RISEDRONATE WEEKLY VIATRIS 35 MG FILM-COATED TABLETS EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Risedronato Semanal Viatris 35 mg film-coated tablets EFG

Sodium risedronate

Read all of this 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet.

Leaflet contents

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

1. What Risedronate Viatris Weekly is and what it is used for

What Risedronate Viatris Weekly is

Risedronate Viatris Weekly belongs to a group of non-hormonal medicines called bisphosphonates, which are used to treat bone diseases. It acts directly on the bones, strengthening them, and thereby reduces the likelihood of fractures.

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

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

Osteoporosis can also affect men, due to various causes including aging and/or low levels of the male hormone testosterone.

The most common bone fractures occur in the vertebrae, hip, and wrist, although they can occur in any bone of the body. Fractures associated with osteoporosis may also cause back pain, loss of height, and a curved spine. Some patients with osteoporosis have no symptoms and may not even be aware they have the condition.

What Risedronate Viatris Weekly is used for

This medicine is used for the treatment of osteoporosis:

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

In men.

2. What you need to know before taking Risedronate Weekly Viatris

Do not take Risedronate Weekly Viatris:

• If you are allergic to sodium risedronate or to any of the other ingredients of this medicine (listed in section 6).
• If your doctor has told you that you have a condition called hypocalcemia (low calcium levels in the blood).
• If you think you might be pregnant, are pregnant, or plan to become pregnant.
• If you are breastfeeding.
• If you have severe kidney disease.
• If you are under 18 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking Risedronate Weekly Viatris:

• If you are unable to remain in an upright position (sitting or standing) for at least 30 minutes.
• If you have bone or mineral metabolism disorders (for example, vitamin D deficiency, parathyroid hormone disorders—both can cause low blood calcium levels).
• If you have previously had esophageal problems (the tube connecting the mouth to the stomach). For example, you may have experienced pain or difficulty swallowing food, or may have been diagnosed with Barrett's esophagus (a condition involving changes in the cells lining the lower esophagus).
• If your doctor has told you that you have an intolerance to certain sugars (such as lactose).
• If you have had or currently have jaw pain, swelling, or "numbness of the jaw," maxillofacial pain, or tooth loss.
• If you are undergoing dental treatment or are scheduled for 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 conditions mentioned above.

Children and adolescents

The use of sodium risedronate is not recommended in children and adolescents (under 18 years of age) due to insufficient safety and efficacy data.

Other medicines and Risedronate Weekly Viatris

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

The following active substances, when taken at the same time, reduce the effectiveness of Risedronate Weekly Viatris:

• Calcium.
• Magnesium.
• Aluminium (e.g. some medicines for indigestion).
• Iron.

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

Risedronate Weekly Viatris with food and drinks

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

Wait at least 30 minutes after taking Risedronate Weekly Viatris before consuming food or drinks (other than tap water).

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 sodium risedronate (the active substance in 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 using machines

It is unknown whether Risedronate Weekly Viatris affects the ability to drive or operate machinery.

Risedronate Weekly Viatris contains lactose

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine (see section 2, “Warnings and precautions”).

3. How to take Risedronate Viatris Weekly

Dosage

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

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

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

To help you remember to take the tablet on the same day each week, there are boxes on the carton. Mark the day of the week you have chosen to take the Risedronate Viatris Weekly tablet. Also, write down the dates on which you will take the tablet.

When to take your Risedronate Viatris Weekly tablet:

Take the risedronate tablet at least 30 minutes before your first meal, drink of the day (except if this drink is tap water), or any other medication of the day.

How to take your Risedronate Viatris Weekly tablet:

• Take the tablet while in an upright position (either sitting or standing) to help prevent stomach acid reflux.
• Swallow the tablet with at least one glass (120 ml) of plain water (tap water).
• Swallow the tablet whole (do not suck or chew the tablet).
• Do not lie down for at least 30 minutes after taking the tablet.

Your doctor will advise you whether you should take calcium and vitamin D supplements if you are not getting enough from your diet.

If you take more Risedronate Viatris Weekly than you should

If you or someone else has accidentally taken more Risedronate Viatris Weekly tablets than prescribed, drink a full glass of milk and contact your doctor.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Risedronate Viatris Weekly

If you forget to take the tablet on your chosen day, take it on the day you remember.

After that, resume taking one tablet once a week on your usual day.

Do not take a double dose to make up for a missed dose.

If you stop taking Risedronate Viatris Weekly

If you stop treatment, you may begin to lose bone mass. Please speak with your doctor before stopping treatment.

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

4. Possible adverse effects

Like all medicines, Risedronate Weekly Viatris can cause adverse effects, although not everyone experiences them.

Stop treatment with Risedronate Weekly Viatris and inform your doctor immediately if you experience any of the following:

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

Inform your doctor immediately if you experience any of the following adverse effects:

• Eye inflammation, usually with pain, redness, and sensitivity to light.
• Jaw bone necrosis (osteonecrosis) associated with delayed healing and infection, often following a tooth extraction (see section 2, "Warnings and precautions").
• Symptoms affecting the oesophagus such as pain and difficulty swallowing, chest pain, and heartburn or worsening of heartburn.

However, in clinical studies, the adverse effects observed were generally mild and did not cause patients to discontinue treatment.

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

Indigestion, nausea, stomach pain, stomach upset or discomfort, constipation, feeling of fullness, abdominal distension, diarrhoea.

Pain in bones, muscles, or joints.

Headache.

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

Inflammation or ulceration of the oesophagus (the tube connecting the mouth to the stomach), causing difficulty and pain when swallowing (see also section 2, "Warnings and precautions"), inflammation of the stomach and duodenum (the intestine into which the stomach empties).

Inflammation of the coloured part of the eye (iris) (painful red eyes possibly with changes in vision).

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

Inflammation of the tongue (swollen, red, possibly painful), narrowing of the oesophagus (the tube connecting the mouth to the stomach).

Abnormal liver function tests have been reported, which can only be diagnosed by a blood test.

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

Talk to your doctor if you have ear pain, ear discharge, and/or an ear infection. These could be signs of damage to the bones of the ear.

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

Allergic reactions such as hives (rash), skin rash, swelling of the face, lips, tongue, and/or neck, difficulty swallowing or breathing. Severe skin reactions, including blisters (vesicles) under the skin, inflammation of small blood vessels characterized by palpable red spots on the skin (leucocytoclastic vasculitis), a serious condition called Stevens-Johnson Syndrome (SJS), with blisters on the skin, mouth, eyes, and other moist body surfaces (genitals); a serious condition called Toxic Epidermal Necrolysis (TEN), causing a red rash in many parts of the body and/or loss of the outer layer of skin.

Hair loss. Allergic reactions (hypersensitivity). Serious liver disorders, especially if you are being treated with other medicines known to cause liver problems. Eye inflammation causing pain and redness.

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

Atypical fractures of the femur (thigh bone) which may rarely occur, particularly in patients on long-term treatment for osteoporosis. Inform your doctor if you notice pain, weakness, or discomfort in your thigh, hip, or groin, as these may be early signs indicating a possible femur fracture.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Risedronate Viatris Weekly

Keep out of the reach and sight of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the blister and outer packaging following EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Risedronate Weekly Viatris

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

Tablet core: pregelatinized corn starch, microcrystalline cellulose, crospovidone, magnesium stearate.

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

Appearance of the product and contents of the pack

Risedronate Weekly Viatris are film-coated, biconvex, round, white tablets with a diameter of 11.2 mm, 5.0 mm thick, and marked with "35" on one side.

This medicine is available in blisters containing 4 or 12 film-coated tablets, and in calendar blister packs containing 4 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder:

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer:

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

For further information about this medicine, contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicine is authorized in the European Economic Area member states under the following names:

Denmark: Vionate Mylan film-coated tablets 35 mg
Spain: Risedronato Semanal Viatris 35 mg film-coated tablets EFG
Italy: Risedronato Mylan 35 mg film-coated tablets
Portugal: Vicendrolin
United Kingdom: Risedronate Sodium 35 mg film-coated tablets

Date of the most recent review of this leaflet: February 2016

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