Risedronate Aurovitas Pharma 75 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Risedronate Aurovitas Pharma 75 mg film-coated tablets EFG

Sodium risedronate

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, 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 must not be given to other people, even if they have the same symptoms as you, since it may harm them.

- If you experience adverse effects, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. See section 4.

Leaflet Contents

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

4. Possible adverse effects

1. Storage of Risedronate Aurovitas Pharma

6. Contents of the container and additional information

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

Risedronato Aurovitas Pharma is a medicine that acts on the bones. It belongs to a group of non-hormonal medicines called "bisphosphonates". The active substance is risedronate (as sodium salt). Risedronato Aurovitas Pharma helps prevent bone loss and reduces the risk of vertebral (spinal) and hip fractures.

Risedronato Aurovitas Pharma is used in adults:

• To treat osteoporosis in postmenopausal women. Osteoporosis is a disease that causes bones to become weak and break more easily. Risedronato Aurovitas Pharma reduces the risk of vertebral and hip fractures.
• To treat osteoporosis in men.
• To prevent and treat bone weakening (osteoporosis) caused by long-term treatment with corticosteroids (such as prednisolone) in men and women whose bone mass density is low and who are expected to continue corticosteroid treatment for at least 6 months.
• To treat osteoporosis in men and women who cannot stand or move normally due to prolonged immobility.

Risedronato Aurovitas Pharma helps prevent bone loss and reduces the risk of vertebral and hip fractures.

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 medicine 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 to occur following a fall or twist.

The most common bone fractures are those of 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 is used for

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

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

Do not take Risedronate 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 the blood)
• If you might 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 are unable to remain in an upright position, either sitting or standing, for at least 30 minutes.
• If you have bone disorders or mineral metabolism problems (for example, vitamin D deficiency, parathyroid hormone disorders, both leading to low blood calcium levels).
• If you have had or currently have problems with your esophagus (the tube connecting the mouth to the stomach). At some point, 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 you have had or currently have pain, swelling, or numbness in the jaw, or "severe jaw discomfort," or if a tooth becomes loose.
• If you are undergoing dental treatment or are scheduled to have dental surgery, inform your dentist that you are receiving treatment with Risedronate Aurovitas Pharma.

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

Children and adolescents

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

Other medicines and Risedronate Aurovitas Pharma

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

• Calcium
• Magnesium
• Aluminium (for example, some medicines for indigestion)
• Iron

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

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

Taking Risedronate Aurovitas Pharma with food and drinks

It is very important that you DO NOT take Risedronate Aurovitas Pharma tablets 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), since they contain calcium (see section 2, “Taking Risedronate Aurovitas Pharma with other medicines”).

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 might 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 substance 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, breastfeeding, planning to become pregnant, or planning to have a baby, consult your doctor or pharmacist before starting this medicine.

Driving and using machines

It is unknown whether Risedronato Aurovitas Pharma affects the ability to drive and use machines.

Risedronato Aurovitas Pharma contains lactose.

If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

Risedronato Aurovitas Pharma contains sodium

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

3. How to take Risedronate Aurovitas Pharma

Follow exactly the instructions for using this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

This medicine is for oral use.

The recommended dose is:

Risedronate Aurovitas Pharma tablets should be taken on the SAME two consecutive days 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 in the morning on the first chosen day. Take the SECOND tablet in the morning of the following day.

Repeat each month, keeping the same two consecutive days. To help you remember when to take the tablets again, you may mark them 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 meal, drink of the day (except if this drink is plain water) or any other medication of the day.

HOW to take Risedronate Aurovitas Pharma tablets

• Take the tablet while in an upright position, either sitting or standing, to help prevent stomach irritation.
• Swallow the tablet with at least one glass (120 ml) of plain tap water. Do not take the tablet with mineral water or any other beverage except plain tap 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 need to take calcium and vitamin supplements if your dietary intake of these is insufficient.

If you take more Risedronato Aurovitas Pharma than you should

If you or someone accidentally takes more Risedronato Aurovitas Pharma tablets than prescribed, drink a full glass of milk and seek medical advice immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service (telephone 91 562 04 20), stating the name of the medicine and the amount taken.

If you forget to take Risedronate Aurovitas Pharma

In any case:

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

If you interrupt treatment with Risedronate Aurovitas Pharma

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

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

4. Possible adverse effects

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

Stop taking Risedronate Aurovitas Pharma and see a 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 such as:
  • Blisters on the skin, mouth, eyes, and other moist body surfaces (genitals) (Stevens-Johnson syndrome)
  • Palpable red spots on the skin (leukocytoclastic vasculitis)
  • Rash affecting many parts of the body and/or loss of the outer layer of skin (toxic epidermal necrolysis)

Contact your doctor promptly if you experience any of the following adverse effects:

• Eye inflammation, usually with pain, redness, and sensitivity to light
• Jaw bone necrosis (osteonecrosis), associated with delayed healing and infection, often following tooth extraction (see section 2, "Warnings and precautions")
• Oesophageal symptoms such as pain when swallowing, difficulty swallowing, chest pain, or onset or worsening of heartburn

Atypical femoral fractures (thigh bone) may rarely occur, particularly in patients on 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 warning signs indicating a possible femoral fracture.

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

Common adverse effects (may affect up to 1 in 10 people):

• Indigestion, nausea, vomiting, stomach pain, stomach discomfort or cramps, constipation, feeling of fullness, bloating, diarrhoea
• Pain in bones, muscles, or joints
• Headache

Uncommon adverse effects (may affect up to 1 in 100 people):

• Inflammation or ulceration of the oesophagus (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 coloured part of the eye (iris) (painful red eyes with possible changes in vision)
• Fever and/or flu-like symptoms

Rare adverse effects (may affect up to 1 in 1,000 people):

• Inflammation of the tongue (red, swollen, possibly painful), narrowing of the oesophagus (the tube connecting the mouth to the stomach)
• Abnormal liver function tests have been reported. This can only be diagnosed by blood tests

Very rare adverse effects (may affect up to 1 in 10,000 people):

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

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse 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 adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Risedronate Aurovitas Pharma

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

Do not use this medicine after the expiry date stated on the packaging 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 drains or household waste. Dispose of unused medicines and their containers at a SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of Risedronate Aurovitas Pharma

• The active substance is sodium risedronate.

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

• The other components are:

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

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

Appearance of the product and contents of the container

Film-coated tablet.

Pink to light pink, biconvex, circular film-coated tablets (11.6 mm diameter), marked with "L" on one side and "62" on the other side of the tablet.

Risedronato Aurovitas Pharma 75 mg tablets are available in transparent PVC – aluminium foil blisters containing 2 and 6 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer responsible:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicinal product is authorised in the European Economic Area member states 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 most recent review of this leaflet: November 2020

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