ALENDRONATE

Main information

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

Documents

Localization

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

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222684
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222684

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

140 ug 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 and CALCIUM SANDOZ 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

Store in Original

Container

Protect from Moisture

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

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

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

Sandoz calcium carbonate tablets)

(S4) Prescription Only Medicine

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

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

Sandoz calcium carbonate tablets)

(S4) Prescription Only Medicine

Components

1. Calcium Sandoz 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 SANDOZ 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 10:58:36 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 10:58:36 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 AND CALCIUM

SANDOZ

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 of the

common questions about

ALENDRONATE PLUS D3 AND

CALCIUM SANDOZ 70 mg/ 140

µg. It is particularly important that

you read the sections “When to take

it” and “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 AND

CALCIUM SANDOZ 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 AND

CALCIUM SANDOZ is

used for

ALENDRONATE PLUS D3 AND

CALCIUM SANDOZ is a

combination medicine consisting of

4 once weekly tablets of

ALENDRONATE PLUS D3

SANDOZ 70 mg/ 140 µg (5600 IU)

together with 24 or 48 tablets of

Calcium Sandoz.

ALENDRONATE PLUS D3 AND

CALCIUM SANDOZ 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 D is an essential nutrient

required for calcium absorption and

healthy bones. Calcium is an

essential mineral, necessary to

maintain the bone structure in the

body.

Understanding bone

Bone is a living, growing tissue.

Throughout life, our bodies are

breaking down old bone and

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 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 is

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 a sponge. Therefore,

osteoporosis is a disease which

causes bones to become more porous,

gradually making them weaker, more

brittle and likely to break.

Osteoporosis is common in

postmenopausal women. The

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, 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

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 as lifting, or from

minor injury that would not

ordinarily fracture normal bone.

ALENDRONATE PLUS D3 AND CALCIUM SANDOZ

V2.0

70 mg/ 140 µg

Fractures usually occur at the hip,

spine, or wrist and can lead not only

to pain, but also to considerable

deformity and disability, such as

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 to 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 D. Very few foods are

natural sources of vitamin D.

Too little vitamin D leads to

inadequate calcium absorption and

low phosphate-minerals that make

bones strong. Even if you are eating a

diet rich in calcium or taking a

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

D deficiency may cause muscle

weakness which can lead to falls and

a higher risk of fracture.

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 do not

achieve the recommended amount of

calcium in their diets and can benefit

from calcium supplements.

Not having enough calcium in your

diet may lead to disorders like

osteoporosis. Making sure you have

enough calcium in your diet is an

important way to slow bone loss and

keep bones strong. If not 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 of calcium is

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 AND CALCIUM

SANDOZ work?

The alendronate in

ALENDRONATE PLUS D3

SANDOZ 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 not

only helps prevent the loss of bone

but actually helps to rebuild bone and

make bone less likely to fracture.

Thus ALENDRONATE PLUS D3

SANDOZ 70 mg /140 µg (5600 IU)

reverses the progression of

osteoporosis.

ALENDRONATE PLUS D3

SANDOZ 70 mg /140 µg (5600 IU)

starts working on the bone cells

immediately, but measurable effects

on bone mass may not be seen for

several months or more.

The alendronate in

ALENDRONATE PLUS D3

SANDOZ 70 mg /140 µg (5600 IU)

belongs to a group of nonhormonal

medicines called bisphosphonates.

In addition to alendronate,

ALENDRONATE PLUS D3

SANDOZ 70 mg /140 µg (5600 IU)

also contains vitamin D, an essential

nutrient required for calcium

absorption and healthy bones.

Calcium Sandoz contains calcium, an

essential mineral necessary to help

maintain the bone structure in the

body.

Before you take

ALENDRONATE PLUS

D3 AND CALCIUM

SANDOZ

You should know that in some

people, ALENDRONATE PLUS D3

SANDOZ 70 mg /140 µg (5600 IU)

can irritate or burn the food pipe

(also called oesophagus). The

chances of this happening should be

reduced when you follow the

instructions for ‘How to take

ALENDRONATE PLUS D3 AND

CALCIUM SANDOZ’ in this leaflet.

When you must not take it

Do not take ALENDRONATE

PLUS D3 SANDOZ 70 mg /140 µg

(5600 IU if:

you have an allergy to ,

ALENDRONATE PLUS D3

SANDOZ 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 Sandoz if

your doctor has told you that

you currently have high blood

calcium

you have kidney stone

you have an allergy to Calcium

Sandoz or any of the

ingredients listed at the end of

this leaflet.

Do not take ALENDRONATE

PLUS D3 AND CALCIUM

SANDOZ if you are pregnant or

breast feeding.

ALENDRONATE PLUS D3 AND

CALCIUM SANDOZ has not been

ALENDRONATE PLUS D3 AND CALCIUM SANDOZ

V2.0

70 mg/ 140 µg

studied in pregnant or breast-feeding

women.

Do not take ALENDRONATE PLUS

D3 AND CALCIUM SANDOZ:

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 AND

CALCIUM SANDOZ, talk to your

doctor.

Do not give ALENDRONATE

PLUS D3 AND CALCIUM

SANDOZ to a child

ALENDRONATE PLUS D3 AND

CALCIUM SANDOZ 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 AND

CALCIUM SANDOZ.

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

SANDOZ 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 as

Calcium Sandoz (as provided in

this pack of ALENDRONATE

PLUS D3 AND CALCIUM

SANDOZ) or Caltrate

vitamins

Therefore, take ALENDRONATE

PLUS D3 SANDOZ 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 AND CALCIUM

SANDOZ. However, both aspirin

and take ALENDRONATE PLUS

D3 SANDOZ 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 or avoid while taking

ALENDRONATE PLUS D3 AND

CALCIUM SANDOZ.

How to take

ALENDRONATE PLUS

D3 AND CALCIUM

SANDOZ

How much to take

Take ALENDRONATE PLUS D3

AND CALCIUM SANDOZ 70 mg/

140 µg only when prescribed by

your doctor.

DAY 1

ALENDRONATE PLUS D3

SANDOZ 70 mg /140 µg (5600 IU)

(white tablet in the blister pack).

The usual dose of ALENDRONATE

PLUS D3 SANDOZ 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

SANDOZ 70 mg /140 µg (5600 IU)

on your chosen day (DAY 1).

Do not take Calcium Sandoz

tablets on DAY 1.

DAYS 2 - 7

Calcium Sandoz (green tablets

supplied in the bottle).

The usual dose of Calcium Sandoz

is one or two tablets daily, as

recommended by your doctor. On

the day after you have taken your

ALENDRONATE PLUS D3 AND

CALCIUM SANDOZ 70 mg/140

µg tablet, take one or two Calcium

Sandoz 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 AND CALCIUM SANDOZ 70

mg/140 µg

Take ALENDRONATE PLUS D3

AND CALCIUM SANDOZ 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 Sandoz

tablets on DAY 1.

ALENDRONATE PLUS D3 AND CALCIUM SANDOZ

V2.0

70 mg/ 140 µg

Swallow one tablet whole with a full

glass of 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 AND CALCIUM SANDOZ 70

mg/140 µg tablet.

It is important to take

ALENDRONATE PLUS D3 AND

CALCIUM SANDOZ 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 PLUS D3

SANDOZ 70 mg /140 µg (5600 IU)

by interfering with the absorption

into the body.

Stay upright for at least 30 minutes

after swallowing

ALENDRONATE

PLUS D3 AND CALCIUM

SANDOZ

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 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

for irritation to your food pipe

(oesophagus).

ALENDRONATE PLUS D3 AND

CALCIUM SANDOZ 70 mg/140 µg

is effective only if taken when your

stomach is empty. Food, drinks other

than plain water, and other medicines

will lessen the effect of

ALENDRONATE PLUS D3

SANDOZ 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 AND

CALCIUM SANDOZ.

Mouth ulcers may occur if the tablet

is chewed or dissolved in the mouth.

DAYS 2 to 7: Calcium Sandoz

Take one or two Calcium Sandoz

tablets, as recommended by your

doctor, for 6 days, starting the day

after you have taken your

ALENDRONATE PLUS D3 AND

CALCIUM SANDOZ 70 mg/140

µg (5600 IU) tablet.

Calcium Sandoz 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 AND

CALCIUM SANDOZ for as long

as your doctor prescribes it.

ALENDRONATE PLUS D3 AND

CALCIUM SANDOZ can only treat

your osteoporosis, by 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

D3 AND CALCIUM SANDOZ, you

should discuss the need to stay on

this medication with your doctor

periodically to determine if

ALENDRONATE PLUS D3 AND

CALCIUM SANDOZ is still right

for you.

If you forget to take it

ALENDRONATE PLUS D3

SANDOZ 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

SANDOZ

70 mg /140 µg (5600 IU)

at the same time you take your

Calcium Sandoz tablet.

Return to taking one tablet of

ALENDRONATE PLUS D3

SANDOZ 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 Sandoz on days

2 to 7, and then repeat the cycle.

Calcium Sandoz:

If you forget to take your Calcium

Sandoz 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 AND

CALCIUM SANDOZ 70 mg/140

µg at the same time you take your

Calcium Sandoz 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, ask 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 AND CALCIUM

SANDOZ

Things you must do

If you develop difficulty or pain

upon swallowing, chest pain, or

new or worsening heartburn, stop

taking ALENDRONATE PLUS D3

ALENDRONATE PLUS D3 AND CALCIUM SANDOZ

V2.0

70 mg/ 140 µg

AND CALCIUM SANDOZ and

call your doctor.

If you become pregnant while

taking ALENDRONATE PLUS D3

AND CALCIUM SANDOZ, 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 you are taking

ALENDRONATE PLUS D3 AND

CALCIUM SANDOZ.

If you develop a toothache or

require a dental procedure, tell

your dentist that you are taking

ALENDRONATE PLUS D3 AND

CALCIUM SANDOZ.

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 AND CALCIUM

SANDOZ 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 AND CALCIUM

SANDOZ that may affect your

ability to drive or operate

machinery. Individual responses to

ALENDRONATE PLUS D3 AND

CALCIUM SANDOZ may vary

(see Side Effects).

Things that would be helpful

for your osteoporosis

Some self-help measures suggested

below may help your osteoporosis.

Talk to your doctor or pharmacist

about these measures and for more

information.

Exercise -

can be helpful in

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 or taking a

calcium supplement like Calcium

Sandoz. 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 on a regular basis,

you may increase your risk of

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 AND

CALCIUM SANDOZ

ALENDRONATE PLUS D3 AND

CALCIUM SANDOZ 70 mg/140 µg

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, 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 AND CALCIUM

SANDOZ.

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 by

sunlight, itchiness

mouth ulcers

blurred vision, pain or redness in

the eye

symptoms of low blood calcium

levels including muscle cramps or

spasms or tingling sensation in

the fingers or around the mouth

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

Calcium Sandoz may need to be

reduced or discontinued.

These side effects are rare, and very

rarely, may be serious.

ALENDRONATE PLUS D3 AND CALCIUM SANDOZ

V2.0

70 mg/ 140 µg

Tell your dentist and doctor

immediately if you notice any of

the following

Jaw-bone or dental problems

(including toothache). Jaw-bone

problems may include infection,

and delayed healing after a tooth

extraction or 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

AND CALCIUM SANDOZ and

tell your doctor immediately:

difficulty or pain upon

swallowing

chest pain

new or worsening heartburn

These side effects may be due to

irritation or ulceration of the food

pipe. They may worsen if you

continue taking the tablets. Rarely,

these side effects may be serious.

If any of the following happen, stop

taking ALENDRONATE PLUS D3

AND CALCIUM SANDOZ 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 in breathing or

swallowing

pinkish, itchy swellings on the

skin, also called hives or

nettlerash

severe skin reactions

black tar-like and/or bloody

stools

These may be serious side effects.

You may 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 AND

CALCIUM SANDOZ.

Rarely, stomach or 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.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

ALENDRONATE PLUS D3 AND

CALCIUM SANDOZ is not

addictive.

After using

ALENDRONATE PLUS D3

AND CALCIUM SANDOZ

Storage

Keep your tablets in the original

containers (blister pack and 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

AND CALCIUM SANDOZ in a

cool dry place where the

temperature will stay below 25°C.

Keep the ALENDRONATE PLUS

D3 AND CALCIUM SANDOZ

tablets away from light or

moisture.

Do not store ALENDRONATE

PLUS D3 AND CALCIUM

SANDOZ, 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 AND CALCIUM

SANDOZ or tablets have passed

their expiry date, your pharmacist

what to do with any that are left over.

Product description

What ALENDRONATE PLUS

D3 AND CALCIUM SANDOZ

70 mg/140 µg looks like

ALENDRONATE PLUS D3 AND

CALCIUM SANDOZ 70 mg/140 µg

is a combination pack consisting of a

box of 4 once weekly tablets of

ALENDRONATE PLUS D3

SANDOZ 70 mg/140 µg (5600 IU)

together with a bottle of 24 or 48

tablets of Calcium Sandoz.

ALENDRONATE PLUS D3

SANDOZ 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 Sandoz are capsule shaped

dark green film coated tablet with a

break bar on one side.

Ingredients

Each ALENDRONATE PLUS D3

SANDOZ 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 is gluten-free,

tartrazine-free and free of other azo

dyes.

ALENDRONATE PLUS D3 AND CALCIUM SANDOZ

V2.0

70 mg/ 140 µg

Calcium Sandoz 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 D3 AND

CALCIUM SANDOZ 70 mg/140 µg:

AUST R 222684

Sponsor

Dr Reddy’s Laboratories (Australia)

Pty Ltd

Level 9 492 St Kilda Road,

Melbourne VIC 3004

Australia

This leaflet was prepared in January

2015.

ALENDRONATE PLUS D3 AND CALCIUM SANDOZ

V2.0

70 mg/ 140 µg

18-9-2018

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance sodium hydrogen carbonate are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of sodium hyd...

Europe - EFSA - European Food Safety Authority Publications

22-2-2012

Decision on general conditional reimbursement for alendronate-containing medicines

Decision on general conditional reimbursement for alendronate-containing medicines

In cooperation with the Reimbursement Committee, we have decided to grant alendronate-containing medicines general conditional reimbursement from 5 March 2012. Reimbursement is conditional as it is reserved for patients with low-energy hip fractures. For any other patients who are treated with alendronate, the doctor must apply for single reimbursement, and the guiding criteria for single reimbursement remain unchanged for these patients. Alendronate is used for the treatment of osteoporosis (brittle bon...

Danish Medicines Agency

22-2-2012

Changed criteria for single reimbursement for osteoporosis medicines other than alendronate

Changed criteria for single reimbursement for osteoporosis medicines other than alendronate

As of 5 March 2012, it will only be possible to obtain a single reimbursement grant for the other medicines used in osteoporosis treatment for patients that cannot use alendronate. The criteria for single reimbursement are changed because of the large price gaps between the different medicines, where the reimbursement price of alendronate is by far the lowest.

Danish Medicines Agency

11-7-2018

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Active substance: Alendronate Sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4518 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/619/T/42

Europe -DG Health and Food Safety

10-7-2018

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Active substance: Alendronate sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4477 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/759/T/39

Europe -DG Health and Food Safety