Product Information for the User

Alendronic Acid/Colecalciferol Tevagen 70 mg/5,600 IU Tablets

Read this entire product information carefully before starting to take this medicine, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this product information. See section 4.
• It is especially important that you understand the information in section 3. How to take Alendronic Acid/Colecalciferol Tevagen, before taking this medicine.

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 calcium absorption 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 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's never too late to start treatment.

Along with your treatment with Alendronate/Colecalciferol Tevagen, your doctor may suggest lifestyle changes to help slow down your disease, such as:

Stopping smokingSmoking appears to increase the rate of bone loss and, therefore, may increase your risk of bone fractures.

ExerciseLike muscles, bones need exercise to stay strong and healthy. Consult your doctor before starting any exercise program.

Eating a balanced dietYour doctor may advise you on your diet or whether you should take any dietary supplements.

Do not takeAlendronate/Colecalciferol Tevagen

• if you are allergic to alendronate, colecalciferol (vitamin D3) or any of the other ingredients of this medicine (listed in section 6)
• if you have certain problems in your throat (esophagus - the tube that connects your mouth to your stomach), such as narrowing or difficulty swallowing
• if you cannot stand or sit up 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 conditions apply to you,do not take 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 have kidney problems
• you have digestive or swallowing problems
• your doctor has told you that you have Barrett's esophagus (a disease associated with changes in the cells that cover the lower part of the esophagus)
• you have poor dental hygiene, gum disease, a planned tooth extraction or do not receive regular dental care
• you have cancer
• you are undergoing chemotherapy or radiation therapy
• 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 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 taking Alendronate/Colecalciferol Tevagen after developing these symptoms (see section 4 “Possible side effects”).

Children and adolescents

This medicineshould not be administered to children under 18 years.

Taking Alendronate/Colecalciferol Tevagen with other medicines

Inform your doctor or pharmacist if you aretaking, havetaken recentlyor 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” andwait at least 30 minutesbefore 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 exercised if taken at the same time as Alendrónate/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 medications; 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:

• thiazide diuretics (used to eliminate water from the body by increasing urine production)
• steroids such as hydrocortisone or prednisolone (used to treat inflammation)
• cardiotonic glucosides such as digitalis (used to treat heart disorders)
• actinomycin (a medicine used to treat certain types of cancer)
• imidazole antifungals (medicines such as clotrimazole and ketoconazole used to treat fungal diseases)

If you are taking any of the medicines mentioned above, your doctor will give you additional instructions.

Taking Alendronate/Colecalciferol Tevagen with food and drinks

It is likely that foods and drinks (including mineral water) will reduce the effectiveness of this medicineif 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 medicineis only intended for use in postmenopausal women. Do not take Alendronate/Colecalciferol Tevagen 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 in doubt, consult your doctor again.

This medicationis only intended for use in postmenopausal women with osteoporosis.

Take one tablet of Alendronate/Colecalciferol Tevagenonce a week.

Follow these instructions carefully to ensure that you benefit from this medication:

1.Choose the day of the week that best suits your routine. Every week, take one tablet of this medication on the day you have chosen.

2.After getting up in the morning andbeforetaking any food, drink, or other medication, swallow the tabletwholeof Alendronate/Colecalciferol Tevagenonly with a full glass oftap water(not less than 200 ml).

• Do nottake it with mineral water (with or without gas), or with any other liquid, including coffee, tea, juice, or milk. Take itonlywith tap water.
• Do notcrush or chew the tablet and do not allow it to dissolve in your mouth
• Do nottake this medication at bedtime or before getting up in the morning.

1. Do notlie down – remain upright (sitting, standing, or walking) – for at least 30 minutes after swallowing the tablet. Do not lie down until after the first meal of the day.

1. After swallowing the tablet of Alendronate/Colecalciferol Tevagen,wait at least 30 minutesbefore taking the first meal, drink, or other medication of the day, including antacids, calcium supplements, and vitamins. Alendronate/Colecalciferol Tevagenis only effective if taken on an empty stomach.

Use in children and adolescents

This medicationshould not be administered to children under 18 years old.

If you take moreAlendronate/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 takeAlendronate/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 original day chosen.

If you interrupt treatment withAlendronate/Colecalciferol Tevagen

It is essential that you continue taking Alendronate/Colecalciferol Tevagenwhile your doctor prescribes the medication. This medicationcan only treat your osteoporosis if you continue taking the tablets.

If you have any other doubts 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:

• Allergic reactions such as urticaria; swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing; severe skin reactions.

Otherside effects include:

Very common (may affect more than 1 in 10 patients):

• Bone, muscle, or joint pain, sometimes severe.

Common (may affectup to1 in 10patients):

• Heat; difficulty swallowing; pain when swallowing; esophageal ulcer (the tube that connects your mouth to your stomach) that may cause chest pain, heat, or difficulty or pain when swallowing,
• Swelling of the joints
• Abdominal pain, uncomfortable sensation in the stomach or belching after eating, constipation; feeling of fullness or bloating in the stomach, diarrhea, flatulence
• Hair loss
• Itching
• Headache
• Dizziness
• Fatigue
• Swelling of the hands or legs.

Uncommon (may affectup to1 in 100patients):

• Nausea, vomiting
• Irritation or inflammation of the throat (esophagus - the tube that connects your mouth to your stomach) or stomach (see section 2 “What you need to know before starting to take Alendronate/Colecalciferol Tevagen”)
• Black stools or stools similar to tar
• Blurred vision, eye pain or redness
• Skin rash, redness of the skin
• Transient symptoms, similar to those of the flu, such as muscle pain, general feeling of discomfort, and sometimes fever (usually appear at the beginning of treatment)
• Alteration of taste.

Rare (may affectup to1 in 1,000patients):

• Symptoms of low calcium levels in the blood, including muscle cramps or spasms and/or tingling in the fingers or around the mouth
• Stomach ulcers or peptic ulcers (sometimes severe or with bleeding)
• Narrowing of the esophagus (esophagus - the tube that connects your mouth to your stomach)
• Skin rash that worsens with sunlight, severe allergic reactions
• Pain in the mouth, and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or tooth loss. These may be signs of jaw bone damage (osteonecrosis) usually associated with delayed healing and infection, often after a dental extraction (see section 2 “What you need to know before starting to take Alendronate/Colecalciferol Tevagen”). Contact your doctor and dentist if you experience these symptoms,
• Atypical femoral fractures that may occur in rare cases, especially in patients undergoing prolonged treatment for osteoporosis. Inform your doctor if you notice pain, weakness, or discomfort in the thigh, hip, or groin, as they may be early symptoms and indicative of a possible femoral fracture,
• Ulcers in the mouth, when the tablets have been chewed or sucked.

Very rare (may affect up to 1 in 10,000 patients):

• Consult your doctor if you have ear pain, the ear is discharging or you have an ear infection. These may be symptoms of damage to the bones in the ear.

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 Vigilance 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 blisterand after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medicines should not be thrown down the drains or in the trash.Dispose of the containers and the

medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacisthow to dispose ofthecontainers and themedicines you no longerneed.By doing so, you will help protect the environment..

Composition ofAlendronic acid/colecalciferol Tevagen

• The active principles are alendronic acid and colecalciferol (vitamin D3).

Each tablet contains 70 mg of alendronic acid as alendronate sodium monohydrate and 140 micrograms (5.600 UI) of colecalciferol (vitamin D3).

• The other components(excipients)are mannitol (E421), microcrystalline cellulose (E460), anhydrous colloidal silica (E551), magnesium stearate (E572), sucrose, copovidone (1201), butylhydroxytoluene (BHT) (E321), medium-chain triglycerides, partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc (E553b).

Appearance ofAlendronic acid/colecalciferol Tevagenand contents of the package

White or off-white tablets, in the shape of a capsule, marked with “A70” on one side and “5600” 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

Czech Republic

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

The 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 packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/78795/P_78795.html