Actonel Semanal 35 mg film-coated tablets
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package leaflet: Information for the patient
Actonel Weekly 35 mg film-coated tablets
Sodium risedronate
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people. It may harm them, even if their symptoms are the same as yours.
- If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.
In this leaflet:
- What Actonel Weekly is and what it is used for
- What you need to know before taking Actonel Weekly
- How to take Actonel Weekly
- Possible side effects
- How to store Actonel Weekly
- 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 curved spine. 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 osteoporosis is severe. It reduces the risk of vertebral and hip fractures.
- in men.
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 are planning 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 upright, 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 calcium levels in the blood).
-
If you have had or currently have problems with your esophagus (the tube connecting your mouth to your stomach). At some point, you may have experienced or currently experience pain or difficulty swallowing food, or you have previously been diagnosed with Barrett’s esophagus (a condition associated with changes in the cells lining the lower part of the esophagus).
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If your doctor has informed you that you have an intolerance to certain sugars (such as lactose).
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If you have had or currently have pain, swelling, or numbness in the jaw, or severe jaw discomfort, or a loose tooth.
-
If you are undergoing dental treatment or are scheduled for a dental procedure, inform your dentist that you are being treated with Actonel.
Your doctor will advise you on what to do if you are taking Actonel and experience 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 its safety and efficacy.
Taking Actonel Weekly 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 Weekly.
Inform 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 Weekly 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), as they 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 Weekly.
Pregnancy and breastfeeding
DO NOT take Actonel Weekly if you could be pregnant, are pregnant, or are planning to become pregnant (see section 2, “Do not take Actonel Weekly”). The potential risk associated with the use of sodium risedronate (the active substance in Actonel Weekly) in pregnant women is unknown.
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 and men.
Consult your doctor or pharmacist before using any medicine.
Driving and using machines
It is unknown whether Actonel Weekly affects the ability to drive or use machines.
Actonel contains lactose
Actonel Weekly contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine (see section 2, **“**Warnings and precautions”).
Actonel contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially “sodium-free”.
3. How to take Actonel Weekly
Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, please 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 chosen day.
To help you take the tablet on the same day each week, there are boxes on the back of the blister pack. Mark the day of the week you have chosen for taking 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 at least 30 minutes before the first meal, drink of the day, (except if that drink is plain water), or any other medication of the day.
How to take Actonel Weekly tablets
- Take the tablet while in an upright position, either sitting or standing, to avoid stomach irritation.
- 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 need to take calcium and vitamin supplements if your dietary intake of these is insufficient.
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 contact your doctor immediately.
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 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 a double dose to make up for a missed dose.
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, Actonel Weekly may have adverse effects, although not everyone experiences them.
Stop taking Actonel and contact your 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 the available data).
- Severe skin reactions that may include blistering of the skin. The frequency of this adverse effect is not known (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 not known (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 not known (cannot be estimated from the available data).
- Jaw bone necrosis (osteonecrosis), associated with delayed healing and infection, often following dental extraction (see section 2, "Warnings and precautions"). The frequency of this adverse effect is not known (cannot be estimated from the available data).
- Symptoms related to the oesophagus 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 treatment for osteoporosis. Inform your doctor if you notice pain, weakness or discomfort in the thigh, hip or groin, as these may be early warning 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, stomach pain, stomach discomfort or cramps, heavy digestion, constipation, sensation of fullness, abdominal distension, diarrhoea
- Bone, muscle and joint pain
- 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/or duodenum (the intestine where 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 oesophagus (the tube connecting the mouth to the stomach).
- Abnormal liver function tests have been reported. This can only be diagnosed by blood tests.
During post-marketing use, the following adverse effects 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 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 Weekly
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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 containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.
6. Package contents and other information
Composition of Actonel
- 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 (excipients) are:
Tablet core: lactose monohydrate (see section 2), crospovidone A, magnesium stearate and microcrystalline cellulose.
Film coating: hypromellose, macrogol, hydroxypropylcellulose, anhydrous colloidal silica, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).
Appearance of the medicine and pack contents
Actonel Weekly 35 mg film-coated tablets are slightly orange-colored oval tablets marked with the letters “RSN” on one side and “35mg” on the other. Each box contains 4 tablets. The tablets are available in blisters of 1, 2, 4, 10, 12 or 16 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 medicine is authorized in the European Economic Area member states under the following names:
Austria: Actonel einmal wöchentlich 35 mg Filmtabletten
Belgium: Actonel 35 mg Wekelijks filmomhulde tabletten,
Actonel 35 mg hebdomadaire comprimé pelliculé,
Actonel 35 mg Wöchentlich Filmtabletten
Cyprus: Actonel 35 mgεπικαλυμμ?ναμελεπτ?υμ?νιοδισκ?α
Denmark: Optinate Septimum filmovertrukne tabletter
Estonia: Actonel 35 mg OAW, õhukese polümeerikattega tabletid
Finland: Optinate Septimum 35 mg kalvopäällysteiset tabletit
France: Actonel 35 mg comprimé pelliculé
Germany: Risedronat Theramex einmal wöchentlich 35 mg Filmtabletten
Greece: Actonel OAW / ''μ?α φορ? την εβδομ?δα''
Hungary: Actonel 35 mg filmtabletta
Iceland: Optinate Septimum 35 mg filmuhúðaðar töflur
Italy: Actonel 35 mg compresse rivestite con film
Luxembourg: Actonel 35 mg hebdomadaire comprimé pelliculé
Malta: Actonel “Once a Week” 35 mg film-coated tablet
Netherlands: Actonel Wekelijks 35 mg, filmomhulde tabletten
Portugal: Actonel 35 mg comprimidos revestidos por película
Spain: Actonel semanal 35 mg comprimidos recubiertos con película
Sweden: Optinate Septimum 35 mg filmdragerade tabletter
Date of the most recent review of this leaflet: October 2024
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/