Bonasol

PACKAGE LEAFLET: INFORMATION FOR THE USER

Bonasol 70mg Oral Solution Weekly

Alendronic Acid
Please read 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 effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

In this leaflet, Bonasol 70mg Oral Solution Weekly will be referred to simply as Bonasol Oral Solution.

1. WHAT BONASOL ORAL SOLUTION IS AND WHAT IT IS USED FOR

Bonasol oral solution belongs to a group of non-hormonal medicines called bisphosphonates. Bonasol oral solution is used for:

• Preventing bone loss (osteoporosis) that occurs in postmenopausal women and helps rebuild bone.
• Reducing the risk of vertebral and hip fractures.

Your doctor has prescribed Bonasol oral solution to treat your osteoporosis and to reduce the risk of vertebral and hip fractures.
What is osteoporosis?
Osteoporosis is a condition characterized by thinning and weakening of the bones. It is common in women after menopause. After menopause, the ovaries stop producing the female hormone estrogen, which helps maintain healthy bones in women. As a result, bone tissue is lost and bones become weaker. The earlier a woman enters menopause, the greater her risk of developing osteoporosis.
In its early stages, osteoporosis usually does not cause symptoms. However, if left untreated, it may lead to bone fractures. Although such fractures typically cause pain, fractures of the spinal bones may go unnoticed until they cause a decrease in height. Bone fractures can occur during normal daily activities such as lifting a heavy object, or following minor injuries that would not normally cause fractures in healthy bones. Bone fractures usually occur in the hip, spine, or wrist and can not only be painful but may also lead to significant problems, such as curvature of the back (kyphosis) and reduced mobility.
How can osteoporosis be treated?
Osteoporosis can be treated, and it is never too late to start treatment. Alendronate not only prevents bone loss, but also helps rebuild bone tissue that has been lost, and reduces the risk of vertebral and hip fractures.
In addition to treatment with Bonasol Oral Solution, your doctor may recommend that you make certain lifestyle changes for your benefit, for example:
Stopping smoking; Smoking appears to increase the rate of bone loss and therefore may increase the risk of fractures.
Engaging in physical exercise; Just like muscles, bones also need exercise to stay strong and healthy. Before starting any exercise program, consult your doctor.
Following a balanced diet; Your doctor can give you advice on proper nutrition or tell you whether you need to take supplements (particularly calcium and vitamin D).

2. WHAT YOU SHOULD KNOW BEFORE TAKING BONASOL ORAL SOLUTION

Do not take Bonasol oral solution if:

• you are allergic (hypersensitive) to alendronate or to any of the other ingredients of Bonasol 70 mg Oral Solution (listed in section 6).
• you have problems with your oesophagus (the tube connecting your mouth to your stomach), such as narrowing or difficulty swallowing liquids.
• your doctor has told you that you have low levels of calcium in your blood.
• you are unable to remain upright in a standing or sitting position for at least 30 minutes.

If you think any of these situations apply to you, do not take the solution.
Talk to your doctor first and follow their instructions.

Warnings and precautions

Talk to your doctor or pharmacist before taking Bonasol Oral Solution if:

• you have any kidney problems.
• you suffer from any allergies.
• you have difficulty swallowing or digesting food.
• your doctor has told you that you have Barrett’s oesophagus (a condition associated with changes in the cells lining the lower oesophagus).
• you have low levels of calcium in your blood.
• you have poor dental health.
• you are scheduled for a tooth extraction.
• you suffer from cancer.
• you are undergoing chemotherapy or radiotherapy.
• you are receiving steroid therapy.
• you do not regularly visit your dentist.
• you have gum disease.
• you currently smoke or have smoked in the past (as this may increase the risk of dental problems).

You may be advised to have a dental examination before starting treatment with Bonasol Oral Solution. During treatment, preventive dental care should be performed as recommended by your dentist. 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 oesophagus (the tube connecting the mouth to the stomach) may occur, often accompanied by symptoms such as chest pain, heartburn or difficulty or pain when swallowing, especially if patients lie down after taking Bonasol Oral Solution. These adverse effects may worsen if patients continue taking Bonasol Oral Solution after experiencing such symptoms.

Children and adolescents

Bonasol Oral Solution must not be given to children and adolescents under 18 years of age due to insufficient data on safety and efficacy.

Other medicines and Bonasol Oral Solution

Tell 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 Bonasol Oral Solution if taken at the same time. Therefore, it is important to follow the instructions provided in section 3. HOW TO TAKE BONASOL ORAL SOLUTION.

Some medicines used for rheumatism or long-term pain, called NSAIDs (e.g. aspirin or ibuprofen), may cause digestive problems. Therefore, caution should be exercised when these medicines are taken together with Bonasol Oral Solution.

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Bonasol Oral Solution with food, drinks and alcohol

Food and drinks (including mineral water) may reduce the effectiveness of Bonasol Oral Solution if taken at the same time. Therefore, it is important to follow the instructions provided in section 3. HOW TO TAKE BONASOL ORAL SOLUTION.

Pregnancy and breastfeeding

Bonasol Oral Solution is intended only for use in postmenopausal women.
Do not take Bonasol Oral Solution if you suspect you are pregnant or if you are breastfeeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Undesirable effects have been reported with the use of alendronate (including blurred vision, dizziness, and severe or mild bone, muscle or joint pain), which may affect your ability to drive or operate machinery. Individual responses to alendronate may vary (see section 4. POSSIBLE ADVERSE EFFECTS).

Bonasol Oral Solution contains

This medicinal product contains Sunset Yellow (E110), methyl- and propyl-parahydroxybenzoates (E218, E216), which may cause allergic reactions (sometimes delayed). Allergy is more likely in individuals who are allergic to aspirin.

If you have any doubts about using this medicine, consult your doctor or pharmacist.

This medicinal product contains 0.15% v/v ethanol (alcohol), which corresponds to up to 115 mg per dose, equivalent to 3 ml of beer or 1.3 ml of wine per dose. This may be harmful for alcoholics and should be taken into account in high-risk groups, such as patients with liver disease or epilepsy.

3. HOW TO TAKE BONASOL ORAL SOLUTION

Always take Bonasol oral solution exactly as directed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one 70 mg unit-dose (100 ml) once weekly.
To ensure you get the maximum benefit from Bonasol oral solution, follow these
instructions carefully.
Choose the day of the week that best fits your routine.
Take Bonasol oral solution once a week on the chosen day.
It is very important to follow these instructions to ensure that Bonasol oral solution
reaches your stomach as quickly as possible and to minimize the risk of irritating the esophagus (the tube between the mouth and stomach).

• In the morning, after getting up, take Bonasol oral solution before taking any food, drink, or other medicines.
• Drink the entire contents of one vial, followed by at least 30 ml (one-sixth of a glass) of tap water. You may drink more tap water if desired.
• Do not take with mineral water (still or sparkling), coffee, tea, fruit juice, or milk.
• Do not lie down; remain upright (sitting, standing, or walking) for at least 30 minutes after taking the solution. Do not lie down until you have eaten your first meal of the day.
• Do not take Bonasol oral solution at bedtime or before getting up in the morning.
• If you experience difficulty or pain when swallowing, chest pain, or new or worsening heartburn, contact your doctor.
• After taking Bonasol oral solution, wait at least 30 minutes before taking any food, drink, or medicine, including antacids, calcium supplements, and vitamins. Bonasol oral solution is effective only when taken on an empty stomach.

If you take more Bonasol oral solution than you should
If you accidentally take too much solution, drink a glass of milk and contact your doctor
immediately. Do not induce vomiting and do not lie down.
If you forget to take Bonasol oral solution
If you forget to take a dose, take it on the morning after the day you missed. Do not take
two doses on the same day. Then resume taking one dose per week on your originally
scheduled day.
If you stop taking Bonasol oral solution
It is important that you continue taking Bonasol oral solution for the entire duration
prescribed by your doctor. Bonasol oral solution can treat your osteoporosis only if you
continue taking it.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Bonasol oral solution may cause adverse reactions, although
not everyone experiences them.
Consult your doctor immediately if you notice any of the following adverse
reactions, which may be serious and for which you may require urgent medical
treatment:
Common: may affect up to 1 in 10 people
burning sensation; difficulty swallowing; pain when swallowing; esophageal ulcers (the
tube connecting the mouth to the stomach) which may cause chest pain, burning, or
difficulty or pain when swallowing
Rare: may affect up to 1 in 1,000 people
allergic reactions such as urticaria; swelling of the face, lips, tongue and/or throat, which
may cause difficulty breathing or swallowing, and severe skin reactions
mouth and/or jaw pain, swelling or ulcers inside the mouth, numbness or a sensation of
heaviness in the jaw, or loss of a tooth. These could be signs of bone damage in the
jaw (osteonecrosis), usually associated with delayed healing and infection, often
following dental extraction, or if you are being treated for cancer.
Uncommonly, an unusual femur fracture may occur, particularly in patients receiving
long-term treatment for osteoporosis. Contact your doctor if you experience pain,
weakness, or discomfort in the thigh, hip, or groin, as this may be an early sign of a
potential femur fracture.
Other adverse reactions include:
Very common: may affect more than 1 in 10 people
bone, muscle, and/or joint pain, which may sometimes be severe
Common: may affect up to 1 in 10 people
abdominal pain; stomach discomfort or burping after meals; indigestion; constipation;
feeling of fullness or bloating in the stomach; diarrhoea; flatulence;
headache, dizziness

• joint swelling
• itching
• alopecia (hair loss)
• fatigue/weakness
• swelling of the hands or legs
• spinning or rotational sensation associated with dizziness (vertigo)

Uncommon: may affect up to 1 in 100 people
nausea; vomiting
irritation or inflammation of the esophagus (the tube between mouth and stomach) or
stomach
dark or tarry stools
blurred vision; eye pain or redness
skin rash; skin redness
transient flu-like symptoms such as muscle pain, general malaise, and sometimes
fever, usually at the beginning of treatment
taste disturbances
Rare: may affect up to 1 in 1,000 people
symptoms of low blood calcium levels, such as muscle cramps or spasms and/or
tingling in the fingers or around the mouth
gastric or peptic ulcers (sometimes severe or accompanied by bleeding)
narrowing of the esophagus (the tube between mouth and stomach)
rash worsened by exposure to sunlight
rarely, an unusual femur fracture may occur, particularly in patients receiving long-term
treatment for osteoporosis. Contact your doctor if you experience pain, weakness, or
discomfort in the thigh, hip, or groin, as this may be an early sign of a potential femur
fracture.
Very rare: may affect up to 1 in 10,000 patients

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

Report these or any other unusual symptoms to your doctor or pharmacist immediately.
It may be helpful to keep a record of the type of symptom experienced, when it occurred,
and how long it lasted.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact
your doctor or pharmacist. You can also report adverse reactions directly via the
national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili. By
reporting adverse reactions, you can help provide more information on the safety of this
medicine.

5. HOW TO STORE BONASOL ORAL SOLUTION

Keep this medicine out of the sight and reach of children.
Do not use Bonasol oral solution after the expiry date stated on the carton and on the bottle.
The expiry date refers to the last day of that month.
Store below 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What Bonasol oral solution contains
Active substance
The active substance is sodium alendronate trihydrate: Each 100 ml of solution contains
70 mg of alendronic acid in the form of sodium alendronate trihydrate.
Excipients
Xanthan gum (E415),
Sodium cyclamate (E952),
Sucralose (E955),
Sunset yellow FCF (E110),
Methyl p-hydroxybenzoate (E218),
Propyl p-hydroxybenzoate (E216),
Orange flavour containing ethanol and butylated hydroxyanisole,
Purified water.

Description of the appearance of Bonasol oral solution and contents of the pack
Bonasol 70 mg oral solution is an orange-coloured solution. It is supplied in
transparent polyethylene terephthalate (PET) bottles with a tamper-evident closure,
in packs containing 1, 2, 4, and 12 bottles. Each bottle contains 100 ml of solution and is for single use only.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Bruno Farmaceutici S.p.a.
Via delle Ande, 15
00144 Roma
Italy

Manufacturer:
Chanelle Medical
Loughrea
Co. Galway
Ireland

Pinewood Laboratories Ltd,
Ballymacarbry, Clonmel,
County Tipperary,
Ireland

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names: