Rybelsus 14 mg comprimidos

Prescribing Information for the Patient

Rybelsus 3mg tablets

Rybelsus 7mg tablets

Rybelsus 14mg tablets

Rybelsus 25mg tablets

Rybelsus 50mg tablets

semaglutide

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

–Keep this prescribing information, as you may need to refer to it again.

–If you have any questions, consult your doctor, pharmacist, or nurse.

–This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.

–If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prescribing information. See section 4.

1.What is Rybelsus and how is it used

2.What you need to know before starting to take Rybelsus

3.How to take Rybelsus

4.Possible adverse effects

5.Storage of Rybelsus

6.Contents of the package and additional information

Rybelsus contains the active ingredient semaglutide. It is a medication used to reduce blood sugar levels.

Rybelsus is used to treat type 2 diabetes that is not adequately controlled with diet and exercise in adults (18 years of age or older):

•as a single medication: when metformin (another diabetes medication) cannot be used or

•with other diabetes medications: when these are insufficient to control blood sugar levels. These may be oral medications or injected insulin.

It is essential to continue with the diet and exercise plan recommended by your doctor, pharmacist, or nurse.

What is type 2 diabetes?

Type 2 diabetes is a condition in which your body does not produce enough insulin, and the insulin your body produces does not lower blood sugar levels as it should. In some cases, your body may produce too much blood sugar. If your blood sugar level increases and remains high for a long period, it may lead to damaging effects such as heart problems, kidney disease, eye disorders, and poor circulation in the extremities. Therefore, it is essential to maintain your blood sugar levels within a normal range.

Do not take Rybelsus

•if you are allergic to semaglutide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take Rybelsus.

Traceability

In order to improve the traceability of biological medicines, record the name and batch number (indicated on the packaging and blister) of the medicine you are taking and provide this information when reporting any adverse effects.

General information

This medicine is not the same as insulin and should not be used if:

•you have type 1 diabetes (your body does not produce any insulin)

•you develop diabetic ketoacidosis. This is a complication of diabetes that is characterized by high blood sugar levels, difficulty breathing, confusion, excessive thirst, sweet-smelling breath or a metallic taste in the mouth.

If you know you are going to undergo surgery under anesthesia

(a state of sleep), inform your doctor that you are taking Rybelsus.

Gastrointestinal and intestinal problems and dehydration

During treatment with this medicine, you may experience nausea, vomiting or diarrhea. These adverse effects can cause dehydration (loss of fluids). It is essential that you drink enough fluids to prevent dehydration. This is especially important if you have kidney problems. If you have any doubts, consult your doctor.

Severe and persistent stomach pain that could be a sign of pancreatitis

If you have a severe and persistent pain in the stomach area, go to your doctor immediately, as it could be a sign of acute pancreatitis.

Low blood sugar (hypoglycemia)

The use of a sulfonylurea or the administration of insulin with Rybelsus may increase the risk of experiencing low blood sugar (hypoglycemia). Consult section 4 to know the warning signs of low blood sugar.

Your doctor may ask you to measure your blood sugar levels. This will help decide if you need to change the dose of sulfonylurea or insulin to reduce the risk of low blood sugar.

Diabetic eye disease (retinopathy)

A sudden improvement in blood sugar control can temporarily worsen diabetic eye disease. If you have diabetic eye disease and experience eye problems during treatment with this medicine, consult your doctor.

Response to treatment

If the response to treatment with semaglutide is less than expected, it may be due to low absorption or variability in absorption and low absolute bioavailability. You should follow the instructions in section 3 to achieve optimal semaglutide effect.

Children and adolescents

This medicine is not recommended for children and adolescents under 18 years of age, as safety and efficacy have not been established in this age group.

Other medicines and Rybelsus

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

Particularly, inform your doctor, pharmacist or nurse if you are using medicines that contain any of the following components:

•levotiroxine used to treat thyroid-related diseases. This is because your doctor may need to check your thyroid hormone levels if you are taking Rybelsus with levotiroxine.

•warfarin or other oral anticoagulants. You may need to have frequent blood tests to determine your blood clotting ability.

•If you are using insulin, your doctor will inform you how to reduce the dose of insulin and recommend more frequent monitoring of your blood sugar levels to avoid hyperglycemia (high blood sugar) and diabetic ketoacidosis (a complication of diabetes that occurs when the body cannot break down glucose because there is not enough insulin).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medicine.

This medicine should not be used during pregnancy because it is unknown whether it affects the unborn baby. Therefore, you should use contraceptive methods while taking this medicine. If you want to become pregnant, consult your doctor on how to change your treatment as you should stop using this medicine at least two months in advance. If you become pregnant while using this medicine, consult your doctor immediately, as you will need to change your treatment.

Do not use this medicine during breastfeeding. This medicine passes into breast milk, and it is unknown how it may affect your baby.

Driving and operating machines

It is unlikely that Rybelsus will affect your ability to drive and operate machines.

Some patients may feel dizzy when taking Rybelsus. If you feel dizzy, be extra careful when driving or operating machines. Consult your doctor for more information.

If you use this medicine with a sulfonylurea or insulin, you may experience low blood sugar (hypoglycemia), which may reduce your ability to concentrate. Do not drive or operate machines if you experience any symptoms of low blood sugar. Consult section 2, “Warnings and precautions”, for information on the increased risk of experiencing low blood sugar and section 4 to know the warning signs of low blood sugar. Consult your doctor for more information.

Rybelsus contains sodium

This medicine contains 23 mg of sodium (main component of table salt/for cooking) in each tablet. This is equivalent to 1% of the maximum daily sodium intake recommended for an adult.

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

How much to take

•The initial dose is one 3mg tablet once a day for a month.

•After a month, your doctor will increase the dose to one 7mg tablet once a day.

•Your doctor will instruct you to maintain the dose for at least a month before increasing to a higher dose.

•Your doctor may increase the dose in a stepwise manner to one 14mg, 25mg, or 50mg tablet once a day if needed.

•Your doctor will prescribe the appropriate dose for you. Do not modify your dose unless your doctor has instructed you to do so.

•Rybelsus must always be taken as one tablet a day. Do not take two tablets to obtain a higher dose.

Administration of this medication

•Take the Rybelsus tablet with an empty stomach after a recommended fasting period of at least 8hours.

•Swallow the Rybelsus tablet whole with a sip of water (up to 120ml). Do not break, crush, or chew the tablet, as it is not known whether it affects the absorption of semaglutide.

•After taking the Rybelsus tablet, wait at least 30minutes before eating, drinking, or taking other oral medications.Waiting less than 30minutes reduces the absorption of semaglutide.

If you take more Rybelsus than you should

If you take more Rybelsus than you should, consult your doctor immediately. You may experience adverse effects such as nausea.

If you forget to take Rybelsus

If you forget to take a dose, omit the missed dose and take the normal dose the next day.

If you interrupt treatment with Rybelsus

Do not discontinue treatment with this medication without consulting your doctor. If you discontinue, your blood sugar levels may increase.

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

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

Severe side effects

Common(may affect up to 1 in 10people)

•diabetic retinopathy complications. Consult your doctor if you experience eye problems, such as changes in vision during treatment with this medicine.

Rare(may affect up to 1 in 1000people)

•severe allergic reactions (anaphylactic reactions). You must seek immediate medical help and inform your doctor immediately if you experience symptoms such as respiratory problems, facial and throat swelling, wheezing, palpitations, pale and cold skin, dizziness or weakness.

•acute pancreatitis that can cause intense stomach and back pain that does not subside. You must consult a doctor immediately if you experience these symptoms.

Unknown frequency(the frequency cannot be estimated from the available data)

•intestinal obstruction. A severe form of constipation with other symptoms such as stomach pain, abdominal swelling, vomiting, etc.

Other side effects

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

•low blood sugar (hypoglycemia), when this medicine is used with other medicines containing a sulfonylurea or insulin. Your doctor may reduce the dose of these medicines before starting to take this medicine.

•nausea; this effect usually disappears over time.

•diarrhea; this effect usually disappears over time.

The warning signs of low blood sugar can appear suddenly. Some of these symptoms are: cold sweat, pale and cold skin, headache, palpitations, nausea or excessive appetite, changes in vision, drowsiness or feeling weak, nervousness, anxiety or confusion, difficulty concentrating or tremors.

Your doctor will instruct you on how to treat low blood sugar and what to do if you experience these warning signs.

Common(may affect up to 1 in 10people)

•low blood sugar (hypoglycemia) when this medicine is used with oral diabetes medicines other than sulfonylurea or insulin

•loss of appetite

•dizziness

•vomiting – this effect usually disappears over time and may occur more frequently as the dose is increased to 25mg and 50mg

•stomach pain

•abdominal swelling

•constipation

•stomach discomfort or indigestion

•inflamed stomach (gastritis); symptoms include stomach pain, nausea or vomiting

•reflux or heartburn; also known as "gastroesophageal reflux disease"

•gas (flatulence)

•fatigue

•increase in pancreatic enzymes (such as lipase and amylase) in blood tests

•change in skin sensitivity – this effect usually disappears over time and may occur with doses of 25mg and 50mg.

Uncommon(may affect up to 1 in 100people)

•allergic reactions such as hives, itching or rashes

•change in the taste of food and drink.

•rapid pulse

•belching

•delayed stomach emptying

•gallstones

•weight loss

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V.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 blister pack and on the outer packaging after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light and moisture.

This medication does not require any special storage temperature.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Rybelsus

•The active ingredient is semaglutide. Each tablet contains 3, 7, 14, 25 or 50 mg of semaglutide.

•The other components in the 3 mg, 7 mg and 14 mg tablets are sodium lauryl sulfate, povidone K90, microcrystalline cellulose and magnesium stearate. See also section 2, “Rybelsus contains sodium”.

•The other components in the 25 mg and 50 mg tablets are sodium lauryl sulfate and magnesium stearate. See also section 2 “Rybelsus contains sodium”.

Appearance of Rybelsus and packaging contents

The Rybelsus 3 mg tablets are white to light yellow in color and oval in shape (7.5 mm x 13.5 mm). They have a "3" on one side and the word "novo" on the other.

The Rybelsus 7 mg tablets are white to light yellow in color and oval in shape (7.5 mm x 13.5 mm). They have a "7" on one side and the word "novo" on the other.

The Rybelsus 14 mg tablets are white to light yellow in color and oval in shape (7.5 mm x 13.5 mm). They have a "14" on one side and the word "novo" on the other.

The Rybelsus 25 mg tablets are white to light yellow in color and oval in shape (6.8 mm x 12 mm). They have a "25" on one side and the word "novo" on the other.

The Rybelsus 50 mg tablets are white to light yellow in color and oval in shape (6.8 mm x 12 mm). They have a "50" on one side and the word "novo" on the other.

The 3 mg, 7 mg, 14 mg, 25 mg and 50 mg tablets are presented in alu/alu blisters and the available packaging sizes are 10, 30, 60, 90 and 100 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and manufacturer

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Denmark

Last revision date of this leaflet:

Other sources of information

The detailed information on this medicine is available on the European Medicines Agency website:https://www.ema.europa.eu/