Prednisolone sodium phosphate 0.5% eye drops

Страна: Великобритания

Язык: английский

Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активный ингредиент:

Prednisolone sodium phosphate

Доступна с:

Special Order

ИНН (Международная Имя):

Prednisolone sodium phosphate

дозировка:

5mg/1ml

Фармацевтическая форма:

Drops

класс:

No Controlled Drug Status

Тип рецепта:

Valid as a prescribable product

Обзор продуктов:

BNF:

тонкая брошюра

MINIMS
® PREDNISOLONE SODIUM PHOSPHATE
0.5% W/V EYE DROPS, SOLUTION
(prednisolone sodium phosphate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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.
The name of your medicine is Minims prednisolone sodium phosphate 0.5%
w/v eye drops, solution but it will be referred to as
Minims throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1. What Minims
is and what it is used for
2. What you need to know before you use your eye drops
3. How to use your eye drops
4. Possible side effects
5. How to store your eye drops
6. Contents of the pack and other information
1. WHAT MINIMS IS AND WHAT IT IS USED FOR
Minims contains a corticosteroid.
It is used to treat inflamed eyes (red and painful) for which the
inflammation is not caused by an infection. The part of the eye
affected will vary depending on the cause of the inflammation.
Your doctor may sometimes prescribe other drugs at the same time to
make sure that the inflammation is treated effectively.
This medicine is indicated for children, adults and the elderly.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE YOUR EYE DROPS
DO NOT USE THESE DROPS IF:

you are allergic to the active substance (prednisolone) or any of the
other ingredients of this medicine (listed in section 6).

you have high pressure inside the eye or you are at risk of developing
glaucoma. Your doctor will have checked for this.

you have an eye infection.

it is intended for long term continuous therapy in children (at the
discretion of the physician).
WARNING AND PRECAUTIONS
Contact your doctor if you exper

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Prednisolone Sodium Phosphate 0.5% w/v Eye and Ear Drops, Solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Prednisolone Sodium Phosphate 0.5% w/v
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Eye and ear drops, solution
Sterilised clear and colourless aqueous solution
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prednisolone Sodium Phosphate Drops is indicated for short term
treatment of steroid
responsive inflammatory conditions of the eye after clinical exclusion
of bacterial,
viral and fungal infections and Non-infected inflammatory conditions
of the ear.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and Children (including the Elderly)
_Eyes _
1 or 2 drops instilled into the eyes every one or two hours until
control is achieved,
when the frequency may be reduced.
_Ears _
2 or 3 drops instilled into the ear every two or three hours until
control is achieved,
when the frequency can be reduced.
Frequency of dosing depends on clinical response. If there is no
clinical response
within 7 days treatment, the drops should be discontinued. Treatment
should be the
lowest effective dose for the shortest possible time. After more
prolonged treatment
(over 6-8 weeks), the drops should be withdrawn slowly to avoid
relapse.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
Bacterial, viral, fungal tuberculous or purulent conditions of the
eye. Use is
contraindicated if glaucoma is present or where herpetic keratitis
(e.g. dendritic ulcer)
is considered a possibility. Inadvertent use of topical steroids in
the latter condition
can lead to the extension of the ulcer and marked visual
deterioration.
In the ear, topical corticosteroids are contraindicated in patients
with fungal diseases
of the auricular structure, and in those with a perforated tympanic
membrane.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Topical corticosteroids should never be given for an un