Acrel Weekly 35 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Acrel Weekly 35mg film-coated tablets

sodium risedronate

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

• Keep this leaflet, as you may need to read it again. If you have any questions, ask 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, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, including any side effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Acrel Weekly is a medication containing the active substance Acidum alendronicum (alendronic acid). It belongs to a group of non-hormonal medicines called bisphosphonates, which help maintain bone strength.

This medicine is used to treat and prevent osteoporosis (a condition causing bones to become weak and more likely to break) in postmenopausal women and in men. It is also used to treat osteoporosis in patients taking corticosteroids (anti-inflammatory medicines).

Additionally, Acrel Weekly is used to treat Paget's disease of bone, a condition in which the natural rebuilding process of bone is disrupted, leading to enlarged and misshapen bones that may be painful and fragile.

By helping to strengthen bones, Acrel Weekly reduces the risk of fractures, particularly in the spine and hip.

What is Acrel Weekly

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

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

Postmenopausal osteoporosis occurs in women after menopause and is characterized by weakening of the bone, making it more fragile and more prone to fractures following a fall or twist.

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

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

What Acrel Weekly is used for

Treatment of osteoporosis in postmenopausal women, including cases where osteoporosis is severe. It reduces the risk of vertebral and hip fractures.

Treatment of osteoporosis in men at high risk of fractures.

2. What you need to know before starting Acrel Weekly

Do not take Acrel Weekly

• If you are allergic 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, if you are pregnant, or if you are planning 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 Weekly

• 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, parathyroid hormone disorders, both of which can cause low calcium levels in the blood).
• If you have or have had problems in the past with your esophagus (the tube connecting the mouth to the stomach). At some point, you may have experienced or currently experience 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 your doctor has told you that you have an intolerance to certain sugars (such as lactose).
• If you have had or currently have pain, swelling, or numbness in the jaw, severe jaw discomfort, or loose teeth.
• If you are undergoing dental treatment or are scheduled to have dental surgery, inform your dentist that you are receiving treatment with Acrel Weekly.

Your doctor will advise you on what to do if you take Acrel Weekly 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.

Taking Acrel Weekly with other medicines

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

• calcium
• magnesium
• aluminium (for example, some medicines for indigestion)
• iron

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

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

Taking Acrel Weekly with food and drinks

It is very important NOT to take Acrel Weekly 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, "Taking Acrel Weekly with other medicines").

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 could 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 sodium risedronate (the active substance 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 may only be used in postmenopausal women and men.

Driving and using machines

It is unknown whether Acrel Weekly affects the ability to drive or operate machinery.

Acrel Weekly contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with him 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; therefore, it is essentially "sodium-free".

3. How to take Acrel weekly

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

The recommended dose is ONE Acrel weekly tablet (35 mg of sodium risedronate) once a week.

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

To help you remember to take 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 for taking the Acrel tablet. Also, write down 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 food, drink of the day (except plain water), or other medication of the day.

HOW to take Acrel weekly tablets

• Take the tablet while in an upright position, either sitting or standing, to help avoid heartburn.
• Swallow the tablet with at least one glass (120 ml) of plain 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 advise you whether you should take calcium and vitamin supplements if your dietary intake of these is insufficient.

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 contact your doctor.

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, indicating the medicine and the amount taken.

If you forget to take Acrel weekly

If you forget to take the tablet on your chosen day, take it as soon as you remember. Then take the next tablet the following week on your usual day.

DO NOT take a double dose to make up for the missed dose.

If you stop taking Acrel weekly

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Stop taking Acrel Weekly 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).

• Severe 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 promptly if you experience any of 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).
• Symptoms affecting the oesophagus 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 femur fractures (thigh bone) may occur rarely, especially in patients on long-term treatment for osteoporosis. Inform your doctor if you notice pain, weakness or discomfort in your thigh, hip or groin, as these may be early symptoms indicating a possible femur 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, stomach pain, cramps or discomfort in the stomach, constipation, bloating, abdominal swelling, diarrhoea.
• Bone, muscle and 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).

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. These 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, discharge from the ear or an ear infection. These could be symptoms of damage to the ear bones.
• Frequency unknown:
  • 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, talk to 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Acrel weekly

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging 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 drains or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Package contents and other information

Composition of Acrel

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

The other components 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 of the product and contents of the pack

Acrel Weekly 35 mg film-coated tablets are slightly orange oval tablets measuring 11.7 x 5.8 mm, marked 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 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, 2nd floor, left side
28027 Madrid
Spain

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

Spain: Acrel Weekly 35 mg film-coated tablets

Sweden: Fortipan Septimum 35 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/