Risedronate Ababor 75 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Risedronato Ababor 75 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 it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

What Risedronato Ababor is

Risedronato 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 thereby reducing the risk of fractures.

Bone is living tissue. The 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 to occur following a fall or twist.

The most common bone fractures are those of the vertebrae, hips, and wrists, although they can occur in any bone of the body. Fractures caused by 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 Risedronato Ababor is used for

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

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

• If you are unable to remain upright (sitting or standing) for at least 30 minutes.
• If you have bone disorders or mineral metabolism problems (for example, vitamin D deficiency or parathyroid hormone disorders, as both can cause low blood calcium levels).
• If you have or have previously had esophageal problems (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 esophagus (a condition associated with changes in the cells lining the lower part of the esophagus).
• If you have had or currently have pain, swelling, or numbness in the jaw, or severe jaw discomfort, or a loose tooth.
• If you are undergoing dental treatment or are scheduled for dental surgery, inform your dentist that you are receiving treatment with Risedronate Ababor.

Your doctor will advise you on what to do if you are taking Risedronate 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 its safety and efficacy.

Taking Risedronate 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 reduce the effect of Risedronate Ababor when taken at the same time:

• Calcium
• Magnesium
• Aluminum (e.g., certain antacids)
• Iron

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

Taking Risedronate Ababor with food and drinks

Wait at least 30 minutes after taking Risedronate Ababor before consuming food or beverages (other than tap water).

It is very important NOT to 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 might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

DO NOT take Risedronate Ababor if you could 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 may only be used in postmenopausal women.

Driving and using machines

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

Risedronate 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 them before taking this medicine.

3. How to take Risedronate Ababor

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:

Risedronate Ababor tablets should be taken two days per month, always on the SAME two consecutive days each month (for example, 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 following morning.

Repeat this every month, keeping the same two consecutive days. To help you remember when to take the tablets again, you may mark them 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 meal, drink of the day (except if this drink is plain tap water), or other medicine of the day.

How to take the Risedronate Ababor tablet

• 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 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 advise you whether you should take calcium and vitamin supplements if the amount you consume in your diet is insufficient.

If you take more Risedronate Ababor than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

If you or someone accidentally took more Risedronate Ababor tablets than prescribed, drink a full glass of milk and seek medical advice.

If you forget to take Risedronate Ababor

In any case:

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

If you interrupt treatment with Risedronate Ababor

If you stop taking the medication, you may begin to lose bone mass. Please consult your doctor before deciding to interrupt the 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 will experience them.

Stop taking Risedronate Ababor and see 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
  • Urticaria and 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").
• Symptoms affecting the esophagus such as pain when swallowing, difficulty swallowing, chest pain, or onset or worsening of heartburn.

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

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

• Indigestion, nausea, vomiting, stomach pain, stomach discomfort or cramps, dyspepsia, constipation, feeling of fullness, abdominal distension, and diarrhea.
• Pain in bones, muscles, or joints.
• Headache.

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

• 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 (part of the intestine where the stomach empties).
• Inflammation of the colored part of the eye (iris) (red, painful eyes, possibly with changes in vision).
• Fever and/or flu-like symptoms.

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

• Inflammation of the tongue (red, swollen, possibly painful), narrowing of the esophagus (the tube connecting the mouth to the stomach).
• Abnormal liver function tests have been reported. These can only be diagnosed by blood tests.
• Allergic inflammation of blood vessels (leukocytoclastic vasculitis).

Very rare adverse effects:

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

After marketing authorization, 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 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) which 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 they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es

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

5. Storage of Risedronate Ababor

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is 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 a SIGRE collection point at your pharmacy.

If you have any doubts, 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

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 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), aluminium lake, quinoline yellow (E104).

Appearance of the medicinal product and contents of the pack

Risedronate Ababor 75 mg film-coated tablets are pink oval tablets of 12.4 x 4.0 mm. The tablets are available in blister packs containing 2, 4, 6 or 8 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

One Pharma S.A.

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

Sximatari Voiotias

Gr e ec e

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

France RISEDRONATE PHARMANEL 75mg, film-coated tablet

Greece RISOSFON 75mg επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α

Portugal: Sodium risedronate/Pharmanel 75mg film-coated tablets

Spain Risedronate Ababor 75mg film-coated tablets EFG

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