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BINOSTO 70 MG EFFERVESCENT TABLETS

Active substance(s): ALENDRONATE SODIUM TRIHYDRATE

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Alendronic acid 70 mg
Effervescent Tablets

Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Binosto if
• you suffer from kidney problems
• you have any swallowing or digestive problems
• your doctor has told you that you have Barrett’s oesophagus
(a condition associated with changes in the cells that line the
lower oesophagus)

MHRA/IMB
submission
required

Yes

PIL updated to the appropriate
QRD template and change to the
description of the solution

13645
CRN

Artwork No. 832758

GKE
Operator

Reason for
Change

Suffix

A

Issued by
Date

Approved by
Date

In case you perceive any undissolved tablet material at the bottom
of the glass, you may stir the solution until it is dissolved.
• Do not take with mineral water (still or sparkling).
• Do not take with coffee or tea.
• Do not take with juice or milk.
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14pt
Helvetica Neue LT Std 8pt
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8pt
8pt

06.03.2017
Date

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Proof No.

2. After getting up for the day and before taking any food, drink, or
other medicine, dissolve your Binosto effervescent tablet in half
a glass of plain water (not less than 120 ml or 4.2 fl.oz) (not
mineral water). Once the fizzing has subsided and the effervescent tablet has completely dissolved to give a clear, to slightly
cloudy solution, drink this solution, followed by at least 30 ml
(one sixth of a glass) of plain water. You may take additional
water.

195 x 396mm

It is very important to follow instructions 2., 3., 4. and 5. to help
the Binosto effervescent tablet as an oral solution, reach your
stomach quickly and help reduce the chance of irritating your
gullet (oesophagus – the tube that connects your mouth with
your stomach).

Dimensions

If you think any of these apply to you, do not take the effervescent
tablets. Talk to your doctor first and follow the advice given.

1. Choose the day of the week that best fits your schedule. Every
week, take one Binosto effervescent tablet as an oral solution on
your chosen day.

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Do not take Binosto
1. if you are allergic (hypersensitive) to alendronate or any of the
other ingredients of this medicine (listed in section 6).
2. if you have certain problems with your gullet (oesophagus – the
tube that connects your mouth with your stomach) such as
narrowing or difficulty swallowing.
3. if you cannot stand or sit upright for at least 30 minutes.
4. if your doctor has told you that you have low blood calcium.

Follow these instructions carefully to make sure you will benefit
from Binosto.

IG Code

2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE BINOSTO

Take one Binosto effervescent tablet once a week, as an oral
solution.

4's

Eating a balanced diet:
Your doctor can advise you about your diet or whether you should
take any dietary supplements (especially calcium and Vitamin D).

Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
Binosto must be dissolved in half a glass of plain water before taking. Do
not chew or swallow the tablet whole.

Pack Size

Exercise:
Like muscles, bones need exercise to stay strong and healthy.
Consult your doctor before you begin any exercise programme.

3. HOW TO TAKE BINOSTO

Leaflet

Stopping smoking:
Smoking appears to increase the rate at which you lose bone and,
therefore, may increase your risk of broken bones.

Binosto contains sodium
This medicinal product contains 26.2 mmol (or 602.54 mg) sodium
per dose. This should be taken into consideration by patients on a
controlled sodium diet.

Component

How can osteoporosis be treated?
Osteoporosis can be treated and it is never too late to begin treatment. Binosto not only prevents the loss of bone but actually helps
to rebuild bone you may have lost and reduces the risk of bones
breaking in the spine and hip.
As well as your treatment with Binosto, your doctor may suggest
you make changes to your lifestyle to help your condition, such as:

Driving and using machines
There have been side effects (including blurred vision, dizziness
and severe bone, muscle or joint pain) reported with alendronate
that may affect your ability to drive or operate machinery. Individual
responses to alendronate may vary (see section 4. POSSIBLE SIDE
EFFECTS).

Arial

Early on, osteoporosis usually has no symptoms.
If left untreated, however, it can result in broken bones. Although
these usually hurt, breaks in the bones of the spine may go unnoticed until they cause height loss.
Broken bones can happen during normal, everyday activity, such
as lifting, or from minor injury that would not generally break normal
bone. Broken bones usually occur at the hip, spine, or wrist and
can lead not only to pain but also to considerable problems like
stooped posture (‘dowager’s hump’) and loss of mobility.

Pregnancy, breast-feeding and fertility
Binosto is only intended for use in postmenopausal women. You
should not take Binosto if you are or think you may be pregnant,
or if you are breast-feeding.

Process Black

What is osteoporosis?
Osteoporosis is a thinning and weakening of the bones.
It is common in women after the menopause. At the menopause,
the ovaries stop producing the female hormone, oestrogen, which
helps to keep a woman’s skeleton healthy. As a result, bone loss
occurs and bones become weaker. The earlier a woman reaches
the menopause, the greater the risk of osteoporosis.

Binosto with food and drink
It is likely that food and beverages (including mineral water) will
make Binosto less effective if taken at the same time. Therefore, it
is important that you follow the advice given in section 3. HOW TO
TAKE BINOSTO.
Point Sizes Used
Min
Max

Binosto is a once weekly treatment.

Other medicines and Binosto
Tell your doctor or pharmacist if you are taking or have recently
taken or might take any other medicines. It is likely that calcium
supplements, antacids, and some oral medicines will interfere with
the absorption of alendronate if taken at the same time. Therefore,
it is important that you follow the advice given in section 3. HOW
TO TAKE BINOSTO.

Fonts Used

What is Binosto used for?
Your doctor has prescribed Binosto to treat your osteoporosis.
Binosto reduces the risk of spine and hip fractures.

Children and adolescents
Binosto should not be given to children and adolescents.

Colours Used

What is Binosto?
Alendronate, the active substance of Binosto belongs to a group
of non-hormonal medicines called bisphosphonates. Binosto prevents the loss of bone that occurs in women after they have been
through the menopause, and helps to rebuild bone. It reduces the
risk of spine and hip fractures.

Irritation, inflammation or ulceration of the gullet (oesophagus –
the tube that connects your mouth with your stomach) often with
symptoms of chest pain, heartburn, or difficulty or pain upon
swallowing may occur, especially if patients do not use enough
water to dissolve the effervescent tablet and/or if they lie down
less than 30 minutes after taking Binosto. These side effects may
worsen if patients continue to take Binosto after developing these
symptoms.

Binosto Alendronic acid 70mg
Effervescent Tablets

1. WHAT BINOSTO IS AND WHAT IT IS USED FOR

It is important to maintain good oral hygiene when being treated
with Binosto. You should have routine dental check-ups throughout
your treatment and you should contact your doctor or dentist if you
experience any problems with your mouth or teeth such as loose
teeth, pain or swelling.

Product Title

What is in this leaflet:
1. What Binosto is and what it is used for
2. What you need to know before you take Binosto
3. How to take Binosto
4. Possible side effects
5. How to store Binosto
6. Contents of the pack and other information

You may be advised to have a dental check-up before starting
treatment with Binosto.

PCP Header Box

Read all of this leaflet carefully before you start taking this
medicine, because it contains important information for
you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if their signs of illness are
the same as yours.
• If you get any side effects, talk to your doctor, or pharmacist
or nurse. This includes any possible side effects not listed in
this leaflet. See section 4.

• you have been told you have low blood calcium
• you have poor dental health, gum disease, a planned extraction
or you don’t receive routine dental care
• you have cancer
• you are undergoing chemotherapy or radiotherapy
• you are taking corticosteroids (such as prednisone or dexamethasone)
• you are or have been a smoker (as this may increase the risk of
dental problems).

MHRA Header Box

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Do not swallow the undissolved effervescent tablet or chew
the effervescent tablet or allow it to dissolve in your mouth.
3. Do not lie down – stay fully upright (sitting, standing or walking) –
for at least 30 minutes after drinking the oral solution containing
the dissolved effervescent tablet. Do not lie down until after your
first food of the day.

often following tooth extraction. Contact your doctor and dentist
if you experience such symptoms.
• unusual fracture of the thigh bone particularly in patients on longterm treatment for osteoporosis may occur rarely. Contact your
doctor if you experience pain, weakness or discomfort in your
thigh, hip or groin as this may be an early indication of a possible
fracture of the thigh bone.
• mouth ulcers when the tablets have been chewed or sucked.

4. Do not take Binosto at bedtime or before getting up for the day.
Very Rare (may affect up to 1 in 10,000 people):
• Talk to your doctor if you have ear pain, discharge from the ear,
and/or an ear infection. These could be signs of bone damage in
the ear.

6. After drinking the oral solution containing the dissolved Binosto
effervescent tablet, wait at least 30 minutes before taking your
first food, drink, or other medicine of the day, including antacids,
calcium supplements and vitamins. Binosto is effective only if
taken when your stomach is empty.

Tell your doctor or pharmacist promptly about these or any other
unusual symptoms.

If you take more Binosto than you should
If you take too many effervescent tablets by mistake, drink a full
glass of milk and contact your doctor immediately.
Do not make yourself vomit, and do not lie down.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Yes
MHRA/IMB
submission
required

Reason for
Change

A
Suffix

13645
CRN

Artwork No. 832758

GKE
Operator

PIL updated to the appropriate
QRD template and change to the
description of the solution

Issued by
Date

Approved by
Date

Marketing Authorisation Holder
Internis Pharmaceuticals Ltd
Linthwaite
Huddersfield
HD7 5QH, UK.

14pt

06.03.2017

Not all pack sizes may be marketed.

Helvetica Neue LT Std 8pt

8pt
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The effervescent tablets are supplied in strips of composite foil.
Each strip contains 2 effervescent tablets packed in individual
units. The strips are packed in cartons in pack sizes of 4, 12 or 24
effervescent tablets.

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What Binosto looks like and contents of the pack
Binosto is available as round, white to off-white, flat faced effervescent tablets of 25 mm diameter and with beveled edges. After
dissolution of the tablet the solution is clear to slightly cloudy.

This leaflet was last revised in January 2017.

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Proof No.

Date

195 x 396mm

Binosto® 70 mg Brausetabletten
Binosto® 70 mg Αναβράζον δισκίο
Binosto® 70 mg comprimidos efervescentes
Steovess® 70 mg Comprimé effervescent
Binosto® Once Weekly 70 mg Effervescent Tablets
Binosto® 70 mg Compresse effervescenti
Binosto® 70 mg comprimidos efervescentes
Binosto® 70 mg Comprimate efervescente
Binosto® 70 mg Effervescent Tablets

Dimensions

DE
EL
ES
FR
IE
IT
PT
RO
UK

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This medicinal product is authorized in the Member States of
the EEA under the following names:

IG Code

Temmler Pharma GmbH
Temmlerstraße 2
35039 Marburg
Germany

4's

Manufacturer

Pack Size

Rare (may affect up to 1 in 1,000 people):
• allergic reactions such as hives; swelling of the face, lips, tongue
and/or throat, possibly causing difficulty breathing or swallowing
• symptoms of low blood calcium levels including muscle cramps
or spasms and/or tingling sensation in the fingers or around the
mouth
• stomach or peptic ulcers (sometimes severe or with bleeding)
• narrowing of the gullet (oesophagus – the tube that connects
your mouth with your stomach)
• rash made worse by sunlight; severe skin reactions
• pain in the mouth, and/or jaw, swelling or sores inside the mouth,
numbness or a feeling of heaviness in the jaw, or loosening of a
tooth. These could be signs of bone damage in the jaw (osteonecrosis) generally associated with delayed healing and infection,

The other ingredients are:
Sodium dihydrogen citrate, citric acid anhydrous, sodium hydrogen
carbonate, sodium carbonate anhydrous, strawberry flavour [maltodextrin (maize), arabic gum, propylene glycol (E 1520), nature-identical flavouring substances], acesulfame potassium, sucralose.

Leaflet

Uncommon (may affect up to 1 in 100 people):
• nausea; vomiting
• irritation or inflammation of the gullet (oesophagus – the tube that
connects your mouth with your stomach) or stomach
• black or tar-like stools
• blurred vision; pain or redness in the eye
• rash; redness of the skin
• transient flu-like symptoms, such as aching muscles, generally
feeling unwell and sometimes with fever usually at the start of
treatment
• taste disturbance

The active substance is:
Alendronate sodium trihydrate
Each effervescent tablet contains 70 mg alendronic acid
as 91.37 mg of alendronate sodium trihydrate.

Component

Common (may affect up to 1 in 10 people):
• heartburn; difficulty swallowing; pain upon swallowing; ulceration
of the gullet (oesophagus – the tube that connects your mouth
with your stomach) which can cause chest pain, heartburn or
difficulty or pain upon swallowing
• joint swelling
• abdominal pain; uncomfortable feeling in the stomach or belching
after eating; constipation; full or bloated feeling in the stomach;
diarrhoea; flatulence
• hair loss; itching
• headache; dizziness
• tiredness; swelling in the hands or legs

What Binosto contains

Arial

Very Common (may affect more than 1 in 10 people)
• bone, muscle and/or joint pain which is sometimes severe

6. CONTENTS OF THE PACK AND OTHER
INFORMATION

Process Black

The following side effects have been reported:

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.

Point Sizes Used
Min
Max

If you have difficulty and/or pain when swallowing, you feel
pain behind the breastbone or new or worsened heartburn,
stop taking Binosto and contact your doctor. If you ignore these
symptoms and continue to take your effervescent tablet, as an oral
solution it is likely that these gullet reactions may get worse.

This medicinal product does not require any special temperature
storage conditions. Store in the original package in order to protect
from moisture. Do not remove the effervescent tablets from the
strip until you are ready to take the medicine.

Fonts Used

All medicines can cause allergic reactions, although serious
allergic reactions are very rare. You should stop taking Binosto
and tell your doctor immediately if you get any of the following
symptoms:
• Sudden wheeziness, difficulty in breathing, swelling of the eyelids, face, throat, tongue, lips, rash or itching (especially affecting
your whole body).
•  a rash made worse by sunlight; blistering or other effects on the
skin, eyes, mouth or genitals, itching or high temperature (symptoms of severe skin reactions called Stevens-Johnson syndrome
or toxic epidermal necrolysis).

Do not use Binosto after the expiry date which is stated on the
carton and the strip after EXP. The expiry date refers to the last day
of that month.

Colours Used

Like all medicines, Binosto can cause side effects, although not
everybody gets them.

Keep this medicine out of the sight and reach of children.

Binosto Alendronic acid 70mg
Effervescent Tablets

4. POSSIBLE SIDE EFFECTS

5. HOW TO STORE BINOSTO

Product Title

If you stop taking Binosto
It is important that you continue taking Binosto for as long as your
doctor prescribes the medicine. Binosto can treat your osteoporosis only if you continue to take the effervescent tablets dissolved
in plain water. If you have any further questions on the use of this
medicine, ask your doctor or pharmacist or nurse.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly by the Yellow Card
Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side
effects, you can help provide more information on the safety of this
medicine.

MHRA Header Box

If you forget to take Binosto
If you miss a dose, just take one effervescent tablet dissolved in
plain water on the morning after you remember, following the aforementioned instructions 2., 3., 4., 5. and 6. Do not take two effervescent
tablets for oral solution on the same day. Return to taking one effervescent tablet for oral solution once a week, as originally scheduled on
your chosen day.

It will help if you make a note of what you experienced, when it
started and how long it lasted.

PCP Header Box

5. If you develop difficulty or pain upon swallowing, chest pain, or
new or worsening heartburn, stop taking Binosto and contact
your doctor.

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