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

Rybelsus^® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Rybelsus^® is used to treat type 2 diabetes in adult patients (aged 18 years and older) that cannot be controlled by diet and exercise alone.

•           Rybelsus^® can be used without other medicines in patients who cannot take metformin (another diabetes medicine).

•           Rybelsus^® can also be used with other medicines for the treatment of diabetes. These may be medicines taken by mouth or given by injection such as insulin.

It is important that you continue with your diet and exercise plan as agreed with your doctor, pharmacist or nurse.

Limitation of Use:

• Rybelsus^® has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.

·         Rybelsus^® is not indicated for use in patients with type 1 diabetes mellitus or for the treatment of patients with diabetic ketoacidosis, as it would not be effective in these settings.

What is type 2 diabetes?

Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body makes does not lower your blood sugar the way it should. In some cases, your body can produce too much blood sugar. If your blood sugar increases and remains high over a long period of time, this can lead to harmful effects such as heart problems, kidney disease, eye disorders and poor circulation in your limbs. That is why it is important to keep 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).

•          Personal or family history of medullary thyroid carcinoma MTC in patient with Multiple Endocrine Neoplasia syndrome type 2 MEN 2.

•          Semaglutide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Diabetic ketoacidosis has been reported in insulin-dependent patients whom had rapid discontinuation or dose reduction of insulin when treatment with a GLP-1 receptor agonist is started

There is no therapeutic experience in patients with congestive heart failure New York Heart Association NYHA class IV and semaglutide is therefore not recommended in these patients Experience with the use of semaglutide in patients with severe renal impairment is limited. Semaglutide is not recommended in patients with end-stage renal disease

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Rybelsus^®.

• Risk of Thyroid C-Cell Tumors

• Use caution in patients with prior anaphylaxis and angioedema history with other GLP-1 receptor agonists. Acute kidney injury and worsening of chronic renal failure, sometimes requiring dialysis, has been reported in patients receiving GLP-1 receptor agonists; Some of these events have been reported in patients without known underlying renal disease. Majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Monitor renal function when initiating or escalating doses of Rybelsus in patients reporting severe adverse gastrointestinal reactions.

Traceability

In order to improve the traceability of biological medicinal products, record the name and the lot number (included on the outer cartons and blister) of the medicine you are taking and provide this information when reporting any side effects.

General:

This medicine is not the same as insulin and you should not use it if:

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

•        you develop diabetic ketoacidosis. This is a complication of diabetes with high blood sugar, breathing difficulty, confusion, excessive thirst, a sweet smell to the breath or a sweet or metallic taste in the mouth.

Stomach and gut problems and dehydration

During treatment with this medicine, you may feel sick (nausea) or be sick (vomiting), or have diarrhoea. These side effects can 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. Talk to your doctor if you have any questions or concerns.

Severe and on-going stomach pain which could be due to an inflamed pancreas

If you have severe and on-going pain in the stomach area – see a doctor straight away as this could be a sign of inflamed pancreas (acute pancreatitis).

Low blood sugar (hypoglycaemia)

Taking a sulfonylurea medicine or insulin with Rybelsus^® might increase the risk of getting low blood sugar (hypoglycaemia). See section 4 for the warning signs of low blood sugar levels.

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

Diabetic eye disease (retinopathy)

Fast improvements in blood sugar control may lead to a temporary worsening of diabetic eye disease. If you have diabetic eye disease and get eye problems while taking this medicine, talk to your doctor.

Treatment response

If the treatment response with semaglutide is lower than expected, this may be due to low absorption caused by variability in absorption and low absolute bioavailability. You should follow the instructions given in section 3 for optimal effect of semaglutide.

Children and adolescents

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

Other medicines and Rybelsus^®

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

In particular, tell your doctor, pharmacist or nurse if you are using medicines containing any of the following:

•        levothyroxine which is used for thyroid disease. This is because your doctor may need to check your thyroid levels if you are taking Rybelsus^® together with levothyroxine.

•        warfarin or similar medicines taken by mouth to reduce blood clotting (oral anti-coagulants). You may need frequent blood tests to check how quickly your blood clots.

•        If you are using insulin, your doctor will tell you how to reduce the dose of insulin and will recommend you to monitor your blood sugar more frequently, in order to avoid hyperglycaemia (high blood sugar) and diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to breakdown glucose because there is not enough insulin).

Pregnancy and breast-feeding

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 if it affects your unborn baby. Therefore, use of contraception is recommended while taking this medicine. If you wish to become pregnant, discuss how to change your treatment with your doctor as you should stop using this medicine at least 2 months in advance. If you become pregnant while using this medicine, talk to your doctor straight away, as your treatment will need to be changed.

Do not use this medicine if you are breast-feeding, as it is unknown if it passes into breast milk.

Driving and using machines

Rybelsus® is unlikely to affect your ability to drive and use machines.

Some patients may feel dizzy when taking Rybelsus®. If you feel dizzy, be extra careful while driving or using machines. Talk to your doctor for the further information.

If you use this medicine in combination with a sulfonylurea or insulin, low blood sugar (hypoglycaemia) may occur which may reduce your ability to concentrate. Do not drive or use machines if you get any signs of low blood sugar. See section 2, ‘Warning and precautions’ for information on increased risk of low blood sugar and section 4 for the warning signs of low blood sugar. Talk to your doctor for further information.

Rybelsus^® contains sodium

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

Gallbladder problems

Gallbladder problems have happened in some people who take Rybelsus^®. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include:

• pain in your upper stomach (abdomen)
• yellowing of skin or eyes (jaundice)
• fever
• clay-colored stools

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

How much to take

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

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

•        Your doctor may increase your dose to 14 mg once a day if your blood sugar is not controlled well enough with a dose of 7 mg once a day.

Your doctor will prescribe the strength that is right for you. Do not change your dose unless your doctor has told you so. It is not recommended to take two 7 mg tablets to get the effect of one 14 mg tablet, as this has not been studied.

Taking this medicine

•        Take your Rybelsus^® tablet on an empty stomach when you first wake up .

•        Swallow your 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 if it affects absorption of semaglutide.

•        After taking your Rybelsus^® tablet wait at least 30 minutes before having your first meal or drink of the day or taking other oral medicines. Waiting less than 30 minutes lowers the absorption of semaglutide.

If you take more Rybelsus^® than you should

If you take more Rybelsus^® than you should, talk to your doctor straight away. You may get side effects such as feeling sick (nausea).

If you forget to take Rybelsus^®

If you forget to take a dose, skip the missed dose and just take your normal dose the next day.

If you stop taking Rybelsus^®

Do not stop using this medicine without talking to your doctor. If you stop using it, your blood sugar levels may increase.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Common (may affect up to 1 in 10 people)

•        complications of diabetic eye disease (retinopathy). You should tell your doctor if you get eye problems, such as changes in vision, during treatment with this medicine.

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

•        serious allergic reactions (anaphylactic reactions). You must get immediate medical help and inform your doctor straight away if you get symptoms such as breathing problems, swelling of face and throat, wheezing, fast heartbeat, pale and cold skin, feeling dizzy or weak.

•        inflamed pancreas (acute pancreatitis) which could cause severe pain in the stomach and back which does not go away. You should see a doctor immediately if you experience such symptoms.

Other side effects

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

•        feeling sick (nausea) – this usually goes away over time

•        diarrhoea – this usually goes away over time

•        low blood sugar (hypoglycaemia) when this medicine is used with medicines that contain a sulfonylurea or insulin. Your doctor may reduce your dose of these medicines before you start using this medicine.

The warning signs of low blood sugar may come on suddenly. They can include: cold sweat, cool pale skin, headache, fast heartbeat, feeling sick (nausea) or very hungry, changes in vision, feeling sleepy or weak, feeling nervous, anxious or confused, difficulty concentrating or shaking.

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

Common (may affect up to 1 in 10 people)

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

•        being sick (vomiting)

•        upset stomach or indigestion

•        inflamed stomach (‘gastritis’) – the signs include stomach ache, feeling sick (nausea) or being sick (vomiting)

•        reflux or heartburn – also called ‘gastro-esophageal reflux disease’

•        stomach pain

•        bloating of the stomach

•        constipation

•        tiredness

•        less appetite

•        gas (flatulence)

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

•        feeling dizzy.

Uncommon (may affect up to 1 in 100 people)

•        weight loss

•        gallstones

•        burping

•        fast pulse

•        allergic reactions like rash, itching or hives

•        a delay in the emptying of the stomach

•        change in the way food or drink tastes.

•        a delay in the emptying of the stomach

•        change in the way food or drink tastes.

Post marketing experince:

•         ileus

•         anaphylaxis, angioedema, rash, urticaria

•         cholecystitis, cholelithiasis requiring cholecystectomy

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

Please report adverse drug events to:

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

Do not use this medicine after the expiry date which is stated on the blister and carton after ‘Expiry’. The expiry date refers to the last day of that month.

Store in the original package in order to protect from light and moisture. Store below 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.