Nalcrom 100mg capsules

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Sodium cromoglicate

Sẵn có từ:

Sanofi

Mã ATC:

A07EB01

INN (Tên quốc tế):

Sodium cromoglicate

Liều dùng:

100mg

Dạng dược phẩm:

Oral capsule

Tuyến hành chính:

Oral

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Valid as a prescribable product

Tóm tắt sản phẩm:

BNF: 01050400; GTIN: 5033929301304

Tờ rơi thông tin

Not. 61(3) Update to Medical Information telephone number
PACKAGE LEAFLET: INFORMATION FOR THE USER
NALCROM
® 100MG CAPSULES
Sodium cromoglicate
IS THIS LEAFLET HARD TO SEE OR READ? PHONE [phone] FOR HELP
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.
WHAT IS IN THIS LEAFLET
1.
What Nalcrom Capsules are and what they are used for
2.
What you need to know before you take Nalcrom Capsules
3.
How to take Nalcrom Capsules
4.
Possible side effects
5.
How to store Nalcrom Capsules
6.
Contents of the pack and other information.
1.
WHAT NALCROM CAPSULES ARE AND WHAT THEY ARE USED FOR
Nalcrom 100mg Capsules (called Nalcrom Capsules in this leaflet)
contains a medicine called sodium
cromoglicate. This belongs to a group of medicines called
anti-allergics.
It works by stopping the release of the natural substances in your
body that can cause an allergic
reaction. It also lowers your response when you are exposed to
substances to which you are allergic.
WHAT NALCROM CAPSULES ARE USED FOR:
•
Nalcrom Capsules are used to treat allergic reactions to certain foods
•
It is only used if you have had a test to prove that you are allergic
to these foods
•
As part of your treatment, your doctor should advise you to avoid
eating certain foods
which may cause an allergic reaction
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NALCROM CAPSULES
DO NOT TAKE NALCROM IF:
X
You are allergic (hypersensitive) to sodium cromoglicate or any of the
other ingredients of
Nalcrom Capsules (listed in section 6)
Signs of an allergic reaction include:

Đặc tính sản phẩm

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nalcrom 100mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active component per capsule is:
Sodium Cromoglicate 100.0mg
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule
Hard gelatin capsule with a clear cap and body, marked ‘SODIUM
CROMOGLICATE 100 mg’ in black and containing a white powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nalcrom is indicated for food allergy (where adequate investigations
have
been performed to determine sensitivity to one or more ingested
allergens) in
conjunction with restriction of main causative allergens.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Nalcrom must be administered orally
Adults (including the elderly)
Initial dose: 2 capsules four times daily before meals
Children (2 – 14 years)
Initial dose: 1 capsule four times daily before meals
For adults (including the elderly) and children, if satisfactorily
control is not
achieved within two to three weeks, the dosage may be doubled but
should not
exceed 40 mg/kg/day.
Maintenance dose: Once a therapeutic response has been achieved, the
dose
may be reduced to the minimum required to maintain the patient free
from
symptoms.
4.3
CONTRAINDICATIONS
Nalcrom is contraindicated in patients with a known hypersensitivity
to sodium
cromoglicate or to any of the excipients listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
None stated
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known
4.6
FERTILITY, PREGNANCY AND LACTATION
Pregnancy
As
with
all
medication
caution
should
be
exercised
especially
during
the
first
trimester of pregnancy. Cumulative experience with sodium cromoglicate
suggests
that it has no adverse effects on fetal development. It should only be
used in
pregnancy where there is a clear need.
Breast-feeding
It is not known whether sodium cromoglicate is excreted in the breast
milk but on the
basis of its physico-chemical properties this is considered unlik