Package Insert: Information for the User

Acrel 75 mg Film-Coated Tablets

Risedronate Sodium

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
  If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Acrel and for what it is used

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

3. How to take Acrel

4. Possible adverse effects

5. Storage of Acrel

6. Contents of the package and additional information

What is Acrel

Acrel belongs to a group of non-hormonal medications called bisphosphonates, which are used for the treatment of bone diseases. Acrel acts directly on the bones, strengthening them and, therefore, reduces the probability of fractures.

The bone is a living tissue. Old bone in 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.

The most likely bone fractures are those of the vertebrae, hip, and wrist, although they can occur in any bone in the body. Fractures associated with osteoporosis 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 Acrel used for

This medication is indicated for the treatment of osteoporosis inwomenafter menopause.

Do not take Acrel

• if you are allergic (hypersensitive) to risedronate sodium or to any of the other components of this medication (listed in section 6)
• if your doctor has told you that you have a condition 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 (for example, vitamin D deficiency, parathyroid hormone alterations, as both produce 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 or have had difficulty swallowing food or been previously informed that you suffer from Barrett's esophagus (a condition associated with changes in the cells that cover the lower part of the esophagus).
• If you have had or have jaw pain, inflammation, or numbness, or a strong pain in the jaw or a tooth that moves.
• If you are undergoing dental treatment or are about to undergo 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 problems mentioned above.

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.

Use of Acrel with other medications

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

• calcium
• magnesium
• aluminum (for example, some medication for indigestion)
• iron

Take these medications at least 30 minutes after taking Acrel.

Inform your doctor or pharmacist that you are using, have used recently, or may need to use any other medication.

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 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, 'Use of Acrel with other medications').

You may 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 risedronate sodium (active ingredient of 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 operating machinery

The effect of Acrel on the ability to drive and operate machinery is unknown.

Acrel 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.

Recommended dose:

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

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

Take the Acrel tablet at least 30 minutes before the first meal, drink (except for tap water) or another medication of the day.

HOW to take Acrel tablets

• Take the tablet while standing upright, either sitting or standing, to avoid stomach burning.
• Swallow the tablet with at least one glass (120 ml) of tap water. Do not take the tablet with mineral water or other drinks that are not tap 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 from your diet is not sufficient.

IF you take more Acrel than you should

If you or someone accidentally took more Acrel 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 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 interrupt the treatment with Acrel

If you stop taking the treatment, you might 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, this medicine may cause side effects, although not everyone will experience them.

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

• Severe allergic reaction symptoms, such as:
• • Swelling of the face, tongue, or throat
  • Difficulty swallowing
  • Rashes and difficulty breathing.

The frequency of this side effect is unknown (cannot be estimated from available data).

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

Inform your doctor quicklyif 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 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 side effect is unknown (cannot be estimated from available data).
• jawbone necrosis (osteonecrosis) associated with delayed healing and infection, usually after a dental extraction (see section 2 "Warnings and precautions"). The frequency of this side effect is unknown (cannot be estimated from available data).
• Esophageal symptoms such as difficulty swallowing, chest pain, and appearance or worsening of stomach acid. This side effect is rare (may affect up to 1 in 100 people).

Atypical femur fractures 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 possible femur fractures.

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

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

• Indigestion, nausea, vomiting, stomach pain, stomach discomfort, constipation, feeling full, abdominal swelling, diarrhea.
• Bone, muscle, or joint pain.
• Headache.

Rare 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 swallowing (see also section 2, "Warnings and precautions"), inflammation of the stomach and duodenum (the intestine where the stomach empties).
• Inflammation of the colored part of the eye (the iris) (red, painful eyes with possible vision changes).
• Fever and/or symptoms similar to the flu.

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

• Lingual inflammation (swollen, red, possibly painful), esophageal narrowing (the tube that connects the mouth to the stomach).
• Abnormal liver test results. 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, ear discharge, or an ear infection. These may be symptoms of damage to the ear bones.
• Unknown frequency:
• • Hair loss
  • Liver diseases, in some cases severe.

Rarely, a 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 Vigilance 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 in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Acrel

The active ingredient is risedronate sodium. Each tablet contains 75 mg of risedronate sodium, equivalent to 69.6 mg of risedronic acid.

The other components are:

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

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

Appearance of the product and content of the container

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

Only some container sizes may be commercially marketed.

Marketing authorization holder and responsible 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 with the following names:

Spain:Acrel75 mg film-coated tablets

Sweden: Fortipan 75 mg film-coated tablets

Last review date of this leaflet inOctober 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/