ARISOCARE 75 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Arisocare 75 mg film-coated tablets EFG

Sodium risedronate

Contents of the pack:

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

1. What is Arisocare and what is it used for

What isArisocare

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 thus reducing the likelihood of fractures.

Bone is a living tissue. Old bone tissue in the skeleton is constantly being renewed and replaced by new bone tissue.

Postmenopausal osteoporosis occurs in women after menopause when the bone begins to weaken, becoming more fragile and prone to fractures 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. Osteoporosis-related fractures can also cause back pain, loss of height, and a curved back. Some patients with osteoporosis may not have symptoms and may not even know they have it.

What is Arisocare used for

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

2. What you need to know before you take Arisocare

Do not takeArisocare

• if you are allergic to sodium risedronate or any of the other ingredients of this medicine (listed in section 6).
• if your doctor has told you that you have a disease called hypocalcemia(low blood calcium levels).
• if you may be pregnant, if you are pregnant, or if you plan to become pregnant.
• if you are breast-feeding.
• if you have severe kidney disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Arisocare.

Be particularly careful and consult your doctor BEFORE starting to takeArisocare

• if you cannot remain upright (either sitting or standing) for at least 30 minutes.
• if you have bone or mineral metabolism problems (e.g., vitamin D deficiency, parathyroid hormone disorders, both producing low blood calcium levels).
• 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 pain or difficulty swallowing food, or you may have been told that you have Barrett's esophagus (a disease associated with changes in the cells that line the lower part of the esophagus).
• if you have had pain, swelling, or numbness in the jaw or "a strong discomfort in the jaw" or a tooth has moved.
• if you are undergoing dental treatment or are going to have dental surgery, inform your dentist that you are receiving treatment with Arisocare.
• your doctor will advise you what to do if you take Arisocare and have any of the above problems.

Children and adolescents

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

Taking Arisocare with other medicines

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

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

• calcium
• magnesium
• aluminum (e.g., some medicines for indigestion)
• iron

Take these medicines at least 30 minutes after taking Arisocare.

Taking Arisocare with food and drinks

It is very important that you DO NOT take Arisocare with food or drinks (other than tap water) because 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, "Using Arisocare with other medicines").

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

Pregnancy and breast-feeding

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 sodium risedronate (the active ingredient in Arisocare) in pregnant women is unknown.

DO NOT take Arisocare if you are breast-feeding (see section 2, "Do not take Arisocare").

Arisocare should only be used in postmenopausal women.

Driving and using machines

It is not known whether Arisocare affects the ability to drive or use machines.

Arisocare contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Arisocare

Follow exactly the administration instructions of this medicine given 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 on the SAME two consecutive days of each month (e.g., 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 on the morning of the first chosen day. Take the SECOND tablet on the morning of the next day.

Repeat every 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 on the space provided on the back of the medicine box.

WHEN to take the Arisocare tablets

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

HOW to take the Arisocare tablets

• Take the tablet while standing or sitting upright to avoid heartburn.
• 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 whole. Do not suck or chew it.
• Do not lie down for at least 30 minutes after taking the tablet.

Your doctor will tell you if you should take calcium and vitamin supplements if the amount you take in your diet is not sufficient.

If you take MORE Arisocare than you should

If you or someone else has taken more Arisocare tablets than prescribed, drink a full glass of milkand go to the doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service (Telephone 91 562 04 20), indicating the name of the medicine 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 during the day.
• DO NOT take three tablets in the same week.

If you STOP taking Arisocare

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Arisocare and go to the doctor immediatelyif 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 (genital areas) (Stevens-Johnson syndrome)
  • Red 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)

Tell your doctor as soon as possibleif you experience any of the following side effects:

• Inflammation of the eyes, usually with pain, redness, and sensitivity to light.
• Jaw bone necrosis (osteonecrosis) associated with delayed healing and infection, often after tooth extraction (see section 2 "Be particularly careful and consult your doctor BEFORE starting to take Arisocare").
• Esophageal symptoms such as pain when swallowing, difficulty swallowing, chest pain, or appearance or worsening of heartburn.

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

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

• Indigestion, nausea, vomiting, stomach pain, discomfort, heavy digestion, constipation, feeling of fullness, abdominal distension, diarrhea.
• Pain in your bones, muscles, or joints.
• Headache.

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

• Inflammation or ulceration of the esophagus (the tube that connects the mouth to the stomach) causing difficulty and pain when swallowing (see also section 2, "Warnings and precautions"), inflammation of the stomach and duodenum (intestine where the stomach empties).
• Inflammation of the colored part of the eye (the iris) (red eyes, painful 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 people)

• Inflammation of the tongue (red, swollen, possibly painful), narrowing of the esophagus (the tube that connects the mouth to the stomach).
• Abnormal liver tests have been reported. This can only be diagnosed through blood tests.

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

• Tell 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 not known):

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

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

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

If you think any of the side effects you are experiencing are serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use, website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Arisocare

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

Do not use this medicine after the expiry date which is stated on the carton after the abbreviation CAD. The expiry date is the last day of the month shown.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Arisocare

• The active ingredient is sodium risedronate. Each tablet contains 75 mg of sodium risedronate (as hemi-pentahydrate), equivalent to 69.6 mg of risedronic acid.
• The other ingredients (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), colloidal anhydrous silica, and red iron oxide (E172) in the coating.

Appearance of the product and pack contents

• Pale pink, round, biconvex film-coated tablet, engraved with "75" on one side.
• The tablets are presented in blister packs of 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 last revision of this leaflet: December 2017

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