Fosamax

PACKAGE LEAFLET

Package leaflet: information for the patient

FOSAMAX 70 mg tablets

alendronic acid
Please 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 adverse reactions, 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 FOSAMAX is and what it is used for
2. What you need to know before taking FOSAMAX
3. How to take FOSAMAX
4. Possible side effects
5. How to store FOSAMAX
6. Package contents and other information

1. What FOSAMAX is and what it is used for

What is FOSAMAX?
FOSAMAX is a tablet containing the active substance alendronic acid (commonly referred to as alendronate) and belongs to a group of non-hormonal medicines called bisphosphonates. FOSAMAX 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 FOSAMAX used for?
Your doctor has prescribed FOSAMAX for the treatment of osteoporosis. It reduces the risk of vertebral and hip fractures.
FOSAMAX 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 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 from 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 (kyphosis) and limitations in movement.
How can osteoporosis be treated?
Along with treatment with FOSAMAX, your doctor may recommend lifestyle changes to improve the condition, such as:
Stop 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 to take dietary supplements (especially calcium and vitamin D).

2. What you need to know before taking FOSAMAX

Do not take FOSAMAX

• if you are allergic to alendronate 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 the advice given.

Warnings and precautions

Talk to your doctor or pharmacist before taking FOSAMAX 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 have regular dental check-ups,
• you have cancer,
• you are undergoing chemotherapy or radiotherapy,
• you are taking angiogenesis inhibitors (such as bevacizumab or thalidomide) used in the treatment of cancer,
• you are taking corticosteroids (such as prednisone or dexamethasone) used to treat conditions such as 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 FOSAMAX.
It is important to maintain good oral hygiene during treatment with FOSAMAX. You should have regular dental check-ups throughout 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 in the upper stomach, 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 FOSAMAX. These side effects may worsen if patients continue taking FOSAMAX after experiencing such symptoms.

Children and adolescents
FOSAMAX must not be given to children and adolescents under 18 years of age.

Other medicines and FOSAMAX
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 may interfere with the absorption of FOSAMAX if taken at the same time. It is therefore important to follow the instructions given in section 3.
Some medicines used for rheumatic conditions or long-term pain, called NSAIDs (e.g. acetylsalicylic acid or ibuprofen), may cause digestive problems. Therefore, caution should be used when taking these medicines together with FOSAMAX.

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

Pregnancy and breastfeeding
FOSAMAX is indicated only for postmenopausal women. Do not take FOSAMAX 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 FOSAMAX (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).

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

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

3. How to take FOSAMAX

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, please consult your doctor or pharmacist.
Take one FOSAMAX tablet once a week.
Follow carefully the instructions below:

1. Choose the day of the week that best fits your routine. Take one FOSAMAX tablet once a week on the chosen day.
   It is very important that you follow steps 2), 3), 4), and 5) to help the FOSAMAX tablet pass quickly into the stomach and help reduce the possibility of irritating the oesophagus (the tube connecting the mouth to the stomach).
2. After getting up and before eating any food, drinking any beverage, or taking any other medicine, swallow the FOSAMAX tablet whole with a full glass of plain tap water (not mineral water) (at least 200 mL), to ensure adequate absorption of FOSAMAX.

• Do not take with mineral water (still or sparkling).
• Do not take with coffee or tea.
• Do not take with juice 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 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 FOSAMAX at bedtime or before getting up in the morning.
5) If you develop difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking FOSAMAX and contact your doctor.
6) After swallowing the FOSAMAX tablet, wait at least 30 minutes before eating, drinking, or taking any other medicines, including antacids, calcium supplements, and vitamins.
FOSAMAX is effective only when taken on an empty stomach.

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

If you stop taking FOSAMAX
It is important that you continue taking FOSAMAX for as long as prescribed by your doctor. Since it is not known how long you should continue treatment, you should periodically consult your doctor to assess whether continued therapy with this medicine is still appropriate for you.

A patient instruction card is included in the FOSAMAX package. It contains important information reminding you how to take FOSAMAX correctly.

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 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; esophageal 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 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,
• uncommonly, 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.

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, which is sometimes severe.

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

• joint swelling,
• abdominal pain; stomach discomfort or burping 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; 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 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: 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 FOSAMAX

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 FOSAMAX contains
The active substance is alendronic acid. Each tablet contains 70 mg of alendronic acid (as sodium trihydrate).
The other components are microcrystalline cellulose (E460), anhydrous lactose (see section 2), sodium croscarmellose, and magnesium stearate (E572).

Description of the appearance of FOSAMAX and package contents
FOSAMAX tablets are available as white, oval-shaped tablets with the outline of a bone engraved on one side and "31" on the other.
The tablets are supplied in aluminium blisters packed in boxes containing the following quantities: 2, 4, 8, 12, or 40 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Organon Italia S.r.l.
Piazza Carlo Magno 21 – 00162 Rome, Italy

Manufacturer
Merck Sharp & Dohme BV
Waarderweg 39 – 2031 BN Haarlem
The Netherlands

Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria: Fosamax einmal wöchentlich 70 mg Tabletten
Belgium: Fosamax 70 mg Hebdomadaire, comprimés
Denmark: Fosamax
France: Fosamax 70 mg, comprimé
Germany: FOSAMAX einmal wöchentlich 70 mg Tabletten
Greece: FOSAMAX 70 mg Μια φορά την εβδομάδα
Ireland: Fosamax Once Weekly 70 mg Tablets
Iceland: Fosamax vikutafla
Italy: FOSAMAX 70 mg compresse
Luxembourg: Fosamax 70 mg Hebdomadaire, comprimés
Norway: Fosamax
The Netherlands: Fosamax 70 mg één tablet per week
Portugal: Fosamax 70 mg
Spain: FOSAMAX Semanal 70 mg comprimidos
United Kingdom (Northern Ireland): FOSAMAX Once Weekly 70 mg Tablets