Rybelsus 7 mg 90 tablets

What is Rybelsus? and when is it used?

Rybelsus contains the active ingredient semaglutide.   It helps your body lower blood sugar levels when they are too high.

Rybelsus is used to treat type 2 diabetes as prescribed by your doctor

• alone if your blood sugar levels are not well controlled by diet and exercise alone and you cannot use metformin (another anti-diabetic medicine), or
• together with other medicines to treat type 2 diabetes if these and diet and physical activity are not enough to control your blood sugar levels.

What precautions should be taken?

It is important that you continue to follow your diet and physical activity as directed by your doctor, pharmacist or nurse.

When should Rybelsus not be taken?

Rybelsus must not be taken

• if you are allergic to semaglutide or any of the other ingredients of this medicine.

When should you be careful when taking  Rybelsus?

Please talk to your doctor or pharmacist before taking Rybelsus.

This medicine must not be used if you:

• Have type 1 diabetes – a condition in which your body does not produce insulin.
• have diabetic ketoacidosis - a complication of diabetes with high blood sugar, labored breathing, confusion, excessive thirst, sweet-smelling breath, or a sweet or metallic taste in the mouth.

Stomach and intestinal problems and loss of fluids

You may experience nausea, vomiting or diarrhea during treatment with this medicine.   These side effects can lead to dehydration (loss of fluids).   It's important that you drink plenty of fluids to prevent dehydration.   This is especially important if you have kidney problems.   Talk to your doctor if you have any questions or concerns.

Severe and persistent abdominal pain caused by inflammation of the pancreas

If you have severe and persistent pain in the abdominal region, see a doctor immediately as this may be a sign of inflammation of the pancreas (pancreatitis).   Inform your doctor or   Your doctor if you have ever suffered from pancreatitis.

Low blood sugar (hypoglycemia)

Combining Rybelsus with a sulfonylurea or insulin could increase the risk of low blood sugar (hypoglycemia).   For more information about the warning signs of hypoglycemia, see the “What side effects can Rybelsus have?”

Your doctor or   Your doctor may ask you to measure your blood sugar levels.   This will help your doctor decide whether the dose of the sulfonylurea or insulin needs to be changed to reduce the risk of hypoglycemia.

Diabetic eye disease (retinopathy, damage to the retina)

A rapid improvement in blood sugar levels can lead to a temporary worsening of diabetic eye disease.   Tell your doctor if you have diabetic eye disease and if you develop eye problems while taking this medicine.

Kidney problems

In people with kidney problems, diarrhea, nausea, and vomiting can cause fluid loss (dehydration), which can worsen kidney problems.  It is important that you drink fluids to reduce the risk of dehydration.

Children and young people

This medicine is not recommended for use in children and adolescents under 18 years of age because its safety and effectiveness have not been established in this age group.

Using Rybelsus with other medicines

Tell your doctor, pharmacist or nurse if you are using, have recently used or plan to use any other medicines.  This also applies to herbal medicines or non-prescription medicines that you have purchased.

In particular, tell your doctor or pharmacist if you are using medicines that contain the active ingredient levothyroxine.  Your doctor may need to check your thyroid levels if you take Rybelsus with levothyroxine.

Using Rybelsus with food and drink

Rybelsus should be taken on an empty stomach (fasting).

This medicine may impair the ability to react, drive and use tools or machines!

If you use this medicine in combination with a sulfonylurea or insulin, you may experience low blood sugar (hypoglycemia), which may affect your ability to concentrate.  Avoid driving or operating machines if you notice signs of hypoglycemia.  For further information, speak to your doctor.

This medicine contains 22.9 mg sodium (main ingredient of table salt) per tablet.  This corresponds to 1% of the recommended maximum daily intake of sodium for adults.

Tell your doctor or pharmacist if you

• suffer from other illnesses,
• Have allergies or
• Take other medicines (including those you bought yourself!) or use externally!

Can Rybelsus be taken during pregnancy or while breastfeeding?

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

This medicine should not be used during pregnancy as it is not known whether it can harm your unborn baby.  For this reason, it is recommended to use contraception while using this medicine.  If you want to become pregnant, you should stop taking this medicine at least two months beforehand.  If you become pregnant while using this medicine, talk to your doctor immediately because your treatment will need to be changed.

Do not use this medicine if you are breast-feeding, as it is not known whether it passes into breast milk.  Talk to your doctor if you want to breastfeed your child.

How do you use Rybelsus?

Always take this medicine exactly as your doctor has told you.  Ask your doctor or pharmacist or nurse if you are not sure.

How much to take

• The starting dose is 1 tablet of 3 mg once a day for one month.
• After one month, your doctor will increase the dose to 1 tablet of 7 mg once a day.
• Your doctor may want to increase the dose to 1 tablet of 14 mg once a day if a daily dose of 7 mg does not reduce blood sugar levels sufficiently.

Do not change the dosage unless your doctor tells you to do so.

How to take this medicine

• Take your Rybelsus tablet on an empty stomach (fasting).
• Swallow the Rybelsus tablet whole with up to half a glass of water (up to 120 ml).
• After taking your Rybelsus tablet, wait at least 30 minutes before taking your first meal or drink of the day or other medicines.

If you take more Rybelsus than you should

If you take more Rybelsus than you should, contact your doctor immediately.  Side effects such as nausea could occur.

If you forget to take Rybelsus

If you forget to take a dose, simply take one tablet the next morning.

If you stop taking Rybelsus

Do not stop using this medicine without consulting your doctor.  If you stop taking it, your blood sugar levels may rise.

The use and safety of Rybelsus in children and adolescents under 18 years of age have not been tested.

Do not change the prescribed dosage on your own.  If you think the medicine is too weak or too strong, talk to your doctor or pharmacist.

What side effects can Rybelsus have?

The following side effects may occur:

Serious side effects

Rare (affects 1 to 10 in 10,000 people)

• Severe allergic reactions (anaphylactic reactions).  You should seek medical help immediately and tell your doctor immediately if you develop symptoms such as difficulty breathing, swelling of the face and throat, wheezing, rapid heartbeat, pale and cold skin, dizziness or weakness.

Very common (affects more than 1 in 10 people)

• Nausea – usually goes away with time
• Diarrhea – usually goes away with time
• Low blood sugar (hypoglycemia) when using this medicine together with other diabetes medicines

The warning signs of hypoglycemia can appear suddenly.  They include, but are not limited to: cold sweat, cool pale skin, headache, fast heartbeat, feeling sick (nausea) or feeling very hungry, vision problems, tiredness or weakness, nervousness, anxiety or confusion, difficulty concentrating or trembling.

Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs.

Hypoglycemia is more likely to occur if you also take a sulfonylurea or use insulin.  Your doctor may want to reduce your dose of these medicines before you start treatment with this medicine.

Common (affects 1 to 10 in 100 people)

• Vomit
• Upset stomach or indigestion
• Inflammation of the stomach lining (gastritis) – signs include stomach pain, nausea or vomiting
• Reflux or heartburn – also known as “gastroesophageal reflux disease”.
• stomach pain
• bloated stomach
• constipation
• Changes in taste sensation
• fatigue
• Decrease in appetite
• Gas (flatulence)
• Increase in pancreatic enzymes (such as lipase and amylase) found in tests
• Worsening of diabetic eye disease

Uncommon (affects 1 to 10 in 1,000 people)

• weight loss
• Gallstones
• Belching
• rapid pulse
• Allergic reactions such as rash, itching or hives
• Inflammation of the gallbladder

Rare (affects 1 to 10 in 10,000 people)

• Inflamed pancreas (acute pancreatitis), which can cause severe pain in the stomach and back that does not go away.   If such symptoms occur, you must immediately consult a doctor.

If you notice any side effects, contact your doctor or pharmacist.   This applies in particular to side effects that are not stated in this leaflet.

What should also be noted?

The medicine may only be used until the date marked “EXP” on the container.   The expiry date refers to the last day of the specified month.

Storage instructions

Do not store above 30°C.

Store in the original packaging to protect the contents from moisture and light.   Keep the tablets in the blister pack until ready to take.   Removing it too early can affect the intended effect.

Keep out of reach of CHILDREN.

More information

The tablets are white to light yellow, oval and debossed with “3”, “7” or “14” on one side and “novo” on the other.

Do not use this medicine if you find that the packaging is damaged or there is evidence that it has been opened.

Do not dispose of drugs in the wastewater or household waste.   Ask your pharmacist how to dispose of medicines if you no longer use them.   You help to protect our environment.

Your doctor or pharmacist can provide you with further information.   These people have the detailed information for specialists.

What is included in Rybelsus?

Active ingredients

Semaglutide.   Each tablet contains 3, 7 or 14 mg of semaglutide.

Excipients

Salcaprozat sodium, povidone, microcrystalline cellulose, magnesium stearate.

Approval number

67446 (Swissmedic)

Where can you get Rybelsus?   Which packs are available?

In pharmacies, only with a prescription.

Tablets of 3 mg: packs of 30 tablets

Tablets of 7 mg: packs of 30 and 90 tablets

Tablets of 14 mg: packs of 30 and 90 tablets

Authorization holder

Novo Nordisk Pharma AG, Kloten

Domicile: Zurich

manufacturer

Novo Nordisk A/S, DK-2880 Bagsværd.