FOSAMAX 70 mg Coated Tablet

Зміст інструкції

1. FOSAMAX 70 mg tablets
   1. What is FOSAMAX and what is it 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. Contents of the pack and other information

FOSAMAX 70 mg tablets

alendronic acid
Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• It is particularly important to understand the information in section 3 before you take this medicine.

Contents of this leaflet:

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

1. What is FOSAMAX and what is it used for

What is FOSAMAX?
FOSAMAX is a tablet containing the active ingredient alendronic acid (commonly called
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 reconstruction. 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 that you must take once a week.
What is osteoporosis?
Osteoporosis is a thinning and weakening of the bones. It is common in women after
menopause. During menopause, the ovaries stop producing female hormones, estrogens, which
help to keep a woman's skeleton healthy. 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 has no symptoms. However, if left untreated, fractures can occur. Although fractures are usually painful, fractures
of the bones of the spine may not be felt until they result in a
decrease in height. Fractures can occur during normal daily activities such as lifting
weights, or with minor trauma that would not be able to cause fractures in normal bone. Fractures typically occur in the hip, spine, or wrist and can be not only painful
but can lead to significant deformities and disability, such as curvature of the spine (hunchback) and limitations
in movement.

How can osteoporosis be treated?
Along with treatment with FOSAMAX, your doctor may suggest changing your lifestyle to improve the
conditions of the disease, such as:

Stop smokingSmoking appears to increase the rate at which bone tissue is lost and, therefore,
can increase the risk of fractures.

ExerciseLike muscles, bones need exercise to stay strong and healthy.
Consult your doctor before starting any exercise program.

Balanced dietYour doctor may provide information on diet or the possible need to
take food supplements (especially calcium and vitamin D).

2. What you need to know before taking FOSAMAX

Do not take FOSAMAX

• if you are allergic to alendronic acid or any of the other ingredients of this medicine (listed in section 6)
• if you have some problems with your esophagus (the tube that connects your mouth to your stomach), such as narrowing or difficulty swallowing
• if you cannot 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
instructions given.

Warnings and precautions
Talk to your doctor or pharmacist before taking FOSAMAX if:

• you suffer from kidney problems,
• you have, or have recently had, difficulty swallowing or problems with your digestive system,
• your doctor has told you that you have Barrett's esophagus (a disease associated with changes in the cells that line the inside of the lower esophagus),
• you have been told that you have a problem with the absorption of minerals in your stomach or intestines (malabsorption syndrome),
• you have been told that you have low levels of calcium in your blood,
• you have poor dental health, have gum disease, are planning to have a tooth extracted or do not have regular check-ups with your dentist,
• you have cancer,
• you are undergoing chemotherapy or radiotherapy,
• you are taking angiogenesis inhibitors (such as bevacizumab or thalidomide) which are used in the treatment of cancer,
• you are taking corticosteroids (such as prednisone or dexamethasone) which are used in the treatment of 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 asked to have a dental check-up 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 the treatment and you should contact your doctor or
dentist if you experience any type of problem with your mouth or teeth such as tooth loss, pain or swelling.
Irritation, inflammation or ulceration of the esophagus (the tube that connects the mouth to the
stomach) may occur, often with symptoms of chest pain, burning in the upper stomach, difficulty or pain
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 to take FOSAMAX after experiencing these symptoms.

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

Other medicines and FOSAMAX
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Calcium supplements, antacids and some oral medicines are likely to 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 for rheumatism or long-term pain called NSAIDs (e.g. acetylsalicylic acid or ibuprofen) may cause digestive problems. Therefore, caution should be exercised when
these medicines are taken at the same time as FOSAMAX.

FOSAMAX with food and drink
Food and beverages (including mineral water) are likely to decrease 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 only indicated for women after menopause. Do not take FOSAMAX if you are pregnant or
suspect you may be pregnant or if you are breastfeeding.

Driving and using machines
Side effects (such as blurred vision, dizziness and severe
bone, muscle or joint pain) have been reported with FOSAMAX that may affect your ability to drive or operate
machinery (see section 4).

FOSAMAXcontains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this
medicine.

FOSAMAXcontains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say it is essentially “sodium-free”.

3. How to take FOSAMAX

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.

Take one FOSAMAX tablet once a week.
Follow the instructions below carefully:

• 1) Choose the day of the week that best suits your activities. Take one FOSAMAX tablet once a week on the day you have chosen.

It is very important that you follow instructions 2), 3), 4), and 5) to facilitate the quick passage of the tablet

of FOSAMAX into the stomach and help reduce the possibility of irritating the esophagus (the channel that connects

the mouth to the stomach).

• 2) After getting out of bed to start the day, and before taking any food, drink or other medicine, swallow the FOSAMAX tablet whole with a full glass of only tap water (not mineral water), (not less than 200 mL), so that FOSAMAX is adequately absorbed.
• Do not take with mineral water (natural or sparkling).
• Do not take with coffee or tea.
• Do not take with juices or milk.

Do not crush or chew or let the tablet dissolve in your mouth due to the possible formation of
ulcers in the oral cavity.

• 3) Do not lie down – keep your torso in an upright position (while sitting, while standing or while 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 out of bed at the start of the day.
• 5) If difficulty or pain occurs when swallowing, chest pain occurs, or heartburn appears or worsens in the upper part of the stomach, stop taking FOSAMAX and contact your doctor.
• 6) After swallowing the FOSAMAX tablet, wait at least 30 minutes before eating, drinking or taking other medicines of the day, including antacids, calcium supplements and vitamins. FOSAMAX is only effective 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 the tablet, it is sufficient to take one FOSAMAX tablet the next morning.
Do not take two tablets on the same day.Afterwards, start taking the
tablet again on the day of the week you have chosen.

If you stop taking FOSAMAX
It is important that you take FOSAMAX until prescribed by your doctor. Since it is not known for
how long you should take FOSAMAX, you should periodically check with your doctor the need to
remain on therapy with this medicine to determine if FOSAMAX is still the right therapy for
you.
A leaflet with instructions for use is included in the FOSAMAX box. It contains important
information that reminds you how to take FOSAMAX correctly.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

See your doctor immediatelyif 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; ulcers of the esophagus (the tube that connects the mouth to the stomach) which can cause chest pain, heartburn or difficulty or pain when swallowing.

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

• allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing; severe skin reactions,
• pain in the mouth, and/or jaw/mandible, swelling or ulcers inside the mouth, numbness or a feeling of heaviness in the jaw/mandible or tooth loss. These may be signs of bone damage in the jaw/mandible (osteonecrosis) generally associated with delayed healing and infection, often after dental extraction. Contact your doctor and dentist if you experience these symptoms,
• rarely, an unusual fracture of the femur may occur, particularly in patients 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 indication of a possible femur fracture,
• bone, muscle and/or joint pain that is severe.

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

• unusual fracture in 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; discomfort in the stomach or belching after meals; constipation; feeling of fullness or bloating in the stomach; diarrhea, intestinal gas,
• hair loss; itching,
• headache; dizziness,
• fatigue; swelling of the hands or legs.

Uncommon (may affect up to 1 in 100):

• nausea; vomiting,
• irritation or inflammation of the esophagus (the tube that connects the mouth to the stomach) or stomach,
• black or tarry stools,
• blurred vision; pain or redness of the eyes,
• skin rash; skin redness,
• transient flu-like symptoms, such as muscle aches, general feeling of unwellness and sometimes with fever, usually at the start of treatment,
• taste disturbance.

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

• 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,
• peptic or stomach ulcers (sometimes severe or with bleeding),
• narrowing of the esophagus (the tube that connects the mouth to the stomach),
• skin rash worsened by exposure to sunlight,
• mouth ulcers.

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

• see your doctor if you experience ear pain, ear discharge and/or ear infection. These episodes may be signs of bone damage in the ear.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the package and on the blister after Expiry. The
expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 FOSAMAX contains
The active ingredient is alendronic acid. Each tablet contains 70 mg of alendronic acid (as sodium
trihydrate).
The other ingredients are microcrystalline cellulose (E460), anhydrous lactose (see section 2),
croscarmellose sodium and magnesium stearate (E572).

Description of the appearance of FOSAMAX and contents of the pack
FOSAMAX tablets are available as white, oval-shaped tablets with the outline of an
image of a bone embossed on one side and “31” on the other.
The tablets are supplied in aluminium blisters in cartons in the following pack sizes: 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 Roma

Manufacturer
Merck Sharp & Dohme BV
Waarderweg 39 – 2031 BN Haarlem
Netherlands
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

This medicinal product is authorised in the Member States of the European Economic Area and in the
United Kingdom (Northern Ireland)under the following denominations:
Austria Fosamax once weekly 70 mg Tablets
Belgium Fosamax 70 mg Hebdomadaire, tablets
Denmark Fosamax
France Fosamax 70 mg, tablet
Germany FOSAMAX once weekly 70 mg Tablets
Greece FOSAMAX 70 mg Μια φορά την εβδομάδα
Ireland Fosamax Once Weekly 70 mg Tablets
Iceland Fosamax weekly tablet
Italy FOSAMAX 70 mg tablets
Luxembourg Fosamax 70 mg Hebdomadaire, tablets
Norway Fosamax
Netherlands Fosamax 70 mg one tablet per week
Portugal Fosamax 70 mg
Spain FOSAMAX Semanal 70 mg tablets
United Kingdom (Northern Ireland) FOSAMAX Once Weekly 70 mg Tablets