Risedronate weekly Aurovitas Pharma 35 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Risedronato Semanal 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, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Risedronato Semanal Aurovitas Pharma is and what it is used for

2. What you need to know before taking Risedronato Semanal Aurovitas Pharma

3. How to take Risedronato Semanal Aurovitas Pharma

4. Possible side effects

5. How to store Risedronato Semanal Aurovitas Pharma

6. Contents of the container and other information

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

What Risedronate Aurovitas Pharma Weekly is

Risedronate Aurovitas Pharma Weekly 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 thereby reducing the likelihood of fractures.

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

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

Osteoporosis can also affect men due to various causes, including aging and/or low levels of the male hormone testosterone.

The most common bone fractures occur in the vertebrae, hip, and wrist, although they can occur in any bone of the body. Fractures associated with osteoporosis may also cause back pain, loss of height, and a curved spine. Some patients with osteoporosis have no symptoms and may not even be aware they have the condition.

What Risedronate Aurovitas Pharma Weekly is used for

This medicine is indicated for the treatment of osteoporosis:

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

In men.

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

Do not take Risedronate Weekly Aurovitas Pharma:

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

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

• If you are unable to remain in an upright position (sitting or standing) for at least 30 minutes.
• If you have bone or mineral metabolism disorders (for example, vitamin D deficiency, parathyroid hormone disorders, both of which can cause low blood calcium levels).
• If you have previously had problems with your esophagus (the tube connecting your mouth to your stomach). For example, you may have experienced pain or difficulty swallowing food, or you have previously been diagnosed with 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 certain sugars (such as lactose).
• If you have had or currently have pain, swelling, or numbness in the jaw, or a "severe jaw discomfort," or if a tooth becomes loose.
• If you are undergoing dental treatment or are scheduled for a dental procedure, inform your dentist that you are being treated with Risedronate Weekly Aurovitas Pharma.

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

Children and adolescents

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

Other medicines and Risedronate Weekly Aurovitas Pharma

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

The following active substances, when taken at the same time, reduce the effect of Risedronate Weekly Aurovitas Pharma:

• 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 NOT to take Risedronate Weekly Aurovitas Pharma with food or with drinks other than plain water, as 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, “Use of Risedronate Weekly Aurovitas Pharma with other medicines”).

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 substance 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 postmenopausal women and men.

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

Driving and using machines

It is unknown whether Risedronate Weekly Aurovitas Pharma affects the ability to drive or operate machinery.

Risedronate Weekly Aurovitas Pharma contains lactose

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain 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 exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

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

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

To help you take the tablet on the same day each week, there is a box on one of the side panels of the carton. 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 meal, 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 stomach irritation.
• 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 advise you whether you should take calcium and vitamin supplements if your dietary intake of these is insufficient.

If you take more Risedronate Weekly Aurovitas Pharma than you should

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

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 forget to take Risedronate Weekly Aurovitas Pharma

If you forget to take the tablet on your chosen day, take it on the day you remember. Take the next tablet one week later on your usual tablet day.

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

If you stop taking Risedronate Weekly Aurovitas Pharma

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

If you have any further 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 everyone experiences them.

Stop taking Risedronato Semanal Aurovitas Pharma and contact your doctor immediately if 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 may include blistering of the skin.

Contact 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 following a tooth extraction (see section 2, “Warnings and precautions”).
• Esophageal-related symptoms such as pain when swallowing, difficulty swallowing, chest pain, or onset or worsening of acid reflux.

However, in clinical studies, the side effects observed were generally mild and did not cause patients to discontinue treatment.

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

• Inflammation or ulceration of the esophagus (the tube connecting the mouth to the stomach), causing difficulty and pain when swallowing (see also section 2, “Warnings and precautions”), inflammation of the stomach and duodenum (the intestine into which the stomach empties).

• Inflammation of the colored part of the eye (iris) (painful red eyes possibly with 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 (tube connecting the mouth to the stomach).
• Abnormal liver function tests have been reported. This can only be diagnosed by blood tests.

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

• Contact your doctor if you have ear pain, ear discharge or an ear infection. These could be symptoms of damage to the ear bones.

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 beginning of treatment, a slight decrease in blood phosphate and calcium levels has been observed in some patients. These changes are usually minor and do not cause symptoms.

Atypical femoral fractures (thigh bone), which may rarely occur, particularly 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 indicating a possible femoral fracture.

Reporting of 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 leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Risedronate Aurovitas Pharma Weekly

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

Do not use this medicine after the expiry date stated on the outer packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Risedronato Semanal Aurovitas Pharma

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

The other components (excipients) are:

Tablet core: 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 contents of the pack

Film-coated tablet.

Risedronato Semanal Aurovitas Pharma 35 mg film-coated tablets EFG are biconvex, film-coated, light orange, circular tablets marked “F27” on one side and smooth on the other.

Risedronato Semanal Aurovitas Pharma 35 mg film-coated tablets EFG are available in:

• Clear PVC/PE/PVdC/Aluminium blister packs in cardboard boxes containing 1, 2, 4, 10, 12 or 16 film-coated tablets.

Only certain pack 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 European Economic Area member states under the following names:

Germany Risedronat Aurobindo einmal wöchentlich 35 mg Filmtabletten

Spain Risedronato Semanal Aurovitas Pharma 35 mg film-coated tablets 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 most recent review of this leaflet: November 2020

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