Alendronic Acid 70 mg Tablets Once Weekly

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Alendronic acid

Disponibil de la:

WPR Healthcare Limited

Codul ATC:

M05BA; M05BA04

INN (nume internaţional):

Alendronic acid

Dozare:

70 milligram(s)

Forma farmaceutică:

Tablet

Calea de administrare:

Oral use

Unități în pachet:

pack of 4 tablets

Tip de prescriptie medicala:

Product subject to prescription which may be renewed (B)

Produs de:

TEVA UK Limited

Grupul Terapeutică:

Bisphosphonates, for the treatment of bone diseases

Zonă Terapeutică:

Bisphosphonates; alendronic acid

Indicații terapeutice:

Treatment of postmenopausal osteoporosis. Alendronic acid reduces the risk of vertebral and hip fractures.

Statutul autorizaţiei:

Authorised

Data de autorizare:

2015-05-29

Prospect

_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALENDRONIC ACID 70 MG
TABLETS ONCE WEEKLY
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 or pharmacist.
This includes any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet:
1.
What Alendronic Acid 70 mg Tablets is and what it is used
for
2.
What you need to know before you take Alendronic Acid 70
mg Tablets
3.
How to take Alendronic Acid 70 mg Tablets
4.
Possible side effects
5.
How to store Alendronic Acid 70 mg Tablets
6.
Contents of the pack and other information
1.
WHAT ALENDRONIC ACID 70 MG TABLETS IS AND WHAT IT IS
USED FOR

Alendronic acid belongs to a group of drugs called
bisphosphonates, which prevent bone loss from the body.

Your medicine is used to treat osteoporosis (thinning of the
bones) in post-menopausal women. It will reduce your risk
of back and hip fractures.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALENDRONIC
ACID 70 MG TABLES
DO NOT TAKE ALENDRONIC ACID 70 MG TABLETS

If you are allergic to alendronic acid or any of the other
ingredients of this medicine (listed in section 6)

If you suffer from certain disorders of the oesophagus (also
called the gullet, the tube that connects your mouth with
your stomach)

If you are unable to stand or sit upright for at least 30
minutes

If you have been told by your doctor that you have low
blood calcium levels.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Alendronic Acid
70 mg Tablets:

If you have difficulty swallowing

If your doctor has told you that you have Barrett’s
oesophagus (a condition associated with change

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Alendronic Acid 70 mg Tablets Once Weekly
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 70 mg alendronic acid (as alendronate sodium
monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
_Product imported from the UK_
White to off-white, flat-faced bevel-edged round tablet, debossed with
T on one side, plain on the other side.
4 CLINICAL PARTICULARS
As per PA0749/016/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0749/016/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Microcrystalline cellulose (E460)
Croscarmellose sodium
Magnesium Stearate
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister pack of 4 tablets contained in a carton.
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6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
WPR Healthcare Limited
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0565/058/