Alendronate Pensapharma: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

ALENDRONATE PENSA PHARMA 70 mg tablets

Alendronic Acid
Generic medicine
Please read this entire leaflet carefully before taking this medicine, even if you have used it before.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you personally. Never give it to others. It may be harmful to other people, even if their symptoms are similar to yours.
If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
It is particularly important to understand the information contained in section 3. HOW TO TAKE ALENDRONATE PENSA PHARMA, before taking this medicine.

Contents of this leaflet:

What ALENDRONATE PENSA PHARMA is and what it is used for
Before you take ALENDRONATE PENSA PHARMA
How to take ALENDRONATE PENSA PHARMA
Possible side effects
How to store ALENDRONATE PENSA PHARMA
Further information

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

What is ALENDRONATE PENSA PHARMA?
ALENDRONATE PENSA PHARMA belongs to a group of non-hormonal medicines called bisphosphonates. ALENDRONATE PENSA PHARMA prevents bone tissue loss that occurs in women after menopause and promotes bone rebuilding. 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 postmenopausal osteoporosis. ALENDRONATE PENSA PHARMA reduces the risk of vertebral and hip fractures.

ALENDRONATE PENSA PHARMA is a treatment to be taken once weekly.

What is osteoporosis?
Osteoporosis is thinning and weakening of the bones. It is common in women after menopause. During menopause, the ovaries stop producing female hormones, estrogens, which help maintain a woman's skeletal health. As a result, bone tissue is lost and bones become weaker. The risk of osteoporosis is greater the earlier a woman reaches menopause.

In its early stages, osteoporosis usually causes no symptoms. However, if left untreated, fractures may occur. Although fractures are typically painful, spinal bone fractures may go unnoticed until they result in a loss of height. Fractures can occur during everyday activities such as lifting heavy objects, or following minor trauma that would not normally cause fractures in healthy bone. Fractures commonly occur in the hip, spine, or wrist and can be not only painful but may also lead to significant deformities and disability, such as curvature of the back (kyphosis) and limitations in movement.

How can osteoporosis be treated?
It is important to remember that osteoporosis can be treated and it is never too late to start. ALENDRONATE PENSA PHARMA not only prevents bone tissue loss but also helps 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 recommend lifestyle changes to improve the condition, such as:

Smoking cessation – smoking appears to increase the rate at which bone tissue is lost and therefore may increase the risk of fractures.

Physical exercise – just as muscles do, bones need physical activity to stay strong and healthy. Consult your doctor before starting any exercise program.

Balanced diet – your doctor can provide information about diet or the possible need for dietary supplements (especially calcium and vitamin D).

2. BEFORE TAKING ALENDRONATE PENSA PHARMA

If any of the following conditions apply to you, inform your doctor or pharmacist before
starting ALENDRONATE PENSA PHARMA 70 mg tablets, as it may not be suitable for you.
Do not take ALENDRONATE PENSA PHARMA if :

you are allergic (hypersensitive) to sodium alendronate trihydrate or to any of the other ingredients.
you have certain disorders of the esophagus (the tube connecting the mouth to the stomach), such as strictures or difficulty swallowing.
you cannot stand or sit upright with your torso erect for at least 30 minutes.
your doctor has told you that you have low levels of calcium in your blood.

Take special care with ALENDRONATE PENSA PHARMA
Before taking ALENDRONATE PENSA PHARMA, it is important to inform your doctor if you have:

Kidney problems
Allergies
Difficulty swallowing or gastrointestinal disorders
Low levels of calcium in your blood. There have been rare reports of symptomatic hypocalcemia, occasionally severe, particularly in patients with predisposing conditions (e.g., hypoparathyroidism, vitamin D deficiency, and calcium malabsorption), especially in patients taking glucocorticoids, which reduce calcium absorption. It is particularly important to ensure adequate calcium and vitamin D intake in patients receiving glucocorticoid therapy.
Been diagnosed with Barrett's esophagus (a condition associated with changes in the cells of the distal esophageal epithelium)
Poor dental hygiene, gum disease, have planned dental extractions, or do not undergo regular dental check-ups
Cancer
Are undergoing chemotherapy or radiotherapy
Are taking corticosteroids (such as prednisone or dexamethasone)
Are or have been a smoker (this may increase the risk of dental problems)

During treatment with alendronate, jaw problems (affecting the maxilla or mandible) may occur, usually in patients with cancer, often following dental extractions and/or local infection. Many of these patients were also receiving chemotherapy and corticosteroids. You should consider having a dental examination before starting treatment with ALENDRONATE PENSA PHARMA.
It is important to maintain good oral hygiene during treatment with ALENDRONATE PENSA PHARMA and to have regular dental check-ups throughout treatment. Contact your doctor or dentist if you experience any mouth or dental problems such as loose teeth, pain, or swelling.
Irritation, inflammation, or ulceration of the esophagus (the tube connecting the mouth to the stomach) may occur, often accompanied by chest pain, heartburn, or 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 ALENDRONATE PENSA PHARMA. These side effects may worsen if patients continue taking ALENDRONATE PENSA PHARMA after experiencing such symptoms.
If you notice any of the above side effects, stop taking the medicine and consult your doctor immediately.
In patients treated with alendronate for prolonged periods, femoral fractures—sometimes preceded by minimal trauma (stress fractures)—have been reported. If you experience pain, weakness, or discomfort in your leg, hip, or groin, inform your doctor promptly, as this may be an early sign of a possible femoral fracture. (See section 4)
Your doctor will decide whether it is necessary to discontinue treatment with ALENDRONATE PENSA PHARMA.
Rare cases of gastric and duodenal ulcers, some of which were severe and associated with complications, have been reported during alendronate use.
In patients treated with bisphosphonates, including alendronate, cases of bone, joint, and/or muscle pain have occurred, occasionally manifesting severely and causing disability. The onset of symptoms has varied from one day to several months after starting treatment. In most patients, discontinuation of treatment led to symptom relief.
Rare cases of severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with the use of alendronate.

Taking other medicines
Calcium supplements, antacids, and certain orally administered medications may interfere with the absorption of ALENDRONATE PENSA PHARMA if taken at the same time.
Therefore, it is important to follow the instructions provided in section 3. HOW TO TAKE ALENDRONATE PENSA PHARMA.
Other medicines used for rheumatism or long-term pain relief, known as NSAIDs (e.g., aspirin or ibuprofen), may cause gastrointestinal problems. Therefore, caution should be exercised when these medicines are taken together with ALENDRONATE PENSA PHARMA.
Always inform your doctor about all medicines you are taking or intend to take, including those available without a prescription.

Taking ALENDRONATE PENSA PHARMA with food and drink
Foods and beverages (including mineral water) may reduce the effectiveness of ALENDRONATE PENSA PHARMA if taken at the same time. Therefore, it is important to follow the instructions given in section 3. HOW TO TAKE ALENDRONATE PENSA PHARMA.

Children and adolescents
ALENDRONATE PENSA PHARMA must not be administered to children or adolescents.

Pregnancy and breastfeeding
ALENDRONATE PENSA PHARMA is intended only for postmenopausal women. Do not take ALENDRONATE PENSA PHARMA if you are pregnant or think you may be pregnant, or if you are breastfeeding.

Driving and using machines
No studies have been conducted on the ability to drive vehicles or operate machinery. However,
certain adverse effects observed with ALENDRONATE PENSA PHARMA
may affect the ability to drive or use machinery. Individual response
to ALENDRONATE PENSA PHARMA may vary (see section “Possible unwanted effects”).

Important information about some excipients in ALENDRONATE PENSA PHARMA
ALENDRONATE PENSA PHARMA contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. HOW TO TAKE ALENDRONATE PENSA PHARMA

Take one tablet of ALENDRONATE PENSA PHARMA once a week.
To obtain benefit from treatment with ALENDRONATE PENSA PHARMA, it is essential to follow the instructions below.

Choose the day of the week that best fits your routine. Take ALENDRONATE PENSA PHARMA once a week on the chosen day.
It is very important to follow instructions 2), 3), 4), and 5) to help ensure rapid entry of the
ALENDRONATE PENSA PHARMA tablet into the stomach and to help reduce the risk of irritating the oesophagus (the tube connecting the mouth to the stomach).
After getting up in the morning and before taking any food, drink, or other medication, swallow the ALENDRONATE PENSA PHARMA tablet whole with a full glass of plain water (not mineral water) (at least 200 ml).

Do not take with mineral water (still or sparkling).
Do not take with coffee or tea.
Do not take with juices or milk.
Do not crush, chew, or allow the tablet to dissolve in the mouth.
Do not lie down – remain in an upright position (sitting, standing, or walking) for at least 30 minutes after swallowing the tablet. Do not lie down until you have eaten something.

ALENDRONATE PENSA PHARMA must not be taken at bedtime or before getting out of bed in the morning.
If you experience difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking ALENDRONATE PENSA PHARMA and contact your doctor immediately.
After swallowing the ALENDRONATE PENSA PHARMA tablet, wait at least 30 minutes before eating, drinking, or taking any other medicines, including antacids, calcium supplements, and vitamins. ALENDRONATE PENSA PHARMA is effective only when taken on an empty stomach.

Paediatric patients: The use of sodium alendronate is not recommended in children under 18 years of age due to insufficient data on safety and efficacy in conditions associated with paediatric osteoporosis.

If you take more ALENDRONATE 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 ALENDRONATE PENSA PHARMA:
If you forget to take your tablet, simply take one tablet of ALENDRONATE PENSA PHARMA the next morning. DO NOT take two tablets on the same day. Then, resume taking your tablet on your chosen day of the week.

If you stop taking ALENDRONATE PENSA PHARMA:
It is important to continue taking ALENDRONATE PENSA PHARMA for as long as prescribed by your doctor. ALENDRONATE PENSA PHARMA is effective in treating osteoporosis only if you continue taking the tablets.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, ALENDRONATE PENSA PHARMA can cause adverse effects,
although not everyone experiences them.
The following terms are used to describe how often adverse effects have been reported:
Very common: (occur in at least 1 out of 10 patients treated)
Common: (occur in at least 1 out of 100 and less than 1 out of 10 patients treated)
Uncommon: (occur in at least 1 out of 1,000 and less than 1 out of 100 patients treated)
Rare: (occur in at least 1 out of 10,000 and less than 1 out of 1,000 patients treated)
Very rare: (occur in less than 1 out of 10,000 patients treated)

Immune system disorders
Rare: allergic reactions such as urticaria; swelling of the face, lips, tongue and/or throat, possibly causing difficulty in breathing or swallowing.

Metabolism and nutrition disorders
Rare: symptoms due to low calcium levels in the blood, 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, eye pain, inflammation (uveitis, scleritis, episcleritis), or eye redness.

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

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

Skin and subcutaneous tissue disorders
Common: alopecia (hair loss), pruritus (itching)
Uncommon: skin rash, erythema
Rare: skin 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: mouth pain, and/or pain in the jaw, swelling or sores in the mouth, numbness or a sensation of heaviness in the jaw, or tooth loss. These may be signs of jaw bone damage (osteonecrosis), usually associated with delayed healing and infection, often following tooth extraction. Contact your doctor or dentist if these symptoms occur.
Rarely, an unusual femur fracture may occur, particularly in patients undergoing long-term treatment for osteoporosis. Contact your doctor if you experience pain, weakness, or discomfort in the thigh, hip, or groin, as this may be an early sign of a possible femur fracture.

General disorders and administration site conditions
Common: asthenia, peripheral oedema (swelling of hands or legs)
Uncommon: transient influenza-like symptoms such as muscle aches, general malaise, and sometimes fever, usually at the beginning of treatment.

Investigations:
Very common: mild and transient decreases in blood calcium and phosphate levels, generally within normal limits.

Inform your doctor or pharmacist immediately if you experience any of these symptoms or any other unusual symptoms.
It may be helpful to keep a record of symptoms, including when they started and how long they lasted.
If any of the adverse effects worsen, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Very rare adverse effects:
Consult your doctor if you experience ear pain, ear discharge, and/or ear infection. These episodes could be symptoms of ear bone damage.

5. HOW TO STORE ALENDRONATE PENSA PHARMA

Keep out of the reach and sight of children.
Do not use ALENDRONATE PENSA PHARMA after the expiry date stated on the
carton after EXP. The expiry date refers to the last day of the month.
Store below 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 no longer required. This will help protect
the environment.

6. OTHER INFORMATION

For further information about this 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 substance
The active substance is sodium alendronate trihydrate. Each tablet contains the equivalent of 70 mg alendronic acid as sodium alendronate 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 approved on
October 2020