Product Information for the Patient

Alendronic Acid Weekly Viatris 70 mg Tablets EFG

Read this entire product information carefully before starting to take this medicine, as it contains important information for you.

• Keep this product information, as you may need to read it again.
  If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.
• It is particularly important that you understand the information in section 3 before taking this medicine.

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

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

3. How to take Alendronic Acid Weekly Viatris

4. Possible side effects

5. Storage of Alendronic Acid Weekly Viatris

6. Contents of the pack and additional information

What is Alendronate Weekly Viatris?

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

What is Alendronate Weekly Viatris used for?

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

Alendronate Weekly Viatris 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.

At first, osteoporosis usually has no symptoms. However, if left untreated, it can result in broken bones. Although these usually hurt, fractures of the bones of the spine can go unnoticed until they cause loss of height. Bones can break during normal daily activity, such as getting up or from minor injuries that would normally not 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 this medication, your doctor may suggest that you make lifestyle changes to help your condition, such as:

Quitting smoking

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

Exercise

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

Following a balanced diet

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

Do not takeAlendronate Sodium Weekly Viatris

• If you are allergic to alendronate or any of the other ingredients in this medication (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

Consult your doctor or pharmacist before starting to take Alendronate Sodium 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 esophagus (a disease associated with changes in the cells that cover 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,
• 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 being treated with 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 alendronate.

It is essential to maintain good oral hygiene while taking this medication. 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.

It may cause irritation, inflammation, or esophageal ulcers (the tube that connects your mouth to your stomach) 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 alendronate. These adverse effects may worsen if patients continue taking alendronate after developing these symptoms.

Children and adolescents

This medication should not be administered to children or adolescents under 18 years old.

Other medications and Alendronate Sodium Weekly Viatris

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

Certain medications for rheumatism or long-term pain called NSAIDs (such as aspirin or ibuprofen) may cause digestive problems. Therefore, caution should be exercised if taken at the same time as alendronate.

Taking Alendronate Sodium Weekly Viatris with food and drinks

It is likely that foods and drinks (including mineral water) will make alendronate less effective if taken at the same time..Therefore, it is essential to follow the advice given in section 3.

Pregnancy and breastfeeding

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

Driving and operating machinery

Adverse effects with this medication (including blurred vision, dizziness, and intense bone, muscle, or joint pain) may affect your ability to drive or operate machinery (see section 4).

Alendronate Sodium Weekly Viatris contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Alendronate Sodium Weekly Viatris contains sodium

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

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

Take one tablet of Alendronate Weekly Viatrisonce a week.

Follow these instructions carefully.

1. Choose the day of the week that best suits your routine. Take one tablet each week on the day you have chosen.

It is very important to follow instructions 2, 3, 4, and 5 to help the Alendronate Weekly Viatris 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 entire tablet of this medication with a full glass of water(not mineral water)(not less than 200 ml), so that alendronate 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 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 lie down until after the first meal of the day.

1. Do not take this medication at bedtimeor before getting up in the morning.

1. If you have difficulty or pain swallowing, chest pain, or new or worsening heartburn, stop takingthis medicationand inform your doctor.

1. After swallowing an alendronate weekly tablet, espare at least 30 minutes before consuming the first meal, drink, or other medication of the day,including antacids, calcium supplements, and vitamins.Alendronate Weeklyis only effective if taken with an empty stomach.

If you take more Alendronate Weekly Viatris than you should

If you accidentally take too many tablets, beat a full glass of milk and immediately consult your doctor. 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 Toxicological Information Service, phone (91) 562 04 20, indicating the medication and the amount ingested.

If you forget to take Alendronate Weekly Viatris

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

If you interrupt treatment with Alendronate Weekly Viatris

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

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

Like all medicines, this medicine may 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:

Common(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), 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,
• 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 signs and indicative of a possible femur fracture,
• intense bone, muscle, and/or joint pain.

Other side effects include

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

• bone, muscle, and/or joint pain, sometimes intense.

Common (may affect up to 1 in 10 people)

• swelling of the joints,
• abdominal pain, uncomfortable sensation in the stomach or belching after eating, constipation, feeling of a full or bloated stomach, diarrhea, 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 (esophagus, the tube that connects your mouth to your stomach) or stomach,
• black stoolsor similar to tar,
• blurred vision, eye pain or redness,
• skin rash, redness of the skin,
• 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 (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 in the fingers or around the mouth,
• stomach ulcers or peptic ulcers (sometimes severe or with bleeding),
• narrowing of the throat (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 draining or you have an ear infection. These may be signs of damage to the bones in your ear.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance 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 this medication after the expiration date that appears on the packaging and the blister pack after CAD or EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Do not dispose of medications through drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofAlendronic Acid WeeklyViatris

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

The other components are lactose monohydrate (see section 2, “Alendronic Acid Weekly Viatris contains lactose”), microcrystalline cellulose (E-460), Povidone (E-1201), sodium croscarmellose (E468) and magnesium stearate (E-470b).

Appearance of the product and contents of the packaging

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 white and opaque PVC.

PVC/Aluminum blisters. The green PVC.

HDPE bottle with a polypropylene screw cap.

Presented in blisters with 4 tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Responsible manufacturer

McDermott Laboratories Ltd. t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate. Grange Road

Dublín - 13

Ireland

or

Mylan Hungary Kft.

Mylan utca 1.

Komarom, 2900

Hungary

Last review date of this leaflet: January 2023

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (https://www.aemps.gob.es/)