Actonel Semanal 35 mg gastro-resistant tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Actonel Weekly 35 mg gastro-resistant tablets

Sodium risedronate

Read the entire leaflet carefully before you start taking this medicine because 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.

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

Leaflet contents

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

2. What you need to know before taking 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 Actonel Weekly is and what it is used for

What Actonel Weekly is

Actonel Weekly belongs to a group of non-hormonal medicines called bisphosphonates, which are used to treat bone diseases. It acts directly on the bones, strengthening them and thereby reducing the likelihood of fractures.

Bone is living tissue. Old bone in the skeleton is constantly being renewed and replaced by new bone.

Postmenopausal osteoporosis occurs in women after menopause, when bone begins to weaken, becomes more fragile, and fractures are more likely following a fall or twist.

Osteoporosis can also affect men, due to various causes including aging and/or low levels of the male hormone testosterone.

The most common bone fractures occur in the vertebrae, hip, and wrist, although they can occur in any bone of the body. Fractures associated with osteoporosis may also cause back pain, loss of height, and a stooped posture. Some patients with osteoporosis have no symptoms and may not even be aware they have the condition.

What Actonel Weekly is used for

This medicine is indicated for the treatment of osteoporosis in postmenopausal women, even if the osteoporosis is severe. It reduces the risk of vertebral and hip fractures.

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

Do not take Actonel Weekly:

• if you are allergic to sodium risedronate or to any of the other ingredients of this medicine (listed in section 6)
• if your doctor has told you that you have a condition called hypocalcemia (low calcium levels in your blood)
• if you could be pregnant, are pregnant, or plan to become pregnant
• if you are breastfeeding
• if you have severe kidney disease

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Actonel Weekly:

• If you are unable to remain in an upright position, either sitting or standing, for at least 30 minutes.
• If you have bone problems or mineral metabolism disorders (for example, vitamin D deficiency, parathyroid hormone disorders, both of which can cause low blood calcium levels).
• If you have or have previously had problems with your esophagus (the tube connecting your mouth to your stomach). At some point, you may have experienced pain or difficulty swallowing food, or have previously been diagnosed with Barrett's esophagus (a condition associated with changes in the cells lining the lower part of the esophagus).
• If you have had or currently have pain, swelling, or numbness in the jaw, severe jaw discomfort, or tooth loss.
• If you are undergoing dental treatment or are scheduled for a dental procedure, inform your dentist that you are being treated with Actonel Weekly.

Your doctor will advise you on what to do if you take Actonel Weekly and have any of the conditions mentioned above.

Children and adolescents

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

Taking Actonel Weekly with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Medicines containing any of the following substances reduce the effect of Actonel Weekly when taken at the same time:

• Calcium
• Magnesium
• Aluminum (for example, some medicines for indigestion)
• Iron

Take these medicines at a different time of day from Actonel Weekly.

Taking Actonel Weekly with food and drink

Actonel Weekly should be taken immediately after breakfast.

Pregnancy and breastfeeding

Do not take Actonel Weekly if you could 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 may only be used in postmenopausal women.

Driving and using machines

It is unknown whether Actonel Weekly affects the ability to drive or operate machinery.

Actonel Weekly contains sodium

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

3. How to take Actonel Weekly

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in 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 fits your schedule. Each week, take the Actonel Weekly tablet on the day you have chosen.

To help you remember to take the tablet on the same day every week, boxes or spaces are included on the Actonel Weekly packaging:

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 down the dates on which you will take the tablet.

When to take Actonel Weekly tablets Take the Actonel Weekly tablet immediately after breakfast. If taken on an empty stomach, there is an increased risk of abdominal pain.

How to take Actonel Weekly tablets

• Actonel Weekly is for oral use.
• Take the tablet while in an upright position (sitting or standing), to avoid heartburn.
• Swallow the tablet with at least one glass (120 ml) of plain 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 advise you whether you should take calcium and vitamin supplements if the amount you obtain from your diet is insufficient.

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 contact your doctor.

In case of overdose or accidental ingestion, contact 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 forget to take the tablet on your chosen day, take it on the day you remember. Then take the next tablet one week later, on your usual tablet-taking day. Do not take two tablets on the same day.

If you stop taking Actonel Weekly

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

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

4. Possible adverse effects

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

Stop taking Actonel Weekly and contact your doctor immediately if you experience any of the following symptoms:

• Signs of a severe allergic reaction, such as:

  • Swelling of the face, tongue, or throat
  • Difficulty swallowing
  • Hives and difficulty breathing.

• The frequency of this adverse effect is unknown (cannot be estimated from available data).

• Serious skin reactions such as:

• Blistering of the skin, mouth, eyes, and other moist areas of the body (genitals) (Stevens-Johnson syndrome)

• Palpable red spots on the skin (leukocytoclastic vasculitis)

• Red skin rash affecting multiple body areas and/or loss of the outer layer of skin (toxic epidermal necrolysis).

The frequency of this adverse effect is unknown (cannot be estimated from available data).

Contact your doctor promptly if you experience any of the following adverse effects:

• Eye inflammation, usually with pain, redness, and sensitivity to light. The frequency of this adverse 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 disturbances. The frequency of this adverse effect is unknown (cannot be estimated from available data).
• Jaw bone necrosis (osteonecrosis), associated with delayed healing and infection, often following a dental extraction (see section 2, “Warnings and precautions”). The frequency of this adverse effect is unknown (cannot be estimated from available data).
• Symptoms related to the esophagus such as pain when swallowing, difficulty swallowing, chest pain, or onset or worsening of heartburn. This adverse effect is uncommon (may affect up to 1 in 100 people).

Atypical femoral fractures (thigh bone) may occur rarely, particularly in patients on long-term osteoporosis treatment. Inform your doctor if you notice pain, weakness, or discomfort in your thigh, hip, or groin, as these may be early signs indicating a possible femoral fracture.

However, in clinical studies, the adverse effects observed were generally mild and did not cause patients to discontinue treatment.

Other possible adverse effects:

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

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

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

• Flu-like illness
• Decrease in white blood cell count
• Depression
• Dizziness, tingling sensation or burning sensation, reduced sensitivity
• Inflammation of the colored part of the eye (iris) (painful red eyes with possible changes in vision), inflammation of the outermost layer of the eye and the inner lining of the eyelids (conjunctivitis), eye redness, blurred vision
• Hot flushes, low blood pressure
• Cough
• Inflammation or ulceration of the esophagus (the tube connecting 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 (the intestine where the stomach empties), reflux from the esophagus or stomach, gastritis, increased stomach acid, stomach hernia, intestinal inflammation, intestinal distension, belching, flatulence, blood in stool, intestinal bleeding, heartburn, hemorrhoids, fecal incontinence
• Numbness of the mouth, swollen tongue, swollen lips, dry mouth, inflamed gums, mouth ulcers
• Skin redness, skin rash, itching, purple spots on the skin, allergic dermatitis
• Fatigue/muscle weakness, muscle spasms, back pain, limb pain, jaw pain, joint pain, neck pain
• Kidney stones
• Ovarian cysts
• Fatigue, chills, flu-like illness, chest pain, fever, facial or body swelling, pain, tiredness
• Increased activity of the parathyroid gland
• Decreased levels of calcium and phosphate in blood, increased calcium levels in blood, decreased platelet count, irregular heartbeat, occult blood in stool, abnormal urine test
• Allergic reactions

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

• Narrowing of the esophagus (the tube connecting the mouth to the stomach), inflammation of the tongue.
• Abnormal liver function tests have been reported. This can only be diagnosed by blood tests.

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

• Consult your doctor if you have ear pain, ear discharge, or an ear infection. These could be symptoms of damage to the ear bones.

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

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Actonel Weekly

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

• The other components are:

Tablet core:

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

Tablet coating:

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

Appearance of the product and contents of the pack

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

The tablet dimensions are: 13 mm in width, 6 mm in length.

Blister packs containing 1, 2, 4, 10, 12 or 16 gastro-resistant tablets.

Only certain 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 medicinal product is authorized in the European Economic Area member states under the following names:

Belgium: Actonel 35 mg wekelijks maagsapresistente tabletten
France: Actonel GR 35 mg comprimé gastro-résistant
Germany: Actonel einmal wöchentlich 35 mg magensaftresistente Tabletten
Greece: Actonel GR
Italy: Actonel
Netherlands: Actonel Wekelijks MSR 35 mg, maagsapresistente tabletten
Portugal: Actonel 35 mg comprimido gastrorresistente
Romania: Actonel 35 mg comprimate gastrorezistente
Spain: Actonel semanal 35 mg comprimidos gastrorresistentes
Sweden: Optinate Septimum

Date of the most recent review of this summary: October 2024

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