Alendronate Doc Generici

Package leaflet: Information for the user

ALENDRONATE DOC Generici 70 mg tablets

Equivalent medicine
Please read this leaflet carefully before 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
• It is especially important to understand the information contained in section 3. How to take ALENDRONATE DOC Generici, before taking this medicine.

Contents of this leaflet:

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

1. What ALENDRONATE DOC Generici is and what it is used for

What is ALENDRONATE DOC Generici?
ALENDRONATE DOC Generici belongs to a group of non-hormonal medicines called bisphosphonates.
ALENDRONATE DOC Generici 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 ALENDRONATE DOC Generici used for?
Your doctor has prescribed ALENDRONATE DOC Generici for the treatment of osteoporosis.
ALENDRONATE DOC Generici reduces the risk of vertebral and hip fractures.
ALENDRONATE DOC Generici is a treatment to be taken once a week.
What is osteoporosis?
Osteoporosis is the thinning and weakening of bones. It is common in women after
menopause. During menopause, the ovaries stop producing female hormones, estrogens, which
help maintain a woman's healthy skeleton. 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, fractures of the spinal bones may go unnoticed until they result in a loss of height. Fractures can occur during everyday activities such as lifting weights, or following minor trauma that would not cause fractures in normal bone. Fractures usually 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 (dowager's hump) 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 DOC Generici 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 DOC Generici, your doctor may recommend lifestyle changes to improve the condition, such as:
Stopping smoking – smoking appears to increase the rate at which bone tissue is lost and therefore may increase the risk of fractures.
Physical exercise – like muscles, 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. What you need to know before taking ALENDRONATE DOC Generics

Do not take ALENDRONATE DOC Generics

• If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• If you have certain diseases of the esophagus (the tube connecting the mouth to the stomach), such as strictures or difficulty swallowing.
• If you are unable to 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 suffer from severe kidney problems.

If you think any of these situations apply to you, do not take the tablets. Consult your doctor and follow the advice given.

Warnings and precautions

Talk to your doctor or pharmacist before taking ALENDRONATE DOC Generics.

Before taking ALENDRONATE DOC Generics, it is important to inform your doctor if:

• You have kidney problems.
• You have allergies.
• You have difficulty swallowing or gastrointestinal disorders.
• You have low levels of calcium in your blood. There have been rare reports of symptomatic hypocalcemia, occasionally severe, often in patients with predisposing conditions (e.g.: hypoparathyroidism, vitamin D deficiency, and calcium malabsorption), particularly in patients taking glucocorticoids, which reduce calcium absorption. It is especially important to ensure adequate calcium and vitamin D intake in patients receiving glucocorticoid therapy.
• You suffer from gum disease.
• You are scheduled for dental surgery.
• Your doctor has told you that you have Barrett's esophagus (a condition associated with changes in the cells lining the lower part of the esophagus).

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 receiving chemotherapy and corticosteroids. Therefore, if you are in any of the following conditions, you should consider the possibility of undergoing a dental examination before starting treatment with ALENDRONATE DOC Generics.

• You have cancer.
• You are undergoing chemotherapy or radiotherapy.
• You are taking steroids.
• You do not regularly visit your dentist.
• You have gum disease.

During treatment, appropriate preventive dental measures should be followed as recommended by your dentist, and good oral hygiene should be maintained. Inform your doctor of any oral symptoms such as tooth mobility, pain, or swelling.

Irritation, inflammation, or ulceration of the esophagus (the tube connecting the mouth to the stomach) may occur, often with symptoms such as chest pain, burning in the upper abdomen, 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 DOC Generics. These side effects may worsen if patients continue taking ALENDRONATE DOC Generics after experiencing symptoms. If you notice any of the side effects described above, stop taking the medicine and contact your doctor.

In patients treated with alendronate for prolonged periods, femoral fractures (with or without minimal trauma, i.e., stress fractures) have been reported. If you experience pain, weakness, or discomfort in your leg, hip, or groin, please inform your doctor, as this could 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 DOC Generics.

Rare cases of serious gastric and duodenal ulcers, some 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, rarely 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.

Children and adolescents

ALENDRONATE DOC Generics must not be administered to children and adolescents.

Other medicines and ALENDRONATE DOC Generics

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Calcium supplements, antacids, and certain oral medications are likely to interfere with the absorption of ALENDRONATE DOC Generics if taken at the same time.

Therefore, it is important to follow the instructions provided in section 3. How to take ALENDRONATE DOC Generics.

Some medicines used for rheumatism or long-term pain known as NSAIDs (e.g., aspirin or ibuprofen) may cause digestive problems. Therefore, caution should be exercised when these medicines are taken concomitantly with ALENDRONATE DOC Generics.

ALENDRONATE DOC Generics with food and drink

Food and beverages (including mineral water) may reduce the effectiveness of ALENDRONATE DOC Generics if taken at the same time. Therefore, it is important to follow the instructions provided in section 3. How to take ALENDRONATE DOC Generics.

Pregnancy and breastfeeding

ALENDRONATE DOC Generics is intended only for postmenopausal women. Do not take ALENDRONATE DOC Generics if you are pregnant or think you may be pregnant or are breastfeeding.

Driving and using machines

No studies have been conducted on the effects on the ability to drive vehicles or operate machinery. However, some adverse effects associated with the use of ALENDRONATE DOC Generics may affect, in some patients, the ability to drive or operate machinery. The effects of ALENDRONATE DOC Generics may vary depending on individual response (see section 4).

ALENDRONATE DOC Generics contains lactose.

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

3. How to take ALENDRONATE DOC Generici

Take this medicine exactly as your doctor has told you. If you are unsure, consult your
doctor or pharmacist.
Take one tablet of ALENDRONATE DOC Generici once a week.
To benefit from treatment with ALENDRONATE DOC Generici, it is essential to follow the instructions
described below.

1. Choose the day of the week that best fits your routine. Take ALENDRONATE DOC Generici once a week on the chosen day.
   It is very important to follow instructions 2), 3), 4), and 5) to help the tablet enter the stomach quickly and reduce the risk of irritating the oesophagus (the tube connecting the mouth to the stomach).
2. After getting up in the morning and before taking any food, drink, or other medication, swallow the ALENDRONATE DOC Generici tablet 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.

The tablet must be swallowed whole. Do not chew or let the tablet dissolve in the mouth.
3) 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 after you have eaten something.
4) ALENDRONATE DOC Generici must not be taken at bedtime or before getting up from bed in the morning.
5) If you experience difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking ALENDRONATE DOC Generici and contact your doctor.
6) After swallowing the ALENDRONATE DOC Generici tablet, wait at least 30 minutes before eating, drinking, or taking any other medicines, including antacids, calcium supplements, and vitamins. ALENDRONATE DOC Generici is effective only when taken on an empty stomach.

If you take more ALENDRONATE DOC Generici 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 DOC Generici
If you forget to take your tablet, simply take one tablet of ALENDRONATE DOC Generici the following morning. DO NOT take two tablets on the same day. Afterwards, resume taking your tablets on your chosen day of the week.

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

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Very common (may affect more than 1 in 10 people)

• Mild and transient decreases in blood calcium and phosphate levels, generally within normal limits;
• Muscle, bone, and/or joint pain, which in some cases may be severe.

Common (may affect up to 1 in 10 people)

• Headache;
• Dizziness;
• Vertigo;
• Abdominal pain;
• Uncomfortable stomach sensation or burping 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 swallowing;
• Hair loss (alopecia);
• Itching;
• Joint swelling;
• Feeling of tiredness (asthenia);
• Swelling of the hands or legs (peripheral oedema).

Uncommon (may affect up to 1 in 100 people)

• Taste disturbances;
• Blurred vision;
• Eye pain or redness;
• Nausea;
• Vomiting;
• Irritation or inflammation of the oesophagus (the tube connecting the mouth to the stomach) or of the stomach;
• Black or dark stools;
• Skin rash;
• Skin redness;
• Transient flu-like symptoms such as muscle pain, general malaise, and sometimes fever, usually at the beginning of treatment.

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

• Allergic reactions such as urticaria; swelling of the face, lips, tongue and/or throat, possibly causing difficulty in breathing or swallowing;
• 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;
• Oesophageal narrowing (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 rash worsened by exposure to sunlight, serious skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis;
• Jaw or mandible problems associated with delayed healing and infection, often following dental extraction;
• Rarely, an unusual femur fracture, particularly in patients on 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.

Very rare (may affect up to 1 in 10,000 people)

• Consult your doctor if you experience ear pain, ear discharge, and/or ear infection. These symptoms could be signs of bone damage in the ear.

Promptly inform your doctor or pharmacist if any of these symptoms occur, or any other unusual symptoms.
It is advisable to record any symptoms that may occur, noting when they started and how long they last.

Reporting of side effects

If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 ALENDRONATE DOC Generici

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 carton after “Exp”. The expiry date refers to the last day of that month.
Do not store above 25°C. Do not remove the tablets from the blister pack before taking them.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

For further information about this product, please contact the Marketing Authorization Holder.

What ALENDRONATE DOC Generici contains

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

Description of the appearance of ALENDRONATE DOC Generici and the contents of the pack

4 tablets in aluminum blisters.

Marketing Authorization Holder

DOC Generici S.r.l. – Via Turati 40 – 20121 Milan - Italy.

Manufacturer

Doppel Farmaceutici S.r.l. – Via Volturno 48 – 20089 Quinto De’ Stampi, Rozzano (Milan) - Italy.