Valni XL 60mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nifedipine

Available from:

Zentiva Pharma UK Ltd

ATC code:

C08CA05

INN (International Name):

Nifedipine

Dosage:

60mg

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Caution - AMP level prescribing advised

Product summary:

BNF: 02060200; GTIN: 5000283605508

Patient Information leaflet

FPO
FPO
Front Back
PATIENT INFORMATION LEAFLET
VALNI XL 30MG & 60MG PROLONGED RELEASE TABLETS
Nifedipine
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 get serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist (See section 4).
In this leaflet:
1. What VALNI XL is and what it is used for
2. Before you take VALNI XL
3. How to take VALNI XL
4. Possible side effects
5. How to store VALNI XL
6. Contents of the pack and other information
1. WHAT VALNI XL IS AND WHAT IT IS USED FOR
VALNI XL Prolonged Release Tablets contain nifedipine
which belongs to a group of medicines called calcium-
channel blockers that act on the cardiovascular
system (the heart and blood vessels). VALNI XL has
been prescribed by your doctor to treat your high
blood pressure or to reduce the frequency of your
anginal attacks. They are called prolonged release
tablets because they are manufactured in a way
that allows the nifedipine to be released and slowly
absorbed by your body over a period of several hours.
In high blood pressure, nifedipine works by widening
the blood vessels. This creates less resistance to
the blood flow, and results in lower blood pressure,
which in turn reduces the strain on your heart.
In angina, nifedipine works by opening up the arteries
supplying the heart muscle and this allows more
blood and oxygen to reach the muscle, decreasing
the chances of angina (chest pains) occurring when
extra strain is placed upon the heart.
2. BEFORE YOU TAKE VALNI XL
Do not take VALNI XL:
•
if you are allergic to nifedipine, other calcium-channel
blockers (e.g verapamil, diltiazem or felodipine) or
any of the other ingredients of VALNI XL
•
if you have been told t

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
VALNI XL 60 mg PROLONGED RELEASE TABLETS
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release tablet contains 60 mg of nifedipine
For the full list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
Prolonged release tablet
Each pale red tablet is round and biconvex and embossed with "60" on
one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The tablets are indicated for:
-
the treatment of all grades of hypertension
-
the prophylaxis of chronic stable angina pectoris, either as
monotherapy or in
combination with a beta-blocker
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
It is recommended that each dose should be taken at approximately 24
hours
intervals i.e. at the same time each day, preferably in the morning.
_Adults:_ In mild to moderate hypertension the recommended initial
dose is one
20 mg tablet once daily. In severe hypertension and the prophylaxis of
angina
pectoris the recommended initial dose is one 30 mg tablet once daily.
The dose
may be adjusted to a maximum of 90 mg once daily.
Prophylactic anti-anginal efficacy is maintained when patients are
switched
from other calcium antagonists e.g. verapamil or diltiazem to Valni
XL. When
patients are switched from other calcium antagonists, the recommended
initial
dose is 30 mg nifedipine, once daily. Subsequent titration to a higher
dosage
should be according to clinical response.
Co-administration with CYP 3A4 inhibitors or CYP 3A4 inducers may
result
in the recommendation to adapt the nifedipine dose or not to use
nifedipine at
all (see Section 4.5).
_Elderly:_ Based on pharmacokinetic data for nifedipine. No dose
adaption in
elderly people above 65 years is necessary
_Patients with Renal Impairment:_ Based on pharmacokinetic data,
dosage
adjustments should not be required for patients with impaired renal
function
(see section 5.2).
_ _
_Paediatric population:_ The safety and efficacy of nifedipine in
children below
18 years of age has not been established.