Aciclovir Apotex 200 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 200 mg tabletten – RVG 118926
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 200 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 200 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
•
treat cold sores, genital herpes and other herpes simplex infections
•
stop these problems returning after you have had them
•
stop these problems in people whose immune systems work less well,
which means their
bodies are less able to fight infections.
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 ph

Productkenmerken

Aciclovir Apotex 200 mg tabletten – RVG 118926
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 200 mg tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg of aciclovir
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White, round, biconvex tablets, with embossement “200” on one side
(9.0±0.2 mm)
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aciclovir Apotex 200 mg tablets are indicated for the treatment of
herpes simplex virus infections of
the skin and mucous membranes including initial and recurrent genital
herpes (excluding neonatal
HSV and severe HSV infections in immunocompromised children).
Aciclovir Apotex 200 mg tablets are indicated for the suppression
(prevention of recurrences) of
recurrent herpes simplex infections in immunocompetent patients.
Aciclovir Apotex 200 mg tablets are indicated for the prophylaxis of
herpes simplex infections in
immunocompromised patients.
Aciclovir Apotex 200 mg tablets are indicated for the treatment of
varicella (chickenpox) and herpes
zoster (shingles) infections.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Dosage in adults _
Treatment of herpes simplex infections: 200 mg Aciclovir Apotex should
be taken five times daily at
approximately four hourly intervals omitting the night time dose.
Treatment should continue for 5
days, but in severe initial infections this may have to be extended.
Aciclovir Apotex 200 mg, tabletten – RVG 118926
MODULE 1.3
Product Information
Version: 2019-01-11
MODULE 1.3.1
Summary of Product Characteristics
Replaces : 2017-10-27
2
In severely immunocompromised patients (e.g. after marrow transplant)
or in patients with impaired
absorption from the gut the dose can be doubled to 400 mg Aciclovir
Apotex or alternatively
intravenous dosing could be considered.
Dosing should begin as early as possible after the