Prospecto:Information for the Patient

Actonel Weekly 35 mg Gastric-Resistant Tablets

Risedronate Sodium

Read this prospectus carefully before starting to take this medication,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult yourdoctoror pharmacist.

-This medication has been prescribedonlyto you, and you should not give it to other people even if they have the same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,even if they are not listed in this prospectus. See section 4.

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

2.What you need to knowbeforestarting totake Actonel Weekly

3.How to take Actonel Weekly

4.Possible adverse effects

5Storage 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, 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.

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 vertebrae, hip, and wrist, although they can occur in any bone of the body. Osteoporosis-related fractures can also produce 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 in women after menopause, even if osteoporosis is severe.Reduces the risk of vertebral and hip fractures.

Do not takeActonel weekly:

• 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 weekly:

• 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 pain in the jaw or tooth loss.
• if you are undergoing dental treatment or will undergo dental intervention, inform your dentist that you are being treated with Actonel weekly.

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

Children and adolescents

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

Actonel weekly with other medications

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

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

• Calcium
• Magnesium
• Aluminum (for example, some antacid medication)
• Iron

Take these medications at a different time of day from when you took Actonel weekly.

Actonel weekly with food and beverages

Actonel weekly should be taken immediately after breakfast.

Pregnancy and lactation

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”).

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.

Driving and operating machinery

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

Actonel weekly contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per gastro-resistant tablet; this is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.If in doubt, consult your doctor or pharmacist again.

The recommended dose is a weekly Actonel tablet (35 mg of risedronate sodium) taken once a week.

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

To facilitate taking the tablet on the same day each week, there are squares or spaces included in the Actonel weekly packaging:

There are squares on the back of the blister pack. Mark the day of the week you have chosen to take the weekly Actonel tablet. Also, write the dates on which you will take the tablet.

When to take Actonel weekly tabletsTake the weekly Actonel tablet immediately after breakfast. If taken on an empty stomach, there is a higher risk of abdominal pain.

How to take Actonel weekly tablets

-Actonel weekly is for oral use.

-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.

-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 from your diet is not sufficient.

If you take more Actonel weekly than you should

If you or someone accidentally takes 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 forget 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 the following week on the day you normally take the tablet. Do not take two tablets on the same day.

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 doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Actonel weekly and see your doctor immediatelyifyou 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, such as:

• Blisters on the skin, mouth, eyes, and other moist areas of the body (genitals) (Stevens-Johnson syndrome)
• Red, palpable rashes on the skin (leucocytoclastic vasculitis)
• Red, inflamed skin rash on multiple parts of the body and/or loss of the outer layer of the skin (toxic epidermal necrolysis).

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 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, pain when swallowing, chest pain, and appearance or worsening of stomach acid. This side effect is rare (may affect up to 1 in 100 people).

Atypical femur 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 of a possible femur fracture.

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

Other possible side effects:

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

• Indigestion, nausea, stomach pain, discomfort or cramps in the stomach, constipation, feeling full, abdominal swelling, diarrhea, vomiting, and abdominal pain.
• Bone, muscle, and joint pain
• Headache.

Rare side effects(may affect up to 1 in 100 patients):

• Flu
• Decreased white blood cell count
• Depression
• Dizziness, tingling, or burning sensation, decreased sensitivity
• Eye inflammation (the colored part of the eye, the iris), red, painful eyes with possible vision changes, conjunctivitis, eye redness, blurred vision.
• Hot flashes, low blood pressure
• Cough
• Esophageal inflammation or ulceration causing difficulty and pain when swallowing (see also section 2, "Warnings and precautions"), stomach inflammation and/or duodenal inflammation, acid reflux from the esophagus or stomach, gastritis, increased stomach acid, stomach hernia, intestinal inflammation, intestinal distension, belching, gas, blood in the stool, intestinal bleeding, acid reflux, hemorrhoids, fecal incontinence.
• Oral numbness, inflamed tongue, inflamed lips, dry mouth, inflamed gums, mouth sores
• Red skin, skin rash, itching, purple spots on the skin, allergic dermatitis
• Muscle weakness, muscle spasms, back pain, limb pain, jaw pain, joint pain, neck pain
• Kidney stones
• Ovarian cysts
• Fatigue, chills, illness similar to the flu, chest pain, fever, facial or body inflammation, pain, fatigue
• Increased parathyroid gland activity
• Decreased calcium and phosphate levels in the blood, increased calcium levels in the blood, decreased platelet count, irregular heartbeat, occult blood in stool, abnormal urine analysis
• Allergic reactions

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

• Narrowing of the esophagus (the tube that connects the mouth to the stomach), tongue inflammation.
• Abnormal liver test results. This can only be diagnosed through blood tests.

Very rare side effects(may affect up to 1 in 10,000 patients):

-Consult your doctor if you have ear pain, ear discharge, or ear infection. These may be symptoms of damage to the bones in the ear.

During post-marketing use, the following side effects have been reported (frequency unknown):

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 theSpanish System for 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.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe box and the blister packafter 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 in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Actonel weekly

• 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 are:

Tablet core:

Microcrystalline cellulose, colloidal anhydrous silica, disodium edetate, sodium carboxymethyl starch (type A) (derived from potato starch), stearic acid, magnesium stearate.

Tablet coating:

Acrylate-methacrylate copolymer (1:1), triethyl citrate, talc, yellow iron oxide (E172), simethicone, polysorbate 80.

Appearance of the product and contents of the package

Actonel weekly 35 mg gastro-resistant tablets are yellow, oval-shaped tablets with "EC 35" engraved on one side.

The tablet dimensions are as follows: 13 mm wide, 6 mm long.

Pouches of 1, 2, 4, 10, 12, or 16 gastro-resistant tablets.

Only some package sizes may be marketed.

Marketing authorization holder

Theramex Ireland Limited

3rd Floor, Kilmore House,

Park Lane, Spencer Dock,

Dublin 1

D01 YE64

Ireland

Responsible 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 European Economic Area member states with the following names:

BelgiumActonel 35 mg wekelijks maagsapresistente tabletten

FranceActonel GR 35 mg comprimé gastro-résistant

GermanyActonel einmal wöchentlich 35 mg magensaftresistente Tabletten

Greece:Actonel GR

ItalyActonel

NetherlandsActonel Wekelijks MSR 35 mg, maagsapresistente tabletten

Portugal:Actonel 35 mg comprimido gastrorresistente

Romania:Actonel 35 mg comprimate gastrorezistente

SpainActonel semanal 35 mg comprimidos gastrorresistentes

SwedenOptinate Septimum

Last review date of thisleaflet:October 2024

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)