Leaflet: information for the user

Arisocare 75 mg film-coated tablets EFG

Risedronate sodium

1. What is Arisocare and what it is used for

2. What you need to know before starting to take Arisocare

3. How to take Arisocare

4. Possible side effects

5. Storage of Arisocare

6. Contents of the pack and additional information

What isArisocare

Arisocarebelongs to a group of non-hormonal medications called bisphosphonates, which are used for the treatment of bone diseases. Arisocare 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 a curved back. Some patients with osteoporosis do not have symptoms and may not even know they have it.

What is Arisocare used for

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

Do not takeArisocare

• if you are allergic to risedronate sodium or any of the other ingredients 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 with your doctor or pharmacist before starting to takeArisocare

Be especially careful and consult with your doctor BEFORE starting to takeArisocare

• 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. At some point you may have had difficulty swallowing food or been told you have Barrett's esophagus (a disease 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 that moves.
• if you are undergoing dental treatment or are about to undergo dental surgery, inform your dentist that you are receiving treatment with Arisocare
• your doctor will advise you what to do if you takeArisocareand have any of the problems mentioned above.

Children and adolescents

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

Taking Arisocare with other medications

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

Themedicines that contain any of the following substances reduce theeffect of Arisocare when taken at the same time:

calcium

magnesium

aluminum (for example, some medication for indigestion)

iron

Take these medications at least 30 minutes after takingArisocare

Taking Arisocare with food and drinks

It is very important that you DO NOT takeArisocarewith food or with beverages (other than tap 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 Arisocare with other medications”).

Take food and drinks (other than tap water) at least 30 minutes after taking your Arisocare tablet.

Pregnancy and breastfeeding

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

DO NOT take Arisocare if you are breastfeeding (see section 2, “Do not take Arisocare”).

Arisocare should only be used in women after menopause.

Driving and operating machinery

The effect of Arisocare on the ability to drive and operate machinery is unknown.

Arisocare contains lactose

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist.

In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Arisocare tablets should be taken two days a month, and always the same two consecutive days of each month (for example, the 1st and 2nd days or 15th and 16th of the month).

Choose the two consecutive days that best fit your schedule. Take one Arisocare tablet in the morning of 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 can mark it on your calendar with a pen or a sticker. You can also write the date in the space behind the box of this medication.

WHEN to take Arisocare tablets

Take the Arisocare tablet at least 30 minutes before the first drink or meal of the day (except in the case of tap water).

HOW to take Arisocare tablets

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

-Swallow the tablet with at least one glass (120 ml) of tap water. Do not take the tablet with mineral water or other drinks that are not tap water.

-Swallow the tablet wholeDo not chew or crush it.

-Do not lie down for at least 30 minutes after taking the tablet.

The 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 Arisocare than you should

If you or someone accidentally took more Arisocare tablets than prescribed, drink afull glass of milkandconsult your doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service (Telephone 91 562 04 20), indicating the name of the medication and the amount taken.

IF you FORGET to take Arisocare

In any case:

-If you forgot your Arisocare 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 Arisocare

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 doubts 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 Arisocare 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, palpable patches on the skin (leucocytoclastic vasculitis)

-Red 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:

• 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 tooth extraction (see section 2 “Be extra careful and consult your doctor before starting to take Arisocare”).
• Esophageal symptoms such as difficulty swallowing, chest pain, or worsening heartburn.

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

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

• Indigestion, nausea, vomiting, stomach pain, discomfort, heavy digestion, constipation, feeling full, abdominal distension, diarrhea.
• Pain in your bones, muscles, or joints.
• 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 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).
• Fever and/or flu-like symptoms (within the first five days after the first administration).

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)

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

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

• Hair loss, skin rash.
• Liver damage, in some cases severe.
• Inflammation of small blood vessels.

Atypical fractures of the femur (thigh bone) may occur in rare cases, especially in patients on long-term treatment for osteoporosis. Inform your doctor if you notice pain, weakness, or discomfort in the thigh, hip, groin, as they may be early signs of a possible femur fracture.

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.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting 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 through theSistemade FarmacovigilanciadeMedicamentosde UsoHumano,website: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 the abbreviation CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions. Store in the original packaging to protect it from light.

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

Composition ofArisocare

- The active ingredient is risedronate sodium. Each tablet contains 75 mg of risedronate sodium (as hemi-pentahydrate), equivalent to 69.6 mg of risedronic acid.

- The other components (excipients) are: microcrystalline cellulose type 101, lactose monohydrate, crospovidone (type A) and magnesium stearate in the tablet core, and hypromellose, hydroxypropylcellulose, macrogol (type 400), macrogol (type 8000), titanium dioxide (E171), anhydrous colloidal silica, and iron oxide red (E172) in the coating.

Appearance of the product and contents of the packaging

- Film-coated tablet with pale pink color, round, biconvex, engraved with “75” on one side.

- The tablets are presented in blisters of 2 film-coated tablets.

Marketing authorization holder

Procare Health Iberia, S.L.

Avda. Miguel Hernández 21, Ground Floor

46450 Benifaió (Valencia)

Spain

Responsible for manufacturing

Adamed Farma, S.A.

ul. Marszalka J. Pilsudskiego 5

95-200 Pabianice

Poland

Last review date of this leaflet: December 2017

The 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