Alendronate acid Alter

Patient Information Leaflet

ACIDO ALENDRONICO ALTER 70 mg film-coated tablets

sodium alendronate
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 give it 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.

Contents of this leaflet:

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

1. What is ACIDO ALENDRONICO ALTER and what is it used for

ACIDO ALENDRONICO ALTER is a film-coated tablet containing the active substance sodium alendronate and belongs to a group of non-hormonal medicines called bisphosphonates. ACIDO ALENDRONICO ALTER 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 ACIDO ALENDRONICO ALTER used for?
Your doctor has prescribed ACIDO ALENDRONICO ALTER for the treatment of osteoporosis. It reduces the risk of vertebral and hip fractures.
ACIDO ALENDRONICO ALTER is a treatment to be taken once a week.
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 the bone becomes 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 normal daily 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 lead to significant deformities and disability, such as curvature of the back (kyphosis) and limitations in movement.
How can osteoporosis be treated?
Along with treatment with ACIDO ALENDRONICO ALTER, 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 advice on diet or the possible need for dietary supplements (especially calcium and vitamin D).

2. What you need to know before taking ACIDO ALENDRONICO ALTER

Do not take ACIDO ALENDRONICO ALTER

• if you are allergic to sodium alendronate or to any of the other ingredients of this medicine (listed in section 6);
• if you have certain problems with your oesophagus (the tube connecting your mouth to your stomach), such as narrowing or difficulty swallowing;
• if you cannot stand or sit upright with your torso straight for at least 30 minutes;
• if your doctor has told you that you have low levels of calcium in your blood.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking ACIDO ALENDRONICO ALTER if:

• you have kidney problems;
• you have or have recently had difficulty swallowing or gastrointestinal disorders;
• your doctor has told you that you have Barrett's oesophagus (a condition associated with changes in the cells lining the lower part of the oesophagus);
• you have been diagnosed with a condition affecting mineral absorption in the stomach or intestines (malabsorption syndrome);
• you have been told you have low levels of calcium in your blood;
• you have poor dental health, gum disease, are scheduled for a dental extraction, or do not regularly visit a dentist;
• you have cancer;
• you are undergoing chemotherapy or radiotherapy;
• you are taking angiogenesis inhibitors (such as bevacizumab or thalidomide) used in cancer treatment;
• you are taking corticosteroids (such as prednisone or dexamethasone) used to treat conditions like asthma, rheumatoid arthritis, or severe allergies;
• you are or have been a smoker (as this may increase the risk of dental problems).

You may be advised to have a dental examination before starting treatment with ACIDO ALENDRONICO ALTER.

It is important to maintain good oral hygiene during treatment with ACIDO ALENDRONICO ALTER. You should have regular dental check-ups throughout your treatment and contact your doctor or dentist if you experience any mouth or dental problems, such as tooth loss, pain, or swelling.

Irritation, inflammation, or ulceration of the oesophagus (the tube connecting the mouth to the stomach) may occur, often accompanied by symptoms such as 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 ACIDO ALENDRONICO ALTER. These side effects may worsen if patients continue taking ACIDO ALENDRONICO ALTER after experiencing such symptoms.

Children and adolescents

ACIDO ALENDRONICO ALTER must not be administered to children and adolescents under 18 years of age.

Other medicines and ACIDO ALENDRONICO ALTER

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 may interfere with the absorption of ACIDO ALENDRONICO ALTER if taken at the same time. Therefore, it is important to follow the instructions provided in section 3.

Some medicines used for rheumatic conditions or long-term pain relief, known as NSAIDs (e.g. acetylsalicylic acid or ibuprofen), may cause gastrointestinal problems. Therefore, caution should be exercised when taking these medicines together with ACIDO ALENDRONICO ALTER.

ACIDO ALENDRONICO ALTER with food and drink

Foods and beverages (including mineral water) may reduce the effectiveness of ACIDO ALENDRONICO ALTER if taken at the same time. Therefore, it is important to follow the instructions given in section 3.

Pregnancy and breastfeeding

ACIDO ALENDRONICO ALTER is indicated only for postmenopausal women.

Do not take ACIDO ALENDRONICO ALTER if you are pregnant, suspect you may be pregnant, or are breastfeeding.

Driving and using machines

With ACIDO ALENDRONICO ALTER, side effects have been reported (e.g. blurred vision, dizziness, and severe bone, muscle, or joint pain) that may affect your ability to drive or operate machinery (see section 4).

ACIDO ALENDRONICO ALTER contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take ACIDO ALENDRONICO ALTER

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Take one tablet of ACIDO ALENDRONICO ALTER once a week.
Carefully follow the instructions below:

1. Choose the day of the week that best fits your routine. Take one tablet of
   ACIDO ALENDRONICO ALTER on that chosen day every week.
   It is very important that you follow instructions 2), 3), 4), and 5) to help ensure rapid delivery of the
   ACIDO ALENDRONICO ALTER tablet into the stomach and to help reduce the risk of irritating the
   oesophagus (the tube connecting 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 ACIDO ALENDRONICO ALTER tablet whole with a full glass
   of tap water only (not mineral water), (at least 200 mL), so that ACIDO
   ALENDRONICO ALTER is adequately absorbed.

• 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, as this may cause mouth ulcers.
3) Do not lie down – remain upright (sitting, standing, or walking) for at least 30 minutes after swallowing the tablet. Do not lie down until you have eaten something.
4) Do not take ACIDO ALENDRONICO ALTER at bedtime or just 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 ACIDO ALENDRONICO ALTER and contact your doctor.
6) After swallowing the ACIDO ALENDRONICO ALTER tablet, wait at least 30 minutes before eating, drinking, or taking any other medicines of the day, including antacids, calcium supplements, and vitamins.
ACIDO ALENDRONICO ALTER is effective only when taken on an empty stomach.
If you take more ACIDO ALENDRONICO ALTER 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 ACIDO ALENDRONICO ALTER
If you forget to take the tablet, simply take one tablet of ACIDO ALENDRONICO
ALTER the following morning.
Do not take two tablets on the same day. Afterwards, resume taking the tablet on your chosen day of the week.
If you stop treatment with ACIDO ALENDRONICO ALTER
It is important that you continue taking ACIDO ALENDRONICO ALTER for as long as prescribed by your doctor. Since it is not known how long you should continue taking ACIDO ALENDRONICO ALTER, you should periodically check with your doctor whether continuing treatment with this medicine is still necessary and whether ACIDO ALENDRONICO ALTER remains the appropriate therapy for you.
If you have any questions about the use of 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.
Contact your doctor immediately if you notice any of the following side effects, which may be serious and for which you may need urgent medical treatment.
Common (may affect up to 1 in 10 people):

• heartburn; difficulty swallowing; pain when swallowing; oesophageal ulcers (the tube connecting the mouth to the stomach), which may cause chest pain, heartburn, or difficulty or pain when swallowing.

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

• allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, possibly causing difficulty breathing or swallowing; severe skin reactions,
• mouth pain, and/or pain in the jaw/mandible, swelling or ulcers inside the mouth, numbness or a sensation of heaviness in the jaw/mandible, or tooth loss. These could be signs of bone damage in the jaw/mandible (osteonecrosis), usually associated with delayed healing and infection, often following dental extraction. Contact your doctor and dentist if you experience such symptoms,
• rarely, an unusual femur fracture may occur, 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 could be an early sign of a possible femur fracture,
• severe bone, muscle, and/or joint pain.

Other side effects include
Very common (may affect more than 1 in 10 people):

• bone, muscle, and/or joint pain, sometimes severe.

Common (may affect up to 1 in 10 people):

• joint swelling,
• abdominal pain; stomach discomfort or belching after meals; constipation; feeling of fullness or bloating in the stomach; diarrhoea; flatulence,
• hair loss; itching,
• headache; dizziness,
• fatigue; swelling of the hands or legs.

Uncommon (may affect up to 1 in 100 people):

• nausea; vomiting,
• irritation or inflammation of the oesophagus (the tube connecting the mouth to the stomach) or stomach,
• black or dark stools,
• blurred vision; eye pain or redness,
• skin rash; redness of the skin,
• flu-like symptoms, such as muscle aches, general malaise, and sometimes fever, usually at the beginning of treatment,
• taste disturbances.

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

• symptoms due to low calcium levels 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 oesophagus (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 people):

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ACIDO ALENDRONICO ALTER

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton 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 medicines 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

What ACIDO ALENDRONICO ALTER contains

• The active substance is alendronate sodium. Each tablet contains 91.35 mg of alendronate sodium trihydrate, equivalent to 70 mg of alendronic acid.
• The other components are: tablet core: microcrystalline cellulose (Avicel Ph 102), sodium croscarmellose (Ac-Di-Sol), anhydrous colloidal silica (Aerosil 200), sodium stearate fumarate (Pruv); coating: opadry 20A28569 (hypromellose, talc).

Description of the appearance of ACIDO ALENDRONICO ALTER and pack contents
ACIDO ALENDRONICO ALTER is available as white, round, film-coated tablets.
The tablets are supplied in Al-PVC/PVDC blisters packed in cartons containing the following quantities: 2, 4, 8, 12 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
LABORATORI ALTER S.r.l. – Via Egadi, 7 – 20144 Milan – Italy.
Manufacturer
LABORATORIOS ALTER, S.A. C/ Mateo Inurria, 30 28036 Madrid – Spain