ALENDRONATO 70 mg /2800 Iu Coated Tablet

Зміст інструкції

1. ALENDRONATO E COLECALCIFEROLO DOC 70 mg/2.800 IU tablets, mg/5.600 IU tablets
   1. What is ALENDRONATE AND COLECALCIFEROL DOC and what is it used for
   2. What you need to know before taking ALENDRONATE AND COLECALCIFEROL DOC
   3. How to take ALENDRONATO E COLECALCIFEROLO DOC
   4. Possible side effects
   5. How to store ALENDRONATO E COLECALCIFEROLO DOC
   6. Contents of the pack and other information
2. ALENDRONATE AND CHOLECALCIFEROL DOC 70 mg/5.600 IU tablets is available in tablets of

ALENDRONATO E COLECALCIFEROLO DOC 70 mg/2.800 IU tablets, mg/5.600 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 they have the same symptoms as you, 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 understand the information in section 3 before taking this medicine.

Contents of this leaflet

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

1. What is ALENDRONATE AND COLECALCIFEROL DOC and what is it used for

What is ALENDRONATE AND COLECALCIFEROL DOC?
ALENDRONATE AND COLECALCIFEROL DOC is a tablet that contains two active ingredients, alendronic acid (commonly called alendronate) and cholecalciferol, 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, 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 comes 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 which can lead to falls and an
increased risk of fractures.

What is ALENDRONATE AND COLECALCIFEROL DOC used for?
Your doctor has prescribed ALENDRONATE AND COLECALCIFEROL DOC for the treatment
of osteoporosis and to reduce the risk of vitamin D deficiency. This medicine 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. In 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 daily activities such as lifting weights, or with minor traumas
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 limitations in movement.

How can osteoporosis be treated?
Along with treatment with ALENDRONATE AND COLECALCIFEROL DOC, 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 fractures.

Exerciseas 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 the possible need to take
food supplements.

2. What you need to know before taking ALENDRONATE AND COLECALCIFEROL DOC

Do not take ALENDRONATE AND COLECALCIFEROL DOC

• if you are allergic to alendronic acid trihydrate, 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 their instructions.

Warnings and precautions
Talk to your doctor or pharmacist before taking ALENDRONATE AND COLECALCIFEROL DOC 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 the esophagus),
• your doctor has told you 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) or 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
ALENDRONATE AND COLECALCIFEROL DOC.
It is important to maintain good oral hygiene during treatment with ALENDRONATE AND
COLECALCIFEROL DOC. 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, burning in the upper stomach, difficulty or pain
swallowing, especially if patients do not drink a full glass of tap water and/or lie down
during the first 30 minutes after taking ALENDRONATE AND COLECALCIFEROL DOC. These side
effects may worsen if patients continue to take ALENDRONATE AND
COLECALCIFEROL DOC after experiencing these symptoms.

Children and adolescents
ALENDRONATE AND COLECALCIFEROL DOC should not be given to children and adolescents
under the age of 18 years.

Other medicines and ALENDRONATE AND COLECALCIFEROL DOC
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 ALENDRONATE AND COLECALCIFEROL DOC 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 ALENDRONATE AND COLECALCIFEROL DOC.
Some medicines or food additives may prevent the vitamin D contained in
ALENDRONATE AND COLECALCIFEROL DOC 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)
can decrease the effectiveness of vitamin D.
For ALENDRONATE AND COLECALCIFEROL DOC 70 mg/2,800 IU tablets only: the addition of other vitamin D supplements may be considered on an individual basis.

ALENDRONATE AND COLECALCIFEROL DOC with food and drink
Foods and drinks (including mineral water) are likely to reduce the effectiveness of ALENDRONATE
AND COLECALCIFEROL DOC 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 drink except tap
water.

Pregnancy and breastfeeding
ALENDRONATE AND COLECALCIFEROL DOC is only indicated for women after menopause. Do
not take ALENDRONATE AND COLECALCIFEROL DOC if you are pregnant or suspect you are
pregnant or if you are breastfeeding.

Driving and using machines
Side effects (such as blurred vision, dizziness and severe bone, muscle or joint pain) have been reported with
ALENDRONATE AND COLECALCIFEROL DOC that may affect your ability to drive or operate machines (see section 4). If you experience any
of these side effects, do not drive until you feel well.

ALENDRONATE AND COLECALCIFEROL DOC 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 ALENDRONATO E COLECALCIFEROLO DOC

Take ALENDRONATO E COLECALCIFEROLO DOC following exactly the instructions of your
doctor or pharmacist. If you have doubts, consult your doctor or pharmacist.

Take one tablet of ALENDRONATO E COLECALCIFEROLO DOC once a
week.
Follow the instructions below carefully:

• 1) Choose a day of the week that best suits your activities. Take one tablet of ALENDRONATO E COLECALCIFEROLO DOC once a week on the chosen day. It is very important that you follow instructions 2), 3), 4) and 5) to facilitate the quick passage of the ALENDRONATO E COLECALCIFEROLO DOC tablet into the stomach and help reduce the possibility of irritating the esophagus (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 ALENDRONATO E COLECALCIFEROLO DOC tablet with a full glass of tap water (not mineral water) (not less than 200 ml), so that ALENDRONATO E COLECALCIFEROLO DOC 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 in an upright position (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) ALENDRONATO E COLECALCIFEROLO DOC should not be taken at bedtime or before getting out of bed at the start of the day.
• 5) If difficulty or pain when swallowing, chest pain, or heartburn in the upper part of the stomach appears or worsens, stop taking ALENDRONATO E COLECALCIFEROLO DOC and contact your doctor.
• 6) After swallowing the ALENDRONATO E COLECALCIFEROLO DOC tablet, wait at least 30 minutes before eating, drinking or taking other medicines of the day, including antacids, calcium supplements and vitamins. ALENDRONATO E COLECALCIFEROLO DOC is only effective when taken on an empty stomach.

If you take more ALENDRONATO E COLECALCIFEROLO DOC 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 ALENDRONATO E COLECALCIFEROLO DOC
If you forget to take the tablet, it is sufficient to take one ALENDRONATO E
COLECALCIFEROLO DOC tablet the next morning. Do not take two tablets on the same day.
Subsequently, start taking the tablet again on the chosen day of the week.

If you stop taking ALENDRONATO E COLECALCIFEROLO DOC
It is important that you take ALENDRONATO E COLECALCIFEROLO DOC until prescribed by
your doctor. Since it is not known how long you should take ALENDRONATO E
COLECALCIFEROLO DOC, you should periodically check with your doctor the need to continue therapy with this medicine to establish whether the use of ALENDRONATO E COLECALCIFEROLO DOC is
still correct 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.
Seek immediate medical attention if you notice any of the following side effects, which may be
serious and may require 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 (esophagus - the channel 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, 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 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 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; 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 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.
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 ALENDRONATO E COLECALCIFEROLO DOC

Keep this medicine out of the sight and reach of children.
Do not use ALENDRONATO E COLECALCIFEROLO DOC 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 to protect the medicine from moisture and light.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ALENDRONATO E COLECALCIFEROLO DOC contains
ALENDRONATO E COLECALCIFEROLO DOC 70 mg/2,800 IU tablets:
The active ingredients are alendronic acid and cholecalciferol (vitamin D3). Each tablet contains 70 mg of
alendronic acid (as sodium trihydrate) and 70 micrograms (2,800 IU) of cholecalciferol (vitamin D3).
ALENDRONATO E COLECALCIFEROLO DOC 70 mg/5,600 IU tablets:
The active ingredients are alendronic acid and cholecalciferol (vitamin D3). Each tablet contains 70 mg of
alendronic acid (as sodium trihydrate) and 140 micrograms (5,600 IU) of cholecalciferol (vitamin D3).
The other ingredients are microcrystalline cellulose (E460), anhydrous lactose, medium chain triglycerides,
gelatin, sodium croscarmellose, sucrose, colloidal silicon dioxide, magnesium stearate (E572), butylated hydroxytoluene
(E321), modified starch (corn).

Description of the appearance of ALENDRONATO E COLECALCIFEROLO DOC and contents of the
pack
ALENDRONATO E COLECALCIFEROLO DOC 70 mg/2,800 IU tablets are available as
white, capsule-shaped tablets, with “28” imprinted on one side and smooth on the other.

ALENDRONATE AND CHOLECALCIFEROL DOC 70 mg/5.600 IU tablets is available in tablets of

white color, with a modified rectangular shape, with “56” imprinted on one side and smooth on the other.
The tablets are supplied in aluminum blisters in cardboard boxes in the following pack sizes:

• 4 tablets (1 blister containing 4 tablets).

It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milano – Italy.

Manufacturer
GE Pharmaceuticals Ltd. - Industrial Zone, ‘Chekanitza-South’ area, Botevgrad, 2140 – Bulgaria.