Package Insert: Information for the User

Risedronate Weekly Aurovitas Pharma 35 mg Film-Coated Tablets

Risedronate Sodium

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

• Keep this package insert, as you may need to read 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, even if they 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.

6.Contents of the pack and additional information

What is Risedronato Semanal Aurovitas Pharma

Risedronato Semanal Aurovitas Pharma belongs to a group of non-hormonal medications called bisphosphonates, which are used for the treatment of bone diseases. It acts directly on the bones, strengthening them and, therefore, reducing the likelihood of fractures.

The bone is a living tissue. The old bone of the skeleton is constantly being renewed and replaced by new bone.

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

Osteoporosis can also be suffered by men 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 of the body. Fractures associated with osteoporosis can also produce back pain, height loss, and curved back. Some patients with osteoporosis do not have symptoms and may not even know they have it.

For what Risedronato Semanal Aurovitas Pharma is used

This medication is indicated for the treatment of osteoporosis:

• Inwomenafter menopause, even if osteoporosis is severe. Reduces the risk of vertebral and hip fractures.

In men.

Do not take Risedronato Semanal Aurovitas Pharma:

• If you areallergicto risedronate sodium or to any of the other components of this medication (listed in section 6).
• If your doctor has told you that you have a condition calledhypocalcemia(low levels of calcium in the blood).
• If you could bepregnant, if you are pregnant or if you plan to become pregnant.
• If you arebreastfeeding
• If you havesevere kidney disease

Warnings and precautions

Consult your doctor or pharmacist before starting to take Risedronato Semanal Aurovitas Pharma:

• If you cannot remain in an upright position (sitting or standing) for at least 30minutes
• If you have bone or mineral metabolism problems (for example, vitamin D deficiency, parathyroid hormone alterations, both producing low levels of calcium 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 have been previously informed that you have Barrett's esophagus (a condition associated with changes in the cells that line 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 jaw pain, swelling, or numbness or a “strong discomfort in the jaw” or a tooth that moves.
• If you are undergoing dental treatment or are about to undergo a dental intervention, inform your dentist that you are being treated with Risedronato Semanal Aurovitas Pharma.

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

Children and adolescents

Risedronato Semanal Aurovitas Pharma is not recommended for use in children and adolescents (under 18 years) because there are not enough data on its safety and efficacy.

Other medications and Risedronato Semanal Aurovitas Pharma

Inform your doctor or pharmacist if you are using, have used recentlyor may need to use any other medication

Medications that contain any of the following substances reduce the effect of Risedronato Semanal Aurovitas Pharma when taken at the same time:

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

Take these medications at least 30 minutes after taking Risedronato Semanal Aurovitas Pharma.

Taking Risedronato Semanal Aurovitas Pharma with food and drinks

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

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

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consultyour doctor or pharmacist before using this medication.

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

DO NOT take Risedronato Semanal Aurovitas Pharma if you are breastfeeding (see section 2, “Do not take Risedronato Semanal Aurovitas Pharma”).

Risedronato Semanal Aurovitas Pharma should only be used to treat women after menopause and men.

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

Driving and operating machinery

The effect of Risedronato Semanal Aurovitas Pharma on the ability to drive and operate machinery is unknown.

Risedronato Semanal Aurovitas Pharma contains lactose

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

Risedronato Semanal Aurovitas Pharma contains sodium

This medication contains less than 23 mg of sodium (1mmol) per coated tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions of this medication 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 risedronate sodium) 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 every week, there is a box on one of the lateral faces of the packaging. 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 in the case of plain water) or other medication of the day.

How to take Risedronate Weekly Aurovitas Pharma

• Take the tablet while in anupright position(sitting or standing) to avoid stomach burning.
• Swallowthe tablet with at least oneglass(120 ml) oftap water.
• Swallow the tablet whole.Do not crush or chew it.
• Do not lie down, at least for 30 minutes after taking the tablet.

Your doctor will tell you if you need to take calcium and vitamin supplements, if the amount you take in your diet is not enough.

If you take more Risedronate Weekly Aurovitas Pharma than you should

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

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 forgot to take Risedronate Weekly Aurovitas Pharma

If you forgot to take the tablet on the chosen day, take the tablet 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 compensate for the missed doses.

If you interrupt treatment with Risedronate Weekly Aurovitas Pharma

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

If you have any other questions about the use of thismedication, ask your doctororpharmacist.

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

Stop takingRisedronate Weekly Aurovitas Pharmaand seek medical attention immediatelyif you experience any of the following symptoms:

• Severe allergic reaction symptoms, such as:

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

• Severe skin reactions that may include the appearance of blisters on the skin.

Inform your doctor quicklyif you experience the following side effects:

• Inflammation of the eyes, usually with pain, redness, and sensitivity to light.
• Bone necrosis of the jaw (osteonecrosis) associated with delayed healing and infection, often after a dental extraction (see section 2, "Warnings and precautions").
• Esophageal symptoms such as difficulty swallowing, chest pain, and appearance or worsening of stomach acid.

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

Rare:may affect up to 1 in 100 people

• Inflammation or ulcer of the esophagus (the tube that connects the mouth to the stomach) causing difficulty and pain swallowing (see also section 2, "Warnings and precautions"), inflammation of the stomach and duodenum (the intestine where the stomach empties).
• Inflammation of the colored part of the eye (the iris) (red, painful 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 test results. 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 may be symptoms of damage to the bones in the ear.

During post-marketing use, the following have been reported (frequency unknown):

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

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

Atypical femoral fractures, which may occur in rare cases, especially in patients receiving long-term treatment for osteoporosis. Inform your doctor if you notice pain, weakness, or discomfort in your thigh, hip, or groin, as these may be early signs and indicative of a possible femoral fracture.

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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance 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.

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

This medication does not require special conservation conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Risedronate Weekly Aurovitas Pharma Composition

The active ingredient is risedronate sodium. Each film-coated tablet contains 35 mg of risedronate sodium (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.

Product appearance and packaging contents

Film-coated tablet.

Risedronate WeeklyAurovitas Pharma35 mg film-coated tablets EFG are biconvex film-coated tablets, orange-yellow in color, circular in shape, marked with “F27” on one side and smooth on the other.

Risedronate WeeklyAurovitas Pharma35 mg film-coated tablets EFG are available in:

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

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible 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 with the following names:

GermanyRisedronatAurobindo once a week 35 mg film-coated tablets

SpainRisedronate Weekly Aurovitas Pharma 35 mg film-coated tablets EFG

FranceRisédronateArrow35 mg, coated tablet

NetherlandsNatriumrisedronaat Aurobindo Wekelijks 35 mg, film-coated tablets

IrelandRisedronate AurobindoOnce a Week 35 mg film-coated tablets

MaltaRisedronate AurobindoOnce a Week 35 mg film-coated tablets

RomaniaRisedronat Aurobindo 35 mg film-coated tablets

Last review date of this leaflet: November 2020

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)