Tildiem LA 300 capsules

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Diltiazem hydrochloride

可用日期:

Sanofi

ATC代码:

C08DB01

INN（国际名称）:

Diltiazem hydrochloride

剂量:

300mg

药物剂型:

Modified-release capsule

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Caution - AMP level prescribing advised

產品總結:

BNF: 02060200; GTIN: 5026474130604

资料单张

PACKAGE LEAFLET:
INFORMATION FOR THE USER
TILDIEM LA 200MG AND
300MG PROLONGED RELEASE
CAPSULES, HARD
Diltiazem hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE.
• 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.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours
• If any of the side effects gets serious, or if you
notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Tildiem LA is and what it is used for
2. Before you take Tildiem LA
3. How to take Tildiem LA
4. Possible side effects
5. How to store Tildiem LA
6. Further information
1. WHAT TILDIEM LA IS AND WHAT IT IS USED FOR
Tildiem LA 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.
This helps to lower your blood pressure.
It also makes it easier for your heart to pump
blood around the body. This helps to prevent
the chest pain caused by angina.
Tildiem LA is used for:
• High blood pressure
• Angina (chest pain)
2. BEFORE YOU TAKE TILDIEM LA
× You are allergic (hypersensitive) to diltiazem
hydrochloride or any of the other ingredients
of Tildiem LA (listed in Section 6 below)
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 Section below: ‘Pregnancy and breast-
feeding’)
× You are having a medicine called dantrolene
used for severe muscle spasms or severe fever
(see Section below: ‘Taking other medicines’)
× You have a very slow heartbeat - less than
50 beats per minute
× You are already taking a medicine containing
ivabradine for the treatment of certain heart
diseases
× You have heart failure and problems with
blood flow to your

产品特点

OBJECT 1
TILDIEM LA 300MG PROLONGED-RELEASE CAPSULES
Summary of Product Characteristics Updated 16-Feb-2018 | SANOFI
1. Name of the medicinal product
Tildiem LA 300mg Prolonged-Release Capsules, Hard
2. Qualitative and quantitative composition
Each capsule contains a combination of immediate-release and
prolonged-release pellets with 300mg
diltiazem hydrochloride as the active ingredient.
For a full list of excipients, see Section 6.1
3. Pharmaceutical form
Prolonged-release capsule, Hard
Opaque capsules with a white body and yellow cap, containing white to
off-white pellets.
4. Clinical particulars
4.1 Therapeutic indications
Mild to moderate hypertension and angina pectoris.
4.2 Posology and method of administration
Tildiem LA 300 is a prolonged release product for once daily dosing.
The capsules should not be crushed
or chewed but swallowed whole with water, ideally before or during a
meal. The dosage requirements
may differ in patients with angina or hypertension.
Tildiem (diltiazem hydrochloride) is available in a range of
presentations to enable dosage to be adjusted
to meet the individual requirements of the patient. Careful titration
of the dose should be considered
where appropriate, as individual patient response may vary. When
changing from one type of Tildiem
formulation to another it may be necessary to adjust the dosage until
a satisfactory response is obtained.
To ensure consistency of response once established, particularly in
the prolonged release formulations,
Tildiem LA 200 and 300 should continue to be prescribed by brand name.
ADULTS:
Angina and hypertension: The usual starting dose is Tildiem LA 200
once daily. This dose may be
increased to Tildiem LA 300 once daily, or 2 capsules of Tildiem LA
200 daily (400 mg), and if clinically
indicated a higher dose of one Tildiem LA 300 plus one Tildiem LA 200
capsule (total 500 mg) may be
considered.
ELDERLY AND PATIENTS WITH IMPAIRED HEPATIC OR RENAL FUNCTION:
Heart rate should be monitored and if it falls below 50 beats per
minute the dose should n