Alendronate acid/colecalciferol Tevagen 70 mg/5,600 IU tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Alendronic acid/colecalciferol Tevagen 70 mg/5,600 IU tablets

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these effects are 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/colecalciferol Tevagen, before taking this medicine.

Leaflet contents:

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

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

What is Alendronic Acid/Cholecalciferol Tevagen?

Alendronic Acid/Cholecalciferol Tevagen is a tablet containing 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 vitamin D deficiency. Alendronic Acid/Cholecalciferol Tevagen reduces the risk of spinal 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 rebuild bone. It reduces the risk of spinal and hip fractures.

What is vitamin D?

Vitamin D is an essential nutrient required for calcium absorption and for maintaining healthy bones. The body can only properly absorb calcium from food if sufficient vitamin D is present. Very few foods contain vitamin D. The main source of vitamin D is exposure to sunlight, which triggers vitamin D production in the 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, increasing the risk of falls and fractures.

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 called estrogens, which help 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 developing osteoporosis.

Osteoporosis initially has no symptoms. However, if left untreated, it can lead to bone fractures. Although fractures are usually painful, spinal fractures may 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 healthy bone. Bone fractures typically occur in the hip, spine, or wrist, and may result not only in pain but also in significant problems such as stooped posture (commonly known as "dowager's hump") and loss of mobility.

How can osteoporosis be treated?

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

In addition to your treatment with Alendronic Acid/Cholecalciferol Tevagen, your doctor may suggest lifestyle changes to help slow the progression of the 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.

2. What you need to know before starting to take Alendronic acid/colecalciferol Tevagen

DO NOT take Alendronic acid/colecalciferol Tevagen

• if you are allergic to alendronic acid, colecalciferol (vitamin D3), or any of the other ingredients of this medicine (listed in section 6)
• if you have certain throat (oesophagus – the tube connecting your mouth to your stomach) problems, such as narrowing or difficulty swallowing
• if you cannot remain upright 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 cases apply to you, DO NOT take the tablets. Consult your doctor first and follow their advice.

Warnings and precautions

Talk to 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 swallowing or digestive problems
• your doctor has told you that you have Barrett’s oesophagus (a condition associated with changes in the cells lining the lower part of the oesophagus)
• you have poor dental hygiene, gum disease, have an upcoming dental extraction, or do not receive regular dental care
• you have cancer
• you are receiving 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 examination before starting treatment with this medicine.

It is important to maintain good oral hygiene while on treatment with 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 swelling.

Irritation, inflammation, or ulceration of the throat (oesophagus – the tube connecting your mouth to your stomach) may occur, often with symptoms such as chest pain, heartburn, or difficulty or pain when swallowing, especially if patients do not drink a full glass of water and/or lie down within 30 minutes after taking this medicine. These adverse effects may worsen if patients continue taking Alendronic acid/colecalciferol 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/colecalciferol Tevagen with other medicines

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

Calcium supplements, antacids, and certain oral medicines may interfere with the absorption of Alendronic acid/colecalciferol if taken at the same time.

Therefore, it is important that you follow the instructions given in section 3 “How to take Alendronic acid/colecalciferol Tevagen” and that you wait at least 30 minutes before taking any other medicine or supplement.

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

Certain medicines or food additives may prevent the absorption of vitamin D from this medicine, including artificial fat substitutes, mineral oils, the weight-loss medicine orlistat, and cholesterol-lowering medicines such as colestyramine and colestipol. Medicines for epileptic seizures (convulsions) 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 remove water from the body by increasing urine production)
• steroids such as hydrocortisone or prednisolone (used to treat inflammation)
• cardiac glycosides such as digoxin (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 listed above, your doctor will give you additional instructions.

Taking Alendronic acid/colecalciferol Tevagen with food and drinks

Food and drinks (including mineral water) may reduce the effectiveness of this medicine if taken at the same time. Therefore, it is important that you follow the advice given in section 3 “How to take Alendronic acid/colecalciferol Tevagen”. You should wait at least 30 minutes before consuming any food or drinks other than water.

Pregnancy and breastfeeding

This medicine is intended for use only in postmenopausal women. You must not take Alendronic acid/colecalciferol Tevagen if you are or think you may be pregnant, or if you are breastfeeding.

Driving and using machines

Adverse effects have been reported with this medicine (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 “Possible side effects”). If you experience any of these adverse effects, you should not drive or operate machinery until you feel better.

Alendronic acid/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.

Alendronic acid/colecalciferol Tevagen contains sodium

This medicine contains less than 1 mmol (23 mg of sodium) per tablet; therefore, it is essentially “sodium-free”.

3. How to take Alendronic acid/colecalciferol Tevagen

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor again.

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

Take one tablet of Alendronic acid/colecalciferol Tevagen once 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/colecalciferol Tevagen tablet whole with a full glass of tap water (not less than 200 ml).

   • Do not take it with mineral water (still or sparkling) or with any other liquid including coffee, tea, juice, or milk. Take it only with tap water.
   • Do not crush or chew the tablet and do not allow it to dissolve in your mouth.
   • Do not take this medicine at bedtime or before getting up in the morning.

2. 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 your first meal of the day.

3. After swallowing the alendronic acid/colecalciferol Tevagen tablet, wait at least 30 minutes before taking your first meal, drink, or other medicine of the day, including antacids, calcium supplements, and vitamins. Alendronic acid/colecalciferol Tevagen is effective only 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/colecalciferol Tevagen than you should

If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately. Do not induce vomiting and do not lie down. In case of overdose or accidental ingestion, contact your doctor, pharmacist, or the Toxicology Information Service immediately at telephone number 915 620 420, stating the medicine and the amount ingested.

If you forget to take alendronic acid/colecalciferol Tevagen

If you miss a dose, take one tablet the morning after you remember. Do not take two tablets on the same day. Then resume taking one tablet once a week on your originally chosen day.

If you stop taking alendronic acid/colecalciferol Tevagen

It is important that you continue taking alendronic acid/colecalciferol Tevagen for as long as your doctor prescribes it. This medicine will treat your osteoporosis only if you continue taking the tablets.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Seek immediate medical advice if you experience any of the following adverse effects, which may be serious and for which you may require urgent medical treatment:

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

Other adverse 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; ulceration in the throat (esophagus – the tube connecting your mouth to your stomach), which may cause chest pain, heartburn, or difficulty or pain when swallowing,
• joint swelling,
• abdominal pain, stomach discomfort or burping after eating, constipation; sensation of fullness or bloating in the stomach, diarrhea, flatulence,
• 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 throat (esophagus – the tube connecting your mouth to your stomach) or stomach (see section 2 “What you need to know before taking alendronic acid/colecalciferol Tevagen”),
• black or tar-like stools,
• blurred vision, eye pain or redness,
• skin rash, redness of the skin,
• transient, flu-like symptoms such as muscle pain, general malaise, and sometimes fever (usually occurring at the beginning of treatment),
• altered taste.

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

• symptoms of low blood calcium levels, including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth,
• stomach ulcers or peptic ulcers (sometimes severe or with bleeding),
• narrowing of the throat (esophagus – the tube connecting your mouth to your stomach),
• skin rash that worsens with sunlight, severe allergic reactions,
• mouth pain, and/or jaw pain, 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 following dental extraction (see section 2 “What you need to know before taking alendronic acid/colecalciferol Tevagen”). Contact your doctor and dentist if you experience these symptoms,
• atypical femoral fractures, which may occur rarely, particularly 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 signs indicating a possible femur fracture,
• mouth ulcers, when 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 ear infection. These could be symptoms of damage to the bones of the ear.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 outer packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Alendronic Acid/Cholecalciferol Tevagen

• The active substances are alendronic acid and cholecalciferol (vitamin D3).

Each tablet contains 70 mg of alendronic acid as sodium alendronate monohydrate and 140 micrograms (5,600 IU) of cholecalciferol (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 hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc (E553b).

Appearance of Alendronic Acid/Cholecalciferol Tevagen and contents of the pack

White or almost white, capsule-shaped tablets, marked with “A70” on one side and “5600” on the other side of the tablet.

The tablets are presented in aluminium 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 commercially available.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Edificio Albatros B, 1st floor

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

The 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 the most recent revision of this package leaflet: November 2020

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

You can access detailed and up-to-date information about this medicine by scanning the QR code included on the outer packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/78795/P_78795.html