ACTONEL WEEKLY 35 mg GASTRO-RESISTANT TABLETS

2. What you need to know before taking Actonel weekly

Do not takeActonel weekly:

• if you are allergic to sodium risedronate or any of the other components of this medication (listed in section 6)
• if your doctor has told you that you have a disease called hypocalcemia (you have low calcium levels in your 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 problems 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 you have had or have pain, swelling, or numbness in the jaw or severe discomfort in the jaw or tooth loss.
• If you are undergoing dental treatment or will undergo dental surgery, 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 above problems.

Children and adolescents

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

Taking Actonel weekly with other medications

Inform your doctor or pharmacist that you are using, have recently used, 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 (e.g., some medication for indigestion)
• Iron

Take these medications at a different time of day than when you take Actonel weekly.

Taking Actonel weekly with food and drinks

Actonel weekly should be administered immediately after breakfast.

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").

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 using machines

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

Actonel weekly contains sodium

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

3. How to take Actonel weekly

Follow the administration instructions for this medication exactly as 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 sodium risedronate) once a week.

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

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

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 tabletsTake the Actonel weekly tablet immediately after breakfast. If you take it 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 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 accidentally 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 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 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 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 questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Stop taking Actonel weekly 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 available data).
• Severe skin reactions such as:

• Blisters on the skin, mouth, eyes, and other moist areas of the body (Stevens-Johnson syndrome)
• Red patches on the skin (leukocytoclastic vasculitis)
• Red rash on several 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).

Tell your doctor right awayif 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).
• 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).
• Jaw bone 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).
• Symptoms related to the esophagus, such as pain when swallowing, difficulty swallowing, chest pain, and 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. 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 trials, the side effects observed were generally mild and did not cause the patient to discontinue treatment.

Other possible side effects:

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

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

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

• Influenza
• Decreased white blood cell count
• Depression
• Dizziness, tingling, or burning sensation, decreased sensitivity
• Inflammation of the colored part of the eye (iris) (red eyes with pain and possible changes in vision), inflammation of the outer layer of the eye and the inner area of the eyelids (conjunctivitis), redness of the eyes, blurred vision.
• Hot flashes, low blood pressure
• Cough
• 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 duodenum (intestine where the stomach empties), reflux from the esophagus or stomach, gastritis, increased acid in the stomach, stomach hernia, intestinal inflammation, intestinal distension, belching, gas, blood in the stool, intestinal bleeding, acidity, hemorrhoids, fecal incontinence.
• Numbness of the mouth, inflamed tongue, inflamed lips, dry mouth, inflamed gums, mouth sores
• Redness of the skin, rash, itching, purple spots on the skin, allergic dermatitis
• Muscle weakness/fatigue, muscle spasms, back pain, pain in the limbs, jaw pain, joint pain, neck pain
• Kidney stones
• Ovarian cysts
• Fatigue, chills, flu-like illness, chest pain, fever, inflammation of the face or body, 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, hidden 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), inflammation of the tongue.
• Abnormal liver tests have been reported. 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, your ear is discharging, or you have an ear infection. These could be symptoms of damage to the bones of the ear.

During post-marketing use, the following side effects have been reported (frequency not known):

• Cases of hair loss.
• Liver disorders, in some cases severe.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Actonel weekly

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the box and blister pack after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Actonel weekly

• The active ingredient is sodium risedronate. Each tablet contains 35 mg of sodium risedronate, equivalent to 32.5 mg of risedronic acid.

• Other components are:

Core of the tablet:

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

Tablet coating:

Methacrylic acid - ethyl acrylate copolymer (1:1), triethyl citrate, talc, yellow iron oxide (E172), simethicone, polysorbate 80.

Appearance of the product and package contents

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

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

Blister packs of 1, 2, 4, 10, 12, or 16 gastro-resistant 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 medication is authorized in the Member States of the European Economic Area under the following names:

Belgium Actonel 35 mg weekly gastro-resistant tablets

France Actonel GR 35 mg gastro-resistant tablet

Germany Actonel once weekly 35 mg gastro-resistant tablets

Greece: Actonel GR

Italy Actonel

Netherlands Actonel Weekly MSR 35 mg, gastro-resistant tablets

Portugal: Actonel 35 mg gastro-resistant tablet

Romania: Actonel 35 mg gastro-resistant tablets

Spain Actonel weekly 35 mg gastro-resistant tablets

Sweden Optinate Septimum

Date of last revision of thisleaflet:October 2024

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