ACTONEL 75 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Actonel 75 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. Storing 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 works directly on the 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 the bone starts 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, 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

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

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 problems or mineral metabolism problems (e.g., vitamin D deficiency, parathyroid hormone disorders, both causing 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 have had pain or difficulty swallowing food, or you have been previously informed that you have Barrett's esophagus (a condition associated with changes in the cells lining the lower esophagus).
• If you have had or have pain, swelling, or numbness in the jaw or "a strong discomfort in the jaw" or a tooth has moved.
• If you are undergoing dental treatment or are going to undergo dental surgery, inform your dentist that you are receiving treatment with Actonel.

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

Children and adolescents

The use of sodium risedronate is not recommended in children and adolescents (under 18 years) due to insufficient data on its 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 indigestion medicine)
• iron

Take these medicines at least 30 minutes after taking Actonel.

Tell your doctor or pharmacist that you are using, have recently used, or may need to use any other medicine.

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 taking Actonel.

Pregnancy and breastfeeding

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 ingredient in Actonel) in pregnant women is unknown.

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

Actonel can only be used in postmenopausal women.

Driving and using machines

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

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.

Recommended dose:

Actonel tablets should be taken on the SAME two consecutive days of each month, for example, on days 1 and 2 or 15 and 16 of the month.

Choose the TWO consecutive days that best fit your schedule. Take ONE Actonel tablet on the morning of the first chosen day. Take the SECOND tablet on the morning of the next day.

Repeat every month, keeping 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 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).

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. Do not take the tablet with mineral water or other drinks that are not plain 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 tell you if you should take calcium and vitamin supplements if the amount you take in your diet is not sufficient.

If you take more Actonel than you should

If you or someone else has taken more Actonel tablets than prescribed, drink a full glass of milk and consult a doctor.

In case of overdose or accidental ingestion, consult the Toxicology Information Service (telephone 91 562 04 20).

If you forget to take Actonel

In any case:

• If you forgot your dose of Actonel in the morning, DO NOT take it later during the day
• DO NOT take three tablets in the same week.

If you stop taking Actonel

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

If you have any other questions about 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 consult a 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 cause blisters on the skin. The frequency of this side effect is not known (cannot be estimated from the available data).

Tell your doctor promptlyif you experience any of the following side effects:

• Inflammation of the eyes, 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 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 of the esophagus such as pain when swallowing, difficulty swallowing, chest pain, and appearance or worsening of stomach acid. This side effect is uncommon (may affect up to 1 in 100 people).

Atypical fractures of the femur (thigh bone) can occur rarely, especially in patients on long-term treatment for osteoporosis. Tell 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 that were 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, vomiting, 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"), inflammation of the stomach and duodenum (intestine where the stomach empties).
• Inflammation of the colored part of the eye (the iris) (red eyes, painful with possible changes in vision).
• Fever and/or flu-like symptoms.

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

• Inflammation of the tongue (red, swollen, 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 through blood tests.

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

• Very rare: Consult your doctor if you have ear pain, your ear is discharging, or you have 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 through the Spanish Medicines and Healthcare Products Agency's online platform: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 is 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 75 mg of sodium risedronate, equivalent to 69.6 mg of risedronic acid).
• The other ingredients (excipients) are:

Core tablet: microcrystalline cellulose, crospovidone, and magnesium stearate.

Film coating: hypromellose, macrogol 400, macrogol 8000, hydroxypropylcellulose, colloidal anhydrous silica, titanium dioxide (E171), red iron oxide (E172).

Appearance and packaging of the product

Actonel 75 mg film-coated tablets are oval, pink tablets 11.7 x 5.8 mm with the letters "RSN" on one face and "75 mg" on the other.

The tablets are available in blisters of 2, 4, 6, or 8 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, 2nd floor left.

28027 Madrid

Spain

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

Belgium: Actonel 75 mg film-coated tablets, Actonel 75 mg comprimé pelliculé, Actonel 75 mg Filmtabletten

Cyprus: Actonel / "2 consecutive days per month" 75 mg film-coated tablets

France: Actonel 75 mg comprimé pelliculé

Germany: Risedronat Theramex 75 mg Filmtabletten

Greece: Actonel "2 consecutive days per month" 75 mg film-coated tablets

Italy: Actonel 75 mg compresse rivestite con film

Luxembourg: Actonel 75 mg comprimé pelliculé

Netherlands: Actonel 75 mg filmomhulde tabletten

Romania: Actonel 75 mg comprimate filmate

Slovenia: Actonel 75 mg filmsko obložene tablete

Spain: Actonel 75 mg comprimidos recubiertos con película

Sweden: Optinate 75 mg filmdragerade tabletter

Date of last revision of this leaflet:October 2024

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