ALENDRONATO 70 mg Coated Tablet

Зміст інструкції

1. ALENDRONATO PENSA PHARMA 70 mg tablets
   1. WHAT IS ALENDRONATE PENSA PHARMA AND WHAT IS IT USED FOR
   2. BEFORE TAKING ALENDRONATO PENSA PHARMA
   3. HOW TO TAKE ALENDRONATO PENSA PHARMA
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE ALENDRONATO PENSA PHARMA
   6. FURTHER INFORMATION

ALENDRONATO PENSA PHARMA 70 mg tablets

Alendronic Acid
Generic medicine
Read this leaflet carefully before taking this medicine, even if it is a repeat prescription.

• 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 personally. Never give it to others. Indeed, this medicine may be dangerous for other individuals, even if their symptoms are the same as yours.
• If any of the side effects gets worse, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.
• It is particularly important to understand the information contained in section 3. HOW TO TAKE ALENDRONATO PENSA PHARMA, before taking this medicine.

Contents of this leaflet:

• 1. What ALENDRONATO PENSA PHARMA is and what it is used for
• 2. Before you take ALENDRONATO PENSA PHARMA
• 3. How to take ALENDRONATO PENSA PHARMA
• 4. Possible side effects
• 5. How to store ALENDRONATO PENSA PHARMA
• 6. Further information

1. WHAT IS ALENDRONATE PENSA PHARMA AND WHAT IS IT USED FOR

What is ALENDRONATE PENSA PHARMA?
ALENDRONATE PENSA PHARMA belongs to a group of non-hormonal drugs
called bisphosphonates. ALENDRONATE PENSA PHARMA 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 ALENDRONATE PENSA PHARMA used for?
Your doctor has prescribed ALENDRONATE PENSA PHARMA for the treatment of osteoporosis.

postmenopausal. ALENDRONATE PENSA PHARMA reduces the risk of vertebral and
hip fractures.

ALENDRONATE PENSA PHARMAis 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 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, for example, curvature of the spine (hunchback) and limitations in movements.

How can osteoporosis be treated?
It is important to remember that osteoporosis can be treated and that it is never too late to
start. ALENDRONATE PENSA PHARMA not only prevents the loss of bone tissue
but helps to rebuild bone that may have been lost and reduces the risk of vertebral and hip fractures.
Along with treatment with ALENDRONATE PENSA PHARMA, your doctor may suggest changing your lifestyle to improve the condition of the disease, such as:

Quit 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. BEFORE TAKING ALENDRONATO PENSA PHARMA

If any of the following applies to you, tell your doctor or pharmacist before
starting to take ALENDRONATO PENSA PHARMA 70 mg tablets, as it may
not be suitable for you.
Do not take ALENDRONATO PENSA PHARMAif:

• 1. you are allergic (hypersensitive) to alendronic acid trihydrate sodium or any of the other ingredients.
• 2. you suffer from some disordersof the esophagus (the channel connecting the mouth to the stomach), such as narrowing and difficulty swallowing.
• 3. you cannot stand or sit upright for at least 30 minutes.
• 4. your doctor has told you that you have low levels of calcium in your blood.

Pay particular attention with ALENDRONATO PENSA PHARMA
Before taking ALENDRONATO PENSA PHARMA it is important to tell your doctor if you
have:

• Kidney problems
• Allergies.
• Difficulty swallowing or problems with the digestive tract.
• Low levels of calcium in your blood. Rare reports of symptomatic hypocalcemia, occasionally severe and often in patients with predisposing conditions (e.g., hypoparathyroidism, vitamin D deficiency and calcium malabsorption), particularly in patients taking glucocorticoids, which reduce calcium absorption, have been reported. It is particularly important to ensure adequate calcium and vitamin D intake in patients undergoing glucocorticoid therapy.
• If your doctor has told you that you have Barrett's esophagus (a condition associated with changes in the cells of the distal esophageal epithelium)
• poor dental hygiene, gum disease, are planning dental extractions or do not have regular dental check-ups
• You have cancer
• You are undergoing chemotherapy or radiotherapy
• You are taking corticosteroids (such as prednisone or dexamethasone)
• You are or have been a smoker (this may increase the risk of dental problems).

During the use of alendronate, problems with the jaw or mandible may occur,
generally in patients with cancer, often after dental extractions and/or
local infection. Many of these patients were undergoing chemotherapy and corticosteroids.
You should consider having a dental examination before
starting treatment with ALENDRONATO PENSA PHARMA .
It is important to maintain good oral hygiene during treatment with
ALENDRONATO PENSA PHARMA and you should have regular dental check-ups throughout
treatment and contact your doctor or dentist if you experience any type of problem with your
mouth or teeth such as mobility, pain or swelling.
Irritation, inflammation or ulceration of the esophagus (the channel connecting
the mouth to the stomach) may occur, often with symptoms of chest pain, burning in the upper stomach,
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 ALENDRONATO PENSA
PHARMA. These side effects may worsen if patients continue to take
ALENDRONATO PENSA PHARMA after experiencing these symptoms.
If you notice the onset of any of the side effects described above, stop taking
the medicine and consult your doctor.
In patients treated with alendronate for long periods, femoral fractures have been reported
with or without a minor injury (stress fractures). If you experience pain, weakness or
discomfort in the leg, hip or groin, please inform your doctor as
this could be an early sign of a possible femoral fracture. (see paragraph 4)
Your doctor will decide whether it is necessary to stop treatment with ALENDRONATO PENSA
PHARMA
During the use of alendronate, rare cases of gastric and duodenal ulcers have been reported,
some of which were severe and associated with complications.
In patients treated with bisphosphonates, including alendronate, cases of bone, joint and/or muscle pain have occurred,
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.
Rare cases of severe skin reactions including Stevens Johnson syndrome and toxic epidermal necrolysis have been reported with alendronate.

Taking other medicines
Calcium supplements, antacids, and some oral medicines are likely to interfere with
the absorption of ALENDRONATO PENSA PHARMA if taken at the same time.
It is therefore important to follow the instructions given in paragraph 3. HOW TO TAKE
ALENDRONATO PENSA PHARMA.
Other 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 at the same time as ALENDRONATO PENSA PHARMA.
Always inform your doctor of all the medicines you are taking or intend to take,
including those available over the counter

Taking ALENDRONATO PENSA PHARMA with food and drink
Foods and beverages (including mineral water) are likely to decrease the effectiveness of
ALENDRONATO PENSA PHARMA if taken at the same time. It is therefore important to follow the
instructions given in paragraph 3. HOW TO TAKE ALENDRONATO PENSA PHARMA.

Children and adolescents
ALENDRONATO PENSA PHARMA should not be given to children and adolescents.

Pregnancy and breastfeeding
ALENDRONATO PENSA PHARMA is only for women after menopause. Do not take
ALENDRONATO PENSA PHARMA if you are pregnant or think you may be or are breastfeeding.

Driving and using machines

No studies have been conducted on the ability to drive vehicles and operate machinery.However,

certain adverse effects that have been observed with ALENDRONATO PENSA PHARMA

may affect the ability to drive or operate machinery. Individual response

to ALENDRONATO PENSA PHARMA may vary (see paragraph “Possible side

effects”).

Important information about some excipients of ALENDRONATO PENSA PHARMA
ALENDRONATO PENSA PHARMA contains lactose. If you have been told by your doctor that you
have an intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE ALENDRONATO PENSA PHARMA

Take one ALENDRONATO PENSA PHARMA tablet once a week.
To obtain benefits from treatment with ALENDRONATO PENSA PHARMA it is necessary to
act as described below.

• 1) Choose the day of the week that best suits your activities. Take ALENDRONATO PENSA PHARMA once a week on the chosen day.

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

tablet ofALENDRONATO PENSA PHARMA 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 medication of the day, swallow the entire ALENDRONATO PENSA PHARMA 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 crush, chew or let the tablet dissolve in your mouth.
• 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.
• 3) ALENDRONATO PENSA PHARMA should not be taken at bedtime or before getting out of bed in the morning.
• 4) If difficulty or pain occurs when swallowing, chest pain appears, or heartburn in the upper part of the stomach develops or worsens, stop taking ALENDRONATO PENSA PHARMA and contact your doctor.
• 5) After swallowing the ALENDRONATO PENSA PHARMA tablet, wait at least 30 minutes before eating, drinking or taking other medications of the day, including antacids, calcium supplements and vitamins. ALENDRONATO PENSA PHARMA is only effective when taken on an empty stomach. Pediatric patients: the use of sodium alendronate is not recommended in children under 18 years of age due to the lack of data on safety and efficacy in conditions associated with pediatric osteoporosis.

If you take more ALENDRONATO PENSA PHARMA 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 ALENDRONATO PENSA PHARMA:
If you forget to take the tablet, simply take one ALENDRONATO PENSA PHARMA tablet the next morning. DO NOT take two tablets in the
same day. Afterwards, start taking the tablet again on the chosen day of the week.

If you stop taking ALENDRONATO PENSA PHARMA
It is important to continue taking ALENDRONATO PENSA PHARMA until prescribed by your doctor. ALENDRONATO PENSA PHARMA 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, ALENDRONATO PENSA PHARMA 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)

Immune system disorders
Rare: allergic reactions such as urticaria; swelling of the face, lips, tongue and/or
throat, which may cause 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: dysgeusia (taste disturbances)

Eye disorders
Uncommon: blurred vision, pain, inflammation (uveitis, scleritis, episcleritis) or
redness of the eyes.

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 ear bone damage.

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 tube connecting the mouth to the stomach) causing chest pain,
burning or difficulty or pain when swallowing.
Uncommon: nausea, vomiting; irritation or inflammation of the esophagus (the tube connecting the
mouth to the stomach) or the stomach; black or tarry stools.
Rare: narrowing of the esophagus (the tube connecting the mouth to the stomach); ulcers
of the mouth when the tablets are chewed or sucked; stomach or peptic ulcers (sometimes severe or with bleeding).

Skin and subcutaneous tissue disorders
Common: alopecia (hair loss), itching
Uncommon: rash, erythema.
Rare: rash worsened by exposure to sunlight, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis

Musculoskeletal and connective tissue disorders
Very common: bone, muscle or joint pain, sometimes severe
Common: joint swelling.
Rare: pain in the mouth, and/or jaw/mandible, swelling or sores inside the mouth,
numbness or a feeling of heaviness in the jaw/mandible, or loosening of teeth. These
can 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 atypical 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 could be an early indication of a possible femur fracture.

System disorders
Common: asthenia, peripheral edema (swelling of the hands or legs)
Uncommon: transient flu-like symptoms, such as muscle pain, general feeling of unwellness
and sometimes with fever, usually at the start of treatment.

Diagnostic tests:
Very common: mild and transient decreases in blood calcium and phosphate levels,
generally within the normal range.
Tell your doctor or pharmacist immediately if you experience these symptoms or any
other unusual symptoms.
It may be helpful to keep a record of the symptoms you have experienced, when they started and how long they lasted.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Very rare side effects:
Contact your doctor if you experience ear pain, ear discharge and/or ear infection.
These episodes may be symptoms of bone damage in the ear.

5. HOW TO STORE ALENDRONATO PENSA PHARMA

Keep out of the reach and sight of children.
Do not use ALENDRONATO PENSA PHARMA after the expiry date which is stated on the
carton after EXP. The expiry date refers to the last day of the 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.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. FURTHER INFORMATION

For further information on the product, please contact the marketing authorisation holder
Genetic S.p.A., Via G. Della Monica 26, 84083 Castel San Giorgio (SA)
Tel.: 089/8289111

What ALENDRONATO PENSA PHARMA contains
Active ingredient
The active ingredient is alendronic acid trihydrate sodium. Each tablet contains the equivalent of 70 mg of alendronic acid, as alendronate sodium trihydrate.

Excipients
Microcrystalline cellulose, anhydrous lactose, sodium croscarmellose, magnesium stearate

Description of the appearance of ALENDRONATO PENSA PHARMA and contents of the
pack
4 or 12 tablets in OPA/ALU/PVC-AL blisters

Marketing authorisation holder
Genetic S.p.A., Via G. Della Monica 26, 84083 Castel San Giorgio (SA)

Exclusive distributor for sale
Pensa Pharma S.p.A.
Via Ippolito Rosellini 12 – 20124 Milano

Manufacturer
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA)

This leaflet was last revised in
October 2020