Adizem-SR 180mg capsules

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Diltiazem hydrochloride
Available from:
Mawdsley-Brooks & Company Ltd
ATC code:
C08DB01
INN (International Name):
Diltiazem hydrochloride
Dosage:
180mg
Pharmaceutical form:
Modified-release capsule
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Caution - AMP level prescribing advised
Product summary:
BNF: 02060200

1109-6

Adizem

®

-SR 90 mg, 120 mg and 180 mg

prolonged-release capsules

Diltiazem hydrochloride

Package Leaflet: Information for the user

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 any get side talk with your doctor.This includes

any possible side effects not listed in this leaflet.See

section 4.

What is in this leaflet:

What

Adizem-SR

capsules are and what they are

used for

What you need to know before you take

Adizem-SR

capsules

How to take

Adizem-SR

capsules

4. Possible side effects

How to store

Adizem-SR

capsules

Contents of the pack and other information

1.

What Adizem-SR capsules are and what

they are used for

These capsules have been prescribed for you to

treat angina (chest pain caused by a reduction of

oxygen to the heart muscle) or high blood pressure

(hypertension). They contain the active ingredient

diltiazem. Diltiazem belongs to a group of medicines

called calcium antagonists. Calcium antagonists

help more blood to reach the heart and reduce

blood pressure. The other ingredients of

Adizem-SR

capsules are listed in section 6 of this leaflet.

Adizem-SR capsules are designed to work properly

over 12 hours. If the capsules are crushed or

chewed, the entire 12‑hour dose may be absorbed

rapidly into your body. This can be dangerous,

causing serious problems such as an overdose.

2.

What you need to know before you take

Adizem-SR capsules

Do not take Adizem-SR capsules if you:

are allergic (hypersensitive) to diltiazem or any of

the other ingredients of the capsules (see section 6

‘Further Information’);

have a slow or irregular heart beat;

have heart failure (which can cause shortness of

breath or ankle swelling).

Children should not take these capsules.

Warnings and precautions

Talk to your doctor or pharmacist before taking these

tablets if you:

have liver or kidney problems as your doctor may

monitor you more closely;

have porphyria (a rare disease of the blood pigments);

have bowel problems.

Other medicines and Adizem-SR capsules

Please tell your doctor or pharmacist if you are taking,

have recently taken or might take any other medicines,

including medicines obtained without a prescription.

If you take

Adizem-SR

capsules with some other

medicines, the effect of

Adizem-SR

capsules or the other

medicine may be changed.

Tell your doctor or pharmacist if you are taking:

any other medicines for high blood pressure, such

as beta blockers (for example atenolol), diuretics

(for example bendrofluazide) or ACE inhibitors

(examples include captopril and enalopril);

medicines known as alpha blockers, which you may

be taking to treat high blood pressure or prostate

disorders (for example prazosin);

any medicines which may cause low blood pressure

or slow heart beat (for example aldesleukin to treat

cancer of the kidneys, or antipsychotics to treat

mental and behavioural disorders);

ivabradine to treat angina;

anti-arrhythmic medicines to treat an irregular or

rapid heart beat (for example digoxin, amiodarone or

beta-blockers);

cilostazol to treat intermittent claudication (a

condition that causes leg pain due to a restriction in

blood supply to the muscles);

medicines known as statins to reduce cholesterol

levels in your blood (examples include simvastatin,

atorvastatin or lovastatin);

medicines known as H

antagonists to treat stomach

ulcers, indigestion or heartburn, such as cimetidine or

ranitidine;

carbamazepine or phenytoin to treat seizures, fits or

convulsions;

medicines known as benzodiazepines to treat anxiety

or help you sleep (examples include midazolam or

triazolam);

medicines known as barbiturates to either treat fits or

to help you sleep (examples include phenobarbital or

primidone);

antidepressants known as tricyclic antidepressants

(examples include amitriptyline or imipramine) or

lithium;

rifampicin to treat tuberculosis;

ciclosporin, sirolimus or tacrolimus to prevent organ

transplant rejection or treat other immune system

disorders;

a specific type of medicine known as a protease

inhibitor to treat HIV (examples include atazanavir or

ritonavir);

dantrolene (a muscle relaxant);

theophylline to treat breathing problems such as

asthma;

medicines known as nitrate derivatives to treat angina

or high blood pressure (examples include glyceryl

trinitrate or isosorbide mononitrate);

medicines for inflammation or allergies, known as

steroids (for example methylprednisolone).

If you are having a general anaesthetic, tell your doctor

that you are taking these capsules.

Adizem-SR capsules with alcohol

Do not take

Adizem-SR

capsules at the same time as an

alcoholic drink.

Pregnancy, breastfeeding and fertility

Do not take

Adizem-SR

capsules if you are pregnant,

likely to become pregnant or are breastfeeding.

Ask your doctor or pharmacist for advice before taking

any medicine.

Driving and using machines

The capsules may cause a number of side effects such as

dizziness and a general feeling of being unwell. These

could affect your ability to drive (see section 4 for a full

list of side effects) and are usually most noticeable when

you start taking the capsules, or when changing to higher

dose. If you are affected you should not drive or operate

machinery.

Adizem-SR capsules contain sucrose.

These capsules contain sucrose which is a form of sugar.

If you have been told by your doctor that you have an

intolerance to some sugars, contact your doctor before

taking these capsules.

3.

How to take Adizem-SR capsules

Always take

Adizem-SR

capsules exactly as your doctor

has told you. The label on your medicine will tell you

how many capsules to take and how often.

Adults (over 18 years of age)

If you are taking these capsules to treat angina the usual

starting dose is one 90 mg capsule every 12 hours.

If you are taking these capsules to lower your blood

pressure then the usual dose is one 120 mg capsule every

12 hours. However, if you are elderly or have kidney

or liver problems then you may need to start on a lower

dose. Your doctor will decide how many capsules you

should take.

Children

Children should not take these capsules.

Do not exceed the dose recommended by your doctor.

You should check with your doctor or pharmacist if you

are not sure.

350x148mm (LSN-NAPP-02) (L) V1

1109-6

This leaflet is also available in large print, Braille or as

an audio CD. To request a copy, please call the RNIB

Medicine Information line (free of charge) on:

0800 198 5000

You will need to give details of the product name and

reference number.

These are as follows:

Product name:

Adizem-SR

prolonged-release capsules

Reference number: 16950/0006

Swallow your capsules whole with a glass of water.

Do

not chew or crush the capsules

You should take your capsules every 12 hours. For

instance, if you take a capsule at 8 o’clock in the

morning, you should take your next capsule at 8 o’clock

in the evening.

If you take more Adizem-SR capsules than you should

or if someone accidentally swallows your capsules

Call your doctor or hospital straight away. People who

have taken an overdose may become very unwell, feel

faint, have a slow heart beat and lose consciousness. They

may need emergency treatment in hospital. When seeking

medical attention make sure that you take this leaflet and

any remaining capsules with you to show to the doctor.

If you forget to take Adizem-SR capsules

If you remember within 4 hours of the time your capsule

was due, take your capsule straight away. Take your next

capsule at your normal time. If you are more than 4 hours

late, please call your doctor or pharmacist for advice. Do

not take a double dose to make up for a forgotten capsule.

If you stop taking Adizem-SR capsules

You should not stop taking these capsules unless your

doctor tells you to. If you want to stop taking your

capsules, discuss this with your doctor first.

If you have any further questions on the use of

Adizem-SR

capsules ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines,

Adizem-SR

capsules can cause side

effects, although not everybody gets them.

Look out for the following severe allergic reactions. They

have occurred in a small number of people, although their

exact frequency cannot be estimated:

swelling of the face or throat;

skin rash or itching especially those covering your

whole body, severe flaking, blistering or peeling of the

skin, with or without a fever.

Tell your doctor immediately if you get any of these.

Very common side effects

(May affect more than 1 in 10

people)

Swelling of the hands, ankles or feet.

Common side effects

(May affect more than 1 in 100

people)

Feeling sick, abdominal pain, indigestion, constipation.

Dizziness, headache.

Flushing or redness of the skin, itching.

A fast, slow or irregular heartbeat.

Generally feeling unwell.

Tiredness.

Uncommon side effects

(May affect up to 1 in 100 people)

Diarrhoea, being sick.

A feeling of faintness, especially on standing up.

Nervousness.

Difficulty in sleeping.

A worsening in liver function tests (seen in a blood test).

Rare side effects

(May affect up to 1 in 1000 people)

Dry mouth.

Hives.

Frequency not known

(frequency can not be estimated

from the available data)

Heart failure which can cause shortness of breath or

ankle swelling.

Inflammation of the liver.

Changes in muscle tone and/or abnormalities of

movement.

Mood changes, including depression.

Skin problems such as an increased sensitivity to

sunlight.

A reduction in blood platelets which increases the risk

of bleeding or bruising.

Breast enlargement in men.

Bleeding, tender or enlarged gums.

Inflammation of blood vessels (often with skin rash).

Sweating.

Low blood pressure.

You may see the remains of the capsules in your faeces.

This should not affect how the capsules work.

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 Adizem-SR capsules

Keep out of the sight and reach of children.

Do not use any capsules after the expiry date which is stated

on the carton. EXP 08 2020 means that you should not take the

capsules after the last day of that month i.e. August 2020.

Do not store your capsules above 25ºC.

Do not take your capsules if they are broken or crushed as

this can be dangerous and can cause serious problems such as

overdose.

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 to protect the

environment.

6.

Contents of the pack and other information

What Adizem-SR capsules contain

The active ingredient is diltiazem hydrochloride. Each capsule

contains 90 mg, 120 mg or 180 mg of diltiazem hydrochloride.

The other ingredients are:

Sucrose

Maize starch

Povidone

Ethylcellulose

Talc

Aquacoat ECD 30

Dibutyl sebacate

Gelatin

Titanium dioxide (E171)

The capsules also contain the following colourants:

120 mg – Iron oxide (E172) and indigo carmine (E132)

180 mg – Iron oxide (E172)

What Adizem-SR capsules look like and the contents of

the pack

Adizem-SR

capsules are marked with the strength

(e.g.90 mg, 120 mg etc.) and coloured as follows:

90 mg – white, 120 mg – white/brown,

180 mg –white/pale brown.

The capsules are packed in blister packs and then boxed in

cardboard cartons. In each carton there are 56 capsules.

Marketing Authorisation Holder

Napp Pharmaceuticals Limited,

Cambridge Science Park, Milton Road,

Cambridge CB4 0GW, UK.

Manufacturer

Bard Pharmaceuticals Limited,

Cambridge Science Park, Milton Road,

Cambridge CB4 0GW, UK.

This leaflet was last revised in January 2017

Adizem

and the NAPP logo are registered trade marks.

© 2008-2016 Napp Pharmaceuticals Limited.

350x148mm (LSN-NAPP-02) (L) V1

ADIZEM SR CAPS PIL UK 1109-6 V1.indd 3

07/03/2017 13:24

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

ADIZEM-SR capsules 180 mg.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains 180 mg diltiazem hydrochloride.

Excipients: also contains sucrose 36.53 mg per capsule.

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Prolonged release capsules

Capsules with white bodies and pale brown caps marked "180 mg" containing

prolonged release microgranules.

4.1

Therapeutic indications

For the management of angina pectoris.

For the treatment of mild to moderate hypertension.

ADIZEM-SR capsules are indicated for use in adults only.

4.2

Posology and method of administration

Posology

Angina

Adults:

The usual initial dose is 90 mg twice daily. Dosage may be increased gradually to

120 mg twice daily or 180 mg twice daily if required. Patients’ responses may vary

and dosage requirements can differ significantly between individual patients.

Elderly and patients with impaired renal or hepatic function:

In the elderly, dosage should commence at 60 mg diltiazem hydrochloride twice daily

and the dose carefully titrated as required.

Hypertension:

Adults:

The usual dose is one ADIZEM-SR 120 tablet or capsule twice daily. Patients may

benefit by titrating from a lower total daily dose.

Elderly and patients with impaired renal or hepatic function:

The starting dose should be 60 mg diltiazem hydrochloride twice daily, increasing to

one ADIZEM-SR 90 mg capsule twice daily and then to one ADIZEM-SR 120 mg

tablet or capsule twice daily if clinically indicated.

Paediatric population:

The ADIZEM preparations are not recommended for children. Safety and efficacy in

children has not been established.

Method of administration

Oral.

To be taken at 12 hour intervals.

Dosage may be taken with or without food, and should be swallowed whole and not

chewed.

In order to avoid confusion, it is suggested that patients once titrated to an effective

dose using either ADIZEM-SR tablets or capsules should remain on this treatment

and should not be changed between different presentations.

ADIZEM-SR capsules should not be taken at the same time as an alcoholic beverage

(see section 4.5).

4.3

Contraindications

Hypersensitivity to diltiazem or to any of the excipients.

Pregnancy and in women of child bearing capacity.

Patients with severe bradycardia (less than 40 bpm), second or third degree heart

block, sick sinus syndrome, decompensated cardiac failure, patients with left

ventricular failure with pulmonary congestion.

Concurrent use with dantrolene infusion because of the risk of ventricular fibrillation

(see section 4.5).

4.4

Special warnings and precautions for use

The product should be used with caution in patients with reduced left ventricular

function. Patients with bradycardia (risk of exacerbation), first degree AV

block or prolonged PR interval should be observed closely.

Diltiazem is considered unsafe in patients with acute porphyria.

Prior to general anaesthesia, the anaesthesist must be informed of ongoing

diltiazem treatment. Depression of cardiac contractility, conductivity and

automaticity, as well as the vascular dilatation associated with anaesthetics

may be potentiated by calcium channel blockers.

Increase of plasma concentrations of diltiazem may be observed in the elderly

and in patients with renal or hepatic insufficiency. The contraindications and

precautions should be carefully observed and close monitoring, particularly of

heart rate, should be carried out at the beginning of treatment.

Calcium channel blocking agents, such as diltiazem, may be associated with

mood changes, including depression.

Like other calcium channel antagonists, diltiazem has an inhibitory effect on

intestinal motility. Therefore it should be used with caution in patients at risk

to develop an intestinal obstruction. Tablet residues from slow release

formulations of the product may pass into the patient’s stools; however, this

finding has no clinical relevance.

Patients with rare hereditary problems of fructose intolerance, glucose-

galactose malabsorption or sucrase-isomaltase insufficiency should not take

this medicine.

4.5

Interaction with other medicinal products and other forms of interaction

Concomitant use contraindicated:

Dantrolene (infusion): Lethal ventricular fibrillation is regularly observed in

animals when intravenous verapamil and dantrolene are administered

concomitantly. The combination of a calcium antagonist and dantrolene is

therefore potentially dangerous (see section 4.3).

Concomitant use requiring caution:

Lithium: Risk of increase in lithium-induced neurotoxicity.

Nitrate derivatives: Increased hypotensive effects and faintness (additive

vasodilatating effects): In all the patients treated with calcium antagonists, the

prescription of nitrate derivatives should only be carried out at gradually

increasing doses.

Theophylline: Increase in circulating theophylline levels.

Alpha-antagonists: Increased antihypertensive effects:

Concomitant treatment with alpha-antagonists may produce or aggravate

hypotension. The combination of diltiazem with an alpha-antagonist should be

considered only with the strict monitoring of the blood pressure.

Amiodarone, digoxin: Increased risk of bradycardia:

Caution is required when these are combined with diltiazem, particularly in elderly

subjects and when high doses are used. Diltiazem hydrochloride may cause small

increases in plasma levels of digoxin, requiring careful monitoring of AV conduction.

Beta-blockers: Possibility of rhythm disturbances (pronounced bradycardia, sinus

arrest), sino-atrial and atrio-ventricular conduction disturbances and heart failure

(synergistic effect). Patients with pre-existing conduction defects should not receive

the combination of diltiazem and beta-blockers. Such a combination must only be

used under close clinical and ECG monitoring, particularly at the beginning of

treatment.

Other antihypertensive drugs: Enhanced antihypertensive effect may occur with

concomitant use of other antihypertensive drugs (e.g. beta-blockers, diuretics, ACE-

inhibitors) or drugs that cause hypotension such as aldesleukin and antipsychotics.

Other antiarrhythmic agents:

Since diltiazem has antiarrhythmic properties, its concomitant prescription

with other antiarrhythmic agents is not recommended (additive risk of

increased cardiac adverse effects). This combination should only be used

under close clinical and ECG monitoring.

Carbamazepine: Increase in circulating carbamazepine levels:

It is recommended that the plasma carbamazepine concentrations be assayed

and that the dose should be adjusted if necessary.

Rifampicin: Risk of decrease of diltiazem plasma levels after initiating therapy

with rifampicin: The patient should be carefully monitored when initiating or

discontinuing rifampicin treatment.

Anti-H

agents (cimetidine, ranitidine): Increase in plasma diltiazem concentrations.

Patients currently receiving diltiazem therapy should be carefully monitored when

initiating or discontinuing therapy with anti-H

agents. An adjustment in diltiazem

daily dose may be necessary.

Protease inhibitors (atazanavir, ritonavir): Increase in plasma diltiazem

concentrations.

Ciclosporin: Increase in circulating cyclosporin levels:

It is recommended that the cyclosporin dose be reduced, renal function be

monitored, circulating cyclosporin levels be assayed and that the dose should

be adjusted during combined therapy and after its discontinuation.

General information to be taken into account:

Due to the potential for additive effects, caution and careful titration are

necessary in patients receiving diltiazem concomitantly with other agents

known to affect cardiac contractility and/or conduction.

Diltiazem is metabolized by CYP3A4. A moderate (less than 2-fold) increase of

diltiazem plasma concentration in cases of co-administration with a stronger CYP3A4

inhibitor has been documented. Diltiazem is also a CYP3A4 isoform inhibitor.

Co-administration with other CYP3A4 substrates may result in an increase in plasma

concentration of either co-administered drug (e.g. cilostazol, ivabradine, sirolimus,

tacrolimus). Care should be exercised in patients taking these drugs. Concomitant use

of diltiazem with cilostazol and ivabradine should be avoided.

Co-administration of diltiazem with a CYP3A4 inducer may result in a

decrease of diltiazem plasma concentrations.

Barbiturates (phenobarbital, primidone): serum levels of diltiazem may be decreased

by concomitant usage of CYP3A4 inducers.

Phenytoin: serum levels of diltiazem may be decreased by concomitant usage of

CYP3A4 inducers. Diltiazem may increase serum levels of phenytoin.

Benzodiazepines (midazolam, triazolam): Diltiazem significantly increases

plasma concentrations of midazolam and triazolam and prolongs their half-

life. Special care should be taken when prescribing short-acting

benzodiazepines metabolized by the CYP3A4 pathway in patients using

diltiazem.

Diltiazem may increase bioavailability of tricyclic antidepressants.

Corticosteroids (methylprednisolone): Inhibition of methylprednisolone

metabolism (CYP3A4) and inhibition of P-glycoprotein: The patient should be

monitored when initiating methylprednisolone treatment. An adjustment in the

dose of methylprednisolone may be necessary.

Statins (simvastatin, atorvastatin, lovastatin): Diltiazem is an inhibitor of CYP3A4

and has been shown to significantly increase the AUC of some statins. The risk of

myopathy and rhabdomyolysis due to statins metabolised by CYP3A4 may be

increased with concomitant use of diltiazem. When possible, a non

CYP3A4-metabolised statin should be used together with diltiazem, otherwise close

monitoring for signs and symptoms of a potential statin toxicity is required.

ADIZEM-SR capsules should not be taken at the same time as alcohol, as it may

increase the rate of release of diltiazem from the prolonged release preparation. In

addition the combination of alcohol and diltiazem may have an additive vasodilatory

effect.

4.6

Fertility, pregnancy and lactation

Pregnancy

There is very limited data from the use of diltiazem in pregnant patients.

Diltiazem has been shown to have reproductive toxicity in certain animal

species (rat, mice, rabbit). Diltiazem is contraindicated during pregnancy (see

section 4.3), as well as in women of child-bearing potential not using effective

contraception.

Breast-feeding

Diltiazem is excreted in breast milk at low concentrations. Breast-feeding while

taking this drug should be avoided. If use of diltiazem is considered medically

essential, an alternative method of infant feeding should be instituted.

4.7

Effects on ability to drive and use machines

Diltiazem has been reported to cause adverse reactions such as dizziness

(common) and malaise (common), which may impair patients’ ability to drive or

operate machinery to a varying extent depending on the dosage and individual

susceptibility. However, no studies have been performed. Therefore, patients

should not drive or operate machinery if affected.

4.8

Undesirable effects

The following frequencies are the basis for assessing undesirable effects:

Very common (

1/10); common (

1/100 to <1/10); uncommon (

1/1,000 to <1/100);

rare (

1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated

from the available data).

Very

common

Common

Uncommon

Rare

Not known

Blood and

lymphatic

system

disorders

Thrombocytopenia

Immune system

disorders

Hypersensitivity

Psychiatric

disorders

Nervousness,

insomnia

Mood changes

(including

depression)

Nervous system

disorders

Headache,

dizziness

Extrapyramidal

syndrome

Cardiac

disorders

Atrioventricular

block (may be

of first, second

or third degree;

bundle branch

block may

occur),

palpitations

Bradycardia

Sinoatrial block,

congestive heart

failure

Vascular

disorders

Flushing

Orthostatic

hypotension

Vasculitis (including

leukocytoclastic

vasculitis), hypotension

Gastrointestinal

disorders

Constipation,

dyspepsia,

gastric pain,

nausea

Vomiting,

diarrhoea

mouth

Gingival hyperplasia

Hepatobiliary

disorders

Hepatic

enzymes

increase (AST,

ALT, LDH,

ALP increase)

Hepatitis

Very

common

Common

Uncommon

Rare

Not known

Skin and

subcutaneous

tissue disorders

Erythema,

pruritus

Urticaria

Photosensitivity

(including lichenoid

keratosis at sun exposed

skin areas),

angioneurotic oedema,

rash, erythema

multiforme (including

Steven-Johnson's

syndrome and toxic

epidermal necrolysis),

hyperhidrosis,

exfoliative dermatitis,

acute generalized

exanthematous

pustulosis, desquamativ

erythema with or

without fever, allergic

dermatitis

Reproductive

system and

breast

disorders

Gynaecomastia

General

disorders and

administration

site conditions

Peripheral

oedema

Malaise, fatigue

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is

important. It allows continued monitoring of the benefit/risk balance of the medicinal

product. Healthcare professionals are asked to report any suspected adverse reactions

via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9

Overdose

The clinical effects of acute overdose can involve pronounced hypotension possibly

leading to collapse, sinus bradycardia with or without isorhythmic dissociation and

atrioventricular conduction disturbances.

Treatment, in a hospital setting, will include gastric lavage and/or osmotic diuresis.

Conduction disturbances may be managed by temporary cardiac pacing.

Proposed corrective treatments: atropine, vasopressors, inotropic agents, glucagon

and calcium gluconate infusion.

Symptomatic bradycardia and high grade atrioventricular block may respond to

atropine and isoprenaline.

The formulation employs a prolonged release system which will continue to release

diltiazem for some hours.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic Properties

Pharmacotherapeutic group: Selective calcium channel blocker with direct

cardiac effects.

ATC Code: C08D B01

Diltiazem is an antianginal agent and calcium antagonist. Diltiazem inhibits

transmembrane calcium entry in myocardial muscle fibres and in vascular

smooth muscle fibres, thereby decreasing the quantity of intracellular calcium

available to the contractile proteins.

5.2.

Pharmacokinetic Properties

ADIZEM-SR

capsules

form

characterised

prolonged

release

diltiazem hydrochloride in the digestive tract. Diltiazem is 80% bound to

human plasma proteins (albumin, acid glucoproteins).

The biotransformation routes are:

Deacetylation

Oxidative o- and n-demethylation

Conjugation of the phenolic metabolites.

The primary metabolites, N-demethyldiltiazem and desacetyldiltiazem exert

less

pharmacological

activity

than

diltiazem.

other

metabolites

pharmacologically inactive.

After administration of 180 to 300 mg of ADlZEM-SR Capsules, a peak

plasma concentration of 80 to 220 ng/ml, respectively, is obtained after about

5.5 hours.

The elimination half-life varies from 6 to 8 hours, depending on the strength.

5.3.

Preclinical Safety Data

There

pre-clinical

data

relevance

prescriber

which

additional to that already included in other sections of the SPC.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients

Capsule contents

Sucrose and maize starch SP microgranules

Povidone

Sucrose

Ethylcellulose

Talc

Aquacoat ECD 30

Dibutyl sebacate

Capsule shells

Titanium dioxide (E171)

Gelatine

Iron oxide (E172)

6.2.

Incompatibilities

None known.

6.3.

Shelf Life

Three years.

6.4.

Special Precautions for Storage

Do not store above 25°C.

6.5.

Nature and Contents of Container

Blister packs (aluminium/PVC) boxed in cardboard cartons.

Pack Sizes: 28, 30, 56,60 capsules (and a sample pack containing up to 8

capsules).

6.6.

Instructions for Use/Handling

Not applicable

ADMINISTRATIVE DATA

MARKETING AUTHORISATION HOLDER

Napp Pharmaceuticals Ltd

Cambridge Science Park

Milton Road

Cambridge

CB4 0GW

8.

MARKETING AUTHORISATION NUMBER(S)

PL 16950/0008

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF

AUTHORISATION

02 October 1992 / 23 September 2003

10

DATE OF REVISION OF THE TEXT

22/03/2017

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