Bisoprolol 10mg tablets

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Bisoprolol fumarate

Inapatikana kutoka:

Arrow Generics Ltd

ATC kanuni:

C07AB07

INN (Jina la Kimataifa):

Bisoprolol fumarate

Kipimo:

10mg

Dawa fomu:

Oral tablet

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 02040000

Taarifa za kipeperushi

PATIENT INFORMATION LEAFLET
SOLOC
10MG TABLETS
BISOPROLOL FUMARATE
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE THIS
MEDICINE.
Keep this leaflet. You may need to read it again. If you have any
further questions, please ask your
doctor or pharmacist. This medicine has been prescribed for you
personally and you should not
pass it on to others. It may harm them, even if their symptoms are the
same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
IN THIS LEAFLET:
1.
What Soloc
Tablets are and what they are used for.
2.
Before you take Soloc
Tablets.
3.
How to take Soloc
Tablets.
4.
Possible side effects.
5.
How to store Soloc
Tablets.
6.
Further information.
1.
WHAT SOLOC
TABLETS ARE AND WHAT THEY ARE USED FOR
Bisoprolol belongs to a class of medicines called beta-blockers, which
help slow the heart beat
and relax blood vessels. This reduces blood pressure and the heart’s
demand for oxygen, and
makes the heart more efficient at pumping blood around the body.
Bisoprolol is used to treat the following conditions:

HIGH BLOOD PRESSURE (HYPERTENSION)

CHEST PAIN (ANGINA):
Bisoprolol helps prevent or reduce chest pains which may occur when
your heart cannot get enough oxygen, such as when doing exercise

STABLE HEART FAILURE.
Bisoprolol is given as an additional treatment to other medications
for
heart failure.
2.
BEFORE YOU TAKE SOLOC
TABLETS
You should only take this medicine if your doctor tells you to.
DO NOT TAKE SOLOC TABLETS IF:
•
You have heart problems such as irregular or slow heart beats, have
heart failure (swelling of
your ankles) that suddenly becomes worse and/or may require hospital
treatment, or have
poor circulation (cramp in the legs or cold feet)
•
You have a condition in which your heart is unable to pump enough
blood to the body
•
You suffer from second or third degree heart block and do not have a
pacemaker
•
You suffer from low heart rate or your heart

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bisoprolol 10mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Bisoprolol 10 mg tablet contains 8.49 mg bisoprolol equivalent to
10 mg
bisoprolol fumarate.
Excipient with known effect_ _
Each tablet contains 130.20 mg of lactose monohydrate per tablet
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
Bisoprolol 10 mg tablets, are mottled beige, round and convex with the
following
identification markings: BI centrally above a break-line with 10
below.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Hypertension
Chronic stable angina pectoris
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage should be individually adjusted. It is recommended to start
with the
lowest possible dose. In some patients, 5 mg per day may be adequate.
The usual dose
is 10 mg once daily with a maximum recommended dose of 20 mg per day.
_Special Populations _
_Renal or liver impairment _
Adjustment of dose in patients with mild to moderate liver- or kidney
impairment is
usually not necessary. In patients with severe renal impairment
(creatinine clearance
< 20 ml/min) or severe liver impairment, the dose should not exceed 10
mg once
daily. This dosage may eventually be divided into halves.
_Elderly _
No dosage adjustment is normally required. It is recommended to start
with the lowest
possible dose.
_Paediatric population _
Bisoprolol tablets are not recommended for use in children due to a
lack of data (see
section 5.3).
_Discontinuation of treatment _
Treatment should not be stopped abruptly (see section 4.4). The dosage
should be
diminished slowly by a weekly halving of the dose.
Method of administration
Bisoprolol 10 mg tablets are for oral administration.
The tablet should be swallowed with a sufficient amount of fluid (e.g.
one glass of
water). The tablet can be taken with or without food.
4.3
CONTRAINDICATIONS
Bisoprolol is contraindicated in patients with:
-
hypersensitiv