ACTONEL 5 MG FILM-COATED TABLETS

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Actonel 5 mg film-coated 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, consult 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 effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Actonel is and what it is used for
2. What you need to know before taking Actonel
3. How to take Actonel
4. Possible adverse effects
5. How to store Actonel
6. Contents of the pack and other information

1. What Actonel is and what it is used for

What Actonel is

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

Bone is a 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 to occur following a fall or twist.

Osteoporosis commonly occurs in women who have gone through menopause and in patients who have been taking corticosteroids for a prolonged period.

The most common osteoporotic 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 curved spine. Some patients with osteoporosis have no symptoms and may not even be aware they have the condition.

What Actonel is used for

In the treatment of osteoporosis

• in women after menopause

In the prevention of osteoporosis

• in women at high risk of developing osteoporosis (including bone mass loss, early menopause, or family history of osteoporosis).
• in postmenopausal women who have been taking high doses of steroids for a long time. The treatment maintains or increases bone mass.

2. What you need to know before starting Actonel

Do not take Actonel

• 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 levels of calcium in the 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:

• If you are unable to remain in an upright position, either sitting or standing, for at least 30 minutes.
• If you have bone 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 the mouth to the stomach). At some point, you may have experienced pain or difficulty swallowing food, or you were previously diagnosed with Barrett's esophagus (a condition associated with changes in the cells lining the lower part of the esophagus).
• If your doctor has informed you that you have an intolerance to certain sugars (such as lactose).
• If you have had or currently have pain, swelling, or numbness in the jaw or jawbone, or a "severe jaw discomfort," or if a tooth becomes loose.
• If you are undergoing dental treatment or are scheduled to have a dental procedure, inform your dentist that you are taking Actonel.

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

Children and adolescents

The use of sodium risedronate is not recommended in children and adolescents (under 18 years of age) due to insufficient data on safety and efficacy.

Taking Actonel with other medicines

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

• calcium
• magnesium
• aluminium (for example, some medicines for indigestion)
• iron

Take these medicines at least 30 minutes after taking Actonel.

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

Taking Actonel with food and drinks

It is very important that you do NOT take Actonel with food or with drinks (other than plain tap water), as they may interfere. In particular, do not take this medicine at the same time as dairy products (such as milk), as they contain calcium (see section 2, "Taking Actonel with other medicines").

Take food and drinks (other than plain tap water) at least 30 minutes after taking Actonel.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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 of using sodium risedronate (the active substance in Actonel) in pregnant women is unknown.

DO NOT take Actonel if you are breastfeeding (see section 2, "Do not take Actonel").

Driving and using machines

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

Actonel contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him or her before taking this medicine.

Actonel contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; therefore, it is essentially "sodium-free".

3. How to take Actonel

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

One Actonel tablet (5 mg sodium risedronate) once daily.

The aluminum blister foil has the days of the week printed on it to help you take the medicine correctly.

WHEN to take Actonel tablets

Take the Actonel tablet at least 30 minutes before your first meal, drink of the day, (except if this drink is plain water) or any other medicine of the day.

Although it is preferable to take this tablet before breakfast, if you have not been able to take Actonel then, you may take it on an empty stomach at the same time each day in one of the following situations:

• Between meals: Actonel must be taken at least 2 hours before or at least 2 hours after any meal, medicine, or drink (other than plain water).

OR:

• In the evening: Actonel must be taken at least 2 hours after the last meal, medicine, or drink (other than plain water) of the day. Actonel must be taken at least 30 minutes before going to bed.

HOW to take Actonel tablets

• Take the tablet while in an upright position, either sitting or standing, to help avoid heartburn.
• Swallow the tablet with at least one glass (120 ml) of plain 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 advise whether you should take calcium and vitamin supplements if your dietary intake of these is insufficient.

Use in children and adolescents

Sodium risedronate is not recommended for use in children under 18 years of age due to limited data on safety and efficacy.

If you take more Actonel than you should

If you have taken more Actonel 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), stating the medication and the amount taken.

If you forget to take Actonel

If you forget to take the tablet at your usual time, you may take it as soon as possible, following the instructions above (for example, before breakfast, between meals, or at night).

Do not take a double dose to make up for the missed dose.

If you stop treatment with Actonel

If you discontinue 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, Actonel can cause adverse effects, although not everyone will experience them.

Stop taking Actonel and seek medical advice 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 the available data).

• Severe skin reactions that may include blistering of the skin. The frequency of this adverse effect is unknown (cannot be estimated from the 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 the 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 the available data).
• Osteonecrosis of the jaw (bone necrosis) associated with delayed healing and infection, often following a tooth extraction (see section 2, "Warnings and precautions"). The frequency of this adverse effect is unknown (cannot be estimated from the available data).
• Esophagus-related symptoms such as pain when swallowing, difficulty swallowing, chest pain, and 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 treatment for osteoporosis. 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 lead to discontinuation of treatment by patients.

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

• Indigestion, nausea, stomach pain, stomach discomfort or cramps, bloating, constipation, feeling of fullness, abdominal distension, diarrhea.
• Pain in bones, muscles or joints.
• Headache.

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

• 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 into which the stomach empties).

• Inflammation of the coloured part of the eye (iris) (painful red eyes with possible changes in vision).

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

• Inflammation of the tongue (swollen, red, possibly painful), narrowing of the esophagus (the tube connecting the mouth to the stomach).
• Abnormal liver test results have been reported. This can only be diagnosed by blood tests.

During post-marketing use, the following have been reported:

• Very rare: Consult your doctor if you have ear pain, ear discharge or an ear infection. These could be symptoms of damage to the ear bones.
• Frequency not known:
• Cases of hair loss.
• Liver disorders, in some cases severe.

Rarely, at the beginning of treatment, a slight decrease in blood phosphate and calcium levels has been observed in some patients. These changes are usually minor and do not cause symptoms.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via 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

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the container 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 a pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Actonel

• The active substance is sodium risedronate. Each tablet contains 5 mg of sodium risedronate (equivalent to 4.64 mg of risedronic acid).
• The other components (excipients) are:

Tablet core: lactose monohydrate (see section 2), crospovidone, magnesium stearate and microcrystalline cellulose.

Film coating: hypromellose, macrogol, hydroxypropylcellulose, colloidal anhydrous silica, titanium dioxide (E171) and yellow iron oxide (E172).

Appearance of the product and contents of the pack

Actonel 5 mg film-coated tablets are yellow, oval-shaped tablets marked with the letters “RSN” on one side and “5mg” on the other.

The tablets are available in blisters containing 14, 28 (2x14), 84 (6x14), or 98 (7x14) film-coated tablets.

Only certain pack sizes may be commercially available.

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the following names:

Belgium: Actonel 5 mg filmomhulde tabletten,
Actonel 5 mg comprimé pelliculé,
Actonel 5 mg Filmtabletten

France: Actonel 5 mg comprimé pelliculé

Germany: Risedronat Theramex 5 mg Filmtabletten

Italy: Actonel 5 mg compresse rivestite con film

Luxembourg: Actonel 5 mg comprimé pelliculé

Netherlands: Actonel 5 mg, filmomhulde tabletten

Spain: Actonel 5 mg comprimidos recubiertos con película

Sweden: Optinate 5 mg filmdragerade tabletter

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

Detailed and up-to-date 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/