Valparin

Main information

  • Trade name:
  • Valparin X500 Tablet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Valparin X500 Tablet
    Malaysia
  • Language:
  • English

Other information

Status

  • Source:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Authorization number:
  • MAL05121152
  • Last update:
  • 28-05-2018

Patient Information leaflet

VALPARIN XR 500 TABLET

Sodium valproate (500mg)

1

Consumer Medication Information leaflet (RiMUP)

What is in this leaflet

What is Valparin XR used for

How Valparin XR works

Before you use Valparin XR

How to use Valparin XR

While you are using it

Side effects

Storage and disposal of Valparin

Product description

Manufacturer

Product

Registration Holder

Date of revision

What Valparin XR is used for

Valparin XR is used for:

treatment

generalised

partial

epilepsy,

particularly

with

the following patterns of seizures:

Absence

(short

period

“blanking out” or staring into

space).

Myoclonic

(brief

shock-like

jerks of a muscle).

Atonic (abrupt loss of muscle

tone).

Tonic-clonic

(loss

consciousness

violent

muscle contractions)

Mixed seizures.

Partial epilepsy:

Simple

(not

affecting

awareness or memory).

Complex seizures.

Secondary generalised seizures

(start in one area and spread to

both sides of the brain).

Specific

syndromes

(West,

Lennox-Gastaut).

How Valparin XR works

Valparin

contains

sodium

valproate.

belongs

group

medicines

called

anti-convulsants

anti-epileptic agents. These medicines

are thought to work by controlling brain

chemicals which send signals to nerves

so that seizures do not happen.

Before you use Valparin XR

When you must not use it

Do not take Valparin XR:

If you are allergic (hypersensitive)

to sodium valproate or any of the

other ingredients.

If you are having liver problems or

you or your family have a history

of liver problems.

having

rare

illness

called porphyria (a rare hereditary

disease in which the blood pigment

hemoglobin

abnormally

metabolized).

Pregnancy and lactation

If

you

are

a

female

patient

of

childbearing age, make sure that you

talk to your doctor about the risks

associated with taking Valparin XR

during pregnancy.

Tell your doctor if you are pregnant

or intend to become pregnant.

Like

most

medicines

this

kind,

Sodium Valproate Valparin XR may

affect your developing baby if taken in

the first trimester of pregnancy, as it is

suspected of causing an increased risk

of malformations in the exposed foetus.

However,

stop

taking

your

medication unless your doctor says so

as there are risks to the mother and

child from uncontrolled epilepsy.

Your doctor may want to adapt your

treatment

and/or

prescribe

dietary

supplements of folate.

Your doctor will discuss the risks and

benefits of taking it if you are pregnant.

Tell

your

doctor

if

you

are

breastfeeding

or

planning

to

breastfeed.

Medicines

used

treatment

epilepsy, including Valparin XR, pass

into

breast

milk.

Your

doctor

will

discuss the risks and benefits of taking

it if you are breastfeeding or planning

to breastfeed.

Before you start use it

Tell your doctor if you have or have

had any medical conditions, especially

the following:

Liver problems (liver insufficiency,

liver damage).

Kidney problems

Have

have

depression,

mood

problems,

suicidal

thoughts or behavior.

Systemic

lupus

erythematosus

(SLE), an autoimmune disease

Symptoms of pancreatitis such as

abdominal pain, nausea, vomiting

or anorexia.

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.

Some medicines and sodium valproate

may interfere with each other. These

include:

Other

medicines

used

treat

epilepsy

e.g.

phenobarbitone,

primidone,

phenytoin,

carbamazepine,

felbamate

lamotrigine.

Carbapenem

agents

(antibiotics

used to treat bacterial infections)

such

imipenem,

meropenem,

erythromycin.

combination of Valparin XR and

carbapenems

should

avoided

because it may decrease the effect

of your medicine.

Colestyramine used to lower blood

fat (cholesterol) levels.

Medicines used to treat depression

e.g. monoamine oxidase inhibitors

(MAOIs).

Benzodiazepines

(medicines

used

as sedatives or to treat anxiety).

Medicines

used

prevents

clotting (such as warfarin).

Some

medicines

used

prevention

treatment

malaria

such

mefloquine

chloroquine.

Cimetidine

used

stomach

ulcers.

Zidovudine (an antiviral agent).

Aspirin.

How to use Valparin XR

How much to use

Monotherapy

Adults:

The starting dose is 600mg daily.

Your doctor will gradually increase

this dose by 200mg every 3 days

depending on your condition.

usual

dose

generally

between 1000mg and 2000mg (20-

30mg

kilogram

body

weight) each day.

This may be increased to 2500mg

each

depending

your

illness.

VALPARIN XR 500 TABLETS

Sodium valproate (500mg)

2

Consumer Medication Information leaflet (RiMUP)

Children over 20 kilograms:

The starting dose should be 400mg

daily. Your doctor should increase

this dose depending on your child’s

Illness.

usual

dose

then

between

20mg and 30mg for each kilogram

of body weight each day.

This may be further increased to

35mg for each kilogram of body

weight each day depending on your

child’s illness.

Follow all directions given to you by

your doctor and pharmacist carefully.

They may differ from the information

contained

this

leaflet.

This

depend on your age, your condition and

whether or not you are taking any other

medicines. If you do not understand the

instructions

label,

your

doctor or pharmacist for help.

When to use it

Valparin XR 500 may be given once or

twice

daily.

tablet

should

swallowed whole and not crushed or

chewed.

How long to use it

Continue

taking

Valparin

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)

If you take too much Valparin XR, call

your

doctor

poison

control

center

right away, or get emergency treatment

at nearest hospital as soon as possible.

If you take too much Valparin XR, the

following effect may happen: nausea,

vomiting,

dizziness,

coma,

weak

muscles and poor reflexes, pupils of the

eye become smaller, breathing problem,

fits (seizure), brain oedema, increased

intracranial

pressure

(pressure

inside

the skull).

While you are using it

Things you must do

Take

your

medicine

exactly

your doctor has told you.

Tell all the doctors, dentists and

pharmacists treating you that you

are taking Valparin XR.

Tell

your

doctor

immediately

you become pregnant while taking

this medication.

Women taking Valparin XR during

pregnancy have a higher risk than

other women of having a child with

an abnormality (like Head and face

deformities including cleft palate (a

depression

lip),

abnormality

spinal

cord

called ‘Spina bifida’).

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 Valparin XR to anyone

else, even if they have the same

symptoms or condition as you..

Things to be careful of

This

medicine

produce

suicidal

thoughts or behavior. If this happens

contact your doctor immediately.

Driving and using machines

This medicine may affect your ability

to drive or use machines. If the tablets

make you feel sick or sleepy do not

drive or use machines and contact your

doctor immediately.

Side effects

Like all medicines, Valparin XR can

cause

side

effects,

although

everybody gets them.

Visit

your

doctor

pharmacist

immediately if you experience any side

effects after taking this medicine:

Increased

liver

enzymes,

liver

dysfunction, severe liver damage,

including liver failure.

Nausea.

Pancreatitis

(inflammation

pancreas).

Allergic

reactions

(ranging

from

rash to hypersensitivity reactions).

Lethargy and confusion, deep loss

consciousness

(coma),

convulsions.

Loss of memory (dementia).

Hair loss.

Feeling shaky (tremor),

Sleepy.

Thrombocytopenia

(decrease

platelets in blood).

Anaemia

(decrease

blood

cell), leucopenia (decrease in white

blood

cell)

pancytopenia

(decrease in blood cells).

Blood clotting problems.

Redness of skin.

Toxic epidermal necrolysis (Severe

blistering rash where layers of the

skin may peel off to leave large

areas of raw exposed skin over the

body).

Stevens-Johnson

syndrome

(Blistering or bleeding of the skin

around the lips, eyes, mouth, nose

and genitals).

Erythema multiforme (skin rash or

skin lesions with a pink/red ring

and a pale centre which may be

itchy, scaly or filled with fluid. The

rash may appear especially on the

palms or soles of your feet).

Peripheral oedema.

Amenorrhoea

(absence

menstrual

period)

irregular

periods.

Reversible

Fanconi’s

syndrome

(kidney malfunction giving rise to

glycosuria (excess of sugar in the

urine),

aminoaciduria

(abnormal

amount

amino

acids

urine),

phosphaturia

(presence

excessive

quantity

phosphates

urine),

uricosuria

(presence

excessive

amounts of uric acid in the urine)).

Tell your doctor immediately, or go to

Accident

Emergency

your

nearest hospital if you notice any of the

following side effects.

The following side effects may be signs

of problems with your liver or pancreas

such as:

Asthenia (weakness).

Anorexia (eating disorder).

Lethargy.

Drowsiness.

Vomiting.

Abdominal pain.

Nausea.

VALPARIN XR 500 TABLETS

Sodium valproate (500mg)

3

Consumer Medication Information leaflet (RiMUP)

This

complete

list

side

effects.

Contact

your

doctor

pharmacist if you experience any side

effects.

If any of the side effects gets serious, or

if you notice any side effects not listed

in this leaflet, please tell your doctor or

pharmacist.

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 Valparin XR

Storage

Keep in a dry place at a temperature not

exceeding 30

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

White,

oblong

shaped

film

coated

tablets with breakline on both sides.

Ingredient

Active ingredient(s)

Sodium Valproate.

Valproic acid.

Inactive ingredient(s)

Colloidal silicon dioxide.

Hydroxypropylmethyl cellulose.

Ethyl cellulose.

Hydrated silica.

Saccharin sodium.

Glycerin.

Titanium dioxide.

Eudragit E 100.

Eudragit NE 30D.

Polyethylene glycol.

Talc.

Methanol.

MAL number:

MAL05121152A

Manufacturer

TORRENT PHARMACEUTICALS

LTD.

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.

Date of revision

22/02/2016

Serial Number

BPFK(R4/1)190216/00051

25-5-2018

Orphan designation:  Treprostinil sodium,  for the: Treatment of chronic thromboembolic pulmonary hypertension

Orphan designation: Treprostinil sodium, for the: Treatment of chronic thromboembolic pulmonary hypertension

On 8 February 2013, orphan designation (EU/3/13/1103) was granted by the European Commission to SciPharm S.a.r.L, Luxembourg, for treprostinil sodium for the treatment of chronic thromboembolic pulmonary hypertension.

Europe - EMA - European Medicines Agency

17-10-2014

PRAC recommends strengthening the restrictions on the use of valproate in women and girls

PRAC recommends strengthening the restrictions on the use of valproate in women and girls

The EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC) recommends strengthening the restrictions on the use of the antiepileptic valproate due to the risk of malformations and developmental problems in children exposed to valproate in the womb.

Danish Medicines Agency

1-6-2018

Valproate

Valproate

Valproate (Active substance: medicinal products containing substances related to valproate (sodium valproate, valproic acid, valproate semisodium, valpromide, valproate magnesium)) - Community Referrals - Art 31 - Commission Decision (2018)3623 of Fri, 01 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1454

Europe -DG Health and Food Safety

28-3-2018

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (Active substance: Sodium (1R,3R,4R,5S)-3-({2-N-acetylamino-2-deoxy-3-O-[(1S)-1-carboxylato-2-cyclohexylethyl]-beta-D-galactopyranosyl}oxy)-4-({6-deoxy-alpha-L-galactopyranosyl}oxy)-5-ethyl-cyclohexan-1-yl-(38-oxo-2,5,8,11,14,17,20,23,26,29,32,35-dodecaoxa-39-azahentetracontan-41-yl)carboxamide) - Transfer of orphan designation - Commission Decision (2018)2011 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/17/T/01

Europe -DG Health and Food Safety

21-3-2018

EU/3/16/1711 (Akcea Therapeutics UK Ltd)

EU/3/16/1711 (Akcea Therapeutics UK Ltd)

EU/3/16/1711 (Active substance: Volanesorsen sodium) - Transfer of orphan designation - Commission Decision (2018)1822 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/082/16/T/01

Europe -DG Health and Food Safety