Ciprofibrate 100mg tablets

Country: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

Ciprofibrate

থেকে পাওয়া:

A A H Pharmaceuticals Ltd

এটিসি কোড:

C10AB08

INN (International Name):

Ciprofibrate

ডোজ:

100mg

ফার্মাসিউটিকাল ফর্ম:

Oral tablet

প্রশাসন রুট:

Oral

শ্রেণী:

No Controlled Drug Status

প্রেসক্রিপশন টাইপ:

Valid as a prescribable product

পণ্য সারাংশ:

BNF: 02120000; GTIN: 5025903012429

তথ্য লিফলেট

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE
•
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. Do
not pass it on to others. It may harm them,
even if their symptoms are the same as yours
•
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist
•
Your doctor may have given you this medicine
before from another company. It may have
looked slightly different. However, either brand
will have the same effect
IN THIS LEAFLET:
1. What Ciprofibrate is and what it is used for
2. Before you take Ciprofibrate
3. How to take Ciprofibrate
4. Possible side effects
5. How to store Ciprofibrate
6. Further 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).
This
belongs
to
a
group
of
medicines commonly known as ‘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. BEFORE YOU TAKE CIPROFIBRATE
DO NOT TAKE CIPROFIBRATE IF:
•
You
are
allergic
(hypersensitive)
to
ciprofibrate or any of the other ingredients of
Ciprofibrate
(see
Section
6:
Further
information)
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling
of your lips, face, throat or tongue.
• You are pregnant, might become pregnant
or
think
you
may
be
pregnant
(see
“Pregnancy
and
breast-feeding”
section
below)
• You are breast-feeding (see “Pregnancy and
breast-feeding” section below)
• You have severe liver or kidney problems
• You are taking ‘fibrates’ (such as clofibrate,
bezafibrate,
fenofibrate
or
gemfibrozil)
–
used to treat high blood f

পণ্য বৈশিষ্ট্য

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