Loss

Package leaflet: Information for the patient

LOSS 70 mg film-coated tablets

alendronic acid
Generic medicine
Read this entire leaflet carefully before taking this medicine, as it contains important information for you.

• 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 only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• It is particularly important to understand the information contained in section 3 before taking this medicine.

Contents of this leaflet:

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

1. What LOSS is and what it is used for

LOSS is a tablet containing the active substance alendronic acid (commonly known as alendronate) and belongs to a group of non-hormonal medicines called bisphosphonates. LOSS 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 LOSS used for?
Your doctor has prescribed LOSS for the treatment of osteoporosis. It reduces the risk of vertebral and hip fractures.
LOSS 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, the 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 the early stages, osteoporosis usually causes no symptoms. However, if left untreated, fractures may occur. Although fractures are usually 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 with minor trauma that would not cause fractures in normal bone. Fractures typically 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 treatment. LOSS not only prevents loss of bone tissue but also helps rebuild bone that may have been lost and reduces the risk of vertebral and hip fractures.

Along with treatment with LOSS, 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 programme.
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 LOSS

Do not take LOSS:

• if you are allergic to alendronic acid 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 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 think any of these apply to you, do not take the tablets. Consult your doctor and follow their advice.

Warnings and precautions

Talk to your doctor or pharmacist before taking LOSS 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 problem in mineral absorption in the stomach or intestine (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 tooth 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 LOSS.
It is important to maintain good oral hygiene during treatment with LOSS. You should have regular dental check-ups throughout your treatment and contact your doctor or dentist if you experience any problems with your mouth or teeth, such as tooth loss, pain, or swelling.

Jaw problems (affecting the jawbone or mandible) may occur during alendronate use, usually in patients with cancer, often following dental extractions and/or local infections. Many of these patients were also receiving chemotherapy and corticosteroids.

Irritation, inflammation, or ulceration of the oesophagus (the tube connecting the mouth to the stomach) may occur, often with symptoms such as chest pain, heartburn, or difficulty or pain when swallowing, especially if patients do not drink a full glass of water and/or lie down within the first 30 minutes after taking LOSS. These side effects may worsen if patients continue taking LOSS after experiencing such symptoms.

If you notice any of the side effects described above, stop taking the medicine and consult your doctor.

In patients taking alendronate for long 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, inform your doctor promptly, as this may be an early sign of a possible femoral fracture. Your doctor will decide whether it is necessary to discontinue treatment with LOSS.

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, which in rare instances were severe and disabling. The onset of symptoms varied from one day to several months after starting treatment. In most patients, symptoms improved after stopping the treatment.

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

LOSS must not be given to children or adolescents under 18 years of age.

Other medicines and LOSS

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

Calcium supplements, antacids, and certain oral medicines may interfere with the absorption of LOSS if taken at the same time. Therefore, it is important to follow the instructions provided in section 3.

Some medicines used for rheumatism or long-term pain, called NSAIDs (e.g. acetylsalicylic acid or ibuprofen), may cause digestive problems. Therefore, caution should be exercised when taking these medicines together with LOSS.

LOSS with food and drink

Food and drinks (including mineral water) may reduce the effectiveness of LOSS if taken at the same time. It is therefore important to follow the instructions given in section 3.

Pregnancy and breastfeeding

LOSS is indicated only for postmenopausal women. Do not take LOSS if you are pregnant or suspect you may be pregnant, or if you are breastfeeding.

Driving and using machines

Undesirable effects have been reported with LOSS (e.g. blurred vision, dizziness, and severe bone, muscle, or joint pain) that may impair your ability to drive or operate machinery (see section 4).

LOSS contains sodium

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

3. How to take LOSS

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take one tablet of LOSS once a week.
Follow the instructions below carefully:

1. Choose the day of the week that best fits your routine. Take one tablet of LOSS once a week on the chosen day.
   It is very important that you follow steps 2), 3), 4), and 5) to help the LOSS tablet reach your stomach quickly and help reduce the risk of irritating your oesophagus (the tube connecting your mouth to your stomach).
2. After getting up from bed to start the day, and before taking any food, drink, or other medicines, swallow the LOSS tablet whole with a full glass of tap water only (not mineral water), (at least 200 ml), so that LOSS is adequately absorbed.

• Do not take with mineral water (still or sparkling).
• Do not take with coffee or tea.
• Do not take with fruit juices or milk.

Do not crush, chew, or allow the tablet to dissolve in the mouth, as this may cause ulcers in the mouth.
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 LOSS 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 LOSS and contact your doctor.
6) After swallowing the LOSS tablet, wait at least 30 minutes before eating, drinking, or taking any other medicines of the day, including antacids, calcium supplements, and vitamins. LOSS is effective only when taken on an empty stomach.

If you take more LOSS 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 LOSS
If you forget to take the tablet, simply take one tablet of LOSS the following morning. Do not take two tablets on the same day. After that, resume taking the tablet on your chosen day of the week.

If you stop taking LOSS
It is important to continue taking LOSS for as long as prescribed by your doctor. Since it is not known how long you should continue treatment, you should periodically check with your doctor whether you should continue therapy with this medicine to determine if LOSS is still the appropriate treatment 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 can 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 jaw/mandible pain, swelling or ulcers inside the mouth, numbness or a sensation of heaviness in the jaw/mandible, or tooth loss. These may 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 femoral fracture may occur, particularly in patients who have been treated for a long time 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 femoral fracture,
• severe bone, muscle and/or joint pain.

Not known (frequency cannot be estimated from the available data):

• unusual fractures occurring at sites other than the femur.

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; intestinal gas,
• 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; skin redness,
• flu-like symptoms, transient in nature, 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 events could be signs of bone damage in the ear.

Reporting of side effects
If you experience 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: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store LOSS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister 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 LOSS contains
The active substance is sodium alendronate trihydrate.
Each tablet contains the equivalent of 70 mg alendronic acid as sodium alendronate trihydrate.
Excipients
Core: microcrystalline cellulose, croscarmellose sodium, anhydrous colloidal silicon dioxide, sodium stearyl fumarate;
Coating: hypromellose, talc.
Description of the appearance of LOSS and the contents of the pack
Film-coated tablets: pack containing 4 or 12 tablets.
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder
So.Se.PHARM S.r.l. - Via dei castelli Romani, 22 – 00071 Pomezia (RM) - Italy
Manufacturer
Special Product’s Line S.p.A
Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR) - Italy