3 mg, 7 mg and 14 mg semaglutide tablets
What Rybelsus is and what it is used for
Rybelsus contains the active substance semaglutide. It is a drug used to lower blood sugar levels.
Rybelsus is used to treat adults (18 years or older) with type 2 diabetes when diet and exercise are not enough:
- as the only medicine – when you can not use metformin (another diabetes medicine) or
- along with other diabetes medicines – when the other medicines are not enough to get your blood sugar under control. These can be medicines that you take by mouth or inject, such as insulin.
You must continue to follow the advice on diet and exercise that you have agreed with 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 that your body produces does not lower your blood sugar properly. In some cases, your body can produce too much blood sugar. If your blood sugar rises and stays high for a long time, it can lead to harmful effects such as heart problems, kidney disease, eye diseases, and poor circulation in your arms and legs. Therefore, it is important to keep your blood sugar levels within a normal level.
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 cautions
Talk to your doctor, pharmacist, or nurse before taking Rybelsus.
Traceability
To facilitate the traceability of biological medicinal products, write down the name of the medicinal product and the batch number (found on the outer cartons and blisters after “lot”) and provide this information when reporting adverse reactions.
Generally:
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 insulin )
- you develop diabetic ketoacidosis. This is a complication of diabetes with high blood sugar, difficulty breathing, confusion, excessive thirst, sweet breath, or a sweet or metallic taste in the mouth.
Gastrointestinal problems
During treatment with this medicine, you may feel unwell, vomit, or have diarrhea. These side effects can cause dehydration (fluid loss). You must drink enough fluids to prevent dehydration. This is especially important if you have kidney problems. Talk to a doctor if you have any questions or concerns.
Severe and persistent abdominal pain that may be due to inflammation of the pancreas
If you have severe and persistent stomach pain – see a doctor immediately as this may be a sign of inflammation of the pancreas ( acute pancreatitis ).
Low blood sugar (hypoglycemia)
Taking a sulphonylurea or insulin with Rybelsus may increase the risk of low blood sugar (hypoglycemia). See section 4 for information on warning signs of low blood sugar.
Your doctor may ask you to test your blood sugar levels. This will help determine if the dose of sulphonylurea or insulin needs to be changed to reduce the risk of low blood sugar.
Diabetic eye disease ( retinopathy )
Rapid improvement in blood sugar control may lead to a temporary worsening of diabetic eye disease. Talk to your doctor if you have diabetic eye disease and have eye problems while taking this medicine.
Treatment response
If the treatment response with semaglutide is lower than expected, it may be due to low uptake. This is because the uptake varies and only a small part of semaglutide is taken up. Therefore, you must follow the instructions in section 3 for the optimal effect of semaglutide.
Children and young people
This medicine is not recommended for children and adolescents under 18 years of age, as safety and efficacy in this age group have not been established.
Other drugs and Rybelsus
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.
Especially if you are taking medicines that contain any of the following, tell your doctor, pharmacist, or nurse:
- levothyroxine is used in thyroid disease. This is because your doctor may need to check your thyroid levels if you are taking Rybelsus with levothyroxine.
- warfarin or similar medicines are taken orally to reduce blood clotting capacity (oral anticoagulants ). You may need to do frequent check-ups to see how fast your blood is clotting.
- If you are taking insulin, your doctor will tell you how to lower your insulin dose and recommend that you measure your blood sugar more often to avoid hyperglycemia (high blood sugar) and diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose because there is not enough insulin ).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, 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 fetus. Therefore, it is recommended that you use contraception when taking this medicine. If you want to get pregnant, you should discuss with your doctor how to change the treatment, as you should stop using this medicine at least 2 months in advance. If you become pregnant while taking this medicine, talk to your doctor immediately as your treatment will need to be changed.
Do not use this medicine if you are breastfeeding, as it is not known if it passes into breast milk.
Driving and using machines
If you use this medicine together with a sulphonylurea or insulin, low blood sugar (hypoglycemia) may occur which may lower your ability to concentrate. Do not drive or use machines if you get signs of low blood sugar. Section 2 “Warnings and precautions” provides information on the increased risk of low blood sugar and Section 4 provides information on the warning signs for low blood sugar. For more information, talk to your doctor.
Rybelsus contains sodium
This medicine contains 23 mg of sodium (the main ingredient in table salt/table salt) in each tablet. This corresponds to 1% of the maximum recommended daily sodium intake for adults.
How to take Rybelsus
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
How much to take
- The starting dose is one 3 mg tablet once a day for a month.
- After one month, the doctor increases the dose to one to 7 mg once daily.
- Your doctor may increase your dose to 14 mg once a day if your blood sugar is not adequately controlled at 7 mg once a day.
Your doctor will prescribe the strength that is right for you. The dose may only be changed as directed by a physician. 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.
Take this medicine
- Take your Rybelsus tablet on an empty stomach at any time of the day.
- Swallow your tablet Rybelsus whole with a little water (up to 120 ml). Do not divide, crush or chew the tablet as it is not known if it affects the uptake of semaglutide.
- Once you have taken your Rybelsus tablet, wait at least 30 minutes before taking your first meal or drink of the day or taking other medicines by mouth. A shorter waiting time than 30 minutes reduces semaglutide uptake.
If you take more Rybelsus than you should
Contact a doctor immediately if you have taken too much Rybelsus. You can get side effects such as nausea.
If you forget to take Rybelsus
If you forget to take a dose, skip the missed dose and only take your normal dose the next day.
If you stop taking Rybelsus
Do not stop using this medicine without talking to your doctor first. If you stop using the medicine, your blood sugar level may rise.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
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 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 medical attention immediately and inform your doctor immediately if you experience symptoms such as difficulty breathing, swelling of the face and throat, wheezing, palpitations, pale and cold skin, dizziness, or weakness.
- inflamed pancreas ( acute pancreatitis ) which can cause severe pain in the abdomen and back and which does not cease. You should see a doctor immediately if you experience such symptoms.
Other side effects are
Very common (may affect more than 1 user in 10)
- nausea – this usually goes away over time
- diarrhea – this usually goes away over time
- low blood sugar (hypoglycemia) when used with medicines containing sulphonylurea 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 may manifest themselves as cold sweats, cold and pale skin, headaches, palpitations, nausea or strong hunger, changes in vision, drowsiness or weakness, nervousness, anxiety or confusion, and 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)
- hypoglycemia (hypoglycemia) when used with oral or non-sulphonylurea or insulin.
- vomiting
- stomach upset or indigestion
- gastritis ( gastritis ) – may manifest as abdominal pain, nausea, or vomiting
- acid reflux or heartburn – also called gastroesophageal reflux disease
- abdominal pain
- swollen stomach
- constipation
- fatigue
- decreased appetite
- gases ( flatulence )
- increase in the pancreatic enzyme (such as lipase and amylase) detected in blood samples.
Uncommon (may affect up to 1 in 100 people)
- weight loss
- gallstone
- burp
- fast pulse.
How to store Rybelsus
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 EXP. The expiration date is the last day of the specified month.
Store in the original package. Sensitive to light. Moisture sensitive. No special temperature instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment
Contents of the packaging and other information
Content declaration
- The active substance is semaglutide. Each tablet contains 3, 7, or 14 mg of semaglutide.
- The other ingredients are salkaprozate sodium, povidone K90, microcrystalline cellulose, and magnesium stearate.
What the medicine looks like and the contents of the pack
Rybelsus 3 mg tablets are white to light yellow and oval (7.5 mm x 13.5 mm). It says “3” on one side and “Novo” on the other side.
Rybelsus 7 mg tablets are white to light yellow and oval (7.5 mm x 13.5 mm). It says “7” on one side and “Novo” on the other side.
Rybelsus 14 mg tablets are white to light yellow and oval (7.5 mm x 13.5 mm). It says “14” on one side and “Novo” on the other side.
3 mg, 7 mg, and 14 mg tablets are available in alu / Alu blister cards in pack sizes of 10, 30, 60, 90, and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Novo Nordisk A / S
Novo Allé
DK-2880 Bagsværd
Denmark