Leaflet: information for the user

Weekly Alendronic Acid Aristo 70 mg tablets EFG

Read this leaflet carefully before you start taking the medicine, because 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they appear in this leaflet. See section 4.
• It is particularly important that you understand the information in section 3. How to take Weekly Alendronic Acid Aristo, before taking this medicine.

1. What is Weekly Alendronic Acid Aristo and what it is used for

2. What you need to know before starting to take Weekly Alendronic Acid Aristo

3. How to take Weekly Alendronic Acid Aristo

4. Possible side effects

5. Storage of Weekly Alendronic Acid Aristo

6. Contents of the pack and additional information

What is Alendronic Acid Weekly Aristo?

Alendronic Acid Weekly Aristo is a tablet that contains the active ingredient alendronate (commonly known as alendronic acid) and belongs to a group of non-hormonal medications called bisphosphonates. Alendronic Acid Weekly Aristo prevents bone loss that occurs in women after menopause and helps to rebuild bone. Alendronic Acid Weekly Aristo reduces the risk of fractures of the spine and hip.

Why is Alendronic Acid Weekly Aristo used?

Your doctor has prescribed Alendronic Acid Weekly Aristo to treat your osteoporosis. It reduces the risk of fractures of the spine and hip.

Alendronic Acid Weekly Aristo is a weekly treatment.

What is osteoporosis?

Osteoporosis is a thinning and weakening of the bones. It is common in women after menopause. During menopause, the ovaries stop producing the female hormone estrogen, which helps to maintain a woman's healthy skeleton. As a result, bone loss occurs and the bones become weaker. The earlier a woman reaches menopause, the greater her risk of osteoporosis.

Osteoporosis usually does not have symptoms early on. However, if left untreated, it can result in broken bones. Although these usually hurt, fractures of the spine bones can go unnoticed until they cause loss of height. Bones can break during normal daily activities, such as getting up or from minor injuries that would not normally break a normal bone. Fractures of bones usually occur in the hip, spine, or wrist and can cause not only pain but also significant problems such as a hunched posture (widow's hump) and loss of mobility.

How can osteoporosis be treated?

In addition to your treatment with Alendronic Acid Weekly Aristo, your doctor may suggest that you make lifestyle changes to help your condition, such as:

Stopping smokingIt appears that smoking increases the rate at which you lose bone and may increase your risk of broken bones.

ExerciseAs muscles, bones need exercise to stay strong and healthy. Consult your doctor before starting any exercise program.

Eating a balanced dietYour doctor may advise you on your diet or whether you should take any dietary supplements (especially calcium and vitamin D).

Do not take Alendronic Acid weeklyAristo

• if you are allergic to alendronic acid or any of the other ingredients of this medicine (listed in section 6)

• if you have certain throat problems (esophagus - the tube that connects your mouth to your stomach), such as narrowing or difficulty swallowing
• if you cannot stand or sit for at least 30 minutes
• if your doctor has told you that you have low blood calcium

If you think any of these cases apply to you, do not take the tablets. Talk to your doctor first and follow their advice.

Warnings and precautions

It is important to tell your doctor before taking Alendronic Acid weekly Aristo if:

• you have kidney problems,
• you have, or have recently had, swallowing problems,
• your doctor has told you that you have Barrett's esophagus (a disease associated with changes in the cells that cover the lower part of the esophagus),
• you have been told that you have mineral absorption problems in your stomach or intestines (malabsorption syndrome),
• you have been told that you have low blood calcium levels,
• you have poor dental hygiene, gum disease, a planned tooth extraction, or do not receive regular dental care,
• you have cancer,
• you are undergoing chemotherapy or radiation therapy,
• you are taking angiogenesis inhibitors (such as bevacizumab or thalidomide) used in cancer treatment,
• you are taking corticosteroids (such as prednisone or dexamethasone) used in the treatment of diseases such as asthma, rheumatoid arthritis, and severe allergies,
• you are or have been a smoker (as this may increase the risk of dental problems).

You may be advised to have a dental check-up before starting treatment with Alendronic Acid Weekly Aristo.

It is essential to maintain good oral hygiene while taking Alendronic Acid Weekly Aristo. You should have regular dental check-ups during your treatment and contact your doctor or dentist if you experience any problems in your mouth or teeth, such as tooth loss, pain, or inflammation.

Irritation, inflammation, or esophageal ulceration may occur, often with symptoms of chest pain, burning, difficulty, or pain swallowing, especially if patients do not drink a full glass of water and/or if they lie down within 30 minutes of taking Alendronic Acid Weekly Aristo. These adverse effects may worsen if patients continue taking Alendronic Acid Weekly Aristo after developing these symptoms.

Children and adolescents

Alendronic Acid Weekly Aristo should not be administered to children or adolescents under 18 years of age.

Other medicines and Alendronic Acid Weekly Aristo

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

It is likely that calcium supplements, antacids, and other oral medicines will interfere with the absorption of Alendronic Acid Weekly Aristo if taken at the same time. Therefore, it is essential to follow the advice given in section 3.

Certain medicines for rheumatism or long-term pain called NSAIDs (such as aspirin or ibuprofen) may cause digestive problems. Therefore, caution should be exercised if these medicines are taken at the same time as Alendronic Acid Weekly Aristo.

Taking Alendronic Acid Weekly Aristo with food and drinksAristowith food and drinks

It is likely that food and drinks (including mineral water) will make Alendronic Acid Weekly Aristo less effective if used at the same time. Therefore, it is essential to follow the advice given in section 3.

Pregnancy and breastfeeding

Alendronic Acid Weekly Aristo is only intended for use in postmenopausal women. Do not take Alendronic Acid Weekly Aristo if you are pregnant or think you may be pregnant, or during breastfeeding.

Driving and operating machinery

Adverse effects with Alendronic Acid Weekly Aristo (such as blurred vision, dizziness, and intense bone, muscle, or joint pain) may affect your ability to drive or operate machinery (see section 4).

This medicine contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

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

Take one weekly Aristo 70 mg Alendronate tabletonce a week.

Follow these instructions carefully.

1. Choose the day of the week that best suits your routine. Each week, take one weekly Aristo Alendronate tablet on the day you have chosen.

It is very important to follow instructions 2, 3, 4, and 5 to help the weekly Aristo Alendronate tablet reach your stomach quickly and reduce the possible irritation of the esophagus (the tube that connects the mouth with the stomach).

1. After getting up in the morning and before taking the first meal, drink, or other medication, swallow the weekly Aristo Alendronate tablet only with a full glass of water (not mineral water) (not less than 200 ml), so that the weekly Aristo Alendronate tablet is absorbed properly.

• Do not take it with mineral water
• Do not take it with coffee or tea
• Do not take it with juices or milk.

Do not crush or chew the tablet, and do not allow it to dissolve in your mouth, due to the possibility of mouth ulcers appearing.

1. Do not lie down - remain upright (sitting, standing, or walking) - for at least 30 minutes after swallowing the tablet. Do not go to bed until after the first meal of the day.

1. Do not take weekly Aristo Alendronate at bedtime or before getting up in the morning.

1. If you have difficulty or pain swallowing, chest pain, or new or worsening heartburn, stop taking weekly Aristo Alendronate and inform your doctor.

1. After swallowing a weekly Aristo Alendronate tablet, wait at least 30 minutes before consuming the first meal, drink, or other medication of the day, including antacids, calcium supplements, and vitamins. Weekly Aristo Alendronate is only effective if taken on an empty stomach.

If you take more weekly Aristo Alendronate than you should

If you accidentally take too many tablets, drink a full glass of milk and go to the doctor immediately. Do not induce vomiting and do not lie down.

For overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 91 562 04 20.

If you forget to take weekly Aristo Alendronate

If you forget a dose, wait until the next morning to take weekly Aristo Alendronate.Do not take two tablets on the same day.Then, take one tablet once a week, on the originally chosen day.

If you interrupt treatment with weekly Aristo Alendronate

It is essential to continue taking weekly Aristo Alendronate for as long as your doctor prescribes the medication. Since it is unknown how long you should take weekly Aristo Alendronate, you should discuss periodically with your doctor the need to continue treatment with this medication to determine if weekly Aristo Alendronate is still suitable for you.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Seek medical attention immediatelyif you notice any of the following side effects, which may be serious, and for which you may need urgent medical treatment:

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

• burning sensation; difficulty swallowing; pain when swallowing; esophageal ulcer (the tube that connects your mouth to your stomach) that may cause chest pain, burning, or difficulty or pain when swallowing.

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

• allergic reactions such as urticaria; swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing; severe skin reactions,
• mouth and/or jaw pain, swelling, or sores inside the mouth, numbness, or a feeling of heaviness in the jaw, or tooth loss. These may be signs of jaw bone damage (osteonecrosis) usually associated with delayed healing and infection, often after a dental extraction. Inform your doctor and dentist if you experience these symptoms,
• atypical femur fractures that 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 they may be early symptoms and indicative of a possible femur fracture,
• intense bone, muscle, and/or joint pain.

Other side effects are:

Very frequent (may affect more than 1 in 10 people):

• occasional intense pain in bones, muscles, and/or joints.

Frequent (at least 1 in 100 patients):

• swelling of the joints,
• abdominal pain; uncomfortable sensation in the stomach or belching after eating; constipation; feeling of fullness or bloating in the stomach; diarrhea; flatulence,
• hair loss; itching,
• headache; dizziness,
• fatigue; swelling of the hands or legs.

Rare (at least 1 in 1,000 patients):

• nausea; vomiting,
• irritation or inflammation of the throat (esophagus - the tube that connects your mouth to your stomach) or stomach,
• black or tar-like stools,
• blurred vision; eye pain or redness,
• skin rash; skin redness,
• transient symptoms similar to the flu, such as muscle pain, general feeling of discomfort, and, sometimes, fever that usually appear at the beginning of treatment,
• alteration of taste.

Rare (at least 1 in 10,000 patients):

• symptoms of low calcium levels in the blood, including muscle cramps or spasms and/or tingling in the fingers or around the mouth,
• stomach ulcers or peptic ulcers (sometimes severe or with bleeding),
• esophageal stricture,
• skin rash that worsens with sunlight,
• mouth ulcers.

Very rare(up to 1 in 10,000 people):

• consultyour doctor if you have ear pain, your ear is discharging, or you have an ear infection. These may be signs of damage to the bones in the ear.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance 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 Alendronic Acid Weekly Aristo 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.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. In this way, you will help protect the environment.

Composition of Alendronic Acid WeeklyAristo

The active ingredient is alendronic acid. Each tablet contains 70 mg of alendronic acid as alendronate sodium trihydrate.

The other components (excipients) are: Microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, sodium stearate fumarate, hydroxypropylmethylcellulose 2910, and talc.

Appearance of the product and contents of the packaging

Alendronic Acid Weekly Aristo 70 mg is presented in the form of coated tablets, oblong in shape, white or off-white in color.

Each package contains 4 tablets.

Holder of the marketing authorization

Aristo Pharma Iberia, S.L.

C/Solana, 26

28850 Torrejón de Ardoz, Madrid

Spain

Responsible for manufacturing

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra

Portugal

Last review date of this leaflet: May 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.ess