Package leaflet: Information for the patient

ALENDROS 10 mg tablets

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 others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Alendros is and what it is used for
What you need to know before taking Alendros
How to take Alendros
Possible side effects
How to store Alendros
Contents of the pack and other information

1. What Alendros is and what it is used for

What Alendros is
Alendros contains the active substance alendronic acid and belongs to a group of
medicines called bisphosphonates, which act on the structure and density
(mineralization) of bones.

What Alendros is used for
Alendros is used to treat a disease that causes bones to become fragile and more likely to break
(osteoporosis) in both men and postmenopausal women.
Alendros is also used in men and women for the treatment and prevention
of osteoporosis caused by a specific class of medicines used to treat inflammation, called glucocorticoids.

What is osteoporosis?
Osteoporosis is a disease that weakens bones, making them more likely to fracture. During
menopause, the ovaries stop producing female hormones, oestrogens, which help maintain a woman’s skeletal health. As a result, bone tissue is lost and bones become more fragile. The risk of osteoporosis is greater the earlier a woman reaches menopause.
Osteoporosis can also occur in men. Glucocorticoids can also cause loss of bone tissue and osteoporosis in both men and women.
In its early stages, osteoporosis usually causes no symptoms. However, if left untreated, fractures may occur. Although fractures are often painful, fractures of the spinal bones may go unnoticed until a decrease in height becomes apparent. Fractures can occur during normal daily activities, such as lifting weights, or following minor trauma that would not normally cause a fracture in healthy bone. Fractures most commonly occur in the hip, spine, or wrist and can be not only painful but may also lead to significant deformity and disability, such as increased curvature of the back (kyphosis) and limitations in movement.

2. What you need to know before taking Alendros

Do not take Alendros

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
if you have problems with your esophagus (the tube connecting your mouth to your stomach) that delay its emptying, such as narrowing (stenosis) or impaired function (achalasia)
if you are unable to remain upright or sitting with your back straight for at least 30 minutes
if you have low levels of calcium in your blood (hypocalcemia)
if you have severe kidney problems (severe renal insufficiency)
if you are pregnant or breastfeeding

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Alendros.

Inform your doctor before starting Alendros:

if you have difficulty swallowing (dysphagia), or if you have gastrointestinal problems such as esophageal diseases, inflammation of the stomach (gastritis), or of the first part of the intestine (duodenitis). If you have previously suffered from severe gastric or duodenal diseases such as ulcers, gastric or intestinal bleeding within the past year, or have undergone surgery on the stomach or esophagus, because Alendros may cause irritation and potentially worsen underlying gastrointestinal disease
if you have been diagnosed with a condition involving changes in the cells lining the lower part of the esophagus (Barrett's esophagus)
if you have cancer
if you are undergoing chemotherapy, radiotherapy, or treatment with medicines that inhibit angiogenesis (the development of new blood vessels from pre-existing ones)
if you are taking medicines for inflammation (glucocorticoids)
if you smoke, as smoking may increase the risk of dental problems

You may be advised to have a dental examination before starting treatment with Alendros.
It is important to maintain good oral hygiene during treatment with Alendros. 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.
If you are under dental care or need a dental procedure or tooth extraction, inform your dentist that you are taking Alendros.
Stop taking Alendros and contact your doctor immediately if you experience difficulty swallowing (dysphagia), pain when swallowing (odynophagia), chest pain (retrosternal pain), or the onset or worsening of heartburn (pyrosis).
If Alendros is not taken correctly or if you continue taking it after experiencing these symptoms, the risk of serious adverse effects on the esophagus may increase.
It is very important that you understand how to take this medicine correctly (see section 3).
Treatment with Alendros should only be started after your doctor has confirmed that your osteoporosis is due to lack of female hormones (estrogens) and/or age, having ruled out other causes.
Alendros may irritate the mucosa of the upper gastrointestinal tract.
The risk of serious adverse effects on the esophagus appears to be higher in patients who do not take Alendros appropriately or who continue taking it after experiencing symptoms of esophageal irritation. It is important to know that failure to follow certain precautions may increase the risk of esophageal problems.
In patients treated with Alendros, adverse effects on the esophagus have been reported, including irritation (esophagitis), lesions (ulcers and erosions), rarely followed by narrowing or perforation. Some of these adverse effects have been severe and required hospitalization.
In cancer patients taking bisphosphonates, mainly by intravenous route, death of bone tissue in the jaw (osteonecrosis) has been reported, usually associated with tooth extraction or local infection (including osteomyelitis). Many of these patients were also receiving chemotherapy and corticosteroids. Osteonecrosis of the jaw has also been reported in patients with osteoporosis taking oral bisphosphonates.
Bone, joint, and muscle pain have been reported in patients treated with bisphosphonates. Since the medicine has been marketed, these symptoms have rarely been severe or disabling (see section 4). The onset of symptoms has varied from one day to several months after starting treatment. In most patients, discontinuation of treatment led to improvement of symptoms. Following re-administration of the same medicine or another from the same class, some patients experienced recurrence of symptoms.
Unusual femoral fractures have been reported, primarily in patients on long-term treatment with this class of drugs for osteoporosis. These fractures occur spontaneously or after minor trauma, and some patients experience thigh or groin pain.
X-rays often reveal these types of fractures (stress fractures) weeks or months before a complete femoral fracture occurs.
Fractures often occur in both femurs (bilateral fractures); therefore, in patients treated with bisphosphonates who have experienced a femoral fracture, the other femur should also be examined.
Delayed healing of these fractures has also been reported. In patients with suspected femoral fracture, your doctor will assess whether bisphosphonate therapy should be discontinued, weighing the benefits against the risks.
During treatment with this type of medicine, you should report any thigh, hip, or groin pain to your doctor. If you experience such symptoms, you should be evaluated to rule out the presence of a femoral fracture.
Since the medicine has been marketed, rare cases of serious skin reactions have been reported, including skin peeling (Stevens-Johnson syndrome) and skin decomposition (toxic epidermal necrolysis).
Before starting Alendros treatment and periodically thereafter, your doctor may request blood tests to monitor your calcium levels (calcemia). Low calcium levels in the blood (hypocalcemia) must be corrected before starting Alendros treatment (see section 2). Your doctor will monitor your blood calcium levels and symptoms of hypocalcemia during Alendros treatment and will also manage other disorders such as vitamin D deficiency.
During treatment with Alendros, rare cases of low calcium levels (hypocalcemia), occasionally severe, have occurred, particularly in conditions that may predispose to hypocalcemia, such as low parathyroid hormone production (hypoparathyroidism), vitamin D deficiency, and calcium malabsorption, especially in patients taking glucocorticoids, which reduce calcium absorption. Adequate calcium and vitamin D intake is recommended in patients receiving glucocorticoids.

Children and adolescents

Alendros is not recommended for children under 18 years of age.

Other medicines and Alendros

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Calcium supplements, antacids, and certain oral medicines may interfere with the absorption of Alendros if taken at the same time. At least 30 minutes must pass after taking Alendros before taking any other medicine (see instructions in section 3 “How to take Alendros”).
Some medicines called NSAIDs (e.g., aspirin or ibuprofen), used to treat joint and bone inflammation (rheumatism) or long-term pain, may cause gastrointestinal disturbances. Therefore, caution should be exercised when taking these medicines together with Alendros.

Alendros with food and drink

Food and drink (including mineral water) may reduce the effectiveness of Alendros if taken at the same time. It is therefore important to follow the instructions provided in section 3 “How to take Alendros”.

Pregnancy and breastfeeding

If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Alendros is indicated only for postmenopausal women.

Driving and using machines

During treatment with Alendros, adverse effects (including blurred vision, dizziness, and severe bone, muscle, or joint pain) have been reported, which may affect your ability to drive or operate machinery. Individual responses to Alendros may vary (see section 4).

Alendros contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Alendros

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 tablet of 10 mg once daily.
The optimal duration of treatment for osteoporosis with this medicine has not been established.
Your doctor will periodically evaluate the optimal duration of treatment based on the benefits achieved versus the potential risks of Alendros, particularly after 5 or more years of use.
Alendros must be taken at least 30 minutes before any food, drink, or other medicine of the day, and only with tap water. Other beverages (including mineral water), food, and certain medicines may reduce the absorption of Alendros (see section 2).
Alendros is effective only when taken on an empty stomach.
To facilitate gastric release and reduce the risk of irritation/local adverse effects and esophageal damage:

take the Alendros tablet in the morning, only after getting up from bed to start the day, with a full glass of tap water (not mineral water, at least 200 ml);
swallow the Alendros tablet whole. Do not chew, crush, or allow the tablet to dissolve in the mouth, due to the potential risk of injury to the mouth and pharynx;
do not lie down until you have eaten something, and ensure at least 30 minutes have passed after taking the Alendros tablet before lying down;
do not take the Alendros tablet at bedtime or before getting up from bed in the morning;
do not take Alendros with coffee or tea;
do not take Alendros with juices or milk;
if you experience difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking Alendros and contact your doctor immediately.

Your doctor may recommend calcium and vitamin D supplements if your dietary intake of these nutrients is inadequate (see section 2).
Use in children and adolescents
Alendros is not recommended for children under 18 years of age.
Use in the elderly
No dose adjustment is necessary in elderly patients.
Use in patients with impaired renal function
No dose adjustment is required in patients with mild to moderate renal impairment (creatinine clearance greater than 35 ml/min). Alendros must not be administered in patients with severe renal impairment (creatinine clearance <35 ml/min), as there is insufficient information available.
If you take more Alendros than you should
If you accidentally take too many tablets, drink a glass of milk or take an antacid and contact your doctor immediately or go to the nearest hospital. Do not induce vomiting and avoid lying down to prevent esophageal irritation.
If you forget to take Alendros
If you forget to take an Alendros tablet, take one tablet the morning after the day you remember.
Do not take a double dose to make up for the missed tablet. Resume taking the tablet daily as previously scheduled. If in doubt, consult your doctor.
If you stop taking Alendros
It is important to continue taking Alendros for as long as prescribed by your doctor. Alendros is effective in treating osteoporosis only if the tablets are taken continuously.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following terms are used to describe how often the side effects have been reported:
Very common (occurs in at least 1 out of 10 treated patients)
Common (occurs in at least 1 out of 100 and less than 1 out of 10 treated patients)
Uncommon (occurs in at least 1 out of 1,000 and less than 1 out of 100 treated patients)
Rare (occurs in at least 1 out of 10,000 and less than 1 out of 1,000 treated patients)
Very rare (occurs in less than 1 out of 10,000 treated patients).

Very common:

bone, muscle or joint pain, often of strong intensity
mild and transient decreases in blood calcium and phosphate levels, generally within normal limits

Common:

headache, dizziness
vertigo
abdominal pain, stomach discomfort or belching after meals, constipation, feeling of fullness or bloating in the stomach, diarrhoea, flatulence (intestinal gas), heartburn, difficulty swallowing, pain when swallowing, oesophageal ulcers causing chest pain, burning sensation or difficulty or pain when swallowing
hair loss (alopecia), itching
joint swelling
fatigue, swelling of the hands or legs (peripheral oedema)

Uncommon:

altered taste (dysgeusia)
blurred vision, eye pain or redness. Inflammation of the eye (uveitis, scleritis, or episcleritis)
nausea, vomiting, irritation or inflammation of the oesophagus or stomach, black or dark stools
skin rash, skin redness
flu-like symptoms such as muscle pain, general feeling of discomfort, and sometimes fever, usually at the beginning of treatment

Rare:

allergic reactions such as hives, swelling of the face, lips, tongue and/or throat, difficulty breathing and swallowing
symptoms due to low calcium levels in the blood including muscle cramps or spasms and/or tingling in the fingers or around the mouth
narrowing of the oesophagus; mouth ulcers when tablets are chewed or sucked; stomach or peptic ulcers (sometimes severe or with bleeding)
skin rash worsened by exposure to sunlight, severe skin reactions such as skin peeling (Stevens-Johnson syndrome) and skin breakdown (toxic epidermal necrolysis)
mouth pain, and/or jaw/mandible pain, swelling or sores inside the mouth, numbness or heaviness in the jaw/mandible or tooth loss. These may be signs of damage to the jaw/mandible bone (osteonecrosis), generally associated with delayed healing and infection, often following tooth extraction. Contact your doctor or 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 could be an early sign of a possible femur fracture

Very rare:

contact your doctor if you experience ear pain, ear discharge and/or ear infection. These episodes could be symptoms 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 or pharmacist.
You can also report side effects directly via the national reporting system at the following website: www.agenziafarmaco.it/it/responsabili
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Alendros

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 blister after EXP.
The expiry date refers to the last day of that month.
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. Package contents and other information

What Alendros contains

The active substance is alendronic acid, sodium salt 13.05 mg, equivalent to alendronic acid 10 mg.
The other ingredients are: microcrystalline cellulose, anhydrous lactose, sodium croscarmellose, magnesium stearate, carnauba wax.

Description of the appearance of Alendros and package contents
Alendros is available as tablets.
The tablets are packaged in opaque PVC/aluminum blisters.
Each blister contains 14 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ABIOGEN PHARMA S.p.A.
Via Meucci, 36 - Ospedaletto - Pisa
Manufacturer responsible for batch release
Merck Sharp & Dohme (Italia) S.p.A.
Via Emilia, 21 - 27100 Pavia
Merck Sharp & Dohme B.V.
Haarlem, The Netherlands

Patient Information Leaflet

ALENDROS 70 mg tablets

alendronic acid
Please read this leaflet carefully before 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, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
It is particularly important to understand the information contained in section 3 before taking this medicine.

Contents of this leaflet:

What ALENDROS is and what it is used for
What you need to know before taking ALENDROS
How to take ALENDROS
Possible side effects
How to store ALENDROS
Contents of the pack and other information

1. What ALENDROS is and what it is used for

What is ALENDROS?
ALENDROS is a tablet containing the active substance alendronic acid (commonly known as alendronate) and belongs to a group of non-hormonal medicines called bisphosphonates. ALENDROS 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.
What is ALENDROS used for?
Your doctor has prescribed ALENDROS for the treatment of osteoporosis. It reduces the risk of vertebral and hip fractures.
ALENDROS is a treatment to be taken once a week.
What is osteoporosis?
Osteoporosis is the thinning and weakening of bones. It is common in women after menopause. During menopause, the ovaries stop producing the female hormones, estrogens, which help maintain a woman's skeletal health. 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 its early stages, osteoporosis usually causes no symptoms. However, if left untreated, fractures may occur. Although fractures are usually painful, fractures of the spinal bones may go unnoticed until they result in a decrease in 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 may also lead to significant deformities and disability, such as curvature of the back (kyphosis) and limitations in movement.
How can osteoporosis be treated?
Along with treatment with ALENDROS, your doctor may recommend 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 can provide information on diet or the possible need for dietary supplements (especially calcium and vitamin D).

2. What you should know before taking ALENDROS

Do not take ALENDROS

if you are allergic to alendronate acid or to 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 cannot stand upright or sit in an upright position 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 tablets. Consult your doctor and follow
the advice given.
Warnings and precautions
Talk to your doctor or pharmacist before taking ALENDROS if:

you have kidney problems,
you have or have recently had difficulty swallowing or digestive problems,
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 told that you have a problem absorbing minerals in your 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 regularly visit a dentist,
you have cancer,
you are undergoing chemotherapy or radiotherapy,
you are taking angiogenesis inhibitors (such as bevacizumab or thalidomide) used in the treatment of cancer,
you are taking corticosteroids (such as prednisone or dexamethasone) used to treat 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 advised to have a dental examination before starting treatment with ALENDROS.
It is important to maintain good oral hygiene during treatment with ALENDROS. 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, burning in the upper stomach,
difficulty or pain when swallowing, especially if patients do not drink a full glass of water and/or
lie down during the first 30 minutes after taking ALENDROS.
These side effects may worsen if patients continue taking ALENDROS after experiencing these
symptoms.
Children and adolescents
ALENDROS must not be given to children and adolescents under 18 years of age.
Other medicines and ALENDROS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines.
Calcium supplements, antacids, and certain oral medicines are likely to interfere with the
absorption of ALENDROS 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 used when these
medicines are taken together with ALENDROS.
ALENDROS with food and drink
Food and drinks (including mineral water) may reduce the effectiveness of ALENDROS if
taken at the same time. It is therefore important to follow the instructions given in section 3.
Pregnancy and breastfeeding
ALENDROS is indicated only for postmenopausal women. Do not take ALENDROS if you are
pregnant or suspect you may be pregnant, or if you are breastfeeding.
Driving and using machines
With ALENDROS, side effects have been reported (e.g. blurred vision, dizziness, and severe
bone, muscle, or joint pain) which may affect the ability to drive or use machinery (see section 4).
ALENDROS contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor
before taking this medicine.
ALENDROS contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take ALENDROS

Take this medicine exactly as directed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take one ALENDROS tablet once a week.
Follow carefully the instructions below:

Choose the day of the week that best fits your routine. Take one
ALENDROS tablet once a week on the chosen day.
It is very important that you follow instructions 2), 3), 4), and 5) to help the ALENDROS tablet reach your stomach quickly and to help reduce the risk of irritating the oesophagus (the tube connecting the mouth to the stomach).
After getting up in the morning and before taking any food, drink, or other medicines, swallow the ALENDROS tablet whole with a full glass of plain tap water (not mineral water), (not less than 200 mL), so that ALENDROS is properly absorbed.

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 crush, chew, or allow the tablet to dissolve in the mouth because of the possible risk of developing mouth ulcers.
3) Do not lie down – remain upright (sitting, standing, or walking) for at least 30 minutes after swallowing the tablet. Do not lie down until you have eaten something.
4) Do not take ALENDROS at bedtime or before getting out of bed in the morning.
5) If you experience difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking ALENDROS and contact your doctor.
6) After swallowing the ALENDROS tablet, wait at least 30 minutes before eating, drinking, or taking any other medicines of the day, including antacids, calcium supplements, and vitamins. ALENDROS is effective only when taken on an empty stomach.
If you take more ALENDROS than you should
If you accidentally take too many 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 ALENDROS
If you forget to take your tablet, simply take one ALENDROS tablet the following morning. Do not take two tablets on the same day. Then resume taking your tablet on your chosen day of the week.
If you stop taking ALENDROS
It is important to continue taking ALENDROS for as long as prescribed by your doctor. Since it is not known how long you should take ALENDROS, you should periodically check with your doctor whether you should continue treatment with this medicine to determine if ALENDROS is still the right therapy for you.
An instruction card is included in the ALENDROS package. It contains important information reminding you how to take ALENDROS correctly.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Contact your doctor immediately if you notice any of the following side effects, which may be serious and for which you may need urgent medical treatment:

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

heartburn; difficulty swallowing; pain when swallowing; oesophageal ulcers (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 could be signs of bone damage in the jaw/mandible (osteonecrosis), usually associated with delayed healing and infection, often following a tooth extraction. Contact your doctor and dentist if you experience such symptoms,
rarely, an unusual fracture of the femur may occur, particularly in patients who have been 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 could be an early sign of a possible femur fracture,
severe bone, muscle, and/or joint pain.

Not known (frequency cannot be estimated from the available data):

unusual fractures occurring at sites other than the femur.

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; intestinal gas,
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; skin redness,
transient flu-like symptoms, such as muscle aches, general malaise, and sometimes fever, usually at the beginning of treatment,
taste disturbance.

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 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 or pharmacist. You can also report side effects directly via the national reporting system at:
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 ALENDROS

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 blister after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions. Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ALENDROS contains
The active substance is alendronic acid. Each tablet contains 70 mg of alendronic acid (as sodium trihydrate).
The other components are microcrystalline cellulose (E460), anhydrous lactose (see section 2), sodium croscarmellose, and magnesium stearate (E572).

Description of the appearance of ALENDROS and package contents
ALENDROS tablets are white, oval-shaped tablets, with the outline of a bone engraved on one side and "31" on the other.
The tablets are supplied in aluminum blisters packed in cartons containing 2, 4, 8 or 12 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
Italy

Manufacturer
Merck Sharp & Dohme BV
Waarderweg 39 - 2031 BN Haarlem
The Netherlands

Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Onely einmal wöchentlich 70 mg Tabletten
Italy: Alendros 70 mg tablets