Product Information for the Patient

Weekly Actonel 35 mg Film-Coated Tablets

Risedronate Sodium

Read this entire product information carefully before starting to take this medication, as it contains important information for you.

• Keep this product information. You may need to read it again.
  If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information.See section 4.

Information in this Product Information:

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

2. What you need to know before starting to take Actonel weekly

3. How to take Actonel weekly

4. Possible adverse effects

5. Storage of Actonel weekly

6. Contents of the package and additional information

What is Actonel weekly

Actonel weekly belongs to a group of non-hormonal medications called bisphosphonates, which are used for the treatment of bone diseases. It acts directly on the bones, strengthening them and, therefore, reducing 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 can also be suffered by men due to numerous 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 of the body. Osteoporosis-related fractures can also cause back pain, height loss, and curved back. Some patients with osteoporosis do not have symptoms and may not even know they have it.

What is Actonel weekly used for

This medication is indicated for the treatment of osteoporosis

-inwomenafter menopause, even if osteoporosis is severe. It reduces the risk of vertebral and hip fractures.

-inmen.

Do not take Actonel weekly

- if you are allergic to risedronate sodium or to 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 (you have low levels of calcium in your blood)

-if you may be pregnant, if you are pregnant, or if you 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 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 pain, swelling, or numbness in the jaw or a strong pain in the jaw or a tooth has moved.

- If you are undergoing dental treatment or will be undergoing a dental procedure, 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

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

Actonel weekly 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 medication for indigestion)
• iron

Take these medications at least 30 minutes after taking Actonel weekly.

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

Actonel with food and drinks

It is very important that you DO NOT take Actonel weekly with food or with beverages (other than plain water) because 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, “Actonel with other medications”).

Take food and drinks (other than plain water) at least 30 minutes after taking 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 (active ingredient of 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 medication.

Driving and operating machinery

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

Actonel contains lactose

Actonel weekly contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication (see section 2, “Warnings and precautions”).

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.

Therecommendeddosageis:

OneActonel 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 every week, there are boxes on the back of the blister. 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 meal, drink (except in the case of tap water) or other medication of the day.

How to take Actonel weekly 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 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 of these in your diet is not sufficient.

If you take moreActonel weekly than you should

If you or someone accidentally has taken more Actonel weekly 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 forgot to take Actonel weekly

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

Do not takea double doseto compensate for the missed dose.

If you interrupt treatment with Actonel weekly

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Actonel weekly may 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.

Common 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

- Bone, muscle, and joint pain

- 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.
• Iris inflammation (red, painful eyes with possible vision changes).

Rare side effects(may affect up to 1 in 1000 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 side effects have been reported:

• Moderately rare: Consult your doctor if you have ear pain, ear discharge, or an ear infection. These may be symptoms of ear bone damage.
• Frequency unknown:
• 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 not listed in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of sightand out of reachof children.

Do not usethis medicationafter the expiration date that appears on the packagingafter CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not dispose of medications through drains or trash.Deposit empty containers and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of empty containers and unused medications. By doing so, you will help protect the environment.

Composition of Actonel

-The active ingredient is risedronate sodium. Each tablet contains 35 mg of risedronate sodium (equivalent to 32.5 mg of risedronic acid).

-The other components (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), and red iron oxide (E172).

Appearance of the product and contents of the package

Actonel Weekly 35 mg film-coated tablets are oval-shaped, slightly orange tablets with the letters “RSN” on one side and “35mg” on the other. Each box contains 4 tablets.The tablets are presented in blisters of 1, 2, 4, 10, 12, or 16 tablets.

Only some package 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:

Austria: Actonel einmal wöchentlich 35 mg Filmtabletten

Bélgica: Actonel 35 mg Wekelijks filmomhulde tabletten,

Actonel 35 mg hebdomadaire comprimé pelliculé,

Actonel 35 mg Wöchentlich Filmtabletten

Chipre: Actonel 35 mgεπικαλυμμ?ναμελεπτ?υμ?νιοδισκ?α

Dinamarca: Optinate Septimum filmovertrukne tabletter

Estonia: Actonel 35 mg OAW, õhukese polümeerikattega tabletid

Finlandia: Optinate Septimum 35 mg kalvopäällysteiset tabletit

Francia: Actonel 35 mg comprimé pelliculé

Alemania:Risedronat Theramex einmal wöchentlich 35 mg Filmtabletten

Grecia: ActonelOAW / ''μ?αφορ?τηνεβδομ?δα''

Hungría: Actonel 35 mgfilmtabletta

Islandia: Optinate Septimum 35 mgfilmuhúðaðartöflur

Italia: Actonel 35 mg compresse rivestite con film

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

Países Bajos: Actonel Wekelijks 35 mg, filmomhulde tabletten

Portugal: Actonel 35 mg comprimidos revestidos por película

España: Actonel semanal 35 mg comprimidos recubiertos con película

Suecia: Optinate Septimum 35 mg filmdragerade tabletter

Last review date of this leaflet:October 2024

The 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/