Alendronic acid Semanal Aurovitas Spain 70 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Alendronic Acid Aurovitas Spain 70 mg tablets EFG

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, consult 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 could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

What is Alendronic Acid Weekly Aurovitas Spain?

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

What is Alendronic Acid Weekly Aurovitas Spain used for?

Your doctor has prescribed weekly alendronic acid to treat your osteoporosis. This medicine reduces the risk of spinal and hip fractures.

Alendronic Acid Weekly 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.

Often, osteoporosis has no symptoms in its early stages. 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 daily activities, such as getting up from a chair, 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 (commonly known as "dowager's hump") and loss of mobility.

How can osteoporosis be treated?

In addition to your treatment with weekly alendronic acid, 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 Alendronic Acid Aurovitas Spain Weekly

Do not take Alendronic Acid Aurovitas Spain Weekly

• If you are allergic to sodium alendronate trihydrate or to any of the other
• components of this medicine (listed in section 6).
• If you have certain disorders of your esophagus (esophagus – the tube connecting your mouth to your stomach), such as narrowing or difficulty swallowing.
• If you cannot remain upright (standing or sitting) 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 weekly alendronic acid tablets 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 esophagus (a condition associated with changes in the cells lining 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, an upcoming dental extraction, or do not receive regular dental care,
• you have cancer,
• you are undergoing 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 weekly alendronic acid.

It is important to maintain good oral hygiene while taking weekly alendronic acid. 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 (esophagus – the tube connecting your mouth to your stomach) may occur, often with symptoms such as chest pain, heartburn, or difficulty or pain when swallowing, particularly in patients who have not taken a full glass of water and/or who have lain down before 30 minutes have passed after taking Alendronic Acid Aurovitas Spain Weekly. These adverse effects may worsen if patients continue taking weekly alendronic acid 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 Aurovitas Spain Weekly

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 weekly alendronic acid if taken at the same time. Therefore, it is important to follow the advice provided in section 3. How to take Alendronic Acid Aurovitas Spain Weekly.

Certain medications used for rheumatic conditions or long-term pain called NSAIDs (e.g., acetylsalicylic acid or ibuprofen) may cause gastrointestinal problems. Therefore, caution should be taken if these medicines are taken at the same time as weekly alendronic acid.

Use of Alendronic Acid Aurovitas Spain Weekly with food, drinks, and alcohol

Food and drinks (including mineral water) may reduce the effectiveness of weekly alendronic acid if taken at the same time. Therefore, it is important to follow the advice provided in section 3. How to take Alendronic Acid Aurovitas Spain Weekly.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Adverse effects have been reported with weekly alendronic acid (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).

Alendronic Acid Aurovitas Spain Weekly contains sodium

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

3. How to take Alendronic Acid Weekly Aurovitas Spain

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

Take one alendronic acid weekly tablet once a week.

Follow these instructions carefully to ensure you benefit from alendronic acid weekly.

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

It is very important that you follow instructions 2, 3, 4 and 5 to help ensure the alendronic acid weekly tablet reaches the stomach quickly and to help reduce the possibility of irritation of the oesophagus (the tube connecting the mouth to the stomach).

1. After getting up in the morning and before taking your first food, drink, or other medication, swallow the tablet whole with a full glass of tap water (not mineral water) (no less than 200 ml), so that the medicine is properly absorbed:

• do not take it with mineral water (still or sparkling),
• do not take it with coffee or tea,
• do not take it with juices or milk.

Do not crush or chew the tablet, nor allow it to dissolve in the mouth, due to the possibility of developing mouth ulcers.

1. 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.

2. Do not take Alendronic Acid Weekly at bedtime or before getting up in the morning.

3. If you experience difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking this medicine and inform your doctor.

4. After swallowing an Alendronic Acid Weekly tablet, wait at least 30 minutes before taking your first food, drink, or other medication of the day, including antacids, calcium supplements, and vitamins. This medicine is only effective if taken on an empty stomach.

If you take more Alendronic Acid Weekly Aurovitas Spain than you should

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

If you forget to take Alendronic Acid Weekly Aurovitas Spain

If you miss a dose, wait until the following morning to take Alendronic Acid Weekly. 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 Weekly Aurovitas Spain

It is important that you take Alendronic Acid Weekly for as long as your doctor has prescribed it. Since it is unknown how long alendronic acid weekly should be taken, you should periodically discuss with your doctor the need to continue treatment to determine whether it is still appropriate for you.

An Instruction Card is included in the package of this medicine. It contains important information to help you remember how to take Alendronic Acid Weekly properly.

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.

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

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

• Burning sensation; difficulty swallowing; pain when swallowing; ulceration 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 tooth loss. These may be signs of bone damage in the jaw (osteonecrosis), usually associated with delayed healing and infection, often following a tooth extraction. Inform your doctor and dentist if you experience these symptoms.
• Atypical femur fractures (thigh bone), which may occur rarely, particularly in patients receiving 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 indicating a possible femur fracture.
• Severe bone, muscle, and/or joint pain.

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

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

Other adverse effects include

Very common (may affect more than 1 in 10 people):

• Bone, muscle, and/or joint pain, sometimes severe.

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

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

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

• Nausea; vomiting.
• Irritation or inflammation of the esophagus (esophagus – the tube connecting your mouth to your stomach) or stomach.
• Black or tarry stools.
• Blurred vision; eye pain or redness.
• Skin rash; redness of the skin.
• Transient flu-like symptoms such as muscle pain, general malaise, sometimes with fever, usually at the beginning of treatment.
• Taste disturbances.

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

• Symptoms of low blood calcium levels including muscle cramps or spasms and/or tingling sensations in the fingers or around the mouth.
• Stomach or peptic ulcers (sometimes severe or with bleeding).
• Narrowing of the esophagus (esophagus – the tube connecting your mouth to your stomach).
• Skin rash that worsens upon exposure to sunlight.
• Mouth ulcers.

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

• Consult your doctor if you have ear pain, ear discharge, or an ear infection. These could be symptoms of bone damage in the ear.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Aurovitas Spain Weekly

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the carton and blister pack after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Alendronic Acid Weekly Aurovitas Spain

• The active substance is alendronic acid. Each tablet contains 70 mg of alendronic acid (equivalent to 91.363 mg of sodium alendronate trihydrate).
• The other components are: microcrystalline cellulose, corn starch, sodium carboxymethyl starch (type A) (derived from potato starch), povidone (Kollidon 30) and magnesium stearate.

Appearance of the medicine and contents of the pack

White to off-white, oval, biconvex, uncoated tablets, engraved with the letter “F” on one side and the number “21” on the other. Size: 12.8 x 7.0 mm.

Alendronic Acid Weekly Aurovitas Spain tablets are available in blisters and HDPE bottles.

Pack sizes:

Blister: 2, 4, 8, 12, 20, 30, 40, 50 and 60 tablets.

HDPE bottle: 30, 50, 60 and 250 tablets.

Only some pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036, Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Cyprus Alendronic Acid Aurobindo 70 mg tablets

Denmark Alendronat “Aurobindo”

Italy Acido Alendronico Aurobindo

Malta Alendronic Acid 70 mg tablets

Netherlands Alendroninezuur Aurobindo 70 mg, tabletten

Spain Ácido Alendrónico semanal Aurovitas Spain 70 mg tablets EFG

Sweden Alendronat Aurobindo 70 mg tabletter

Date of the most recent revision of this leaflet: July 2025

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