Naproxen 25mg/ml oral suspension sugar free

Страна: Великобритания

Язык: английский

Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активный ингредиент:

Naproxen

Доступна с:

Orion Pharma (UK) Ltd

код АТС:

M01AE02

ИНН (Международная Имя):

Naproxen

дозировка:

25mg/1ml

Фармацевтическая форма:

Oral suspension

Администрация маршрут:

Oral

класс:

No Controlled Drug Status

Тип рецепта:

Valid as a prescribable product

Обзор продуктов:

BNF: 10010100; GTIN: 6432100027184

тонкая брошюра

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NAPROXEN 25 MG/ML ORAL SUSPENSION
Naproxen
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 of illness 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.
WHAT IS IN THIS LEAFLET
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
1.
WHAT NAPROXEN IS AND WHAT IT IS USED FOR
Naproxen oral solution contains as an active substance naproxen which
is a ‘Non-Steroidal Anti
Inflammatory Drug’ or NSAID. Naproxen alleviates inflammation and
pain by reducing the formation
of mediators causing pain and inflammation in the body .
Therapeutic uses of this medicine
Naproxen is used in the treatment of inflammation and pain in the
following diseases and conditions:
rheumatoid arthritis, ankylosing spondylitis, osteoarthrosis, acute
gout, acute musculoskeletal
disorders, and menstrual pain.
This medicine may also have been prescribed by a doctor for some other
diseases than those
mentioned in this package leaflet.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NAPROXEN
DO NOT TAKE NAPROXEN, IF YOU
•
have a history of asthma, rhinitis, nasal polyps or rashes associated
with the use of
acetylsalicylic acid (aspirin) or other NSAIDs
•
you are allergic to naproxen, acetylsalicylic acid or other
anti-inflammatory analgesics or any of
the other ingredients of this medicine (listed in section 6).
•
have gastric or duodenal ulcer
•
have a history of gastric or duodenal ulcer or bleeding that have
recurred

Характеристики продукта

OBJECT 1
NAPROXEN ORION 25 MG/ML ORAL SUSPENSION
Summary of Product Characteristics Updated 26-Apr-2016 | Orion Pharma
(UK) Limited
1. Name of the medicinal product
Naproxen Orion 25 mg/ml oral suspension
2. Qualitative and quantitative composition
One milliliter contains 25 mg naproxen.
Excipients with known effect:
Sorbitol 400 mg/ml
Methyl parahydroxybenzoate 1 mg/ml
Propyl parahydroxybenzoate 0.2 mg/ml
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral suspension.
White or off-white, homogeneous suspension.
4. Clinical particulars
4.1 Therapeutic indications
Adults:
• Rheumatoid arthritis, spondyloarthropathies (including ankylosing
spondylitis)
• Osteoarthrosis
• Acute gout
• Acute musculoskeletal disorders with pain
• Dysmenorrhoea
Children:
• Juvenile rheumatoid arthritis
4.2 Posology and method of administration
Posology
Adverse drug reactions may be reduced by using the lowest effective
dose for the shortest duration
possible to manage the symptoms (see section 4.4).
Adults:
Usually, 250–500 mg (10–20 ml) twice a day based on the individual
need.
If the predominant symptom in rheumatoid arthritis is morning
stiffness, a single dose of 500–750 mg
(20–30 ml) in the evenings may be adequate.
In the treatment of acute gout, the recommended dose is 750 mg at once
then 250 mg every 8 hours until
the attack has passed.
In the treatment of acute musculoskeletal disorders and dysmenorrhoea
the recommended dose is 500 mg
initially followed by 250mg at 6–8 hour intervals as needed, with a
maximum daily dose after the first
day of 1250 mg.
Paediatric population (over 5 years):
For juvenile rheumatoid arthritis: in children aged over 5 years, the
recommended daily dose is 10 mg/kg
divided into two doses. Dosing as per the table below. Patients
weighing over 50 kg may be administered
the adult dosage.
body weight
daily dose
body weight
daily dose
20–24 kg
4 ml x 2
35–40 kg
7 ml x 2
25–29 kg
5 ml x 2
40–44 kg
8 ml x 2
30–34 kg
6 ml x 2
45–49 kg
9 ml x 2
Elderly patients