Prospect: information for the patient

Risedronate Aurovitas Pharma 75 mg film-coated tablets EFG

Risedronate sodium

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed for you alone, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

4.Possible side effects

1. Storage of Risedronate Aurovitas Pharma

6.Contents of the pack and additional information

What is Risedronato Aurovitas Pharma

Risedronato Aurovitas Pharma belongs to a group of non-hormonal medications called bisphosphonates, which are used for the treatment of bone diseases (of the bones). This medication acts directly on the bones strengthening them and, therefore, reduces the probability of fractures.

The bone is a living tissue. Old bone in 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.

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

What is Risedronato Aurovitas Pharma used for

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

Do not take Risedronato Aurovitas Pharma

• If you are allergic to sodium risedronate 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 called hypocalcemia (low levels of calcium in the blood)
• If you may 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 Risedronato Aurovitas Pharma:

• If you cannot remain upright, either sitting or standing, for at least 30 minutes.
• 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 or have had problems with your esophagus (the tube that connects the mouth to the stomach). At some point, you may have or have had difficulty swallowing food or have been previously informed that you have Barrett's esophagus (a condition associated with changes in the cells that cover the lower part of the esophagus).
• If you have had or have jaw pain, swelling, or numbness, or a "strong pain in the jaw" or a tooth has moved.
• If you are undergoing dental treatment or are about to undergo dental surgery, inform your dentist that you are receiving treatment with Risedronato Aurovitas Pharma.

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

Children and adolescents

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

Other medications and Risedronato Aurovitas Pharma

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

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

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

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

Taking Risedronato Aurovitas Pharma with food and beverages

It is very important not to take Risedronato Aurovitas Pharma tablets with food or beverages (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 Risedronato Aurovitas Pharma with other medications").

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

Pregnancy, breastfeeding, and fertility

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

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

Risedronato 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 operating machinery

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

Risedronato Aurovitas Pharma contains lactose.

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

Risedronato Aurovitas Pharma contains sodium

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

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

This medication is for oral use.

The recommended dose is:

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

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

Repeat every month, maintaining 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 Risedronato Aurovitas Pharma tablets

Take the Risedronato Aurovitas Pharma tablet at least 30 minutes before the first meal, drink, or other medication of the day (except in the case of water).

HOW to take Risedronato Aurovitas Pharma tablets

• Take the tablet while standing upright, either sitting or standing, to avoid stomach burning.
• Swallow the tablet with at least one glass (120 ml) of tap water (faucet water). Do not take the tablet with mineral water or other beverages that are not tap water.
• Swallow the tablet whole. Do not chew or crush it.
• Do not lie down for at least 30 minutes after taking the tablet.

Your doctor will indicate if you should take calcium and vitamin supplements, if the amount you take from your diet is not sufficient.

IF you take more Risedronato Aurovitas Pharma than you should

If you or someone accidentally took more Risedronato 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 Toxicological Information Service (phone 91 562 04 20), indicating the name of the medication and the amount taken.

IF you forget to take Risedronato Aurovitas Pharma

In any case:

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

IF you interrupt treatment with Risedronato Aurovitas Pharma

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

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

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

Stop taking Risedronato Aurovitas Pharma and see your doctor 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 such as:
• • Blisters on the skin, mouth, eyes, and other moist areas of the body (genitals) (Stevens-Johnson syndrome).
  • Red, itchy 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).

Inform your doctor quicklyif you experience the following side effects:

• Eye inflammation, usually with pain, redness, and sensitivity to light.
• jawbone necrosis (osteonecrosis) associated with delayed healing and infection, often after tooth extraction (see section 2 “Warnings and precautions”).
• Esophageal symptoms such as difficulty swallowing, chest pain, or worsening heartburn.

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 these may be early signs of a possible femur fracture.

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

Frequent side effects(may affect up to 1 in 10 patients):

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

Infrequent 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 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 vision changes).
• 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 test results. This can only be diagnosed through blood tests.

Very rare side effects(may affect up to 1 in 10,000 patients):

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

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

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

Rarely, a decrease in blood phosphate and calcium levels has been observed in some patients at the beginning of treatment. 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 that does not appear in this leaflet. 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.

Do not use this medication after the expiration date that appears on the packaging after CAD. 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 drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Risedronate Aurovitas Pharma

• The active ingredient is risedronate sodium.

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

• The other components are:

Tablet core: lactose monohydrate, microcrystalline cellulose, crospovidone (Type A), low-viscosity hydroxypropylcellulose, and magnesium stearate.

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

Appearance of the product and content of the container

Coated tablet.

Coated tablets of pink to light pink biconvex, circular shape (diameter 11.6 mm) marked with “L” on one face and “62” on the other face of the tablet.

Risedronate Aurovitas Pharma 75 mg tablets are available in transparent PVC – aluminum foil blisters containing 2 and 6 coated tablets.

Only some container sizes may be marketed.

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

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:

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

Last review date of this leaflet: November 2020

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