TANATRIL TABLETS 5 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

IMIDAPRIL HCl

Available from:

MITSUBISHI TANABE PHARMA SINGAPORE PTE. LTD.

ATC code:

C09AA16

Dosage:

5 mg

Pharmaceutical form:

TABLET

Composition:

IMIDAPRIL HCl 5 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

PT Mitsubishi Tanabe Pharma Indonesia

Authorization status:

ACTIVE

Authorization date:

1999-01-06

Summary of Product characteristics

1
03-7-2023
SELECTIVE ANGIOTENSIN-CONVERTING ENZYME INHIBITOR
TANATRIL
® TABLETS 5 MG
TANATRIL
® TABLETS 10 MG
(IMIDAPRIL HYDROCHLORIDE)
Caution: Use only pursuant to the prescription or directions of a
physician, etc.
Storage
Store at below 30° C. Avoid humidity after opening.
Expiration date
Indicated on the package and container.
CONTRAINDICATIONS (TANATRIL IS CONTRAINDICATED IN THE FOLLOWING
PATIENTS.)
1) Patients with a history of hypersensitivity to any of the
ingredients of the drug.
2) Patients with a history of angioedema (Angioedema due to drug such
as angiotensin
converting enzyme (ACE) inhibitors, etc., hereditary angioedema,
acquired angioedema,
idiopathic angioedema, etc.) [Angioedema associated with dyspnea may
occur.]
3) Patients undergoing apheresis by an adsorber using dextran sulfate
immobilized cellulose,
tryptophan immobilized poly-vinyl alcohol or polyethylene
terephthalate [shock may occur.] (See
PRECAUTIONS - " Drug Interactions" section.)
4) Patients who undergo hemodialysis with acrylonitrile methallyl
sulfonate sodium membrane
(AN69
®
) [ Anaphylactoid symptom may occur.] (See PRECAUTIONS - Drug
Interactions.)
5) Pregnant women or women who may possibly be pregnant. [See
PRECAUTIONS – Use In
Patients with Reproductive Potential.]
6) Patients with diabetes mellitus or renal impairment (GFR < 60
ml/min/1.73 m
2
) being treated
with aliskiren fumarate (excluding patients with markedly uncontrolled
blood pressure even after
antihypertensive treatment with other drugs) [Increased risk for
nonfatal stroke, renal impairment,
hyperkalemia, and hypotension have been reported.] (See" Important
Precautions" section.)
7) Patients receiving sacubitril valsartan sodium hydrate or patients
within 36 hours of
discontinuation of the drug [Angioedema may occur.] (See “Drug
Interactions” section)
DESCRIPTION
Brand name
TANATRIL
Tablets 5mg
TANATRIL
Tablets 10 mg
Active ingredient (per tablet)
Imidapril hydrochloride
5mg
per tablet
10 mg
per tablet
Dosage form
Plain tablets
Color
White
Appearance