ACTONEL WEEKLY 35 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Actonel Weekly 35 mg Film-Coated Tablets

Risedronate Sodium

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.

In this leaflet:

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

1. What is Actonel Weekly and what is it used for

What is Actonel Weekly

Actonel Weekly belongs to a group of non-hormonal medicines called bisphosphonates, which are used for the treatment of bone diseases. It 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 bone begins to weaken, becomes more fragile, and is more likely to fracture after a fall or twist.

Osteoporosis can also affect men due to various 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 in the body. Osteoporosis-related fractures can also cause back pain, height loss, and a curved back. Some patients with osteoporosis may not have symptoms and may not even know they have it.

What is Actonel Weekly used for

This medicine 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.
• in men.

2. What you need to know before you take Actonel Weekly

Do not take Actonel Weekly

• 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 disease 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 Weekly:

• 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 calcium levels 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 had or been told you have Barrett's esophagus (a condition associated with changes in the cells lining the lower esophagus).
• If your doctor has informed 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 a strong discomfort in the jaw or a tooth is loose.
• If you are undergoing dental treatment or will undergo dental surgery, inform your dentist that you are being treated 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 risedronate sodium is not recommended in children and adolescents (under 18 years) due to insufficient data on its safety and efficacy.

Taking Actonel Weekly 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 medication for indigestion)
• iron

Take these medicines at least 30 minutes after taking Actonel Weekly.

Inform 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 Weekly 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 it contains calcium (see section 2, "Taking Actonel with other medicines").

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

Pregnancy and breastfeeding

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

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

Actonel Weekly can only be used in postmenopausal women and men.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

It is unknown if Actonel Weekly affects the ability to drive and use machines.

Actonel contains lactose

Actonel Weekly contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine (see section 2, "Warnings and precautions").

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 Weekly

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

The recommended dose is:

One Actonel Weekly tablet (35 mg of risedronate sodium) once a week.

Choose the day of the week that best suits your schedule. Each week, take the Actonel Weekly tablet on the chosen day.

To facilitate taking the tablet on the same day each week, there are boxes on the back of the blister pack. Mark the day of the week you have chosen to take the Actonel Weekly tablet. Also, write the dates on which you will take the tablet.

When to take Actonel Weekly tablets

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

How to take Actonel Weekly 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.
• Swallow the tablet whole (without chewing or sucking it).
• Do not lie down for at least 30 minutes after taking the tablet.

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

If you take more Actonel Weekly than you should

If you or someone else has taken more Actonel Weekly 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 Weekly

If you have forgotten to take the tablet on the chosen day, take it on the day you remember. And take the next tablet the following week, on the day you normally take the tablet.

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

If you stop taking Actonel Weekly

If you stop 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 Weekly can cause side effects, although not everybody gets them.

Stop taking Actonel and consult 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 unknown (cannot be estimated from the available data).

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

Tell your doctor immediatelyif 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 unknown (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 unknown (cannot be estimated from the 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 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 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, stomach pain, discomfort or cramps in the stomach, heavy digestion, constipation, feeling of fullness, abdominal distension, diarrhea
• Bone, muscle, and joint pain
• 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/or the duodenum (intestine where the stomach empties).
• 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 through blood tests.

During post-marketing use, the following side effects 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 levels in the blood 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, consult your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Actonel Weekly

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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Actonel

• The active substance is risedronate sodium. Each tablet contains 35 mg of risedronate sodium (equivalent to 32.5 mg of risedronic acid).
• The other ingredients (excipients) are:

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

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

Appearance and packaging of the product

Actonel Weekly 35 mg film-coated tablets are oval, slightly orange tablets with the letters "RSN" on one face and "35mg" on the other. Each carton contains 4 tablets. The tablets are presented in blisters of 1, 2, 4, 10, 12, or 16 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, planta 2ª izquierda.

28027 Madrid

Spain

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

Austria: Actonel einmal wöchentlich 35 mg Filmtabletten

Belgium: Actonel 35 mg Wekelijks filmomhulde tabletten, Actonel 35 mg hebdomadaire comprimé pelliculé, Actonel 35 mg Wöchentlich Filmtabletten

Cyprus: Actonel 35 mg επικαλυμμ?ναμελεπτ?υμ?νιοδισκ?α

Denmark: Optinate Septimum filmovertrukne tabletter

Estonia: Actonel 35 mg OAW, õhukese polümeerikattega tabletid

Finland: Optinate Septimum 35 mg kalvopäällysteiset tabletit

France: Actonel 35 mg comprimé pelliculé

Germany: Risedronat Theramex einmal wöchentlich 35 mg Filmtabletten

Greece: ActonelOAW / ''μ?α φορ? την εβδομ?δα''

Hungary: Actonel 35 mg filmtabletta

Iceland: Optinate Septimum 35 mg filmuhúðaðartöflur

Italy: Actonel 35 mg compresse rivestite con film

Luxembourg: Actonel 35 mg hebdomadaire comprimé pelliculé, Malta: Actonel “Once a Week” 35mg film-coated tablet

Netherlands: Actonel Wekelijks 35 mg, filmomhulde tabletten

Portugal: Actonel 35 mg comprimidos revestidos por película

Spain: Actonel semanal 35 mg comprimidos recubiertos con película

Sweden: Optinate Septimum 35 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 Healthcare Products (AEMPS) http://www.aemps.gob.es/