Acrel 75 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Acrel 75 mg film-coated tablets

Sodium risedronate

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Acrel is and what it is used for
2. What you need to know before taking Acrel
3. How to take Acrel
4. Possible side effects
5. How to store 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 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 to occur following a fall or twist.

The most common bone fractures occur in the vertebrae, hip, and wrist, although they can happen in any bone of the body. Osteoporosis-related fractures may also cause back pain, loss of height, and a curved back. Some patients with osteoporosis have no symptoms and may not even be aware they have the condition.

What Acrel is used for

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

2. What you need to know before taking Acrel

Do not take Acrel

• if you are allergic (hypersensitive) 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 Acrel

• 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, as both can cause low blood calcium levels).
• If you currently have or have previously had problems with your esophagus (the tube connecting your mouth to your stomach). At some point, you may have experienced pain or difficulty swallowing food, or you may have previously been diagnosed with Barrett's esophagus (a condition associated with changes in the cells lining the lower part of the esophagus).
• If you have had or currently have pain, swelling, or numbness in the jaw, severe jaw discomfort, or a loose tooth.
• If you are undergoing dental treatment or are scheduled for dental surgery, inform your dentist that you are receiving treatment with Acrel.

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

Children and adolescents

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

Use of Acrel with other medicines

Medicines containing any of the following substances reduce the effect of Acrel 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 Acrel.

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Taking Acrel with food and drinks

It is very important NOT to take Acrel 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, 'Use of Acrel with other medicines').

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

Pregnancy and breastfeeding

DO NOT take Acrel if you could be pregnant, are pregnant, or plan to become pregnant (see section 2, “Do not take Acrel”). The potential risk of sodium risedronate (the active substance in Acrel) in pregnant women is unknown.

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

Acrel may only be used in postmenopausal women.

Driving and using machines

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

Acrel contains sodium

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

3. How to take Acrel

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

Recommended dose:

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

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

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

WHEN to take Acrel tablets

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

HOW to take Acrel tablets

• Take the tablet while in an upright position, either sitting or standing, to help prevent stomach irritation.
• Swallow the tablet with at least one glass (120 ml) of plain water. Do not take the tablet with mineral water or other beverages—only 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 the amount you obtain from your diet is insufficient.

If you take more Acrel than you should

If you or someone accidentally takes more Acrel 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 at telephone number: 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Acrel

In any case:

• If you forget your morning dose of Acrel, DO NOT take it later during that day
• DO NOT take three tablets within the same week.

If you interrupt treatment with Acrel

If you stop taking the treatment, you may begin to lose bone mass. Please consult your doctor before deciding to interrupt the treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Stop taking Acrel and contact your doctor immediately if you experience any of the following adverse 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 adverse effect is unknown (cannot be estimated from available data).

• Serious skin reactions that may include blistering of the skin. The frequency of this adverse effect is unknown (cannot be estimated from available data).

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

• Eye inflammation, usually with pain, redness, and sensitivity to light. The frequency of this adverse effect is unknown (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 unknown (cannot be estimated from available data).
• Jaw bone necrosis (osteonecrosis) associated with delayed healing and infection, usually following a dental extraction (see section 2 "Warnings and precautions"). The frequency of this adverse effect is unknown (cannot be estimated from available data).
• Oesophageal symptoms 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 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 symptoms 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 people):

• Indigestion, nausea, vomiting, stomach pain, stomach cramps or discomfort, constipation, feeling of fullness, abdominal bloating, diarrhoea.
• Bone, muscle or joint pain.
• Headache.

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

• 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 into which 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 people):

• Inflammation of the tongue (swollen, red, possibly painful), narrowing of the oesophagus (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 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 bones of the ear.
• Frequency not known:
  • Hair loss
  • Liver disorders, in some cases severe.

Rarely, at the beginning of treatment, a 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 can 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 Acrel

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to 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 collection point at 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 Acrel

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 are:

Tablet core: 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 contents of the pack

Acrel 75 mg film-coated tablets are pink oval tablets of 11.7 x 5.8 mm, with the letters "RSN" on one side and "75 mg" on the other. Each box contains 2, 4, 6 or 8 tablets.

Only certain 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain: Acrel 75 mg film-coated tablets
Sweden: Fortipan 75 mg film-coated tablets

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/