ALENDRONATE

Main information

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

Documents

Localization

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

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222685
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222685

ALENDRONATE PLUS D3 CAL 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 CAL 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 Light

Store in Original

Container

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

4 week supply (4 x Alendronate Plus D3-DRLA 70 mg/ 140 ug alendronic

acid (as sodium) 70 mg and colecalciferol 140 microgram tablets and 24

ReddyCal calcium carbonate tablets)

(S4) Prescription Only Medicine

4 week supply (4 x Alendronate Plus D3-DRLA 70 mg/ 140 ug alendronic

acid (as sodium) 70 mg and colecalciferol 140 microgram tablets and 48

ReddyCal calcium carbonate tablets)

(S4) Prescription Only Medicine

Components

1. ReddyCal tablets bottle

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

2. Alendronate plus D3 - DRLA 70 mg/140 ug alendronic acid (as sodium) 70 mg and colecalciferol 140 microgram tablets blister pack

Dosage Form

Tablet

Route of Administration

Oral

Public Summary

Page 1 of

Produced at 26.11.2017 at 10:58:07 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

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

© 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 10:58:07 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 CAL

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

µg.

particularly

important

that

read

sections

“When

take

it”

“How to take it” before you take this

medicine. This leaflet does not contain

all the available information.

It does not take the place of talking to

your doctor and pharmacist.

All medicines have risks and benefits.

Your doctor has weighed the risks of

you taking Alendronate Plus D3 Cal

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 Cal is used for

Alendronate

Plus

combination medicine consisting of 4

once weekly tablets of Alendronate

Plus

DRLA

(5600

together

with

tablets of ReddyCal.

Alendronate Plus D3 Cal is used to

treat

osteoporosis

provide

additional

vitamin

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 is an essential

mineral,

necessary

maintain

bone structure in the 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

process

usually in balance, so that the amount

bone

lost

about

equal

amount that is replaced. This balanced

process keeps your skeleton healthy

and strong. After about age 35 this

balance is disturbed, with bone loss

occurring at a 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

become

thinner

weaker,

therefore are more likely to break.

Osteoporosis

“Osteo”

means

bone,

“porosis”

means something that has holes in it,

like a sponge. Therefore, osteoporosis

disease

which

causes

bones

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

female

hormone, oestrogen, or are removed

(which may occur, for example, at the

time of a hysterectomy). At this time,

bone

removed

faster

than

formed, so bone loss occurs and 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

result

broken

bones,

also

called

fractures.

Although

fractures

usually

cause

pain,

fractures

bones of the spine may go unnoticed

until they cause height loss. Fractures

occur

during

normal,

everyday

activity, such as lifting, or from minor

injury

that

would

ordinarily

fracture

normal

bone.

Fractures

usually occur at the hip, spine, or wrist

and can lead not only to pain, but also

considerable

deformity

disability,

such

stooped

posture

from curvature of the spine, and loss

of mobility.

What

should

I

know

about

vitamin D?

Vitamin

essential

nutrient,

required for calcium

absorption and

healthy

bones.

main

source

through exposure to summer sunlight,

which makes vitamin D in our skin.

Clothing

block

prevent

enough sunlight from getting through.

In addition, as people age, their skin

becomes less able to make vitamin D.

Very few foods are 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

have

enough

vitamin

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 CAL 70 mg/ 140 µg_v1.0

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

calcium

young

children,

teenagers

and older men and women all have

greater

than

average

requirements.

Many Australian adults do not achieve

the recommended amount of calcium

their

diets

benefit

from

calcium supplements.

Not having enough calcium in your

diet

lead

disorders

like

osteoporosis. Making sure you have

enough

calcium

your

diet

important way to slow bone loss and

keep

bones

strong.

enough

calcium from food and supplements

can be absorbed to keep blood calcium

normal, the body will remove calcium

from the bones. If your dietary intake

calcium

constantly

low,

your

body will eventually remove so much

calcium from the skeleton that your

bones will become weak and brittle

and more likely to break.

How does Alendronate

Plus D3 Cal work?

The alendronate in Alendronate Plus

D3 - DRLA 70 mg /140 µg (5600 IU)

works by slowing down the process of

old bone being removed, which allows

the bone-forming cells time to rebuild

normal

bone.

Alendronate

only

helps

prevent

loss

bone

actually

helps

rebuild

bone

make bone less likely to fracture.

Thus, Alendronate Plus D3 DRLA 70

mg /140 µg (5600 IU) reverses the

progression of osteoporosis.

Alendronate Plus D3 DRLA 70 mg

/140 µg (5600 IU) starts working on

bone

cells

immediately,

measurable effects on bone mass may

seen

several

months

more.

The alendronate in Alendronate Plus

D3 DRLA 70 mg /140 µg (5600 IU)

belongs to a group of nonhormonal

medicines called bisphosphonates.

addition

alendronate,

Alendronate Plus D3 DRLA 70 mg

/140

(5600

also

contains

vitamin

essential

nutrient

required for calcium

absorption and

healthy bones.

ReddyCal

contains

calcium,

essential

mineral

necessary

help

maintain

bone

structure

body.

Before

you

take

Alendronate

Plus

D3

Cal

You should know that in some people,

Alendronate Plus D3 DRLA 70 mg

/140 µg (5600 IU) can irritate or burn

food

pipe

(also

called

oesophagus).

chances

this

happening

should

reduced

when

you follow the instructions for ‘How

to take’ Alendronate Plus D3 Cal in

this leaflet.

When you must not take it

Do not take Alendronate Plus D3

DRLA 70 mg /140 µg (5600 IU if:

you

have

an

allergy

to

,

Alendronate Plus D3 DRLA 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 ReddyCal if

your

doctor

has

told

you

that

you

currently

have

high

blood

calcium

you have kidney stone

you have an allergy to ReddyCal

or any of the ingredients listed at

the end of this leaflet.

Do not take Alendronate Plus D3

Cal if you are pregnant or breast

feeding.

Alendronate Plus D3 Cal has not been

studied in pregnant or breast-feeding

women.

Do not take Alendronate Plus D3 Cal

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 Cal, talk to your doctor.

Do

not

give

Alendronate Plus

D3

Cal to a child

Alendronate Plus D3 Cal has not been

studied in 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 or 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 Cal.

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 Plus D3 - DRLA 70 mg

/140 µg (5600 IU) if taken at the

same time. These include:

antacids, medicines used to treat

indigestion e.g. Gaviscon, Mylanta

calcium

supplements

such

ReddyCal (as provided in this pack

Alendronate

Plus

Cal)

Caltrate

vitamins

ALENDRONATE PLUS D3 CAL 70 mg/ 140 µg_v1.0

Therefore,

take

Alendronate

Plus

D3 - DRLA 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 CAL. However, both aspirin and

take Alendronate Plus D3 - DRLA 70

mg /140 µg (5600 IU) may increase

the chance of stomach upsets.

Your doctor or pharmacist has more

information on medicines to be careful

with

avoid

while

taking

Alendronate Plus D3 Cal.

How

to

take

Alendronate

Plus

D3

Cal

How much to take

Take Alendronate Plus D3 Cal 70

mg/ 140 µg only when prescribed by

your doctor.

DAY 1

Alendronate Plus D3 - DRLA 70 mg

/140 µg (5600 IU) (white tablet in

the blister pack).

The usual dose of Alendronate Plus

D3 - DRLA 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 Plus D3 -

DRLA 70 mg /140 µg (5600 IU) on

your chosen day (DAY 1).

Do

not

take

ReddyCal

tablets

on

DAY 1.

DAYS 2 - 7

ReddyCal (green tablets supplied in

the bottle).

The usual dose of ReddyCal is one

or

two

tablets

daily,

as

recommended by your doctor. On

the day after you have taken your

Alendronate Plus D3 Cal 70 mg/140

µg tablet, take one or two ReddyCal

tablets.

Continue taking these every day for

a

total

of

6

days.

Follow

all

directions

given

to

you

by

your

doctor carefully.

They may differ from the 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 Cal 70

mg/140 µg

Take Alendronate Plus D3 Cal 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

ReddyCal

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 Cal

70 mg/140 µg tablet.

important

take

Alendronate

Plus D3 Cal with plain water only, not

mineral water. Food, other drugs and

mineral

water

other

drinks,

including fruit juices, coffee and tea,

will reduce the effect of Alendronate

Plus D3 - DRLA 70 mg

/140 µg

(5600

interfering

with

absorption into the body.

Stay upright for at least 30 minutes

after swallowing Alendronate Plus

D3 Cal 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

walking

around)

least 30 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 D3 Cal 70 mg/140

µg is effective only if taken when

your stomach is empty. Food, drinks

other

than

plain

water,

other

medicines

will

lessen

effect

Alendronate Plus D3 - DRLA 70 mg

/140 µg (5600 IU) by interfering with

its absorption into the body.

Do not chew or suck on a tablet of

Alendronate Plus D3 CAL.

Mouth ulcers may occur if the tablet is

chewed or dissolved in the mouth.

DAYS 2 to 7: ReddyCal

Take one or two ReddyCal tablets,

as recommended by your doctor, for

6 days, starting the day after you

have taken your Alendronate Plus

D3

Cal

70

mg/140

µg

(5600

IU)

tablet.

ReddyCal 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 Cal for as long

as your doctor prescribes it.

Alendronate

Plus

only

treat

your

osteoporosis,

helping

prevent

further

loss

bone

continuing to rebuild bone, if you take

as directed. Since it is not known how

long you should take Alendronate Plus

D3 CAL, you should discuss the need

to stay on this medication with your

doctor

periodically

determine

Alendronate Plus D3 Cal is still right

for you.

If you forget to take it

Alendronate Plus D3 - DRLA 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 Plus

D3 - DRLA 70 mg /140 µg (5600

IU) at the same time you take your

ReddyCal tablet.

Return

to

taking

one

tablet

of

Alendronate Plus D3 - DRLA 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 ReddyCal on days

2 to 7, and then repeat the cycle.

ReddyCal:

ALENDRONATE PLUS D3 CAL 70 mg/ 140 µg_v1.0

If you forget to take your ReddyCal

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 Cal 70 mg/140 µg at the same

time

you

take

your

ReddyCal

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

Cal

Things you must do

If

you

develop

difficulty

or

pain

upon swallowing, chest pain, or new

or worsening heartburn, stop taking

Alendronate Plus D3 Cal and call

your doctor.

If

you

become

pregnant

while

taking

Alendronate

Plus

D3

Cal,

stop taking the tablets and tell your

doctor.

If you are about to be started on any

medicine,

tell

your

doctor

pharmacist

that

taking

Alendronate Plus D3 Cal.

If

you

develop

a

toothache

or

require a dental procedure, tell your

dentist

that

you

are

taking

Alendronate Plus D3 Cal.

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

Cal 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

Cal that may affect your ability to

drive

or

operate

machinery.

Individual responses to Alendronate

Plus

D3

Cal

may

vary

(see

Side

Effects).

Things that would be helpful

for your osteoporosis

Some

self-help

measures

suggested

below

help

your

osteoporosis.

Talk

your

doctor

pharmacist

about

these

measures

more

information.

Exercise

-

helpful

building

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

-

balanced diet.

may need to increase the amount

of calcium in your diet by eating

calcium-rich

foods

taking

calcium

supplement

like

ReddyCal. 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

drink.

drink

excessively on a regular basis, you

increase

your

risk

developing osteoporosis.

Side effects

Tell your doctor or pharmacist as soon

as possible if you do not feel well

while you are taking Alendronate Plus

D3 Cal

Alendronate Plus D3 Cal 70 mg/140

helps

most

people

with

osteoporosis,

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

uncomfortable

feeling

stomach or belching after eating,

also called dyspepsia, or heartburn

feeling sick (nausea), vomiting

constipation, diarrhoea

headache

aching

muscles,

joints

and/or

bones, which rarely can be 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

Cal.

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

blood

calcium

levels including muscle cramps or

spasms or tingling sensation in the

fingers or around the mouth

ALENDRONATE PLUS D3 CAL 70 mg/ 140 µg_v1.0

new or unusual pain in your hip or

thigh

symptoms of a kidney stone such

as severe, lower back or abdominal

pain or difficulty in passing urine.

If you have a kidney stone, your

dose of ReddyCal 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

include

infection,

and delayed healing after a tooth

extraction

other

work

that

involves drilling into the jaw-bone.

These side effects are rare and may be

serious.

If any of the following happen, stop

taking Alendronate Plus D3 Cal and

tell your doctor immediately:

difficulty or pain upon swallowing

chest pain

new or worsening heartburn

These

side

effects

irritation

ulceration

food

pipe.

They

worsen

continue

taking

tablets.

Rarely,

these side effects may be serious.

If any of the following happen, stop

taking Alendronate Plus D3 Cal 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 or nettlerash

severe skin reactions

black tar-like and/or bloody stools

These

serious

side

effects.

need

urgent

medical

attention. These side effects are rare.

have

swelling

described

above, you may be having a serious

allergic reaction to Alendronate Plus

D3 Cal.

Rarely,

stomach

duodenal

ulcers

(some severe) have occurred, but it is

not 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.

alarmed

this

list

possible

side

effects.

experience any of them.

Alendronate

Plus

addictive.

After

using

Alendronate

Plus D3 Cal

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 Cal in a

cool

dry

place

where

the

temperature will stay below 25°C.

Keep the Alendronate Plus D3 Cal

tablets away from light or moisture.

Do not store Alendronate Plus D3

Cal, 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

Cal or tablets have passed their expiry

date, your pharmacist what to do with

any that are left over.

Product description

What

Alendronate

Plus

D3

Cal 70 mg/140 µg looks like

Alendronate Plus D3 Cal 70 mg/140

µg is a combination pack consisting of

once

weekly

tablets

Alendronate

Plus

-DRLA

mg/140 µg (5600 IU) together with a

bottle of 24 or 48 tablets of ReddyCal.

Alendronate

Plus

-DRLA

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.

ReddyCal

capsule

shaped

dark

green film coated tablet with a break

bar on one side.

Ingredients

Each Alendronate Plus D3 -DRLA 70

mg/140 µg (5600 IU) tablet contains

70 mg of alendronate sodium and 70

µg or 140 µg of colecalciferol as the

active ingredients.

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.

ReddyCal contains 1250 mg calcium

carbonate

equivalent

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 D3 Cal

70 mg/140 µg: AUST R 222685

Sponsor

Reddy’s

Laboratories

(Australia)

Pty Ltd

Level 9 492 St Kilda Road,

Melbourne VIC 3004

Australia

This leaflet was prepared in December

2014.

ALENDRONATE PLUS D3 CAL 70 mg/ 140 µg_v1.0

18-9-2018

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Danish Medicines Agency

22-2-2012

Changed criteria for single reimbursement for osteoporosis medicines other than alendronate

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Danish Medicines Agency

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