Cuvarlix

Main information

  • Trade name:
  • Cuvarlix Capsule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Cuvarlix Capsule
    Malaysia
  • Language:
  • English

Status

  • Source:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Authorization number:
  • MAL07050025
  • Last update:
  • 28-05-2018

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

CUVARLIX CAPSULE

Orlistat (120mg)

1

Consumer Medication Information Leaflet (RiMUP)

What is in this leaflet

What CUVARLIX Capsule is used

How CUVARLIX Capsule works

Before you use CUVARLIX Capsule

How to use CUVARLIX Capsule

While you are using it

Side effects

Storage and Disposal of CUVARLIX

Capsule

Product Description

Manufacturer

Product

Registration Holder

Date of revision

What CUVARLIX Capsule is used for

It is used to treat obesity in conjunction

with

calorie

intake

diet.

approved for obese

individuals

with a

body mass index (BMI) of 30 or more

kilograms / square meter in the presence

of other risk factors, such as diabetes, high

blood pressure, or high cholesterol.

How CUVARLIX Capsule works

CUVARLIX Capsule contains the active

ingredient

orlistat.

works

digestive system to block the absorption

of fat into the body from the food you eat.

Fats from the food you eat need to be

broken down by enzymes called lipases

before they can be absorbed into the body.

Orlistat attaches to these enzymes in the

digestive system and blocks them from

breaking down about 30% of the fat you

have

eaten

during

your

meal.

undigested fat cannot be absorbed and is

then eliminated by your body.

Before you use CUVARLIX Capsule

-When you must not use it

Do not take CUVARLIX Capsule if you:-

allergic

(hypersensitive)

CUVARLIX Capsule or to any of the

other

ingredients

contained

CUVARLIX Capsule

have chronic malabsorption syndrome

(insufficient

absorption

nutrients

from alimentary tract)

if you have cholestasis (liver disorder)

Pregnancy and lactation

Do not take CUVARLIX Capsule if you

are pregnant, trying to get pregnant or

think you may be pregnant.

Do not take CUVARLIX Capsule if you

are breast-feeding. Ask your doctor or

pharmacist for advice before taking any

medicine if you are breast feeding.

-Before you start to use it

Inform your doctor or pharmacist before

taking this medicine if you have:

problems with your thyroid

diabetes

If you are not sure if any of the above

conditions

apply

you,

talk

your

doctor

pharmacist

before

using

CUVARLIX Capsule

-Taking other medicines

Tell your doctor or pharmacist if you are

taking any other medicines including any

that you buy without a prescription from

a pharmacy, supermarket or health food

shop.

CUVARLIX

Capsule

modify

activity of

Anticoagulant

medicines

(e.g.

warfarin) -Your doctor may need to

monitor your blood coagulation when

you take CUVARLIX Capsule

Ciclosporin

Using

CUVARLIX

Capsule

with

ciclosporin

recommended. If you do use it, your

doctor

need

monitor

your

ciclosporin

blood

levels

more

frequently than usual

Amiodarone - You should ask your

doctor for advice.

Acarbose - CUVARLIX Capsule is

not recommended for people taking

acarbose (an anti-diabetic medication)

Oral

diabetic

medication

(e.g.

(e.g.

sulfonylureas, metformin) or insulin.

Doctor might reduce the dose.

CUVARLIX

Capsule

reduces

absorption

soluble

nutrients

particularly beta-carotene and vitamin D.

You should therefore follow your doctor

or pharmacist’s advice in taking a well-

balanced diet rich in fruit and vegetables

they

suggest

take

multivitamin

supplement

that

contains

fat-soluble

vitamins.

supplement

should be taken once a day at least 2 hours

before or after taking orlistat, such as

bedtime.

How to use CUVARLIX Capsule

-How much to use

Follow all directions given to you by your

doctor and pharmacist carefully. They

differ

from

information

contained in this leaflet. If you do not

understand the instructions on the label of

your

medicine,

your

doctor

pharmacist for help.

Adults

The usual dose of CUVARLIX Capsule is

one 120 mg capsule taken with each of the

three main meals per day. It can be taken

during a meal or up to one hour after a

meal. The capsule should be swallowed

with water.

CUVARLIX

Capsule

should

taken

with a well-balanced, calorie controlled

diet that is rich in fruit and vegetables and

contains

average

calories from fat. Your daily intake of fat,

carbohydrate

protein

should

distributed over three meals. This means

will

usually

take

capsule

breakfast time, one capsule at lunch time

and one capsule at dinner time.

To gain optimal benefit from the use of

CUVARLIX Capsule, avoid the intake of

food containing fat between meals, such

as biscuits, chocolate and savoury snacks.

CUVARLIX Capsule only works in the

presence of dietary fat. Therefore, if you

miss a main meal or if you have a meal

containing no fat, CUVARLIX Capsule

need not be taken.

-When to use it

directed

your

doctor

pharmacist.

2

Consumer Medication Information Leaflet (RiMUP)

CUVARLIX CAPSULE

Orlistat (120mg)

-How long to use it

Continue taking CUVARLIX Capsule for

as long as your doctor recommends.

-If you forget to use it

Take the missed dose as soon as you

remember. If it is almost time for your

next dose,

wait until then to take the

medicine and skip the missed dose. Do

not take a double dose to make up for the

missed dose.

-If you use too much (overdose)

Contact your doctor immediately or go to

Emergency

Department

your

nearest

hospital

think

anyone else may have taken too much of

this medicine. Do this even if there are no

signs of discomfort or poisoning. You

may need urgent medical attention.

While you are using it

-Things you must do

Take

your

medicine

exactly

your

doctor or pharmacist has told you.

When seeking other treatment, inform all

the doctors, dentists and pharmacists that

you are taking CUVARLIX Capsule.

Tell

your

doctor

immediately

become

pregnant

while

taking

this

medication.

-Things you must not do

Do not stop taking the medicine unless

advised by your doctor.

Do not take any new medicines without

consulting your doctor or pharmacist.

give

CUVARLIX

Capsule

anyone else even if they have the same

symptoms or condition as you.

-Things to be careful of

Weight

loss

affect

dose

medicines taken for other conditions (e.g.

diabetes). Be sure to discuss with your

doctor

pharmacist

about

these

medicines and any others you may be

taking.

gain

maximum

benefit

from

CUVARLIX Capsule, you should follow

the nutrition program recommended to

you by your doctor.

CUVARLIX Capsule can cause harmless

changes in your bowel habits such as fatty

or oily stools due to the elimination of

undigested

your

faeces.

possibility of this happening may increase

if CUVARLIX Capsule is taken with a

diet high in fat.

The use of an additional contraceptive

method is recommended while you are

using

CUVARLIX

Capsule

prevent

possible failure of oral contraception that

could occur in case of severe diarrhoea.

Side effects

Like all medicines, CUVARLIX Capsule

cause

side

effects,

although

everybody gets them.

The majority of unwanted effects related

to the use of CUVARLIX Capsule result

from its action which is localized in your

digestive system. These side effects occur

beginning

treatment

experienced

particularly

after

meals

containing high levels of fat. Normally,

these

symptoms

disappear

when

continue using CUVARLIX Capsule and

keep to your recommended diet.

Very common side effects (affects more

than 1 user in 10)

headache,

upper respiratory infection

abdominal pain/discomfort

increased defecation

oily discharge

oily or fatty stools

liquid stools

gas with little discharge

oil evacuation

low blood sugar levels

The effect of orlistat is seen as soon as 24

hours

after

dosing.

Upon

discontinuation

therapy,

faecal

content usually returns to pre-treatment

levels, within 48 to 72 hours.

Common side effects (affects 1 to 10 users

in 100)

Rectal pain/discomfort

soft stools

fecal incontinence (uncontrolled)

lower respiratory infection

urinary tract infection

tooth/gum disorder

irregularity of menstrual cycle

anxiety

tiredness

Rare side effects (affects 1 to 10 users in

10 000)

Allergic

reactions

main

symptoms are itching, rash, swelling

and severe difficulty in breathing.

Very rare side effects (affects less than 1

user in 10 000)

Diverticulitis

Inflammation

diverticula (small pouches within the

wall

digestive

tract),

particularly in the colon.

Increases in the levels of some liver

enzymes may be found in blood tests.

Hepatitis (inflammation of the liver).

Symptoms can include yellowing of

skin

eyes,

itching,

dark

coloured urine, stomach pain and liver

tenderness (indicated by pain at the

right

side upper part of abdomen),

sometimes with loss of appetite.

Gallstones.

Oxalate nephropathy (buildup of calcium

oxalate which may lead to kidney stones).

Stop taking CUVARLIX Capsule and see

a doctor straight away if you notice any of

the serious side effects listed above. You

may need urgent medical treatment:

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 / Side Effects / AEFI

/ Vaccine Safety).

3

Consumer Medication Information Leaflet (RiMUP)

CUVARLIX CAPSULE

Orlistat (120mg)

Storage and Disposal of CUVARLIX

Capsule

- Storage

Keep out of reach and sight of children.

Store below 30°C. Protect from light.

Do not take CUVARLIX capsule after the

expiry date stated on the label.

- Disposal

Medicines should not be disposed of via

wastewater or household waste. Ask your

pharmacist how to dispose of medicines

no longer required. These measures will

help to protect the environment.

Product Description

-What it looks like

Turquoise/turquoise hard gelatin capsule

with Pharmaniaga icon.

-Ingredients

- Active ingredient(s):

Each capsule contains Orlistat 120mg

- Inactive ingredient(s):

Microcrystalline

Cellulose,

Sodium

Lauryl Sulphate, Povidone and Sodium

Starch Glycolate

-MAL number(s):

MAL07050025AZ

Manufacturer

Pharmaniaga

Manufacturing

Berhad

(60016-D),

11A,

Jalan

P/1,

Kawasan

Perusahaan

Bangi,

43650

Bandar

Baru

Bangi,

Selangor Darul Ehsan, Malaysia.

Product Registration Holder

Pharmaniaga

Manufacturing

Berhad

(60016-D),

11A,

Jalan

P/1,

Kawasan

Perusahaan

Bangi,

43650

Bandar

Baru

Bangi,

Selangor Darul Ehsan, Malaysia.

Date of revision

08/08/2017

Serial Number

BPFK(R4/1)310717/00186