ACREL SEMANAL 35 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Acrel Weekly 35mg Film-Coated Tablets

risedronate sodium

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. Do not pass it on to others. 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. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Acrel Weekly and what is it used for
2. What you need to know before you take Acrel Weekly
3. How to take Acrel Weekly
4. Possible side effects
5. Storing Acrel Weekly
6. Contents of the pack and other information

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

What is Acrel Weekly

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

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

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

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

The most likely bone fractures are those of the vertebrae, hip, and wrist, although they can occur in any bone in the body. Osteoporosis-related fractures can also cause back pain, loss of height, and a curved back. Some patients with osteoporosis may not have symptoms and may not even know they have it.

What Acrel Weekly is used for

Treatment of osteoporosis in women after menopause, even if osteoporosis is severe. Reduces the risk of vertebral and hip fractures.

Treatment of osteoporosis in men with a high risk of fractures.

2. What you need to know before you take Acrel Weekly

Do not take Acrel Weekly

• If you are allergic to risedronate sodium or any of the other ingredients of this medicine (listed in section 6).
• If your doctor has told you that you have a disease called hypocalcemia (low blood calcium levels).
• If you may 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 taking Acrel Weekly.

• If you cannot stay upright (sitting or standing) for at least 30 minutes.

• If you have bone or mineral metabolism problems (e.g., vitamin D deficiency, parathyroid hormone disorders, both causing low blood calcium levels).
• If you have or have had problems with your esophagus (the tube that connects the mouth to the stomach). At some point, you may have had or been told you have esophagitis (inflammation of the esophagus) or esophageal ulcers, or you may have been diagnosed with Barrett's esophagus (a condition associated with changes in the cells lining the lower esophagus).
• If your doctor has told you that you have an intolerance to certain sugars (such as lactose).
• If you have had or have pain, inflammation, or numbness in the jaw or a strong discomfort in the jaw or a tooth has moved.
• If you are undergoing dental treatment or are going to have dental surgery, inform your dentist that you are receiving treatment with Acrel Weekly.

Your doctor will advise you what to do if you take Acrel Weekly and have any of the problems mentioned above.

Children and adolescents

Risedronate sodium is not recommended for use in children under 18 years due to the lack of data on safety and efficacy.

Using Acrel Weekly with other medicines

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

• calcium
• magnesium
• aluminum (e.g., some medicines for indigestion)
• iron

Take these medicines at least 30 minutes after taking Acrel Weekly.

Tell your doctor or pharmacist that you are using, have recently used, or might use any other medicines.

Taking Acrel Weekly with food and drinks

It is very important that you do not take Acrel Weekly with food or drinks (other than plain water) because they can 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, "Using Acrel Weekly with other medicines").

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

Pregnancy and breastfeeding

Do not take Acrel Weekly if you may be pregnant, are pregnant, or plan to become pregnant (see section 2, "Do not take Acrel Weekly"). The potential risk associated with the use of risedronate sodium (the active ingredient in Acrel Weekly) in pregnant women is unknown.

Do not take Acrel Weekly if you are breastfeeding (see section 2, "Do not take Acrel Weekly").

Acrel Weekly can only be used in postmenopausal women and men.

Driving and using machines

It is unknown whether Acrel Weekly affects the ability to drive and use machines.

Acrel Weekly contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine (see section 2, "Warnings and precautions").

Acrel Weekly 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 Acrel Weekly

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is one 35 mg film-coated tablet of Acrel Weekly (containing 35 mg of risedronate sodium) once a week.

Choose the day of the week that best suits your schedule. Each week, take the Acrel Weekly tablet on the chosen day.

To facilitate taking 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 to take the Acrel Weekly tablet. Also, write down the dates when you will take the tablet.

When to take Acrel Weekly tablets

Take the Acrel Weekly tablet at least 30 minutes before the first food, drink of the day (except plain water) or other medicine of the day.

How to take Acrel Weekly tablets

• Take the tablet while standing or sitting upright to avoid heartburn.
• Swallow the tablet with at least one glass (120 ml) of plain water.
• Swallow the tablet whole (without chewing or sucking it).
• Do not lie down for at least 30 minutes after taking the tablet.

Your doctor will tell you if you need to take calcium and vitamin supplements if the amount you get from your diet is not sufficient.

If you take more Acrel Weekly than you should

If you or someone else has accidentally taken more Acrel Weekly tablets than prescribed, drink a full glass of milk and consult a doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Acrel Weekly

If you have forgotten to take the tablet on the chosen day, take it on the day you remember. And take the next tablet the following week, on the day you normally take the tablet.

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

If you stop taking Acrel Weekly

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Acrel Weekly and contact your doctor immediatelyif you experience any of the following side effects:

• 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 side effect is unknown (cannot be estimated from the available data).

• Severe skin reactions that can include blistering of the skin. The frequency of this side effect is unknown (cannot be estimated from the available data).

Tell your doctor as soon as possibleif you experience any of the following side effects:

• Eye inflammation, usually with pain, redness, and sensitivity to light. The frequency of this side 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 changes. The frequency of this side effect is unknown (cannot be estimated from the available data).
• Jawbone necrosis (osteonecrosis) associated with delayed healing and infection, usually after a tooth extraction (see section 2, "Warnings and precautions"). The frequency of this side effect is unknown (cannot be estimated from the available data).
• Symptoms in the esophagus such as pain when swallowing, difficulty swallowing, chest pain, and appearance or worsening of heartburn. This side effect is uncommon (may affect up to 1 in 100 people).

Atypical fractures of the thigh bone (femur) can occur rarely, especially in patients on long-term treatment for osteoporosis. Tell your doctor if you notice pain, weakness, or discomfort in the thigh, hip, or groin, as these may be early symptoms of a possible femur fracture.

However, in clinical studies, the side effects that were observed were generally mild and did not cause the patient to stop treatment.

Common side effects(may affect up to 1 in 10 people)

• Indigestion, nausea, stomach pain, cramps or discomfort in the stomach, constipation, feeling full, abdominal swelling, diarrhea.
• Bone, muscle, and joint pain.
• Headache.

Uncommon side effects(may affect up to 1 in 100 people)

• Inflammation or ulceration of the esophagus (the tube that connects the mouth to the stomach) causing difficulty and pain when swallowing (see also section 2, "Warnings and precautions"), inflammation of the stomach and duodenum (intestine where the stomach empties).
• Inflammation of the colored part of the eye (the iris) (red eyes, painful with possible changes in vision).

Rare side effects(may affect up to 1 in 1,000 people)

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

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

• Very rare: Consult your doctor if you have ear pain, your ear is discharging, or you have an ear infection. These could be symptoms of damage to the bones of the ear.
• Frequency unknown:
  • Hair loss
  • Liver disease, in some cases severe.

Rarely, at the start of treatment, a decrease in phosphate and calcium blood levels has been observed in some patients.

These changes are usually small and do not cause symptoms.

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Acrel Weekly

• 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 carton after EXP. The expiry date is the last day of the month shown.
• This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Acrel

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

The other ingredients are:

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

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

Appearance and packaging

Acrel Weekly 35 mg film-coated tablets are oval, slightly orange tablets, 11.7 x 5.8 mm in size, with the letters "RSN" on one face and "35 mg" on the other. The tablets are packaged in blisters containing 1, 2, 4, 10, 12, or 16 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

The marketing authorization holder is

Theramex Ireland Limited

3rd Floor, Kilmore House,

Park Lane, Spencer Dock,

Dublin 1

D01 YE64

Ireland

The manufacturer is

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 under the following names:

Spain:Acrel Weekly35 mg film-coated tablets

Sweden:Fortipan Septimum35 mg film-coated tablets

Date of last revision of this leaflet:October 2024.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es