RISEDRONATE WEEKLY AUROVITAS PHARMA 35 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Risedronate Weekly Aurovitas Pharma 35 mg film-coated tablets EFG

Sodium risedronate

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 is Risedronate Weekly Aurovitas Pharma and what is it used for
2. What you need to know before you take Risedronate Weekly Aurovitas Pharma
3. How to take Risedronate Weekly Aurovitas Pharma
4. Possible side effects
5. Storing Risedronate Weekly Aurovitas Pharma

1. Package contents and further information

1. What is Risedronate Weekly Aurovitas Pharma and what is it used for

What is Risedronate Weekly Aurovitas Pharma

Risedronate Weekly Aurovitas Pharma belongs to a group of non-hormonal medicines called bisphosphonates, which are used to treat bone diseases. It acts directly on the bones, strengthening them and thus reducing the likelihood of fractures.

Bone is a living tissue. Old bone in the skeleton is constantly being renewed and replaced by new bone.

Postmenopausal osteoporosis occurs in women after menopause when the bone begins to weaken, is more fragile, and fractures are more likely after a fall or twist.

Men can also suffer from osteoporosis due to numerous causes, including aging and/or low levels of male hormone, testosterone.

The most likely bone fractures are those of the vertebrae, hip, and wrist, although they can occur in any bone in the body. Osteoporosis-related fractures can also cause back pain, loss of height, and a curved back. Some patients with osteoporosis do not have symptoms and may not even know they have it.

What is Risedronate Weekly Aurovitas Pharma used for

This medicine is indicated for the treatment of osteoporosis:

• In women after menopause, even if osteoporosis is severe. It reduces the risk of vertebral and hip fractures.

In men.

2. What you need to know before you take Risedronate Weekly Aurovitas Pharma

Do not take Risedronate Weekly Aurovitas Pharma:

• If you are allergic to sodium risedronate or any of the other ingredients of this medicine (listed in section 6).
• If your doctor has told you that you have a disease called hypocalcemia (you have low calcium levels in your blood).
• If you could be pregnant, are pregnant, or plan to become pregnant.
• If you are breastfeeding.
• If you have severe kidney disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Risedronate Weekly Aurovitas Pharma:

• If you cannot remain upright (sitting or standing) for at least 30 minutes.
• If you have bone problems or mineral metabolism problems (e.g., vitamin D deficiency, parathyroid hormone disorders, both producing low calcium levels in the blood).
• If you have had problems with your esophagus (the tube that connects the mouth to the stomach) in the past. For example, you may have had pain or difficulty swallowing food, or you have been previously informed that you have Barrett's esophagus (a condition associated with changes in the cells lining the lower part of the esophagus).
• If your doctor has informed you that you have an intolerance to some sugars (such as lactose).
• If you have had or have pain, swelling, or numbness in the jaw or "a strong discomfort in the jaw" or a tooth has moved.
• If you are undergoing dental treatment or are going to undergo dental surgery, inform your dentist that you are being treated with Risedronate Weekly Aurovitas Pharma.

Your doctor will advise you what to do if you take Risedronate Weekly Aurovitas Pharma and have any of the above problems.

Children and adolescents

Risedronate Weekly Aurovitas Pharma is not recommended for use in children and adolescents (under 18 years) due to insufficient data on its safety and efficacy.

Other medicines and Risedronate Weekly Aurovitas Pharma

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Medicines that contain any of the following substances reduce the effect of Risedronate Weekly Aurovitas Pharma when taken at the same time:

• Calcium.
• Magnesium.
• Aluminum (e.g., some medicines for indigestion).
• Iron.

Take these medicines at least 30 minutes after taking Risedronate Weekly Aurovitas Pharma.

Taking Risedronate Weekly Aurovitas Pharma with food and drinks

It is very important that you DO NOT take Risedronate Weekly Aurovitas Pharma with food or drinks (other than plain water) because they may interfere. In particular, do not take this medicine at the same time as dairy products (such as milk) as they contain calcium (see section 2, "Using Risedronate Weekly Aurovitas Pharma with other medicines").

Take food and drinks (other than plain water) at least 30 minutes after Risedronate Weekly Aurovitas Pharma.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

DO NOT take Risedronate Weekly Aurovitas Pharma if you could be pregnant, are pregnant, or plan to become pregnant (see section 2, "Do not take Risedronate Weekly Aurovitas Pharma"). The potential risk associated with the use of sodium risedronate (the active ingredient in Risedronate Weekly Aurovitas Pharma) in pregnant women is unknown.

DO NOT take Risedronate Weekly Aurovitas Pharma if you are breastfeeding (see section 2, "Do not take Risedronate Weekly Aurovitas Pharma").

Risedronate Weekly Aurovitas Pharma should only be used to treat women after menopause and men.

Consult your doctor or pharmacist before starting to take any medicine.

Driving and using machines

It is not known whether Risedronate Weekly Aurovitas Pharma affects the ability to drive and use machines.

Risedronate Weekly Aurovitas Pharma contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Risedronate Weekly Aurovitas Pharma contains sodium

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

3. How to take Risedronate Weekly Aurovitas Pharma

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

The recommended dose is:

Take one Risedronate Weekly Aurovitas Pharma tablet (35 mg of sodium risedronate) once a week.

Choose the day of the week that best suits your schedule. Each week, take the Risedronate Weekly Aurovitas Pharma tablet on the chosen day.

To facilitate taking the tablet on the same day each week, there is a box on one of the side faces of the package. Mark the day of the week you have chosen to take the Risedronate Weekly Aurovitas Pharma tablet.

When to take Risedronate Weekly Aurovitas Pharma tablets

Take the Risedronate Weekly Aurovitas Pharma tablet at least 30 minutes before the first food, drink of the day (except if this drink is plain water) or other medicine of the day.

How to take Risedronate Weekly Aurovitas Pharma

• Take the tablet while in an upright position (sitting or standing) to avoid heartburn.
• Swallow the tablet with at least one glass (120 ml) of plain water (tap water).
• Swallow the tablet whole. Do not chew or suck it.
• Do not lie down for at least 30 minutes after taking the tablet.

Your doctor will tell you if you should take calcium and vitamin supplements if the amount you take in your diet is not sufficient.

If you take more Risedronate Weekly Aurovitas Pharma than you should

If you or someone else has taken more Risedronate Weekly Aurovitas Pharma tablets than prescribed, drink a full glass of milk and consult your doctor.

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

If you forget to take Risedronate Weekly Aurovitas Pharma

If you have forgotten to take the tablet on the chosen day, take it on the day you remember. Take the next tablet the following week, on the day you normally take the tablet.

Do not take a double dose to make up for forgotten doses.

If you stop taking Risedronate Weekly Aurovitas Pharma

If you stop taking the treatment, you may start to lose bone mass. Please consult your doctor before deciding to stop treatment.

If you have any other 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.

Stop taking Risedronate Weekly Aurovitas Pharma and consult your doctor immediatelyif you experience any of the following symptoms:

• Symptoms of a severe allergic reaction, such as:

• Swelling of the face, tongue, or throat.
• Difficulty swallowing.
• Hives and difficulty breathing.

• Severe skin reactions that can include blistering of the skin.

Tell your doctor promptly if you experience any of the following side effects:

• Inflammation of the eyes, usually with pain, redness, and sensitivity to light.
• Jaw bone necrosis (osteonecrosis) associated with delayed healing and infection, often after a tooth extraction (see section 2, "Warnings and precautions").
• Symptoms related to the esophagus, such as pain when swallowing, difficulty swallowing, chest pain, and worsening of heartburn.

However, in clinical studies, the side effects that were observed were generally mild and did not cause the patient to stop treatment.

Frequent: may affect up to 1 in 10 people

• Indigestion, nausea, stomach pain, stomach cramps or discomfort, constipation, feeling full, abdominal distension, diarrhea.
• Pain in your bones, muscles, or joints.
• Headache.

Uncommon: may affect up to 1 in 100 people

• Inflammation or ulceration of the esophagus (the tube that connects the mouth to the stomach) causing difficulty and pain when swallowing (see also section 2, "Warnings and precautions"), stomach inflammation, and duodenum inflammation (the intestine where the stomach empties).
• Inflammation of the colored part of the eye (the iris) (red eyes with possible changes in vision).

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

• Inflammation of the tongue (swollen, red, possibly painful), narrowing of the esophagus (the tube that connects the mouth to the stomach).
• Abnormal liver tests have been reported. This can only be diagnosed through blood tests.

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

• Consult 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.

During post-marketing use, the following have been reported (frequency not known):

• Cases of hair loss.
• Liver disorders, in some cases severe.

Rarely, at the start of treatment, a slight decrease in phosphate and calcium levels in the blood has been observed in some patients. These changes are usually small and do not cause symptoms.

Atypical fractures of the femur (thigh bone), which can occur rarely, especially in patients on long-term treatment for osteoporosis. Tell your doctor if you notice pain, weakness, or discomfort in the thigh, hip, or groin, as these may be early symptoms of a possible femur fracture.

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 through 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. Storing Risedronate Weekly Aurovitas Pharma

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

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

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and further information

Composition of Risedronate Weekly Aurovitas Pharma

The active ingredient is sodium risedronate. Each film-coated tablet contains 35 mg of sodium risedronate (equivalent to 32.4 mg of risedronic acid).

The other ingredients (excipients) are:

Core of the tablet: lactose monohydrate, crospovidone, hydroxypropylcellulose, magnesium stearate, and microcrystalline cellulose.

Coating: hypromellose, titanium dioxide (E171), macrogol 400, hydroxypropylcellulose, yellow iron oxide (E172), macrogol 8000, red iron oxide (E172), and anhydrous colloidal silica.

Appearance of the product and package contents

Film-coated tablet.

Risedronate Weekly Aurovitas Pharma 35 mg film-coated tablets EFG are biconvex film-coated tablets, light orange in color, circular in shape, marked with "F27" on one face and smooth on the other.

Risedronate Weekly Aurovitas Pharma 35 mg film-coated tablets EFG are available in:

• PVC transparent/PE/PVdC/Aluminum blister pack in a cardboard box with 1, 2, 4, 10, 12, or 16 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avenida 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Germany Risedronat Aurobindo einmal wöchentlich 35 mg Filmtabletten

Spain Risedronato Semanal Aurovitas Pharma 35 mg comprimidos recubiertos con película EFG

France Risédronate Arrow 35 mg, comprimé pelliculé

Netherlands Natriumrisedronaat Aurobindo Wekelijks 35 mg, filmomhulde tabletten

Ireland Risedronate Aurobindo Once a Week 35 mg film-coated tablets

Malta Risedronate Aurobindo Once a Week 35 mg film-coated tablets

Romania Risedronat Aurobindo 35 mg comprimate filmate

Date of the last revision of this leaflet: November 2020

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