Codeïnefosfaat 1A Pharma 20 mg, tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

CODEINEDIWATERSTOFFOSFAAT 0,5-WATER 20 mg/stuk SAMENSTELLING overeenkomend met ; CODEINE 14,7 mg/stuk

INN (Algemene Internationale Benaming):

CODEINEDIWATERSTOFFOSFAAT 0,5-WATER 20 mg/stuk SAMENSTELLING overeenkomend met ; CODEINE 14,7 mg/stuk

farmaceutische vorm:

Tablet

Samenstelling:

AARDAPPELZETMEEL ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B), AARDAPPELZETMEEL ; CELLULOSE, MICROKRISTALLIJN (E 460) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

1900-01-01

Bijsluiter

1A Pharma GmbH
Page 1/10
Codeïnefosfaat 1A Pharma 10, 15, 20, 30 mg,
tabletten
RVG 127427-30
1313-v2
1.3.1.3 bijsluiter
Februari 2024
BIJSLUITER: INFORMATIE VOOR DE PATIËNT
CODEÏNEFOSFAAT SANDOZ 10 MG, TABLETTEN
CODEÏNEFOSFAAT SANDOZ 15 MG, TABLETTEN
CODEÏNEFOSFAAT SANDOZ 20 MG, TABLETTEN
CODEÏNEFOSFAAT SANDOZ 30 MG, TABLETTEN
codeïnefosfaathemihydraat
_ _
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 (or for your child) 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 [nationally completed name] is and what it is used for
2. What you need to know before you take [nationally completed name]
3. How to take [nationally completed name]
4. Possible side effects
5. How to store [nationally completed name]
6. Contents of the pack and other information
1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] contains the active substance codeine. It
belongs to the group of
weak pain medications, so called opioid analgesics, and can be used
alone or in combination
with other pain medication such as paracetamol. Codeine is also used
to treat coughing (by
suppressing the cough) and diarrhoea (by its action on the gut).
[Nationally completed name] is used for:
•
short-term relief of moderate pain that cannot be relieved by other
pain medication like (only)
paracetamol or ibuprofen in adults and children older than 12 years of
age,
•
treatment of symptoms of a dry cough in adults and children older than
12 years of age,
•
treatment of symptoms of diarrhoea in adults if treatment with
loperamide (a diarrhoea

Productkenmerken

1A Pharma GmbH
Page 1/15
Codeïnefosfaat 1A Pharma 10, 15, 20, 30 mg,
tabletten
RVG 127427-30
1311-V2
1.3.1.1 SmPC
Februari 2024
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Codeïnefosfaat 1A Pharma 10 mg, tabletten
Codeïnefosfaat 1A Pharma 15 mg, tabletten
Codeïnefosfaat 1A Pharma 20 mg, tabletten
Codeïnefosfaat 1A Pharma 30 mg, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
{[Nationally completed name] 10 mg tablets}
Each tablet contains 10 mg codeine phosphate hemihydrate equivalent to
7.37 mg of codeine.
{[Nationally completed name] 15 mg tablets}
Each tablet contains 15 mg codeine phosphate hemihydrate equivalent to
11.05 mg of codeine.
_ _
{[Nationally completed name] 20 mg tablets}
Each tablet contains 20 mg codeine phosphate hemihydrate equivalent to
14.73 mg of codeine.
{[Nationally completed name] 30 mg tablets}
Each tablet contains 30 mg codeine phosphate hemihydrate equivalent to
22.10 mg of codeine.
Excipient(s) with known effect
{[Nationally completed name] 10 mg tablets}
Each tablet contains 29.45 mg lactose (as monohydrate).
{[Nationally completed name] 15 mg tablets}
Each tablet contains 44.18 mg lactose (as monohydrate).
{[Nationally completed name] 20 mg tablets}
Each tablet contains 58.90 mg lactose (as monohydrate).
{[Nationally completed name] 30 mg tablets}
Each tablet contains 88.35 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
1A Pharma GmbH
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Codeïnefosfaat 1A Pharma 10, 15, 20, 30 mg,
tabletten
RVG 127427-30
1311-V2
1.3.1.1 SmPC
Februari 2024
Tablet
{[Nationally completed name] 10 mg tablets}
White or almost white, biconvex tablet of round shape (diameter 6 mm),
debossed ‘COD’ over ‘10’ on
one side.
{[Nationally completed name] 15 mg tablets}
White or almost white, biconvex tablet of round shape (diameter 7 mm),
debossed ‘COD’ over ‘15’ on
one side.
_ _
{[Nationally completed name] 20 mg tablets}
White or almost white, biconvex tablet of round shape (diameter 8 mm),
debosse