Alendronate and colecalciferol Aurobindo: detailed information

Package leaflet: Information for the user

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

Equivalent medicine
Please read this leaflet carefully before taking this medicine because 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, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
It is very important to read section 3 before taking this medicine.

Contents of this leaflet:

What Acido alendronico e colecalciferolo Aurobindo is and what it is used for
What you need to know before taking Acido alendronico e colecalciferolo Aurobindo
How to take Acido alendronico e colecalciferolo Aurobindo
Possible side effects
How to store Acido alendronico e colecalciferolo Aurobindo
Contents of the pack and other information

1. What is Alendronic Acid and Colecalciferol Aurobindo and what is it used for?

What is Alendronic Acid and Colecalciferol Aurobindo?
Alendronic Acid and Colecalciferol Aurobindo is a tablet containing two active substances: alendronic acid (commonly known as alendronate) and colecalciferol, also known as vitamin D3.

What is alendronate?
Alendronate belongs to a group of non-hormonal medicines called bisphosphonates. Alendronate prevents bone tissue loss 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 adequately absorb calcium from food only if sufficient vitamin D is present. Very few foods contain vitamin D. The main source of vitamin D in summer comes from exposure to sunlight, which triggers vitamin D production in the skin. With aging, the skin produces less vitamin D. Too low levels of vitamin D can lead to bone tissue loss and osteoporosis. Severe vitamin D deficiency can cause muscle weakness, increasing the risk of falls and fractures.

What is Alendronic Acid and Colecalciferol Aurobindo used for?
Your doctor has prescribed Alendronic Acid and Colecalciferol Aurobindo for the treatment of osteoporosis and to reduce the risk of vitamin D deficiency. It reduces the risk of spinal and hip fractures in postmenopausal women.

What is osteoporosis?
Osteoporosis is a condition characterized by thinning and weakening of the bones. It is common in women after menopause. During menopause, the ovaries stop producing female hormones, estrogens, which help maintain a woman's skeletal health. As a result, bone tissue is lost and bones become weaker. The earlier a woman reaches menopause, the greater her risk of developing osteoporosis.

In its early stages, osteoporosis usually causes no symptoms. However, if left untreated, fractures may occur. Although fractures are typically painful, spinal bone fractures may go unnoticed until they result in a decrease in height. Fractures can occur during everyday activities such as lifting weights, or from minor trauma that would not normally cause fractures in healthy bone. Fractures commonly occur in the hip, spine, or wrist and can be not only painful but may also lead to significant deformities and disability, such as curvature of the back (kyphosis) and loss of mobility.

How can osteoporosis be treated?
Along with treatment with Alendronic Acid and Colecalciferol Aurobindo, your doctor may recommend lifestyle changes to improve the condition, such as:
Smoking cessation Smoking appears to increase the rate at which bone tissue is lost and therefore may increase the risk of fractures.
Physical exercise Like muscles, bones need physical activity to stay strong and healthy. Consult your doctor before starting any exercise program.
Balanced diet Your doctor may provide you with information about diet or the possible need for 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 alendronate acid, colecalciferol, or any of the other ingredients of this medicine (listed in section 6),
if you have certain problems with your oesophagus (the tube connecting your mouth to your stomach), such as strictures 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 you fall into any of these categories, do not take the tablets. Consult your doctor and follow their advice.

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 gastrointestinal disorders,
your doctor has told you that you have Barrett's oesophagus (a condition associated with changes in the cells lining the lower part of the oesophagus),
you have been diagnosed with malabsorption of minerals in the stomach or intestine (malabsorption syndrome),
you have poor dental health, gum disease, are planning a tooth extraction, or do not regularly visit your dentist,
you have cancer,
you are undergoing chemotherapy or radiotherapy,
you are taking angiogenesis inhibitors (such as bevacizumab or thalidomide), used in the treatment of cancer,
you are taking corticosteroids (such as prednisone or dexamethasone), used to treat 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 advised to have a dental examination 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 throughout treatment and contact your doctor or dentist if you experience any mouth or dental problems such as tooth loss, pain, or swelling.

Irritation, inflammation, or ulceration of the oesophagus (the tube connecting the mouth to the stomach) may occur, often accompanied by symptoms such as chest pain, burning sensation 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 during the first 30 minutes after taking Acido alendronico e colecalciferolo Aurobindo.
These side effects may worsen if patients continue taking Acido alendronico e colecalciferolo Aurobindo after experiencing such symptoms.

Children and adolescents
Acido alendronico e colecalciferolo Aurobindo must not be administered to children or adolescents under 18 years of age.

Other medicines and Acido alendronico e colecalciferolo Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Calcium supplements, antacids, and certain oral medicines may interfere with the absorption of Acido alendronico e colecalciferolo Aurobindo if taken at the same time. Therefore, it is important to follow the instructions in section 3 and wait at least 30 minutes before taking any other oral medicines or supplements.

Some medicines used for rheumatism or long-term pain, called NSAIDs (e.g. acetylsalicylic acid or ibuprofen), may cause digestive problems. Therefore, caution should be exercised when taking these medicines together with Acido alendronico e colecalciferolo Aurobindo.

Certain medicines or food additives may prevent the vitamin D in Acido alendronico e colecalciferolo Aurobindo from being absorbed, including artificial fat substitutes, mineral oils, weight-loss medicines, orlistat, and cholesterol-lowering medicines such as cholestyramine and colestipol. Antiepileptic medicines (for seizures/epilepsy) (such as phenytoin or phenobarbital) may reduce the effectiveness of vitamin D. Additional vitamin D supplementation may need to be considered on an individual basis.

Acido alendronico e colecalciferolo Aurobindo with food, drinks and alcohol
Food and drinks (including mineral water) may reduce the effectiveness of Acido alendronico e colecalciferolo Aurobindo if taken at the same time. Therefore, it is important to follow the instructions in section 3. You must wait at least 30 minutes before consuming any food or drink other than tap water.

Pregnancy, breastfeeding and fertility
Acido alendronico e colecalciferolo Aurobindo is indicated only for postmenopausal women. 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 may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Undesirable effects (e.g. blurred vision, dizziness, and severe bone, muscle or joint pain) have been reported with Acido alendronico e colecalciferolo Aurobindo, which may affect your ability to drive or use 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 your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Alendronic Acid and Colecalciferol Aurobindo

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Take one tablet of Alendronic Acid and Colecalciferol Aurobindo once a
week.
Follow carefully the instructions below.

Choose the day of the week that best fits your routine. Take one tablet of
Alendronic Acid and Colecalciferol Aurobindo once a week on the chosen day.
It is very important that you follow steps 2), 3), 4) and 5) to help ensure rapid passage of the
tablet into the stomach and to help reduce the possibility of irritating the oesophagus (the tube connecting the mouth to the stomach).
After getting up in the morning and before taking any food, drink or other medicine, swallow the tablet whole with a full glass of tap water (not mineral water) (at least 200 ml), so that Alendronic Acid and Colecalciferol 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 the mouth, due to the possible risk of developing ulcers in the mouth.
3) Do not lie down – remain upright (sitting, standing or walking) for at least 30 minutes after swallowing the tablet. Do not lie down until you have eaten something.
4) Alendronic Acid and Colecalciferol Aurobindo must not be taken at bedtime or before getting up in the morning.
5) If you experience difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking Alendronic Acid and Colecalciferol Aurobindo and contact your doctor.
6) After swallowing the tablet of Alendronic Acid and Colecalciferol Aurobindo, wait at least
30 minutes before eating, drinking or taking any other medicines of the day, including antacids, calcium supplements and vitamins. Alendronic Acid and Colecalciferol Aurobindo is effective only when taken on an empty stomach.
If you take more Alendronic Acid and Colecalciferol 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 Alendronic Acid and Colecalciferol Aurobindo
If you forget to take the tablet, take one tablet the morning after you remember. Do not take two tablets on the same day. Then resume your weekly dosing schedule on your originally chosen day of the week.
If you stop taking Alendronic Acid and Colecalciferol Aurobindo
It is important that you continue taking Alendronic Acid and Colecalciferol Aurobindo for as long as prescribed by your doctor. Since it is not known how long you will need to take Alendronic Acid and Colecalciferol Aurobindo, you should periodically check with your doctor whether continuing treatment with this medicine is still appropriate for you.
A patient instruction card is included in the package of Alendronic Acid and Colecalciferol Aurobindo. It contains important information reminding you how to take Alendronic Acid and Colecalciferol Aurobindo correctly.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Contact your doctor immediately if 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 sensation in the upper stomach; difficulty swallowing; pain when swallowing; esophageal ulcers (in the tube connecting the mouth to the stomach), which may cause chest pain, burning in the upper stomach, 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, possibly causing difficulty breathing or swallowing; severe skin reactions;
mouth pain, and/or jaw/mandible pain, swelling or ulcers inside the mouth, numbness or a sensation 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 following dental extraction. Contact your doctor and dentist if you experience such symptoms;
uncommonly, an unusual femur fracture may occur, particularly in patients receiving long-term treatment for osteoporosis. Contact your doctor if you experience pain, weakness, or discomfort in the thigh, hip, or groin, as this could be an early sign 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):

joint swelling,
abdominal pain; stomach discomfort or belching after meals; constipation; feeling of fullness or bloating in the stomach; diarrhoea, 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 connecting the mouth to the stomach) or stomach,
black or dark stools,
blurred vision; eye pain or redness,
skin rash; skin redness,
flu-like symptoms, such as muscle aches, general malaise, and sometimes fever, usually at the beginning of treatment,
altered taste.

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

symptoms due to low calcium levels 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 people):
Contact your doctor if you experience ear pain, ear discharge, and/or ear infection.
These events could be signs of bone damage in the ear.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 Alendronic Acid and Colecalciferol Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Store in the original blister to protect the medicine from light and moisture.
Do not dispose of any medicine via 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 e colecalciferolo Aurobindo contains

The active substances are alendronic acid and colecalciferol (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 colecalciferol (vitamin D3) (as concentrated colecalciferol, 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 colecalciferol (vitamin D3) (as concentrated colecalciferol, in powder form).
Each tablet contains 64 mg of lactose (as anhydrous lactose) and 27.5 mg of sucrose.

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

Description of the appearance of Acido alendronico e colecalciferolo Aurobindo and the
contents of the pack
Tablet.
Acido alendronico e colecalciferolo Aurobindo 70 mg/2800 IU tablets
White to off-white, biconvex, oblong-shaped tablets, with "2800" printed on one side,
measuring 12.3±0.2 mm in length and 6.5±0.2 mm in width.
Acido alendronico e colecalciferolo Aurobindo 70 mg/5600 IU tablets
White to off-white, modified rectangular-shaped tablets, with "5600" printed on one
side, measuring 11.4±0.2 mm in length and 7.2±0.2 mm in width.
Acido alendronico e colecalciferolo Aurobindo tablets 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 European Economic Area (EEA) Member States under the following names:
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