Noumed Paracetamol Osteo

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Paracetamol 665mg

Available from:

Noumed Pharmaceuticals Limited

Dosage:

665 mg

Pharmaceutical form:

Modified release tablet

Composition:

Active: Paracetamol 665mg Excipient: Croscarmellose sodium Hypromellose Magnesium stearate Maize starch Opadry white OY-58900 Povidone

Prescription type:

Restricted

Therapeutic indications:

Effective for the relief of persistent pain associated with osteoarthritis for up to eight hours

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/CR Al - 96 tablets - 48 months from date of manufacture stored at or below 30°C - Blister pack, PVC/Al - 96 tablets - 48 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al - 96 tablets - 48 months from date of manufacture stored at or below 30°C

Authorization date:

2020-01-14

Patient Information leaflet

NEW ZEALAND CONSUMER MEDICINE INFORMATION
NOUMED PARACETAMOL OSTEO
_PARACETAMOL 665 MG _
Modified-release Tablet, coated
PAGE 1 OF 7
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using Noumed
Paracetamol Osteo.
This leaflet answers some common questions about Noumed Paracetamol
Osteo.
It does not contain all the available information.
It does not take the place of talking to your pharmacist or doctor.
All medicines have risks and benefits. Your doctor has weighed the
risks of you using
Noumed Paracetamol Osteo against the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the medicine. You may need to read it again.
WHAT NOUMED PARACETAMOL OSTEO USED FOR
Noumed Paracetamol Osteo provides effective relief of persistent pain
associated with
Osteoarthritis for up to 8 hours.
Paracetamol works to stop the pain messages from getting through to
the brain. It also
acts in the brain to reduce fever.
ASK YOUR PHARMACIST OR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT THIS
MEDICINE.
Your pharmacist or doctor may have recommended it for another reason.
Do not give to children under 12 years of age.
BEFORE YOU USE NOUMED PARACETAMOL OSTEO
_ _
Do not take more than the recommended dose as it may cause serious
harm to your liver.
_ _
_WHEN YOU MUST NOT USE IT _
DO NOT USE NOUMED PARACETAMOL OSTEO IF YOU HAVE AN ALLERGY TO:
• Any medicine containing paracetamol
NEW ZEALAND CONSUMER MEDICINE INFORMATION
Page 2 of 7
• Any of the ingredients listed at the end of this leaflet
Some of the symptoms of an allergic reaction may include:
• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body
• rash, itching or hives on the skin
DO NOT USE THIS MEDICINE IF YOU ARE TAKING ANY OTHER PRESCRIPTION OR
NON-PRESCRIPTION
MEDICINES CONTAINING PARACETAMOL TO TREAT PAIN, FEVER, SYMPTOMS OF
COLD AND FLU, OR
TO AID SLEEP.
ALWAYS READ AND FOLLOW THE LABEL

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Page 1 of 7
1
PRODUCT NAME
Noumed Paracetamol Osteo
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient:_ Paracetamol 665 mg/tablet
_Excipients: _For full list of excipients, see section 6.1_. _
3
PHARMACEUTICAL FORM
_Presentation: _Coated, modified-release tablet,
White to
off-white, capsule-
shaped, biconvex
tablets; plain on both sides. Tablet cannot be
halved.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
For the relief of persistent pain associated with osteoarthritis for
up to 8 hours.
4.2
Dose and method of administration
_Dose _
Adults and children aged 12 years and over: Swallow 2 tablets with
water or other fluid, three times a
day, every 6 to 8 hours as required. Swallow whole do not crush or
chew.
Maximum of 6 tablets in 24 hours.
Do not use for more than a few days at a time in adults except on
medical advice. Should not be used
for more than 48 hours for children aged 12 – 17 years, except on
medical advice.
Children under 12 years: Do not give to children under 12 years of
age.
Take orally with water or other fluid. Do not chew or suck, as it
impairs the modified release
properties.
Method of administration: Take with water or other fluid.
Can be taken with or without food.
The 3 doses should be equally spaced throughout the day.
The tablets must not be crushed.
Do not exceed the stated dose.
The lowest dose necessary to achieve efficacy should be used for the
shortest duration of treatment.
Should not be used with other paracetamol-containing products. Minimum
dosing interval: 6 hours.
Maximum daily dose for children 12 years of age to adults: 4000 mg.
NEW ZEALAND DATA SHEET
Page 2 of 7
4.3
Contraindications
This product is contraindicated in patients with a previous history of
hypersensitivity to paracetamol
or to any of the excipients listed in Section 6.1.
4.4
Special warnings and precautions for use
Contains paracetamol. Do not use with any other paracetamol-containing
products. The concomitant
use with other products containing paracetamol may lead to a