VASOTRATE

Main information

  • Trade name:
  • VASOTRATE OD
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • VASOTRATE OD
    Malaysia
  • Language:
  • English

Other information

Status

  • Source:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Authorization number:
  • MAL07061363
  • Last update:
  • 28-05-2018

Patient Information leaflet

VASOTRATE OD

Isosorbide Mononitrate Sustained Release Tablets 60 mg

1

Consumer Medication Information leaflet (RiMUP)

What is in this leaflet

What is Vasotrate OD used for

How Vasotrate OD works

Before you use Vasotrate OD

How to use Vasotrate OD

While you are using it

Side effects

Storage and Disposal of Vasotrate

Product Description

Manufacturer

Product

Registration Holder

Date of revision

What Vasotrate OD is used for

Vasotrate OD is used to prevent chest

pain

(angina

pectoris).

recommended

relief

chest

pain during acute attacks.

How Vasotrate OD works

Isosorbide

mononitrate

belongs

group of medicines called nitrates. It

works by relaxing the blood vessels,

letting more blood and oxygen reaches

the heart.

Before you use Vasotrate OD

When you must not use it

Do not take this medicine if you are:

Hypersensitive to nitrates or any of

the ingredients.

Pregnant, trying to get pregnant or

think you may be pregnant.

Breast-feeding. Ask your doctor or

pharmacist for advice before taking

any medicine.

Taking

phosphodiesterase

type

inhibitors,

such

sildenafil,

tadalafil and vardenafil.

Do not take isosorbide mononitrate if

have

following

medical

conditions:

Extremely low blood pressure.

Shock

states

collapse

including

those

caused

blood pressure or failing heart.

certain

diseases

pericardium (a double-walled sac

containing the heart).

Pericarditis

(swelling

around

heart).

Weakened muscle of the heart.

Pregnancy and lactation

Do not take Vasotrate OD if you are

pregnant, trying to get pregnant or think

you may be pregnant.

Do not take Vasotrate OD if you are

breast-feeding.

your

doctor

pharmacist for advice before taking any

medicine.

Before you start use it

You must tell your doctor if you have

any of these medical conditions:

Low blood pressure (this can make

feel

faint,

weak

dizzy,

especially

stand

suddenly).

Brain damage.

Heart disease.

Reduced oxygen level in the blood

(hypoxaemia).

Blood deficiency (anaemia).

Taking other medicines

Tell your doctor if you are taking any

other medicines, including any that you

without

prescription

from

pharmacy, supermarket or health food

shop.

Tell your doctor if you are taking any

other medicines, including:

Medicines used to treat impotence

in men e.g. sildenafil, vardenafil,

tadalafil.

Medicines used to treat high blood

pressure and heart conditions, such

calcium

antagonists

(like

amlodipine), ACE inhibitors (like

captopril), beta blockers, diuretics,

tricyclic

antidepressants

(like

imipramine).

How to use Vasotrate OD

How much to use

Adults:

VASOTRATE OD 60mg (one tablet)

once daily given in the morning. The

dose may be increased to 120mg (two

tablets) daily, both to be taken once

daily in the morning. Your doctor may

titrate

dose

minimise

possibility

headache,

initiating

treatment with 30mg (half a tablet) for

the first 2-4 day.

When to use it

Vasotrate

Tablets

must

chewed

crushed.

They

should

swallowed whole with half a glass of

water.

How long to use it

Continue taking Vasotrate OD 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 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

are no signs of discomfort or poisoning.

You may need urgent medical attention.

If you take too much Vasotrate OD, the

following effect may happen: Pulsing

headache.

excitation,

flushing,

sweating,

feeling

sick

(nausea),

vomiting,

head

spinning,

fainting,

increase in heart rate and fall in blood

pressure.

While you are using it

Things you must do

Take

your

medicine

exactly

your

doctor

told

you.

Tell

doctors,

dentists

pharmacists

treating

that

taking

Vasotrate OD.

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.

take

medicines

without consulting your doctor.

give

Vasotrate

anyone else, even if they have the

same

symptoms

condition

you.

Do not take medicines known as

phosphodiesterase type 5 inhibitor

used to treat impotence (or erectile

dysfunction)

whilst

this

medicine.

VASOTRATE OD

Isosorbide Mononitrate Sustained Release Tablets 60 mg

2

Consumer Medication Information leaflet (RiMUP)

Things to be careful of

Driving and using machines

This medicine may affect your ability

to drive or use machines. If the tablets

make you feel sick, dizzy or drowsiness

or tired do not drive or use machines

and contact your doctor immediately.

Side effects

Like all medicines, Vasotrate OD can

cause

side

effects,

although

everybody gets them.

Visit

your

doctor

pharmacist

immediately if you experience any side

effects after taking this medicine.

Low blood pressure when standing

up (postural hypotension), increase

heart

rate,

chest

pain

obstruction

coronary

arteries

(angina

pectoris),

heart

failure,

high

blood

pressure,

syncope,

irregular heartbeat, slow heart rate

(bradycardia),

abnormal

heart

sound,

abnormal,

heart

attack.

Somnolence,

coughing,

sensation

tingling,

tickling,

prickling,

pricking

burning

(paresthesia),

insomnia

(inability

to get sleep or stay asleep), vertigo

(feeling

that

your

environment

moving

spinning),

tremor,

agitation,

amnesia

(loss

memories),

impaired concentration, depression,

confusion,

anxiety

nervousness.

Abdominal

pain,

diarrhea,

flatulence,

increased

sweating,

back pain, dyspepsia (indigestion),

rhinitis (inflammation of the inside

nose),

constipation,

tooth

disorder,

vomiting,

loose

stools,

gastric

ulcer

bleeding,

duodenal

ulcer, dizziness, nausea, headache,

fatigue,

mouth

flushing,

inflammation of the lining of the

stomach.

Rash,

pruritus

(itching),

chronic

inflammation

skin

(symptoms

like

dryness,

redness,

blistering of skin) acne (scaly red

skin), abnormal hair texture, skin

disorder,

allergic

reaction,

skin

nodule.

Inflammation

vagina,

prostatic

disorder,

kidney

stone,

urinary

tract

infection,

polyuria

(excess

production

urine),

female

breast

pain,

impotence,

decreased

libido

(low

sexual

desire).

Asthenia

(abnormal

physical

weakness

lack

energy),

feeling of warmth, fever, flu-like

symptoms,

discomfort

uneasiness

(malaise),

rigors,

ache,

nose

bleeding,

bacterial

infection, weight decrease, weight

increase,

peripheral

edema

(swelling

legs

caused

abnormal accumulation of fluid in

the body tissues).

Inflammation

gallbladder,

enlarged

liver,

diabetes

mellitus,

high

levels

uric

acid,

cerebrovascular

disorder

(conditions

caused

problems

that affect the blood supply to the

brain), increase in liver enzyme.

Conjunctivitis

(itchy

eyes,

with

discharge

crusty

eyelids),

double

vision,

abnormal

vision,

photophobia (extreme sensitivity to

light).

Joint

pain,

joint

inflammation,

frozen shoulder, muscle weakness,

myalgia

(muscle

pain),

inflammation

muscle,

tendon

disorder, musculoskeletal pain.

Difficulty in breathing, respiratory

infection,

bronchitis

(infection

main

airways

lungs

(bronchi), causing them to become

irritated

inflamed),

bronchospasm

(tightening

airways

going

into

lungs),

inflammation of throat, pneumonia

(lung

infection),

respiratory

disorder

(disorder

related

respiration

organ),

pulmonary

infiltration (deposition of substance

denser than air, such as pus, blood,

or protein, which lingers within the

lungs), increased sputum, sinusitis

and nasal congestion.

Reduced

numbers

blood

cells (anemia), reduced numbers of

white

blood

cells

(leucopenia,

neutropenia,

agranulocytosis),

reduced

numbers

platelets

(thrombocytopenia), high levels of

cholesterol

lipid/fat,

hypocalcemia

(low

level

calcium in the blood).

report

side

effects

adverse drug reactions directly to the

National

Centre

Adverse

Drug

Reaction Monitoring by calling Tel: 03-

78835550,

visiting

website

portal.bpfk.gov.my

(Consumers

Reporting).

Storage

and

Disposal

of

Vasotrate

OD

Storage

Keep in dry place at a temperature

not exceeding 30

C, protect from

light.

Disposal

Medicines should not be disposed of

via wastewater or household waste. Ask

your

pharmacist

dispose

medicines

longer

required.

These

measures

will

help

protect

environment.

Product Description

What it looks like

Light yellow coloured round biconvex,

film coated tablets with breakline on

one side.

Ingredients

Active ingredient

Isosorbide mononitrate.

Inactive ingredients

Lactose.

Hydroxypropyl methylcellulose.

Talc.

Magnesium stearate.

Ethyl cellulose.

Diethyl phthalate.

Titanium dioxide.

Ferric Oxide Yellow.

MAL number:

MAL07061363AZ

Manufacturer

TORRENT PHARMACEUTICALS

.

Indrad 382 721, District: Mehsana,

INDIA.

Product Registration Holder

Laboratories

Torrent

(Malaysia)

Sdn.

Bhd.

Suite E-08-08 Plaza Mont Kiara,

No. 2 Jalan Kiara, Mont Kiara,

50480 Kuala Lumpur,

Malaysia.

VASOTRATE OD

Isosorbide Mononitrate Sustained Release Tablets 60 mg

3

Consumer Medication Information leaflet (RiMUP)

Date of revision

06/06/2016

Serial Number

BPFK(R4/1)110815/00239