FEMINAX TABLETS 500 8 100 50 Milligram Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
28-11-2015
Summary of Product characteristics
(SPC)
21-10-2017
Active ingredient:
PARACETAMOL, CAFFEINE, CODEINE PHOSPHATE, HYOSCINE HYDROBROMIDE
Available from:
Bayer Limited
ATC code:
N02AA59
INN (International Name):
PARACETAMOL, CAFFEINE, CODEINE PHOSPHATE, HYOSCINE HYDROBROMIDE
Dosage:
500 8 100 50 Milligram
Pharmaceutical form:
Tablets
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Natural opium alkaloids
Authorization status:
Authorised
Authorization date:
2009-12-04
Patient Information leaflet
Package Leaflet: Information for the patient
Feminax Tablets
Paracetamol 500 mg, Codeine Phosphate 8 mg,
Hyoscine Hydrobromide 100 micrograms, Caffeine (as monohydrate) 50 mg
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 pharmacist has
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.
WHAT IS IN THIS LEAFLET:
1.
What Feminax Tablets are and what they are used for
2. What you need to know before you take Feminax Tablets
3. How to take Feminax Tablets
4. Possible side effects
5. How to store Feminax Tablets
6. Contents of the pack and other information
1. WHAT FEMINAX TABLETS ARE AND WHAT THEY ARE USED FOR
Feminax Tablets rapidly relieve period pain. They relieve the cramping pain and
backache you experience with period pain.
This product contains codeine. Codeine belongs to a group of medicines called opioid
analgesics which act to relieve pain. It can be used on its own or in combination with
other pain killers such as paracetamol.
Hyoscine hydrobromide is a drug that relaxes smooth muscle and may relieve spasms.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FEMINAX TABLETS
DO NOT TAKE FEMINAX TABLETS:
• if you are allergic to paracetamol, codeine, hyoscine or caffeine
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Feminax Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
A white oval, biconvex tablet with bevelled edges, with a score line
on one side. The other side is embossed with
‘Feminax’. The scoreline is only to facilitate breaking for ease
of swallowing and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of pain and discomfort associated with menstrual
periods.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults:_
Adults and girls over 12 years:
Up to 2 tablets every 4 hours.
Not more than 6 tablets in 24 hours.
The duration of treatment should be limited to 3 days and if no
effective pain relief is achieved the patients/carers should be
advised to seek the views of a physician.
_Elderly persons:_
Not applicable.
_Children aged less than 12 years:_
Not applicable.
Codeine should not be used in children below the age of 12 years
because of the risk of opioid toxicity due to the variable
and unpredictable metabolism of codeine to morphine (see sections 4.3
and 4.4).
Method of administration
Oral.
Paracetamol
500.0 mg
Codeine Phosphate
8.0 mg
Hyoscine Hydrobromide
100.0 micrograms
Caffeine Monohydrate
equivalent to anhydrous caffeine
50.0 mg
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