Controloc

Main information

  • Trade name:
  • Controloc 20mg Tablet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Controloc 20mg Tablet
    Malaysia
  • Language:
  • English

Status

  • Source:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Authorization number:
  • MAL20032151
  • Last update:
  • 28-05-2018

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

Consumer Medication Information Leaflet (RiMUP)

CONTROLOC 20MG TABLETS

Pantoprazole sodium (20mg)

__________________________________________________________________________________________

1

What is in this leaflet

What Controloc is used for

How Controloc works

Before you use Controloc

How to use Controloc

While you are using it

Side Effects

Storage and Disposal of

Controloc

Product Description

Manufacturer and Product

Registration Holder

Date of Revision

What Controloc is used for

Controloc is used in adults and

children 12 years and older:

Mild reflux disease

and associated

symptoms (e.g.

heartburn, acid

regurgitation, pain on

swallowing)

Long-term management

and prevention of relapse

reflux esophagitis

(inflammation or irritation

of esophagus caused by a

return flow of fluid from

stomach)

In adults:

Prevention of stomach and

intestinal ulcer induced by

Non-Steroidal Anti-

Inflammatory Drugs

(NSAIDs)

How Controloc works

Controloc belongs to a

medicine group known as

proton pump inhibitors (PPIs).

Controloc reduces the amount

of acid in your stomach.

Controloc may help your acid-

related symptoms, but you

could still

have serious

stomach problems. Talk with

your doctor.

Before you use Controloc

When you must not use it

You should not take Controloc

if you are allergic to

pantoprazole or any of the

other ingredients of this

medicine.

Before you start to use it

Before you take Controloc,

tells your doctor if you

:

have liver problems

Are pregnant or plan to

become pregnant. It is not

known if Controloc can

harm your unborn baby.

are breast-feeding or

planning to breast-feed.

Your doctor should

decide if you will take

Controloc or breast-feed.

You should not do both

without first talking with

your doctor.

Have reduced body stores

or risk factors for reduced

vitamin B12 absorption

Doctor will plan a few

tests if you have any

alarm symptom (e.g.

significant unintentional

weight loss, recurrent

vomiting, swallowing

difficulty, vomiting

blood, low red blood cells

or black, tarry stools) and

when gastric ulcer is

suspected or present,

cancer need to be

diagnosed.

Taking other medicines

Tell your doctor about all the

medicines you take including

prescription and non-

prescription medicines,

vitamins, and herbal

supplements. Controloc may

affect how other medicines

work, and other medicines may

affect how Controloc works.

Especially tell your doctor if

you take:

Atazanavir or nelfinavir

(medicines for Human

Immunodeficiency Virus

(HIV))

Methotrexate

(chemotherapy medication

used to treat cancer)

Tacrolimus (prevent

transplant rejection),

Fluvoxamine (for

depression or anxiety

disorder)

Warfarin, phenprocoumon

(prevent blood clotting)

How to use Controloc

How much to use

Take 1 Controloc 20mg

each day for symptom

relieve

Take 1 Controloc 20mg

for long-term

management and 2

Controloc 20mg if

relapse occur.

One Controloc 20mg for

prevention of stomach

and intestinal ulcer

induced by NSAIDs.

When to use it

Controloc is taken as advised

by your doctor.

How long to use it

2-4-weeks for symptom

relief and 4 week

treatment for healing of

associated esophagitis

(inflammation of

esophagus). If this is not

sufficient, healing will

usually be achieved

within a further 4

weeks.

If you forget to use it

If you miss a dose, take it as

soon as you remember. If you

do not remember until it is time

for your next dose, skip the

missed dose, and take the next

dose at your regular time. Do

not take 2 doses of Controloc at

the same time.

If you use too much

(overdose)

If you take too much

Controloc, call your doctor or

go to the nearest hospital

emergency room right away.

While you are using it

Things you must do

Controloc should be swallowed

Consumer Medication Information Leaflet (RiMUP)

CONTROLOC 20MG TABLETS

Pantoprazole sodium (20mg)

__________________________________________________________________________________________

2

whole with water.

Things you must not do

Controloc should not be

chewed or crushed.

Things to be careful of

There is increased risk

for bone fracture for

people who received

high-doses, or used

more than a year or

longer.

There is an increased

risk of bacteria

infection.

Liver enzymes should

be monitored for long-

term use.

Low magnesium level

(hypomagnesemia)

has been rarely

reported in individuals

treated with PPIs for

at least three months

(in most cases after a

year of therapy).

Serious consequences

of hypomagnesemia

include muscle spasm,

irregular heart beat,

and fits.

For those expected to

be on prolonged

treatment or who take

PPIs with medications

such as digoxin or

medicines that may

cause

hypomagnesemia (e.g.

diuretics), doctor may

consider measuring

magnesium levels

before starting PPI

treatment and

periodically during

treatment.

Side Effects

The uncommon side effects of

Controloc include:

Sleep disorder

Headache

Dizziness

Diarhoea

Nausea

Vomiting

Constipation

Dry mouth, abdominal

pain and discomfort

Liver enzymes increased

Rash

fatigue

You may report any side

effects or adverse drug

reactions directly to the

National Centre for Adverse

Drug Reaction Monitoring by

calling Tel: 03-78835550, or

visiting the website

npra.moh.gov.my (Public

Reporting Medicinal Problems

/ Side Effects / AEFI / Vaccine

Safety)

Storage and Disposal of

Controloc

Storage

Store Controloc below 30°C.

Keep Controloc and all

medicines out of the reach of

children.

Disposal

Do not throw away any

medicines via wastewater or

household waste. Ask your

pharmacist how to throw away

medicines you no longer use.

These measures will help

protect the environment.

Product Description

What it looks like

Controloc is supplied as

film-coated tablet that are

yellow, biconvex and

printed with P20 in brown

ink on one side.

Ingredients

Active ingredient

Pantoprazole Sodium

Inactive ingredients

Sodium carbonate;

Mannitol; Crospovidone;

Povidone K90; Calcium

stearate; Hypromellose

2910; Povidone K25;

Titanium dioxide E171;

Yellow ferric oxide E172;

Propylene glycol; Triethyl

citrate; Methaacrylic acid

– ethyl acrylate

Copolymer (1:1);

Polysorbate 80; Sodium

Laurisulfate; Printing ink.

MAL Number

MAL20032151AZ

Manufacturer

Takeda GmbH,

Production Site Oranienburg

Lehnitzstrasse 70-98

D-16515 Oranienburg

Germany

Product Registration Holder

Takeda Malaysia Sdn Bhd

Unit TB-L13-1, Level 13,

Tower B, Plaza 33,

No. 1, Jalan Kemajuan,

Seksyen 13,

46200 Petaling Jaya, Selangor,

Malaysia

.

Date of Revision

29/08/2017 (CCDS v3.1)

Serial Number

NPRA(R4/1)290817/00235