Risedronate Ababor 35 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Risedronato SemanalAbabor 35 mg film-coated tablets EFG

Sodium risedronate

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Risedronate Weekly Ababor is and what it is used for
2. What you need to know before starting to take Risedronate Weekly Ababor
3. How to take Risedronate Weekly Ababor
4. Possible side effects
5. Storage of Risedronate Weekly Ababor
6. Package contents and additional information

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

Risedronate Ababor Weekly 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 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 following a fall or minor injury.

Osteoporosis can also affect men due to various causes, including aging and/or low levels of the male hormone testosterone.

The most common bone fractures occur in the spine, hip, and wrist, although they can occur in any bone of the body. Fractures associated with osteoporosis 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 Risedronate Ababor Weekly is 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 at high risk of fractures.

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

Do not take Risedronato Semanal Ababor

• 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 calcium levels in the blood)
• if you could 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 of age

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Risedronato Semanal Ababor

• If you are unable to remain in an upright position, either sitting or standing, for at least 30 minutes.
• If you have bone problems or mineral metabolism disorders (for example, vitamin D deficiency, parathyroid hormone disorders, both leading to low calcium levels in the blood).
• If you have or have previously had problems with your oesophagus (the tube connecting the mouth to the stomach). At some point you may have experienced pain or difficulty swallowing food, or you may have previously been diagnosed with Barrett’s oesophagus (a condition associated with changes in the cells lining the lower part of the oesophagus).
• If you have had or currently have pain, swelling, or numbness in the jaw, severe jaw discomfort, or loose teeth.
• If you are undergoing dental treatment or are scheduled for dental surgery, inform your dentist that you are being treated with Risedronato Semanal Ababor.

Your doctor will advise you on what to do if you take Risedronato Semanal Ababor and experience 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 safety and efficacy.

Taking Risedronato Semanal Ababor 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 may reduce the effect of Risedronato Semanal Ababor when taken at the same time:

• Calcium
• Magnesium
• aluminium (e.g. some medicines for indigestion)
• iron

Take these medicines at least 30 minutes after taking Risedronato Semanal Ababor.

Taking Risedronato Semanal Ababor with food and drinks

Take food and beverages (other than tap water) at least 30 minutes after taking Risedronato Semanal Ababor.

It is very important NOT to take Risedronato Semanal Ababor with food or with beverages (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 Risedronato Semanal Ababor with other medicines”).

Pregnancy and breastfeeding

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

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

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

Risedronato Semanal Ababor may only be used in postmenopausal women and in men.

Driving and using machines

It is unknown whether Risedronato Semanal Ababor affects the ability to drive or operate machinery.

Risedronato Semanal Ababor contains maltose

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

3. How to take Risedronate Ababor Weekly

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medicine is taken orally.

Recommended dose:

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

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

When to take the Risedronate Ababor Weekly tablets

Take the Risedronate Ababor Weekly tablet at least 30 minutes before the first meal, drink of the day (except if this drink is plain tap water), or any other medication of the day.

How to take Risedronate Weekly Ababor tablets

• Take the tablet while in an upright position (sitting or standing) to 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—only 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 need to take calcium and vitamin supplements if the amount you get from your diet is insufficient.

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 at telephone number 91 562 04 20, stating the medication and the amount ingested. If you or someone accidentally takes more Risedronate Weekly Ababor tablets than prescribed, drink a full glass of milk and seek medical attention immediately.

If you forget to take Risedronate Weekly Ababor

If you forget to take the tablet on your scheduled day, take it as soon as you remember. Then take the next tablet one week later, on your usual tablet day.

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

If you stop taking Risedronate Weekly Ababor

If you stop treatment, you may begin to lose bone mass. Please consult your doctor before deciding to discontinue 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 Risedronate Weekly Ababor and contact 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.
• Urticaria, skin rashes.

Severe skin reactions such as:

• Blisters on the skin, mouth, eyes, and other moist areas of the body (genitals) (Stevens-Johnson syndrome).
• Palpable red spots on the skin (leukocytoclastic vasculitis).
• Red rash affecting many parts of the body and/or loss of the outer layer of skin (toxic epidermal necrolysis).

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

• Eye inflammation, usually with pain, redness, and sensitivity to light.
• Jaw bone necrosis (osteonecrosis) associated with delayed healing and infection, frequently following tooth extraction (see section 2, "Warnings and precautions").
• Esophageal symptoms such as pain when swallowing, difficulty swallowing, chest pain, and onset or worsening of heartburn.

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

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

• Indigestion, nausea, vomiting, stomach pain, stomach discomfort or cramps, dyspepsia, constipation, sensation of fullness, abdominal distension, diarrhea.
• Bone, muscle, or joint pain.
• Headache.

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

• Inflammation or ulceration of the esophagus (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 colored part of the eye (iris) (painful red eyes possibly with changes in vision).

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

• Inflammation of the tongue (swollen, red, possibly painful), narrowing of the esophagus (the 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:

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

After marketing authorization, the following adverse effects have been reported (frequency not known):

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

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.

Atypical femoral fractures (thigh bone) 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.

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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaRAM.es.

By reporting adverse 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and additional 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 components (excipients) are:

Tablet core:

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), quinoline yellow aluminium lake (E104).

Appearance of the medicinal product and contents of the container

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder:

Ababor Pharmaceuticals, S. L
Chile, nº 4 – Building 1 – Office 1 - Las Matas
Las Rozas (28290) Madrid

Manufacturer responsible for manufacturing:

One Pharma S.A.
N.N.R. Athion-Lamias 60th Km
Sximatari Voiotias
Greece

This medicinal product is authorized in the European Economic Area member states under the following names:

Greece: RISOSFON 35mg ep??a??µµ??a µe ?ept? ?µ???? d?s??a
Portugal: Risedronato de sódio/Pharmanel 35mg comprimidos revestidos por película
Spain: Risedronato Semanal Ababor 35mg comprimidos recubiertos con pelicula EFG

Date of the most recent review of this leaflet: August 2014

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