Tildiem 60mg modified-release tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Diltiazem hydrochloride

Dostupné z:

Sigma Pharmaceuticals Plc

ATC kód:

C08DB01

INN (Medzinárodný Name):

Diltiazem hydrochloride

Dávkovanie:

60mg

Forma lieku:

Modified-release tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Caution - AMP level prescribing advised

Prehľad produktov:

BNF: 02060200

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
TILDIEM® 60MG MODIFIED-RELEASE TABLETS
(diltiazem hydrochloride)
The name of your medicine is Tildiem 60mg Modified-Release Tablets,
but will be referred to as Tildiem throughout the remainder of the
leaflet.
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 possible side effects not listed in this leaflet. See section
4.
WHAT IS IN THIS LEAFLET:
1. What Tildiem is and what it is used for
2. What you need to know before you take Tildiem
3. How to take Tildiem
4. Possible side effects
5. How to store Tildiem
6. Contents of the pack and other information
1. WHAT TILDIEM IS AND WHAT IT IS USED FOR
Tildiem contains a medicine called diltiazem hydrochloride. This
belongs
to a group of medicines called ‘calcium-channel blockers’. It
works by
making your blood vessels wider, which makes it easier for your heart
to
pump blood around the body. This helps to prevent the chest pain
caused by angina.
TILDIEM IS USED FOR:
•
Angina (chest pain)
•
Stopping you getting angina in the future
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TILDIEM
DO NOT TAKE THIS MEDICINE IF:
•
You are allergic (hypersensitive) to diltiazem hydrochloride or any of
the other ingredients of Tildiem (listed in section 6).
•
Signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat or tongue.
•
You are breast-feeding or planning to breast-feed (see below:
‘Pregnancy and breast-feeding’).
•
You are having a medicine called dantrolene used for severe
muscle spasms or severe fever (see below: ‘Other medicines and
T

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tildiem 60mg Modified-Release Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 60 mg of the active substance diltiazem
hydrochloride.
Also contains: 125.5 mg of lactose monohydrate and 28 mg of
hydrogenated
castor oil.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Modified release tablet.
White, round, biconvex tablets engraved with`TILDIEM 60' or `DILT 60'
or
`DTZ
60' on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis and treatment of Angina Pectoris
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults
The usual dose is one tablet (60 mg) three times daily. However,
patient
responses may vary, and dosage requirements can differ significantly
between
individual patients. If necessary, the divided dose may be increased
to
360mg/day. Higher doses up to 480mg/day have been used with benefit in
some patients especially in unstable angina. There is no evidence of
any
decrease in efficacy at these high doses.
Elderly and patients with impaired hepatic or renal function
The recommended starting dose is one tablet (60 mg) twice daily. The
heart rate should be measured regularly in these groups of patients
and the
dose should not be increased if the heart rate falls below 50 beats
per minute.
Paediatric population
Safety and efficacy in children have not been established. Therefore,
diltiazem
is not recommended for use in children.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to diltiazem or to any of the excipients listed in
section
6.1.
•
Sick sinus syndrome, 2nd or 3rd degree AV block in patients without a
functioning pacemaker.
•
Severe bradycardia (less than 50 beats per minute). Left ventricular
failure
with pulmonary stasis.
•
Lactation.
•
Concurrent use with dantrolene infusion (see section 4.5).
•
Combination with ivabradine (see section 4.5).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients with rare hereditary problems of galactose intolerance, the
Lapp
lactase defi