RISEDRONATE ABABOR 75 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Risedronate Ababor 75 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 the pack:

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

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

What Risedronate Ababor is

Risedronate 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 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, hips, and wrists, although they can occur in any bone in the body. Fractures caused by osteoporosis 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 Risedronate Ababor is used for

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

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

Do not take Risedronate 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 calcium levels 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.
• If you are under 18 years old.

Warnings and precautions

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

• If you cannot remain upright (either sitting or standing) for at least 30 minutes.
• If you have bone problems or mineral metabolism problems (e.g., vitamin D deficiency or parathyroid hormone disorders, as both can cause a decrease in blood calcium levels).
• If you have or have had esophageal problems (the duct that connects the mouth to the stomach). At some point, you may have had or been told you have esophageal Barrett's (a condition associated with changes in the cells that line the lower part of the esophagus).
• If you have had or have pain, swelling, or numbness in the jaw or a strong discomfort in the jaw or a tooth moves.
• If you are undergoing dental treatment or are going to undergo dental surgery, inform your dentist that you are receiving treatment with Risedronate Ababor.

Your doctor will advise you what to do if you take Risedronate Ababor 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 old) due to insufficient data on its safety and efficacy.

Taking Risedronate Ababor with other medicines

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

Medicines that contain any of the following substances reduce the effect of Risedronate Ababor when taken at the same time:

• Calcium
• Magnesium
• Aluminum (e.g., some remedies for indigestion)
• Iron

Take these medicines at least 30 minutes after taking your Risedronate Ababor tablet.

Taking Risedronate Ababor with food and drinks

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

It is very important that you DO NOT take Risedronate Ababor with food or drinks (other than 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 Risedronate Ababor with other medicines').

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

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

Risedronate Ababor can only be used in postmenopausal women.

Driving and using machines

It is not known whether Risedronate Ababor affects the ability to drive and use machines.

Risedronate Ababor contains maltose

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

3. How to take Risedronate Ababor

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

This medicine is taken orally.

Recommended dose:

Risedronate Ababor 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 Risedronate Ababor tablet in the morning on the first chosen day. Take the SECOND tablet the next morning.

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.

When to take the Risedronate Ababor tablet

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

How to take the Risedronate Ababor tablet

• Take the tablet while standing or sitting upright to avoid stomach upset.
• 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 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 taken more Risedronate Ababor tablets than prescribed, drink a full glass of milk and go to the doctor.

If you forget to take Risedronate Ababor

In any case:

• If you forgot your Risedronate Ababor dose in the morning, DO NOT take it later that day.
• DO NOT take three tablets in the same week.

If you stop taking Risedronate Ababor

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

If you have any further questions on the use of this product, 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 Ababor and contact a 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
  • Rash and skin eruptions

• Severe skin reactionssuch as:
• • Blisters on the skin, mouth, eyes, and other moist areas of the body (Stevens-Johnson syndrome)
  • Red palpable spots on the skin (leukocytoclastic vasculitis)
  • Red rash over 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 in 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").
• Symptoms in the esophagus 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 or cramps in the stomach, heavy digestion, constipation, feeling of fullness, abdominal distension, and 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 duct 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 (part of the 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

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 duct that connects the mouth to the stomach).
• Abnormal liver function tests have been reported. This can only be diagnosed by blood tests.
• Allergic inflammation of blood vessels (leukocytoclastic vasculitis).

Very rare side effects:

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

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

• Cases of 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 levels in the blood has been observed in some patients. These changes are usually small and do not cause symptoms.

Atypical fractures of the femur (thigh bone) may 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 via the Spanish Medicines Monitoring System: www.notificaRAM.es

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

5. Storing Risedronate 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 refers to 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 a pharmacy for proper disposal.

If you are unsure how to dispose of unused medicines, ask your pharmacist for advice. This will help protect the environment.

6. Contents of the pack and other information

Contents of Risedronate Ababor

The active substance is sodium risedronate. Each tablet contains 75 mg of sodium risedronate, equivalent to 69.6 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, red iron oxide (E172), aluminum lacquer, quinoline yellow (E104).

Appearance of the product and contents of the pack

Risedronate Ababor 75 mg film-coated tablets are oval, pink tablets, 12.4 x 4.0 mm in size. The tablets are presented in blisters of 2, 4, 6, or 8 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. Athinon-Lamias 60th Km

Sximatari Voiotias

Greece

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

France RISEDRONATE PHARMANEL 75mg, film-coated tablet

Greece RISOSFON 75mg, film-coated tablets

Portugal: Risedronate sodium/Pharmanel 75mg film-coated tablets

Spain Risedronate Ababor 75mg film-coated tablets EFG

Date of last revision of this leaflet:August 2014