Package Insert: Patient Information

Risedronate Ababor 75 mg Film-Coated Tablets

Risedronate sodium

Read this package insert carefully before starting to take this medication, as it may contain important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.See section4

What is Risedronato Ababor

Risedronato Ababor belongs to a group of non-hormonal medications called bisphosphonates, which are used for the treatment of bone diseases. It acts directly on the bones, strengthening them and, therefore, reduces the probability of fractures.

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

Postmenopausal osteoporosis appears in women after menopause when the bone begins to weaken, becomes more fragile, and fractures are more likely to occur 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 produce 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 Risedronato Ababor used for

This medication is indicated for the treatment of osteoporosis in women after menopause.

Do not take Risedronato Ababor

• If you are allergic to sodium risedronate or to any of the other components of this medication (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, if you are pregnant, or if you 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 Risedronato Ababor

• If you cannot remain in an upright position (either sitting or standing) for at least 30 minutes.
• If you have bone or mineral metabolism problems (for example, vitamin D deficiency or parathyroid hormone alterations, as both produce a decrease in blood calcium).
• If you have or have had problems in the past with the esophagus (the tube that connects the mouth to the stomach). At some point, you may have or have had difficulty swallowing food or have been previously informed that you have esophageal Barrett's syndrome (a condition associated with changes in the cells that cover the lower part of the esophagus).
• If you have had or have pain, swelling, or numbness in the jaw or a strong pain in the jaw or a tooth that moves.
• If you are undergoing dental treatment or are about to undergo dental surgery, inform your dentist that you are receiving treatment with Risedronato Ababor.

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

Children and adolescents

Risedronate sodium is not recommended for use in children and adolescents (under 18 years old) due to a lack of sufficient data on its safety and efficacy.

Taking Risedronato Ababor with other medications

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

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

• Calcium
• Magnesium
• Aluminum (for example, some antacids)
• Iron

Take these medications at least 30 minutes after taking your Risedronato Ababor tablet.

Taking Risedronato Ababor with food and drinks

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

It is very important that you DO NOT take Risedronato Ababor with food or drinks (other than tap water) because they may interfere. In particular, do not take this medication at the same time as dairy products (such as milk) as they contain calcium (see section 2, 'Taking Risedronato Ababor with other medications').

Pregnancy and breastfeeding

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

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

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

Risedronato Ababor can only be used in postmenopausal women.

Driving and operating machinery

The effect of Risedronato Ababor on the ability to drive and operate machinery is unknown.

Risedronato Ababor contains maltose

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

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

This medication is taken orally.

Recommended dose:

Risedronato Ababor tablets should be taken two days a month and always on the same two consecutive days of each month (for example, the 1st and 2nd days, or the 15th and 16th days of the month).

Choose the two consecutive days that best fit your schedule. Take one Risedronato Ababor tablet in the morning on the first chosen day. Take the second tablet in the morning on the following day.

Repeat every month, maintaining 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 Risedronato Ababor tablet

Take the Risedronato Ababor tablet at least 30 minutes before the first meal, drink, or other medication of the day (except in the case of water from the tap).

How to take the Risedronato Ababor tablet

• Take the tablet while standing upright (either sitting or standing) to avoid stomach burning.
• Swallow the tablet with at least one glass (120 ml) of tap water. Do not take the tablet with mineral water or other beverages that are not tap water.
• Swallow the tablet whole. Do not chew or crush it.
• Do not lie down for at least 30 minutes after taking the tablet.

Your doctor will indicate if you should take calcium and vitamin supplements, if the amount you take from your diet is not sufficient.

If you take more Risedronato Ababor than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Phone 91 562 04 20, indicating the medication and the amount ingested.

If you or someone accidentally took more Risedronato Ababor tablets than prescribed, drink a full glass of milk and see your doctor.

If you forgot to take Risedronato Ababor

In any case:

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

If you interrupt treatment with Risedronato Ababor

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications,this medicationcan cause side effects, although not everyone will experience them.

Stop taking Risedronato Ababor and see your doctor immediately if you experience any of the following symptoms:

• Signs of asevere allergic reaction, such as:
• • Swelling of the face, tongue, or throat
  • Difficulty swallowing
  • Hives and difficulty breathing
  • Urticaria and skin eruptions

• Severe skin reactionssuch as:
• • Blisters on the skin, mouth, eyes, and other moist areas of the body (genitals) (Stevens-Johnson syndrome)
  • Red, palpable patches on the skin (leucocytoclastic vasculitis)
  • Red rash over many parts of the body and/or loss of the outer layer of the skin (toxic epidermal necrolysis).

Inform your doctor quicklyif you experience the following side effects:

• Inflammation in the eyes, usually with pain, redness, and sensitivity to light.
• jawbone necrosis (osteonecrosis) associated with delayed healing and infection, often after a tooth extraction (see section 2 "Warnings and precautions").
• Esophageal symptoms such as difficulty swallowing, chest pain, or worsening heartburn.

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

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

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

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

• Inflammation or ulceration of the esophagus (the tube that connects the mouth to the stomach) causing difficulty and pain 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 (iris) (red, painful, and possible vision changes).
• Fever and/or flu-like symptoms.

Rare side effects(may affect up to 1 in 1000 patients)

• Inflammation of the tongue (red, swollen, and possibly painful), narrowing of the esophagus (the tube that connects the mouth to the stomach).
• Abnormal liver function test results. This can only be diagnosed through blood tests.
• Allergic inflammation of blood vessels (leucocytoclastic vasculitis).

Very rare side effects:

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

During post-marketing use, the following have been reported (frequency unknown):

• Cases of hair loss.
• Alterations in the liver, in some cases severe.
• Inflammation of small blood vessels.

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

Atypical femoral fractures that may occur in rare cases, especially 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 of a possible femoral fracture.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this leaflet.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es

Byreportingsideeffectsyoucancontributetoprovidingmoreinformationaboutthesafetyofthismedication.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy.at the pharmacy.

If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need.This will help protect the environment.

Contents of Risedronato Ababor

The active ingredient is risedronate sodium. Each tablet contains 75 mg of risedronate sodium, which is equivalent to 69.6 mg of risedronic acid.

The other components (excipients) are:

Tablet core:

Maltose (Advantose 100)

Microcrystalline cellulose

Sodium croscarmellose

Magnesium stearate.

Coating:

Opadry II Pink, a compound consisting of: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide red (E172), aluminum lacquer, quinoline yellow (E104).

Appearance of the product and contents of the packaging

Risedronato Ababor 75 mg film-coated tablets are oval-shaped pink tablets measuring 12.4 x 4.0 mm. The tablets are presented in blisters of 2, 4, 6 or 8 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder

Ababor Pharmaceuticals, S. L

C) Chile, nº 4 – Edificio 1 – Office 1- Las Matas

Las Rozas (28290) Madrid

Responsible for manufacturing

One Pharma S.A.

N.N.R. Athinon-Lamias60thKm

Sximatari Voiotias

Greece

This medicine is authorized in the member states of the European Economic Area with the following names:

FranceRISEDRONATE PHARMANEL 75mg, coated tablet

GreeceRISOSFON 75mg επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α

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

SpainRisedronato Ababor 75mg film-coated tablets EFG

Date of the last review of this leaflet:August 2014