Feminax tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Paracetamol; Codeine phosphate; Hyoscine hydrobromide; Caffeine hydrate

Available from:

Bayer Plc

ATC code:

N02BE51

INN (International Name):

Paracetamol; Codeine phosphate; Hyoscine hydrobromide; Caffeine hydrate

Dosage:

500mg ; 8mg ; 100microgram ; 54.64mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

Schedule 5 (CD Inv)

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF:

Patient Information leaflet

PATIENT INFORMATION LEAFLET
Bayer Cross
FEMINAX® ULTRA
250 MG GASTRO-RESISTANT TABLETS
Naproxen (250 mg)
This leaflet contains important information about Feminax® Ultra 250
mg Gastro-resistant
tablets (referred to as Feminax® Ultra from now on). Please read it
carefully before you take
these tablets.
WHAT IS FEMINAX® ULTRA FOR?
These tablets contain 250 mg of naproxen. This medicine is used to
treat period pain (also
called menstrual pain or dysmenorrhoea)

Naproxen belongs to a group of painkillers called Non-Steroidal
Anti-inflammatory
Drugs (also called NSAIDs)

Other medicines in this group include ibuprofen and aspirin.
WHO SHOULD TAKE FEMINAX® ULTRA?
Only take this medicine if you are between 15 and 50 years old. Ask
your doctor, pharmacist
or nurse if you need more information.
THINGS TO KNOW BEFORE TAKING FEMINAX® ULTRA
DO NOT TAKE THIS MEDICINE IF YOU HAVE, OR HAVE EVER HAD A STOMACH
ULCER, OR OTHER SERIOUS
STOMACH PROBLEMS

This includes any stomach pain that did not go away and any bleeding
in the stomach

If you have ever had anything like this then you should not take these
tablets.
DO NOT TAKE THIS MEDICINE IF YOU HAVE SEVERE HEART FAILURE.
DO NOT TAKE THIS MEDICINE IF YOU ARE ALREADY TAKING ASPIRIN, LOW DOSE
ASPIRIN OR ANY
OTHER NON-STEROIDAL ANTI-INFLAMMATORY DRUG (NSAID) LIKE IBUPROFEN.
THIS INCLUDES
CYCLO-OXYGENASE-2 SELECTIVE INHIBITORS (COX2) LIKE CELECOXIB.
DO NOT TAKE THIS MEDICINE IF YOU HAVE EVER HAD AN ALLERGIC REACTION
TO:

Naproxen, aspirin, ibuprofen, or another non-steroidal
anti-inflammatory drug (NSAID)

Anything else in these tablets (look at the list in the ‘What is in
these tablets’ section, at
the end of the leaflet).
Allergic reactions can include wheezing, itchy runny nose, rashes or
swelling of the skin.
DO NOT TAKE THIS MEDICINE UNLESS YOUR DOCTOR SAID YOU CAN, IF:

You are breast feeding, or there is a chance you may be pregnant

You started to have period pain more than a year after your first
period.
DO NOT TAKE THIS MEDICINE, UNLESS YOU

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Feminax
®
Ultra 250mg Gastro-Resistant Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg of Naproxen. For full list of excipients,
see 6.1.
3
PHARMACEUTICAL FORM
Gastro-Resistant Tablet
White, round, biconvex enteric-coated tablets, overprinted in black
3N3.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Indicated for the treatment of primary dysmenorrhoea in women aged 15
to 50
years.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
To be taken preferably with or after food swallowed whole with water.
Adolescents (post puberty) and adult females between the ages of 15
and 50:
On the first day 2 tablets (500 mg) should be taken initially and then
one tablet
(250 mg) after 6 to 8 hours if needed.
On the second and third day, if needed, one tablet (250mg) should be
taken every
6 to 8 hours. Not more than 3 tablets to be taken per day. The maximum
duration of continuous treatment in any one cycle (period) is 3 days.
4.3
CONTRAINDICATIONS
Naproxen is contra-indicated in patients with a history of, or active
peptic
ulceration and active gastrointestinal bleeding.
Naproxen
is
contra-indicated
in
patients
with
a
history
of
gastrointestinal
bleeding or perforation, related to previous NSAIDs therapy.
Naproxen
is
contra-indicated
for
patients
with
known
hypersensitivity
to
naproxen, naproxen sodium formulations or any of the excipients.
Naproxen should not be given to patients in whom aspirin or other
non-steroidal
anti-inflammatory/analgesic drugs induce the syndrome of asthma,
rhinitis or
urticaria.
Naproxen should not be given to patients with severe heart failure.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Undesirable effects may be minimised by using the lowest effective
dose for the
shortest duration necessary to control symptoms (see warnings on GI
and
cardiovascular risks below).
_Cardiovascular and cerebrovascular effects _
Caution (discussion with doctor or pharmacist) is required prior to
sta