ALENDRONATO 70 mg Coated Tablet

Зміст інструкції

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

ALENDRONATO PHARMACARE

70mg tablets
alendronic acid
Generic medicine

Read this 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 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 contained in section 3 before taking this medicine.

Contents of this leaflet:

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

1. What is Alendronato Pharmacare and what is it used for

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

Alendronato Pharmacare 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 Alendronato Pharmacare, 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, may 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 on the possible
need to take food supplements (especially calcium
and vitamin D).

2. What you need to know before taking Alendronato Pharmacare

DO NOT take Alendronato Pharmacare

• if you are allergic to alendronic acid or any of the other ingredients of this medicine (listed in section 6);
• if you have problems with your esophagus (the tube that connects your mouth to your stomach) or other factors that delay the emptying of the esophagus, such as a severe narrowing of the esophagus or failure of the esophageal muscles to relax (achalasia);
• if you cannot stand or sit upright for at least 30 minutes;
• if you have low levels of calcium in your blood (hypocalcemia).

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 Alendronato Pharmacare:

• if you have kidney problems;
• if you have or have recently had difficulty swallowing or problems with your digestive system;
• if your doctor has told you that you have Barrett's esophagus (a disease associated with changes in the cells lining the lower part of the esophagus);
• if you have been told you have a problem with the absorption of minerals in the stomach or intestine (malabsorption syndrome);
• if you have been told you have low levels of calcium in your blood;
• if you have poor dental health, gum disease, are planning to have a tooth extracted, or do not have regular dental check-ups;
• if you have cancer;
• if you are undergoing chemotherapy or radiotherapy;
• if you are taking angiogenesis inhibitors (such as bevacizumab or thalidomide) which are used in the treatment of cancer;
• if 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;
• if you smoke 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 Alendronato Pharmacare.
During treatment with Alendronato Pharmacare it is important to maintain good
oral hygiene and you should have regular dental check-ups throughout the
treatment and contact your doctor or dentist if you notice any problems with your mouth or
teeth such as tooth mobility, pain or swelling.
Esophageal irritation, inflammation or ulceration (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 within 30 minutes of taking
Alendronato Pharmacare. These side effects may worsen if patients
continue to take Alendronato Pharmacare after experiencing these symptoms.

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

Other medicines and Alendronato Pharmacare
Tell your doctor or pharmacist if you are taking, have recently taken or
may take any other medicines.
Calcium supplements, antacids and some oral medicines are likely to interfere
with the absorption of Alendronato Pharmacare 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 Alendronato
Pharmacare.

Alendronato Pharmacare with food and drink
Food and beverages (including mineral water) are likely to reduce the effectiveness of
Alendronato Pharmacare if taken at the same time. It is therefore important to follow the
instructions given in section 3.

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

Driving and using machines
Alendronato Pharmacare may cause side effects such as dizziness, vertigo, blurred vision, bone, muscle or joint pain. Consequently, the ability to react may
be impaired and the ability to drive vehicles and operate machinery may be
compromised (see section 4).

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

Alendronato Pharmacare contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is
essentially ‘sodium-free’.

3. How to take Alendronato Pharmacare

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

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

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

It is very important that you strictly follow the following instructions 2), 3), 4) and 5) to

facilitate the quick passage of the Alendronato Pharmacare tablet 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 or drink or other medicine, swallow the Alendronato Pharmacare tablet with a full glass of only tap water (not mineral water), (not less than 200 ml); so that Alendronato Pharmacare 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. Due to the risk of ulcers in the mouth and throat, the tablet should not be broken, chewed or dissolved in the mouth.
• 3) Do not lie down – keep your torso upright (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 the Alendronato Pharmacare tablet at bedtime or before getting up.
• 5) If difficulty or pain when swallowing, chest pain occurs, or heartburn in the upper stomach appears or worsens, stop taking Alendronato Pharmacare and contact your doctor.
• 6) After swallowing the Alendronato Pharmacare tablet, wait 30 minutes before eating, drinking or taking other medicines of the day, including antacids, calcium supplements and vitamins. Alendronato Pharmacare is only effective when taken on an empty stomach.

If you take more Alendronato Pharmacare than you should
If you have taken more tablets than you should, 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 Alendronato Pharmacare
If you forget to take a tablet at the right time, take it the next morning.
Start taking a tablet as originally scheduled on the day of the week
chosen. Do not take a double dose if you have forgotten to take the previous dose for
a week or more.

If you stop taking Alendronato Pharmacare
It is important that you take Alendronato Pharmacare for as long as prescribed by your doctor. Since
it is not known how long you should take Alendronato Pharmacare, you should
periodically check with your doctor about the need to remain on therapy with this
medicine to determine if Alendronato Pharmacare is still the right therapy for you.
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.

Go to your doctor immediatelyif you notice any of the following side effects, which may be serious, and for which you may need urgent medical treatment:

• heartburn; difficulty swallowing; pain when swallowing; ulcers of the esophagus (the channel 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 people):

• allergic reactions such as hives, swelling of the face, lips, tongue and/or throat, possible cause of 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 could 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 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 may 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, sometimes severe.

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

• headache, dizziness;
• abdominal pain, discomfort in the stomach or belching after meals; constipation; feeling of fullness or bloating in the stomach; diarrhea, intestinal gas;
• hair loss, itchy skin;
• swelling of the joints;
• feeling of weakness, swelling of arms and legs (edema).

Uncommon (may affect up to 1 in 100 people):

• changes in the sense of taste;
• blurred vision; pain or redness of the eyes);
• nausea, vomiting;
• inflammation of the lining of the stomach, inflammation of the esophagus (the channel connecting the mouth to the stomach);
• black stools and/or stools containing traces of blood;
• skin rash, redness of the skin;
• transient flu-like symptoms (muscle pain, feeling unwell and, rarely, fever) generally at the beginning of treatment.

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

• hypersensitivity reactions (including hives and swelling of face, lips, tongue and/or throat);
• low levels of calcium in the blood with symptoms such as cramps or muscle spasms, tingling in the fingers or around the mouth;
• narrowing of the esophagus (the channel connecting the mouth to the stomach);
• peptic or stomach ulcers (sometimes severe or with bleeding);
• skin rash with sensitivity to sunlight.

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

• Contact 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:
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 Alendronato Pharmacare

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 outer packaging and on the
blister after “EXP”. The expiry date refers to the last day of that month.
Do not store at a temperature above 25 °C.
Store in the original package to protect it from moisture.
Do not dispose of any medicine in wastewater. 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 Alendronato Pharmacare contains

• The active ingredient is alendronic acid. Each tablet contains 70 mg of alendronic acid (as alendronate sodium trihydrate).
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, magnesium stearate (Ph.Eur.).

Description of the appearance of Alendronato Pharmacare and contents of the pack
Alendronato Pharmacare is a white to off-white tablet.
Alendronato Pharmacare is available in packs of 2, 4, 8, 12 and 40 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Pharmacare Srl
Via Marghera 29
20149 Milano
Italy

Manufacturer
Lachifarma S.R.L. Laboratorio Chimico Farmaceutico Salentino – SS16 Zona Industriale -

• 73010 - Zollino (LE) (Italy)

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

This leaflet was last updated on