ADRONAT 10 mg Tablets

Зміст інструкції

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

ADRONAT 10 mg tablets

alendronic acid

Read this leaflet carefully before you start 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 pass it on to others, even if they have the same symptoms as you, as it may 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 Adronat is and what it is used for
• 2. What you need to know before you take Adronat
• 3. How to take Adronat
• 4. Possible side effects
• 5. How to store Adronat
• 6. Contents of the pack and other information

1. What is Adronat and what is it used for

What is Adronat
Adronat 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 is Adronat used for
Adronat is used to treat a disease that makes bones fragile and more likely to break
(osteoporosis) in men and women after menopause.
Adronat 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 to the point of fracture. In
menopause, the ovaries no longer produce female hormones, estrogens, which contribute to
maintaining a healthy female 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
loss of bone tissue and osteoporosis in both men and women.
In the early stages, osteoporosis usually has no 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 trauma 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, for example, an increased curvature of the back
(kyphosis) and limitations in movement.

2. What you need to know before you take Adronat

Do not take Adronat

• 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 connecting your mouth to your stomach) that delay its emptying, such as narrowing (stenosis) and impaired function (achalasia).
• if you are unable to remain upright (standing or sitting) 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 Adronat
Tell your doctor before starting to take Adronat:

• 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 serious 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 Adronat 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 Adronat.
It is important to maintain good oral hygiene during treatment with Adronat. You should have regular dental check-ups throughout the treatment and contact your doctor or dentist if you experience any type of problem 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 Adronat.
Stop taking Adronat 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 Adronat properly or if you continue to take it after experiencing these symptoms, the risk of serious esophageal side effects may worsen.
It is very important that you know exactly how to take this medicine (see section 3).
Therapy with Adronat should only be started after your doctor has determined that the cause of your osteoporosis is a lack of female hormones (estrogens) and/or age, excluding other causes.
Adronat can irritate the mucous membrane of the upper gastrointestinal tract.
The risk of serious side effects in the esophagus appears to be greater in patients who do not take Adronat properly or who continue to take it after symptoms of esophageal irritation.
Esophageal side effects such as irritation (esophagitis), lesions (ulcers and erosions) rarely followed by narrowing or perforation have been reported in patients treated with Adronat. Some of these side effects have been severe and have required hospitalization.
In patients with cancer who were taking bisphosphonates, mainly intravenously, death of the jaw/maxillary bone tissue (osteonecrosis) has been reported, generally associated with tooth extraction or local infection (including osteomyelitis). Many of these patients were also treated with chemotherapy and corticosteroids. Osteonecrosis of the jaw/maxillary 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. After re-administration of the same medicine or another of the same class, some patients have had a recurrence of symptoms.
Unusual femoral fractures 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 fracture of one femur, the other should also be examined.
Limited healing of these fractures has also been reported. In patients with suspected femoral fracture, the doctor will assess the interruption of therapy with bisphosphonates while awaiting to evaluate the benefit to the patient, in relation to the risk.
During treatment with this type of medicine, it is advisable to report to the doctor any type of pain in the thigh, hip or groin and, if you experience such symptoms, you should undergo a check-up to rule out a femoral fracture.
Since the medicine has been available on the market, rare reports of severe skin reactions including blistering forms (Stevens-Johnson syndrome) and skin decomposition (toxic epidermal necrolysis) have been made.
Before starting therapy with Adronat and periodically thereafter, your doctor will likely request a check of your blood calcium levels (calcemia). Low blood calcium levels (hypocalcemia) must be corrected before starting therapy with Adronat (see section 2). The doctor should monitor blood calcium levels and symptoms of hypocalcemia during therapy with Adronat and also treat other disorders, such as vitamin D deficiency.
During treatment with Adronat, rare cases of low calcium levels (hypocalcemia), occasionally severe, have occurred, particularly in the presence of conditions that can favor hypocalcemia, such as, for example, poor production of thyroid hormones (hypoparathyroidism), vitamin D deficiency and impaired calcium absorption, particularly in patients taking glucocorticoids, medicines that reduce calcium absorption. It is recommended to ensure adequate intake of calcium and vitamin D in patients undergoing therapy with glucocorticoids.

Children and adolescents
Adronat is not recommended in children under 18 years of age.

Other medicines and Adronat
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including over-the-counter medicines.
Calcium supplements, antacids and some oral medicines are likely to interfere with the absorption of Adronat if taken at the same time. At least 30 minutes must pass after taking Adronat before you can take any other medicine (see the instructions in section 3 "How to take Adronat").
Some medicines called NSAIDs (such as aspirin or ibuprofen) for the treatment of inflammation of the joints and bones (rheumatism) or for long-term pain may cause disturbances in the digestive system. Therefore, caution should be exercised when these medicines are taken at the same time as Adronat.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Adronat is only indicated for women after menopause.

Driving and operating machinery
Side effects (including blurred vision, dizziness and severe bone, muscle or joint pain) have been reported during the taking of Adronat that may alter your ability to drive vehicles or operate machinery. The response to Adronat may vary from individual to individual (see section 4).

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

3. How to take Adronat

Take this medicine always exactly as your doctor or pharmacist has told you. If you have doubts, consult 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 Adronat, particularly after 5 or more years of use.
Adronat must be taken at least 30 minutes before any food, drink or
medicine of the day together only with tap water. Other beverages
(including mineral water), food and some medicines are likely to reduce the absorption of Adronat
(see paragraph 2).
Adronat is only effective when taken on an empty stomach.
To facilitate release at the level of the stomach and reduce the possibility of irritation/undesirable
local and esophageal effects:

• take the Adronat tablet in the morning, only after getting out of bed to start the day, with a glass of tap water (not mineral water, not less than 200 ml);
• swallow the Adronat tablet whole. Do not chew, crush or allow the tablet to 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 that at least 30 minutes have passed since taking the Adronat tablet;
• do not take the Adronat tablet when going to bed or before getting out of bed at the start of the day;
• do not take Adronat with coffee or tea
• do not take Adronat with juices or milk
• if you experience difficulty or pain swallowing, chest pain, or heartburn occurs or worsens, stop taking Adronat and contact your doctor.

Your doctor may advise you to take calcium and vitamin D supplements if their
intake with a normal diet is not adequate (see paragraph 2).

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

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 insufficiency (creatinine clearance greater than 35 ml/min). Adronat should not be
administered to patients with severe renal insufficiency (creatinine clearance <35
ml/min), as there is no information on this.

If you take more Adronat 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 Adronat
If you forget to take an Adronat tablet, take one tablet the next morning
on 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 Adronat
It is important to continue taking Adronat as long as prescribed by your doctor. Adronat 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 everybody gets them.
To describe how often side effects have been reported, the following terms are used:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Very rare (may affect up to 1 in 10,000 people).

• 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 tarry stools
• skin rash, skin redness
• transient flu-like symptoms such as muscle aches, general feeling of discomfort 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, possible cause of 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; mouth ulcers 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:

• see 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 Adronat

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 pack 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 in 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 Adronat contains

• The active ingredient is sodium alendronate 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 Adronat and contents of the pack
Adronat is presented 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
NEOPHARMED GENTILI S.r.l.
Via S. Giuseppe Cottolengo 15, 20143 Milan

Manufacturer responsible for batch release
Doppel Farmaceutici S.r.l.
Via Volturno, 48 – Quinto De’ Stampi
20089 Rozzano (Milan)

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

1. What is ADRONAT and what is it used for

What is ADRONAT?
ADRONAT is a tablet containing the active substance alendronic acid (commonly called
alendronate) and belongs to a group of non-hormonal medicines called bisphosphonates.
ADRONAT 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 ADRONAT used for?
Your doctor has prescribed ADRONAT for the treatment of osteoporosis. It reduces the risk of vertebral and hip
fractures.

ADRONAT 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. During menopause, the ovaries stop producing female hormones, estrogens, which
help to keep a woman's skeleton healthy. As a result, bone tissue is lost and the bone becomes weaker. The risk of osteoporosis is greater the earlier a woman reaches menopause.
In the early stages, osteoporosis usually has no symptoms. However, if left untreated, fractures can occur. Even though 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, spine, or wrist and
can be not only painful but can lead to significant deformities and disability, such as
curvature of the back (hunchback) and limitations in movement.

How can osteoporosis be treated?
Along with treatment with ADRONAT, your doctor may suggest changing your lifestyle to
improve the condition of the disease, such as:

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

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

Balanced dietYour doctor can provide information on diet or the possible need to
take dietary supplements (especially calcium and vitamin D).

2. What you need to know before taking ADRONAT

Do not take ADRONAT:

• 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 ADRONAT if:

• you have kidney problems,
• you have, or have recently had, difficulty swallowing or problems with your digestive system,
• your doctor has told you that you have Barrett's esophagus (a disease associated with changes in the cells lining the lower part of your esophagus),
• you have been told that you have a problem with the absorption of minerals in your stomach or intestines (malabsorption syndrome),
• you have been told that you have low levels of calcium in your blood,
• you have poor dental health, have gum disease, are planning to have a tooth extracted, or do not have regular check-ups with your dentist,
• you have cancer,
• you are undergoing chemotherapy or radiotherapy,
• you are taking angiogenesis inhibitors (such as bevacizumab, or thalidomide) which are used in the treatment of cancer,
• you are taking corticosteroids (such as prednisone or dexamethasone) which are used 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
ADRONAT.
It is important to maintain good oral hygiene during treatment with ADRONAT.
You should have regular dental check-ups during treatment and contact your
doctor or dentist if you experience any problems with your mouth or teeth such as tooth loss,
pain or swelling.
Irritation, inflammation or ulceration of the esophagus (the tube connecting the
mouth to the stomach) may occur, often with symptoms of chest pain, 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 ADRONAT. These side effects
may worsen if patients continue to take ADRONAT after experiencing these symptoms.

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

Other medicines and ADRONAT
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 ADRONAT 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 ADRONAT.

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

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

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

ADRONAT contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your
doctor before taking this medicine.

ADRONAT contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say it is essentially
‘sodium-free'.

3. How to take ADRONAT

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

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

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

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

ADRONAT 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 up from bed to start the day, and before taking any food, drink or other medicine, swallow the ADRONAT tablet whole with a full glass of only tap water (not mineral water), (not less than 200 mL), so that ADRONAT 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 or 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 in an upright position (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 ADRONAT at bedtime or before getting out of bed in the morning.
• 5) If difficulty or pain occurs when swallowing, chest pain occurs, or heartburn appears or worsens, stop taking ADRONAT and contact your doctor.
• 6) After swallowing the ADRONAT tablet, wait at least 30 minutes before eating, drinking or taking other medicines of the day, including antacids, calcium supplements and vitamins. ADRONAT is only effective when taken on an empty stomach.

If you take more ADRONAT 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 ADRONAT
If you forget to take the tablet, it is sufficient to take one ADRONAT tablet the next morning. DO NOT take two tablets on the same day.Afterwards, start taking the tablet again on the chosen day of the week.

If you stop taking ADRONAT
It is important that you take ADRONAT until prescribed by your doctor. Since it is not known how long you should take ADRONAT, you should periodically check with your doctor the need to remain on therapy with this medicine to determine if ADRONAT is still the right therapy for you.
A package leaflet is included in the ADRONAT box. It contains important information that reminds you how to take ADRONAT correctly.
If you have any doubts 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 everybody gets them.

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

• heartburn; difficulty swallowing; pain when swallowing; 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 tooth loss. These may be signs of bone damage in the jaw/mandible (osteonecrosis) generally associated with delayed healing and infection, often following dental extraction. Contact your doctor and dentist if you experience such symptoms,
• rarely, an unusual fracture of the femur may occur, particularly in patients being treated for osteoporosis for a long time. 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,
• bone, muscle and/or joint pain that is severe.

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 illness 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 ADRONAT

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 medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ADRONAT 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 ADRONAT and contents of the pack
ADRONAT 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, 12 or
40 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
NEOPHARMED GENTILI S.p.A.
Via San Giuseppe Cottolengo, 15 – 20143 Milano

Manufacturer
DOPPEL Farmaceutici S.r.l
Via Volturno, 48
Quinto De’ Stampi

• 20089 – Rozzano (MI)

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Italy ADRONAT 70 mg tablets