ALENDRONIC ACID WEEKLY AUROVITAS SPAIN 70 mg TABLETS

Introduction

Package Leaflet: Information for the User

Alendronic Acid Weekly Aurovitas Spain 70 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

What is Alendronic Acid Weekly Aurovitas Spain?

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

What is Alendronic Acid Weekly Aurovitas Spain used for?

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

Alendronic Acid Weekly is aweekly 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 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.

For a long time, osteoporosis usually has no symptoms. However, if left untreated, it can result in broken bones. Although these usually hurt, spinal fractures may 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. Fractures usually occur in the hip, spine, or wrist and can cause not only pain but also significant problems such as a stooped posture (dowager's hump) and loss of mobility.

How can osteoporosis be treated?

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

• Stopping smoking: Smoking appears to increase the rate at which you lose bone and may therefore 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.

Eat a balanced diet: Your 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 Aurovitas Spain

Do not take Alendronic Acid Weekly Aurovitas Spain

• If you are allergic to alendronate sodium trihydrate 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

Talk to your doctor or pharmacist before starting to take alendronic acid weekly tablets if:

• you have kidney problems,
• you have, or have had recently, problems with your digestive system or swallowing,
• your doctor has told you that you have Barrett's esophagus (a condition 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 health, gum disease, a planned dental extraction, or do not receive regular dental care,
• you have cancer,
• you are undergoing chemotherapy or radiotherapy,
• you are taking angiogenesis inhibitors (such as bevacizumab or thalidomide) used in the treatment of cancer,
• 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 alendronic acid weekly.

It is important to maintain good oral hygiene when you are taking alendronic acid weekly. 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 ulceration of the throat (esophagus - the tube that connects your mouth to your stomach) may occur, often with symptoms such as chest pain, heartburn, or difficulty or pain swallowing, especially in patients who do not drink a full glass of water and/or if they lie down less than 30 minutes after taking Alendronic Acid Weekly Aurovitas Spain. These side effects may worsen if patients continue taking alendronic acid weekly after developing these symptoms.

Children and adolescents

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

Other medicines and Alendronic Acid Weekly Aurovitas Spain

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 if taken at the same time. Therefore, it is important that you follow the advice given in section 3. How to take Alendronic Acid Weekly Aurovitas Spain.

Certain medicines for rheumatism or long-term pain, called NSAIDs (e.g., aspirin or ibuprofen), may cause stomach problems. Therefore, caution should be exercised if these medicines are taken at the same time as alendronic acid weekly.

Using Alendronic Acid Weekly Aurovitas Spain with food, drinks, and alcohol

Food and drinks (including mineral water) may make alendronic acid weekly less effective if taken at the same time. Therefore, it is important that you follow the advice given in section 3. How to take Alendronic Acid Weekly Aurovitas Spain.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Side effects with alendronic acid weekly (e.g., blurred vision, dizziness, and severe bone, muscle, or joint pain) have been reported that may affect your ability to drive or use machines (see section 4).

Alendronic Acid Weekly Aurovitas Spain contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Alendronic Acid Weekly Aurovitas Spain

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

Take one Alendronic Acid Weekly tabletonce a week.

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

1. Choose the day of the week that best fits your schedule. Every week, take one alendronic acid weekly tablet 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 whole with a full glass of tap water (not less than 200 ml), so that the medicine is absorbed properly:

• do not take it with mineral water (with or without gas),
• do not take it with coffee or tea,
• do not take it with juices or milk.

Do not crush or chew the tablet or let it dissolve in your mouth, due to the possibility of ulcers in the 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 Alendronic Acid Weekly at bedtime or before getting up in the morning.

1. If you have difficulty or pain swallowing, chest pain, or new or worsening heartburn, stop taking this medicine and contact your doctor.

1. After swallowing an Alendronic Acid Weekly tablet, wait at least 30 minutes before consuming your first food, drink, or other medicine 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, 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 take too many tablets, drink a glass of milk and consult 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 next morning to take Alendronic Acid Weekly. Do not take two tablets on the same day.Then take one tablet once a week, on the 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 prescribes the medicine. Since it is not known how long you should take Alendronic Acid Weekly, you should discuss with your doctor periodically the need to continue treatment with this medicine to determine if it is still suitable for you.

A Instructions Card is included in the package of this medicine. It contains important information to remind you how to take Alendronic Acid Weekly properly.

If you have any further questions on 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, which may be serious, and for which you may need urgent medical treatment:

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

• Heartburn; difficulty swallowing; pain when swallowing; ulcers in the throat (esophagus - the tube that connects your mouth to your stomach) that can cause chest pain, heartburn, or 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 may be signs of damage to the jawbone (osteonecrosis) usually associated with delayed healing and infection, often after a dental 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 signs of a possible fracture of the femur,
• Severe bone, muscle, and/or joint pain.

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 people):

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

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

• Swollen joints.
• Abdominal pain; feeling sick in the stomach or belching after eating; constipation; feeling full or bloated in the stomach; diarrhea; gas.
• Hair loss; itching.
• Headache; dizziness.
• Tiredness; swelling of hands or feet.

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

• Nausea; vomiting.
• Irritation or inflammation of the esophagus (esophagus - the tube that connects your mouth to your stomach) or stomach.
• Black or tarry stools.
• Blurred vision; eye pain or redness.
• Rash; skin redness.
• Transient flu-like symptoms such as muscle pain, general feeling of being unwell, sometimes with fever, usually at the start 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 sensation in the fingers or around the mouth.
• Stomach or peptic ulcers (sometimes severe or with bleeding).
• Narrowing of the esophagus (esophagus - the tube that connects your mouth to your stomach).
• Skin rash that worsens when exposed to sunlight.
• Ulcers in the mouth.

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

• Talk to your doctor if you have ear pain, your ear is discharging, or you have 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 via the Spanish Pharmacovigilance System for Human Use Medicines: https://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 Aurovitas Spain

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 which is stated on the carton and blister after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container contents and additional information

Composition ofAlendronic Acid Aurovitas Spain weekly

• The active ingredient 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 product and container contents

White to off-white, oval, biconvex, uncoated tablets, engraved with the letter "F" on one side and with the number "21" on the other. The size is 12.8 x 7.0 mm.

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

Container sizes:

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

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

Only some container sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 authorized in the Member States of the European Economic Area under the following names:

Cyprus Alendronic Acid Aurobindo 70 mg δισκ?α

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 comprimidos EFG

Sweden Alendronat Aurobindo 70 mg tabletter

Date of the last revision of this leaflet:July 2025

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