ALENDROS 10 mg Таблетка

Содержание инструкции

1. ALENDROS 10 mg tablets
   1. What Alendros is and what it is used for
   2. What you need to know before taking Alendros
   3. How to take Alendros
   4. Possible side effects
   5. How to store Alendros
   6. Contents of the pack and other information
2. ALENDROS 70 mg tablets
   1. What is ALENDROS and what is it for
   2. What you need to know before taking ALENDROS
   3. How to take ALENDROS
   4. Possible side effects
   5. How to store ALENDROS
   6. Contents of the pack and other information

ALENDROS 10 mg 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. See section 4.

Contents of this leaflet:

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

1. What Alendros is and what it is used for

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

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

What is osteoporosis?
Osteoporosis is a disease that makes bones more fragile until they break. In
menopause, the ovaries no longer produce female hormones, estrogens, which contribute to
maintaining a woman's healthy skeleton. As a result, bone tissue is lost and
the bone becomes more fragile. The risk of osteoporosis is greater the earlier
a woman reaches menopause.
Osteoporosis can also occur in men. Glucocorticoids can also cause
bone tissue loss and osteoporosis in both men and women.
In the early stages, osteoporosis normally does not cause symptoms. However, if left untreated,
fractures can occur. Even though fractures are usually
painful, fractures of the vertebral bones may not be noticed until
a decrease in height is observed. Fractures can occur during
normal daily activity, such as lifting weights and even minor injuries that would not normally
cause fractures in healthy bone. Fractures occur most frequently in the hip, in the
spine or in the wrist and can be not only painful but can lead to
significant deformities and disability, such as an 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 ingredient or to any of the other ingredients of this medicine (listed in section 6)
• if you have problems with your esophagus (the tube that connects your mouth to your stomach) that delay its emptying, such as narrowing (stenosis) and impaired function (achalasia)
• if you are unable to stand or sit upright 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.
Tell your doctor before starting to take Alendros:

• if you have difficulty swallowing (dysphagia), or if you have problems with your digestive system such as esophageal diseases, inflammation of the stomach (gastritis) or the first part of the intestine (duodenitis). If you have previously suffered from severe stomach or duodenal diseases such as ulcers, gastric or intestinal bleeding that occurred in the last year, or if you have undergone surgery on your stomach or esophagus, as Alendros may have irritant effects and potentially worsen underlying gastrointestinal disease
• if you have been told you have a condition associated with changes in the cells lining the lower 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 existing ones)
• if you are taking medicines for the treatment of inflammation (glucocorticoids)
• if you smoke, because smoking can increase the risk of dental problems

You may be asked to have a dental check-up (odontiatric) 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 the treatment and should contact your doctor or dentist if you experience any problems with your mouth or teeth such as tooth loss, pain or swelling.
If you are under the care of a dentist or need to have dental surgery or a tooth extraction, tell the dentist that you are taking Alendros.
Stop taking Alendros and tell your doctor immediately if you have difficulty swallowing (dysphagia), if you experience pain when swallowing (odynophagia), chest pain (retrosternal pain) or if you experience the onset or worsening of a burning sensation in your chest (pyrosis).
If you do not take Alendros appropriately or if you continue to take it after experiencing these symptoms, the risk of serious adverse effects in the esophagus may worsen.
It is very important that you know how to take this medicine correctly (see section 3).
Therapy with Alendros should only be started after your doctor has established that the cause of your osteoporosis is a lack of female hormones (estrogens) and/or age, excluding other causes.
Alendros can irritate the mucous membrane of the upper gastrointestinal tract.
The risk of serious adverse effects in the esophagus appears to be greater in patients who do not take Alendros appropriately or who continue to take it after symptoms of irritation of the esophagus. It is important to know that if certain precautions are not followed, the risk of problems with the esophagus may increase.
Adverse effects on the esophagus such as irritation (esophagitis), lesions (ulcers and erosions) rarely followed by narrowing or perforation have been reported in patients treated with Alendros. Some of these adverse effects have been severe and have required hospitalization.
In patients with cancer who were taking bisphosphonates, mainly intravenously, death of the jaw/mandible bone tissue (osteonecrosis) has been reported, usually associated with tooth extraction or local infection (including osteomyelitis). Many of these patients were also treated with chemotherapy and corticosteroids. Osteonecrosis of the jaw/mandible has also been reported in patients with osteoporosis who were taking oral bisphosphonates.
Bone, joint and muscle pain have been reported in patients treated with bisphosphonates. Since the medicine was marketed, these symptoms have rarely been severe or caused disability (see section 4). The time of onset of symptoms has varied from one day to several months after starting treatment. In most patients, stopping treatment led to an improvement in symptoms.
Following a new administration of the same medicine or another of the same class, some patients have experienced a recurrence of symptoms.
Unusual fractures of the femur have been reported, mainly in patients undergoing long-term therapy with this class of drugs for osteoporosis. These fractures occur spontaneously or after minor trauma and some patients experience pain in the thigh or groin.
Often, X-rays reveal this type of fracture (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 suffered a femur fracture, the other femur should also be examined.
Limited healing of these fractures has also been reported. In patients with suspected femur fracture, the doctor will assess the interruption of therapy with bisphosphonates pending evaluation of the benefit to the patient, in relation to the risk.
During treatment with this type of medicine, it is advisable to report any type of pain in the thigh, hip or groin to the doctor and, if such symptoms occur, you should undergo a check-up to rule out a femur fracture.
Since the medicine has been available on the market, there have been rare reports of severe skin reactions including blistering forms (Stevens-Johnson syndrome) and skin decomposition (toxic epidermal necrolysis).
Before starting therapy with Alendros and subsequently periodically, the doctor will likely request a check of calcium levels in the blood (calcemia). Low calcium levels in the blood (hypocalcemia) must be corrected before starting therapy with Alendros (see section 2). The doctor should monitor calcium levels in the blood and symptoms of hypocalcemia during therapy with Alendros and also treat other disorders, such as vitamin D deficiency.
During treatment with Alendros, rare cases of low calcium levels (hypocalcemia), occasionally severe, have occurred, particularly in the presence of conditions that may favor hypocalcemia, such as, for example, poor production of thyroid hormones (hypoparathyroidism), vitamin D deficiency and malabsorption of calcium, particularly in patients taking glucocorticoids, medicines that reduce calcium absorption. Adequate intake of calcium and vitamin D is recommended in patients undergoing therapy with glucocorticoids.

Children and adolescents
Alendros is not recommended in 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 available without a prescription.
Calcium supplements, antacids and some oral medicines are likely to interfere with the absorption of Alendros if taken at the same time. At least 30 minutes must pass after taking Alendros before you can take any other medicine (see the instructions provided in section 3 “How to take Alendros”).
Some medicines called NSAIDs (e.g. aspirin or ibuprofen) for the treatment of inflammation of the joints and bones (rheumatism) or for long-term pain may cause disorders of the digestive system. Therefore, caution should be exercised when these medicines are taken at the same time as Alendros.

Alendros with food and drink
Food and drinks (including mineral water) are likely to decrease 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 are pregnant or are planning a pregnancy, or if you are breastfeeding with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Alendros is indicated only for women after menopause.

Driving and using machines
Adverse effects (including blurred vision, dizziness and severe bone, muscle or joint pain) have been reported during the taking of Alendros that may alter your ability to drive vehicles or use machines. The response to Alendros may vary for each individual (see section 4).

Alendros contains lactose
If your doctor has diagnosed you with intolerance to some sugars, contact them before taking this medicine.

3. How to take Alendros

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The recommended dose is 1 tablet of 10 mg once a day.
The optimal duration of osteoporosis treatment with this medicine has not been established.
The doctor will periodically assess the optimal duration of treatment based on the benefits
obtained 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
medicine of the day, together only with plain water. Other beverages
(including mineral water), food and some medicines are likely to reduce the absorption of Alendros
(see section 2).
Alendros is only effective when taken on an empty stomach.
To facilitate release at the stomach level and thus reduce the possibility of irritation/local and esophageal side effects:

• take the Alendros tablet in the morning, only after getting out of bed to start the day, with a glass of plain water (not mineral water, not less than 200 ml);
• swallow the Alendros tablet whole. Do not chew, crush or let the tablet dissolve in your mouth, due to the potential risk of injury to the mouth and pharynx;
• do not lie down until you have eaten something and, before lying down, make sure at least 30 minutes have passed since taking the Alendros tablet;
• do not take the Alendros tablet when going to bed or before getting out of bed at the start of the day;
• do not take Alendros with coffee or tea
• do not take Alendros with juices or milk
• if you experience difficulty or pain swallowing, chest pain, or heartburn occurs or worsens, stop taking Alendros and contact your doctor.

Your doctor may advise you to take calcium and vitamin D supplements if their
intake with a normal diet is inadequate (see section 2).

Use in children and adolescents
Alendros is not recommended in children under the age of 18 years.

Use in the elderly
No dose adjustment is necessary in elderly patients

Use in case of impaired renal function
No dose adjustment is necessary in patients with mild to
moderate renal impairment (creatinine clearance greater than 35 ml/min). Alendros should not be
administered to patients with severe renal impairment (creatinine clearance <35
ml/min), as there is no information on this.

If you take more Alendros than you should
If you have accidentally taken too many tablets, drink a glass of milk or take antacids
and contact your doctor immediately or go to the nearest hospital. Do not induce vomiting
and do not lie down to avoid irritation of the esophagus.

If you forget to take Alendros
If you forget to take an Alendros tablet, take one tablet the morning
after the day you remembered.
Do not take a double dose to make up for the missed tablet. Resume
taking the tablet daily, as previously established. If in doubt, contact 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 for the treatment of osteoporosis only if you continue to take the tablets.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

• bone, muscle or joint pain, often severe
• mild and transient decreases in calcium and phosphate levels in the blood, generally within the normal range.

Common:

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

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 esophagus or stomach, black or dark stools
• skin rash, skin redness
• transient flu-like symptoms such as muscle aches, general malaise and sometimes with 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 esophagus; ulcers of the mouth when the 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 blistering (Stevens-Johnson syndrome) and skin decomposition (toxic epidermal necrolysis)
• pain in the mouth, and/or jaw/mandible, swelling or sores inside the mouth, numbness or feeling of heaviness in the jaw/mandible or tooth loss. These may be signs of damage to the jaw 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 may be an early indication of a possible femur fracture

Very rare:

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
You can also report side effects directly through the national reporting system at: 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 which is stated on the package and blister
after EXP.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in the drain 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 Alendros contains

• The active ingredient is sodium alendronate 13.05 mg, corresponding 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 contents of the pack
Alendros is available in tablet form.
The tablets are packaged in opaque PVC and aluminium 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, Netherlands

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

1. What is ALENDROS and what is it for

What is ALENDROS?
ALENDROS is a tablet containing the active ingredient alendronic acid (commonly
called 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 reconstruction. It reduces the risk of vertebral and
hip fractures.

What is ALENDROS for?
Your doctor has prescribed ALENDROS for the treatment of osteoporosis. It reduces the risk of
vertebral and hip fractures.

ALENDROS is a treatment that 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. In 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 bones of the spine may not be felt until they result in a decrease in height. Fractures can occur during
normal daily activities such as lifting weights, or with minor traumas that would not be able to
cause fractures in normal bone. Fractures usually occur in the hip, in the
spine or in the wrist and can be not only painful but can lead to
significant deformities and disabilities, such as curvature of the spine (hunchback) and limitations in
movements.

How can osteoporosis be treated?
Along with treatment with ALENDROS, 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, may 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 can provide information on diet or the possible need
to take food supplements (especially calcium and vitamin
D).

2. What you need to know before taking ALENDROS

Do not take ALENDROS

• if you are allergic 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 that connects your mouth to your stomach), such as narrowing or difficulty swallowing
• if you cannot 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 tablets. Consult your doctor and follow the instructions 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 problems with your digestive system,
• your doctor has told you that you have Barrett's esophagus (a disease associated with changes in the cells that line 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 dental check-ups,
• 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 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 asked to have a dental check-up before starting treatment with ALENDROS.
It is important to maintain good oral hygiene during treatment with ALENDROS. You should have regular dental check-ups during treatment and should contact your doctor or dentist if you experience any oral or dental problems such as tooth loss, pain or swelling.
Irritation, inflammation or ulceration of the esophagus (the tube that connects the mouth to the stomach) may occur, often with symptoms of chest pain, heartburn, difficulty or pain swallowing, especially if patients do not drink a full glass of water and/or lie down within 30 minutes of taking ALENDROS.
These side effects may worsen if patients continue to take ALENDROS after experiencing these symptoms.

Children and adolescents
ALENDROS should not be given to children and adolescents under the age of 18 years.

Other medicines and ALENDROS
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 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 exercised when these medicines are taken at the same time as ALENDROS.

ALENDROS with food and drink
Food and beverages (including mineral water) are likely to 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 only indicated for women after menopause. Do not take ALENDROS if you are pregnant or suspect you might 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 ALENDROS that may affect your ability to drive or operate machinery (see section 4).

ALENDROS contains lactose
If your doctor has told you that you have an intolerance to some 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 following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

Take one ALENDROS tablet once a week.
Follow the instructions below carefully:

• 1) Choose a day of the week that best suits your activities. Take one ALENDROS tablet once a week on the day you have chosen.

It is very important that you follow instructions 2), 3), 4), and 5) to facilitate quick passage

of the ALENDROS tablet 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, swallow one ALENDROS tablet whole with a full glass (not less than 200 mL) of plain tap water (not mineral water), so that ALENDROS is adequately absorbed.
• Do not take with mineral water (natural or sparkling).
• Do not take with coffee or tea.
• Do not take with juices or milk.

Do not crush, chew, or let the tablet dissolve in your mouth due to the possible
formation of ulcers in the oral cavity.

• 3) Do not lie down – keep your torso upright (while sitting, while standing, or while 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 difficulty or pain occurs when swallowing, chest pain appears, or heartburn develops or worsens, stop taking ALENDROS and contact your doctor.
• 6) After swallowing the ALENDROS tablet, wait at least 30 minutes before eating, drinking, or taking other medicines of the day, including antacids, calcium supplements, and vitamins. ALENDROS is only effective 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 the tablet, simply take one ALENDROS tablet
the next morning. Do not take two tablets on the same day.Afterwards,
start taking the tablet again on the day of the week you have chosen.

If you stop taking ALENDROS
It is important that you take 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 to assess the need to remain on therapy with this medicine to
determine if ALENDROS is still the right therapy for you.
A package leaflet is included in the ALENDROS box. It contains important
information that reminds you how to take ALENDROS correctly.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Go to your doctor immediatelyif you notice any of the following side effects, which may be serious, and for which you might need urgent medical treatment:
Common (may affect up to 1 in 10 people):

• heartburn; difficulty swallowing; pain when swallowing; ulcers of the esophagus (the tube 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 may 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 loss of a tooth. These could be signs of bone damage in the jaw/mandible (osteonecrosis) generally associated with delayed healing and infection, often after tooth extraction. Contact your doctor and dentist if you experience these symptoms,
• rarely, an unusual fracture of the femur can occur, particularly in patients being 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 indication of a possible femur fracture,
• bone, muscle and/or joint pain that is severe.

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

• unusual fracture in 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 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, intestinal gas,
• 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 tube 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,
• taste disturbance.

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

• symptoms due to low levels of calcium 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 esophagus (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):

• see 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 or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly through 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 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 special storage conditions. Do not dispose of
any medicines in the 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 ALENDROS contains
The active ingredient is alendronic acid. Each tablet contains 70 mg of alendronic acid,
(as sodium trihydrate).
The other ingredients are microcrystalline cellulose (E460), anhydrous lactose (see section
2), sodium croscarmellose and magnesium stearate (E572).

Description of the appearance of ALENDROS and contents of the pack
ALENDROS tablets are available as white, oval-shaped tablets, with the outline of a bone image imprinted
on one side and “31” on the other.
The tablets are supplied in aluminium blisters in cartons in the following pack sizes: 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

Manufacturer
Merck Sharp & Dohme BV
Waarderweg 39 - 2031 BN Haarlem
Netherlands
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations:
Austria Onely once weekly 70 mg tablets
Italy Alendros 70 mg tablets