Alendronate and colecalciferol Doc Generici: detailed information

Patient Information Leaflet: Information for the User

ALENDRONATE AND COLECALCIFEROL DOC 70 mg/2,800 IU tablets, mg/5,600 IU tablets

Equivalent medicine
Please read all of 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 they have the same symptoms as you, because it may be harmful to them.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
It is very important to understand the information contained in section 3 before taking this medicine.

Contents of this leaflet

What ALENDRONATE AND COLECALCIFEROL DOC is and what it is used for
What you need to know before taking ALENDRONATE AND COLECALCIFEROL DOC
How to take ALENDRONATE AND COLECALCIFEROL DOC
Possible side effects
How to store ALENDRONATE AND COLECALCIFEROL DOC
Contents of the pack and other information

1. What ALENDRONATO E COLECALCIFEROLO DOC is and what it is used for

What is ALENDRONATO E COLECALCIFEROLO DOC?
ALENDRONATO E COLECALCIFEROLO DOC is a tablet containing two active substances: alendronic acid (commonly called 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 comes during summer through 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 cause bone tissue loss and osteoporosis. Severe vitamin D deficiency can lead to muscle weakness, increasing the risk of falls and fractures.

What is ALENDRONATO E COLECALCIFEROLO DOC used for?
Your doctor has prescribed ALENDRONATO E COLECALCIFEROLO DOC for the treatment of osteoporosis and to reduce the risk of vitamin D deficiency. This medicine 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 risk of osteoporosis is greater the earlier a woman reaches menopause.

In its early stages, osteoporosis usually causes no symptoms. However, if left untreated, fractures may occur. Although fractures are usually 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 typically occur in the hip, spine, or wrist and can be not only painful but may also lead to significant deformities and disabilities, such as curvature of the back (kyphosis) and limitations in movement.

How can osteoporosis be treated?
Along with treatment with ALENDRONATO E COLECALCIFEROLO DOC, 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: just as muscles do, bones need physical activity to remain strong and healthy. Consult your doctor before starting any exercise program.
Balanced diet: your doctor can provide information about diet or the possible need for dietary supplements.

2. What you should know before taking ALENDRONATE AND COLECALCIFEROL DOC

Do not take ALENDRONATE AND COLECALCIFEROL DOC

if you are allergic to sodium alendronate trihydrate, 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 narrowing or difficulty swallowing,
if you are unable to remain upright (sitting or standing) 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 advice.

Warnings and precautions

Talk to your doctor or pharmacist before taking ALENDRONATE AND COLECALCIFEROL DOC if:

you have kidney problems,
you currently have or have recently had difficulty swallowing or gastrointestinal disorders,
your doctor has diagnosed you with Barrett's oesophagus (a condition involving changes in the cells lining the lower part of the oesophagus),
your doctor has told you that you have a problem absorbing minerals in the stomach or intestine (malabsorption syndrome),
you have poor dental health, gum disease, are scheduled for a tooth extraction, or do not regularly visit a dentist,
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 advised to have a dental examination 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 throughout treatment and 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 oesophagus (the tube connecting the mouth to the stomach) may occur, often accompanied by symptoms such as chest pain, heartburn, or 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 ALENDRONATE AND COLECALCIFEROL DOC. These side effects may worsen if patients continue taking ALENDRONATE AND COLECALCIFEROL DOC after experiencing such symptoms.

Children and adolescents

ALENDRONATE AND COLECALCIFEROL DOC must not be administered to children and adolescents under 18 years of age.

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 certain oral medications may interfere with the absorption of ALENDRONATE AND COLECALCIFEROL DOC if taken at the same time. It is therefore important to follow the instructions provided in section 3 and wait at least 30 minutes before taking any other oral medication or supplements.

Certain medicines used for rheumatism or long-term pain, known as NSAIDs (e.g. acetylsalicylic acid or ibuprofen), may cause gastrointestinal problems. Therefore, caution should be exercised when taking these medicines together with ALENDRONATE AND COLECALCIFEROL DOC.

Some medicines or food additives may prevent the vitamin D in ALENDRONATE AND COLECALCIFEROL DOC from being absorbed properly. These include artificial fat substitutes, mineral oils, weight-loss medicines such as orlistat, and cholesterol-lowering medicines such as cholestyramine and colestipol. Antiepileptic medicines (for seizures or epilepsy), such as phenytoin or phenobarbital, may reduce the effectiveness of vitamin D.

Only for ALENDRONATE AND COLECALCIFEROL DOC 70 mg/2,800 IU tablets: additional vitamin D supplements may be considered on an individual basis.

ALENDRONATE AND COLECALCIFEROL DOC with food and drink

Foods and beverages (including mineral water) may reduce the effectiveness of ALENDRONATE AND COLECALCIFEROL DOC if taken at the same time. It is therefore 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 and breastfeeding

ALENDRONATE AND COLECALCIFEROL DOC is indicated only for postmenopausal women. Do not take ALENDRONATE AND COLECALCIFEROL DOC if you are pregnant or suspect you may be pregnant, or if you are breastfeeding.

Driving and using machines

With ALENDRONATE AND COLECALCIFEROL DOC, side effects have been reported (e.g. blurred vision, dizziness, and severe bone, muscle, or joint pain) 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 well again.

ALENDRONATE AND COLECALCIFEROL DOC 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 ALENDRONATE AND CHOLECALCIFEROL DOC

Take ALENDRONATE AND CHOLECALCIFEROL DOC exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Take one tablet of ALENDRONATE AND CHOLECALCIFEROL DOC once weekly.
Follow the instructions below carefully:

Choose the day of the week that best fits your routine. Take one tablet of ALENDRONATE AND CHOLECALCIFEROL DOC once a week on the chosen day.
It is very important that you follow instructions 2), 3), 4), and 5) to help the tablet reach your stomach quickly and to help reduce the risk of irritating the oesophagus (oesophagus – the tube connecting the mouth to the stomach).
After getting up in the morning and before taking any food, drink, or other medication, swallow the ALENDRONATE AND CHOLECALCIFEROL DOC tablet whole with a full glass of tap water (not mineral water) (at least 200 ml), to ensure adequate absorption of ALENDRONATE AND CHOLECALCIFEROL DOC.

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, as this may cause mouth ulcers.
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) ALENDRONATE AND CHOLECALCIFEROL DOC 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 ALENDRONATE AND CHOLECALCIFEROL DOC and contact your doctor immediately.
6) After swallowing the ALENDRONATE AND CHOLECALCIFEROL DOC tablet, wait at least 30 minutes before eating, drinking, or taking any other medications of the day, including antacids, calcium supplements, and vitamins. ALENDRONATE AND CHOLECALCIFEROL DOC is effective only when taken on an empty stomach.

If you take more ALENDRONATE AND CHOLECALCIFEROL 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 ALENDRONATE AND CHOLECALCIFEROL DOC
If you forget to take your tablet, simply take one tablet of ALENDRONATE AND CHOLECALCIFEROL DOC the following morning. Do not take two tablets on the same day.
After that, resume taking the tablet on your chosen day of the week.

If you stop taking ALENDRONATE AND CHOLECALCIFEROL DOC
It is important to continue taking ALENDRONATE AND CHOLECALCIFEROL DOC for as long as your doctor has prescribed it. Since it is not known how long you should continue treatment, you should periodically consult your doctor to reassess the need for continuing therapy and to determine whether continued use of ALENDRONATE AND CHOLECALCIFEROL DOC remains appropriate for you.

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 everybody gets them.

Go to your doctor immediately if you notice any of the following side effects, which can 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; oesophageal ulcers (oesophagus – 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 pain, swelling or ulcers inside the mouth, numbness or a feeling of heaviness in the jaw, or tooth loss. These may be signs of bone damage in the jaw (osteonecrosis), usually associated with delayed healing and infection, often following a tooth extraction. Contact your doctor and dentist if you experience these symptoms,
rarely, an unusual femur fracture may occur, particularly in patients who have been 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 could be an early sign of a possible femur fracture,
severe bone, muscle, and/or joint pain.

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 oesophagus (the tube connecting the mouth to the stomach) or stomach,
black or dark stools,
blurred vision; eye pain or redness,
skin rash; redness of the skin,
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 oesophagus (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):

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

Reporting of side effects
If you get any side effects, 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.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 ALENDRONATE AND COLECALCIFEROLO DOC

Keep this medicine out of the sight and reach of children.
Do not use ALENDRONATE AND COLECALCIFEROLO DOC after the expiry date stated on the
pack 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 moisture and light.
Do not store above 25°C.
Do not dispose of medicines 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 ALENDRONATE AND COLECALCIFEROL DOC contains
ALENDRONATE AND COLECALCIFEROL DOC 70 mg/2,800 IU tablets:
The active substances are alendronic acid and colecalciferol (vitamin D3). Each tablet contains 70 mg of
alendronic acid (as sodium trihydrate) and 70 micrograms (2,800 IU) of colecalciferol (vitamin D3).
ALENDRONATE AND COLECALCIFEROL DOC 70 mg/5,600 IU tablets:
The active substances are alendronic acid and colecalciferol (vitamin D3). Each tablet contains 70 mg of
alendronic acid (as sodium trihydrate) and 140 micrograms (5,600 IU) of colecalciferol (vitamin D3).
The other components are microcrystalline cellulose (E460), anhydrous lactose, medium-chain triglycerides,
gelatin, sodium croscarmellose, sucrose, colloidal silicon dioxide, magnesium stearate (E572), butylated hydroxytoluene
(E321), modified starch (maize).

Description of the appearance of ALENDRONATE AND COLECALCIFEROL DOC and package contents
ALENDRONATE AND COLECALCIFEROL DOC 70 mg/2,800 IU tablets are white, capsule-shaped tablets,
with "28" engraved on one side and smooth on the other.
ALENDRONATE AND COLECALCIFEROL DOC 70 mg/5,600 IU tablets are white, modified rectangular-shaped tablets,
with "56" engraved on one side and smooth on the other.
The tablets are supplied in aluminum blisters packed in cardboard boxes in the following pack sizes:

4 tablets (1 blister containing 4 tablets).

Not all pack sizes may be 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.