ALENDRONATE

Main information

  • Trade name:
  • ALENDRONATE PLUS D3 CALCIUM ACTAVIS alendronic acid (as sodium) 70 mg and colecalciferol 140 microgram tablet and calcium 500 mg
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ALENDRONATE PLUS D3 CALCIUM ACTAVIS alendronic acid (as sodium) 70 mg and colecalciferol 140 microgram tablet and calcium 500 mg
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222686
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222686

ALENDRONATE PLUS D3 CALCIUM ACTAVIS alendronic acid (as sodium) 70 mg and colecalciferol 140

microgram tablet and calcium 500 mg tablet composite pack

ARTG entry for

Medicine Registered

Sponsor

Dr Reddys Laboratories Australia Pty Ltd

Postal Address

Level 9 / 492 St Kilda Road,MELBOURNE, VIC, 3004

Australia

ARTG Start Date

14/01/2015

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. ALENDRONATE PLUS D3 CALCIUM ACTAVIS alendronic acid (as sodium) 70 mg and colecalciferol 140

microgram tablet and calcium 500 mg tablet composite pack

Product Type

Composite Pack

Effective date

12/07/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

for the treatment of:

·Osteoporosis in select patients where vitamin D and calcium supplementation is recommended,Prior to treatment, osteoporosis must be confirmed

·the finding of low bone mass of at least 2 standard deviations below the gender specific mean for young adults or by

·the presence of osteoporotic fracture

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Multiple containers

Not recorded

2 Years

Store below 25

degrees Celsius

Not recorded

Protect from Moisture

Protect from Light

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

4 week supply (4 x ALENDRONATE D3 70 mg/ 140 ug alendronic acid (as

sodium) 70 mg and colecalciferol 140 microgram tablets and 48 Calcium

Actavis calcium carbonate tablets)

(S4) Prescription Only Medicine

4 week supply (4 x ALENDRONATE D3 70 mg/ 140 ug alendronic acid (as

sodium) 70 mg and colecalciferol 140 microgram tablets and 24 Calcium

Actavis calcium carbonate tablets)

(S4) Prescription Only Medicine

Components

1. ALENDRONATE D3 70 mg/140 ug alendronic acid (as sodium) 70 mg and colecalciferol 140 microgram tablets blister pack

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

White to off-white, modified capsule-shaped uncoated tablet, debossed with

"ADC' on one side and '56' on the other side.

Active Ingredients

alendronate sodium

91.37 mg

colecalciferol

.14 mg

microcrystalline cellulose

187.63 mg

2. Calcium Actavis tablets bottle

Public Summary

Page 1 of

Produced at 26.11.2017 at 10:57:38 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Capsule shaped dark green film coated tablet with a break bar on one side

Active Ingredients

Calcium carbonate

1.25 g

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 2 of

Produced at 26.11.2017 at 10:57:38 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

ALENDRONATE

PLUS

D3 CALCIUM ACTAVIS

70 mg/ 140 µg

Contains the active ingredient alendronate sodium/colecalciferol and calcium carbonate

Consumer Medicine Information

What is in this leaflet

This

leaflet

answers

some

common

questions

about

Alendronate

Plus

Calcium

Actavis

µg.

particularly important that you read

the sections “When to take it” and

“How to take it” before you take this

medicine.

This

leaflet

does

contain all the available information.

It does not take the place of talking to

your doctor and pharmacist

medicines

have

risks

benefits.

Your

doctor

weighed

the risks of you taking Alendronate

Plus D3 Calcium Actavis against the

benefits they expect it will have for

you.

If

you

have

any

concerns

about

taking

this

medicine,

ask

your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What

Alendronate

Plus

D3

Calcium

Actavis is used for

Alendronate

Plus

Calcium

Actavis is a combination medicine

consisting of 4 once weekly tablets

of Alendronate D3 70 mg/ 140 µg

(5600 IU) together with 24 or 48

tablets of Calcium Actavis.

Alendronate

Plus

Calcium

Actavis is used to treat osteoporosis

and to provide additional vitamin D

and additional calcium.

Osteoporosis is caused by changes in

the way bone is normally maintained.

Vitamin

essential

nutrient

required for calcium absorption and

healthy

bones.

Calcium

essential

mineral,

necessary

maintain

bone

structure

body.

Understanding bone

Bone

living,

growing

tissue.

Throughout

life,

bodies

breaking

down

bone

rebuilding new bone in a continuous

cycle. Until our late 20s, while bones

are still developing, we gain bone by

building

more than

we lose. From

then until about age 35 the process is

usually in balance, so that the amount

of bone lost is about equal to the

amount

that

replaced.

This

balanced process keeps your skeleton

healthy and strong. After about age

this

balance

disturbed,

with

bone

loss

occurring

slightly

faster rate than it can be replaced. In

women, after menopause, hormonal

changes cause bone loss at an even

faster

rate.

When

bone

loss

excessive, bones can become thinner

and weaker, and therefore are more

likely to break.

Osteoporosis

“Osteo” means bone, and “porosis”

means something that has holes in it,

like

sponge.

Therefore,

osteoporosis

disease

which

causes bones to become more porous,

gradually making them weaker, more

brittle and likely to break.

Osteoporosis

common

postmenopausal

women.

menopause occurs when the ovaries

virtually stop producing the female

hormone, oestrogen, or are removed

(which may occur, for example, at

the time of a hysterectomy). At this

time, bone is removed faster than it is

formed,

bone

loss

occurs

bones become weaker. The earlier a

woman reaches the menopause, the

greater the risk of osteoporosis.

Osteoporosis also occurs in men but

is less common than in women.

Early on, osteoporosis usually has no

symptoms. However, if left untreated

it can result in broken bones, also

called fractures. Although fractures

usually cause pain, fractures of the

bones of the spine may go unnoticed

until they cause height loss. Fractures

may occur during normal, everyday

activity,

such

lifting,

from

minor

injury

that

would

ordinarily

fracture

normal

bone.

Fractures

usually occur at the hip,

spine, or wrist and can lead not only

pain,

also

considerable

deformity

disability,

such

stooped posture from curvature of the

spine, and loss of mobility.

What should I know about

vitamin D?

Vitamin D is an essential nutrient,

required for calcium absorption and

healthy bones. The main source is

through

exposure

summer

sunlight, which makes vitamin D in

our skin. Clothing or sun block can

prevent enough sunlight from getting

through. In addition, as people age,

their skin becomes less able to make

vitamin

Very

foods

natural sources of vitamin D.

little

vitamin

leads

inadequate

calcium

absorption

phosphate-minerals

that

make

bones strong. Even if you are eating a

diet

rich

calcium

taking

calcium

supplement,

your

body

cannot

absorb

calcium

properly

unless you have enough vitamin D.

Too little vitamin D may lead to bone

loss and osteoporosis. Severe vitamin

deficiency

cause

muscle

weakness which can lead to falls and

a higher risk of fracture.

Alendronate Plus D3 Calcium Actavis 70 mg/ 140 µg_v.10

What should I know about

calcium?

Calcium is vital for healthy teeth and

bones and also plays a crucial role in

other systems of the body, such as

the health and functioning of nerves

and muscle tissue. People at different

life stages need different amounts of

calcium - young children, teenagers

and older men and women all have

greater

than

average

requirements.

Many

Australian

adults

achieve the recommended amount of

calcium in their diets and can benefit

from calcium supplements.

Not having enough calcium in your

diet

lead

disorders

like

osteoporosis. Making sure you have

enough calcium in your diet is an

important way to slow bone loss and

keep

bones

strong.

enough

calcium from food and supplements

absorbed

keep

blood

calcium

normal,

body

will

remove calcium from the bones. If

your

dietary

intake

calcium

constantly

low,

your

body

will

eventually remove so much calcium

from

skeleton

that

your

bones

will

become

weak

brittle

more likely to break.

How

does

Alendronate

Plus

D3

Calcium

Actavis

work?

The alendronate in Alendronate D3

70 mg /140 µg (5600 IU) works by

slowing

down

process

bone being removed, which allows

bone-forming

cells

time

rebuild normal bone. Alendronate not

only helps prevent the loss of bone

but actually helps to rebuild bone and

make bone less likely to fracture.

Thus, Alendronate D3 70 mg /140 µg

(5600 IU) reverses the progression of

osteoporosis.

Alendronate

/140

(5600 IU) starts working on the bone

cells

immediately,

measurable

effects on bone mass may not be seen

for several months or more.

The alendronate in Alendronate D3

70 mg /140 µg (5600 IU) belongs to

a group of nonhormonal medicines

called bisphosphonates.

addition

alendronate,

Alendronate

/140

(5600 IU) also contains vitamin D,

essential

nutrient

required

calcium

absorption

healthy

bones.

Calcium

Actavis

contains

calcium,

an essential mineral necessary to help

maintain

bone

structure

body.

Before

you

take

Alendronate

Plus

D3

Calcium Actavis

should

know

that

some

people, Alendronate D3 70 mg /140

µg (5600 IU) can irritate or burn the

food pipe (also called oesophagus).

The chances of this happening should

reduced

when

follow

instructions

‘How

take

Alendronate

Plus

Calcium

Actavis’ in this leaflet.

When you must not take it

Do not take ALENDRONATE D3

70 mg /140 µg (5600 IU if:

you

have

an

allergy

to

,

ALENDRONATE

D3

70

mg

/140 µg (5600 IU or any of the

ingredients listed at the end of

this leaflet

you

have

certain

disorders

of

the

food

pipe

(oesophagus)

including

those

that

cause

difficulty in swallowing

you are unable to stand or sit

upright for at least 30 minutes

your doctor has told you that

you currently have low blood

calcium

your

dentist

advises

you

to

consult your doctor first

Do not take Calcium Actavis if

your doctor has told you that

you currently have high blood

calcium

you have kidney stone

you have an allergy to Calcium

Actavis

or

any

of

the

ingredients listed at the end of

this leaflet.

Do not take Alendronate Plus D3

Calcium

Actavis

if

you

are

pregnant or breast feeding.

Alendronate

Plus

Calcium

Actavis

been

studied

pregnant or breast-feeding women.

take

Alendronate

Plus

Calcium Actavis:

the

packaging

is

damaged

or

shows signs of tampering

the expiry date on the blister

pack has passed.

If you take this medicine after the

expiry date has passed, it may not

work.

If you are not sure whether you

should

start

taking

Alendronate

Plus D3 Calcium Actavis, talk to

your doctor.

Do not give Alendronate Plus D3

Calcium Actavis to a child

Alendronate

Plus

Calcium

Actavis

been

studied

children.

Before you start to take it

Tell your doctor if:

1.

You plan to become pregnant

or breast-feed

2.

You

have

any

medical

conditions,

especially

the

following:

kidney disease

swallowing

digestive

problems, such as ulcers

3. You have any allergies to any

other

medicines

or

any

other

substances,

such

as

foods,

preservatives or dyes

4.

You

have

dental

or

jaw-bone

problems or are planning to have

a course of dental surgery.

5.

You

currently

smoke

or

have

been a smoker in the past.

If you have not told your doctor

about any of the above, tell them

before you take any Alendronate

Plus D3 Calcium Actavis.

Taking other medicines

Tell your doctor if you are taking

any

other

medicines

including

medicines that you buy without a

prescription from your pharmacy,

supermarket or health food shop.

Some medicines may affect the way

other medicines work.

Some

medicines

are

likely

to

interfere

with

the

absorption

of

ALENDRONATE D3 70 mg /140

µg (5600 IU) if taken at the same

time. These include:

Alendronate Plus D3 Calcium Actavis 70 mg/ 140 µg_v.10

antacids, medicines used to treat

indigestion

e.g.

Gaviscon,

Mylanta

calcium

supplements

such

Calcium Actavis (as provided in

this

pack

ALENDRONATE

PLUS D3 CALCIUM ACTAVIS)

or Caltrate

vitamins

Therefore, take Alendronate D3 70

mg /140 µg (5600 IU) at least 30

minutes before taking any of these

or other medicines to make sure

there

is

no

problem

with

absorption.

Check

with

your

doctor or pharmacist if you are not

sure whether you are taking any of

these medicines.

You can take aspirin while you are

being treated with Alendronate Plus

D3 Calcium Actavis. However, both

aspirin and take Alendronate D3 70

mg /140 µg (5600 IU) may increase

the chance of stomach upsets.

Your doctor or pharmacist has more

information

medicines

careful

with or avoid while taking

Alendronate

Plus

Calcium

Actavis.

How

to

take

Alendronate

Plus

D3

Calcium Actavis

How much to take

Take

Alendronate

Plus

D3

Calcium

Actavis

70

mg/

140

µg

only

when

prescribed

by

your

doctor.

DAY 1

ALENDRONATE D3 70 mg /140

µg (5600 IU) (white tablet in the

blister pack).

The usual dose of ALENDRONATE

D3 70 mg /140 µg (5600 IU) is one

tablet once a week.

Choose the day of the week that

best

fits

your

schedule.

Every

week,

take

one

tablet

of

ALENDRONATE D3 70 mg /140

µg (5600 IU) on your chosen day

(DAY 1).

Do

not

take

Calcium

Actavis

tablets on DAY 1.

DAYS 2 – 7

Calcium

Actavis

(green

tablets

supplied in the bottle).

The usual dose of Calcium Actavis

is

one

or

two

tablets

daily,

as

recommended by your doctor. On

the day after you have taken your

Alendronate

Plus

D3

Calcium

Actavis 70 mg/140 µg tablet, take

one or two Calcium Actavis tablets.

Continue

taking

these

every

day

for a total of 6 days. Follow all

directions

given

to

you

by

your

doctor carefully.

They

differ

from

information contained in this leaflet.

If

you

do

not

understand

the

instructions on the box, ask your

doctor or pharmacist for help.

When and how to take it

DAY

1:

Alendronate

Plus

D3

Calcium Actavis 70 mg/140 µg

Take

Alendronate

Plus

D3

Calcium

Actavis

70

mg/140

µg

after getting up for the day and

before

taking

your

first

food,

beverage or other medication. Do

not take it at bedtime.

Do

not

take

Calcium

Actavis

tablets on DAY 1.

Swallow one tablet whole with a full

glass

plain

water

[not

mineral

water, not coffee or tea, not juice].

Do not take any food, medicines or

drinks other than plain tap water

with

your

Alendronate

Plus

D3

Calcium

Actavis

70

mg/140

µg

tablet.

It is important to take Alendronate

Plus D3 Calcium Actavis with plain

water only, not mineral water. Food,

other drugs and mineral water and

other drinks, including

fruit juices,

coffee and tea, will reduce the effect

of Alendronate D3 70 mg /140 µg

(5600

interfering

with

absorption into the body.

Stay upright for at least 30 minutes

after swallowing Alendronate Plus

D3 Calcium Actavis

70 mg/140 µg

(5600 IU) and do not take any food,

medicines

or

drinks

other

than

plain tap water during this time.

Do not lie down immediately after

swallowing it.

It is important to stay upright (sitting,

standing or walking around) for at

least

minutes

after

swallowing

your tablet.

It is also very important to stay

upright until after you have eaten

your first food of the day.

These actions

will help

make sure

your

tablet

reaches

your

stomach

quickly and help reduce the potential

irritation

your

food

pipe

(oesophagus).

Alendronate

Plus

Calcium

Actavis 70 mg/140 µg is effective

only if taken when your stomach is

empty. Food, drinks other than plain

water,

other

medicines

will

lessen the effect of Alendronate D3

/140

(5600

interfering

with

absorption

into

the body.

Do not chew or suck on a tablet of

Alendronate

Plus

D3

Calcium

Actavis.

Mouth ulcers may occur if the tablet

is chewed or dissolved in the mouth.

DAYS 2 to 7: Calcium Actavis

Take one or two Calcium Actavis

tablets, as recommended by your

doctor, for 6 days, starting the day

after

you

have

taken

your

Alendronate

Plus

D3

Calcium

Actavis 70 mg/140 µg (5600 IU)

tablet.

Calcium

Actavis

may

be

taken

before or with food.

THIS SEVEN DAY CYCLE IS TO

BE REPEATED EACH WEEK.

How long to take it

It

is

important

that

you

take

Alendronate

Plus

D3

Calcium

Actavis for as long as your doctor

prescribes it.

Alendronate

Plus

Calcium

Actavis

only

treat

your

osteoporosis,

helping

prevent

further loss of bone and continuing to

rebuild bone, if you take as directed.

Since it is not known how long you

should

take

Alendronate

Plus

Calcium Actavis, you should discuss

the need to stay on this medication

with

your

doctor

periodically

Alendronate Plus D3 Calcium Actavis 70 mg/ 140 µg_v.10

determine

Alendronate

Plus

Calcium Actavis is still right for you.

If you forget to take it

ALENDRONATE D3 70 mg /140

µg (5600 IU) :

If you miss a tablet, take one tablet

on

the

morning

after

you

remember.

Do

not

take

two

tablets

on

the

same day.

Do not take your Alendronate D3

70

mg

/140 µg (5600 IU) at the

same time you take your Calcium

Actavis tablet.

Return

to

taking

one

tablet

of

ALENDRONATE D3 70 mg /140

µg

(5600

IU)

once

a

week,

as

originally

scheduled

on

your

chosen day (DAY 1) followed by

one

or

two

tablets

of

Calcium

Actavis on days 2 to 7, and then

repeat the cycle.

Calcium Actavis:

If you forget to take your Calcium

Actavis dose, then just skip that

dose

and

continue

taking

your

tablets

on

the

day

that

you

remember. Do not take more than

your daily dose on any given day.

Do not take your Alendronate Plus

D3 Calcium Actavis 70 mg/140 µg

at

the

same

time

you

take

your

Calcium Actavis tablets.

If you are not sure about what to

do,

talk

to

your

doctor

or

pharmacist.

If you have trouble remembering to

take

your

medicine,

your

pharmacist for some hints.

If

you

take

too

much

(overdose)

Immediately telephone your doctor

or the Poisons Information Centre

(telephone 13 11 26 or go to the

accident

and

emergency

department

at

your

nearest

hospital, if you think that you or

anyone else may have take a large

number of the tablets. Do this even

if there are no signs of discomfort

or poisoning.

If you take too many tablets at one

time, drink a full glass of milk. Do

not

induce

vomiting.

Do

not

lie

down.

While

you

are

using

Alendronate

Plus

D3

Calcium Actavis

Things you must do

If you develop difficulty or pain

upon

swallowing,

chest

pain,

or

new or worsening heartburn, stop

taking

Alendronate

Plus

D3

Calcium

Actavis

and

call

your

doctor.

If

you

become

pregnant

while

taking

Alendronate

Plus

D3

Calcium Actavis, stop taking the

tablets and tell your doctor.

If you are about to be started on any

new medicine, tell your doctor and

pharmacist

that

taking

Alendronate

Plus

Calcium

Actavis.

If

you

develop

a

toothache

or

require

a

dental

procedure,

tell

your dentist that you are taking

Alendronate

Plus

D3

Calcium

Actavis.

If you develop new or unusual pain

in your leg, tell your doctor.

Rarely,

patients

have

experienced

fracture in a specific part of the thigh

bone.

Make sure you have an adequate

intake of calcium in your diet.

Your doctor, dietician or pharmacist

can tell you what foods you should

eat.

Things you must not do

Do not give Alendronate Plus D3

Calcium

Actavis

to

anyone

else,

even

if

they

have

the

same

condition as you.

Things to be careful of

There

have

been

side

effects

reported with Alendronate Plus D3

Calcium

Actavis

that

may

affect

your

ability

to

drive

or

operate

machinery. Individual responses to

Alendronate

Plus

D3

Calcium

Actavis

may

vary

(see

Side

Effects).

Things that would be helpful

for your osteoporosis

Some self-help

measures suggested

below may help your osteoporosis.

Talk

your

doctor

pharmacist

about these measures and for more

information.

Exercise

-

helpful

building and maintaining strong

bones. Regular exercise such as a

brisk walk is a good idea. Talk to

your doctor before you begin any

exercise program.

Diet -

eat a balanced diet. You

may need to increase the amount

of calcium in your diet by eating

calcium-rich

foods

taking

calcium supplement like Calcium

Actavis. Your doctor will advise

you.

Smoking -

appears to increase the

rate at which you lose bone and,

therefore, may increase your risk

of fracture. Your doctor may ask

you to stop smoking or at least

cut down.

Alcohol -

your doctor may advise

you to cut down the amount of

alcohol you drink. If you drink

excessively

regular

basis,

increase

your

risk

developing osteoporosis.

Side effects

Tell

your

doctor

pharmacist

soon as possible if you do not feel

well

while

taking

Alendronate

Plus

Calcium

Actavis.

Alendronate

Plus

Calcium

Actavis

mg/140

helps

most

people with osteoporosis, but it may

have unwanted side effects in a few

people. All medicines can have side

effects. Sometimes they are serious,

most of the time they are not. You

may need medical treatment if you

get some of the side effects

Ask your doctor or pharmacist to

answer

any

questions

you

may

have.

Tell your doctor or pharmacist if

you notice any of the following and

they worry you:

stomach pain, gas in the stomach

or bowel, wind

an uncomfortable feeling in the

stomach or belching after eating,

also

called

dyspepsia,

heartburn

Alendronate Plus D3 Calcium Actavis 70 mg/ 140 µg_v.10

feeling sick (nausea), vomiting

constipation, diarrhoea

headache

aching

muscles,

joints

and/or

bones,

which

rarely

severe.

flu-like symptoms typically at the

start of treatment, such as aching

muscles, generally feeling unwell

and rarely fever.

swelling of joints

dizziness or spinning sensation

unusual tiredness or weakness

swelling of hands, ankles or feet

hair loss

changed sense of taste

Most of these are the more common

side effects of Alendronate Plus D3

Calcium Actavis.

For the most part, these have been

mild.

Tell

your

doctor

immediately

if

you notice any of the following:

skin rash or redness of the skin,

sometimes

made

worse

sunlight, itchiness

mouth ulcers

blurred vision, pain or redness in

the eye

symptoms of low blood calcium

levels including muscle cramps or

spasms

tingling

sensation

the fingers or around the mouth

new or unusual pain in your hip

or thigh

symptoms of a kidney stone such

severe,

lower

back

abdominal

pain

difficulty

passing

urine.

have

kidney

stone,

your

dose

Calcium Actavis may need to be

reduced or discontinued.

These side effects are rare, and very

rarely, may be serious.

Tell

your

dentist

and

doctor

immediately if you notice any of

the following

Jaw-bone

dental

problems

(including

toothache).

Jaw-bone

problems may include infection,

and delayed healing after a tooth

extraction

other

work

that

involves

drilling

into

jaw-

bone.

These side effects are rare and may

be serious.

If any of the following happen, stop

taking

Alendronate

Plus

D3

Calcium

Actavis

and

tell

your

doctor immediately:

difficulty

pain

upon

swallowing

chest pain

new or worsening heartburn

These

side

effects

irritation

ulceration

food

pipe.

They

worsen

continue taking the tablets. Rarely,

these side effects may be serious.

If any of the following happen, stop

taking

Alendronate

Plus

D3

Calcium

Actavis

and

tell

your

doctor

immediately

or

go

to

Accident and Emergency at your

nearest hospital:

swelling of the face, lips, mouth,

throat or tongue which may cause

difficulty

breathing

swallowing

pinkish,

itchy

swellings

skin,

also

called

hives

nettlerash

severe skin reactions

black

tar-like

and/or

bloody

stools

These may be serious side effects.

need

urgent

medical

attention. These side effects are rare.

If you have the swelling described

above, you may be having a serious

allergic reaction to Alendronate Plus

D3 Calcium Actavis.

Rarely, stomach or duodenal ulcers

(some severe) have occurred, but it is

known

whether

these

were

caused by this medicine.

Other side effects not listed above

may also occur in some patients.

Tell your doctor if you notice any

other effects.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

Alendronate

Plus

Calcium

Actavis is not addictive.

After

using

Alendronate

Plus D3 Calcium Actavis

Storage

Keep

your

tablets

original

containers

(blister

pack

bottle

pack) until it is time to take them.

If you take tablets out of the original

containers they may not keep well.

Keep

Alendronate

Plus

D3

Calcium Actavis in a cool dry place

where

the

temperature

will

stay

below 25°C. Keep the Alendronate

Plus

D3

Calcium

Actavis

tablets

away from light or moisture.

Do not store Alendronate Plus D3

Calcium

Actavis,

or

any

other

medicine, in the bathroom or near

a sink. Do not leave it in the car or

on window sills.

Heat and dampness can destroy some

medicines.

Keep

it

where

children

cannot

reach it.

A locked cupboard at least one and a

half metres above the ground is a

good place to store medicines.

Disposal

If your doctor or pharmacist tells you

to stop taking Alendronate Plus D3

Calcium

Actavis

tablets

have

passed

their

expiry

date,

your

pharmacist what to do with any that

are left over.

Product description

What

Alendronate

Plus

D3

Calcium Actavis 70 mg/140

µg looks like

Alendronate

Plus

Calcium

Actavis

mg/140

combination pack consisting of a box

once

weekly

tablets

Alendronate D3 70 mg/140 µg (5600

IU) together with a bottle of 24 or 48

tablets of Calcium Actavis.

Alendronate D3 70 mg/140 µg (5600

IU) are white to off- white, modified

capsule

shaped

uncoated

tablet,

debossed

with ‘ADC’ on one side

and ‘56’ on the other side.

Calcium Actavis are capsule shaped

dark green film coated tablet with a

break bar on one side.

Ingredients

Each Alendronate D3 70 mg/140 µg

(5600 IU) tablet contains 70 mg of

alendronate sodium and 70 µg or 140

colecalciferol

active

ingredients.

Alendronate Plus D3 Calcium Actavis 70 mg/ 140 µg_v.10

It also contains the following inactive

ingredients:

microcrystalline cellulose

medium chain triglycerides

gelatin

croscarmellose sodium

sucrose

colloidal anhydrous silica

magnesium stearate

butylated hydroxytoluene

povidone

This

medicine

gluten-free,

tartrazine-free and free of other azo

dyes.

Calcium Actavis contains 1250 mg

calcium carbonate equivalent to 500

mg elemental calcium.

It also contains the following inactive

ingredients:

microcrystalline cellulose

crospovidone

croscarmellose sodium

povidone

magnesium stearate

hypromellose

macrogol 8000

chlorophyllin-copper complex

titanium dioxide

carnauba wax

Australian

Registration

Numbers

Alendronate

Plus

Calcium

Actavis

70 mg/140 µg: AUST R 222686

Sponsor

Dr Reddy’s Laboratories (Australia)

Pty Ltd

Level 9 492 St Kilda Road,

Melbourne VIC 3004

Australia

This

leaflet

prepared

December 2014.

Alendronate Plus D3 Calcium Actavis 70 mg/ 140 µg_v.10

18-9-2018

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