ALENDRONIC ACID WEEKLY VIATRIS 70 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Alendronic Acid Viatris 70 mg Tablets EFG

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 before you take this medicine.

Contents of the Package Leaflet

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

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

What is Alendronic Acid Viatris?

Alendronic Acid Viatris 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 prevents bone loss that occurs in women after menopause and helps rebuild bone. Alendronic acid reduces the risk of spine and hip fractures.

What is Alendronic Acid Viatris used for?

Your doctor has prescribed this medicine to treat your osteoporosis. It reduces the risk of spine and hip fractures.

Alendronic Acid Viatris 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 maintain a woman's healthy skeleton. As a result, bone loss occurs and bones become weaker. The earlier a woman reaches menopause, the greater the risk of osteoporosis.

At first, 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 significant problems such as stooped posture (dowager's hump) and loss of mobility.

How can osteoporosis be treated?

In addition to your treatment with this medicine, your doctor may suggest that you make lifestyle changes to help your condition, such as:

Quitting 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 you take Alendronic Acid Viatris

Do not take Alendronic Acid Viatris

• 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 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

Talk to your doctor or pharmacist before starting Alendronic Acid Viatris if:

• you have kidney problems,
• you have, or have recently had, digestive problems or swallowing problems,
• your doctor has told you that you have Barrett's esophagus (a condition 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 radiation therapy,
• 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.

It is important to maintain good oral hygiene when taking this medicine. 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 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 before 30 minutes after taking alendronic acid. These side effects can worsen if patients continue taking alendronic acid after developing these symptoms.

Children and adolescents

This medicine must not be given to children and adolescents under 18 years.

Other medicines and Alendronic Acid Viatris

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 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.

Taking Alendronic Acid Viatris with food and drinks

Food and drinks (including mineral water) can make alendronic acid less effective if taken at the same time. Therefore, it is important that you follow the advice given in section 3.

Pregnancy and breastfeeding

This medicine is only intended for use in postmenopausal women. Do not take alendronic acid if you are pregnant or think you may be pregnant, or if you are breastfeeding.

Driving and using machines

Side effects with this medicine (including blurred vision, dizziness, and severe bone, muscle, or joint pain) have been reported that may affect your ability to drive or use machines (see section 4).

Alendronic Acid Viatris contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Alendronic Acid Viatris contains sodium

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

3. How to take Alendronic Acid Viatris

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

Take one Alendronic Acid Viatris tablet once a week.

Follow these instructions carefully.

1. Choose the day of the week that best fits your routine. Each week, take one 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 Viatris tablet reach your stomach quickly and help reduce the possibility of irritating your 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 tablet whole with a full glass of water (not less than 200 ml), so that alendronic acid is absorbed properly.

• Do not take it with mineral water (with or without gas).
• 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 lie down until after your first meal of the day.

1. Do not take this medicine 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 this medicine and inform your doctor.

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

If you take more Alendronic Acid Viatris 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone (91) 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Alendronic Acid Viatris

If you miss a dose, wait until the next morning to take this medicine. Do not take two tablets on the same day. Then, take one tablet once a week on the original day you chose.

If you stop taking Alendronic Acid Viatris

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

If you have any other questions about the use of this medicine, 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 side effects, which can be serious and may require urgent medical treatment:

Common (may affect up to 1 in 10 people)

• heartburn, difficulty swallowing, pain when swallowing, ulcers in the esophagus (the tube that connects your mouth to your stomach), which can cause chest pain.

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 signs of a possible fracture of the femur,
• severe bone, muscle, and/or joint pain.

Frequency not known (cannot be estimated from the available data)

• atypical fracture in places other than the thigh bone (femur).

Other side effects include

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

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

Common (may affect up to 1 in 10 people)

• 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 (may affect up to 1 in 100 people)

• nausea, vomiting,
• irritation or inflammation of the 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,
• transient symptoms similar to flu-like symptoms such as muscle pain, general feeling of being unwell, and sometimes fever, which usually appear at the beginning of treatment,
• altered taste.

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

• 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 esophagus (the tube that connects your mouth to your stomach),
• skin rash that worsens with sunlight,

• mouth ulcers.

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

• consult your doctor if you have ear pain, your ear is discharging, or you have 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website (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 Viatris

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month shown.

No special storage conditions are required.

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 Viatris

The active substance is alendronic acid. Each tablet contains 70 mg of alendronic acid.

The other ingredients are lactose monohydrate (see section 2, "Alendronic Acid Viatris contains lactose"), microcrystalline cellulose (E-460), povidone (E-1201), sodium croscarmellose (E468), and magnesium stearate (E-470b).

Appearance of the product and pack contents

The tablets are white, biconvex, marked with "AD70" on one side and "G" on the other.

PVC/Aluminum blisters. The PVC is transparent.

PVC/Aluminum blisters. The PVC is white and opaque.

PVC/Aluminum blisters. The PVC is green.

HDPE bottle with a screw cap made of polypropylene.

It is available in blisters of 4 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer

Mylan Hungary Kft.

Mylan utca 1.

Komarom, 2900

Hungary

Date of last revision of this leaflet: September 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (https://www.aemps.gob.es/)