RISEDRONATE AUROVITAS PHARMA 75 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Risedronate Aurovitas Pharma 75 mg Film-Coated Tablets EFG

Sodium Risedronate

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

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Contents of the Package Leaflet

1. What is Risedronate Aurovitas Pharma and what is it used for
2. What you need to know before taking Risedronate Aurovitas Pharma
3. How to take Risedronate Aurovitas Pharma

4.

1. Storage of Risedronate Aurovitas Pharma

6.

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

What is Risedronate Aurovitas Pharma

Risedronate Aurovitas Pharma belongs to a group of non-hormonal medications called bisphosphonates, which are used to treat bone diseases. This medication 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, becoming more fragile and prone to fractures after a fall or twist.

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 may not have symptoms and may not even know they have it.

What is Risedronate Aurovitas Pharma used for

This medication is indicated for the treatment of osteoporosis in postmenopausal women.

2. What you need to know before taking Risedronate Aurovitas Pharma

Do not take Risedronate Aurovitas Pharma

• If you are allergic to sodium risedronate or any of the other components of this medication (listed in section 6)
• If your doctor has told you that you have a condition called hypocalcemia (low calcium levels in the 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 Aurovitas Pharma:

• If you cannot remain upright, either sitting or standing, for at least 30 minutes.
• If you have bone or mineral metabolism problems (e.g., vitamin D deficiency, parathyroid hormone disorders, both producing low calcium levels in the blood).
• If you have or have had problems with your esophagus (the tube that connects the mouth to the stomach). At some point, you may have had or been told you have esophageal Barrett's (a condition associated with changes in the cells lining the lower esophagus).
• If you have had or have pain, swelling, or numbness in the jaw or "severe jaw discomfort" or have had a tooth move.
• If you are undergoing dental treatment or are going to have dental surgery, inform your dentist that you are receiving treatment with Risedronate Aurovitas Pharma.

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

Children and Adolescents

The use of sodium risedronate is not recommended in children (under 18 years) due to insufficient data on its safety and efficacy.

Other Medications and Risedronate Aurovitas Pharma

Medications containing any of the following substances reduce the effect of Risedronate Aurovitas Pharma when taken at the same time:

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

Take these medications at least 30 minutes after taking Risedronate Aurovitas Pharma tablets.

Inform your doctor or pharmacist that you are taking, have recently taken, or may need to take any other medication.

Taking Risedronate Aurovitas Pharma with Food and Drinks

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

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

Pregnancy, Breastfeeding, and Fertility

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

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

Risedronate Aurovitas Pharma can only be used in postmenopausal women.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before starting to take this medication.

Driving and Using Machines

It is unknown if Risedronate Aurovitas Pharma affects the ability to drive and use machines.

Risedronate Aurovitas Pharma contains lactose.

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Risedronate Aurovitas Pharma contains sodium

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

3. How to Take Risedronate Aurovitas Pharma

Follow your doctor's instructions for taking this medication exactly. If you are in doubt, consult your doctor or pharmacist again.

This medication is for oral use.

The recommended dose is:

Risedronate Aurovitas Pharma tablets should be taken on the SAME two consecutive days of each month, for example, days 1 and 2, or 15 and 16 of the month.

Choose the TWO consecutive days that best fit your schedule to take Risedronate Aurovitas Pharma. Take ONE Risedronate Aurovitas Pharma tablet on the morning of the first chosen day. Take the SECOND tablet on the morning of the next day.

Repeat every month, keeping the same two consecutive days. To help you remember when to take the tablets again, you can mark it on your calendar with a pen or a sticker.

WHEN to Take Risedronate Aurovitas Pharma Tablets

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

HOW to Take Risedronate Aurovitas Pharma Tablets

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

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

If You Take More Risedronate Aurovitas Pharma Than You Should

If you or someone else has accidentally taken more Risedronate 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 (telephone 91 562 04 20), indicating the name of the medication and the amount taken.

If You Forget to Take Risedronate Aurovitas Pharma

In any case:

• If you forgot your Risedronate Aurovitas Pharma dose in the morning, DO NOT take it later during the day.
• DO NOT take three tablets in the same week.

If You Stop Taking Risedronate Aurovitas Pharma

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

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone gets them.

Stop taking Risedronate 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 such as:
• • Blisters on the skin, mouth, eyes, and other moist surfaces of the body (genital area) (Stevens-Johnson Syndrome).
  • Red patches on the skin (leucocytoclastic vasculitis).
  • Rash on many parts of the body and/or loss of the outer layer of the skin (toxic epidermal necrolysis).

Tell your doctor promptlyif 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 tooth extraction (see section 2, "Warnings and Precautions").
• Esophageal symptoms such as pain when swallowing, difficulty swallowing, chest pain, or worsening of heartburn.

Atypical fractures of the thigh bone (femur) 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 femur fracture.

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

Common Side Effects(may affect up to 1 in 10 patients):

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

Uncommon Side Effects(may affect up to 1 in 100 patients):

• 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"), inflammation of the stomach and duodenum (intestine where the stomach empties).
• Inflammation of the colored part of the eye (the iris) (red eyes with possible changes in vision).
• Fever and/or flu-like symptoms.

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

• Inflammation of the tongue (red, swollen, 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 Side Effects(may affect up to 1 in 10,000 patients):

• Tell your doctor if you have ear pain, ear discharge, and/or ear infection. These may be signs of damage to the ear bone.

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

• Hair loss.
• Liver disorders, in some cases severe.

Rarely, at the start of treatment, a 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.

Reporting Side Effects:

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

5. Storage of Risedronate Aurovitas Pharma

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the Packaging and Additional Information

Composition of Risedronate Aurovitas Pharma

• The active ingredient is sodium risedronate.

Each tablet contains 75 mg of sodium risedronate (as hemipentahydrate).

• The other ingredients are:

Core of the tablet: lactose monohydrate, microcrystalline cellulose, crospovidone (Type A), low-viscosity hydroxypropylcellulose, and magnesium stearate.

Film coating: hypromellose, titanium dioxide (E171), macrogol 400, red iron oxide (E172).

Appearance of the Product and Contents of the Packaging

Film-coated tablet.

Risedronate Aurovitas Pharma 75 mg film-coated tablets are pink to light pink, biconvex, circular (diameter 11.6 mm), marked with "L" on one face and "62" on the other face of the tablet.

Risedronate Aurovitas Pharma 75 mg film-coated tablets are available in transparent PVC blister packs - aluminum foil containing 2 and 6 film-coated tablets.

Not all pack sizes may be marketed.

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

Italy: Risedronate Aurobindo

Netherlands: Risedronaatnatrium Aurobindo 75 mg, filmomhulde tabletten

Romania: Risedronat Aurobindo 75 mg comprimate filmate

Spain: Risedronato Aurovitas Pharma 75 mg comprimidos recubiertos con película EFG

Date of the Last Revision of this Package Leaflet: November 2020

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