BINOSTO 70 mg Effervescent Tablet

Зміст інструкції

1. Binosto 70 mg Effervescent Tablets
   1. What is Binosto and what is it used for
   2. What you need to know before taking Binosto
   3. How to take Binosto
   4. Possible side effects
   5. How to store Binosto
   6. Contents of the pack and other information

Binosto 70 mg Effervescent Tablets

Alendronic Acid

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist or nurse. See section 4.
• It is particularly important to understand the information in section 3 before you take this medicine.

Contents of 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

1. What is Binosto and what is it used for

Binosto is an effervescent tablet containing the active ingredient alendronic acid
(commonly called alendronate) and belongs to a group of non-hormonal medicines
called bisphosphonates. Binosto prevents the loss of bone tissue that occurs in women after
menopause and promotes bone rebuilding. It reduces the risk of vertebral and hip fractures.
Your doctor has prescribed Binosto for the treatment of osteoporosis. Binosto reduces the risk of
vertebral and hip fractures.

Binosto must be taken once a week
What is osteoporosis?
Osteoporosis is a thinning and weakening of the bones. It is common in women after
menopause. During menopause, the ovaries stop producing female hormones, estrogens, which
help to keep a woman's skeleton healthy. As a result, bone tissue is lost and the bone becomes weaker. The risk of osteoporosis is greater the earlier a woman reaches menopause.
In the early stages, osteoporosis usually has no symptoms. However, if left untreated, fractures can occur. Although fractures are usually painful, fractures of the vertebrae may not be felt until they result
in a loss of height. Fractures can occur during normal daily activities
such as lifting weights, or with minor trauma that would not be able to cause fractures in normal bone. Fractures usually occur in the hip, spine, or wrist and
can be not only painful but can lead to significant problems, such as curvature of the
back (dowager's hump) and limitations in movement.

How can osteoporosis be treated?
Osteoporosis can be treated and it is never too late to start treatment. Binosto
not only prevents the loss of bone tissue but helps to rebuild bone that may have been
lost and reduces the risk of vertebral and hip fractures.
Along with treatment with Binosto, your doctor may suggest changing your lifestyle to
improve the condition of the disease, such as:

Stop smokingSmoking appears to increase the rate at which bone tissue is lost and,
therefore, can increase the risk of fractures.

ExerciseLike muscles, bones need exercise to stay strong and
healthy. Consult your doctor before starting any exercise program.

Balanced dietYour doctor may advise you on your diet or tell you if you need to take dietary supplements (especially calcium and Vitamin D).

2. What you need to know before taking Binosto

Do not take Binosto

• if you are allergic (hypersensitive) to alendronic acid or any of the other ingredients of this medicine (listed in section 6).
• if you have certain problems with your esophagus (the tube connecting your mouth to your stomach), such as narrowing or difficulty swallowing
• if you are unable to stand or sit upright for at least 30 minutes
• if your doctor has told you that you have low levels of calcium in your blood.

If you think any of these apply to you, do not take the effervescent tablets. Consult your doctor first and follow their instructions.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Binosto if:

• you have kidney problems,
• you have, or have recently had, difficulty swallowing or problems with your digestive system,
• your doctor has told you that you have Barrett's esophagus (a disease associated with changes in the cells lining the lower part of your esophagus),
• you have been told that you have a problem with the absorption of minerals in your stomach or intestines (malabsorption syndrome),
• you have been told that you have low levels of calcium in your blood,
• you have poor dental health, have gum disease, are planning to have a tooth extracted or do not have regular check-ups with your dentist,
• you have cancer,
• you are undergoing chemotherapy or radiotherapy,
• you are taking angiogenesis inhibitors (such as bevacizumab, or thalidomide) which are used in the treatment of cancer,
• you are taking corticosteroids (such as prednisone or dexamethasone) which are used in the treatment of conditions such as asthma, rheumatoid arthritis and severe allergies,
• you are or have been a smoker (as this may increase the risk of dental problems).

You may be asked to have a dental check-up before starting treatment with Binosto.
It is important to maintain good oral hygiene during treatment with Binosto.
You should have regular 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 tooth loss, pain or swelling.
Irritation, inflammation or ulceration of the esophagus (the tube connecting the mouth to the stomach) may occur, often with symptoms of chest pain, heartburn or difficulty or pain when swallowing, especially if patients do not use enough water to dissolve the effervescent tablets and/or if they lie down during the first 30 minutes after taking Binosto.
These side effects may worsen if patients continue to take Binosto after experiencing these symptoms.

Children and adolescents:
Binosto should not be given to children and adolescents under 18 years of age.

Other medicines and Binosto
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Calcium supplements, antacids, and some oral medicines are likely to interfere with the absorption of alendronic acid if taken at the same time.
It is therefore important to follow the instructions given in section 3.
Some medicines for rheumatism or long-term pain called NSAIDs (e.g. acetylsalicylic acid or ibuprofen) may cause digestive problems. Therefore, caution should be exercised when these medicines are taken at the same time as Binosto.

Binosto with food and drink
Food and beverages (including mineral water) are likely to decrease the effectiveness of Binosto if taken at the same time. It is therefore important to follow the instructions given in section 3.

Pregnancy and breastfeeding
Binosto is only indicated for women after menopause. Do not take Binosto if you are pregnant or suspect you may be pregnant or if you are breastfeeding.

Driving and using machines
Side effects (such as blurred vision, dizziness and severe bone, muscle or joint pain) have been reported with alendronic acid that may affect your ability to drive or operate machinery (see section 4).

Binosto contains sodium
This medicine contains 630 mg of sodium (the main component of table salt) per dose.
This is equivalent to 30% of the maximum recommended daily intake of sodium for an adult.
This should be taken into consideration by patients who are on a low-sodium diet.

3. How to take Binosto

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.

Binosto must be dissolved in half a glass of tap water before being taken.
Do not chew or swallow the tablet whole.
Take oneBinosto effervescent tablet once a week, as an oral solution.
Follow the instructions below carefully:

• 1) Choose a day of the week that best suits your activities. Take one Binosto effervescent tablet as an oral solution every week on the chosen day.

It is very important that you follow instructions 2), 3), 4) and 5) to facilitate the quick passage of the
Binosto effervescent tablet, as an oral solution, into the stomach and help reduce the
possibility of irritating the esophagus (the channel that connects the mouth to the stomach).

• 2) After getting out of bed to start the day, and before taking any food, drink or other medicine, dissolve the Binosto effervescent tablet in half a glass of tap water (not less than 120 ml) (not mineral water). Once it has finished fizzing and the effervescent tablet has completely dissolved, giving rise to a solution from clear to slightly cloudy, drink this

solution and then at least 30 ml of tap water (one sixth of a glass). You can drink further
water.
If you see undissolved parts of the tablet at the bottom of the glass, you can stir the
solution until they are dissolved.

• Do not take with mineral water (still or sparkling).
• Do not take with coffee or tea.
• Do not take with juices or milk.

Do not swallow the undissolved effervescent tablet or chew it or let the effervescent
tablet dissolve in your mouth.

• 3) Do not lie down – keep your torso upright (while sitting, while standing, while walking) – for at least 30 minutes after drinking the oral solution containing the dissolved effervescent tablet. Do not lie down until you have eaten something.
• 4) Do not take Binosto at bedtime or before getting out of bed in the morning.
• 5) If you experience difficulty or pain when swallowing, chest pain, or heartburn occurs or worsens, stop taking Binosto and contact your doctor.
• 6) After drinking the oral solution containing the dissolved Binosto effervescent tablet, wait at least 30 minutes before eating, drinking or taking other medicines of the day, including antacids, calcium supplements and vitamins. Binosto is only effective when taken on an empty stomach.

If you take more Binosto than you should
If you have accidentally taken too many Binosto effervescent tablets, drink a full glass
of milk and contact your doctor immediately. Do not induce vomiting and do not lie down.

If you forget to take Binosto
If you forget to take a dose, simply take one effervescent tablet dissolved in
tap water the morning after the day you remember, following the instructions above
in points 2), 3), 4), 5) and 6). Do not take two effervescent tablets for oral solution

on the same day.Afterwards, resume taking the effervescent tablet for oral solution
once a week, on the chosen day.

If you stop taking Binosto
It is important to continue taking Binosto until prescribed by your doctor. Since it is not known how long you should take Binosto, you should periodically check with your
doctor the need to remain on therapy with this medicine to determine if Binosto is
still the right therapy for you.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist or
nurse.

4. Possible side effects

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

See your doctor immediatelyif you notice any of the following symptoms, which may be
serious and may require urgent medical treatment:
Common (may affect up to 1 in 10 people):

• heartburn; difficulty swallowing; pain when swallowing; ulceration of the esophagus (the channel connecting the mouth to the stomach) which can cause chest pain, heartburn or difficulty or pain when swallowing.

Rare (may affect up to 1 in 1,000):

• allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, which can cause difficulty breathing or swallowing; severe skin reactions,
• pain in the mouth, and/or jaw/mandible, swelling or ulcers inside the mouth, numbness or a feeling of heaviness in the jaw/mandible or tooth loss. These may be signs of bone damage in the jaw/mandible (osteonecrosis) generally associated with delayed healing and infection, often after dental extraction. Contact your doctor and dentist if you experience these symptoms,
• rarely, an unusual fracture of the femur may occur, particularly in patients treated for a long time for osteoporosis. Contact your doctor if you experience pain, weakness or discomfort in the thigh, hip or groin as this may be an early indication of a possible femur fracture.

Other side effects include
Very common (may affect more than 1 in 10 people):

• bone, muscle and/or joint pain which is sometimes severe.

Common (may affect up to 1 in 10 people):

• joint swelling,
• abdominal pain; discomfort in the stomach or belching after meals, constipation; feeling of fullness or bloating in the stomach; diarrhea; flatulence,
• hair loss; itching,
• headache; dizziness,
• fatigue; swelling of the hands or legs.

Uncommon (may affect up to 1 in 100):

• nausea; vomiting,
• irritation or inflammation of the esophagus (the channel connecting the mouth to the stomach) or the stomach,
• black or tarry stools,
• blurred vision; pain or redness of the eyes,
• skin rash; skin redness,
• transient flu-like symptoms, such as muscle aches, general feeling of unwellness and sometimes with fever, usually at the beginning of treatment,
• altered taste.

Rare (may affect up to 1 in 1,000):

• symptoms due to low blood calcium levels including muscle cramps or spasms and/or tingling in the fingers or around the mouth,
• peptic or stomach ulcers (sometimes severe or with bleeding),
• narrowing of the esophagus (the channel connecting the mouth to the stomach),
• skin rash worsened by exposure to sunlight,
• mouth ulcers.

Very rare (may affect up to 1 in 10,000):

• Contact your doctor if you experience ear pain, ear discharge and/or ear infection. These episodes may be signs of bone damage in the ear.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects
directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Binosto

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature.
Store in the original package to protect the medicine from moisture. Do not remove the
effervescent tablet from the blister until you are ready to take the medicine.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Binosto contains
The active ingredient is alendronic acid sodium trihydrate.

• Each effervescent tablet contains alendronic acid sodium trihydrate equivalent to 70 mg of alendronic acid.
• The other ingredients are:
• Sodium citrate dihydrate, anhydrous citric acid, sodium hydrogen carbonate, anhydrous sodium carbonate, strawberry aroma [maltodextrin (corn), gum arabic, propylene glycol (E 1520), nature-identical flavouring substances], acesulfame potassium, sucralose.

Description of the appearance of Binosto and contents of the pack
Binosto is available as white to off-white, flat, round effervescent tablets with
a diameter of 25 mm and with bevelled edges.
The effervescent tablets are supplied in composite foil blisters. Each blister contains 2
individually packaged effervescent tablets. The blisters are packaged in cardboard boxes in packs of 4, 12 or 24 effervescent tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Abiogen Pharma S.p.A.
Via Meucci, 36
Ospedaletto - Pisa

Manufacturer
Temmler Pharma GmbH
Temmlerstrasse 2, 35039 Marburg
Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
CY Binosto 70 mg Αναβράζον δισκίο
DE Binosto 70 mg Brausetabletten
DK Binosto 70 mg Brusetabletter
FI Binosto 70 mg Poretabletit
EL Binosto 70 mg Αναβράζον δισκίο
FR Steovess 70 mg Comprimé effervescent
IE Binosto Once Weekly 70 mg Effervescent Tablets
IT Binosto 70 mg Compresse effervescenti
NO Binosto 70 mg Brusetablett
PT Binosto 70 mg comprimidos efervescentes
RO Binosto 70 mg, Comprimate efervescente
SE Binosto® 70mg Brustabletter