NUROMOL DUAL ACTION PAIN RELIEF; ibuprofen 200mg and paracetamol 500mg liquid capsules, blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ibuprofen, Quantity: 200 mg; paracetamol, Quantity: 500 mg

Available from:

Reckitt Benckiser Pty Ltd

Pharmaceutical form:

Capsule, soft

Composition:

Excipient Ingredients: titanium dioxide; povidone; Gelatin; macrogol 400; propylene glycol; macrogol 4000; fumaric acid; purified water; partially dehydrated liquid sorbitol

Administration route:

Oral

Units in package:

20s, 10s

Prescription type:

(S3) Pharmacist Only Medicine, (S2) Pharmacy Medicine

Therapeutic indications:

Temporary relief of acute (short term) pain and / or inflammation associated with headache, migraine headache, tension headache, sinus pain, toothache, dental procedures, backache, muscular aches and pains, period pain, sore throat, tennis elbow, rheumatic pain and arthritis, and the aches and pains associated with colds and flu

Product summary:

Visual Identification: white coloured, oblong shaped, opaque, soft gelatin capsules containing white coloured oily mass; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2019-10-16

Patient Information leaflet

Nuromol®
NUROMOL
®
ACTIVE INGREDIENT(S): _Ibuprofen 200 mg and paracetamol 500 mg_
CONSUMER MEDICINE INFORMATION (CMI)
This leaflet provides important information about using
Nuromol. YOU SHOULD ALSO SPEAK TO YOUR DOCTOR OR
PHARMACIST IF YOU WOULD LIKE FURTHER INFORMATION OR IF YOU
HAVE ANY CONCERNS OR QUESTIONS ABOUT USING NUROMOL.
WHERE TO FIND INFORMATION IN THIS LEAFLET:
1.
Why am I using Nuromol?
2.
What should I know before I use Nuromol?
3.
What if I am taking other medicines?
4.
How do I use Nuromol?
5.
What should I know while using Nuromol?
6.
Are there any side effects?
7.
Product details
1.
WHY AM I USING NUROMOL
NUROMOL CONTAINS THE ACTIVE IBUPROFEN AND PARACETAMOL.
Ibuprofen belongs to a group of medicines called non-
steroidal anti-inflammatory drugs (NSAIDs). Paracetamol
works to stop the pain messages from getting through to
the brain.
NUROMOL® IS AN ANALGESIC (PAIN RELIEVER). IT WORKS TO
RELIEVE ACUTE (SHORT TERM) PAIN AND / OR INFLAMMATION
ASSOCIATED WITH HEADACHE, MIGRAINE HEADACHE, TENSION
HEADACHE, SINUS PAIN, TOOTHACHE, DENTAL PROCEDURES,
BACKACHE, MUSCULAR ACHES AND PAINS, PERIOD PAIN, SORE
THROAT, TENNIS ELBOW, RHEUMATIC PAIN AND ARTHRITIS, AND
THE ACHES AND PAINS ASSOCIATED WITH COLDS AND FLU.
2.
WHAT SHOULD I KNOW BEFORE I USE
NUROMOL?
WARNINGS
DO NOT USE NUROMOL IF:
•
you are allergic to ibuprofen, paracetamol or any of
the ingredients listed at the end of this leaflet.
•
you are allergic to any other medicine for pain relief
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
Always check the ingredients to make sure you can use
this medicine.
DO NOT USE NUROMOL IF YOU HAVE THE FOLLOWING
CONDITIONS:
•
liver or kidney disease
•
heart problems
•
asthma
•
a stomach ulcer or duodenal ulcer or if you have had
either of these conditions or gastric bleeding or other
gastrointestinal diseases in the past
•
recently

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – NUROMOL DUAL ACTION PAIN RELIEF
(IBUPROFEN 200 MG AND PARACETAMOL 500 MG) LIQUID CAPSULES
1
NAME OF THE MEDICINE
Ibuprofen and Paracetamol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nuromol Dual Action Pain Relief contains Ibuprofen 200 mg and
Paracetamol 500
mg as active ingredients. This formulation may contain traces of
sulfites, as this
formulation contains gelatin. For the full list of excipients, see
Section 6.1 List of
excipients.
3
PHARMACEUTICAL FORM
Nuromol Dual Action Pain Relief is a white coloured, oblong shaped and
opaque
soft gelatin capsules containing white coloured oily mass.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nuromol Dual Action Pain Relief is indicated for temporary relief of
acute (short term)
pain and / or inflammation associated with headache, migraine
headache, tension
headache, sinus pain, toothache, dental procedures, backache, muscular
aches and
pains, period pain, sore throat, tennis elbow, rheumatic pain and
arthritis, and the aches
and pains associated with colds and flu.
4.2
DOSE AND METHOD OF ADMINISTRATION
The lowest effective dose should be used for the shortest duration
necessary to relieve
symptoms (see section 4.4)
ADULTS UNDER 65 YEARS OF AGE: 1 soft capsule, 3 times a day (every 8
hours) when
necessary. Not to be taken for more than 3 days at a time unless
advised by a doctor.
CHILDREN FROM 12 YEARS OF AGE AND ADOLESCENTS: 1 soft capsule, 3 times
a day (every 8
hours) when necessary. Not to be taken for more than 2 days at a time
unless advised
by a doctor.
ELDERLY: Nuromol Dual Action Pain Relief is contraindicated in adults
aged 65 years
and over.
PREGNANCY: see Section 4.3 contraindications and Section 4.6
Fertility, pregnancy, and
lactation.
2
4.3
CONTRAINDICATIONS
This product is contraindicated:
•
In patients with a known hypersensitivity to ibuprofen, paracetamol or
any other
constituent of the medicinal product
•
In patients with a history of hypersensitivity reactions (e.g.
bronchospasm,
angioedema, rhinitis o