Product Information for the User

Risedronate Weekly Viatris 35 mg TabletsCoated with FilmEFG

Risedronate sodium

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 should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this product information.

What isRisedronate Weekly Viatris

Risedronate Weekly Viatris belongs to a group of non-hormonal medications called bisphosphonates, which are used for the treatment of bone diseases. It acts directly on the bones strengthening them, and therefore, reduces the probability of fractures.

The bone is a living tissue. Old bone in the skeleton is constantly being renewed and replaced by new bone.

Postmenopausal osteoporosis appears in women after menopause when the bone begins to weaken, becomes more fragile, and fractures are more likely to occur after a fall or a twist.

Osteoporosis can also be suffered by men due to numerous causes, including aging and/or low levels of the male hormone, testosterone.

The most likely bone fractures are those of the vertebrae, hip, and wrist, although they can occur in any bone in the body. Fractures associated with osteoporosis can also produce back pain, loss of height, and a curved back. Some patients with osteoporosis do not have symptoms and may not even know they have it.

What is Risedronate Weekly Viatris used for

This medication is used for the treatment of osteoporosis:

• In women after menopause, even if osteoporosis is severe. Reduces the risk of vertebral and hip fractures.

In men.

Do not takeRisedronate Weekly Viatris:

• If you are allergicto risedronate sodiumor to any of the other ingredients of this medication (listed in section 6).
• If your doctor has told you that you have a condition calledhypocalcemia(low levels of calcium in the blood).
• If you think you might bepregnant, are pregnantor plan to become pregnant.
• If you are breastfeeding.
• If you havesevere kidney disease.
• If you are under 18 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Risedronate Weekly Viatris:

• If you cannot stay upright (sitting or standing) for at least 30 minutes.
• If you have bone or mineral metabolism problems (for example, vitamin D deficiency, parathyroid hormone alterations, both produce low levels of calcium in the blood).

• If in the past you have had esophageal problems (the tube that connects the mouth to the stomach). For example, you may have had pain or difficulty swallowing food or previously mentioned that you have Barrett's esophagus (a condition associated with changes in the cells that cover the lower esophagus).
• If your doctor has indicated that you have intolerance to certain sugars (such as lactose).
• If you have had or have jaw pain, inflammation or "numbness", maxillary pain or tooth loss.
• If you are undergoing dental treatment or are going to undergo dental surgery, inform your dentist that you are being treated with Risedronate Weekly Viatris.

Your doctor will advise you on what to do if you are taking Risedronate Weekly Viatris and have any of the problems mentioned above.

Children and adolescents

Risedronate sodium is not recommended for use in children or adolescents (under 18 years old) due to insufficient safety and efficacy data.

Other medications andRisedronate Weekly Viatris

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

Medications that contain any of the following substances reduce the effect of Risedronate Weekly Viatris when taken at the same time:

• Calcium.
• Magnesium.
• Aluminum (for example, some medications for indigestion).
• Iron.

Take these medications, at least, 30 minutes after taking Risedronate Weekly Viatris.

Risedronate Weekly Viatriswith food and drinks

It is very important that you DO NOT take Risedronate Weekly Viatris with food or drinks (other than tap water). In particular, do not take this medication at the same time as dairy products (such as milk) as they contain calcium (see section 2, “Other medications andRisedronate Weekly Viatris”).

Take food and drinks (except tap water), at least, 30 minutes after taking Risedronate Weekly Viatris.

Pregnancy and breastfeeding

DO NOT take Risedronate Weekly Viatris if you might be pregnant, are pregnant or plan to become pregnant (see section 2, “Do not take Risedronate Weekly Viatris”). The potential risk associated with the use of risedronate sodium (active substance of Risedronate Weekly Viatris) in pregnant women is unknown.

DO NOT take Risedronate Weekly Viatris if you are breastfeeding (see section 2, “Do not take Risedronate Weekly Viatris”).

Driving and operating machinery

The effect of Risedronate Weekly Viatris on the ability to drive or operate machinery is unknown.

Risedronate Weekly Viatris contains Lactose

This medicationcontains lactose. If your doctor has indicated that you have intolerance to certain sugars, consult with him before taking this medication (see section 2, “Warnings and precautions”).

Dosage

Follow exactly the administration instructions for Risedronate Weekly Viatris as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The recommended dose isone Risedronate Weekly Viatris tablet (35 mg of risedronate sodium) once a week.

Choose the day of the week that best suits your schedule. Each week, take the Risedronate Weekly Viatris tablet on the chosen day.

To facilitate taking the tablet on the same day every week, there are boxes on the packaging. Mark the day of the week you have chosen to take the Risedronate Weekly Viatris tablet. Also, write the dates on which the tablet will be taken.

When to take your Risedronate Weekly Viatris tablet

Take the risedronate tablet at least 30 minutes before the first meal, drink of the day (except in the case of tap water) or other medication of the day.

How to take your Risedronate Weekly Viatris tablet

• Take the tablet while inan upright position(either sitting or standing) to avoid stomach acid.
• Swallow the tabletwith, at least, oneglass(120 ml) oftap water.
• Swallow the tablet whole(do not chew or crush the tablet).
• Do not lie down, at least, for 30 minutes afterhaving taken the tablet.

Your doctor will tell you if you should take calcium and vitamin D supplements, if you are not getting enough in your diet.

If you take moreRisedronate Weekly Viatristhan you should

If you or another person have accidentally taken more Risedronate Weekly Viatris tablets than prescribed, drink afull glass of milkandconsult your doctor.

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 taken.

If you forget to takeRisedronate Weekly Viatris

If you have forgotten to take the tablet on the chosen day, take it on the day you remember.

Then, go back to taking one tablet once a week, on the day you normally take the tablet.

DO NOT take a double dose to make up for the missed doses.

If you interrupt treatment withRisedronate Weekly Viatris

If you stop taking the treatment, you may start losing bone mass. Please talk to your doctor before interrupting treatment.

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

Like all medicines, Risedronate Weekly Viatris may cause side effects, although not everyone will experience them.

Stop taking Risedronate Weekly Viatris and tell your doctor right awayif you experience any of the following:

• Severe allergic reaction symptoms such as:
• • Swelling of the face, tongue, or throat.
  • Difficulty swallowing.
  • Hives and difficulty breathing.
• Severe skin reactions that may include blisters on the skin.

Tell your doctor right awayif you experience any of the following side effects:

• Eye inflammation, usually with pain, redness, and sensitivity to light.
• jawbone necrosis (osteonecrosis) associated with delayed healing and infection, often after a dental extraction (see section 2, "Warnings and precautions").
• Esophageal symptoms such as, pain and difficulty swallowing, chest pain, and heartburn or worsening heartburn.

However, in clinical studies, the side effects observed were generally mild and did not cause the patient to interrupt treatment.

Common side effects(may affect up to 1 in 10 people):

Indigestion, nausea, stomach pain, stomach upset or discomfort, constipation, feeling full, abdominal distension, diarrhea.

Bone, muscle, or joint pain.

Headache.

Uncommon side effects(may affect up to 1 in 100 people):

Esophagitis or stomach ulcer (the tube that connects the mouth to the stomach) causing difficulty and pain swallowing (see also section 2 "Warnings and precautions"), stomach and duodenal inflammation (intestine where the stomach empties).

Eye inflammation (iris) (red, painful eyes with possible vision changes).

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

Tongue inflammation (swollen, red, possibly painful), esophageal narrowing (the tube that connects the mouth to the stomach).

Abnormal liver test results, which can only be diagnosed through blood tests.

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

Speak to your doctor if you have ear pain, ear discharge, and/or ear infection. These may be signs of ear bone damage.

During post-marketing experience, the following side effects have been reported (frequency not known):

Allergic reactions such as urticaria (hives), skin rash, facial swelling, lip, tongue, and/or neck swelling, difficulty swallowing or breathing. Severe skin reactions, including blisters under the skin,inflammation of small blood vessels, characterized by palpable red spots on the skin (leukocytoclastic vasculitis), a serious disease called Stevens-Johnson Syndrome (SSJ), with blisters on the skin, mouth, eyes, and other moist body surfaces (genitals); a serious disease called Toxic Epidermal Necrolysis (TEN), which causes a red rash on many parts of the body and/or loss of the outer layer of the skin.

Hair loss. Allergic reactions (hypersensitivity). Severe liver damage, especially if being treated with other medications known to cause liver problems. Eye inflammation that causes pain and redness.

Rarely, a mild decrease in blood phosphate and calcium levels has been observed in some patients at the beginning of treatment. These changes are usually small and do not cause symptoms.

Atypical femur fractures that may occur in rare cases, 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 they may be early signs of a possible femur fracture.

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance 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 out of reach and sight of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the blister and packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofRisedronate Weekly Viatris

• The active ingredient is risedronate sodium. Each tablet contains 35 mg of risedronate sodium (equivalent to 32.5 mg of risedronic acid).
• The other components (excipients) are:

Tablet core: pregelatinized cornstarch, microcrystalline cellulose, crospovidone, magnesium stearate.

Tablet coating:hypromellose, lactose monohydrate, titanium dioxide (E171), macrogol 4000.

Appearance of the product and contents of the package

Risedronate Weekly Viatris are film-coated, biconvex, round, white tablets, with a diameter of11.2 mm,5.0 mmin thickness and with “35”engraved on one side.

This medication is presented in blisters containing 4, 12 film-coated tablets and in a calendar blister of 4 film-coated tablets.

Only some package sizes may be commercially available.

Marketing Authorization Holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing:

McDermott Laboratories Ltd. t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate,

Grange Road, Dublin 13

Ireland

Or

Pharmathen International S.A.

Sapes Industrial Park

Block 5, 69300 Rodopi,

Greece

Or

Pharmathen, S.A.

6, Dervenakion str.

153 51 Pallini, Attiki,

Greece

Or

Mylan Hungary Kft.

Mylan Utca 1

Komárom, 2900

Hungary

Further information about this medication can be obtained by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

DenmarkVionateMylan film-coated tablets 35 mg

SpainRisedronate Weekly Viatris 35 mg film-coated tablets EFG

ItalyRisedronate Mylan 35mg film-coated tablets

PortugalVicendrolin

United KingdomRisedronate Sodium 35mg film-coated tablets

Last review date of this leaflet:February 2016

Further detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/