Aciclovir ratiopharm 50 mg/g, crème

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

ACICLOVIR 50 mg/g

Beschikbaar vanaf:

Ratiopharm GmbH Graf-Arco-Strasse 3 89079 ULM (DUITSLAND)

ATC-code:

D06BB03

INN (Algemene Internationale Benaming):

ACICLOVIR 50 mg/g

farmaceutische vorm:

Crème

Samenstelling:

CETYLALCOHOL ; DIMETICON (E 900) ; MACROGOL-30-ETHER GLYCEROLMONOSTEARAAT ; PARAFFINE, VLOEIBAAR (E905) ; PARAFFINE, ZACHT (E 905) ; PROPYLEENGLYCOL (E 1520) ; WATER, GEZUIVERD,

Toedieningsweg:

Cutaan gebruik

Therapeutisch gebied:

Aciclovir

Product samenvatting:

Hulpstoffen: CETYLALCOHOL; DIMETICON (E 900); MACROGOL-30-ETHER GLYCEROLMONOSTEARAAT; PARAFFINE, VLOEIBAAR (E905); PARAFFINE, ZACHT (E 905); PROPYLEENGLYCOL (E 1520); WATER, GEZUIVERD;

Autorisatie datum:

1997-10-22

Bijsluiter

Aciclovir, cream, NL/H/0320/001, 09.03.2021
Comment from PT: shaded in yellow
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ACICLOVIR RATIOPHARM 50 MG/G, CRÈME
aciclovir
Rx:
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.
OTC:
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Alwaysuse this medicine exactly as described in this leaflet or as
your doctor or pharmacist have told
you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
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.
-
You must talk to a doctor if you do not feel better or if you feel
worse after x days.
WHAT IS IN THIS LEAFLET
1.
What Aciclovir cream is and what it is used for
2.
What you need to know before you use Aciclovir cream
3.
How to use Aciclovir cream
4.
Possible side effects
5.
How to store Aciclovir cream
6.
Contents of the pack and other information
1.
WHAT ACICLOVIR CREAM IS AND WHAT IT IS USED FOR
Aciclovir is an antiviral agent.
Aciclovir cream is applied to the skin to treat herpes simplex virus
infections, including first and
repeated attacks of genital herpes and herpes of the lips (cold
sores).
You must talk to your doctor if you do not feel better or if you feel
worse after 10 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ACICLOVIR CREAM
DO NOT USE ACICLOVIR CREAM
-
if you are
ALLERGIC TO ACICLOVIR, VALACICLOV

Productkenmerken

Aciclovir, cream, NL/H/0320/001, 11.03.2020
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Aciclovir ratiopharm 50 mg/g, crème
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of Aciclovir 50 mg/g cream contains 50 mg of aciclovir.
Excipients with known effect:
Each g contains 250 mg propylene glycol (E1520).
Each g contains 15 mg cetyl alcohol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream.
Soft white odourless cream.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aciclovir cream is indicated for the treatment of immunocompetent
patients with localised skin
infections caused by the Herpes simplex virus including initial and
recurring herpes genitalis and
herpes labialis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Aciclovir cream should be applied to infected skin areas 5 times daily
at approximately 4 hourly
intervals, omitting the night time application.
Method of administration
Aciclovir cream should be applied to the lesions or impending lesions
as early as possible after the
start of an infection.
Treatment should be continued for 5 days. If, after 5 days, healing is
not complete then treatment can
be continued for up to an additional 5 days.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance, valaciclovir, propylene
glycol or to any of the excipients
listed in section 6.1.
Aciclovir, cream, NL/H/0320/001, 11.03.2020
2
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Aciclovir 50 mg/g cream is not recommended for application to mucous
membranes, such as in the
mouth, eye or vagina, as it may be irritant. Particular care should be
taken to avoid accidental
introduction into the eye.
Patients with genital herpes should abstain from sexual activity for
as long as lesions are visible to
avoid transmission of infection to their partners.
The severity of recurrent infections varies as a function of the
patient's immune status, episode
frequency and duration, size of total lesion area and presence or
absence of systemic reactions.
Pa