Ciprofibrate 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ciprofibrate

Available from:

Advanz Pharma

ATC code:

C10AB08

INN (International Name):

Ciprofibrate

Dosage:

100mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02120000; GTIN: 05060055200034

Patient Information leaflet

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

Summary of Product characteristics

OBJECT 1
CIPROFIBRATE 100MG TABLETS
Summary of Product Characteristics Updated 04-Apr-2016 | ADVANZ Pharma
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
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