ACREL 75 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Acrel 75 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. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get 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 pack

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

1. What Acrel is and what it is used for

What Acrel is

Acrel belongs to a group of non-hormonal medicines called bisphosphonates, which are used to treat bone diseases. Acrel acts directly on the bones, strengthening them and thus 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 the bone begins to weaken, becoming more fragile and prone to fractures after a fall or twist.

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 is used for

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

2. What you need to know before you take Acrel

Do not take Acrel

• if you are allergic (hypersensitive) to sodium risedronate 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 calcium levels in the blood)
• 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

Consult your doctor or pharmacist before starting to take Acrel

• If you cannot remain upright, either sitting or standing, for at least 30 minutes.
• If you have bone or mineral metabolism problems (e.g., vitamin D deficiency, parathyroid hormone disorders, as both can cause 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 esophageal pain or difficulty swallowing food, or you have been previously informed that you suffer from Barrett's esophagus (a condition associated with changes in the cells lining the lower esophagus).
• 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.

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

Children and adolescents

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

Using Acrel with other medicines

Medicines that contain any of the following substances reduce the effect of Acrel when taken at the same time:

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

Take these medicines at least 30 minutes after taking Acrel.

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

Taking Acrel with food and drinks

It is very important that you DO NOT take Acrel 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 with other medicines').

You can take food and drinks (other than plain water) at least 30 minutes after taking Acrel.

Pregnancy and breastfeeding

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

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

Acrel can only be used in postmenopausal women.

Driving and using machines

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

Acrel 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

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Recommended dose:

Acrel tablets should be taken on the SAME two consecutive days of 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 Acrel tablet on the morning of the first chosen day. Take the SECOND tablet on the morning of the next day.

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

WHEN to take the Acrel tablets

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

HOW to take the Acrel tablets

• Take the tablet while standing or sitting upright to avoid stomach upset.
• Swallow the tablet with at least one glass (120 ml) of plain water. Do not take the tablet with mineral water or other drinks 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 indicate if you should take calcium and vitamin supplements if the amount you take in your diet is not sufficient.

If you take more Acrel than you should

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

In any case:

• If you forgot your Acrel dose in the morning, DO NOT take it later that day
• DO NOT take three tablets in the same week.

If you stop taking Acrel

If you stop taking the 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 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 promptlyif you experience 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).
• Jaw bone 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).
• Esophageal symptoms such as pain when swallowing, difficulty swallowing, chest pain, and appearance or worsening of stomach acid. 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 can 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, vomiting, stomach pain, cramps or discomfort in the stomach, constipation, feeling of fullness, abdominal swelling, diarrhea.
• Bone, muscle, or joint pain.
• Headache.

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

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

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

• Tongue inflammation (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 through 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 of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is 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. Storage of Acrel

• 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. Place the empty packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Acrel

The active substance is sodium risedronate. Each film-coated tablet contains 75 mg of sodium risedronate, equivalent to 69.6 mg of risedronic acid.

The other ingredients are:

Core tablet: microcrystalline cellulose, crospovidone A, and magnesium stearate.

Film coating: hypromellose, macrogol 400, macrogol 8000, hydroxypropylcellulose, colloidal anhydrous silica, titanium dioxide (E171), and red iron oxide (E172).

Appearance of the product and pack contents

Acrel 75 mg film-coated tablets are oval, pink tablets, 11.7 x 5.8 mm in size, with the letters "RSN" on one face and "75 mg" on the other. Each carton contains 2, 4, 6, or 8 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, 2ª planta izquierda.

28027 Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain:Acrel75 mg film-coated tablets

Sweden:Fortipan75 mg film-coated tablets

Date of last revision of this leafletOctober 2024.

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