ACIDO 70 mg Coated Tablet

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1. Alendronic acid and cholecalciferol Aurobindo 70 mg/2800 IU tablets, mg/5600 IU tablets
   1. What is Acido alendronico e colecalciferolo Aurobindo and what is it used for?
   2. What you need to know before taking Acido alendronico e colecalciferolo Aurobindo
   3. How to take Acido alendronico e colecalciferolo Aurobindo
   4. Possible side effects
   5. How to store Acido alendronico e colecalciferolo Aurobindo
   6. Package contents and other information

Alendronic acid and cholecalciferol Aurobindo 70 mg/2800 IU tablets, mg/5600 IU tablets

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 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 very important to read section 3 before taking this medicine.

Contents of this leaflet:

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

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

What is Acido alendronico e colecalciferolo Aurobindo?
Acido alendronico e colecalciferolo Aurobindo is a tablet that contains two active ingredients, alendronic acid (commonly called alendronate) and colecalciferol, known as vitamin D3.

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, required for calcium absorption and bone health. The body can only adequately absorb calcium from food if it has enough vitamin

• D. Foods containing vitamin D are very few. The main intake of vitamin D occurs in summer through exposure to sunlight, which produces vitamin D in the skin. With aging, the 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 isAcido alendronico e colecalciferolo Aurobindo used for?
Your doctor has prescribed Acido alendronico e colecalciferolo Aurobindo for the treatment of osteoporosis and to reduce the risk of vitamin D deficiency. It 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 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 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, spine, or wrist and can be not only painful but can lead to significant deformities and disability, such as, for example, curvature of the back (hunchback) and loss of mobility.

How can osteoporosis be treated?
Along with treatment with Acido alendronico e colecalciferolo Aurobindo, your doctor may suggest changing your lifestyle to improve your condition, 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 give you information about diet or the possible need to take dietary supplements.

2. What you need to know before taking Acido alendronico e colecalciferolo Aurobindo

Do not take Acido alendronico e colecalciferolo Aurobindo:

• 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 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 Acido alendronico e colecalciferolo Aurobindo
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 lower part of the esophagus),
• you have been told that you have a problem with the absorption of minerals in the stomach or intestine (malabsorption syndrome),
• 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 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
Acido alendronico e colecalciferolo Aurobindo.
It is important to maintain good oral hygiene during treatment with Acido
alendronico e colecalciferolo Aurobindo. 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 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 Aurobindo.
These side effects may worsen if patients continue to take Acido alendronico e
colecalciferolo Aurobindo after experiencing these symptoms.

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

Other medicines and Acido alendronico e colecalciferolo Aurobindo
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 by mouth
are likely to interfere with the absorption of Acido alendronico e colecalciferolo Aurobindo if taken at the same
time. It is therefore important to follow the instructions given in section 3 and wait at least 30 minutes
before taking any other medicine taken by mouth or supplements.
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
Aurobindo.
Some medicines or food additives may prevent the vitamin D contained in
Acido alendronico e colecalciferolo Aurobindo 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. Adding other vitamin D supplements may be considered on an individual basis.

Acido alendronico e colecalciferolo Aurobindo with food, drinks and alcohol
Food and drinks (including mineral water) are likely to decrease the effectiveness of Acido
alendronico e colecalciferolo Aurobindo if taken at the same time. It is therefore important to follow the
instructions given in section 3. You should wait at least 30 minutes before taking any food and
drinks except tap water.

Pregnancy, breastfeeding and fertility
Acido alendronico e colecalciferolo Aurobindo is only indicated for women after menopause. Do
not take Acido alendronico e colecalciferolo Aurobindo if you are pregnant or suspect you might be pregnant or if you are
breastfeeding.
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
Side effects (e.g.
blurred vision, dizziness and severe bone, muscle or joint pain) have been reported with Acido alendronico e colecalciferolo Aurobindo that may affect your ability to drive or operate machinery (see section 4). If you experience
any of these side effects, do not drive until you feel better.

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

3. How to take Acido alendronico e colecalciferolo Aurobindo

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

Take one tablet of Acido alendronico e colecalciferolo Aurobindo 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 Aurobindo once a week on the day chosen.

It is very important that you follow instructions 2), 3), 4) and 5) to facilitate rapid entry of the
tablet of Acido alendronico e colecalciferolo Aurobindo 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 Aurobindo with a full glass of tap water (not mineral water) (not less than 200 ml), so that Acido alendronico e colecalciferolo Aurobindo 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, chew or allow the tablet to 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 Aurobindo should not be taken when going to bed or before getting out of bed at the start of the day.

• 5) If you experience difficulty or pain when swallowing, chest pain, or heartburn appears or worsens, stop taking Acido alendronico e colecalciferolo Aurobindo and contact your doctor.
• 6) After swallowing the tablet of Acido alendronico e colecalciferolo Aurobindo, 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 Aurobindo is only effective when taken on an empty stomach.

If you take more Acido alendronico e colecalciferolo Aurobindo 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 Aurobindo
If you forget to take the tablet, take one tablet the morning after you remember it. Do not take two tablets on the same day. Start taking the tablet again on
the day of the week chosen as at the beginning.

If you stop taking Acido alendronico e colecalciferolo Aurobindo
It is important that you take Acido alendronico e colecalciferolo Aurobindo until prescribed by
your doctor. Because it is not known how long you will need to take Acido alendronico e colecalciferolo
Aurobindo, you should periodically check with your doctor about the need to continue therapy with
this medicine to determine if the use of Acido alendronico e colecalciferolo Aurobindo is still
appropriate for you.
A leaflet is included in the box of Acido alendronico e colecalciferolo Aurobindo with instructions for
use. It contains important information that reminds you how to take Acido alendronico e
colecalciferolo Aurobindo 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.

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:

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

• burning in the upper part of the stomach; difficulty swallowing; pain when swallowing; ulcers of the esophagus (the tube that connects the mouth to the stomach) which can cause chest pain, burning in the upper part of the stomach, or difficulty or pain when swallowing.

Rare(may affect up to 1 in 1000):

• allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, which can 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.

Other side effects include
Very common(may affect more than 1 in 10 people):

• bone, muscle and/or joint pain that 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 people):

• nausea; vomiting,
• irritation or inflammation of the esophagus (the tube that connects the mouth to the stomach) or the stomach,
• black or tarry stools,
• blurred vision; eye pain or redness,
• 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 1000):

• 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 a 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 Acido alendronico e colecalciferolo Aurobindo

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 box and on the blister after
EXP. The expiry date refers to the last day of that month.
Store in the original blister pack to protect the medicine from light and moisture.
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. Package contents and other information

What Acido alendronico e colecalciferolo Aurobindo contains

• The active ingredients are alendronic acid and cholecalciferol (vitamin D3).

Acido alendronico e colecalciferolo Aurobindo 70 mg/2800 IU tablets
Each tablet contains 70 mg of alendronic acid (as sodium trihydrate) and 70 micrograms
(2800 IU) of cholecalciferol (vitamin D3) (as concentrated cholecalciferol, in powder form).
Each tablet contains 90 mg of lactose (as anhydrous lactose) and 13.7 mg of sucrose.

Acido alendronico e colecalciferolo Aurobindo 70 mg/5600 IU tablets
Each tablet contains 70 mg of alendronic acid (as sodium trihydrate) and 140 micrograms
(5600 IU) of cholecalciferol (vitamin D3) (as concentrated cholecalciferol, in powder form).
Each tablet contains 64 mg of lactose (as anhydrous lactose) and 27.5 mg of sucrose.

• The other ingredients are: anhydrous lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, sunflower oil (refined), butylated hydroxytoluene (E321), gelatin (gelling grade), sucrose, corn starch, aluminium and magnesium silicate.

Description of the appearance of Acido alendronico e colecalciferolo Aurobindo and contents of the
pack
Tablet.

Acido alendronico e colecalciferolo Aurobindo 70 mg/2800 IU tablets
White to off-white, biconvex, oblong-shaped tablets, imprinted with “2800” on one side,
with a length of 12.3±0.2 mm and a width of 6.5±0.2 mm.

Acido alendronico e colecalciferolo Aurobindo 70 mg/5600 IU tablets
White to off-white, modified rectangular-shaped tablets, imprinted with “5600” on one
side, with a length of 11.4±0.2 mm and a width of 7.2±0.2 mm.
The tablets of Acido alendronico e colecalciferolo Aurobindo are available in blister packs.

Packs: 4 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
Via S. Giuseppe 102
21047 Saronno (VA), Italy

Manufacturer
PHARMATHEN S.A
6, Dervenakion street, Pallini, Attiki

• 15351- Greece

Pharmathen International S.A.
Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi

• 69300- Greece

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Italy: Acido Alendronico e Colecalciferolo Aurobindo
Portugal: Ácido alendrónico + Colecalciferol Aurovitas
Spain: Ácido alendrónico/Colecalciferol Aurovitas 70 mg/2.800 UI/70 mg/5.600 UI
comprimidos EFG