Naproxennatrium Aurobindo 220 mg, zachte capsules

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

NAPROXENNATRIUM 220 mg/stuk SAMENSTELLING overeenkomend met ; NAPROXEN 200 mg/stuk

Beschikbaar vanaf:

Apotex Europe BV Archimedesweg 2 2333 CN LEIDEN

ATC-code:

M01AE02

INN (Algemene Internationale Benaming):

NAPROXENNATRIUM 220 mg/stuk SAMENSTELLING overeenkomend met ; NAPROXEN 200 mg/stuk

farmaceutische vorm:

Capsule, zacht

Samenstelling:

GELATINE (E 441) ; GLYCEROL (E 422) ; ISOPROPYLALCOHOL ; LECITHINE (E 322) ; MACROGOL 600 ; MELKZUUR (D,L,+- VORM) (E 270) ; PATENTBLAUW V (E 131) ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) 17,7 mg/stuk ; SORBITOL VLOEIBAAR, GEDEELTELIJK GEDEHYDRATEERD ; TRIGLYCERIDEN MIDDELLANGE KETEN ; WATER, GEZUIVERD, GELATINE (E 441) ; GLYCEROL (E 422) ; ISOPROPYLALCOHOL ; LECITHINE (E 322) ; MACROGOL 600 ; MELKZUUR (D,L,+- VORM) (E 270) ; PATENTBLAUW V (E131) ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) 17,7 mg/stuk ; SORBITOL VLOEIBAAR, GEDEELTELIJK GEDEHYDRATEERD ; TRIGLYCERIDEN MIDDELLANGE KETEN ; WATER, GEZUIVERD,

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Naproxen

Product samenvatting:

Hulpstoffen: GELATINE (E 441); GLYCEROL (E 422); ISOPROPYLALCOHOL; LECITHINE (E 322); MACROGOL 600; MELKZUUR (D,L,+- VORM) (E 270); PATENTBLAUW V (E131); POVIDON K 30 (E 1201); PROPYLEENGLYCOL (E 1520) 17,7 mg/stuk; SORBITOL VLOEIBAAR, GEDEELTELIJK GEDEHYDRATEERD; TRIGLYCERIDEN MIDDELLANGE KETEN; WATER, GEZUIVERD;

Autorisatie datum:

2017-09-28

Bijsluiter

NAPROXENNATRIUM AUROBINDO 220 MG, ZACHTE CAPSULES – RVG 118864
MODULE 1.3
Product Information
Version: 2210
MODULE 1.3.1
Package Leaflet
Replaces :
2207
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NAPROXENNATRIUM AUROBINDO 220 MG, ZACHTE CAPSULES
naproxennatrium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take 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 3 days in case
of fever and 5 days in case of pain.
WHAT IS IN THIS LEAFLET
:
1. What Naproxennatrium Aurobindo 220 is and what it is used for
2. What you need to know before you take Naproxennatrium Aurobindo 220
3. How to take Naproxennatrium Aurobindo 220
4. Possible side effects
5. How to store Naproxennatrium Aurobindo 220
6. Contents of the pack and other information
1. WHAT NAPROXENNATRIUM AUROBINDO 220
IS AND WHAT IT IS USED FOR
Naproxennatrium
Aurobindo
220
contains
naproxen
which
is
an
anti-inflammatory,
pain-
relieving and antipyretic medicine. It belongs to a group of medicines
named NSAID (non-
steroidal anti-inflammatory drugs).
Naproxennatrium Aurobindo 220 is used in adults and children from 12
years of age for short
term treatment of pain.
INDICATIONS FOR USE
Treatment of minor and moderate pain, such as:
-
Headache,
-
toothache,
-
muscle pain,
-
arthralgia,
-
back pain,
-
painful menstruation,
-
minor pain associated with the cold.
-
Reducing fever.
NAPROXENNATRIUM AUROBINDO 220 MG, ZACHTE CAPSULES – RVG 118864
MODULE 1.3
Product Information
Version: 2210
MODULE 1.3.1
Package Leaflet
Replaces :
2207
2
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NAPROXENNATRIUM AUROBINDO

Productkenmerken

NAPROXENNATRIUM AUROBINDO 220 MG, ZACHTE CAPSULES RVG 118864
MODULE 1
Administrative information and prescribing information
1.3.1 1.3.1 SAMENVATTING VAN DE PRODUCTKENMERKEN
Versie 2210 Pag. 1 van 10
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Naproxennatrium Aurobindo 220 mg, zachte capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains Naproxen sodium 220 mg equivalent to 200 mg
naproxen
Excipients with known effect:
Sorbitol, 65.3 mg per capsule, soft
Lecithin originating from soya oil
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Capsules, soft.
Blue transparent soft gelatin capsule containing 220 mg of naproxen
sodium per capsule.
Approximately 20 to 22 mm in length and 8 to 10 mm in width.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of minor and moderate pain, such as:
- Headache,
- toothache,
- muscle pain,
- arthralgia,
- back pain,
- painful menstruation
- minor pain associated with the cold.
- Reducing fever.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and children from 12 years of age and above:
- General: Take 1 capsule every 8 to 12 hours.
NAPROXENNATRIUM AUROBINDO 220 MG, ZACHTE CAPSULES RVG 118864
MODULE 1
Administrative information and prescribing information
1.3.1 1.3.1 SAMENVATTING VAN DE PRODUCTKENMERKEN
Versie 2210 Pag. 2 van 10
2
An initial dose of 2 capsules may be taken and, if the complaints
persist, followed by one capsule
after 12 hours.
Maximal daily dose is 3 capsules per 24 hours.
Elderly from 65 years old:
Not more than 2 capsules per 24 hours.
Renal impairment
Naproxen should be given at the lowest effective dose in patients with
mild renal impairment and
renal function should be carefully monitored. Naproxen should be
avoided if possible in patients
with moderate renal impairment and is contraindicated in severe renal
impairment (see section 4.3
and 4.4).
Hepatic impairment
Naproxen should be used with caution in patients with impaired hepatic
function. Naproxen
should be avoi