RISEDRONATE WEEKLY ABABOR 35 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Risedronate WeeklyAbabor35 mg film-coated tablets EFG

Sodium risedronate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of thepackage leaflet:

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

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

Risedronate Weekly Ababor belongs to a group of non-hormonal medicines called bisphosphonates, which are used to treat bone diseases. It 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.

Postmenopausal osteoporosis occurs in women after menopause when the bone begins to weaken, becomes more fragile, and fractures are more likely after a fall or twist.

Men can also suffer from osteoporosis due to various 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. 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 Risedronate Weekly Ababor used for

This medicine is indicated for the treatment of osteoporosis in postmenopausal women, even if the osteoporosis is severe. It reduces the risk of vertebral and hip fractures.

For the treatment of osteoporosis in men with a high risk of fractures.

2. What you need to know before you take Risedronate Weekly Ababor

Do not takeRisedronate Weekly Ababor

• 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, are pregnant, or plan to become pregnant
• if you are breastfeeding
• if you have severe kidney disease
• if you are under 18 years old

Warnings and precautions

Consult your doctor or pharmacist before starting to take Risedronate Weekly Ababor

• If you cannot remain upright (either sitting or standing) for at least 30 minutes.
• If you have bone problems (such as bone cancer or Paget's disease) or mineral metabolism problems (such as vitamin D deficiency, parathyroid hormone disturbances, both producing low blood calcium levels).
• If you have or have had problems with your esophagus (the tube that connects your mouth to your stomach). At some point, you may have had or been told you have esophagitis (inflammation of the esophagus), dysphagia (difficulty swallowing), or esophageal stricture (narrowing of the esophagus), or you have been informed that you have Barrett's esophagus (a condition associated with changes in the cells lining the lower esophagus).
• If you have had or have 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 undergo dental surgery, inform your dentist that you are receiving treatment with Risedronate Weekly Ababor.

Your doctor will advise you what to do if you take Risedronate Weekly Ababor and have any of the problems mentioned above.

Children and adolescents

The use of sodium risedronate is not recommended in children and adolescents under 18 years old, as there are not enough data on its safety and efficacy.

Taking Risedronate Weekly Ababor with other medicines

Tell your doctor or pharmacist that you are taking or have recently taken or may have to take any other medicines.

Medicines containing any of the following substances may reduce the effect of Risedronate Weekly Ababor 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 Risedronate Weekly Ababor.

Taking Risedronate Weekly Ababor with food and drinks

Take food and drinks (other than tap water) at least 30 minutes after taking Risedronate Weekly Ababor.

It is very important that you do not take Risedronate Weekly Ababor 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, "Taking Risedronate Weekly Ababor with other medicines").

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

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

Do not take Risedronate Weekly Ababor if you are breastfeeding (see section 2, "Do not take Risedronate Weekly Ababor").

Risedronate Weekly Ababor can only be used in postmenopausal women and men.

Driving and using machines

It is not known if Risedronate Weekly Ababor affects the ability to drive or use machines.

Risedronate Weekly Ababor contains maltose

This medicine contains maltose (a glucose derivative). If you have been informed by your doctor that you have an intolerance to some sugars, consult with him before taking this medicine.

3. How to take Risedronate Weekly Ababor

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

This medicine is taken orally

Recommended dose:

Take 1 tablet of Risedronate Weekly Ababor (35 mg sodium risedronate) once a week.

Choose the day of the week that best suits your schedule. Each week, take the Risedronate Weekly Ababor tablet on the chosen day.

When to take the Risedronate Weekly Ababor tablets

Take the Risedronate Weekly Ababor 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 Risedronate Weekly Ababor 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 Risedronate Weekly Ababor than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Phone 91 562 04 20, indicating the medicine and the amount ingested. If you or someone else has accidentally taken more Risedronate Weekly Ababor tablets than prescribed, drink a full glass of milk and go to the doctor.

If you forget to take Risedronate Weekly Ababor

If you have forgotten to take the tablet on the chosen day, take it on the day you remember. And take the next tablet the following week, on the day you normally take the tablet.

Do not take two tablets on the same day to make up for the missed dose.

If you stop taking Risedronate Weekly Ababor

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

If you have any other 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 Risedronate Weekly Ababor and contact your 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.
• Rash and difficulty breathing.

Severe skin reactions such as:

• Blisters on the skin, mouth, eyes, and other moist areas 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 promptlyif 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, "Warnings and precautions").
• Esophageal symptoms such as pain when swallowing, difficulty swallowing, chest pain, and 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 or cramps in the stomach, heavy digestion, constipation, feeling of fullness, abdominal distension, diarrhea.
• Pain in 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).

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

• Inflammation of the tongue (swollen, red, 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 by blood tests.

Very rare side effects:

• Tell your doctor if you have ear pain, discharge, or infection. These could be signs of bone damage in the ear.

During post-marketing use, the following have been reported (frequency not known):

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

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.

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.

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 Agency's website http://www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Risedronate Weekly Ababor

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 EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

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

6. Contents of the pack and further information

Composition of Risedronate Weekly Ababor

The active substance is sodium risedronate. Each film-coated tablet contains 35 mg of sodium risedronate (equivalent to 32.5 mg of risedronic acid).

The other ingredients (excipients) are:

Core of the tablet:

Maltose (Advantose 100)

Microcrystalline cellulose

Sodium croscarmellose

Magnesium stearate

Film coating:

Opadry II Pink composed of: Polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide red (E172), aluminum lake of quinoline yellow (E104).

Appearance of the product and contents of the pack

Risedronate Weekly Ababor 35 mg film-coated tablets are oval, pink, biconvex tablets, 9.8x3.0 mm in size.

The tablets are presented in blisters of 1, 2, 4, 10, 12, or 16 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder:

Ababor Pharmaceuticals, S.L.

• Chile, nº 4 – Edificio 1 – Oficina 1- Las Matas

Las Rozas (28290) Madrid

Manufacturer:

One Pharma S.A.

N.N.R. Athion-Lamias 60th Km

Sximatari Voiotias

Greece

This medicine is authorized in the Member States of the European Economic Area under the following names:

Greece: RISOSFON 35mg film-coated tablets

Portugal: Risedronate sodium/Pharmanel 35mg film-coated tablets

Spain: Risedronate Weekly Ababor 35mg film-coated tablets EFG

Date of last revision of this leaflet: August 2014

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/