Aciclovir Apotex 800 mg tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

ACICLOVIR

Beschikbaar vanaf:

Apotex Europe BV Archimedesweg 2 2333 CN LEIDEN

ATC-code:

J05AB01

INN (Algemene Internationale Benaming):

ACICLOVIR

farmaceutische vorm:

Tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201), CELLULOSE, MICROKRISTALLIJN (E 460) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POVIDON K 30 (E 1201),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Aciclovir

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); POVIDON K 30 (E 1201);

Autorisatie datum:

2017-09-29

Bijsluiter

Aciclovir Apotex 800 mg tabletten – RVG 118927
MODULE 1.3
Product Information
Version: 2017-10-27
MODULE 1.3.1
Summary of Product Characteristics
Replaces : 2017-09-29
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACICLOVIR APOTEX 800 MG TABLETTEN
Aciclovir
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Aciclovir Apotex is and what it is used for
2. What you need to know before you take Aciclovir Apotex
3. How to take Aciclovir Apotex
4. Possible side effects
5. How to store Aciclovir Apotex
6. Contents of the pack and other information
1.
WHAT ACICLOVIR APOTEX IS AND WHAT IT IS USED FOR
Aciclovir Apotex 800 mg tablets contain a medicine called aciclovir.
This belongs to a group of
medicines known as antivirals. It works by killing or stopping the
growth of viruses.
Aciclovir Apotex can be used to:
•
treat chickenpox and shingles
2.
WHAT YOUR NEED TO KNOW BEFORE YOU TAKE ACICLOVIR APOTEX
DO NOT TAKE ACICLOVIR APOTEX:
•
if you are allergic to aciclovir or valaciclovir or any of the other
ingredients of this medicine
(listed in section 6).
Do not take Aciclovir Apotex if the above applies to you. If you are
not sure, talk to your doctor
or pharmacist before taking Aciclovir Apotex.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Aciclovir Apotex if:
•
you have kidney problems
•
you are over 65 years of age
If you are not sure if the above apply to you, talk to your doctor or
pharmacist before taking
Aciclovir Apotex.
Aciclovir Apotex 800 mg tabletten – RVG

Productkenmerken

Aciclovir Apotex 800 mg tabletten – RVG 118927
MODULE 1.3
Product Information
Version: 2019-01-11
MODULE 1.3.1
Summary of Product Characteristics
Replaces : 2017-10-27
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Aciclovir Apotex 800 mg tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 800 mg of aciclovir
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White, elongated, biconvex tablets score on one side (length 19.3±0.2
mm, width 10.5±0.2 mm)
The score line is only to faciliate breaking for ease of swallowing
and not to divide in equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aciclovir Apotex 800 tablets are indicated for the treatment of
varicella (chickenpox) and herpes
zoster
(shingles)
infections
(excluding
neonatal
HSV
and
severe
HSV
infections
in
immunocompromised children).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Dosage in adults _
Treatment of varicella and herpes zoster infections: 800 mg of
aciclovir should be taken five times
daily at approximately four-hourly intervals, omitting the night time
dose. Treatment should continue
for seven days.
In severely immunocompromised patients (e.g. after marrow transplant)
or in patients with impaired
absorption from the gut, consideration should be given to intravenous
dosing.
Dosing should begin as early as possible after the start of an
infection: Treatment of herpes zoster
yields better results if initiated as soon as possible after the onset
of the rash. Treatment of
chickenpox in immunocompetent patients should begin within 24 hours
after onset of the rash.
_Paediatric population _
Aciclovir Apotex 800 mg, tabletten – RVG 118927
MODULE 1.3
Product Information
Version: 2019-01-11
MODULE 1.3.1
Summary of Product Characteristics
Replaces : 2017-10-27
2
Treatment of varicella infection
6 years and over: 800 mg acyclovir four times daily
Treatment should continue for five days.
No specific data are available on the treatment of herpes zoster
infec