Prospect: Patient Information

Risedronate WeeklyAbabor35 mg Film-Coated Tablets

Risedronate sodium

Read this prospect carefully before starting to take the medicine, as it contains important information for you.

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

Content of theprospect:

1. What Risedronate WeeklyAbaboris and for what it is used
2. What you need to know before starting to take Risedronate WeeklyAbabor
3. How to take Risedronate WeeklyAbabor
4. Possible adverse effects
5. Storage of Risedronate WeeklyAbabor
6. Contents of the package and additional information

Abaloparatide Weekly 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 their fractures.

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

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

Osteoporosis can also be suffered by men due to numerous 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 of the body. Osteoporosis-related fractures can also produce back pain, height loss, and curved back. Some patients with osteoporosis do not have symptoms and may not even know they have it.

For what Abaloparatide Weekly is used

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

For the treatment of osteoporosis in men withhighfracture risk.

Do not takeRisedronate Weekly Ababor

• if you are allergic to risedronate sodium or 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 levels of calcium 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 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 (of the bones) or mineral metabolism problems (for example, vitamin D deficiency, parathyroid hormone alterations, both producing low levels of calcium in the blood).
• If you have or have had problems with your 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 Barrett's esophagus (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 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

Risedronate sodium is not recommended for use in children and adolescents under 18 due to insufficient data on its safety and efficacy.

Taking Risedronate Weekly Ababor with other medicines

Inform your doctor or pharmacist that you are taking or have taken recently or may need to take any other medicine.

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

• Calcium
• Magnesium
• Aluminum (for example, some antacid medication)
• 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 with 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, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

DO NOT take Risedronate Weekly Ababor if you could 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 risedronate sodium 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 operating machinery

The effect of Risedronate Weekly Ababor on the ability to drive or operate machinery is unknown.

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 certain sugars, consult with him before taking this medicine.

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

This medicationis takenby mouth

Recommended dose:

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

Choose the day of the week that best suits your schedule. Take the Risedronate Semanal Ababor tablet every week on the chosen day.

When to take Risedronate Semanal Ababor tablets

Take the Risedronate Semanal Ababor tablet at least 30 minutes before the first meal, drink of the day (except in the case of plain tap water(from the faucet)or another medication of the day).

How to take Risedronate Semanal Ababor tablets

• Take the tabletwhile 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 tell you if you need to take calcium and vitamin supplements, if the amount you take from your diet is not sufficient.

If you take more Risedronate Semanal 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 Risedronate Semanal Ababor tablets than prescribed, drink a full glass of milk and see a doctor.

If you forget to take Risedronate Semanal Ababor

If you forgot to take the tablet on the chosen day, take the tablet on the day you remember.And take the next tablet a week later, 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 interrupt treatment with Risedronate Semanal Ababor

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

Severe allergic reaction symptoms such as:

• Swelling of the face, tongue, or throat.
• Difficulty swallowing.
• Hives and difficulty breathing.
• Urticaria, skin eruptions.

Severe skin reactions such as:

• Blisters on the skin, mouth, eyes, and other moist areas of the body (genitals) (Stevens-Johnson syndrome).
• Red, palpable patches on the skin (leucocitoclástic 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 of the eyes, usually with pain, redness, and sensitivity to light.
• Bone necrosis of the jaw (osteonecrosis) associated with delayed healing and infection, often after tooth extraction (see section 2, "Warnings and precautions").
• Esophageal symptoms such as chest pain, difficulty swallowing, and worsening heartburn.

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

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

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

Less frequent 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 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 (iris) (red, painful eyes with possible changes in vision).

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

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

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):

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

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

Atypical fractures of the femur (thigh bone) 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 femur fracture.

Reporting of side effects

If you experience any type of side effect,consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use http://www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 notrequire special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Risedronate Weekly Ababor

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

The other components (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), quinoline yellow aluminium lake (E104).

Appearance of the product and contents of the packaging

Risedronate Weekly Ababor 35 mg film-coated tablets are oval, pink, biconvex tablets measuring 9.8 x 3.0 mm.

The tablets are presented in a blister pack of 1, 2, 4, 10, 12, or 16 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. Athion-Lamias 60 th Km

Sximatari Voiotias

Greece

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

Greece: RISOSFON 35mg ep??a??µµ??a µe ?ept? ?µ???? d?s??a

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

Spain: Risedronate S emanal Ababor 35mg film-coated tablets EFG

Last review date of this prospectus: August 2014

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) h t tp://www.aemps.gob.es/