Nebivolol 10mg tablets

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Nebivolol hydrochloride

Prieinama:

DE Pharmaceuticals

ATC kodas:

C07AB12

INN (Tarptautinis Pavadinimas):

Nebivolol hydrochloride

Dozė:

10mg

Vaisto forma:

Oral tablet

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 02040000

Pakuotės lapelis

Package leaflet: Information for the patient
(Nebivolol)
NEBIVOLOL 10 MG TABLETS
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 (also referred to as Nebivolol throughout this
leaflet)
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 70years 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:
o
low blood pressure
o
serious circulation problems in the arms or legs
o
very slow heartbeat (less than 60 beats per minute)
o
certain other serious heart rhythm problems (e.g. 2nd and 3rd
degree atrioventricular block, heart conduction disorders).
•
heart failure, which has just occurred, or which has recently
become worse, or you are receiving treatment for circulatory
shock due to acute heart failure by intravenous drip feed to help
your heart work.
•
asthma or wheezing (now or in the past), untreated
phaeochromocytoma, a tumour located on top of the kidneys
(in the adrenal glands)
•
liver function disorder
•
a metabolic disorder (metabolic acidosis), for example,
diabetic ketoacidosis.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taki

Prekės savybės

OBJECT 1
NEBIVOLOL 10MG TABLETS
Summary of Product Characteristics Updated 13-Mar-2019 | 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 10 mg Tablets
2. Qualitative and quantitative composition
Each tablet contains 10.90 mg nebivolol hydrochloride corresponding to
10 mg nebivolol
Excipient(s) with known effect: 139.55 mg of lactose
monohydrate/tablet
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
10 mg: Circular, white, shallow, biconvex uncoated tablets engraved
with 'G' and 'N' on either side of break
line on one side and plain on other side.
The tablet can be divided into equal doses.
4. Clinical particulars
4.1 Therapeutic indications
Hypertension
Treatment of essential hypertension
Chronic heart failure (CHF)
Treatment of stable mild and moderate chronic heart failure in
addition to standard therapies in elderly
patients > 70 years.
4.2 Posology and method of administration
Posology
Hype