Atrogel Arnica gel

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Предлага се от:

A.Vogel UK Ltd

АТС код:

n/a

Лекарствена форма:

Cutaneous gel

Начин на приложение:

Cutaneous

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 10030200; GTIN: 7610313202003 7610313202508

Листовка

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Information
Do's and Don'ts for using Atrogel
Using Atrogel
Patient Information Leaflet
Atrogel
®
1. What Atrogel is and
what it is used for
Atrogel is a traditional herbal
medicinal product used to relieve
Muscular aches, pains and
stiffness
Sprains
Bruises
Swelling after injury
This is based on traditional use only.
2. What you need to
know before you use
Atrogel
Do not use Atrogel
If you are allergic to:
Arnica or plants of the daisy
(Asteraceae/Compositae)
family. Arnica is a member of
the daisy family.
Any of the other ingredients
of this product (listed in
section 6).
Take special care with
Atrogel
Do not use more than the leaflet
tells you to.
Do not use in or near your eyes,
nose, mouth or other sensitive
areas. It may cause irritation.
Do not use on broken, cut or
irritated skin. It may cause
irritation.
See your doctor, pharmacist or
qualified healthcare practitioner
if your symptoms worsen, or do
not improve within 2 weeks.
Pregnancy and breast-
feeding
Do not use if you are pregnant
or breast-feeding.
3. How to use Atrogel
When first opening the tube check
that the seal is not broken. Remove
seal before use.
Recommended dose
Adults, older people and
children:
Apply 2 - 10 cm gently to the
affected area. Use 2 to 4 times a
day.
Do not use more than the leaflet
tells you to.
For use on the skin only. This means
you can use Atrogel on your skin
but not in or near your eyes, nose,
mouth or other sensitive areas.
Do not apply if your skin surface is
broken, cut or irritated.
If you use more Atrogel
than you should
Your skin may become red or
irritated. If this happens stop
using Atrogel.
If you forget to use Atrogel
Do not worry about the missed
dose. Apply the next dose as
usual.
Important things you need
to know
This product is used to relieve
muscular aches and pains.
This product is suitable for
adults, older people and
children.
Don't use this product if you
are allergic to Arnica or any of
the ingredients: see section 6.
Before you use this product:
read section 2.
Dosage instr

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Atrogel Muscle Aches & Pains Arnica Gel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g gel contains:
500 mg extract (as liquid extract) of fresh Arnica Flowers (_Arnica
montana _L.)
(equivalent to 120 - 200 mg fresh Arnica Flowers)
Extractant: ethanol 58 %v/v
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Gel.
It is a slightly cloudy, golden-brown to green yellow coloured gel
with a
characteristic odour of Arnica.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
A traditional herbal medicinal product used for the symptomatic relief
of muscular
aches, pains and stiffness, sprains, bruises and swelling after
contusions, exclusively
based on long-standing use.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults: Apply 2 - 10 cm gently to the affected area 2 to 4 times
daily.
Children and the elderly: Apply similarly as described for adults
(above).
For cutaneous use only.
4.3
CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to Arnica preparations,
other
members of the Asteraceae (Compositae) family, or one of the
excipients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Do not exceed the stated dose.
If the condition worsens, or if symptoms persist for more than two
weeks, or if
adverse events not mentioned in the package leaflet occur, consult a
healthcare
practitioner.
For cutaneous use only. Do not use on broken or irritated skin. Avoid
contact
with eyes and mucous membranes. Discontinue use if redness, irritation
or dry
skin occurs.
Keep out of the sight and reach of children.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.6
PREGNANCY AND LACTATION
Pregnancy: There is no evidence of the safety of the product in human
pregnancy, nor is there any evidence from animal studies. Although no
adverse reactions have been observed, the use of the product during
pregnancy
should be avoided unless under the guidance of a medical practitioner.
Lactation: There is no evidence to su