ALENDRONIC ACID WEEKLY DAVUR 70 mg TABLETS

Introduction

Package Leaflet: Information for the User

Alendronic Acid Weekly Davur 70 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• 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, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
• It is especially important that you understand the information in section 3.

Contents of the Package Leaflet

1. What is Alendronic Acid Weekly Davur and what is it used for
2. What you need to know before you take Alendronic Acid Weekly Davur
3. How to take Alendronic Acid Weekly Davur
4. Possible side effects
5. Storage of Alendronic Acid Weekly Davur
6. Package Contents and Further 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 that contains the active ingredient alendronic acid (commonly called 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 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 keep a woman's skeleton healthy. As a result, bone loss occurs and the bones become weaker. The earlier a woman reaches menopause, the greater the risk of osteoporosis.

Long before menopause, osteoporosis usually has no symptoms. However, if left untreated, it can result in broken bones. Although these usually hurt, spine fractures can go unnoticed until they cause loss of height. 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 considerable problems such as a hunched posture (dowager's hump) and loss of mobility.

How can osteoporosis be treated?

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

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

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

Eat a balanced dietYour doctor may advise you on your diet or whether you should take any dietary supplements (especially calcium and vitamin D).

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

Do not take Alendronic Acid Weekly Davur

• if you are allergic (hypersensitive) to alendronic acid (alendronate sodium) or any of the other ingredients of this medicine (listed in section 6)
• if you have certain problems with your 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 blood calcium levels

If you think any of these 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 this medicine if:

• you have kidney problems
• you have, or have recently had, digestive problems or swallowing 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 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, a planned dental extraction, or do not receive regular dental care
• you have cancer
• you are undergoing chemotherapy or radiotherapy
• you are undergoing treatment with angiogenesis inhibitors (such as bevacizumab or thalidomide) used in the treatment of cancer
• if you are taking corticosteroids (such as prednisone or dexamethasone) used to treat diseases such as asthma, rheumatoid arthritis, and severe allergies
• if 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 - if you have gum disease

It is important to maintain good oral hygiene when taking alendronate. You should have regular dental check-ups and contact your doctor or dentist if you experience any problems with your mouth or teeth, such as tooth loss, pain, or swelling.

Irritation, inflammation, or ulcers of the esophagus (the tube that connects your mouth to your stomach) may occur, often with symptoms of chest pain, heartburn, difficulty or pain swallowing, especially if patients do not drink a full glass of water and/or if they lie down less than 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 should 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 take any other medicines.

Calcium supplements, antacids, and other oral medicines 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 for rheumatism or long-term pain called NSAIDs (such as aspirin or ibuprofen) may cause stomach problems. Therefore, caution should be exercised if these medicines are taken at the same time as alendronate.

Taking Alendronic Acid Weekly Davur with food and drinks

Food and drinks (including mineral water) are likely to make Alendronic Acid Weekly Davur less effective 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 only intended 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 taking any medicine.

Driving and using machines

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

3. How to take Alendronic Acid Weekly Davur 70 mg

Follow the instructions for administration of this medicine exactly as indicated by your doctor. In case of 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 suits your routine. Each week, take one tablet of Alendronic Acid Weekly Davur on the day you have chosen

1. After getting up in the morning and before taking your first food, drink, or other medicine, swallow the tablet with a full glass of water (at least 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 let it dissolve in your mouth.

1. Do not lie 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. Do not take this medicine at bedtime or before getting up in the morning.
2. If you have difficulty or pain swallowing, chest pain, or new or worsening heartburn, stop taking the medicine and inform your doctor.
3. After swallowing a tablet of Alendronic Acid Weekly Davur, wait at least 30 minutes before consuming your first food, drink, or other medicine of the day, including antacids, calcium supplements, and vitamins. Alendronic acid is only effective if 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone (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 next morning to take the medicine. Do not take two tablets on the same day.Then, take one tablet once a week, on the original day you chose.

If you stop taking Alendronic Acid Weekly Davur

It is important that you take the medicine for as long as your doctor has indicated. Since it is not known how long you should take this medicine, you should discuss with your doctor periodically the need to continue treatment with this medicine to determine if alendronic acid is still suitable for you.

If you have any further 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.

See your doctor immediatelyif you notice any of the following side effects that may be serious and require urgent medical attention:

Common (may affect up to 1 in 10 people)

• Heartburn, difficulty swallowing, pain when swallowing; ulcers in the esophagus (the tube that connects your mouth to your stomach), which can cause chest pain, heartburn, difficulty or pain 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 can cause difficulty breathing or swallowing; severe skin 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 can be signs of damage to the jawbone (osteonecrosis) usually associated with delayed healing and infection, often after a tooth extraction. Inform your doctor and dentist if you experience these symptoms,
• atypical fractures of the thigh bone (femur) that can 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 femur,
• severe pain in bones, muscles, and/or joints.

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

• atypical fracture in places other than the thigh bone (femur).

Other side effects include

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

• severe pain in bones, muscles, and/or joints.

Common (may affect up to 1 in 10 patients)

• joint swelling,
• abdominal pain, uncomfortable feeling in the stomach or belching after eating, constipation, diarrhea, difficulty swallowing, flatulence, feeling full or bloated stomach,
• hair loss; itching,
• headache, dizziness,
• fatigue, swelling of the hands or feet.

Uncommon (may affect up to 1 in 100 patients)

• nausea, vomiting,
• irritation or inflammation of the esophagus (the tube that connects your mouth to your stomach) or stomach,

• black or tarry stools,
• blurred vision, pain or redness in the eye,
• skin rash, redness of the skin,
• flu-like symptoms, such as muscle pain, general feeling of being unwell, and sometimes fever, which usually occur at the start of treatment,

• altered taste.

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

• 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 esophagus (the tube that connects 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 bones of 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 and Health Products Agency (AEMPS) via their website: www.notificaRAM.es. By reporting side 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 of children.

No special storage conditions are required.

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

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Further 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 ingredients (excipients) are: Microcrystalline cellulose, crospovidone, and magnesium stearate.

Appearance of the product and package contents

Alendronic Acid Weekly Davur 70 mg is presented in tablet form. The tablets are white, oval, and flat, marked on one side with "70".

Each pack contains 4 tablets.

Marketing Authorization Holder:

Teva Pharma, S.L.U.

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

Alcobendas, 28108 Madrid (Spain)

Manufacturer:

Teva Pharma S.L.U.

Malpica Industrial Estate, C/ C 4.

50016 - Zaragoza.

Date of last revision of this leaflet: November 2024

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/