Package Insert: Information for the User

Alendronic Acid Weekly Aurovitas Spain 70 mg Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

What is Weekly Alendronic Acid Aurovitas Spain?

Weekly Alendronic Acid Aurovitas Spain 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. Weekly alendronic acid prevents bone loss that occurs in women after menopause and helps to rebuild bone. It reduces the risk of fractures of the spine and hip.

What is Weekly Alendronic Acid Aurovitas Spain used for?

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

Weekly Alendronic Acid 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 maintain a woman's healthy skeleton. As a result, bone loss occurs and bones become weaker. The earlier a woman reaches menopause, the greater her risk of osteoporosis.

Long before, osteoporosis usually has no symptoms. However, if left untreated, it can result in broken bones. Although these usually hurt, fractures of the bones of the spine can go unnoticed until they cause loss of height. Bones can break during normal daily activity, such as getting up or from minor injuries that would normally not 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 weekly alendronic acid, your doctor may suggest that you make lifestyle changes to help your condition, such as:

• Stopping smoking: It appears that smoking increases the rate at which you lose bone and, therefore, may increase your risk of broken bones.
• Exercise: As 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 on your diet or whether you should take any dietary supplements (especially calcium and vitamin D).

Do not take Alendronic AcidweeklyAurovitas Spain

• If you are allergic to sodium alendronate trihydrate or any of the other

components of this medication (listed in section 6).

• If you have certain esophageal abnormalities (esophagus - the tube that connects your mouth to your stomach), such as narrowing or difficulty swallowing.
• If you cannot remain 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 alendronic acid weekly 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 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 being treated with angiogenesis inhibitors (such as bevacizumab or thalidomide) used in cancer treatment,
• You are taking corticosteroids (such as prednisone or dexamethasone) used in the treatment of 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 essential to maintain good oral hygiene while taking alendronic acid weekly. 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 occur irritation, inflammation, or ulceration of the throat (esophagus - the tube that connects your mouth to your stomach), often with symptoms such as chest pain, burning, or difficulty or pain swallowing, especially in patients who have not drunk a full glass of water and/or if they lay down before 30 minutes have passed after taking Alendronic Acid Weekly Aurovitas Spain. These adverse effects may worsen if patients continue taking alendronic acid weekly after developing these symptoms.

Children and adolescents

This medication should not be administered to children or adolescents under 18 years of age.

Other medications and Alendronic Acid Weekly Aurovitas Spain

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

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 these medications are taken at the same time as alendronic acid weekly.

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

It is likely that food and drinks (including mineral water) will make alendronic acid weekly less effective, if taken at the same time. Therefore, it is essential to 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 medication if you are pregnant or think you may be pregnant, or during breastfeeding.

Driving and operating machinery

Adverse effects with alendronic acid weekly (such as blurred vision, dizziness, and severe bone, muscle, or joint pain) may affect your ability to drive or operate machinery (see section 4).

Sodium

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

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

Take one alendronate weekly tabletonce a week.

Follow these instructions carefully to ensure you benefit from alendronate weekly.

1. Choose the day of the week that best suits your routine. Every week, take one alendronate weekly tablet on the day you have chosen.

It is very important to follow instructions 2, 3, 4, and 5 to help the alendronate weekly tablet reach your stomach quickly and 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 whole with a full glass of tap water (not mineral water) (not less than 200 ml), so that the medication 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, as there is a possibility of mouth ulcers appearing.

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 the first meal of the day.

4) Do not take alendronate 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 medication and inform your doctor.

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

If you take morealendronate weekly Aurovitas Spainthan you should

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

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

If you forgot to takealendronate weekly Aurovitas Spain

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

If you interrupt treatment withalendronate weekly Aurovitas Spain

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

In the box of this medication, there is a Instructions Card. It contains important information to remind you how to take alendronate weekly properly.

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

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

Seek medical attention immediatelyif you notice any of the following side effects, which may be serious, and for which you may need urgent medical treatment:

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

• Burning sensation; difficulty swallowing; pain when swallowing; esophageal ulcer (the tube that connects your mouth to your stomach) that 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 urticaria; swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing; severe skin reactions,
• Mouth 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 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 symptoms and indicative of a possible femur fracture,
• Intense bone, muscle, and/or joint pain.

Other side effects include

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

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

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

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

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

• Nausea; vomiting.
• Irritation or inflammation of the esophagus (the tube that connects your mouth to your stomach) or stomach.
• Stool that is black or like tar.
• Blurred vision; eye pain or redness.
• Skin rash; skin redness.
• Transient flu-like symptoms such as muscle pain, general discomfort, sometimes with fever, usually at the beginning of treatment.
• Alterations in taste.

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

• 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).
• Narrowing of the esophagus (the tube that connects your mouth to your stomach).
• Skin rash that worsens with exposure to sunlight.
• Mouth ulcers.

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

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special storage conditions.

Do not use this medicationafter the expiration date that appears on the packaging and the blister pack after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition ofAlendronic Acid weekly Aurovitas Spain

• The active ingredient is alendronic acid. Each tablet contains 70 mg of alendronic acid (equivalent to 91,363 mg of alendronate sodium trihydrate).
• The other components are:microcrystalline cellulose, cornstarch, carboxymethylcellulose sodium (type A) (derived from potato starch), povidone (Kollidon 30) and magnesium stearate.

Appearance of Alendronic Acid weekly Aurovitas Spain and packaging contents

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

The tablets are supplied in PVC/PE/PVdC – Aluminum blisters.

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

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036, Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Responsible for Manufacturing

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the member states of the European Economic Area with the following names:

Republic of CzechAlendronic acid Aurovitas

CyprusAlendronic Acid Aurobindo 70 mg δισκ?α

DenmarkAlendronat “Aurobindo”

ItalyAcido Alendronico Aurobindo

MaltaAlendronic Acid 70 mg tablets

NetherlandsAlendroninezuurAurobindo70 mg, tabletten

RomaniaAcid Alendronic Aurobindo 70 mg comprimate

SpainAlendrónico Acid weekly Aurovitas Spain 70 mg tablets EFG

SwedenAlendronat Aurobindo 70 mg tabletter

United KingdomAlendronic Acid 70 mg tablets

Last review date of this leaflet:April 2022

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