Rybelsus 9 mg tablets

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Rybelsus 1.5 mg tablets

Rybelsus 4 mg tablets

Rybelsus 9 mg tablets

Rybelsus 25 mg tablets

Rybelsus 50 mg tablets

semaglutide

Read this 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, pharmacist, or nurse.
• 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, because it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if the side effects are not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Rybelsus is and what it is used for

Rybelsus contains the active substance semaglutide. It is a medicine used to lower blood sugar levels.

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

• as a single medication: when metformin (another diabetes medicine) cannot be used, or
• in combination with other diabetes medicines: when these are not sufficient to control your blood sugar levels. These may be medicines taken orally or injected, such as insulin.

It is important that you continue following 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 does produce does not lower blood sugar as it should. In some cases, your body may produce too much blood sugar. If your blood sugar level rises and remains high for a prolonged period, it may lead to harmful effects such as heart problems, kidney disease, eye disorders, and poor circulation in the limbs. For this reason, it is important to keep your blood sugar levels within a normal range.

2. What you need to know before taking Rybelsus

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

Talk to your doctor, pharmacist, or nurse before starting Rybelsus.

Traceability

To improve the traceability of biological medicines, record the name and batch number (shown on the outer packaging and blister) of the medicine you are taking and provide this information when reporting any adverse reaction.

General information

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

• you have type 1 diabetes (your body produces no insulin)
• you develop diabetic ketoacidosis. This is a complication of diabetes characterized by high blood sugar levels, difficulty breathing, confusion, excessive thirst, sweet-smelling breath, or a sweet or metallic taste in the mouth.

If you know you are going to undergo surgery requiring anesthesia (a state of unconsciousness), inform your doctor that you are taking Rybelsus.

Gastrointestinal problems and dehydration

During treatment with this medicine, you may experience nausea, vomiting, or diarrhea. These side effects may cause dehydration (loss of fluids). It is important 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 due to inflammation of the pancreas

If you have severe and persistent pain in the stomach area, contact your doctor immediately, as it could be a symptom of inflammation of the pancreas (acute pancreatitis).

Low blood sugar level (hypoglycemia)

Taking a sulfonylurea or using insulin together with Rybelsus may increase the risk of low blood sugar levels (hypoglycemia). See section 4 for symptoms indicating low blood sugar.

Your doctor may ask you to monitor your blood sugar levels. This will help determine whether the dose of sulfonylurea or insulin needs to be adjusted to reduce the risk of low blood sugar.

Diabetic eye disease (retinopathy)

A rapid improvement in blood sugar control may 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 lower than expected, it may be due to low absorption caused by variability in absorption and low absolute bioavailability. Follow the instructions in section 3 to achieve the optimal effect of semaglutide.

Sudden changes in vision

If you experience sudden vision loss or a rapid worsening of vision during treatment with this medicine, consult your doctor immediately for advice. This could be due to a very rare adverse effect called non-arteritic anterior ischemic optic neuropathy (NAION) (see section 4: Serious adverse effects). Your doctor may perform an eye examination and you may need to stop treatment with this medicine.

Patients with delayed gastric emptying (gastroparesis)

If you have slow (delayed) gastric emptying, known as gastroparesis, the use of Rybelsus may cause severe or serious gastrointestinal side effects. Consult your doctor before using Rybelsus.

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

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

In particular, inform your doctor, pharmacist, or nurse if you are taking medicines containing any of the following ingredients:

• Levothyroxine used to treat thyroid-related conditions. This is because your doctor may need to monitor your thyroid hormone levels if you are taking Rybelsus together with levothyroxine.
• Warfarin or similar oral anticoagulants used to reduce blood clotting (oral anticoagulants). Frequent blood tests may be needed to assess your blood's clotting ability.
• If you are using insulin, your doctor will advise you on how to reduce the insulin dose 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 due to insufficient insulin).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become 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 must use contraception while taking this medicine. If you plan to become pregnant, consult your doctor about changing your treatment, as you must stop taking this medicine at least two months in advance. If you become pregnant while using this medicine, consult your doctor immediately, as your treatment will need to be changed.

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 using machines

It is unlikely that Rybelsus will affect your ability to drive or operate machinery.

Some patients may feel dizzy when taking Rybelsus. If you feel dizzy, take special care when driving or operating machinery. Consult your doctor for more information.

If you take this medicine with a sulfonylurea or insulin, you may experience low blood sugar (hypoglycemia), which may impair your concentration. Do not drive or operate machinery if you experience any symptoms of low blood sugar. See section 2, “Warnings and precautions,” for information on the increased risk of low blood sugar, and section 4 for symptoms indicating low blood sugar. Consult your doctor for more information.

Rybelsus contains sodium

Rybelsus 1.5 mg, 4 mg, and 9 mg tablets: This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially “sodium-free.”

Rybelsus 25 mg and 50 mg tablets: This medicine contains 23 mg of sodium (the main component of table/cooking salt) in each tablet. This corresponds to 1% of the maximum daily sodium intake recommended for an adult.

3. How to take Rybelsus

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

How much to take

• The starting dose is one 1.5 mg tablet once daily for one month.
• After one month, your doctor will increase the dose to one 4 mg tablet once daily.
• Your doctor will advise you to maintain the dose for at least one month before increasing to a higher dose.
• Your doctor may gradually increase the dose to one 9 mg, 25 mg, or 50 mg tablet once daily, if needed.
• Your doctor will prescribe the appropriate dose for you. Do not change your dose unless instructed by your doctor.
• Rybelsus should always be taken as one tablet per day. Do not take two tablets to achieve the effect of a higher dose.

How to take this medicine

• Take the Rybelsus tablet on an empty stomach after a recommended fasting period of at least 8 hours.
• Swallow the Rybelsus tablet whole with a sip of water (up to 120 ml). Do not split, crush, or chew the tablet, as it is not known whether this affects semaglutide absorption.
• After taking the Rybelsus tablet, wait at least 30 minutes before eating, drinking, or taking any other oral medications. Waiting less than 30 minutes reduces semaglutide absorption.

If you take more Rybelsus than you should

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

If you forget to take Rybelsus

If you forget to take a dose, skip the missed dose and take your next dose at the usual time the following day.

If you stop taking Rybelsus

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

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

4. Possible adverse effects

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

Serious adverse effects

Frequent (may affect up to 1 in 10 people)

• Complications of diabetic eye disease (retinopathy). 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 1,000 people)

• Severe allergic reactions (anaphylactic reactions). You must seek immediate medical help and inform your doctor immediately if you experience symptoms such as breathing difficulties, swelling of the face and throat, wheezing, palpitations, pale and cold skin, dizziness or weakness.
• Inflammation of the pancreas (acute pancreatitis), which may cause severe stomach and back pain that does not go away. You should consult a doctor immediately if you experience these symptoms.

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

• A disease of the eye called non-arteritic anterior ischaemic optic neuropathy (NAION), which may cause painless vision loss in one eye. You should contact your doctor immediately if you experience sudden or progressive worsening of vision (see section 2: “Sudden changes in vision”).

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

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

Other adverse effects

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

• Low blood sugar level (hypoglycaemia), when this medicine is used with other medicines containing a sulphonylurea or insulin. Your doctor may reduce the dose of these medicines before you start taking this medicine.
• Nausea; this effect usually disappears with time.
• Diarrhoea; this effect usually disappears with time.

Warning signs of low blood sugar may appear suddenly. Some of these symptoms include cold sweating, cold and pale skin, headache, palpitations, nausea or excessive hunger, changes in vision, drowsiness or feeling weak, nervousness, anxiety or confusion, difficulty concentrating or trembling.

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

Frequent (may affect up to 1 in 10 people)

• Low blood sugar level (hypoglycaemia) when this medicine is used with oral diabetes medicines other than sulphonylureas or insulin
• Decreased appetite
• Dizziness
• Vomiting – this effect usually disappears with time and may occur more frequently when increasing the dose to 25 mg and 50 mg
• Stomach pain
• Stomach bloating
• 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
• Increased pancreatic enzymes (such as lipase and amylase) in blood tests
• Change in skin sensation – this effect usually disappears with time and may occur more frequently at doses of 25 mg and 50 mg than at 1.5 mg, 4 mg and 9 mg
• Headache

Uncommon (may affect up to 1 in 100 people)

• Allergic reactions such as rash, itching or hives
• Change in taste of food and drink
• Rapid pulse
• Burping
• Delayed emptying of the stomach
• Gallstones
• Weight loss

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rybelsus

Keep this medicine out of the sight and reach of children.

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

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

This medicine does not require any special storage temperature conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rybelsus

• The active substance is semaglutide. Each tablet contains 1.5, 4, 9, 25, or 50 mg of semaglutide.
• The other components are sodium caprate, magnesium stearate. See also section 2, “Rybelsus contains sodium”.

What Rybelsus looks like and contents of the pack

Rybelsus 1.5 mg tablets are white to off-white in colour and are round in shape (6.5 mm in diameter). They have "1.5" on one side and the word "novo" on the other.

Rybelsus 4 mg tablets are white to off-white in colour and are round in shape (6.5 mm in diameter). They have "4" on one side and the word "novo" on the other.

Rybelsus 9 mg tablets are white to off-white in colour and are round in shape (6.5 mm in diameter). They have "9" on one side and the word "novo" on the other.

Rybelsus 25 mg tablets are white to off-white in colour and are oval in shape (6.8 mm x 12 mm). They have "25" on one side and the word "novo" on the other.

Rybelsus 50 mg tablets are white to off-white in colour and are oval in shape (6.8 mm x 12 mm). They have "50" on one side and the word "novo" on the other.

The 1.5 mg, 4 mg, 9 mg, 25 mg, and 50 mg tablets are supplied in alu/alu blisters. The available pack sizes are 10, 30, 60, 90, and 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

Date of the most recent revision of this leaflet:

Other sources of information

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