Parmid XL 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Felodipine

Available from:

Sandoz Ltd

ATC code:

C08CA02

INN (International Name):

Felodipine

Dosage:

10mg

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02060200

Summary of Product characteristics

PARMID XL 10 MG PROLONGED RELEASE TABLETS
Summary of Product Characteristics Updated 28-May-2015 | Sandoz
Limited
1. Name of the medicinal product
Parmid XL 10 mg Prolonged Release Tablets
2. Qualitative and quantitative composition
Each prolonged release tablet contains 10mg of felodipine.
Excipient(s) with known effect:
lactose monohydrate (92.50 mg/tablet)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged release tablets
Round, pale red to grey-red, biconvex film-coated tablet with
embossment “F10“
4. Clinical particulars
4.1 Therapeutic indications
Hypertension
Stable angina pectoris
4.2 Posology and method of administration
Posology
_Hypertension_
The dose should be adjusted individually. Treatment can be started
with 5 mg once daily. Depending on
the patient's response, the dosage can, where applicable, be decreased
to 2.5 mg or increased to 10 mg
daily. If necessary another antihypertensive agent may be added. The
standard maintenance dose is 5 mg
once daily. For a dose of 2.5 mg a medicinal product with an
appropriate strength should be used.
_Angina pectoris_
The dose should be adjusted individually. Treatment should be
initiated with 5 mg once daily and, if
needed, increased to 10 mg once daily.
_Elderly population_
Initial treatment with lowest available dose should be considered.
_Renal impairment_
Dose adjustment is not needed in patients with impaired renal
function.
_Hepatic impairment_
Patients with impaired hepatic function may have elevated plasma
concentrations of felodipine and may
respond to lower doses (see section 4.4)
For a dose of 2.5 mg a medicinal product with an appropriate strength
has to be used.
_Paediatric population_
There is limited clinical trial experience of the use of felodipine in
hypertensive paediatric patients (see
sections 5.1 and 5.2).
Method of administration
The tablets should be taken in the morning and be swallowed with
water. In order to keep the prolonged-
release properties, the tablets must not be divided, crushed or
chewed. Th