Product Information for the User
Alendronic Acid/Colecalciferol Tevagen 70 mg/2,800 IU Tablets
Read this entire product information carefully before starting to take this medicine, as it contains important information for you.
1.What is Alendronic Acid/Colecalciferol Tevagen and what is it used for
2.What you need to know before starting to take Alendronic Acid/Colecalciferol Tevagen
3.How to take Alendronic Acid/Colecalciferol Tevagen
4.Possible adverse effects
5.Storage of Alendronic Acid/Colecalciferol Tevagen
6.Contents of the package and additional information
What is Alendronate/Colecalciferol Tevagen?
Alendronate/Colecalciferol Tevagen is a tablet that contains two active ingredients, alendronate (as alendronate sodium monohydrate) and colecalciferol (also known as vitamin D3).
What is Alendronate/Colecalciferol Tevagen used for?
Your doctor has prescribed Alendronate/Colecalciferol Tevagen to treat your osteoporosis and because you are at risk of having a vitamin D deficiency. Alendronate/Colecalciferol Tevagen reduces the risk of vertebral and hip fractures in women after menopause.
What is alendronate?
Alendronate belongs to a group of non-hormonal medications called bisphosphonates. Alendronate prevents bone loss (osteoporosis), and helps to rebuild bone. It reduces the risk of vertebral and hip fractures.
What is vitamin D?
Vitamin D is an essential nutrient, necessary for the absorption of calcium and to maintain healthy bones. The body can only absorb calcium correctly from food if it contains sufficient vitamin D. Very few foods contain vitamin D. The main source of vitamin D is through exposure to sunlight, which produces vitamin D in our skin. As we age, our skin produces less vitamin D. A vitamin D deficiency can lead to bone loss and osteoporosis. In severe cases, a vitamin D deficiency can cause muscle weakness, which can result in falls and increase the risk of fractures.
What is osteoporosis?
Osteoporosis is a thinning and weakening of the bones. It is common in women after menopause. During menopause, the ovaries stop producing a type of female hormone, estrogen, which helps to maintain a healthy skeleton. As a result, bone loss occurs, and the bones become more fragile. The earlier a woman reaches menopause, the greater her risk of osteoporosis.
Initially, osteoporosis does not present symptoms. However, if left untreated, it can cause bone fractures. Although these are usually painful, vertebral fractures can go unnoticed until they cause loss of height. Weakened bones can break during normal daily activities, such as standing up or from minor injuries that would not normally break a normal bone. Bone fractures typically occur in the hip, spine, or wrist, and can cause not only pain but also significant problems such as a hunched back (widow's hump) and loss of mobility.
How can osteoporosis be treated?
Osteoporosis can be treated and it is never too late to start treatment.
Along with your treatment with Alendronate/Colecalciferol Tevagen, your doctor may suggest that you make lifestyle changes to help slow down your disease, such as:
Stopping smoking | Smoking appears to increase the rate of bone loss and, therefore, may increase your risk of bone fractures. |
Exercise | Like muscles, bones need exercise to stay strong and healthy. Consult your doctor before starting any exercise program. |
Eating a balanced diet | Your doctor may advise you on your diet or whether you should take any dietary supplements. |
Do not takeAlendronate/Colecalciferol Tevagen
If you think any of these cases apply to you,do nottake the tablets. Consult your doctor first and follow their advice.
Warnings and precautions
Consult your doctor or pharmacist before starting to take this medicine. It is important that you consult your doctor before taking this medicine if:
You may be advised to have a dental check-up before starting treatment with this medicine.
It is essential to maintain good oral hygiene while taking this medicine. You should have routine dental check-ups during your treatment and contact your doctor or dentist if you experience any problems in your mouth or teeth, such as tooth loss, pain or inflammation.
It may cause irritation, inflammation or esophageal ulcer (esophagus - the tube that connects your mouth to your stomach), often with symptoms of chest pain, burning, or difficulty or pain swallowing, especially if patients do not drink a full glass of water and/or if they lie down before 30 minutes after taking this medicine. These adverse effects may worsen if patients continue to take Alendronate/Colecalciferol Tevagen after developing these symptoms (see section 4 “Possible side effects”).
Children and adolescents
This medicine should not be administered to children under 18 years old.
Alendronate/Colecalciferol Tevagen with other medicines
Inform your doctor or pharmacist if you aretaking, haverecentlytakenor may have to take any other medicine.
Calcium supplements, antacids, and some oral medicines may interfere with the absorption of Alendronate/Colecalciferol if taken at the same time.
Therefore, it is essential to follow the instructions given in section 3 “How to take Alendronate/Colecalciferol Tevagen” and wait at least 30 minutes before taking any other medicine or supplement.
Certain medicines for rheumatism or long-term pain called NSAIDs (such as aspirin or ibuprofen) may cause digestive problems. Therefore, caution should be taken if these medicines are taken at the same time as Alendronate/Colecalciferol Tevagen.
Certain medicines or food additives may prevent the absorption of vitamin D from this medicine, including artificial fat substitutes, mineral oils, weight loss medication, orlistat, and cholesterol-lowering medicines; cholestyramine and colestipol. Medicines for epilepsy (seizures) may reduce the effectiveness of vitamin D. In some cases, your doctor may prescribe additional vitamin D supplements.
Medicines containing colecalciferol (vitamin D3) may interact with the following:
If you are taking any of the medicines mentioned above, your doctor will give you additional instructions.
Alendronate/Colecalciferol Tevagen with food and drinks
It is likely that foods and drinks (including mineral water) will reduce the effectiveness of this medicine if taken at the same time. Therefore, it is essential to follow the instructions given in section 3 “How to take Alendronate/Colecalciferol Tevagen”. You should wait at least 30 minutes before taking any food and drinks except water.
Pregnancy and breastfeeding
This medicine is only intended for use in postmenopausal women. Do not take Alendronate/Colecalciferol if you are or think you may be pregnant, or if you are breastfeeding.
Driving and operating machinery
Adverse effects have been reported with this medicine(such as blurred vision, dizziness and severe bone, muscle or joint pain) that may affect your ability to drive or operate machinery (see section 4 “Possible side effects”). If you experience any of these adverse effects, do not drive or operate machinery until you feel better.
Alendronate/Colecalciferol Tevagen contains sucrose
If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.
Alendronate/Colecalciferol Tevagen contains sodium
This medicine contains less than 1 mmol (23 mg of sodium) per tablet; this is, essentially “sodium-free”.
Follow exactly the administration instructions of this medication as indicated by your doctor. Even if you are unsure, consult your doctor again.
This medication is only intended for use in postmenopausal women with osteoporosis.
Take one Ácido alendrónico/colecalciferol Tevagen tablet once a week.
Follow these instructions carefully to ensure you benefit from this medication:
2.After getting up in the morning andbeforetaking any food, drink, or other medication, swallow the entire Ácido alendrónico/colecalciferol Tevagen tabletonly with a full glass oftap water(not less than 200 ml).
Use in children and adolescents
This medicationmust not be administered to children under 18 years old.
If you take moreÁcido alendrónico/colecalciferol Tevagenthan you should
If you accidentally take too many tablets, drink a full glass of milk and see your doctorimmediately. Do not induce vomiting and do not lie down.In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested.
If you forget to takeÁcido alendrónico/colecalciferol Tevagen
If you forget a dose, take one tablet the next morning after remembering.Do not take two tablets on the same day. Then, go back to taking one tablet once a week, on the originally chosen day.
If you interrupt treatment withÁcido alendrónico/colecalciferol Tevagen
It is essential that you continue taking Ácido alendrónico/colecalciferol Tevagenwhile your doctor prescribes the medication. This medicationcan only treat your osteoporosis if you continue taking the tablets.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Consult 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:
Otherside effects include
Very common (may affect more than 1 in 10 patients):
Common (may affectup to1in 10 patients):
Uncommon (may affectup to1in 100 patients):
Rare (may affectup to1in 1,000 patients):
Very rare (may affect up to 1 in 10,000 patients):
Reporting of side effects
If you experience side effects, consult your doctor or pharmacist, even if they are possible side effects that do not appear in this leaflet.Also, you can report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
Keepthis medicationout of the sight and reach of children.
Do not usethis medicationafter the expiration date that appears on thecontainer and blisterpackage after CAD. The expiration date is the last day of the month indicated.
This medication does not require special storage conditions.
Medications should not be disposed of through drains or trash.Deposit the containers and
medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacisthow to dispose ofthecontainers and themedications you no longerneed.By doing so, you will help protect the environment.
Composition ofAlendronic acid/colecalciferol Tevagen
Each tablet contains 70 mg of alendronic acid as alendronate sodium monohydrate and 70 micrograms (2,800 UI) of colecalciferol (vitamin D3).
Appearance ofAlendronic acid/colecalciferol Tevagen and contents of the package
White or off-white capsules, with a shape of a capsule, marked with “A70” on one side and “2800” on the other side of the tablet.
The tablets are presented in aluminum blisters in packages of 4, 4 x 1, 4 (calendar pack), 12, 12 (calendar pack), 16, 24 or 28 tablets.
Only some package sizes may be marketed.
Marketing Authorization Holder
Teva Pharma, S.L.U.
C/ Anabel Segura, 11. Edificio Albatros B, 1st floor
28108 Alcobendas, Madrid
Spain
Responsible for manufacturing
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 Debrecen
Hungary
or
Pharmachemie B.V.
Swensweg 5, 2031 GA Haarlem
Netherlands
or
Teva Czech Industries s.r.o.
Ostravska 29, c.p. 305, 74770 Opava-Komarov
Republic of Czech
or
Teva Operations Poland Sp. z.o.o
ul. Mogilska 80. 31-546, Krakow
Poland
or
Merckle GmbH
Ludwig-Merckle-Straße 3, 89143 Blaubeuren
Germany
or
Merckle GmbH
Graf-Arco-Str. 3, 89079 Ulm
Germany
or
BALKANPHARMA – DUPNITSA AD, 3 Samokovsko Shosse Str.,
Dupnitsa, 2600, Bulgaria
Last revision date of thisleaflet:November 2020
Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/
You can access detailed and updated information on this medicine by scanning the QR code included in the carton with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/78794/P_78794.html
The average price of Acido alendronico/colecalciferol tevagen 70 mg/2.800 ui comprimidos in June, 2025 is around 17.92 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.