Ciprofibrate 100mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Ciprofibrate

Tilgjengelig fra:

CST Pharma Ltd

ATC-kode:

C10AB08

INN (International Name):

Ciprofibrate

Dosering :

100mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 02120000; GTIN: 5055946807331

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
CIPROFIBRATE 100MG TABLETS
• 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.
WHAT IS IN THIS LEAFLET
1. What Ciprofibrate is and what it is used for
2. What you need to know before you take
Ciprofibrate
3. How to take Ciprofibrate
4. Possible side effects
5. How to store Ciprofibrate
6. Contents of the pack and other information
1. WHAT CIPROFIBRATE IS AND
WHAT IT IS USED FOR
The name of your medicine is Ciprofibrate
100mg Tablets (called ciprofibrate throughout
this leaflet). It contains a medicine called
ciprofibrate. This belongs to a group of
medicines called ‘fibrates’.
These medicines are used to lower the level of
fats (lipids) in the blood. For example the fats
known as triglycerides.
Ciprofibrate is used alongside a low fat diet and
other non-medical treatments such as exercise
and weight loss, to lower levels of fats in the
blood.
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE CIPROFIBRATE
DO NOT TAKE CIPROFIBRATE:
-
if you are allergic to ciprofibrate or any of the
other ingredients of this medicine (listed in
section 6) Signs of an allergic reaction
include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat or
tongue
-
if you have previously taken ciprofibrate (or
related substances) and your skin reacted
badly to sunlight
-
if you are pregnant, might become pregnant
or think you may be pregnant (see
“Pregnancy and breast-feeding” section
below)
-
if you are breast-feeding (see “Pregnancy and
breast-feeding” section below)
-
if you have severe liver

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ciprofibrate 100mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100mg ciprofibrate as the active ingredient.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White to Off White capsule shaped tablet plain on one side and break
line on
other side.
The break line is only to facilitate breaking for ease of swallowing
and not to
divide into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ciprofibrate
tablets
are
indicated
as
an
adjunct
to
diet
and
other
non-
pharmacological treatment (e.g. exercise, weight reduction) for the
following:
-
Treatment
of
severe
hypertriglyceridaemia
with
or
without
low
HDL
cholesterol.
-
Mixed hyperlipidaemia when a statin is contraindicated or not
tolerated.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
The recommended dosage is one tablet (100mg ciprofibrate) per day.
This dose
should not be exceeded (see Precautions).
Elderly Patients
As for adults, but see Precautions and Warnings.
Use in Case of Impaired Renal Function
In
moderate
renal
impairment
(creatinine
clearance
30-80
ml/min/1.73m2)
it
is
recommended that dosage be reduced to one tablet every other day.
Patients should be
carefully monitored. Ciprofibrate should not be used in severe renal
impairment
(creatinine clearance <30 ml/min/1.73m2).
Use in Children
Not recommended since safety and efficacy in children has not been
established.
Method of administration
For oral use.
4.3
CONTRAINDICATIONS
Hypersensitivity
to
the
active
substance
or
to
any
of
the
excipients
listed
in
section6.1.
Severe hepatic impairment.
Severe renal impairment (creatinine clearance <30 ml/min/1.73m2).
Pregnancy and lactation, or when pregnancy is suspected.
Concurrent use with another fibrate.
Previous phototoxicity caused by fibrates
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Special warnings
Patients with rare hereditary problems of galactose intolerance, the
Lapp
lactose deficiency or glucose-gala