ALENDRONIC ACID/CHOLECALCIFEROL TEVAGEN 70 mg/2,800 IU TABLETS

Introduction

Package Leaflet: Information for the User

Alendronic Acid/Cholecalciferol Tevagen 70 mg/2,800 IU Tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
• It is especially important that you understand the information in section 3, “How to take Alendronic Acid/Cholecalciferol Tevagen”, before taking this medicine.

Contents of the pack

1. What is Alendronic Acid/Cholecalciferol Tevagen and what is it used for
2. What you need to know before you take Alendronic Acid/Cholecalciferol Tevagen
3. How to take Alendronic Acid/Cholecalciferol Tevagen
4. Possible side effects
5. Storage of Alendronic Acid/Cholecalciferol Tevagen
6. Contents of the pack and other information

1. What is Alendronic Acid/Cholecalciferol Tevagen and what is it used for

What isAlendronic Acid/Cholecalciferol Tevagen?

Alendronic Acid/Cholecalciferol Tevagen is a tablet that contains two active substances, alendronic acid (as alendronate sodium monohydrate) and cholecalciferol (also known as vitamin D3).

What is Alendronic Acid/Cholecalciferol Tevagen used for?

Your doctor has prescribed Alendronic Acid/Cholecalciferol Tevagen to treat your osteoporosis and because you are at risk of having a vitamin D deficiency. Alendronic Acid/Cholecalciferol Tevagen reduces the risk of vertebral and hip fractures in postmenopausal women.

What is alendronic acid?

Alendronic acid belongs to a group of non-hormonal medicines called bisphosphonates. Alendronic acid 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 for maintaining healthy bones. The body can only absorb calcium properly 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. Vitamin D deficiency can lead to bone loss and osteoporosis. In severe cases, 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 keep the skeleton healthy. As a result, bone loss occurs and bones become more fragile. The earlier a woman reaches menopause, the greater the risk of osteoporosis.

Initially, osteoporosis does not have symptoms. However, if left untreated, it can cause bone fractures. Although these are usually painful, vertebral fractures can go unnoticed until they cause a loss of height. Weakened bones can break during normal daily activity, such as when getting up or from minor injuries that would not normally break a bone. Bone fractures usually occur in the hip, spine, or wrist and can cause not only pain but also significant problems such as a hunched posture (dowager's hump) and loss of mobility.

How can osteoporosis be treated?

Osteoporosis can be treated, and it's never too late to start treatment.

As well as your treatment with Alendronic Acid/Cholecalciferol Tevagen, your doctor may suggest that you make changes to your lifestyle to help slow down your disease, such as:

2. What you need to know before you take Alendronic Acid/Cholecalciferol Tevagen

Do not takeAlendronic Acid/Cholecalciferol Tevagen

• if you are allergic to alendronic acid, cholecalciferol (vitamin D3), or any of the other ingredients of this medicine (listed in section 6)
• if you have certain problems in the throat (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 calcium levels in your blood.

If you think any of these 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 this medicine. It is important that you consult your doctor before taking this medicine if:

• you have kidney problems
• you have swallowing or digestive problems
• your doctor has told you that you have Barrett's esophagus (a disease associated with changes in the cells that line the lower part of the esophagus)
• you have poor dental hygiene, gum disease, a planned dental extraction, or do not receive regular dental care
• you have cancer
• you are undergoing chemotherapy or radiotherapy
• 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 important to maintain good oral hygiene when taking this medicine. You should have regular dental check-ups during your treatment and should contact your doctor or dentist if you experience any problems in your mouth or teeth, such as tooth loss, pain, or inflammation.

Irritation, inflammation, or ulceration of the throat (esophagus - the tube that connects your mouth to your stomach) may occur, often with symptoms of chest pain, heartburn, or difficulty or pain when 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 side effects may worsen if patients continue taking Alendronic Acid/Cholecalciferol Tevagen after developing these symptoms (see section 4 "Possible side effects").

Children and adolescents

This medicine must not be given to children under 18 years of age.

Taking Alendronic Acid/Cholecalciferol Tevagen with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Calcium supplements, antacids, and some oral medicines may interfere with the absorption of Alendronic Acid/Cholecalciferol Tevagen if taken at the same time.

Therefore, it is important that you follow the instructions given in section 3 "How to take Alendronic Acid/Cholecalciferol Tevagen" and wait at least 30 minutesbefore taking any other medicine or supplement.

Certain medicines for rheumatism or long-term pain relief called NSAIDs (e.g., aspirin or ibuprofen) may cause digestive problems. Therefore, caution should be exercised if these medicines are taken at the same time as Alendronic Acid/Cholecalciferol Tevagen.

Certain medicines or food additives may prevent the absorption of vitamin D from this medicine, including artificial fat substitutes, mineral oils, weight loss medicine, orlistat, and medicines to lower cholesterol levels; 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 cholecalciferol (vitamin D3) may interact with the following:

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

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

Taking Alendronic Acid/Cholecalciferol Tevagen with food and drinks

Food and drinks (including mineral water) are likely to reduce the effectiveness of this medicine if taken at the same time. Therefore, it is important that you follow the instructions given in section 3 "How to take Alendronic Acid/Cholecalciferol Tevagen". You should wait at least 30 minutesbefore taking any food or drinks except water.

Pregnancy and breast-feeding

This medicine is only intended for use in postmenopausal women. You should not take Alendronic Acid/Cholecalciferol Tevagen if you are pregnant or think you may be pregnant, or if you are breast-feeding.

Driving and using machines

Some side effects of this medicine (e.g., blurred vision, dizziness, and severe bone, muscle, or joint pain) may affect your ability to drive or use machines (see section 4 "Possible side effects"). If you experience any of these side effects, do not drive or use machines until you feel better.

Alendronic Acid/Cholecalciferol Tevagen contains sucrose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Alendronic Acid/Cholecalciferol Tevagen contains sodium

This medicine contains less than 1 mmol (23 mg of sodium) per tablet; this is essentially "sodium-free".

3. How to take Alendronic Acid/Cholecalciferol Tevagen

Follow the instructions for administration of this medicine exactly as prescribed by your doctor. If you are unsure, consult your doctor again.

This medicine is only intended for use in postmenopausal women with osteoporosis.

Take one Alendronic Acid/Cholecalciferol Tevagen tabletonce a week.

Follow these instructions carefully to ensure you benefit from this medicine:

1. Choose the day of the week that best fits your routine. Each week, take one tablet of this medicine on the day you have chosen.

1. After getting up in the morning and before taking any food, drink, or other medicine, swallow the Alendronic Acid/Cholecalciferol Tevagen tablet whole with a full glass of tap water (at least 200 ml).
   • Do nottake it with mineral water (with or without gas) or with any other liquid, including coffee, tea, juice, or milk. Take it onlywith tap water.
   • Do notcrush or chew the tablet and do not let it dissolve in your mouth.
   • Do nottake this medicine at bedtime or before getting up in the morning.

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

1. After swallowing the tablet of this medicine, wait at least 30 minutesbefore taking your first food, drink, or other medicine of the day, including antacids, calcium supplements, and vitamins. This medicine is only effective if taken on an empty stomach.

Use in children and adolescents

This medicine must not be given to children under 18 years of age.

If you take more Alendronic Acid/Cholecalciferol Tevagen than you should

If you take too many tablets by mistake, drink a glass of milk and contact your doctor immediately. 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 Toxicology Information Service, telephone 915 620 420, indicating the medicine and the amount taken.

If you forget to take Alendronic Acid/Cholecalciferol Tevagen

If you forget a dose, take a single tablet the next morning after you remember. Do nottake two tablets on the same day. After that, take one tablet once a week on the originally chosen day.

If you stop taking Alendronic Acid/Cholecalciferol Tevagen

It is important that you continue taking Alendronic Acid/Cholecalciferol Tevagen while your doctor prescribes the medicine. This medicine can only treat your osteoporosis if you continue taking the tablets.

If you have any other questions 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.

Consult your doctor immediately if you experience any of the following side effects, which may be serious and require urgent medical attention:

• allergic reactions such as hives; 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 people):

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

Common (may affect up to 1 in 10 people):

• heartburn; difficulty swallowing; pain when swallowing; ulcer in the throat (esophagus - the tube that connects your mouth to your stomach) that may cause chest pain, heartburn, or difficulty or pain when swallowing,
• swelling of the joints
• abdominal pain, uncomfortable feeling in the stomach, or belching after eating, constipation; feeling of fullness or bloating, diarrhea, flatulence
• hair loss
• itching
• headache
• dizziness
• fatigue
• swelling of the hands or feet.

Uncommon (may affect up to 1 in 100 people):

• 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 you take Alendronic Acid/Cholecalciferol Tevagen")
• black or tarry stools
• blurred vision, eye pain, or redness
• skin rash, redness of the skin
• transient symptoms, similar to flu-like symptoms, such as muscle pain, general feeling of being unwell, and sometimes fever (usually appearing at the beginning of treatment)
• altered taste.

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

• symptoms of low calcium levels in the blood, including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth
• stomach or duodenal ulcers (sometimes severe or with bleeding)
• narrowing of the throat (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 ulcers inside the mouth, numbness or a feeling of heaviness in the jaw, or tooth loss. These may be signs of damage to the bone in the jaw (osteonecrosis) usually associated with delayed healing and infection, often after a dental extraction (see section 2 "What you need to know before you take Alendronic Acid/Cholecalciferol Tevagen"). Contact your doctor and dentist if you experience these symptoms,
• atypical fractures of the thigh that may occur rarely, especially in patients on long-term treatment for osteoporosis. Inform your doctor if you notice pain, weakness, or discomfort in the thigh, hip, or groin, as these may be early symptoms of a possible fracture of the thigh,
• mouth ulcers, when the tablets have been chewed or sucked.

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

• consult your doctor if you have ear pain, discharge from the ear, or an ear infection. These could be symptoms of damage to the bones in the ear.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Alendronic Acid/Colecalciferol Tevagen

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging and blister after CAD. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofAlendronic Acid/Colecalciferol Tevagen

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

Each tablet contains 70 mg of alendronic acid as alendronate sodium monohydrate and 70 micrograms (2,800 IU) 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, polyvinyl alcohol - partially hydrolyzed, titanium dioxide (E171), macrogol 3350, talc (E553b).

Appearance ofAlendronic Acid/Colecalciferol Tevagen and Package Contents

White or almost white capsules, marked with "A70" on one side and "2800" on the other side of the tablet.

The tablets are presented in aluminum blisters in packs of 4, 4 x 1, 4 (calendar pack), 12, 12 (calendar pack), 16, 24, or 28 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Edificio Albatros B, 1ª planta

28108 Alcobendas, Madrid, Spain

Manufacturer

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

Date of Last Revision of thisProspectus:November 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/78794/P_78794.html