Arisocare 75 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Arisocare 75 mg film-coated tablets EFG

Sodium risedronate

Package leaflet contents:

1. What Arisocare is and what it is used for
2. What you need to know before taking Arisocare
3. How to take Arisocare
4. Possible side effects
5. Storage of Arisocare
6. Contents of the pack and other information

1. What Arisocare is and what it is used for

What Arisocare is

Arisocare belongs to a group of non-hormonal medicines called bisphosphonates, which are used to treat bone diseases. Arisocare acts directly on the bones, strengthening them and thereby reducing the likelihood of fractures.

Bone is a 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 minor trauma.

The most common bone fractures occur in the vertebrae, hip, and wrist, although they can occur in any bone of the body. Osteoporosis-related fractures may also cause back pain, loss of height, and a stooped posture. Some patients with osteoporosis have no symptoms and may not even be aware they have the condition.

What Arisocare 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 Arisocare

Do not take Arisocare

• 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 could be pregnant, if you are pregnant, or if you are planning to become pregnant.
• if you are breastfeeding.
• if you have severe kidney disease.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Arisocare.

Take special care and consult your doctor BEFORE starting to take Arisocare

• 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 of which can cause low calcium levels in the blood).
• if you have previously had esophageal problems (the tube connecting the mouth to the stomach). At some point, you may have experienced pain or difficulty swallowing food, or you have 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 a "severe jaw pain" or if a tooth becomes loose.
• if you are undergoing dental treatment or are scheduled for dental surgery, inform your dentist that you are receiving treatment with Arisocare.
• your doctor will advise you on what to do if you take Arisocare and have any of the conditions mentioned above.

Children and adolescents

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

Taking Arisocare with other medicines

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

Medicines containing any of the following substances reduce the effect of Arisocare when taken at the same time:

• calcium
• magnesium
• aluminium (for example, certain medicines for indigestion)
• iron

Take these medicines at least 30 minutes after taking Arisocare.

Taking Arisocare with food and drinks

It is very important NOT to take Arisocare with food or with drinks (other than plain tap water), as they may interfere. In particular, do not take this medicine at the same time as dairy products (such as milk), as they contain calcium (see section 2, "Taking Arisocare with other medicines").

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

Pregnancy and breastfeeding

DO NOT take Arisocare if you are pregnant, think you might be pregnant, or plan to become pregnant (see section 2, "Do not take Arisocare"). The potential risk associated with the use of sodium risedronate (the active substance in 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 postmenopausal women.

Driving and using machines

It is unknown whether Arisocare affects the ability to drive or use machinery.

Arisocare contains lactose

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with your doctor before taking this medicine.

3. How to take Arisocare

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist.

If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Arisocare tablets should be taken two days per month, always on the SAME two consecutive days of 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. Take ONE Arisocare tablet in the morning on the first chosen day. Take the SECOND tablet the following morning.

Repeat this every month, always on the same two consecutive days. To help you remember when to take the tablets again, you may mark it on your calendar with a pen or a sticker. You can also write the date in the space provided on the back of this medicine package.

WHEN to take Arisocare tablets

Take the Arisocare tablet at least 30 minutes before your first meal, drink of the day (except if that drink is tap water), or other medicine of the day.

HOW to take Arisocare tablets

• Take the tablet while in an upright position (either sitting or standing) to help avoid stomach irritation.
• Swallow the tablet with at least one glass (120 ml) of tap water. Do not take the tablet with mineral water or other beverages except 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 should take calcium and vitamin supplements if the amount you obtain from your diet is insufficient.

If you take MORE Arisocare than you should

If you or someone accidentally takes more Arisocare tablets than prescribed, drink a full glass of milk and contact your doctor.

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 Arisocare

In any case:

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

If you INTERRUPT treatment with Arisocare

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

Stop taking Arisocare and see your 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 surfaces of the body (genitals) (Stevens-Johnson Syndrome)
  • Palpable red spots on the skin (leukocytoclastic vasculitis)
  • Red rash in many parts of the body and/or shedding of the outer layer of skin (toxic epidermal necrolysis)

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

• Inflammation of the eyes, usually with pain, redness, and sensitivity to light.
• Osteonecrosis of the jaw (osteonecrosis) associated with delayed healing and infection, frequently following tooth extraction (see section 2, "Take special care and consult your doctor before starting Arisocare").
• Symptoms affecting the oesophagus such as pain when swallowing, difficulty swallowing, chest pain, or onset or worsening of heartburn.

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

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

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

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

• 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 (within the first five days after the first dose).

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

• Inflammation of the tongue (red, swollen, possibly painful), narrowing of the oesophagus (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 patients)

• Consult your doctor if you have ear pain, ear discharge, 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 not known):

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

Atypical femoral fractures (thigh bone) which may occur rarely, particularly in patients on long-term 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 indicating a possible femoral fracture.

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult 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, website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Arisocare

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 the abbreviation EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Arisocare

• The active substance is sodium risedronate. Each tablet contains 75 mg of sodium risedronate (as hemi-pentahydrate), equivalent to 69.6 mg of risedronic acid.
• The other components (excipients) are: microcrystalline cellulose type 101, monohydrate lactose, crospovidone (type A), and magnesium stearate in the tablet core; and hypromellose, hydroxypropylcellulose, polyethylene glycol (type 400), polyethylene glycol (type 8000), titanium dioxide (E171), anhydrous colloidal silica, and red iron oxide (E172) in the coating.

Appearance of the product and pack contents

• Pale pink, film-coated, round, biconvex tablet, engraved with "75" on one side.
• Tablets are supplied in blisters containing 2 film-coated tablets.

Marketing Authorization Holder

Procare Health Iberia, S.L.

Avda. Miguel Hernández 21, Bajo

46450 Benifaió (Valencia)

Spain

Manufacturer

Adamed Farma, S.A.

ul. Marszalka J. Pilsudskiego 5

95-200 Pabianice

Poland

Date of the most recent revision of this package leaflet: December 2017

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