Actonel 75 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Actonel 75 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, 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, talk to your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. See section 4.

Leaflet contents

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 side 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 following a fall or twist.

The most common bone fractures are those of the vertebrae, hip, and wrist, although they can occur in any bone of the body. Osteoporosis-related fractures 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

This medicine is indicated for the treatment of osteoporosis in postmenopausal women.

2. What you need to know before taking 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 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, disorders of parathyroid hormone, both of which may cause low calcium levels in the blood).
• If you have or have previously had problems with your oesophagus (the tube connecting the mouth to the stomach). At some point, you may have experienced pain or difficulty swallowing food, or have previously been diagnosed with Barrett’s oesophagus (a condition associated with changes in the cells lining the lower part of the oesophagus).
• If you have had or currently have pain, swelling or numbness in the jaw, or “severe jaw discomfort”, or if a tooth becomes loose.
• If you are undergoing dental treatment or are scheduled to have dental surgery, inform your dentist that you are being treated with 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 (e.g. 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 NOT to take Actonel with food or with drinks (other than plain water), as they may interfere. In particular, do not take this medicine at the same time as dairy products (such as milk), which contain calcium (see section 2, “Taking Actonel with other medicines”).

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

Pregnancy and breastfeeding

DO NOT take Actonel if you could be pregnant, are pregnant, or plan to become pregnant (see section 2, “Do not take Actonel”). The potential risk associated with the use of 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”).

Actonel may only be used in postmenopausal women.

Driving and using machines

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

Actonel contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; i.e., essentially “sodium-free”.

3. How to take Actonel

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

Recommended dose:

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

Choose the TWO consecutive days that best fit your schedule. Take ONE Actonel tablet in the morning on the first chosen day. Take the SECOND tablet in the morning on the following day.

Repeat each month, keeping the same two consecutive days. To help you remember when to take the tablets again, you may mark them on your calendar with a pen or a sticker.

WHEN to take Actonel tablets

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

HOW to take Actonel tablets

• Take the tablet while in an upright position, either sitting or standing, to avoid stomach discomfort.
• Swallow the tablet with at least one glass (120 ml) of plain water. Do not take the tablet with mineral water or other beverages that are not plain 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 advise you whether you should take calcium and vitamin supplements if your dietary intake of these is insufficient.

If you take more Actonel than you should

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service (telephone 91 562 04 20).

If you forget to take Actonel

In any case:

• If you forget your morning dose of Actonel, DO NOT take it later during the day.

-DO NOT take three tablets in the same week.

If you interrupt treatment with Actonel

If you stop taking the medication, you may begin to lose bone mass. Please consult your doctor before deciding to interrupt 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 may cause adverse effects, although not everyone experiences them.

Stop taking Actonel and see a doctor immediately if 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 adverse effect is not known (cannot be estimated from available data).

• Severe skin reactions that may cause blisters on the skin. The frequency of this adverse effect is not known (cannot be estimated from available data).

Tell your doctor immediately if you experience any of the following adverse effects:

• Inflammation of the eyes, usually with pain, redness, and sensitivity to light. The frequency of this adverse effect is not known (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 not known (cannot be estimated from available data).

• Osteonecrosis of the jaw (bone necrosis) associated with delayed healing and infection, frequently following tooth extraction (see section 2 “Warnings and precautions”). The frequency of this adverse effect is not known (cannot be estimated from available data).

• Symptoms affecting the oesophagus 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 rarely occur, particularly 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 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.

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

• Indigestion, nausea, vomiting, stomach pain, stomach discomfort or cramps, heavy digestion, constipation, feeling of fullness, abdominal distension, diarrhoea.
• Pain in bones, muscles, or joints.
• Headache.

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

• Inflammation or ulceration of the oesophagus (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 duodenum (the intestine where the stomach empties).
• Inflammation of the coloured part of the eye (iris) (painful, red eyes with possible changes in vision).
• Fever and/or flu-like symptoms.

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

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

After marketing authorization, the following have been reported:

• Very rare: Consult your doctor if you have ear pain, ear discharge, or ear infection. These could be symptoms of damage to the bones of the ear.
• 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 it is a possible adverse effect not listed in this leaflet. You may 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 sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after EXP.

The expiry date is 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 Point in your pharmacy. 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 75 mg of sodium risedronate, equivalent to 69.6 mg of risedronic acid.
• The other components (excipients) are:

Tablet core: microcrystalline cellulose, crospovidone, and magnesium stearate.

Film coating: hypromellose, polyethylene glycol 400, polyethylene glycol 8000, hydroxypropyl cellulose, anhydrous colloidal silica, titanium dioxide (E171), iron oxide red (E172).

Appearance of the product and contents of the pack

Actonel 75 mg film-coated tablets are pink oval tablets 11.7 x 5.8 mm in size, marked with the letters “RSN” on one side and “75 mg” on the other.

The tablets are supplied in blisters containing 2, 4, 6 or 8 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 Member States of the European Economic Area under the following names:

Belgium: Actonel 75 mg filmomhulde tabletten,
Actonel 75 mg comprimé pelliculé,
Actonel 75 mg Filmtabletten

Cyprus: Actonel / ''2 συνεχ?μενες ημ?ρες το μ?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 mg comprimidos recubiertos con película

Sweden: Optinate 75 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/