Naproxen 250mg tablets

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Naproxen

Dostępny od:

Teva UK Ltd

Kod ATC:

M01AE02

INN (International Nazwa):

Naproxen

Dawkowanie:

250mg

Forma farmaceutyczna:

Oral tablet

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 10010100; GTIN: 5017007053835

Ulotka dla pacjenta

NAPROXEN 250 MG AND 500 MG
TABLETS
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
only. Do not pass it on to others. It may harm
them, even if their signs 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.
IMPORTANT SAFETY INFORMATION ABOUT THIS
MEDICINE:
• DO NOT TAKE IF you have a PEPTIC ULCER
(ulcer in your stomach or duodenum) or
BLEEDING IN YOUR STOMACH, or have had TWO
OR MORE EPISODES of peptic ulcers, stomach
bleeding or perforation.
• STOP TAKING THE MEDICINE AND SEEK
IMMEDIATE MEDICAL HELP IF YOU SUFFER FROM
ANY OF THE FOLLOWING AT ANY TIME DURING
YOUR TREATMENT:
o Pass blood in your faeces
(stools/motions)
o Pass black tarry stools
o Vomit any blood or dark particles that
look like coffee grounds.
• STOP TAKING THE MEDICINE AND TELL YOUR
DOCTOR IF YOU EXPERIENCE indigestion or
heartburn, abdominal pain (pains in your
stomach) or other abnormal stomach
symptoms.
• YOUR DOCTOR SHOULD PRESCRIBE THE LOWEST
DOSE WHICH IS EFFECTIVE FOR YOU FOR THE
SHORTEST PERIOD NECESSARY. THIS WILL HELP TO
REDUCE THE POSSIBILITY OF ANY SIDE EFFECTS.
DO NOT EXCEED THE PRESCRIBED DOSE OR
DURATION OF TREATMENT.
NOW READ THE REST OF THIS LEAFLET. It includes
other important information on the safe and
effective use of this medicine that might be
especially important for you.
1. WHAT NAPROXEN IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
NAPROXEN
3. HOW TO TAKE NAPROXEN
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE NAPROXEN
6. CONTENTS OF THE PACK AND OTHER INFORMATION
WHAT NAPROXEN IS AND WHAT IT IS
USED FOR
Naproxen is a non-steroidal anti-inflammatory
drug (NSAID).
Naproxen tablets are used in adults:
• to treat rheumatoid arthritis, o

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Naproxen 250 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg Naproxen Ph. Eur.
Excipient(s) with known effect
One Naproxen 500 mg Tablet contains 75.85 mg of lactose monohydrate
Ph. Eur.
Also contains 0.024mg sunset yellow (E110).
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Flat yellow, circular bevel edged tablets marked "APS" or plain on one
side
and "250 0538" with a breakline on the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADULTS:
Naproxen tablets are indicated for the treatment of rheumatoid
arthritis, osteoarthrosis
(degenerative arthritis), ankylosing spondylitis, acute gout, acute
musculoskeletal
disorders (such as sprains and strains, direct trauma, lumbosacral
pain, cervical
spondylitis, tenosynovitis, fibrositis) and dysmenorrhoea.
Children:
Juvenile rheumatoid arthritis
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Undesirable effects may be minimised by using the lowest effective
dose for
the shortest duration necessary to control symptoms (see section 4.4).
_Adults _
Rheumatoid Arthritis, osteoarthrosis, and ankylosing spondylitis:
500 mg to 1 g per day in two divided doses at 12 hour intervals or
alternatively, as a single administration. In the following cases a
loading dose
of 750mg or 1g per day for the acute phase is recommended:
a) In patients reporting severe night-time pain/or morning stiffness.
b) In patients being switched to Naproxen from a high dose of another
anti-
rheumatic compound.
c) In osteoarthrosis where pain is the predominant symptom.
Acute gout:
750 mg immediately, then 250 mg every 8 hours until the attack has
passed.
Acute Musculoskeletal Disorders and Dysmenorrhoea.
500 mg initially, then 250 mg every 6 - 8 hours as needed. The maximum
daily dose (after the first day) is 1250 mg.
_Paediatric population _
For the treatment of juvenile rheumatoid arthritis in children over 5
years of
age, the usual dosage is 10 mg/kg bodyweigh