Tanatril 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Imidapril hydrochloride

Available from:

Northumbria Pharma Ltd

ATC code:

C09AA16

INN (International Name):

Imidapril hydrochloride

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050501; GTIN: 5028613001882

Patient Information leaflet

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PACKAGE LEAFLET:
INFORMATION FOR

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tanatril 10 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Imidapril hydrochloride 10 mg
Excipient with known effect:
Lactose, 72 mg per tablet
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablets
Off-white oblong biconvex tablets with a plane edge, scored on both
sides.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tanatril is indicated for the treatment of essential hypertension in
adults.
(See sections 4.3, 4.4, 4.5 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology- _Adults_
Treatment should be initiated with 5 mg once a day.
If optimum control of blood pressure has not been achieved after at
least 3 weeks of
treatment, the daily dose should be increased to 10 mg, which has been
determined to
be the most effective daily dose.
However, in a small number of patients it might be necessary to
increase the daily
dose to 20 mg (recommended maximum dose) or preferably, to consider
combination
therapy with a diuretic.
It has not been assessed whether hypertensive patients would benefit
from a
combination of imidapril with other antihypertensive therapies.
(See sections 4.3, 4.4, 4.5 and 5.1).
- _Older People_ (65 years or older)
The initial dose is 2.5 mg once a day. The dose should be titrated
according to blood
pressure response. The recommended maximum dose is 10 mg once a day.
- _Patients with renal impairment_
Imidapril and its pharmacologically active metabolite, imidaprilat,
are predominantly
excreted via the kidney.
Renal function should be evaluated before commencing therapy with
imidapril in
patients suspected of renal impairment.
Creatinine clearance may be determined prior to treatment by using the
formula of
COCKROFT & GAULT (Nephron 1976; 16: 31-41):
Cl Crea = (140-age [years]) x body weight [kg]
72 x serum creatinine [mg/dl]
(for women the resulting value will be multiplied with 0.85; if the
unit
μ
mol/l is used
instead of mg/dl, 72 will be repl