Alendronate acid weekly Viatris 70 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Alendronic Acid Viatris 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, 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, and you should not give it to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• It is particularly important that you understand the information in section 3 before taking this medicine.

Leaflet contents

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

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

What is Alendronic Acid Viatris Weekly?

Alendronic Acid Viatris 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 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 Weekly used for?

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

Alendronic Acid Viatris Weekly is a weekly treatment.

What is osteoporosis?

Osteoporosis is the 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 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 developing osteoporosis.

At first, osteoporosis usually has no symptoms. However, if left untreated, it can lead to broken bones. Although these typically cause pain, fractures of the spinal bones may go unnoticed until they cause loss of height. Bones may break during normal daily activities, such as rising from a chair, or due to 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 (commonly known as "dowager's hump") and loss of mobility.

How can osteoporosis be treated?

As part of your treatment with this medicine, your doctor may also 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 programme.

*Follow 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 Alendronate Weekly Viatris

Do not take Alendronate Weekly Viatris

• If you are allergic to alendronate or 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 (standing or sitting) 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

Talk to your doctor or pharmacist before starting Alendronate Weekly Viatris if:

• you have kidney problems,
• you have or have recently had digestive problems or difficulty 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 from your stomach or intestines),
• you have been told you have low 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 receiving 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 alendronate.

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

Irritation, inflammation, or ulceration of the 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 or lie down within 30 minutes after taking alendronate. These adverse effects may worsen if patients continue taking alendronate after developing such symptoms.

Children and adolescents

This medicine should not be given to children or adolescents under 18 years of age.

Other medicines and Alendronate Weekly Viatris

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 medicines may interfere with the absorption of alendronate 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 relief, known as NSAIDs (e.g. acetylsalicylic acid or ibuprofen), may cause gastrointestinal problems. Therefore, caution should be taken if these medicines are used together with alendronate.

Taking Alendronate Weekly Viatris with food and drink

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

Pregnancy and breastfeeding

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

Driving and using machines

Adverse effects have been reported with this medicine (including blurred vision, dizziness, and severe bone, muscle, or joint pain) which may affect your ability to drive or operate machinery (see section 4).

Alendronate Weekly Viatris contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult with them before taking this medicine.

Alendronate Weekly Viatris contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; that is, essentially “sodium-free”.

3. How to take Alendronate Acid Weekly Viatris

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

Take one tablet of Alendronate Acid Weekly Viatris 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 steps 2, 3, 4, and 5 to help ensure the alendronate tablet reaches the stomach quickly and to help reduce the potential for irritation of the esophagus (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 whole with a full glass of water (not mineral water) (no less than 200 ml), so that alendronate acid is properly absorbed.

• Do not take it with mineral water (carbonated or still).
• 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 this medicine 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 this medicine and inform your doctor.

6. After swallowing an alendronate weekly tablet, wait at least 30 minutes before consuming any food, drink, or other medication of the day, including antacids, calcium supplements, and vitamins. Alendronate weekly is only effective when taken on an empty stomach.

If you take more Alendronate Acid Weekly 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone (91) 562 04 20, stating the medicine and the amount ingested.

If you forget to take Alendronate Acid Weekly Viatris

If you miss a dose, wait until the following morning to take this medicine. 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 Alendronate Acid Weekly Viatris

It is important that you take this medicine for as long as your doctor has prescribed it. Since it is unknown how long alendronate 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 medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

Contact your doctor immediately if you notice any of the following adverse effects, which may be serious and for which you may require urgent medical treatment:

Common (may affect up to 1 in 10 people)

• heartburn, difficulty swallowing, pain when swallowing, ulcer in the throat (oesophagus – the tube connecting your mouth to your stomach), which may 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 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 bone damage in the jaw (osteonecrosis), usually associated with delayed healing and infection, often following a dental extraction. Inform your doctor and dentist if you experience these symptoms,
• atypical fractures of the femur (thigh bone), which may occur rarely, particularly 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 possible femur fracture,
• severe bone, muscle and/or joint pain.

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

• atypical fractures in sites other than the femur (thigh bone).

Other adverse 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, stomach discomfort or burping after eating, constipation, feeling of fullness or bloating in the stomach, diarrhoea, flatulence,
• hair loss, itching,
• headache, dizziness,
• fatigue, swelling of the hands or legs.

Uncommon (may affect up to 1 in 100 people)

• nausea, vomiting,
• irritation or inflammation of the throat (oesophagus – the tube connecting your mouth to your stomach) or of the 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 (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 throat (oesophagus – the tube connecting your mouth to your stomach),
• skin rash that worsens with sunlight exposure,
• mouth ulcers.

Very rare (may affect 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 bone damage in the ear.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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 Viatris 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 and blister after CAD or EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Package contents and other information

Composition of Alendronic Acid Weekly Viatris

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

The other components are monohydrate lactose (see section 2, “Alendronic Acid Weekly Viatris contains lactose”), microcrystalline cellulose (E-460), povidone (E-1201), sodium croscarmellose (E-468) and magnesium stearate (E-470b).

Appearance of the product and contents of the container

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 polypropylene screw cap.

Presented in blisters containing 4 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer

Mylan Hungary Kft.

Mylan utca 1.

Komarom, 2900

Hungary

Date of the most recent revision of this leaflet: September 2025

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