Label: information for the user

Weekly Acrel 35mg film-coated tablets

risedronate sodium

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, 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 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 label. See section 4.

1. What isAcrel weeklyand what it is used for

2. What you need to know before starting to takeAcrel weekly

3. How to takeAcrel weekly

4. Possible adverse effects

5. Storage ofAcrel weekly

6. Contents of the pack and additional information

What is Acrel weekly

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

The bone is a living tissue. The old bone of the skeleton is constantly being renewed and replaced by new bone.

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

Osteoporosis can also be suffered by men due to numerous 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 of the body. Fractures associated with osteoporosis can also produce back pain, height loss, and curved back. Some patients with osteoporosis do not have symptoms and may not even know they have it.

For what Acrel weekly is used

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

Do not take Acrel weekly

• If you are allergic to risedronate sodium or 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, if you are pregnant, or if you plan to become pregnant
• If you are breastfeeding
• If you have severe kidney disease.

Warnings and precautions

Consult with your doctor or pharmacist before starting to take Acrel weekly

• 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, both producing 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 have 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 your doctor has indicated that you have an intolerance to certain sugars (such as lactose).
• 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 going to undergo 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 scarcity of data on safety and efficacy.

Use of Acrel weekly with other medications

Medications that contain any of the following substances reduce the effect of Acrel weekly 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 weekly.

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

Taking Acrel weekly with food and drinks

It is very important that you DO NOT take Acrel weekly with food or with beverages (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) since they contain calcium (see section 2, “Use of Acrel weekly with other medications”).

Take food and drinks (other than plain water) at least 30 minutes after taking 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 (active ingredient of 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 operating machines

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

Acrel weekly contains lactose

If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication (see section 2, “Warnings and precautions”).

Acrel weekly 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.

The recommended dose isone Acrel weekly tablet (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 the intake of the tablet on the same day every week, there are boxes on the back of the blister. Mark the day of the week you have chosen to take the Acrel tablet. Also, write the dates on which you will take the tablet.

WHEN to take Acrel weekly tablets

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

HOW to take Acrel weekly 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.
• 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 indicate if you should take calcium and vitamin supplements, if the amount you take of these in your diet is not sufficient.

IF you take more Acrel weekly than you should

If you or someone accidentally has taken more Acrel weekly 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 weekly

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

DO NOT take a double dose to compensate for the missed dose.

IF you interrupt treatment with Acrel weekly

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

If you have any other questions 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 weekly 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 changes. 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 symptoms and indicative of possible femur fracture.

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, stomach pain, stomach upset, constipation, feeling full, abdominal swelling, diarrhea.

- Bone, muscle, and joint pain.

- Headache.

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

• Esophageal inflammation or ulceration (the tube that connects the mouth to the stomach) causing difficulty and pain swallowing (see also section 2, "Warnings and precautions"), stomach and duodenal inflammation.
• Iris inflammation (red, painful eyes with possible vision changes).

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

• Lingual inflammation (swollen, red, possibly painful tongue), 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 ear infection. These may be symptoms of ear bone damage.

-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 35 mg of risedronate sodium, equivalent to 32.5 mg of risedronic acid.

The other components are:

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

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

Appearance of the product and content of the container

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

Only some sizes of packaging 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: Acrel weekly 35 mg film-coated tablets

Sweden: Fortipan Septimum 35 mg film-coated tablets

Last review date of this leaflet in October 2024.

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es /