Ciprofibrate 100mg tablets

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Ciprofibrate

Prieinama:

Zentiva Pharma UK Ltd

ATC kodas:

C10AB08

INN (Tarptautinis Pavadinimas):

Ciprofibrate

Dozė:

100mg

Vaisto forma:

Oral tablet

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 02120000; GTIN: 5000283653608

Pakuotės lapelis

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 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.
• 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
CIPROFIBRATE 100MG TABLETS
PACKAGE LEAFLET:
INFORMATION FOR THE USER
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:
Important
information
about
some
of
the
ingredients of ciprofibrate
Ciprofibrate 100mg tablets contain lactose.
If you have been told by your doctor that you
have an intolerance to some sugars contact your
doctor before taking this medicinal product.
This medicine contains less than 1mmol sodium
(23mg)
per
dose,
that
is
to
say
essentially
‘sodium free’.
Take special care with ciprofibrate.
Check with your doctor or pharmacist
before taking ciprofibrate if you:
•
have unexpected muscle pains,
tenderness or weakness
• have liver or kidney problems
• have an u

Prekės savybės

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.
Excipients with known effect :Each tablet contains 28 mg lactose
monohydrate
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet.
White to off white round tablets with a breakline on one side and
embossed
‘S170’ on the other
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
_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 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.
_Use in Children _
Not recommended since safety and efficacy in children has not been
established.
Ciprofibrate tablets are for oral administration only.
4.3
CONTRAINDICATIONS
Severe hepatic impairment.
Severe renal impairment.
Pregnancy and lactation, or when pregnancy is suspected.
Concurrent use with another fibrate.
Hypersensitivity to the active substance or to any component of the
product.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
MYALGIA/MYOPATHY:
- Patients should be advised to report unexplained muscle pain,
tenderness or
weakness immediately.
CPK
levels
should
be
assessed
immediately
in
patients
reporting
these
symptoms. Therapy should be discontinued if myopathy is diagnosed or
if
markedly elevated CPK levels (levels exceedin