ALENDRONIC ACID WEEKLY ARISTO 70 mg TABLETS

Introduction

Package Leaflet: Information for the User

Alendronic Acid Aristo 70 mg Tablets

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• It is especially important that you understand the information in section 3, “How to take Alendronic Acid Aristo”, before you take this medicine.

Contents of the Package Leaflet

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

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

What is Alendronic Acid Aristo?

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

What is Alendronic Acid Aristo used for?

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

Alendronic Acid Aristo is a weekly treatment.

What is osteoporosis?

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

For a long time, osteoporosis usually has no symptoms. However, if left untreated, it can result in broken bones. Although these usually hurt, spine fractures can go unnoticed until they cause loss of height. Bones can break during normal daily activity, such as when getting up or from minor injuries that would not normally break a bone. Bone fractures usually occur in the hip, spine, or wrist and can cause not only pain but also considerable problems such as stooped posture (dowager's hump) and loss of mobility.

How can osteoporosis be treated?

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

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

ExerciseLike 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).

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

Do not take Alendronic Acid Aristo

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

• if you have certain problems with your gullet (esophagus - the tube that connects your mouth to your stomach), such as narrowing or difficulty swallowing
• if you cannot stand or sit up 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. Talk to your doctor first and follow their advice.

Warnings and precautions

It is important that you tell your doctor before taking Alendronic Acid Aristo 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 esophagus (a disease associated with changes in the cells that line the lower part of the esophagus)
• you have been told that you have problems absorbing minerals 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 dental extraction, or do not receive regular dental care
• you have cancer
• you are undergoing chemotherapy or radiotherapy
• you are undergoing treatment with angiogenesis inhibitors (such as bevacizumab or thalidomide) used in the treatment of cancer
• 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 Aristo.

It is important to maintain good oral hygiene when taking Alendronic Acid Aristo. You should have regular dental check-ups during your treatment and should 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 ulcers of the gullet (esophagus - the tube that connects your mouth to your stomach) can occur, often with symptoms of chest pain, heartburn, difficulty or pain when swallowing, especially if patients do not drink a full glass of water and/or if they lie down less than 30 minutes after taking Alendronic Acid Aristo. These adverse effects can worsen if patients continue taking Alendronic Acid Aristo after developing these symptoms.

Children and adolescents

Alendronic Acid Aristo should not be given to children and adolescents under 18 years of age.

Other medicines and Alendronic Acid Aristo

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

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

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

Taking Alendronic Acid Aristo with food and drinks

Food and drinks (including mineral water) are likely to make Alendronic Acid Aristo less effective if taken at the same time. Therefore, it is important that you follow the advice given in section 3.

Pregnancy and breastfeeding

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

Driving and using machines

Alendronic Acid Aristo has been reported to cause adverse effects (such as blurred vision, dizziness, and severe bone, muscle, or joint pain) that may affect your ability to drive or use machines (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

Follow the instructions for administration of this medicine exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist again.

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

Follow these instructions carefully.

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

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

1. After getting up in the morning and before taking your first food, drink, or other medicine, swallow the Alendronic Acid Aristo tablet with a full glass of water (not mineral water) (at least 200 ml), so that Alendronic Acid Aristo 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 or allow it to dissolve in your mouth, due to the possibility of ulcers in the mouth.

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

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

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

1. After swallowing an Alendronic Acid Aristo tablet, wait at least 30 minutes before taking your first food, drink, or other medicine of the day, including antacids, calcium supplements, and vitamins. Alendronic Acid Aristo is only effective if taken on an empty stomach.

If you take more Alendronic Acid Aristo 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

If you miss a dose, wait until the next morning to take Alendronic Acid Aristo. Do not take two tablets on the same day.Afterward, take one tablet once a week, on the originally chosen day.

If you stop taking Alendronic Acid Aristo

It is important that you continue taking Alendronic Acid Aristo for as long as your doctor prescribes the medicine. Since it is not known how long you should take Alendronic Acid Aristo, you should discuss with your doctor periodically the need to continue treatment with this medicine to determine if Alendronic Acid Aristo is still suitable for you.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

See your doctor immediatelyif you notice any of the following serious side effects, which may require urgent medical treatment:

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

• heartburn; difficulty swallowing; pain when swallowing; ulcers in the gullet (esophagus - the tube that connects your mouth to your stomach) that can cause chest pain, heartburn, 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 can cause difficulty breathing or swallowing; severe skin reactions
• pain in the mouth and/or jaw, swelling or ulcers inside the mouth, numbness or a feeling of heaviness in the jaw, or tooth loss. These can be signs of damage to the jawbone (osteonecrosis) usually associated with delayed healing and infection, often after a tooth extraction. Inform your doctor and dentist if you experience these symptoms
• atypical fractures of the thigh bone (femur) that can 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 symptoms of a possible fracture of the femur
• severe pain in bones, muscles, and/or joints

Other side effects are:

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

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

Frequent (at least 1 in 100 patients):

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

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

• nausea; vomiting
• irritation or inflammation of the gullet (esophagus - the tube that connects your mouth to your stomach) or stomach
• black or tarry stools
• blurred vision; eye pain or redness
• skin rash; redness of the skin
• symptoms similar to flu, such as muscle pain, general feeling of being unwell, and sometimes fever, which usually occur at the start of treatment
• alteration of taste

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

• symptoms of low blood calcium levels, including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth
• stomach or duodenal ulcers (sometimes severe or with bleeding)
• narrowing of the gullet (esophagus - the tube that connects 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 an ear infection. These could be symptoms of damage to the bones of the ear

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) at https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Alendronic Acid Aristo

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

Do not use Alendronic Acid Aristo after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Alendronic Acid Aristo

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

The other ingredients (excipients) are: microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, sodium stearyl fumarate, hypromellose 2910, and talc.

Appearance of the product and pack contents

Alendronic Acid Aristo 70 mg is presented as white or almost white, oblong, film-coated 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 last revision of this leaflet: May 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es