1. What is Actonel and what is it used for
2. What you need to know before taking Actonel
3. How to take Actonel
4. Possible side effects
5. Storage of Actonel
6. Contents of the pack and additional information
What is Actonel
Actonel belongs to a group of non-hormonal medications called bisphosphonates, which are used for the treatment of bone diseases (bone disorders). Actonel acts directly on the bones, strengthening them, and therefore reduces the likelihood of fractures.
The bone is a living tissue. The old bone of 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 is often found in women who have passed menopause and also in patients who are taking corticosteroids for an extended period.
The most likely bone fractures are those of the vertebrae, hip, and wrist, although they can occur in any bone of the body. Osteoporosis-related fractures can also cause back pain, loss of height, and a curved back. Some patients with osteoporosis do not have symptoms and may not even know they have it.
What is Actonel used forActonel
For the treatment of osteoporosis
For the prevention of osteoporosis
Do not take Actonel
-if you are allergic to risedronate sodium or any of the other ingredients of this medication (listed in section 6)
Warnings and precautions
Consult your doctor or pharmacist before starting to take Actonel:
Your doctor will advise you what to do if you take Actonel and have any of the problems mentioned above.
Children and adolescents
Actonel is not recommended for use in children and adolescents (under 18 years) due to insufficient data on its safety and efficacy.
Taking Actonel with other medications
Medications containing any of the following substances reduce the effect of Actonel when taken at the same time:
Take these medications at least 30 minutes after taking Actonel.
Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication.
Taking Actonel with food and drinks
It is very important that you DO NOT take Actonel with food or drinks (other than tap water) as they may interfere. In particular, do not take this medication at the same time as dairy products (such as milk) as they contain calcium (see section 2, "Taking Actonel with other medications").
Take food and drinks (other than tap water) at least 30 minutes after taking Actonel.
If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.
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 associated with the use of risedronate sodium (Actonel's active ingredient) in pregnant women is unknown.
DO NOT take Actonel if you are breastfeeding (see section 2, "Do not take Actonel").
Driving and operating machinery
The effect of Actonel on the ability to drive and operate machinery is unknown.
Actonel contains lactose
This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.
Actonel contains sodium
This medication contains less than 1 mmol of sodium (23 mg) per coated tablet; this is, essentially "sodium-free".
Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
The recommended dose isof:
One Actonel tablet (5 mg risedronate sodium) once a day.
The aluminum foil of the blister pack has the days of the week printed on it to facilitate the administration of the medication.
WHEN to take Actonel tablets
Take the Actonel tablet at least 30 minutes before the first meal, drink of the day (except in the case of water), or another medication of the day.
Although it is preferable to take this tablet before breakfast, if you have not been able to take Actonel then, you can take it with an empty stomach, at the same time of day, in one of the following cases:
OR:
Your doctor will tell you if you should take calcium and vitamin supplements, if the amount you take from your diet is not enough.
Use in children and adolescents
Risedronate sodium is not recommended for use in children under 18 years due to the scarcity of 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 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 have forgotten to take the tablet at your usual time, you can take the tablet as soon as possible, in accordance with the previous instructions (e.g., before breakfast, between meals, or at night).
Do not take a double dose to compensate for the missed dose.
If you stop taking the treatment, you may start losing bone mass. Please consult your doctor before deciding to interrupt the treatment.
If you have any other doubts about the use of this medication, ask your doctor or pharmacist.
Like all medicines, Actonel can cause side effects, although not everyone will experience them.
Stop taking Actonel and see your doctor immediatelyif you experience any of the following symptoms:
The frequency of this side effect is unknown (cannot be estimated from available data).
Inform your doctor quicklyif you experience the following side effects:
Atypical femoral 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 and indicative of a possible femoral fracture.
However, in clinical studies, the side effects observed were generally mild and did not cause the patient to interrupt treatment.
Frequent side effects(may affect up to 1 in 10 patients):
-Indigestion, nausea, stomach pain, discomfort, or cramps, heavy digestion, constipation, feeling full, abdominal distension, diarrhea.
-Pain in your bones, muscles, or joints.
-Headache.
Rare side effects(may affect up to 1 in 100 patients):
- Inflammation of the colored part of the eye (iris) (red, painful eyes with possible vision changes).
Rare side effects(may affect up to 1 in 1,000 patients):
During post-marketing use, the following have been reported:
Rarely, a mild decrease in blood phosphate and calcium levels has been observed in some patients at the beginning of treatment. These changes are usually small and do not cause symptoms.
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 the Spanish System for the 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.
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the packaging after 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 trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.
Composition of Actonel
-The active ingredient is risedronate sodium. Each tablet contains 5 mg of risedronate sodium (equivalent to 4.64 mg of risedronic acid).
-The other components (excipients) are:
Core tablet: lactose monohydrate (see section 2), crospovidone, magnesium stearate, and microcrystalline cellulose.
Film coating: hypromellose, macrogol, hydroxypropylcellulose, anhydrous colloidal 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 oval-shaped yellow tablets with the letters “RSN” on one face and “5mg” on the other.
The tablets are presented in blisters of 14, 28 (2x14), 84 (6x14), 98 (7x14) film-coated tablets..
Only some pack sizes may be marketed.
Marketing Authorization Holder
Theramex Ireland Limited
3rdFloor, Kilmore House,
Park Lane, Spencer Dock,
Dublin 1
D01 YE64
Ireland
Responsible for manufacturing
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 member states of the European Economic Area with 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
Last review date of this leaflet:October 2024
Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.