Vivacor 10mg tablets

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Bisoprolol fumarate

Tersedia dari:

Lexon (UK) Ltd

Kode ATC:

C07AB07

INN (Nama Internasional):

Bisoprolol fumarate

Dosis:

10mg

Bentuk farmasi:

Oral tablet

Rute administrasi :

Oral

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 02040000

Selebaran informasi

BISOPROLOL 5 MG AND 10 MG TABLETS
PATIENTS INFORMATION LEAFLET
This leaflet gives you some important information about your
medicine. Please read it carefully before you start taking your
medicine.
ABOUT YOUR MEDICINE
Bisoprolol Tablets are coated tablets containing either 5 mg or 10 mg
of the active ingredient Bisoprolol fumarate.
WHAT IS YOUR MEDICINE USED FOR?
Bisoprolol Tablets are used:
• to reduce high blood pressure (hypertension).
• to relieve chest pain (angina)
BEFORE YOU TAKE BISOPROLOL TABLETS
DO NOT USE BISOPROLOL TABLETS IF YOU:
• have you ever had an allergic (hypersensitive) reaction to
bisoprolol fumarate or any of the ingredients in the tablet with
symptoms of a rash, itching or difficulty breathing.
• have suffered from sudden heart failure, irregular heart beats or
a
slow heart rate
• suffer from extremely low blood pressure
• suffer from lung disease, asthma, have a family history of asthma.
• suffer from diseases which affect blood flow to your fingers and
toes e.g Raynaud’s syndrome
• have untreated adrenal gland tumour called phaeochromocytoma
• have metabolic acidosis which would be measured by a blood test
by your doctor
TAKE SPECIAL CARE WITH BISOPROLOL TABLETS
Tell your doctor or pharmacist before you start using these tablets
if you:
• suffer from any heart disease, including heart failure and angina
• suffer from bronchospasm associated with bronchial asthma and
other lung diseases
• suffer from severe kidney or liver disease
• suffer from uncontrolled diabetes
• are fasting
• having desensitisation treatment for allergies
• suffer from psoriasis or have a history of psoriasis
• have thyroid problems
• are due to go into hospital for an operation then tell your
doctor.
Treatment with Bisoprolol should not be stopped suddenly especially in
patients already with heart disease.
POM
1
4
XXXXXXX
PC NO. 3014
Very rare (affects less than 1 person in 10,000):
• irritation and redness of the eye (conjunctivitis)
• hair loss
• appearance or worsening

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Vivacor 10mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains bisoprolol as 10mg of bisoprolol fumarate.
Refer to Section 6.1 for excipients.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Description: Round, biconvex, light brown coloured, film-coated
tablets with a
scoreline on one face.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Management of hypertension.
Management of angina pectoris.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ROUTE OF ADMINISTRATION
Oral
POSOLOGY
_Adults: _The usual dose is 10mg once daily with a maximum recommended
dose of
20mg per day. In some patients 5mg per day may be adequate.
Experience of the use of bisoprolol fumarate in renal dialysis
patients is limited;
however, there is no evidence that the dosage regimen needs to be
altered.
_Elderly: _No dosage adjustment is normally required but 5mg per day
may be
adequate in some patients; as for other adults, dosage may have to be
reduced in cases
of severe renal or hepatic dysfunction.
_Children: _There is no paediatric experience with bisoprolol,
therefore its use cannot
be recommended for children.
_Renal impairment:_ In patients with final stage impairment of renal
(creatinine
clearance <20ml/min), use a maximum 10mg daily in severe renal
impairment
_Severe liver impairment:_ Maximum 10mg daily in severe liver
impairment
4.3
CONTRAINDICATIONS
As with other beta-adrenoceptor antagonists bisoprolol fumarate should
not be used
in cases of:
•
Hypersensitivity to bisoprolol fumarate or any other ingredients in
the tablet.
•
Acute heart failure or during episodes of heart failure decompensation
requiring
iv inotropic therapy.
•
Cardiogenic shock.
•
Marked bradycardia (heart rate less than 60 beats per minute prior to
start of
therapy).
•
Sinoatrial block
•
Second or third degree AV block (without a pacemaker)
•
Sick sinus syndrome.
•
Extreme hypotension (systolic blood pressure < 100mmHg)
•
Severe bronchial asthma or severe chronic o