Voren

Main information

  • Trade name:
  • Voren Enteric Microencapsulated Capsule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Voren Enteric Microencapsulated Capsule
    Malaysia
  • Language:
  • English

Other information

Status

  • Source:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Authorization number:
  • MAL19987985
  • Last update:
  • 28-05-2018

Patient Information leaflet

VOREN ENTERIC MICROENCAPSULATED CAPSULE

Diclofenac sodium (50mg)

1

Consumer Medication Information Leaflet (RiMUP)

What is in this leaflet

What VOREN is used for

How VOREN works

Before you use VOREN

How to use VOREN

While you are using it

Side effects

Storage and Disposal of VOREN

Product Description

Manufacturer and Product

Registration Holder

Date of revision

What VOREN

is used for

It is used for:

Inflammatory and degenerative forms

of rheumatism

Rheumatoid

arthritis

(systemic

inflammatory disorder that affects

joints)

Ankylosing

spondylitis

(chronic

inflammatory

disease

skeleton)

Osteoarthritis

(degenerative

joint

disease)

Spondylarthritis

(inflammation

the joint)

Non-articular

rheumatism

(musculoskeletal

aches

pains

which do not arise from joints).

Post

traumatic

inflammation

swelling.

How VOREN works

VOREN

contains

substance

called

Diclofenac.

belongs

group

medicines

called

non-steroidal

anti-

inflammatory

agents

(NSAIDs)

which

reduces fever, pain and inflammation.

VOREN

enteric

coated

tablet

allow

medication to be distributed on a larger

surface area which can reduce the risk of

damage caused by the dumping of the

medication

area.

Moreover,

VOREN enteric-coated can also achieve

more

stable

plasma

concentration,

releases

medication

more

slowly,

providing

better

dosage

accuracy

increased bioavaibility.

Before you use VOREN

When you must not use it

Do not use VOREN:

If you are aspirin-sensitive.

If you have active stomach ulcer or

stomach and intestinal bleeding.

have

allergy

hypersensitivity

Diclofenac,

other

NSAIDs

other

ingredients listed at the end of this

leaflet

Before you start to use it

Tell your doctor or pharmacist:

If you have heart disease or stroke

If you have high blood pressure

Diclofenac may cause severe skin

reactions,

e.g.

toxic

epidermal

necrolysis,

Steven-Johnson

Sydrome.

Symptoms

may include

skin

rash,

blisters

peel

off.

These could be signs of a serious

condition. If these reactions occur,

stop

seek

medical

assistance right away.

If you have or have had ulceration,

bleeding

perforation

stomach and intestinal

suffering

from

dyspepsia

(discomfort at the epigastric region

due to digestion problem).

If you have bleeding disorder

have

kidney

liver

problem

If you are concomitantly administer

anti-inflammatory

drugs

other

non-steroidal

anti-inflammatory

drugs

including

aspirin

(blood

thinning agent)

If you have fluid retention or heart

failure.

If you have infection.

Please consult your doctor before

start

VOREN

pregnant, plan to become pregnant,

breast-feeding or intend to breast-

feed.

Your

doctor

will

have

weighed

risks

taking

VOREN against the benefits they

expect it will have for you.

Taking other medicines

Tell your doctor if you are taking any

other

medicines,

including

that

you buy without a prescription from a

pharmacy, supermarket or health food

shop.

Some

medicines

when

taken

with

VOREN may interfere with each other.

These include:

Potassium-sparing diuretics, water

pills

Aspirin, for blood thinning

Warfarin, medicine to prevent

blood clot

Digoxin, medicine for heart

Methotrexate, a medicine used to

treat rheumatoid arthritis, as well as

some types of cancers

Cyclosporin

medicine

used

after

organ transplant

7.

Oral hypoglycemics, for diabetes

How to use VOREN

How much to use

Adult: 1 capsule twice daily

Please follow the instruction given by

your doctor. Your doctor might want

to prescribe you the lowest effective

dose for the shortest duration.

When to use it

Use as directed by your doctor or

pharmacist.

How long to use it

Continue taking VOREN

for as long as

your doctor recommends.

If you forget to use it

If you miss a dose of VOREN, take it

as soon as possible. If it is approaching

time for the next dose, skip the missed

dose

back

your

regular

dosing schedule. Do not double doses.

If you use too much (overdose)

Contact your doctor immediately or go

to the Emergency Department of your

nearest hospital, if you think you or

anyone else may have taken too much

of this medicine. Do this even if there

signs

discomfort

poisoning.

need

urgent

medical attention.

Taking

many tablets

may cause

stomach

intestinal,

kidney,

brain toxicities, stomach and intestinal

bleeding,

kidney

failure,

convulsion

and coma.

While you are using it

Things you must do

Take your medicine exactly as your

doctor has told you.

2

Consumer Medication Information Leaflet (RiMUP)

Tell

doctors,

dentists

pharmacists treating you that you are

taking VOREN.

Tell your doctor immediately if you

become

pregnant

while

taking

this

medication

.

Things you must not do

Do not stop taking the medicine unless

advised by your doctor.

take

medicines

without consulting your doctor.

Do not give VOREN

to anyone else,

even if they have the same symptoms

or condition as you.

Things to be careful of

careful

driving

operating

machinery

until

know

VOREN affects you

Side effects

Stomach and intestinal side effects are

common.

Other side effects are:

Central

nervous

system:

Headache,

insomnia,

somnolence

(sleepiness)

and dizziness

Kidney

toxicity,

edema

(swelling),

palpitation

(feel

your

heart

beat),

minor

hearing

disorders,

blood

disorder

(Thrombocytopenia

eosinophilia).

- Skin disorder: rashes or skin eruptions

- Cases of hair loss, bullous eruption,

erythema

multiforme,

Stevens

Johnson

syndrome,

toxic

epidermal

necrolysis

(Lyell’s

syndrome),

photosensitivity reactions have been

reported.

Like all medicines, VOREN can cause

side effects, although not everybody gets

them.

Visit

your

doctor

pharmacist

immediately if you experience any side

effects after taking this medicine.

report

side

effects

adverse

drug

reactions

directly

National

Centre

Adverse

Drug

Reaction Monitoring by calling Tel: 03-

78835550,

visiting

website

portal.bpfk.gov.my

(Consumers

Reporting).

Storage and Disposal of VOREN

Storage

Keep in a tight container. Store below

30 °C, protect from light and moisture.

Disposal

Medicines should not be disposed of

wastewater

household

waste.

Ask your pharmacist how to dispose of

medicines no longer required. These

measures

will

help

protect

environment.

Product Description

What it looks like

hard

gelatin

transparent

body

containing

milky-

white pellets.

Ingredients

Active ingredient:

Diclofenac sodium

MAL number:

MAL19987985A

Manufacturer & Product Registration

Holder

Y.S.P. Industries (M) Sdn. Bhd.

&

Jalan

P/7,

Section

Kawasan

Perindustrian

Bandar

Baru

Bangi,

43000

Kajang,

Selangor

D.E.,

Malaysia.

Date of revision

28/12/2015

Serial Number:

BPFK(R4/1)101215/00489

25-5-2018

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