ACIDO 70 mg Coated Tablet

Зміст інструкції

1. ACIDO ALENDRONICO FG 70 mg tablets
   1. What is Acido Alendronico FG and what is it used for
   2. What you need to know before taking Acido Alendronico FG
   3. How to take Acido Alendronico FG
   4. POSSIBLE SIDE EFFECTS
   5. How to store Acido Alendronico FG
   6. Contents of the pack and other information

ACIDO ALENDRONICO FG 70 mg tablets

Alendronic acid as alendronate sodium trihydrate

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

1. What is Acido Alendronico FG and what is it used for

What is Acido Alendronico FG
Acido Alendronico FG belongs to a group of non-hormonal drugs called
bisphosphonates. Acido Alendronico FG 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 Acido Alendronico FG used for
Your doctor has prescribed Acido Alendronico FG for the treatment of osteoporosis. Acido
Alendronico FG reduces the risk of vertebral and hip fractures.

Acido Alendronico FG 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 vertebrae may not be felt
until they result in a decrease in height. Fractures can
occur during daily activities such as lifting weights, or with minor trauma 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 spine (hunchback) and limitations in movement.

How can osteoporosis be treated?
It is important to remember that osteoporosis can be treated and that it is never too late
to start. Acido Alendronico FG not only prevents bone loss but
helps to rebuild bone that may have been lost and reduces the risk of vertebral and hip fractures.
Along with treatment with Acido Alendronico FG, your doctor may suggest changing
your lifestyle to improve the condition, 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 dietary supplements (especially
calcium and vitamin D).

2. What you need to know before taking Acido Alendronico FG

Do not take Acido Alendronico FG:

• If you are allergic to alendronic acid trihydrate sodium or any of the other ingredients of this medicine (listed in section 6).
• If you have certain diseases of the esophagus (the channel that connects the mouth to the stomach), such as narrowing and difficulty swallowing.
• If you cannot stay upright or seated with your torso erect for at least 30 minutes.
• If your doctor has told you that you have low levels of calcium in your blood.
• If you suffer from severe kidney problems.

If you think you fall into any of these cases, do not take the tablets. Consult your treating doctor and follow the advice given.

Warnings and precautions
Talk to your doctor or pharmacist before taking Acido Alendronico FG.
Before taking Acido Alendronico FG it is important to inform your doctor if:

• you have Barrett's esophagus (a condition associated with changes in the cells of the distal esophageal epithelium)
• you have kidney problems
• you have allergies
• you have difficulty swallowing or problems with the digestive system
• you have low levels of calcium in your blood. There have been rare reports of symptomatic hypocalcemia, occasionally severe and often affecting patients with predisposing conditions (e.g., hypoparathyroidism, vitamin D deficiency and calcium malabsorption), particularly in patients taking glucocorticoids, which reduce calcium absorption
• you are taking glucocorticoids. It is particularly important to ensure adequate intake of calcium and vitamin D in patients undergoing therapy with these medicines
• you have gum disease
• you are planning dental surgery.

During treatment with Acido Alendronico FG, problems with the jaw or mandible may occur, associated with delayed healing and infections, generally in patients with cancer, often after dental extraction and/or local infection. Many of these patients were undergoing chemotherapy and corticosteroids.
Therefore, you must maintain good oral hygiene and report any oral symptoms to your doctor, such as tooth mobility, pain or swelling (see section 4).
If you are in the specified conditions below, you should consider whether to undergo a dental examination before starting treatment with Acido Alendronico FG.

• You have cancer
• You are undergoing chemotherapy or radiotherapy
• You are taking steroids
• You do not have regular dental check-ups
• You have gum disease

Appropriate preventive dental procedures should be followed during treatment, as recommended by your dentist.
Cases of bone, joint and/or muscle pain have occurred in patients treated with bisphosphonates, including alendronate, which in rare cases have manifested severely and caused disability. The onset of symptoms has varied, from one day to several months after the start of treatment. In most patients, discontinuation of treatment led to relief of symptoms (see section 4).
Fractures of the femur, preceded or not by minor injury (stress fractures), have been reported in patients treated with alendronate for long periods. If you feel weakness or discomfort in your thigh, hip or groin, please report it to your doctor as it may be an early indication of a possible femur fracture (see section 4).
The doctor will decide whether it is necessary to stop treatment with Acido Alendronico FG.
Rare cases of gastric and duodenal ulcers have been reported during the use of alendronate, some of which were severe and associated with complications.
Irritation, inflammation or ulceration of the esophagus (the channel 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 during the first 30 minutes after taking Acido Alendronico FG. These side effects may worsen if patients continue to take Acido Alendronico FG after experiencing these symptoms.
Severe skin reactions, including Stevens Johnson syndrome and toxic epidermal necrolysis, may also occur (see section 4).
Contact your doctor if you experience ear pain, ear discharge and/or ear infection (see section 4).
If you notice the onset of any of the side effects described above, stop taking the medicine and consult your doctor.

Children and adolescents
The use of alendronic acid sodium is not recommended in children under 18 years of age due to the lack of safety and efficacy data in conditions associated with pediatric osteoporosis.

Other medicines and Acido Alendronico FG
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Calcium supplements, antacids, and some oral medications are likely to interfere with the absorption of Acido Alendronico FG if taken at the same time.
It is therefore important to follow the instructions given in section 3. How to take Acido Alendronico FG.
Some medicines for rheumatism or long-term pain called NSAIDs (e.g., aspirin or ibuprofen) may cause digestive problems. Therefore, caution should be exercised when these medicines are taken in conjunction with Acido Alendronico FG.

Acido Alendronico FG with food and drink
Foods and beverages (including mineral water) are likely to decrease the effectiveness of Acido Alendronico FG if taken at the same time. It is therefore important to follow the instructions given in section 3. How to take Acido Alendronico FG.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Acido Alendronico FG is only for postmenopausal women. Do not take Acido Alendronico FG if you are pregnant or think you might be or are breastfeeding.

Driving and operating machinery
Acido Alendronico FG should not affect your ability to drive or operate machinery. However, some adverse reactions reported with Acido Alendronico FG, such as blurred vision, dizziness, muscle, bone and/or joint pain, sometimes severe, may affect your ability to drive or operate machinery. Individual responses to Acido Alendronico FG may vary (see section 4).

Acido Alendronico FG contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine.

3. How to take Acido Alendronico FG

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

Take one Acido Alendronico FG tablet once a week.
To obtain benefits from treatment with Acido Alendronico FG it is necessary to act as
described below.

• 1) Choose the day of the week that best suits your activities. Take Acido Alendronico FG once a week on the chosen day.

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

of the Acido Alendronico FG 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 of the day, swallow the Acido Alendronico FG tablet with a full glass of only water (not mineral water) (not less than 200 ml).
• 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 chew or let the tablet dissolve in your mouth.

• 3) Do not lie down – keep the torso in an upright position (whether sitting, standing, or walking) – for at least 30 minutes after swallowing the tablet. Do not lie down until you have eaten something.
• 4) Acido Alendronico FG should not be taken when lying down or before getting out of bed in the morning.
• 5) If difficulty or pain swallowing, chest pain, or heartburn in the upper stomach occurs or worsens, stop taking Acido Alendronico FG and contact your doctor.
• 6) After swallowing the Acido Alendronico FG tablet, wait at least 30 minutes before eating, drinking, or taking other medicines of the day, including antacids, calcium supplements, and vitamins. Acido Alendronico FG is only effective when taken on an empty stomach.

In case of inadequate dietary intake, your doctor may prescribe calcium and
vitamin D supplements, to be taken at least 30 minutes after taking Acido Alendronico FG.

If you take more Acido Alendronico FG than you should
In case of overdose, side effects on the upper gastrointestinal tract may occur, such as stomach upset, heartburn, esophagitis,
gastritis and ulcer.
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 Acido Alendronico FG
If you forget to take the tablet, simply take one Acido
Alendronico FG tablet the next morning. Do not take a double dose to make up for the
missed tablet.
Then, start taking the tablet again on the chosen day of the week.

If you stop taking Acido Alendronico FG
It is important to continue taking Acido Alendronico FG as long as prescribed by
your doctor. Acido Alendronico FG is effective for the treatment of osteoporosis only if
you continue to take the tablets.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

Immune system disorders
Rare: allergic reactions such as hives; swelling of the face, lips, tongue
and/or throat, possible cause of difficulty breathing and swallowing.

Metabolism and nutrition disorders
Rare: symptoms due to low blood calcium levels including muscle cramps or spasms
and/or tingling in the fingers or around the mouth.

Nervous system disorders
Common: headache, dizziness.
Uncommon: altered taste.

Eye disorders
Uncommon: blurred vision, eye pain or redness.

Ear and labyrinth disorders
Common: vertigo.
Very rare: contact your doctor if you experience ear pain, ear discharge
and/or ear infection. These episodes may be symptoms of bone damage
to the ear.

Gastrointestinal disorders
Common: abdominal pain; unpleasant sensation in the stomach or belching after
meals; constipation; feeling of fullness or bloating in the stomach; diarrhea,
flatulence; heartburn; difficulty swallowing; pain
when swallowing; ulcers of the esophagus (the channel connecting the mouth to the
stomach) causing chest pain, burning or difficulty or pain in
swallowing.
Uncommon: nausea; vomiting; irritation or inflammation of the esophagus (the channel that
connects the mouth to the stomach) or the stomach; black or dark stools.
Rare: narrowing of the esophagus (the channel connecting the mouth to the stomach);
ulcers of the mouth when the tablets are chewed or sucked;
ulcers of the stomach or peptic (sometimes severe or with bleeding).

Skin and subcutaneous tissue disorders
Common: hair loss, itching.
Uncommon: skin rash, skin redness.
Rare: skin rash worsened by exposure to sunlight, severe
skin reactions including Stevens Johnson syndrome and toxic epidermal
necrosis.

Musculoskeletal and connective tissue disorders
Very common: muscle, bone and/or joint pain sometimes severe.
Common: joint swelling.
Rare: Problems with the jaw or mandible associated with delayed healing and
infection, often after dental extraction. 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 it may be an early indication of a possible femur fracture.

Systemic disorders and conditions related to the site of administration
Common: fatigue, swelling of the hands or legs
Uncommon: flu-like transient symptoms, such as muscle aches, general feeling of
illness and sometimes with fever, usually at the beginning of treatment.

Laboratory tests:
Very common: mild and transient decreases in calcium and phosphate levels in the
blood, usually within the normal range.
It may be helpful to note the symptoms that have occurred, their onset and
their duration.

Reporting of side effects
If you get any side effects, even those not listed in this
leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can
help provide more information on the safety of this medicine.

5. How to store Acido Alendronico FG

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 packaging after
Exp. The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25°C. Do not remove the tablets from the blister
pack until it is time to take them.
Do not use this medicine if you notice visible signs of deterioration.
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 Acido Alendronico FG contains

• The active ingredient is alendronic acid sodium trihydrate. Each tablet contains the equivalent of 70 mg of alendronic acid, as alendronic acid sodium trihydrate.
• The other ingredients are microcrystalline cellulose, anhydrous lactose, sodium croscarmellose, magnesium stearate

Description of the appearance of Acido Alendronico FG and contents of the pack
Pack of 4 tablets in aluminum blisters

Marketing Authorisation Holder
FG S.r.l. - Via San Rocco, 6 – 85033 Episcopia (PZ)

Manufacturer
Doppel Farmaceutici S.r.l. – Via Volturno, 48 – 20089 Quinto De’ Stampi (Rozzano –
MI)