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PATIENT INFORMATION LEAFLET

Risedronate Weekly Aristo 35 mg Film-Coated Tablets

Risedronate sodium

Read 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Risedronate Weekly Aristo is and what it is used for

2. What you need to know before you start taking Risedronate Weekly Aristo

3. How to take Risedronate Weekly Aristo

4. Possible side effects

5. Storage of Risedronate Weekly Aristo

6. Contents of the pack and additional information

Risedronate 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, reduces the likelihood 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.

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 in the body. Osteoporosis-related fractures 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.

What is Risedronato Semanal Aristo used for

This medication is indicated for the treatment of osteoporosis

- inwomenafter menopause, even if osteoporosis is severe. It reduces the risk of vertebral and hip fractures.

- inmen.

Do not takeRisedronate WeeklyAristo

- 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 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 Risedronate Weekly Aristo:

- If you cannot remain in an upright position, 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 had problems with your esophagus (the tube that connects the mouth to the stomach) in the past. You may have had difficulty swallowing food.

- 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 pain in the jaw or a tooth that moves.

- If you are undergoing dental treatment or will be undergoing a dental procedure, inform your dentist that you are taking Risedronate Weekly Aristo.

If you have any of the above problems, inform your doctor before taking this medication.

Children and adolescents

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

Taking Risedronate Weekly Aristo with other medications

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

- calcium

- magnesium

- aluminum (for example, some antacids)

- iron

Take these medications at least 30 minutes after taking Risedronate Weekly Aristo.

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

Taking Risedronate Weekly Aristo with food and drinks

It is very important not to take Risedronate Weekly Aristo 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 Weekly Aristo with other medications”).

Do not consume food, drinks (except plain water), and other medications for at least 30 minutes after taking this medication.

Pregnancy and breastfeeding

Do not take this medication if you may be pregnant, are pregnant, or plan to become pregnant (see section 2, “Do not take Risedronate Weekly Aristo”). The potential risk associated with the use of risedronate sodium (active ingredient of this medication) in pregnant women is unknown.

Do not take this medication if you are breastfeeding (see section 2, “Do not take Risedronate Weekly Aristo”).

This medication may only be used in postmenopausal women and men.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery:

The effect of Risedronate Weekly Aristo on the ability to drive and operate machinery is unknown.

Risedronate Weekly Aristo 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.

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

The recommended dose is:

Take ONE Risedronato Semanal Aristo tablet (35 mg of risedronate sodium) once a week.

Choose the day of the week that best suits your schedule. Each week, take the Risedronato Semanal Aristo tablet on the chosen day.

When to Take Risedronato Semanal Aristo Tablets

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

How to Take Risedronato Semanal Aristo Tablets

- Take the tablet while standing upright, either sitting or standing, to avoid stomach burning.

- Swallow the tablet with at least one glass (120ml) of tap water.

- Swallow the tablet whole (do not chew or suck on 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 Semanal Aristo Than You Should

If you or someone accidentally takes more Risedronato Semanal Aristo tablets than prescribed, drink a full glass of milk and see 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 taken.

If You Forget to Take Risedronato Semanal Aristo

If you forget to take the tablet on the chosen day, take the tablet on the day you remember. Then, 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 dose.

If You Interrupt Treatment with Risedronato Semanal Aristo

If you interrupt 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 this medication, ask your doctor or pharmacist.

Like all medicines, Aristo Weekly Risedronate can cause side effects, although not everyone will experience them.

Stop taking Aristo Weekly Risedronate 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 that may include:

-Blisters on the skin, mouth, eyes, and other moist areas of the body (genitals) (Stevens-Johnson syndrome),

-Red, palpable rashes on the skin (leucocytoclastic vasculitis),

-Red rash in 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:

- Inflammation of the eyes, usually with pain, redness, and sensitivity to light.

- Jawbone osteonecrosis (bone death) associated with delayed healing and infection, often after a tooth extraction (see section 2, "Warnings and precautions").

- Symptoms related to the esophagus, 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 patients to interrupt treatment.

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

- Indigestion, nausea, stomach pain, discomfort, heavy digestion, constipation, feeling full, abdominal distension, diarrhea

- Bone, muscle, and joint pain

- 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 swallowing (see also section 2, "Warnings and precautions"), inflammation of the stomach and/or duodenum (intestine where the stomach empties).

- Inflammation of the colored part of the eye (iris) (red, painful eyes with possible vision changes).

Rare side effects(may affect up to 1 in 1,000 patients)

- 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.

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

- Cases of hair loss.

- Liver alterations, in some cases severe.

- Inflammation of small blood vessels.

Rarely, a mild 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.

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.

Very rare

- Consult your doctor if you have ear pain,ear dischargeorsuffer from an ear infection. These may be symptomsof damageto thebones of theear.

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this leaflet.

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 national notification system:www.notificaRAM.es. By reporting side effects, you can contribute toproviding more information about 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 in the 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 WeeklyAristo

Theactive ingredientisrisedronate sodium. Each film-coated tablet contains 35 mg of risedronate sodium (equivalent to 32.5 mg of risedronic acid).

The other components (excipients) are:

•Core of the tablet:Pre-gelatinized cornstarch, microcrystalline cellulose, crospovidone, magnesium stearate

•Film coating:White Opadry containing: titanium dioxide (E-171), lactose monohydrate, macrogol, hypromellose (E-464)

Appearance of the product and content of the packaging

Risedronate Weekly Aristo 35 mg film-coated tablets are white, round, biconvex tablets with the inscription “35” on one face.

The tablets are presented in aluminum PVC/PE/PVDC blisters with 4 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing.

Holder of the marketing authorization

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid- Spain

Responsible for manufacturing

Pharmathen S.A.

Dervenakion 6

Pallini 15351

Attiki (Greece)

Pharmathen International S.A.

Sapes Industrial Park

Block 5

69300 Rodopi

Greece

Last review date of this leaflet:February 2016

“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/”