Bonviva

Main information

  • Trade name:
  • Bonviva Film-coated Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Bonviva Film-coated Tablets
    Malaysia
  • Language:
  • English

Status

  • Source:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Authorization number:
  • MAL20071629
  • Last update:
  • 28-05-2018

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

Consumer Medication Information Leaflet (RiMUP)

BONVIVA

®

FILM-COATED TABLETS

Ibandronic Acid (150mg)

__________________________________________________________________________________________

1

What is in this leaflet

What Bonviva is used for

How Bonviva works

Before you use Bonviva

How to use Bonviva

While you are using it

Side Effects

Storage and Disposal of

Bonviva

Product Description

Manufacturer and Product

Registration Holder

Date of Revision

What Bonviva is used for

Bonviva is a prescription

medicine used to treat

osteoporosis in women after

menopause. Bonviva helps

reduce the chance of having

fracture (break).

How Bonviva works

Bonviva contains the active

ingredient ibandronic acid.

Bonviva belongs to a group of

medicines called

bisphosphonates. Bonviva

reduces bone loss, with no

direct effect on bone formation

and increases bone mass.

Before you use Bonviva

When you must not use it

You should not take Bonviva if

you:

Are allergic to ibandronic

acid or any of the other

ingredients of this

medicine. (see section

Product description).

Are pregnant or

breastfeeding.

Cannot stand or sit

upright for at least 60

minutes.

Have certain problem

with your esophagus.

Have low levels of

calcium in your blood.

Less than 18 years old.

Before you start to use it

Before you take Bonviva, tells

your doctor if you:

Have problems with

swallowing

Have stomach or

digestive problems.

Have disturbances of

bone and mineral

metabolism.

Plan to have dental

surgery or teeth removed.

Have severe kidney

problems where

creatinine clearance is

<30 mL/min.

Plan to become pregnant

or breast-feeding.

Have cancer

Have other concomitant

therapies, e.g.,

chemotherapy,

radiotherapy,

corticosteroid

Have other diseases e.g.,

low red blood cell count

or hemoglobin, impaired

blood clotting, infection,

pre-existing dental

disease.

Taking other medicines

Tell your doctor if you are

taking any other medicines,

including prescription and non-

prescription medicines,

vitamins, and herbal

supplements. Especially tell

your doctor if you take:

Antacids for heartburn

Calcium supplements or

other multivalent cations

(such as aluminium,

magnesium, iron)

Nonsteroidal anti-

inflammatory (NSAID)

medicines for pain and

inflammation.

Other medicines not listed

above may also interact with

Bonviva. Your doctor and

pharmacist have more

information on medicines to be

careful with or avoid while

taking this medicine.

How to use Bonviva

How much to use

Take one Bonviva tablet once a

month, preferably taken on the

same date each month.

When you use it

Bonviva works only if taken on

an empty stomach.Take one

Bonviva tablet, after you get up

for the day and before taking

your first food, drink or other

medicine.

How long to use it

Continue taking Bonviva for as

long as your doctor

recommends.

If you forget to use it

If you miss a dose of Bonviva,

do not take it later in the day.

Take the morning after the

tablet is remembered unless the

time to the next scheduled dose

is within 7 days, you should

then return to taking the dose

once a month on the originally

scheduled date. Call your

doctor for instructions.

If you use too much

(overdose)

If you take too much Bonviva,

it may result in upper

gastrointestinal adverse events,

such as upset stomach,

heartburn, esophagus or

stomach inflammation or ulcer.

Owing to the risk of

esophageal irritation, do not try

to vomit. Do not lie down.

Contact your doctor

immediately or go to the

Emergency Department of your

nearest hospital.

While you are using it

Things you must do

Take Bonviva while you

are sitting or standing.

Swallow Bonviva tablet

with a full glass (180 to

240ml) of plain water

only.

Consumer Medication Information Leaflet (RiMUP)

BONVIVA

®

FILM-COATED TABLETS

Ibandronic Acid (150mg)

__________________________________________________________________________________________

2

You should take

supplemental calcium or

vitamin D if dietary

intake is inadequate.

Things you must not do

Do not chew or suck on

a tablet of Bonviva.

Do not stop taking

Bonviva without first

checking with your

doctor.

Do not give Bonviva to

anyone else, even if

they have the same

symptoms or condition

as you.

Things to be careful of

After swallowing Bonviva

tablet, wait at least 60 minutes:

Before you lie down?

Before you take your

first food or drink

except for plain water.

Please note that

mineral waters should

not be used.

Side effects

The more common side effects

of Bonviva include:

Stomach area (abdominal

pain)

Nausea

Gastric inflammation

Diarrhea

Muscle or joint pain

Flu-like symptoms

The serious side effects of

Bonviva include:

Esophagus problems

Severe jaw bone problems

(osteonecrosis)

You may get allergic reactions,

such as hives, breathing

difficulties, swelling of your

face, lips, tongue or throat, or

feeling faint.

Tell your doctor if you have

any side effect that bothers you

or that does not go away. These

are not all the possible side

effects of Bonviva. For more

information, ask your doctor or

pharmacist.

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

Bonviva

Storage

Keep out of reach and sight of

children. Do not store Bonviva

above 30°C.

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

Bonviva is supplied as

tablets that are white to off-

white, film-coated and

oblong shaped marked

‘BNVA’ on one side, and

‘150’ on the other side.

Ingredients

Active ingredient

Ibandronic Acid monosodium

salt monohydrate.

Inactive ingredients

Tablet core

: Lactose

monohydrate, povidone,

cellulose microcrystalline,

crospovidone, stearic acid,

silica colloidal anhydrous

Tablet coating

: hypromellose,

titanium dioxide, talc (opadry

00A28646), macrogol 6000

MAL Number

MAL20071629AZ

Manufacturer

F.Hofmann-La Roche Ltd,

Basel

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

Serial Number

NPRA(R4/1)290817/00237