ACIDO 70 mg /2800 Iu Coated Tablet

Зміст інструкції

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

Equivalent 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 give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any undesirable effect occurs, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• It is very important to understand the information contained in section 3. How to take Acido alendronico e colecalciferolo EG, before taking this medicine.

Contents of this leaflet

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

1. What is Acido alendronico e colecalciferolo EG and what is it used for

What is Acido alendronico e colecalciferolo EG?
Acido alendronico e colecalciferolo EG is a tablet that contains two active ingredients, alendronic acid (commonly
called alendronate) and colecalciferol, known as vitamin D.

What is alendronate?
Alendronate belongs to a group of non-hormonal medicines called bisphosphonates.
Alendronate prevents the loss of bone tissue that occurs in women after menopause
and promotes bone rebuilding. Alendronate reduces the risk of vertebral and hip fractures.

What is vitamin D?
Vitamin D is an essential nutrient, necessary for calcium absorption and
bone health. The body can only absorb calcium adequately from food if it has
enough
vitamin D. Very few foods contain vitamin D. The main source of
vitamin D is in summer through exposure to sunlight, which produces vitamin D
in the
skin. As you age, your skin produces less vitamin D. Too low levels of vitamin D
can cause loss of bone tissue and osteoporosis. A severe deficiency of vitamin D
can cause muscle weakness that can lead to falls and an increased risk of
fractures.

What is Acido alendronico e colecalciferolo EG used for?
Your doctor has prescribed Acido alendronico e colecalciferolo EG for the treatment
of osteoporosis and to reduce the risk of vitamin D deficiency. Acido alendronico e
colecalciferolo EG reduces the risk of vertebral and
hip fractures in women after menopause.

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, bone fractures can occur. Even though fractures are usually
painful, fractures of the vertebrae may not be felt until they result in a decrease in height. Bone fractures can occur during
daily activities, such as lifting weights, or with minor trauma that would not normally be able to
cause fractures in normal bone. Fractures usually occur in the hip, in the
spine or in the wrist and can be not only painful but can lead to significant
problems, such as curvature of the spine (hunchback) and loss of mobility.

How can osteoporosis be treated?
Along with treatment with Acido alendronico e colecalciferolo EG, 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 bone fractures.

Exerciseas muscles do, 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.

2. What you need to know before taking Acido

alendronico e colecalciferolo EG
Do not take Acido alendronico e colecalciferolo EG

• if you are allergic to alendronic acid, cholecalciferol or any of the other ingredients of this medicine (listed in section 6),
• if you have certain problems with your esophagus (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 given instructions.

Warnings and precautions
Talk to your doctor or pharmacist before taking Acido alendronico e colecalciferolo EG 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 lining the lower part of your esophagus),
• your doctor has told you that you have a problem with the absorption of minerals in your stomach or intestines (malabsorption syndrome),
• you have poor dental health, gingivitis, are planning to have a tooth extracted, 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),
• you are taking corticosteroids (such as prednisone or dexamethasone),
• 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
Acido alendronico e colecalciferolo EG.
It is important to maintain good oral hygiene during treatment with Acido
alendronico e colecalciferolo EG. You should have regular dental check-ups during the
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 connecting the
mouth to the stomach) may occur, often with symptoms of chest pain, burning in the upper stomach,
difficulty or pain when swallowing, especially if patients do not drink a full glass of tap water
and/or lie down within the first 30 minutes after taking Acido alendronico e colecalciferolo EG.
These undesirable effects may worsen if patients continue to take Acido alendronico e colecalciferolo EG
after experiencing these symptoms.

Children and adolescents
Acido alendronico e colecalciferolo EG should not be given to children and adolescents under the age of
18 years.

Other medicines andAcido alendronico e colecalciferolo EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Calcium supplements, antacids and some medicines taken orally are likely to interfere with the absorption of
Acido alendronico e colecalciferolo EG if taken at the same time.
It is therefore important to follow the instructions given in section 3 “How to take Acido alendronico e
colecalciferolo EG” and wait at least 30 minutes before taking any other supplement or
medicine taken orally.
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 Acido alendronico e
colecalciferolo EG.
Some medicines or food additives may prevent the vitamin D contained in
Acido alendronico e colecalciferolo EG from entering the body, including artificial fat substitutes, mineral oils, weight loss medicines, orlistat, and cholesterol-lowering medicines,
cholestyramine and colestipol. Medicines for seizures (epilepsy) (such as phenytoin or
phenobarbital) may decrease the effectiveness of vitamin D.
The addition of other vitamin D supplements may be considered on an individual basis.

Acido alendronico e colecalciferolo EG with food and drink
Food and beverages (including mineral water), if taken at the same time, are likely to
decrease the effectiveness of Acido alendronico e colecalciferolo EG. Therefore, it is important to follow the instructions given in
section 3 “How to take Acido alendronico e colecalciferolo EG”. You should wait at least
30 minutes before taking any food and drink, except for tap water.

Pregnancy and breastfeeding
Acido alendronico e colecalciferolo EG is only indicated for women after menopause.
Do not take Acido alendronico e colecalciferolo EG if you are
pregnant or suspect you might be pregnant, or if you are breastfeeding.

Driving and using machines
Adverse effects (e.g.
blurred vision, dizziness and severe bone, muscle or joint pain) have been reported with Acido alendronico e colecalciferolo EG that may
interfere with the ability to drive or operate machines (see Possible side effects). If you experience any of these adverse effects, do not drive until
your condition has improved.

Acido alendronico e colecalciferolo EG contains lactose and sucrose.
If you have been diagnosed with an intolerance to certain sugars, contact your doctor before taking
this medicine.

3. How to take Acido alendronico e colecalciferolo EG

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

Take one tablet of Acido alendronico e colecalciferolo EG once a week.
Follow the instructions below carefully:

• 1) Choose the day of the week that best suits your activities. Take one tablet of Acido alendronico e colecalciferolo EG once a week on the chosen day.

It is very important that you follow instructions 2), 3), 4) and 5) to facilitate the quick entry of the
tablet of Acido alendronico e colecalciferolo EG into the stomach and help reduce the
possibility of irritating the esophagus (the tube 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 whole tablet of Acido alendronico e colecalciferolo EG with a full glass of tap water (not mineral water) (not less than 200 ml), so that Acido alendronico e colecalciferolo EG 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 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) Acido alendronico e colecalciferolo EG should not be taken at bedtime or before getting out of bed in the morning.
• 5) If you experience difficulty or pain when swallowing, chest pain, or heartburn occurs or worsens, stop taking Acido alendronico e colecalciferolo EG and contact your doctor.
• 6) After swallowing the tablet of Acido alendronico e colecalciferolo EG, wait at least 30 minutes before eating, drinking or taking other medicines of the day, including antacids, calcium supplements and vitamins. Acido alendronico e colecalciferolo EG is effective only when taken on an empty stomach.

If you take more Acido alendronico e colecalciferolo EG 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 Acido alendronico e colecalciferolo EG
If you forget to take the tablet, simply take one tablet of Acido alendronico e
colecalciferolo EG 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 Acido alendronico e colecalciferolo EG
It is important that you take Acido alendronico e colecalciferolo EG until prescribed by
your doctor. Since it is not known how long you should take Acido alendronico e
colecalciferolo EG, you should periodically check with your doctor the need to continue therapy
with this medicine to establish whether the use of Acido alendronico e colecalciferolo EG is
still correct for you.
A package leaflet is included in the box of Acido alendronico e colecalciferolo EG.
It contains important information that reminds you how to take Acido alendronico e
colecalciferolo EG 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.

Go to your doctor immediately if you notice any of the following side effects, which may be serious and for which you might need urgent medical treatment:
Common (may affect up to 1 in 10 people):

• burning in the upper stomach; difficulty swallowing; pain when swallowing; ulcers of the esophagus (the tube connecting the mouth to the stomach) which can cause chest pain, burning in the upper stomach 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, 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 loss of a tooth. 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 a 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 it 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 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, general feeling of unwellness and sometimes with fever usually at the beginning of treatment,
• altered taste.

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 Acido alendronico e colecalciferolo EG

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 blister and the package after
EXP. The expiry date refers to the last day of that month.
Store in the original blister to protect the medicine from moisture and light.
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