Alendronic acid Semanal Davur 70 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Alendronic Acid Weekly Davur 70 mg Tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you; do not give it to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
• It is particularly important that you understand the information in section 3.

Contents of the leaflet

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

1. What is Alendronic Acid Weekly Davur 70 mg Tablets and what is it used for

What is Alendronic Acid Weekly Davur?

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

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 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 maintain a woman's skeleton in good health. As a result, bone loss occurs and bones become weaker. The earlier a woman reaches menopause, the greater her risk of developing osteoporosis.

Long before menopause, osteoporosis usually has no symptoms. However, if left untreated, it can lead to broken bones. Although fractures are usually painful, spinal bone fractures may go unnoticed until they cause loss of height. Bones may break during normal everyday 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 cause not only pain but also significant problems such as stooped posture ("dowager's hump") and loss of mobility.

How can osteoporosis be treated?

As well as treatment with this medicine, your doctor may suggest lifestyle changes to help manage your condition, such as:

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

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 about your diet or whether you should take any dietary supplements (especially calcium and vitamin D).

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

Do not take Alendronic Acid Weekly Davur

• if you are allergic to alendronic acid (sodium alendronate) or to any of the other ingredients of this medicine (listed in section 6)
• if you have certain abnormalities in your throat (oesophagus—the tube connecting your mouth to your stomach), such as narrowing or difficulty swallowing
• if you cannot remain upright (sitting or standing) for at least 30 minutes
• if your doctor has told you that you have low blood calcium levels

If you think any of these situations apply to you, do not take the tablets. Speak to your doctor first and follow the advice given.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine if:

• you have kidney problems
• you have or have recently had digestive problems or difficulty swallowing
• 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 been told that you have problems absorbing minerals in your stomach or intestines (malabsorption syndrome)
• you have been told that you have low blood calcium levels
• you have poor dental hygiene, gum disease, an upcoming dental extraction, or do not receive regular dental care
• you have cancer
• you are receiving chemotherapy or radiotherapy
• you are being treated with angiogenesis inhibitors (such as bevacizumab or thalidomide) used in cancer treatment
• you are taking corticosteroids (such as prednisone or dexamethasone) used to treat conditions 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 examination before starting treatment with this medicine—especially if you have gum disease.

It is important to maintain good oral hygiene while taking alendronate. You should have regular dental check-ups during treatment and should 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 Alendronic Acid Weekly Davur. These adverse effects may worsen if patients continue taking Alendronic Acid Weekly Davur after developing these symptoms.

Children and adolescents

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

Other medicines and Alendronic Acid Weekly Davur

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

Calcium supplements, antacids, and other oral medications may interfere with the absorption of Alendronic Acid Weekly Davur if taken at the same time. Therefore, it is important that you follow the advice given in section 3.

Certain medicines used for rheumatism or long-term pain called NSAIDs (for example, aspirin or ibuprofen) may cause gastrointestinal problems. Therefore, caution should be taken if these medicines are taken together with alendronate.

Taking Alendronic Acid Weekly Davur with food and drinks

Food and drinks (including mineral water) may reduce the effectiveness of Alendronic Acid Weekly Davur if taken at the same time. Therefore, it is important that you follow the advice given in section 3.

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Adverse effects have been reported with this medicine (including blurred vision, dizziness, and severe bone, muscle, or joint pain) that may affect your ability to drive or operate machinery. Individual responses to Alendronic Acid Weekly Davur may vary (see section 4).

3. How to take Alendronic Acid Weekly Davur 70 mg

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Take one tablet of Alendronic Acid Weekly Davur once a week.

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

It is very important that you follow steps 2, 3, 4, and 5 to ensure the tablet reaches the stomach quickly and to help reduce the potential for irritation of the esophagus (the tube connecting the mouth to the stomach).

2. After getting up in the morning and before taking any food, drink, or other medication, swallow the tablet with a full glass of plain water (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 alendronic acid tablet or allow it to 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 your first meal of the day.

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

5. If you experience difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking the medicine and contact your doctor immediately.

6. After swallowing one tablet of Alendronic Acid Weekly Davur, wait at least 30 minutes before taking any food, drink, or other medication of the day, including antacids, calcium supplements, and vitamins. Alendronic acid is only effective when taken on an empty stomach.

If you take more Alendronic Acid Weekly Davur 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 or pharmacist immediately, or call the Toxicology Information Service at telephone number (91) 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Alendronic Acid Weekly Davur

If you miss a dose, wait until the following morning to take the medicine. 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 treatment with Alendronic Acid Weekly Davur

It is important to continue taking the medicine for as long as your doctor has instructed. Since the optimal duration of treatment with this medicine is unknown, you should periodically discuss with your doctor whether continuing treatment is still appropriate for you.

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 experiences them.

Contact your doctor immediately if you notice any of the following adverse effects, which may be serious and for which you may need urgent treatment:

Common (may affect up to 1 in 10 people)

• Burning sensation, difficulty swallowing, pain when swallowing; ulcer in the throat (esophagus – the tube connecting your mouth to your stomach), which may cause chest pain, burning, or difficulty or pain when swallowing.

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

• Allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing; severe skin reactions,
• Pain in the mouth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loss of a tooth. These may be signs of jaw bone damage (osteonecrosis), usually associated with delayed healing and infection, often following a dental extraction. Inform your doctor and dentist if you experience these symptoms,
• Atypical femur fractures (thigh bone), which may rarely occur, 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,
• Severe bone, muscle, and/or joint pain.

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

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

Other adverse effects include

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

• Pain, sometimes severe, in bones, muscles, and/or joints.

Common (may affect up to 1 in 10 patients)

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

Uncommon (may affect up to 1 in 100 patients)

• Nausea, vomiting,
• Irritation or inflammation of the throat (esophagus – the tube connecting your mouth to your stomach) or of the stomach,
• 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 feeling of discomfort, and sometimes fever, which usually occur at the beginning of treatment,
• Altered taste.

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

• 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 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,
• Mouth ulcers.

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 ear bones.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products, Website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Alendronic Acid Weekly Davur 70 mg

Keep out of sight and reach.

No special storage conditions required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE collection 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 Weekly Davur

The active substance 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 contents of the pack

Alendronic Acid Weekly Davur 70 mg is presented as tablets. The tablets are white, oval-shaped and flat, marked on one side with "70".

Each pack contains 4 tablets.

Marketing Authorization Holder:

Teva Pharma, S.L.U.

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

Alcobendas, 28108 Madrid (Spain)

Manufacturer:

Teva Pharma S.L.U.

Polígono Malpica c/ C 4.

50016 - Zaragoza.

Date of the latest revision of this leaflet: November 2024

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