Alendronate and colecalciferol Teva Italia: detailed information

Package leaflet: Information for the user

ALENDRONATE AND COLECALCIFEROL TEVA ITALIA 70 mg/2800 IU tablets, mg/5600 IU tablets

Alendronic acid/colecalciferol
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 pass it on to other people, even if their symptoms are the same as yours, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
It is very important to read section 3, How to take ALENDRONATE AND COLECALCIFEROL TEVA ITALIA, before taking this medicine.

Contents of this leaflet:

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

1. What ALENDRONATE AND CHOLECALCIFEROL TEVA ITALIA is and what it is used for

What ALENDRONATE AND CHOLECALCIFEROL TEVA ITALIA is
ALENDRONATE AND CHOLECALCIFEROL TEVA ITALIA is a tablet containing two active substances, alendronic acid (commonly referred to as alendronate) and cholecalciferol (also known as vitamin D).

What alendronate is
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 vitamin D is
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 little vitamin D can lead to bone tissue loss and osteoporosis. Severe vitamin D deficiency may cause muscle weakness, increasing the risk of falls and fractures.

What ALENDRONATE AND CHOLECALCIFEROL TEVA ITALIA is used for
Your doctor has prescribed ALENDRONATE AND CHOLECALCIFEROL TEVA ITALIA for the treatment of osteoporosis and to reduce the risk of vitamin D deficiency. ALENDRONATE AND CHOLECALCIFEROL TEVA ITALIA reduces the risk of spinal and hip fractures in postmenopausal women.

What osteoporosis is
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 increases 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 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 may not only be painful but also lead to significant deformities and disability, such as curvature of the back (dowager's hump) and movement limitations.

How osteoporosis can be treated
Along with treatment with ALENDRONATE AND CHOLECALCIFEROL TEVA ITALIA, your doctor may recommend lifestyle changes to improve the condition, such as:
Stopping smoking – 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 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 need to know before taking ALENDRONATE AND COLECALCIFEROL TEVA

ITALY
DO NOT take ALENDRONATE AND COLECALCIFEROL TEVA ITALY

if you are allergic to alendronic acid, colecalciferol (vitamin D), 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 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 ALENDRONATE AND COLECALCIFEROL TEVA ITALY. It is important to inform your doctor before taking ALENDRONATE AND COLECALCIFEROL TEVA ITALY if:

you have kidney problems
you have difficulty swallowing or gastrointestinal disorders
your doctor has diagnosed you with Barrett's oesophagus (a condition associated with changes in the cells lining the lower part of the oesophagus)
you have been told you have malabsorption of 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)
you are taking 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 examination before starting treatment with ALENDRONATE AND COLECALCIFEROL TEVA ITALY.
It is important to maintain good oral hygiene during treatment with ALENDRONATE AND COLECALCIFEROL TEVA ITALY. 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 with symptoms such as chest pain, burning in the upper stomach, or 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 ALENDRONATE AND COLECALCIFEROL TEVA ITALY.
These side effects may worsen if patients continue taking ALENDRONATE AND COLECALCIFEROL TEVA ITALY after experiencing such symptoms (see section 4 “Possible side effects”).

Children and adolescents
ALENDRONATE AND COLECALCIFEROL TEVA ITALY must not be given to children and adolescents under 18 years of age.

Other medicines and ALENDRONATE AND COLECALCIFEROL TEVA ITALY
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 are likely to interfere with the absorption of ALENDRONATE AND COLECALCIFEROL TEVA ITALY if taken at the same time.
Therefore, it is important to follow the instructions provided in section 3 “How to take ALENDRONATE AND COLECALCIFEROL TEVA ITALY” and wait at least 30 minutes before taking any other oral medicine or supplement.
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 used when these medicines are taken together with ALENDRONATE AND COLECALCIFEROL TEVA ITALY.
Some medicines or food additives may prevent the vitamin D in ALENDRONATE AND COLECALCIFEROL TEVA ITALY from being absorbed by the body, including artificial fat substitutes, mineral oils, weight-loss medicines (orlistat), and cholesterol-lowering medicines (cholestyramine and colestipol). Antiepileptic medicines (for seizures or epilepsy) (such as phenytoin or phenobarbital) may reduce the effectiveness of vitamin D. Additional vitamin D supplementation may be considered on an individual basis.

ALENDRONATE AND COLECALCIFEROL TEVA ITALY with food and drinks
Food and drinks (including mineral water) are likely to reduce the effectiveness of ALENDRONATE AND COLECALCIFEROL TEVA ITALY if taken at the same time. Therefore, it is important to follow the instructions in section 3 “How to take ALENDRONATE AND COLECALCIFEROL TEVA ITALY”. You must wait at least 30 minutes before consuming any food or drink other than water.

Pregnancy and breastfeeding
ALENDRONATE AND COLECALCIFEROL TEVA ITALY is indicated only for postmenopausal women. Do not take ALENDRONATE AND COLECALCIFEROL TEVA ITALY if you are pregnant or think you might be pregnant, or if you are breastfeeding.

Driving and using machines
With ALENDRONATE AND COLECALCIFEROL TEVA ITALY, side effects have been reported (e.g. blurred vision, dizziness, and severe bone, joint, or muscle pain) that may affect your ability to drive or operate machinery (see section 4 “Possible side effects”). If you experience any of these side effects, do not drive until you feel well.

ALENDRONATE AND COLECALCIFEROL TEVA ITALY contains sucrose.
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. How to take ALENDRONATE AND COLECALCIFEROL TEVA ITALIA

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Take one tablet of ALENDRONATE AND COLECALCIFEROL TEVA ITALIA once a week.
To obtain benefit from treatment with ALENDRONATE AND COLECALCIFEROL TEVA ITALIA, it is essential that you carefully follow the instructions below:

Choose the day of the week that best fits your routine. Take one tablet of ALENDRONATE AND COLECALCIFEROL TEVA ITALIA once a week on the chosen day.
It is very important that you follow instructions 2), 3), 4), and 5) to help the tablet pass quickly into the stomach and help reduce the risk 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 ALENDRONATE AND COLECALCIFEROL TEVA ITALIA tablet whole with a full glass of tap water (not mineral water) (at least 200 ml), to ensure adequate absorption of ALENDRONATE AND COLECALCIFEROL TEVA ITALIA.

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 risk of developing mouth ulcers.

Do not lie down – remain upright (sitting, standing, or walking) for at least 30 minutes after swallowing the tablet. Do not lie down until after you have eaten something.
ALENDRONATE AND COLECALCIFEROL TEVA ITALIA must not be taken at bedtime or before getting up from bed in the morning.
If you experience difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking ALENDRONATE AND COLECALCIFEROL TEVA ITALIA and contact your doctor.
After swallowing the ALENDRONATE AND COLECALCIFEROL TEVA ITALIA tablet, wait at least 30 minutes before eating, drinking, or taking any other medicines, including antacids, calcium supplements, or vitamins. ALENDRONATE AND COLECALCIFEROL TEVA ITALIA is effective only when taken on an empty stomach.

If you take more ALENDRONATE AND COLECALCIFEROL TEVA ITALIA 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 COLECALCIFEROL TEVA ITALIA
If you forget to take your tablet, simply take one tablet of ALENDRONATE AND COLECALCIFEROL TEVA ITALIA the following morning. Do not take two tablets on the same day. Afterwards, resume taking the tablet on your chosen day of the week.

If you stop taking ALENDRONATE AND COLECALCIFEROL TEVA ITALIA
It is important to continue taking ALENDRONATE AND COLECALCIFEROL TEVA ITALIA for as long as your doctor prescribes it. Since it is not known how long you should continue treatment, you should periodically check with your doctor whether continuing therapy with this medicine is still 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 everyone gets them.

Contact your doctor immediately if you experience 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):

Heartburn; difficulty swallowing; pain when swallowing; oesophageal ulcers (the tube connecting the mouth to the stomach) which may cause chest pain, heartburn, 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), usually associated with delayed healing and infection, often following tooth extraction. Contact your doctor and dentist if you experience such 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, which is 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 eye redness
Skin rash, skin redness
Flu-like symptoms, such as muscle aches, general malaise, and sometimes fever, usually at the start of treatment
Taste disturbances.

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

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 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 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.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 COLECALCIFEROL TEVA ITALIA

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.
This medicine requires no special storage conditions.
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 ALENDRONATO E COLECALCIFEROLO TEVA ITALIA contains

The active substances are alendronic acid and cholecalciferol (vitamin D). Each tablet contains 70 mg of alendronic acid (as alendronate sodium monohydrate) and 70 micrograms (2800 IU) of cholecalciferol (vitamin D). Each tablet contains 70 mg of alendronic acid (as alendronate sodium monohydrate) and 140 micrograms (5600 IU) of cholecalciferol (vitamin D).
The other components (excipients) are: Tablet core: mannitol (E421), microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate. Pellet composition: sucrose, microcrystalline cellulose, copovidone, butylated hydroxytoluene (BHT), medium-chain triglycerides. Film-coated pellet: Opadry II 85F18378: polyvinyl alcohol – partially hydrolyzed, titanium dioxide (E171), macrogol 3350, talc.

Description of the appearance of ALENDRONATO E COLECALCIFEROLO TEVA ITALIA and contents of the pack
ALENDRONATO E COLECALCIFEROLO TEVA ITALIA 70 mg/2800 IU tablets are capsule-shaped, white to off-white tablets, marked with “A70” on one side and “2800” on the other side of the tablet.
ALENDRONATO E COLECALCIFEROLO TEVA ITALIA 70 mg/5600 IU tablets are capsule-shaped, white to off-white tablets, marked with “A70” on one side and “5600” on the other side of the tablet.
The tablets are supplied in blisters made of OPA/Al/PVC-Aluminum, packed in cartons containing 4, 4 x 1, 4 (calendar pack), 12, 12 (calendar pack), 16, 24 or 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milan, Italy
Manufacturers
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 Debrecen - Hungary
Merckle GmbH
Graf-Arco-Str. 3, 89079 Ulm - Germany
Merckle GmbH
Ludwig-Merckle-Straße 3, 89143 Blaubeuren – Germany
Teva Pharma B.V.
Swensweg 5, 2031 GA Haarlem – The Netherlands
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80, 31-546 Kraków – Poland