Alendronic acid semanal Aristo 70 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Alendronic Acid Aristo Weekly 70 mg tablets EFG

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

• Keep this leaflet. 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. It could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects listed in this leaflet. See section 4.
• It is particularly important that you understand the information in section 3. How to take Alendronic Acid Aristo Weekly, before taking this medicine.

Leaflet contents

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

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

What is Alendronic Acid Aristo Weekly?

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

For what is Alendronic Acid Aristo Weekly used?

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

Alendronic Acid Aristo Weekly is a weekly treatment.

What is osteoporosis?

Osteoporosis is 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 maintain a woman's skeleton in good health. As a result, bone loss occurs and bones become weaker. The earlier a woman reaches menopause, the greater her risk of osteoporosis.

For a long time, osteoporosis usually has no symptoms. However, if left untreated, it can lead to broken bones. Although fractures are usually painful, spinal bone fractures may go unnoticed until they cause loss of height. Bones may break during normal everyday activities, such as getting up from a chair, or from minor injuries that would not normally break a healthy bone. Bone fractures usually occur in the hip, spine, or wrist and can cause not only pain but also significant problems such as stooped posture ("dowager's hump") and loss of mobility.

How can osteoporosis be treated?

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

Stopping smoking Smoking appears to increase the rate at which you lose bone and therefore may increase your risk of broken bones.

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

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

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

Do not take Alendronic Acid Aristo Weekly

• if you are allergic to alendronic acid or to any of the other ingredients of this medicine (listed in section 6)
• if you have certain abnormalities in your throat (oesophagus – the tube connecting your mouth to your stomach), such as narrowing or difficulty swallowing
• if you cannot remain upright (sitting or standing) for at least 30 minutes
• if your doctor has told you that you have low blood calcium levels

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

Warnings and precautions

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

• you have kidney problems,
• you have or have recently had digestive problems when swallowing,
• your doctor has told you that you have Barrett’s oesophagus (a condition associated with changes in the cells lining the lower part of the oesophagus),
• you have been diagnosed with malabsorption (difficulty absorbing minerals in your stomach or intestines),
• you have been told you have low or high blood calcium levels,
• you have poor dental hygiene, gum disease, an upcoming dental extraction, or do not receive regular dental care,
• you have cancer,
• you are undergoing chemotherapy or radiotherapy,
• you are being treated with angiogenesis inhibitors (such as bevacizumab or thalidomide) used in cancer treatment,
• you are taking corticosteroids (such as prednisone or dexamethasone) used to treat conditions like asthma, rheumatoid arthritis, or 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 examination before starting treatment with Alendronic Acid Aristo Weekly.

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

Irritation, inflammation, or ulceration of the throat (oesophagus – the tube connecting your mouth to your stomach) may occur, often with symptoms such as chest pain, heartburn, or difficulty or pain when swallowing, especially if patients do not drink a full glass of water and/or lie down within 30 minutes after taking Alendronic Acid Aristo Weekly. These adverse effects may worsen if patients continue taking Alendronic Acid Aristo Weekly after developing these symptoms.

Children and adolescents

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

Other medicines and Alendronic Acid Aristo Weekly

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

Calcium supplements, antacids, and other oral medications may interfere with the absorption of Alendronic Acid Weekly if taken at the same time. Therefore, it is important to follow the advice given in section 3.

Certain medicines used for rheumatic conditions or long-term pain called NSAIDs (e.g. acetylsalicylic acid or ibuprofen) may cause gastrointestinal problems. Therefore, caution should be taken if these medicines are taken together with Alendronic Acid Aristo Weekly.

Taking Alendronic Acid Aristo Weekly with food and drink

Food and beverages (including mineral water) may reduce the effectiveness of Alendronic Acid Weekly if taken at the same time. Therefore, it is important to follow the advice given in section 3.

Pregnancy and breastfeeding

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

Driving and using machines

Adverse effects have been reported with Alendronic Acid Aristo Weekly (e.g. blurred vision, dizziness, and severe bone, muscle, or joint pain) which 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; this is essentially “sodium-free”.

3. How to take Alendronic Acid Aristo Weekly

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

Take one tablet of Alendronic Acid Aristo Weekly 70 mg once a week.

Follow these instructions carefully.

1. Choose the day of the week that best fits your routine. Each week, take one tablet of Alendronic Acid Aristo Weekly on the day you have chosen.

It is very important that you follow steps 2, 3, 4 and 5 to help ensure the tablet of Alendronic Acid Aristo Weekly reaches your stomach quickly and to help reduce the possible irritation of the oesophagus (the tube connecting the mouth to the stomach).

2. After getting up in the morning and before taking any food, drink, or other medication, swallow the tablet of Alendronic Acid Aristo Weekly with a full glass of plain water (not mineral water) (at least 200 ml), so that Alendronic Acid Aristo Weekly is properly absorbed.

• 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, nor allow it to dissolve in your mouth, due to the risk of developing mouth ulcers.

3. Do not lie down – remain upright (sitting, standing, or walking) – for at least 30 minutes after swallowing the tablet. Do not lie down until after your first meal of the day.

4. Do not take Alendronic Acid Aristo Weekly at bedtime or before getting up in the morning.

5. If you experience difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking Alendronic Acid Aristo Weekly and inform your doctor.

6. After swallowing a tablet of Alendronic Acid Aristo Weekly, wait at least 30 minutes before taking any food, drink, or other medication of the day, including antacids, calcium supplements, and vitamins. Alendronic Acid Aristo Weekly is only effective when taken on an empty stomach.

If you take more Alendronic Acid Aristo Weekly than you should

If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately. Do not induce vomiting and do not lie down.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20.

If you forget to take Alendronic Acid Aristo Weekly

If you miss a dose, wait until the following morning to take Alendronic Acid Aristo Weekly. Do not take two tablets on the same day. Then resume taking one tablet once a week on your originally chosen day.

If you stop taking Alendronic Acid Aristo Weekly

It is important that you continue taking Alendronic Acid Aristo Weekly for as long as your doctor has prescribed it. Since it is unknown how long Alendronic Acid Aristo Weekly should be taken, you should periodically discuss with your doctor whether continuing treatment with this medicine is still appropriate for you.

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

4. Possible adverse effects

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

Contact your doctor immediately if you experience any of the following adverse 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; ulcer in the throat (esophagus – the tube connecting your mouth to your stomach) which may cause chest pain, burning sensation, or difficulty or pain when swallowing.

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

• allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing; severe skin reactions,
• pain in the mouth and/or jaw, swelling or sores inside the mouth, numbness or a sensation of heaviness in the jaw, or loss of a tooth. These may be signs of jaw bone damage (osteonecrosis), usually associated with delayed healing and infection, often following a dental extraction. Inform your doctor and dentist if you experience these symptoms,
• atypical femoral fractures (thigh bone) which may occur rarely, especially 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 signs indicating a potential femoral fracture,
• severe bone, muscle and/or joint pain.

Other adverse effects are:

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

• pain, sometimes severe, in bones, muscles and/or joints.

Common (affects at least 1 in 100 patients):

• joint swelling,
• abdominal pain; uncomfortable feeling in the stomach or burping 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.

Uncommon (affects at least 1 in 1,000 patients):

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

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

• symptoms of low calcium levels in the blood, including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth,
• stomach ulcers or peptic ulcers (sometimes severe or with bleeding),
• narrowing of the throat (esophagus – the tube connecting your mouth to your stomach),
• skin rash that worsens with sunlight,
• mouth ulcers.

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

• consult your doctor if you have ear pain, discharge from the ear, or suffer from an ear infection. These could be symptoms of damage to the bones of the ear.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 Alendronic Acid Aristo Weekly

Keep this medicine out of the sight and reach of children.

Do not use Alendronic Acid Aristo Weekly after the expiry date stated on the packaging after EXP. The expiry date is 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 containers and unused medicines at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Alendronic Acid Aristo Weekly

The active substance 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 stearyl fumarate, hypromellose 2910 and talc.

Appearance of the medicinal product and contents of the pack

Alendronic Acid Aristo Weekly 70 mg is presented as white or almost white, film-coated, oblong tablets.

Each pack contains 4 tablets.

Marketing Authorization Holder

Aristo Pharma Iberia, S.L.
C/Solana, 26
28850 Torrejón de Ardoz, Madrid
Spain

Manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra
Portugal

Date of the most recent revision of this leaflet: May 2023

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