Binosto

Package leaflet: Information for the patient

Binosto 70 mg Effervescent Tablets

Alendronic Acid
Please read all of this leaflet carefully before taking this medicine, because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.
• It is especially important to understand the information contained in section 3 before taking this medicine.

Contents of this leaflet:
1 What Binosto is and what it is 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

1. What Binosto is and what it is used for

Binosto is an effervescent tablet containing the active substance alendronic acid
(commonly known as alendronate) and belongs to a group of non-hormonal medicines called bisphosphonates. Binosto prevents bone tissue loss that occurs in women after menopause and promotes bone rebuilding. It reduces the risk of spinal 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 thinning and weakening of the bones. It is common in women after menopause. During menopause, the ovaries stop producing female hormones, oestrogens, which help maintain a woman's healthy skeleton. 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 causes no symptoms. However, if left untreated, fractures may occur. Although fractures are usually painful, spinal bone fractures may go unnoticed until they result in a loss of height. Fractures can occur during normal daily activities such as lifting weights, or following minor trauma that would not cause fractures in normal bone. Fractures typically occur in the hip, spine or wrist and can be not only painful but also lead to significant problems, such as curvature of the back (widow's hump) and movement limitations.

How can osteoporosis be treated?
Osteoporosis can be treated, and it is never too late to start treatment. Binosto not only prevents bone tissue loss but also helps rebuild bone that may have been lost and reduces the risk of spinal and hip fractures.
Alongside treatment with Binosto, your doctor may suggest lifestyle changes to improve the condition, such as:
Stopping smoking Smoking appears to increase the rate at which bone tissue is lost and therefore may increase the risk of fractures.
Physical exercise Like muscles, bones need physical activity to stay strong and healthy. Consult your doctor before starting any exercise programme.
Balanced diet Your doctor may advise you on diet or tell you if you need to take dietary supplements (especially calcium and Vitamin D).

2. What you should know before taking Binosto

Do not take Binosto

• if you are allergic (hypersensitive) to alendronate or any of the other ingredients of this medicine (listed in section 6).
• if you have certain problems with your oesophagus (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 the advice given.

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 gastrointestinal disorders,
• your doctor has told you that you have Barrett’s oesophagus (a condition associated with changes in the cells lining the lower part of the oesophagus),
• you have been diagnosed with a condition affecting mineral absorption in the stomach or intestine (malabsorption syndrome),
• you have been told that you have low levels of calcium in your blood,
• you have poor dental health, gum disease, are scheduled for a tooth extraction, or do not have regular dental check-ups,
• you have cancer,
• you are undergoing chemotherapy or radiotherapy,
• you are taking angiogenesis inhibitors (such as bevacizumab or thalidomide) used in cancer treatment,
• you are taking corticosteroids (such as prednisone or dexamethasone) used to treat conditions like asthma, rheumatoid arthritis, or severe allergies,
• you are or have been a smoker (as this may increase the risk of dental problems).

You may be advised to have a dental examination 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 contact your doctor or dentist if you experience any mouth or dental problems such as tooth loss, pain, or swelling.
Irritation, inflammation, or ulceration of the oesophagus (the tube connecting the mouth to the stomach) may occur, often with symptoms such as chest pain, heartburn, or difficulty or pain when swallowing, especially if patients have not used enough water to dissolve the effervescent tablets and/or lie down during the first 30 minutes after taking Binosto.
These side effects may worsen if patients continue taking Binosto after experiencing such symptoms.

Children and adolescents:
Binosto must not be administered to children and adolescents under 18 years of age.

Other medicines and Binosto
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Calcium supplements, antacids, and certain oral medications may interfere with the absorption of alendronate if taken at the same time.
Therefore, it is important to follow the instructions provided in section 3.
Some medicines used for rheumatic conditions or long-term pain, called NSAIDs (e.g. acetylsalicylic acid or ibuprofen), may cause gastrointestinal problems. Therefore, caution should be used when taking these medicines together with Binosto.

Binosto with food and drink
Food and beverages (including mineral water) may reduce the effectiveness of Binosto if taken at the same time. Therefore, it is important to follow the instructions provided in section 3.

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

Driving and using machines
With alendronate, side effects have been reported (e.g. blurred vision, dizziness, and severe bone, muscle, or joint pain) that may affect the ability to drive or operate machinery (see section 4).

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

3. How to take Binosto

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Binosto must be dissolved in half a glass of tap water before taking.
Do not chew or swallow the tablet whole.
Take one effervescent tablet of Binosto once a week as an oral solution.
Follow the instructions below carefully:

1. Choose a day of the week that best fits your routine. Take one effervescent tablet as an oral solution of Binosto every week on the chosen day.

It is very important that you follow steps 2), 3), 4), and 5) to help the effervescent tablet, as an oral solution, reach your stomach quickly and to help reduce the risk of irritating your oesophagus (the tube connecting your mouth to your stomach).

2. After getting up in the morning 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) (do not use mineral water).
   Once the tablet has finished fizzing and has completely dissolved, resulting in a solution ranging from clear to slightly cloudy, drink the solution and then at least 30 ml of tap water (one-sixth of a glass). You may drink additional water.
   If you see undissolved parts of the tablet at the bottom of the glass, you may stir the solution until fully 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 effervescent tablet undissolved, do not chew it, and do not allow the effervescent tablet to dissolve in your mouth.

3. Do not lie down – remain 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 you have eaten something.

4. Do not take Binosto at bedtime or before getting up in the morning.

5. If you experience difficulty or pain when swallowing, chest pain, or new or worsening heartburn, 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 any other medicines of the day, including antacids, calcium supplements, and vitamins. Binosto is effective only when taken on an empty stomach.

If you take more Binosto than you should
If you accidentally take 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 one effervescent tablet for oral solution once a week on your chosen day.

If you stop taking Binosto
It is important to continue taking Binosto for as long as prescribed by your doctor. Since it is not known how long you should take Binosto, you should periodically consult your doctor to assess whether continued treatment with this medicine is still appropriate for you.

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Binosto can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience any of the following symptoms, which may be serious and for which you may require urgent medical treatment:
Common (may affect up to 1 in 10 people):

• heartburn; difficulty swallowing; pain when swallowing; oesophageal ulceration (the tube connecting the mouth to the stomach), which may cause chest pain, heartburn, or difficulty or pain when swallowing.

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; severe skin reactions,
• mouth pain, and/or jaw/mandible pain, swelling or ulcers inside the mouth, numbness or a sensation of heaviness in the jaw/mandible, or tooth loss. These may be signs of bone damage in the jaw/mandible (osteonecrosis), usually associated with delayed healing and infection, often following dental extraction. Contact your doctor and dentist if you experience such symptoms,
• rarely, an unusual femur fracture may occur, particularly in patients on long-term osteoporosis treatment. Contact your doctor if you experience pain, weakness, or discomfort in the thigh, hip, or groin, as this could be an early sign 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, sometimes severe.

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

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

Uncommon (may affect up to 1 in 100 people):

• nausea; vomiting,
• irritation or inflammation of the oesophagus (the tube connecting the mouth to the stomach) or stomach,
• black or dark stools,
• blurred vision; eye pain or redness,
• skin rash; redness of the skin,
• transient flu-like symptoms such as muscle aches, general malaise, and sometimes fever, usually at the beginning of treatment,
• altered taste.

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

• symptoms due to low calcium levels in the blood, including muscle cramps or spasms and/or tingling sensations in the fingers or around the mouth,
• peptic or stomach ulcers (sometimes severe or with bleeding),
• narrowing of the oesophagus (the tube 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 people):

• Consult your doctor if you experience ear pain, ear discharge, and/or ear infection. These events could be signs of bone damage in the ear.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via 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 stated on the carton and on the strip after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Store in the original packaging to protect the medicine from moisture. Do not remove the effervescent tablet from the strip until ready to take the medicine.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Binosto contains
The active substance is sodium alendronate trihydrate.

• Each effervescent tablet contains sodium alendronate trihydrate equivalent to 70 mg of alendronic acid.
• The other components are:
  Dihydric sodium citrate, anhydrous citric acid, sodium hydrogen carbonate, anhydrous sodium carbonate, strawberry flavour [maltodextrins (maize), gum arabic, propylene glycol (E 1520), natural-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 bevelled edges, 25 mm in diameter.
The effervescent tablets are supplied in composite foil strips. Each strip contains 2 individually packaged effervescent tablets. The strips are packed in cardboard cartons containing 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 European Economic Area countries under the following names:
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