Alendronate acid FG

Package leaflet: Information for the patient

Alendronic Acid FG 70 mg tablets

Alendronic acid as sodium alendronate trihydrate
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, ask 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 effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Acido Alendronico FG is and what it is used for

What Acido Alendronico FG is
Acido Alendronico FG is a tablet containing the active substance acidum alendronicum (commonly known as alendronate) and belongs to a group of non-hormonal medicines called bisphosphonates. Acido Alendronico FG prevents bone tissue loss that occurs in women after menopause and promotes bone rebuilding. It reduces the risk of vertebral and hip fractures.

What Acido Alendronico FG is used for
Your doctor has prescribed Acido Alendronico FG for the treatment of osteoporosis. Acido Alendronico FG reduces the risk of vertebral and hip fractures.
Acido Alendronico FG 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 healthy skeleton. 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, vertebral fractures may go unnoticed until they result in a decrease in 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 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?
Along with treatment with Acido Alendronico FG, your doctor may suggest 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
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 should know before taking Alendronic Acid FG

Do not take Alendronic Acid FG:

• 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 situations 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 Alendronic Acid FG if:

• you have kidney problems
• you have or have recently had difficulty swallowing or gastrointestinal problems
• 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 told that you have a problem with mineral absorption in the stomach or intestine (malabsorption syndrome)
• you have been told that 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, and 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 Alendronic Acid FG.
It is important to maintain good oral hygiene during treatment with Alendronic Acid FG. 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 with symptoms such as chest pain, burning sensation 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 Alendronic Acid FG. These side effects may worsen if patients continue taking Alendronic Acid FG after experiencing such symptoms.

Children and adolescents

Alendronic Acid FG must not be given to children and adolescents under 18 years of age.

Other medicines and Alendronic Acid FG

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

Calcium supplements, antacids, and certain oral medicines are likely to interfere with the absorption of Alendronic Acid FG if taken at the same time.
Therefore, it is important to follow the instructions provided in section 3. How to take Alendronic Acid FG.

Some medicines used for rheumatism or long-term pain known as NSAIDs (e.g. acetylsalicylic acid or ibuprofen) may cause gastrointestinal problems. Therefore, caution should be exercised when these medicines are taken together with Alendronic Acid FG.

Alendronic Acid FG with food and drinks

Food and drinks (including mineral water) are likely to reduce the effectiveness of Alendronic Acid FG if taken at the same time. Therefore, it is important to follow the instructions provided in section 3. How to take Alendronic Acid FG.

Pregnancy and breastfeeding

If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Alendronic Acid FG is indicated only for postmenopausal women. Do not take Alendronic Acid FG if you are pregnant or suspect you may be pregnant, or if you are breastfeeding.

Driving and using machines

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

Alendronic Acid FG contains lactose and sodium

Lactose: If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

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

3. How to take Alendronic Acid FG

Take this medicine exactly as your doctor or pharmacist has told you.
If you are unsure, consult your doctor or pharmacist.
Take one Alendronic Acid FG tablet once a week.
Carefully follow the instructions below:

1. Choose the day of the week that best fits your routine. Take one tablet of Alendronic Acid FG once a week on your chosen day.
   It is very important that you follow steps 2), 3), 4), and 5) to help the Alendronic Acid FG tablet reach the stomach quickly and to help 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 medicines, swallow the Alendronic Acid FG tablet whole with a full glass of tap water only (not mineral water) (at least 200 mL), so that Alendronic Acid FG 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 mouth ulcers.
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 you have eaten something.
4) Do not take Alendronic Acid FG at bedtime or before getting up in the morning.
5) If you experience difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking Alendronic Acid FG and contact your doctor.
6) After swallowing the Alendronic Acid FG tablet, wait at least 30 minutes before eating, drinking, or taking any other medicines, including antacids, calcium supplements, and vitamins. Alendronic Acid FG is effective only when taken on an empty stomach.

If you take more Alendronic Acid FG 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 Alendronic Acid FG
If you forget to take your tablet, simply take one tablet of Alendronic Acid FG 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 taking Alendronic Acid FG
It is important to continue taking Alendronic Acid FG for as long as prescribed by your doctor. Since it is not known how long you should take Alendronic Acid FG, you should periodically check with your doctor whether continuing treatment is still appropriate for you.

A patient instruction card is included in the Alendronic Acid FG package. It contains important information reminding you how to take Alendronic Acid FG correctly.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
See a doctor immediately if you experience 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 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.
• uncommonly, 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 may be an early sign of a possible femoral fracture.

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, 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, transient, such as muscle aches, general malaise, and sometimes fever, usually at the beginning of treatment,
• taste disturbance.

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 effect, 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Alendronic Acid FG

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 packaging after Exp. The expiry date refers to the last day of that month.
Store below 25°C. Do not remove the tablets from the blister pack before the time of taking.
Do not use this medicine if you notice any visible signs of deterioration.
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. Contents of the pack and other information

What Acido Alendronico FG contains

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

Description of the appearance of Acido Alendronico FG and pack sizes
Packs containing 4 and 12 oval tablets, white to off-white in aluminium blisters.
Marketing Authorization Holder
FG S.r.l. - Via San Rocco, 6 – 85033 Episcopia (PZ)
Manufacturer
Doppel Farmaceutici S.r.l. – Via Volturno, 48 – 20089 Quinto De’ Stampi (Rozzano – MI)
Vamfarma S.r.l. - Via Kennedy, 5 - 26833 – Comazzo (LO)