FENO-TG 160mg tablet

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

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Active ingredient:
FENOFIBRATE
Available from:
UNIMED SDN BHD
INN (International Name):
FENOFIBRATE
Units in package:
3x10'stablet Tablets
Manufactured by:
Troikaa Pharmaceuticals Ltd
Authorization number:
MAL11045012AZ

Documents in other languages

Patient Information leaflet Patient Information leaflet - Malay

14-12-2017

Consumer Medication Information Leaflet (RiMUP)

FENO-TG 160 MG TABLET

Fenofibrate 160 mg

1

What is in this leaflet

What Feno-TG is used for

How Feno-TG

works

Before you use Feno-TG

How to use Feno-TG

While you are using it

Side effects

Storage and Disposal of Feno-TG

Product Description

Manufacturer

Product

Registration Holder

Date of revision

What

Feno-TG is used for

FENO-TG is used to lower the level of

fats (lipids) in the blood. For example the

fats known as triglycerides. It is used,

alongside

diet

other

nonmedical treatments such as exercise

and weight loss, to lower levels of fats in

the blood.

How works

FENO-TG works through the activation

cell

nuclear

receptor

called

peroxisome

proliferator-activated

receptor alpha, which reduces the amount

of triglycerides and bad cholesterol made

body

increases

good

cholesterol.

Before you use Feno-TG

When you must not use it

Do not take Feno-TG if:

You have an allergy to FENO-TG or

any ingredients of it and

Gemfibrozil

Before you start use it

Tell your doctor if:

You have any allergies to any other

medicines or any other substances,

such as food, preservatives or dyes.

You are pregnant or intend to become

pregnant and breast-feeding or intend

to breast-feed.

have

have

other

medical

conditions,

including:

Kidney

problems

muscular

aching, tenderness or weakness not

caused by exercise.

Pregnancy and lactation

Ask your doctor or pharmacist for advice

before taking this medicine if you are

pregnant or breast-feeding.

Taking other medicines

Please tell your doctor if you are taking or

have recently taken any other medicines,

including medicines obtained without a

prescription.

In particular please let your doctor know

if you already take:

Anti-coagulants to thin your blood ,

other drugs used to control lipid (fat)

levels in the blood and Ciclosporin

(an immunosuppressant)

How to use

Feno-TG

How much to use

Always take FENO-TG 160 mg exactly as

your doctor has told you. The usual dose

for adults is one tablet of FENO-TG 160

mg a day. You should check with your

doctor if you are not sure. Tablet should

be swallowed during a meal with water.

When to use it

FENO-TG can be taken at any time of the

day. Any dietary measures started before

treatment

with

FENO-TG

should

continued. Take FENO-TG at about the

same time each day. Taking tablets at the

same time each day will have the best

effect. It will also help you remember

when to take the tablets.

How long to use it

forget

that

fenofibrate

effective,

needs

taken

very

regularly and for as long as your doctor

has recommended, even if this duration is

very long time. Do not stop taking this

medicine unless your doctor has told you.

If you forget to use it

Do not take a double dose to make up for

a forgotten tablet. Take the next dose with

your next meal and then carry on taking

your tablets as usual. If you are worried

about this talk to your doctor.

If you use too much (overdose)

If you accidentally take more dose than

you should or if someone else has taken

your

medicine,

contact

your

nearest

hospital casualty department or tell your

doctor immediately.

While you are using it

Things you must do

Have your blood fats checked when

requested by your doctor to make

sure FENO-TG is working.

If you become pregnant while you are

taking FENO-TG stop taking it and

contact your doctor immediately.

If you are about to be started on any

new medicine tell your doctor and

pharmacist

that

taking

FENO-TG

Things you must not do

Do not give FENO-TG to anyone else,

even if they have the same condition as

you and do not use FENO-TG to treat any

other complaints unless your doctor tells

you to.

Things to be careful of

Discontinue use if irritation or sensitivity

reaction develops.

Avoid

drinking

large

quantities

alcohol.

Drinking

large

quantities

alcohol

increase

your

chance

FENO-TG causing liver problems.

Side effects

Like all medicines, FENO-TG can cause

side effects although not everybody gets

them. Tell your doctor immediately

if you

experience

following

symptoms after taking this medicine as

the symptoms can be severe.

Abdominal pain

Back pain

Headache

Diarrhea

Nausea

Constipation

Rhinitis

Joint disorder

Leg cramp

Consumer Medication Information Leaflet (RiMUP)

FENO-TG

Fenofibrate 160 mg

2

report

side

effects

adverse

drug

reactions

directly

National

Centre

Adverse

Drug

Reaction Monitoring by calling Tel: 03-

78835550,

visiting

website

npra.moh.gov.my

(Public

Reporting

Medicinal Problems/ Sides Effects / AEFI

/ Vaccine Safety).

Storage and Disposal of

Feno-TG

Storage

Store below 30°C, Protected from light.

Disposal

Medicines should not be disposed of via

wastewater or household waste. Ask

your

pharmacist

dispose

medicines no longer required. These

measures

will

help

protect

environment.

Product Description

What it looks like

Orange colored, round shape, biconvex

film coated tablet.

Ingredients

Active ingredient

Fenofibrate 160 mg

Inactive ingredients

Disodium

Edetate,

Microcrystalline

Cellulose,

Sodium

Starch

Glycollate,

Starch,

Isopropyl

Alcohol,

Polyvinylpyrrolidone

K-30,

Crospovidone, Sodium Lauryl Sulphate,

Magnesium

Stearate,

Talc,

Ethyl

Cellulose,

Hydroxypropylmethyl

Cellulose, Lake of Sunset Yellow (Dye

Content 12 – 17%), Methylene Chloride,

Propylene Glycol, Titanium Dioxide.

MAL number(s):

MAL11045012AZ

Manufacturer

Troikaa Pharmaceuticals Ltd.

C-1, Sara Industrial Estate, Selaqui,

Dehradun-248197, Uttarakhand, India

.

Product Registration Holder

Unimed Sdn Bhd

53, Jalan Tembaga SD 5/2B,

Bandar Sri Damansara,

52200, Kuala Lumpur, Malaysia.

Date of revision

08/09/2017

Serial Number:

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