ACIDO 70 mg Coated Tablet

Зміст інструкції

1. Acido Alendronico Aurobindo 70 mg tablets
   1. What is Acido Alendronico Aurobindo and what is it used for
   2. What you need to know before taking Acido Alendronico Aurobindo
   3. How to take Acido Alendronico Aurobindo
   4. Possible side effects
   5. How to store Acido Alendronico Aurobindo
   6. Package contents and other information

Acido Alendronico Aurobindo 70 mg tablets

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:
What is Acido Alendronico Aurobindo and what it is used for
What you need to know before taking Acido Alendronico Aurobindo
How to take Acido Alendronico Aurobindo
Possible side effects
How to store Acido Alendronico Aurobindo
Contents of the pack and other information

1. What is Acido Alendronico Aurobindo and what is it used for

What is Acido Alendronico Aurobindo?
Alendronic acid belongs to a group of medicines called “bisphosphonates”. Acido Alendronico
Aurobindo 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 Acido Alendronico Aurobindo used for?
Your doctor has prescribed Acido Alendronico Aurobindo for the treatment of osteoporosis. Acido
Alendronico Aurobindo reduces the risk of vertebral and hip fractures.

Acido Alendronico Aurobindo 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. In menopause, the ovaries stop producing female hormones, estrogens, which
help to keep a woman's skeleton healthy. Consequently, 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. 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 cause a
decrease in height. Fractures can occur during daily activities, such as lifting weights or
with minor trauma that would not be able to cause fractures in normal bone. Fractures normally occur in the hip, spine or wrist and can cause only pain but
also significant problems such as curvature of the spine (“dowager's hump”) and loss of mobility.

How can osteoporosis be treated?
Osteoporosis can be treated and it is never too late to start treatment. Acido Alendronico
Aurobindo not only prevents the loss of bone tissue but helps to rebuild bone that may have been
lost and reduces the risk of vertebral and hip fractures.
Along with treatment with alendronic acid, your doctor may suggest you change your lifestyle to
improve the condition of the disease, such as:

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

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

Balanced diet:Your doctor can give you information about diet or the need to take
food supplements (especially calcium and Vitamin D).

2. What you need to know before taking Acido Alendronico Aurobindo

Do not take Acido Alendronico Aurobindo
if you are allergic to alendronic acid sodium trihydrate or to 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
It is important to inform your doctor before starting to take Acido Alendronico tablets if:
you have kidney problems;
you have 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 low levels of calcium in your blood;
you have poor dental health, gum problems, 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 corticosteroids (such as prednisone or dexamethasone);
you are or have been a smoker (as this can increase the risk of dental problems)
Before starting treatment with Acido Alendronico Aurobindo, you may be asked to have a dental check-up.
During treatment with Acido Alendronico Aurobindo, it is important to maintain good oral hygiene. 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 (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 Acido Alendronico Aurobindo.
These side effects may worsen if patients continue to take Acido Alendronico Aurobindo after experiencing these symptoms.

Other medicines and Acido Alendronico Aurobindo
Calcium supplements, antacids and some medicines taken orally are likely to interfere with the absorption of Acido Alendronico Aurobindo if taken at the same time.
Therefore, it is important to follow the instructions given in section 3 “How to take Acido Alendronico Aurobindo”.
Some medicines for rheumatism or long-term pain called NSAIDs (e.g. aspirin or ibuprofen) can cause irritation of the digestive tract. Therefore, caution should be exercised when these medicines are taken at the same time with Acido Alendronico Aurobindo.
Tell your doctor if you are taking, have recently taken or might take any other medicines.

Taking Acido Alendronico Aurobindo with food, drinks and alcohol
Food and beverages (including mineral water) are likely to reduce the effectiveness of Acido Alendronico Aurobindo if taken at the same time. Therefore, it is important to follow the instructions given in section 3 “How to take Acido Alendronico Aurobindo”.

Children and adolescents
Acido Alendronico Aurobindo should not be given to children and adolescents.

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

Driving and operating machinery
Side effects (such as blurred vision, dizziness and severe bone, joint or muscle pain) have been reported with Acido Alendronico Aurobindo that may affect your ability to drive and operate machinery. Individual responses to Acido Alendronico Aurobindo may vary (see section 4 “Possible side effects”).

3. How to take Acido Alendronico Aurobindo

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

Take one tablet of Acido Alendronico Aurobindo once a week.
To obtain benefits from the treatment it is important to carefully follow the instructions below:
Choose the day of the week that best suits your activities. Take one tablet of
Acido Alendronico Aurobindo once a week on the chosen day.

It is very important that you follow instructions 2), 3), 4), 5) and 6) to facilitate the entry of the tablet

ofAcido Alendronico Aurobindo into the stomach and help reduce the possibility of irritating

the esophagus (the channel that connects the mouth to the stomach).
After getting out of bed, and before taking any food, drink or other medicine of the
day, swallow the Acido Alendronico Aurobindo tablet whole with a full glass of tap water
(not mineral water) (not less than 200 ml or 7 fl. oz.)
Do not take it with mineral water (still or sparkling)
Do not take it with coffee or tea
Do not take it with juices or milk
Do not crush or chew the tablet or let it dissolve in your mouth.
Do not lie down – keep the torso upright (while sitting, while standing, while
walking) – for at least 30 minutes after swallowing the tablet. Do not lie down until you have
eaten something.
Acido Alendronico Aurobindo should not be taken when lying down or before getting up from
bed at the beginning of the day.
If difficulty or pain when swallowing, chest pain, or heartburn in the upper part of the
stomach appears or worsens, stop taking Acido Alendronico Aurobindo and contact your doctor.
After swallowing the Acido Alendronico Aurobindo tablet, wait at least 30 minutes before
eating, drinking or taking other medicines of the day, including antacids, calcium supplements and
vitamins. Acido Alendronico Aurobindo is only effective when taken on an empty stomach.

If you take moreAcido Alendronico 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.

What to do if you forget to takeAcido Alendronico Aurobindo
If you forget a dose, take one tablet the next morning. Do not take two tablets on the same

day.Afterwards, start taking the tablet on the chosen day of the week.

If you stop taking Acido Alendronico Aurobindo
It is important to continue taking Acido Alendronico Aurobindo as long as prescribed by your doctor.
Acido Alendronico Aurobindo is effective for the treatment of osteoporosis only if you continue to
take the tablets.
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.
The frequency of possible side effects listed below is defined using the following
convention:
Very common (affects at least 1 in 10 patients treated)
Common (affects at least 1 in 100 and less than 1 in 10 patients treated)
Uncommon (affects at least 1 in 1,000 and less than 1 in 100 patients treated)
Rare (affects at least 1 in 10,000 and less than 1 in 1,000 patients treated)
Very rare (affects less than 1 in 10,000 patients treated)
Very common:
Bone, muscle and/or joint pain which is sometimes severe;
Common:
burning; difficulty swallowing; pain when swallowing; ulcers of the esophagus (the channel connecting the
mouth to the stomach) causing chest pain, burning or difficulty or pain when swallowing
joint swelling
abdominal pain; discomfort in the stomach or belching after meals; constipation;
feeling of fullness or bloating in the stomach; diarrhea; flatulence;
hair loss; itching
headache; dizziness
fatigue, swelling of the hands or legs
Uncommon:
nausea, vomiting
irritation or inflammation of the esophagus (the channel connecting the mouth to the stomach) or the
stomach)
black or dark 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 start of treatment
taste disturbance
Rare:
allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, possible
cause of difficulty breathing and swallowing
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 channel connecting the mouth to the stomach)
skin rash worsened by exposure to sunlight; severe skin reactions
pain in the mouth, and/or jaw/lower jaw, swelling or ulcers inside the mouth,
numbness or a feeling of heaviness in the jaw/lower jaw, or tooth loss. These
may be signs of damage to the jaw bone (osteonecrosis) generally associated
with delayed healing and infection, often after dental extraction. Contact your doctor and dentist if
you experience such symptoms
Fractures in the femur (thigh bone) can rarely occur, particularly in patients undergoing
long-term treatment. 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.
mouth ulcers when the tablets are chewed or sucked
Very rare (may affect up to one person in 10,000):

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

Tell your doctor or pharmacist immediately if you notice any of these or other unusual symptoms.
It is helpful to make a note of any symptoms that occur, when they started and how long they lasted.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this
leaflet. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Acido Alendronico Aurobindo

Keep this medicine out of sight and reach of children.
This medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date which is stated on the pack after SCAD. The expiry date refers to the last day of that month.
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. Package contents and other information

What Acido Alendronico Aurobindo contains

• The active ingredient is alendronic acid. Each tablet contains 70 mg of alendronic acid (equivalent to 91.363 mg of sodium alendronate trihydrate
• The other ingredients are: Microcrystalline cellulose, corn starch, sodium starch glycolate (Type A), povidone (Kollidon 30) and magnesium stearate

Description of the appearance of Acido Alendronico Aurobindo and package contents
White to off-white, oval, biconvex, uncoated tablets with “F” printed on one side and “21”
on the other side. The tablet size is 12.8 mm x 7.0 mm.
The tablets are supplied in blister packs made of PVC/Aclar - Aluminum
Packs: 2, 4, 8, 12, 20, 30, 40, 50 or 60 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l
via San Giuseppe 102
21047 Saronno (VA)

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000.
Malta

This medicinal product is authorised in the Member States of the European Economic Area under the following
denominations:
Czech Republic Alendronic acid Aurobindo 70 mg tablety
Cyprus Alendronic Acid Aurobindo 70 mg δισκία
Denmark Alendronat “Aurobindo”
Finland Alendronat Aurobindo 70 mg tabletit
Italy: Acido Alendronico Aurobindo
Malta Alendronic Acid 70 mg tablets
Netherlands: Alendroninezuur Aurobindo 70 mg, tabletten
Poland: Alendronat Aurobindo
Romania: Acid Alendronic Aurobindo 70 mg comprimate
Spain: Acido Alendrónico semanal Aurovitas Spain 70 mg comprimidos EFG
Sweden Alendronat Aurobindo 70 mg tabletter
United Kingdom: Alendronic Acid 70 mg tablets