GENALEN 10 mg Tablet

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1. GENALEN 70 mg tablets
   1. What is GENALEN and what is it used for
   2. What you need to know before taking GENALEN
   3. How to take GENALEN
   4. Possible side effects
   5. How to store and GENALEN
   6. Contents of the pack and other information

GENALEN 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 they have the same symptoms as you, as it may 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 GENALEN is and what it is used for
• 2. What you need to know before you take GENALEN
• 3. How to take GENALEN
• 4. Possible side effects
• 5. How to store GENALEN
• 6. Contents of the pack and other information

1. What is GENALEN and what is it used for

What is GENALEN?
GENALEN is a tablet containing the active ingredient alendronic acid (commonly called
alendronate) and belongs to a group of non-hormonal medicines called bisphosphonates.
GENALEN 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 GENALEN used for?
Your doctor has prescribed GENALEN for the treatment of osteoporosis. It reduces the risk of vertebral and hip
fractures.

GENALEN is a treatment that must be taken 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. Even though 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 usually 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 GENALEN, your doctor may suggest changing your lifestyle to
improve the condition 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 can provide information on diet or the possible need to
take dietary supplements (especially calcium and vitamin D).

2. What you need to know before taking GENALEN

Do not take GENALEN:

• if you are allergic to alendronic acid or any of the other ingredients of this medicine (listed in section 6);
• if you have certain 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 GENALEN if:

• you have 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,
• 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 dental check-ups,
• you have cancer,
• you are having 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 to treat certain conditions (for example 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
GENALEN.
It is important to maintain good oral hygiene during treatment with
GENALEN. You should have regular dental check-ups during treatment and should
contact your doctor or dentist if you experience any problems 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, heartburn, 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 GENALEN. These undesirable effects
may worsen if patients continue to take GENALEN after experiencing these
symptoms.

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

Other medicines and GENALEN
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 GENALEN 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 used
when these medicines are taken at the same time as GENALEN.

GENALEN withfoods and drinks
Foods and beverages (including mineral water) are likely to decrease the effectiveness of
GENALEN if taken at the same time. It is therefore important to follow the instructions given in
section 3.

Pregnancy and breastfeeding
GENALEN is only indicated for women after menopause. Do not take GENALEN if you are pregnant or
suspect you may be pregnant or if you are breastfeeding.

Driving and using machines
Adverse effects (for example blurred vision, dizziness and
severe bone, muscle or joint pain) have been reported with GENALEN that may interfere with the ability to drive vehicles
or operate machines. Individual responses to GENALEN may vary (see
section 4).

GENALEN contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking
this medicine.

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

3. How to take GENALEN

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

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

• 1) Choose a day of the week that best suits your activities. Take one GENALEN tablet once a week on the chosen day. It is very important that you follow instructions 2), 3), 4) and 5) to facilitate the fast entry of theGENALENtabletinto the stomach and help reduce the possibility of irritating the esophagus (thechannel that connects 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 GENALEN tablet whole with a glass full of only tap water (not mineral water), (not less than 200 mL), so that GENALEN 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 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 GENALEN at bedtime or before getting out of bed in the morning.
• 5) If difficulty or pain occurs when swallowing, chest pain occurs, or heartburn in the upper stomach appears or worsens, stop taking GENALEN and contact your doctor.
• 6) After swallowing the GENALEN tablet, wait at least 30 minutes before eating, drinking or taking other medicines of the day, including antacids, calcium supplements and vitamins. GENALEN is effective only when taken on an empty stomach.

If you take more than GENALEN than you should
If you accidentally take too many tablets, drink a glass full of milk and contact your
doctor immediately. Do not induce vomiting and do not lie down.

If you forget to take GENALEN
If you forget to take the tablet, just take one GENALEN tablet the
next morning. DO NOT take two tablets on the same day.Afterwards, start
taking the tablet again on the chosen day of the week.

If you stop taking GENALEN
It is important that you take GENALEN until prescribed by your doctor. Since
you do not know how long you should take GENALEN, you should periodically check with
your doctor the need to remain on therapy with this medicine to determine if
GENALEN is still the right therapy for you.
A package leaflet is included in the GENALEN box. It contains important
information that reminds you how to take GENALEN 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.

See your doctor immediatelyif you notice any of the following side effects, which may
be serious and may require urgent medical treatment:
Common (may affect up to 1 in 10 people):

• heartburn; difficulty swallowing; pain when swallowing; ulcers of the esophagus (the tube connecting 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 loss of a tooth. These could be signs of bone damage in the jaw/mandible (osteonecrosis) generally associated with delayed healing and infection, often following dental extraction. Contact your doctor and dentist if you experience such symptoms,
• rarely, an unusual fracture of the femur can 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 could be an early indication of a possible femur fracture,
• bone, muscle and/or joint pain that is severe.

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 connecting the mouth to the stomach) or the 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, feeling unwell and sometimes with fever, usually at the beginning 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 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):

• 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. This includes any possible side effects not listed
in this leaflet. 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 and GENALEN

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
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 any medicine in 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 the medicine containsGENALEN
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),
sodium croscarmellose and magnesium stearate (E572) (See section 2. “GENALEN contains
lactose”).

Description of the appearance of GENALEN and contents of the pack
GENALEN tablets are available as white, oval-shaped tablets, with the outline of a bone image imprinted
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
NEOPHARMED GENTILI S.p.A.
Via San Giuseppe Cottolengo, 15 – 20143 Milano
Manufacturer
DOPPEL Farmaceutici S.r.l
Via Volturno, 48
Quinto De’ Stampi

• 20089 – Rozzano (MI)

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Italy GENALEN 70 mg tablets