you feel better. If you stop, your illness may get worse.
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 everyone gets them.
Stop taking Diltiazem HCl and see a doctor or go to a hospital straight away if:
It is not known how often these side effects happen

You have an allergic reaction. The signs may include: a red or lumpy rash, swallowing or
breathing problems, swelling of your lips, face, eyelids, throat or tongue

You get blistering or peeling of the skin around the lips, eyes, mouth, nose or genitals, flulike symptoms or fever. This could be an illness called “Stevens-Johnson syndrome”

You get a severe blistering rash in which layers of the skin may peel off to leave large areas
of raw exposed skin over the body. You may feel generally unwell, have a fever, chills or
aching muscles. This could be an illness called “Toxic Epidermal Necrolysis”

You have a skin rash or skin problems with a pink or red ring and a pale centre which may
be itchy, scaly, or filled with fluid. The rash is most likely to happen on the palms or soles
or your feet. These could be signs of a serious allergy to the medicine called “erythema
multiforme”.
Stop taking Diltiazem HCl and see a doctor or go to hospital straight away, if you notice any of
the side effects above.

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Company name
Product name Diltiazem HCl 200 mg and 300 mg
prolonged-release capsules, hard

Module 1.3.1.3
Package Leaflet

Tell your doctor straight away if you notice any of the following serious side effects – you
may need urgent medical treatment:
Common (affects less than 1 in 10 people)

Slow or uneven heartbeat

Very fast, uneven or forceful heartbeat (palpitations).
It is not known how often these side effects happen

Skin rash caused by narrow or blocked blood vessels (called ‘vasculitis’)

Being short of breath, feeling tired along with swollen ankles or legs. These could be signs
of heart failure

Unusual movements of the tongue, muscle spasms in your face, rolling eyes or trembling

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

Getting sunburnt more easily and more severely than someone not taking Diltiazem HCl.
You should use sun protection whilst taking this medicine

Breast enlargement in men.
Tell your doctor straight away if you notice any of the side effects above.
Tell your doctor as soon as possible if you have any of the following side effects:
Very common (affects more than 1 in 10 people)

Swelling of the lower legs.
Common (affects less than 1 in 10 people)

Indigestion, stomach pain, constipation or diarrhoea.
Uncommon (affects less than 1 in 100 people)

Feeling dizzy, light-headed or faint when you stand or sit up quickly (low blood pressure).
Rare (affects less than 1 in 1,000 people)

Dry mouth

Itchy, lumpy rash (called ‘urticaria’).
It is not known how often these side effects happen

Swollen gums.
Tell your doctor as soon as possible if you notice any of the side effects above.
Tell your doctor or pharmacist if any of the following side effects get serious or last longer
than a few days:
Common (affects less than 1 in 10 people)

Headache

Flushing (feeling of warmth)

Feeling sick (nausea) or being sick (vomiting)

General feeling of being unwell

Feeling weak or tired

Feeling dizzy

Skin redness.
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Company name
Product name Diltiazem HCl 200 mg and 300 mg
prolonged-release capsules, hard

Module 1.3.1.3
Package Leaflet

Uncommon (affects less than 1 in 100 people)

Difficulty sleeping.

Nervousness
It is not known how often these side effects happen

Mood changes, including depression

Bleeding or bruising under the skin.

gingival hyperplasia

decrease of platelets (thrombocytopenia

Tell your doctor or pharmacist if any of the side effects above get serious or last longer than a
few days.
Blood tests
Diltiazem HCl can change the levels of liver enzymes shown up
in blood tests. This can mean that your liver is not working properly.
If you get any of the side effects, talk to your doctor or pharmacist. This includes any side effects
not listed in this leaflet.
5.

How to store Diltiazem HCl

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after ‘EXP’. The
expiry date refers to the last day of that month.
Store in the original packaging.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help protect the environment.
6.

Contents of the pack and other information

What Diltiazem HCl contains
The active substance is Diltiazem Hydrochloride.
The other ingredients are (for Diltiazem HCl 200 mg) povidone, talc, ethylcellulose, stearic
acid, gelatine and titanium dioxide (E171).
The other ingredients are (for Diltiazem HCl 300 mg) povidone, talc, ethylcellulose, stearic
acid, gelatine and titanium dioxide (E171), quinoline yellow (E104) and indigotine carmine
(E132).
What Diltiazem HCl 200 mg and Diltiazem HCl 300 mg look like and contents of the pack

Diltiazem HCl 200mg capsules are opaque capsules with a white body and cap.

Diltiazem HCl 300mg capsules are opaque capsules with a white body and green cap.

The capsules are provided in blister packs containing 7 or 28 capsules. Not all pack sizes
may be marketed.
Marketing Authorisation Holder and Manufacturer:
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Company name
Product name Diltiazem HCl 200 mg and 300 mg
prolonged-release capsules, hard

Module 1.3.1.3
Package Leaflet

Marketing Authorisation Holder:
ADOH B.V.
Godfried Bomansstraat 31
6543 JA Nijmegen
The Netherlands
Manufacturer 1:
Lamp San Prospero S.p.A.
Via della Pace 25/A,
41030 San Prospero, Modena
Italy
Manufacturer 1:
Farmea
Rue Bouché Thomas, 10
ZAC D'Orgemont
49007 Angers Cedex
France
This medicinal product is authorised in the Member States of the EEA under the following
names:
Portugal
Germany
France
Spain

Diltiazem HCl ADOH 200 mg, cápsulas duras de libertação prolongada
Diltiazem HCl ADOH 300 mg, cápsulas duras de libertação prolongada
Diltiazem HCl ADOH 200 mg, Hartkapseln, retardiert
Diltiazem HCl ADOH 300 mg, Hartkapseln, retardiert
Diltiazem HCl ADOH 200 mg, gélules à libération prolongée
Diltiazem HCl ADOH 300 mg, gélules à libération prolongée
Diltiazem HCl ADOH 200 mg, cápsulas de liberación prolongada, duras
Diltiazem HCl ADOH 200 mg, cápsulas de liberación prolongada, duras

This leaflet does not contain all the information about your medicine. If you have any questions
or are not sure about anything, ask your doctor or pharmacist.
This leaflet was last revised in 08/2012

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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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