Patient Information Leaflet: Product Information

Actonel 5 mg Film-Coated Tablets

Risedronate Sodium

Read this 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, ask yourpharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

1. What is Actonel and what is it used for

2. What you need to know before taking Actonel

3. How to take Actonel

4. Possible side effects

5. Storage of Actonel

6. Contents of the pack and additional information

What is Actonel

Actonel belongs to a group of non-hormonal medications called bisphosphonates, which are used for the treatment of bone diseases (bone disorders). Actonel acts directly on the bones, strengthening them, and therefore reduces the likelihood of fractures.

The bone is a living tissue. The old bone of 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.

Osteoporosis is often found in women who have passed menopause and also in patients who are taking corticosteroids for an extended period.

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 cause 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 Actonel used forActonel

For the treatment of osteoporosis

• inwomenafter menopause

For the prevention of osteoporosis

• inwomen at high risk of developing osteoporosis(including bone loss, premature menopause, or a family history of osteoporosis).
• in women after menopause who have been taking high doses of steroids for a long time.The treatment maintains or increases bone mass.

Do not take Actonel

-if you are allergic to risedronate sodium or any of the other ingredients of this medication (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 may be pregnant, are pregnant, or plan to become pregnant
• if you are breastfeeding
• if you have severe kidney disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Actonel:

• 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, 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 your doctor has informed you that you have an intolerance to some sugars (such as lactose).
• If you have had or have jaw pain, swelling, or numbness, or "severe jaw pain" or a tooth has moved.
• If you are undergoing dental treatment or are about to undergo a dental procedure, inform your dentist that you are taking Actonel.

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

Children and adolescents

Actonel is not recommended for use in children and adolescents (under 18 years) due to insufficient data on its safety and efficacy.

Taking Actonel with other medications

Medications containing any of the following substances reduce the effect of Actonel when taken at the same time:

• calcium
• magnesium
• aluminum (for example, some antacid medication)
• iron

Take these medications at least 30 minutes after taking Actonel.

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

Taking Actonel with food and drinks

It is very important that you DO NOT take Actonel with food or drinks (other than tap water) as 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 Actonel with other medications").

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

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

Driving and operating machinery

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

Actonel contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Actonel contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per coated tablet; this is, essentially "sodium-free".

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

The recommended dose isof:

One Actonel tablet (5 mg risedronate sodium) once a day.

The aluminum foil of the blister pack has the days of the week printed on it to facilitate the administration of the medication.

WHEN to take Actonel tablets

Take the Actonel tablet at least 30 minutes before the first meal, drink of the day (except in the case of water), or another medication of the day.

Although it is preferable to take this tablet before breakfast, if you have not been able to take Actonel then, you can take it with an empty stomach, at the same time of day, in one of the following cases:

• Between meals: Actonel must be taken at least 2 hours before or at least 2 hours after taking any meal, medication, or drink (other than water).

OR:

• At night: Actonel must be taken at least 2 hours after taking the last meal, medication, or drink (other than water) of the day. Actonel must be taken at least 30 minutes before going to bed.

HOW to take Actonel tablets

• 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.
• Swallow the tablet whole.Do not chew or suck it.
• Do not lie down, at least for 30 minutes after taking the tablet.

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

Use in children and adolescents

Risedronate sodium is not recommended for use in children under 18 years due to the scarcity of data on safety and efficacy.

IF you take more Actonel than you should

If you have taken more Actonel tablets than prescribed, drink a full glass of milk and see your doctor.

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 taken.

IF you forget to take Actonel

If you have forgotten to take the tablet at your usual time, you can take the tablet as soon as possible, in accordance with the previous instructions (e.g., before breakfast, between meals, or at night).

Do not take a double dose to compensate for the missed dose.

IFyou interrupt treatment with Actonel

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 medicines, Actonel can cause side effects, although not everyone will experience them.

Stop taking Actonel 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.

The frequency of this side effect is unknown (cannot be estimated from available data).

• Severe skin reactions that may include skin blistering. The frequency of this side effect is unknown (cannot be estimated from available data).

Inform your doctor quicklyif you experience the following side effects:

• Eye inflammation, usually with pain, redness, and sensitivity to light. The frequency of this side effect is unknown (cannot be estimated from available data).
• Orbital inflammation – inflammation of the structures surrounding the eyeball. Symptoms may include: pain, swelling, redness, protrusion of the eyeball, and vision changes. The frequency of this side effect is unknown (cannot be estimated from available data).
• jawbone necrosis (osteonecrosis) associated with delayed healing and infection, often after a tooth extraction (see section 2, "Warnings and precautions"). The frequency of this side effect is unknown (cannot be estimated from available data).
• Esophageal symptoms such as difficulty swallowing, chest pain, and appearance or worsening of stomach acid. This side effect is rare (may affect up to 1 in 100 people).

Atypical femoral fractures that may occur in rare cases, especially in patients undergoing prolonged 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 and indicative of a possible femoral fracture.

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, stomach pain, discomfort, or cramps, heavy digestion, constipation, feeling full, abdominal distension, diarrhea.

-Pain in your bones, muscles, or joints.

-Headache.

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

• Esophageal inflammation or ulceration (the tube that connects the mouth to the stomach) causing difficulty and pain swallowing (see also section 2, "Warnings and precautions"), stomach and/or duodenal inflammation.

- Inflammation of the colored part of the eye (iris) (red, painful eyes with possible vision changes).

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

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

During post-marketing use, the following have been reported:

• Moderately rare: Consult your doctor if you have ear pain, ear discharge, or an ear infection. These may be symptoms of damage to the ear bones.
• Unknown frequency:
• hair loss cases.
• Liver alterations, in some cases severe.

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.

Reporting 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:https://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 not require special storage conditions.

Medications should not be disposed of through drains or trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Actonel

-The active ingredient is risedronate sodium. Each tablet contains 5 mg of risedronate sodium (equivalent to 4.64 mg of risedronic acid).

-The other components (excipients) are:

Core tablet: lactose monohydrate (see section 2), crospovidone, magnesium stearate, and microcrystalline cellulose.

Film coating: hypromellose, macrogol, hydroxypropylcellulose, anhydrous colloidal silica, titanium dioxide (E171), and yellow iron oxide (E172).

Appearance of the product and contents of the pack

Actonel 5 mg film-coated tablets are oval-shaped yellow tablets with the letters “RSN” on one face and “5mg” on the other.

The tablets are presented in blisters of 14, 28 (2x14), 84 (6x14), 98 (7x14) film-coated tablets..

Only some pack sizes may be marketed.

Marketing Authorization Holder

Theramex Ireland Limited

3rdFloor, Kilmore House,

Park Lane, Spencer Dock,

Dublin 1

D01 YE64

Ireland

Responsible for manufacturing

Balkanpharma-Dupnitsa AD

3, Samokovsko Shosse Str.

2600 Dupnitsa

Bulgaria

Local Representative

Theramex Healthcare Spain, S.L.

Calle Martínez Villergas 52, Edificio C, planta 2ª izquierda.

28027 Madrid

Spain

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

Belgium:Actonel 5 mg filmomhulde tabletten,

Actonel 5 mg comprimé pelliculé,

Actonel 5 mg Filmtabletten

France:Actonel 5 mg comprimé pelliculé

Germany:Risedronat Theramex 5 mg Filmtabletten

Italy:Actonel 5 mg compresse rivestite con film

Luxembourg:Actonel 5 mg comprimé pelliculé

Netherlands:Actonel 5 mg, filmomhulde tabletten

Spain:Actonel 5 mg comprimidos recubiertos con película

Sweden:Optinate 5 mg filmdragerade tabletter

Last review date of this leaflet:October 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/