Product Information for the User

Alendronic Acid Weekly Davur 70 mg Tablets EFG

Read this entire product information carefully before starting to take the medication.

• Keep this product information, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this product information, inform your doctor or pharmacist.
• It is particularly important that you understand the information in section 3.

1. What is Alendronic Acid Weekly Davur and for what it is used

2. What you need to know before starting to take Alendronic Acid Weekly Davur

3. How to take Alendronic Acid Weekly Davur

4. Possible adverse effects

5. Storage of Alendronic Acid Weekly Davur

6. Contents of the package and additional information

What is Alendronic Acid Weekly Davur?

Alendronic Acid Weekly Davur is a tablet that contains the active ingredient alendronic acid (commonly known as alendronate) and belongs to a group of non-hormonal medications called bisphosphonates. It prevents bone loss that occurs in women after menopause and helps to rebuild bone. Alendronic acid reduces the risk of fractures of the spine and hip.

What is Alendronic Acid Weekly Davur used for?

Your doctor has prescribed alendronic acid to treat your osteoporosis. It reduces the risk of hip fractures.

Alendronic Acid Weekly Davur is a weekly treatment

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 the female hormone estrogen, which helps to maintain a woman's healthy skeleton. As a result, bone loss occurs and the bones become weaker. The earlier a woman reaches menopause, the greater her risk of osteoporosis.

Usually, osteoporosis does not have symptoms before menopause. However, if left untreated, it can result in broken bones. Although these usually hurt, vertebral fractures may go unnoticed until they cause loss of height. Bones can break during normal daily activities, such as getting up, or from minor injuries that would not normally break a normal bone. Fractures of bones usually occur in the hip, spine, or wrist and can cause not only pain but also significant problems such as a hunched posture (widow's hump) and loss of mobility.

How can osteoporosis be treated?

In addition to your treatment with this medication, your doctor may suggest that you make lifestyle changes to help your condition, such as:

Stopping smokingIt appears that smoking increases the rate at which you lose bone and, therefore, may increase your risk of broken bones.

ExerciseAs 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 (especially calcium and vitamin D).

Do not take AcidAlendrónico Weekly Davur

• if you are allergic (to acid alendrónico (alendronate sodium) or to any of the other components of this medication (listed in section 6)
• if you have certain throat (esophagus - the tube that connects the mouth to the stomach) problems such as narrowing or difficulty swallowing
• if you cannot stay standing or sitting for at least 30 minutes
• if your doctor has told you that you have low blood calcium

If you think any of these cases apply to you, do not take the tablets. Talk to your doctor first and follow their advice.

Warnings and precautions

Consult your doctor or pharmacist before starting to take
this medication if:

• you have kidney problems
• you have, or have recently had, 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 been told that you have mineral absorption problems in your stomach or intestines (malabsorption syndrome)
• you have been told that you have low blood calcium
• 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 undergoing treatment with angiogenesis inhibitors (such as bevacizumab or thalidomide) used in cancer treatment
• you are taking corticosteroids (such as prednisone or dexamethasone) used to treat diseases such as asthma, rheumatoid arthritis, and severe allergies
• 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 medication- you have gum disease

It is essential to maintain good oral hygiene while taking alendronate. You should have regular 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, difficulty, or pain swallowing, especially if patients do not drink a full glass of water and/or if they lie down within 30minutes after taking Acid Alendrónico Weekly Davur. These adverse effects may worsen if patients continue taking Acid Alendrónico Weekly Davur after developing these symptoms.

Children and adolescents

This medicationshould not be administered to children or adolescentsunder 18 years of age.

Other medications and Acid Alendrónico Weekly Davur

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

It is likely that calcium supplements, antacids, and other oral medications will interfere with the absorption of Acid Alendrónico Weekly Davur, if taken at the same time. Therefore, it is essential to follow the advice given in section 3.

Certain medications 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 alendronate.

Taking Acid Alendrónico Weekly Davur with food and drinks

It is likely that food and drinks (including mineral water) will make Acid Alendrónico Weekly Davur less effective, if taken at the same time. Therefore, it is essential to follow the advice given in section 3.

Pregnancy and breastfeeding

This medicationis only intended for use in postmenopausal women. Do not take acid alendrónico if you are pregnant or think you may be, or during breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Adverse effects with this medication (including blurred vision, dizziness, and intense bone, muscle, or joint pain) may affect your ability to drive or operate machinery. Individual responses to Acid Alendrónico Weekly Davur may vary (see section 4).

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Take one tablet of Alendronate Weekly Davuronce a week.

1. Choose the day of the week that best suits your routine. Each week, take one tablet of Alendronate Weekly Davur on the day you have chosen.

It is very important to follow instructions 2, 3, 4, and 5 to help the tablet reach the stomach quickly and help reduce possible irritation of the esophagus (the tube that connects the mouth with the stomach).

2. After getting up in the morning and before taking the first meal, drink, or other medication, swallow the tablet only with a full glass ofwater(not less than 200 ml).

- do not take it with mineral water

- do not take it with coffee or tea

- do not take it with juices or milk.

Do not chew the alendronate tablet or let it dissolve in the mouth.

3. 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 the first meal of the day.

4. Do not take this medication at bedtime or before getting up in the morning.

5. If you have difficulty or pain swallowing, chest pain, or new or worsening heartburn, stop taking the medication and inform your doctor.

6. After swallowing a tablet of Alendronate Weekly Davur, wait at least 30 minutes before consuming the first meal, drink, or other medication of the day, including antacids, calcium supplements, and vitamins. Alendronate is only effective if taken on an empty stomach.

If you take more Alendronate Weekly Davur than you should

If you accidentally take too many tablets, drink a full glass of milk and immediately consult your doctor. Do not induce vomiting and do not lie down.

In case of overdose or accidental ingestion, immediately consult your doctor or pharmacist or call the Toxicological Information Service, phone (91) 562 04 20, indicating the medication and the amount ingested.

If you forget to take Alendronate Weekly Davur

If you forget a dose, wait until the next morning to take the medication.Do not take two tablets on the same day.Then, take one tablet once a week, on the original day chosen.

If you interrupt treatment withAlendronateWeekly Davur

It is essential to take the medication for as long as your doctor has indicated.Since it is unknown how long you should take this medication, you should periodically discuss with your doctor the need to continue treatment with this medication to determine if alendronate is still suitable for you.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Seek medical attention immediatelyif you notice any of the following serious side effects that may require urgent treatment:

Frequent (may affect up to1 in 10 people)

• Burning sensation, difficulty swallowing, pain when swallowing; esophageal ulcers (in the tube that connects the mouth to the stomach), which may cause chest pain, burning sensation, or difficulty swallowing.

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

• Allergic reactions such as urticaria; swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing; severe skin reactions,
• Dental 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 after a dental extraction. Inform your doctor and dentist if you experience these symptoms,
• Atypical femur fractures (thigh bone 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 signs and indicative of a possible femur fracture,
• Intense bone, muscle, and/or joint pain.

Frequency not known (cannot be estimated from available data):

• Atypical fractures in locations other than the femur (thigh bone).

Other side effects include

Very frequent(may affect more than 1 in 10 patients)

• Painin some cases intense of bones, muscles, and/or joints.

Frequent (may affect up to1 in 10 patients)

• Joint swelling,
• Abdominal pain,uncomfortable sensation in the stomach or belching after eating,constipation, diarrhea, difficulty swallowing, flatulence, feeling of fullness or feeling of stomach swelling,
• Hair loss; itching,
• Headache, dizziness,
• Fatigue, swelling of the hands or legs.

Not uncommon (may affect up to1 in 100 patients)

• Nausea, vomiting,
• Irritation or inflammation of the throat (esophagus - the tube that connects the mouth to the stomach) or stomach,

• Black stools or tar-like stools,
• Blurred vision, eye pain or redness,
• Rash, skin redness,
• Transient symptoms similar to the flu, such as muscle pain, general feeling of discomfort, and sometimes fever that usually appear at the beginning of treatment,

• Alteration of taste.

Rare (may affect up to1 in 1,000 patients)

• 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),
• Esophageal stricture (the tube that connects the mouth to the stomach),
• Rash that worsens with sunlight,
• Mouth ulcers.

Very rare(may affect up to1 in 10,000 people)

• Consultyour doctor if you have ear pain, the ear is draining or you have an ear infection. These may be signs of damage to the bones in the ear.

Reporting side effects

If you experience any type of side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use, Website:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach.

No special storage conditions are required.

Do not use this medication after the expiration date indicated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Alendronic Acid Weekly Davur

The active ingredient is alendronic acid. Each tablet contains 70 mg of alendronic acid as alendronate sodium trihydrate.

The other components (excipients) are:Microcrystalline cellulose, crospovidone, and magnesium stearate.

Appearance of the product and content of the packaging

Alendronic Acid Weekly Davur 70 mg is presented in the form of tablets. The tablets are white, oval, and flat, marked on one face with “70”.

Each package contains 4 tablets.

Holder of the marketing authorization:

Teva Pharma, S.L.U.

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

Alcobendas, 28108 Madrid (Spain)

Responsible for manufacturing:

Teva Pharma S.L.U.

Malpica Industrial Estate, C/ C 4.

50016 - Zaragoza.

Date of the last review of this leaflet: November 2024

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/