ACTONEL 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Actonel 5 mg Film-Coated Tablets

Sodium Risedronate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again. If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Actonel and what is it used for
2. What you need to know before you take Actonel
3. How to take Actonel
4. Possible side effects
5. Storage of Actonel
6. Contents of the pack and other information

1. What is Actonel and what is it used for

What is Actonel

Actonel belongs to a group of non-hormonal medicines called bisphosphonates, which are used for the treatment of bone diseases. Actonel acts directly on bones, strengthening them and reducing the likelihood of fractures.

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

Postmenopausal osteoporosis occurs in women after menopause when bone begins to weaken, becoming more fragile and prone to fractures after a fall or twist.

Osteoporosis is common in women who have gone through menopause and also in patients taking corticosteroids for a long time.

The most likely bone fractures are those of the vertebrae, hip, and wrist, although they can occur in any bone in the body. Osteoporosis-related fractures can also cause back pain, loss of height, and a curved back. Some patients with osteoporosis may not have symptoms and may not even know they have it.

What Actonel is used for

In the treatment of osteoporosis

• in women after menopause

In the prevention of osteoporosis

• in women at high risk of osteoporosis (including bone mass loss, early menopause, or 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.

2. What you need to know before you take Actonel

Do not take Actonel

• 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 disease called hypocalcemia (low blood calcium levels)
• 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 upright, either sitting or standing, for at least 30 minutes.
• If you have bone or mineral metabolism problems (e.g., vitamin D deficiency, parathyroid hormone disorders, both producing low blood calcium levels).
• 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 had or been told you have esophagitis (inflammation of the esophagus) or esophageal stricture (narrowing of the esophagus), or you may have been informed that you have Barrett's esophagus (a condition associated with changes in the cells lining the lower esophagus).
• If your doctor has told you that you have an intolerance to some sugars (such as lactose).
• If you have had or have pain, swelling, or numbness in the jaw or mouth, or "a strong discomfort in the jaw" or a loose tooth.
• If you are undergoing dental treatment or are going to have 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

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

Taking Actonel with other medicines

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

• calcium
• magnesium
• aluminum (e.g., some antacids)
• iron

Take these medicines at least 30 minutes after taking Actonel.

Inform your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines.

Taking Actonel with food and drinks

It is very important that you DO NOT take Actonel with food or drinks (other than plain water) because they can 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 Actonel with other medicines").

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

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 using this medicine.

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 sodium risedronate (the active substance of Actonel) in pregnant women is unknown.

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

Driving and using machines

It is not known if Actonel affects the ability to drive and use machines.

Actonel contains lactose

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

Actonel contains sodium

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

3. How to take Actonel

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

The recommended dose is:

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

The aluminum foil of the blister pack is printed with the days of the week to help you take the medicine.

WHEN to take the Actonel tablets

Take the Actonel tablet at least 30 minutes before the first food, drink, or other medicine of the day (except if this drink is plain water).

Although it is preferable to take this tablet before breakfast, if you were unable to take Actonel then, you can take it with an empty stomach, at the same time every 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 food, medicine, or drink (other than plain water).

OR:

• In the evening: Actonel must be taken at least 2 hours after taking the last food, medicine, or drink (other than plain water) of the day. Actonel must be taken at least 30 minutes before bedtime.

HOW to take Actonel tablets

• Take the tablet while standing or sitting upright to avoid heartburn.
• Swallow the tablet with at least one glass (120 ml) of plain water (tap water).
• Swallow the tablet whole. Do not chew or suck it.
• Do not lie down for at least 30 minutes after taking the tablet.

Your doctor will tell you if you should take calcium and vitamin supplements if the amount you take in your diet is not sufficient.

Use in children and adolescents

Sodium risedronate is not recommended for use in children under 18 years due to insufficient 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 consult your doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount taken.

If you forget to take Actonel

If you have forgotten to take the tablet at the scheduled time, you can take it as soon as possible, according to the instructions above (e.g., before breakfast, between meals, or in the evening).

Do not take a double dose to make up for the forgotten dose.

If you stop taking Actonel

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Actonel can cause side effects, although not everybody gets them.

Stop taking Actonel and contact your doctor immediatelyif 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.

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

• Severe skin reactions that can include blistering of the skin. The frequency of this side effect is not known (cannot be estimated from the available data).

Tell your doctor as soon as possibleif you experience any of the following side effects:

• Eye inflammation, usually with pain, redness, and sensitivity to light. The frequency of this side effect is not known (cannot be estimated from the 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 not known (cannot be estimated from the available data).
• Jaw 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 not known (cannot be estimated from the available data).
• Symptoms related to the esophagus such as pain when swallowing, difficulty swallowing, chest pain, and worsening of heartburn. This side effect is uncommon (may affect up to 1 in 100 people).

Atypical fractures of the thigh bone (femur) can occur rarely, 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 symptoms of a possible femur fracture.

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

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

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

Uncommon 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 when swallowing (see also section 2, "Warnings and precautions"), stomach and/or duodenal inflammation.

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

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

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

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

• Very rare: Consult your doctor if you have ear pain, discharge from the ear, or an ear infection. These could be symptoms of damage to the bones of the ear.
• Frequency not known:
• Cases of hair loss.
• Liver disorders, in some cases severe.

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

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Actonel

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Actonel

• The active substance is sodium risedronate. Each tablet contains 5 mg of sodium risedronate (equivalent to 4.64 mg of risedronic acid).
• The other ingredients (excipients) are:

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

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

Appearance and packaging of the product

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

The tablets are available in blister packs of 14, 28 (2x14), 84 (6x14), and 98 (7x14) film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Theramex Ireland Limited

3rd Floor, Kilmore House,

Park Lane, Spencer Dock,

Dublin 1

D01 YE64

Ireland

Manufacturer

Balkanpharma-Dupnitsa AD

3, Samokovsko Shosse Str.

2600 Dupnitsa

Bulgaria

Local representative

Theramex Healthcare Spain, S.L.

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

28027 Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under 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

Date of last revision of this leaflet:October 2024

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