Pindolol 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Pindolol

Available from:

A A H Pharmaceuticals Ltd

ATC code:

C07AA03

INN (International Name):

Pindolol

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02040000; GTIN: 5025903003267

Patient Information leaflet

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20 Jan 2019
Pindolol 5mg x 100
Label Leaflet
1610320
457773
1610320
04569/0118
Gerard
LL0430AF
124
N/A
360149 P3
4
United Kingdom
N/A
5016695160078
4
Black
Myriad Pro
52 x 101 mm
7.5pt
4pt
Min text size
Keyline
2/40
2
PINDOLOL 5 MG
TABLETS
100 TABLETS
5
MG
EACH TABLET CONTAINS: Pindolol 5 mg.
DOSAGE: Oral Use. Read the package leaflet
before use.
DO NOT TAKE THIS MEDICINE
IF YOU HAVE A HISTORY OF WHEEZING OR
ASTHMA. KEEP OUT OF THE SIGHT AND REACH
OF CHILDREN. Store below 25˚C. Store in the
original package in order
to protect from light.
PL 04569/0118
POM
Mylan, Potters Bar, Herts,
EN6 1TL, U.K.
LL0430AF
1610320
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Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Pindolol 5 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg pindolol.
For the full list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White, flat bevelled edged tablet, marked “PL” breakline “5”
on one side of the tablet
and “G” on the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicine is indicated in adults for the treatment of
essential hypertension. It is also
used as a prophylactic treatment of angina pectoris.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
Essential hypertension: Initially one 5 mg tablet two or three times a
day. According to the
response of the patient the dose may be increased at weekly intervals
to a maximum of 45 mg
given in divided doses twice or three times daily.
Once daily dosage schedule: Further work shows that many patients
respond to a once daily
dosage regime. Initially 15 mg (3 tablets) should be taken once a day
with breakfast and
adjusted according to individual response up to a maximum of 45 mg (9
tablets). Most
patients respond to a once daily dose of between 15-30 mg (3-6
tablets).
The onset of action of this medicine is usually rapid, with most
patients showing a response
within the first one to two weeks of treatment. However, the maximum
response may take
several weeks to develop.
Prophylactic treatment of
Angina pectoris: Usually 2.5 mg to 5 mg of Pindolol three times a
day according to response. It reduces the frequency and severity of
anginal attacks and
increases work capacity.
_Elderly patients_
No evidence exists that elderly patients require different dosages or
show different side-
effects from younger patients.
Paediatric population
The safety and efficacy of this medicine in children has not been
established. Pindolol tablets
are therefore not recommended for use in children.
Method of administration
For oral administration only.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to an