Nebivolol 2.5mg tablets

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Nebivolol hydrochloride

Prieinama:

Glenmark Pharmaceuticals Europe Ltd

ATC kodas:

C07AB12

INN (Tarptautinis Pavadinimas):

Nebivolol hydrochloride

Dozė:

2.5mg

Vaisto forma:

Oral tablet

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 02040000; GTIN: 5060204160066

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER
NEBIVOLOL 2.5 MG TABLETS
NEBIVOLOL 5 MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
-
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 only. Do not pass it on to
others.
It may harm them, even if their signs of illness 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.
WHAT IS IN THIS LEAFLET:
1.
What Nebivolol Tablets is and what it is used for
2.
What you need to know before you take Nebivolol Tablets
3.
How to take Nebivolol Tablets
4.
Possible side effects
5.
How to store Nebivolol Tablets
6.
Contents of the pack and other information
1.
WHAT NEBIVOLOL TABLETS IS AND WHAT IT IS USED FOR
Nebivolol Tablets contains nebivolol, a cardiovascular drug belonging
to the
group of selective beta-blocking agents (i.e. with a selective action
on the
cardiovascular system). It prevents increased heart rate, controls
heart pumping
strength. It also exerts a dilating action on blood vessels, which
contributes as well
to lower blood pressure.
It is used to treat raised blood pressure (hypertension).
Nebivolol Tablets is also used to treat mild and moderate chronic
heart failure in
patients aged 70 years or over, in addition to other therapies.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEBIVOLOL TABLETS
DO NOT TAKE NEBIVOLOL TABLETS:
•
If you are allergic to nebivolol or any of the other ingredients of
this medicine
(listed in section 6).
•
If you have one or more of the following disorders:
-
low blood pressure
-
serious circulation problems in the arms or legs
-
very slow heartbeat (less than 60 heart beats per minute)
-
certain other serious heart rhythm problems (e.g. 2
nd
and 3
rd
degree
atrioventricular block, heart conduction disorders)
-
heart failur

Prekės savybės

OBJECT 1
NEBIVOLOL 2.5MG TABLETS
Summary of Product Characteristics Updated 21-Sep-2022 | Glenmark
Pharmaceuticals Europe Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Nebivolol 2.5 mg Tablets
Nebivolol 5 mg Tablets
2. Qualitative and quantitative composition
Each tablet contains 2.725 mg nebivolol hydrochloride corresponding to
2.5 mg nebivolol
Excipient(s) with known effect: 72.5 mg of lactose monohydrate/tablet
Each tablet contains 5.45 mg nebivolol hydrochloride corresponding to
5mg nebivolol Excipient: 145.0 mg
of lactose monohydrate/tablet
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
2.5mg : Capsule shaped, white biconvex uncoated tablets with breakline
on one side and plain on the other
side
The tablet can be divided into equal halves.
5mg: Circular, white, shallow biconvex uncoated tablets engraved with
'N' and 'L' on either side of the
breakline on one side and plain on other side.
The tablet can be divided into equal halve