Patient Information Leaflet

Actonel 75 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 your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on 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. Actonel acts directly on the bones, strengthening them, and thus reduces the likelihood of fractures.

The bone is a living tissue. Old bone in 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.

The most likely bone fractures are those of the vertebrae, hip, and wrist, although they can occur in any bone in the body. Fractures associated with osteoporosis 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 for

This medication is indicated for the treatment of osteoporosis inwomenafter menopause.

Do not take Actonel

• if you are allergic to risedronate sodium or any of the other components of this medication (listed in section 6)
• if your doctor has told you that you have a condition called hypocalcemia (low calcium levels 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 upright, 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 causing 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 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 you have had or have jaw pain, swelling, or numbness, or a "strong jaw pain" or a tooth that moves.
• If you are undergoing dental treatment or are about 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

Risedronate sodium is not recommended for use in children and adolescents (under 18 years) due to a lack of sufficient data on its safety and efficacy.

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 medication for indigestion)
• iron

Take these medications at least 30 minutes after taking Actonel.

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

Actonel with food and beverages

It is very important that you DO NOT take Actonel with food or beverages (other than plain 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, "Actonel with other medications").

Take food and beverages (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 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").

Actonel can only be used in postmenopausal women.

Driving and operating machinery

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

Actonel contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per coated tablet; it 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.

Recommended dose:

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

Choose the TWO consecutive days that best fit your schedule. Take ONE Actonel tablet in the morning of the first chosen day. Take the SECOND tablet in the morning of the following 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 meal, drink (except in the case of water) or other medication of the day.

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

IF you take more Actonel than you should

If you or someone accidentally took more Actonel tablets than prescribed, drink a full glass of milk and see your doctor.

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

IF you forgot to take Actonel

In any case:

-If you forgot your Actonel dose in the morning, DO NOT take it later in the day

-DO NOT take three tablets in the same week.

IF you 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, including:
• • 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 cause blisters on the skin. The frequency of this side effect is unknown (cannot be estimated from available data).

Inform your doctor quicklyif you experience 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 available data).

• Inflammation of the orbit – 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 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 worsening or appearance 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, side effects were generally mild and did not cause patients to interrupt treatment.

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

-Indigestion, nausea, vomiting, 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):

-Inflammation or ulceration of the esophagus (the tube that connects the mouth to the stomach) causing difficulty and pain swallowing (see also section 2, “Warnings and precautions”), inflammation of the stomach and duodenum (the intestine where the stomach empties).

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

-Fever and/or flu-like symptoms.

Very rare side effects(may affect up to 1 in 1000 patients):

-Inflammation of the tongue (red, swollen, possibly painful), narrowing of the esophagus (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 bones in the ear.
• Unknown frequency:
• hair loss.
• Liver changes, 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 point of the pharmacy.In case of 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 75 mg of risedronate sodium, equivalent to 69.6 mg of risedronic acid).

-The other components (excipients) are:

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

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

Appearance of the product and contents of the package

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

The tablets are presented in blisters of 2, 4, 6, or 8 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:

Belgium: Actonel 75 mg filmomhulde tabletten,

Actonel 75 mg comprimé pelliculé,

Actonel 75 mg Filmtabletten

Cyprus: Actonel/ ''2συνεχ?μενεςημ?ρεςτομ?να'' 75 mg επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α

France: Actonel 75 mg comprimé pelliculé

Germany: Risedronat Theramex 75 mg Filmtabletten

Greece: Actonel''2 συνεχ?μενες ημ?ρες το μ?να'' 75 mg επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α

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 mgcomprimidos recubiertos con película

Sweden: Optinate 75 mg filmdragerade tabletter

Last revision 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/