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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 adults (aged 18 years and over) with type 2 diabetes when diet and exercise are not enough:
alone - when you cannot use metformin (another diabetes medicine) or
with other diabetes medicines – when other medicines are not enough to
control your blood sugar levels. These can be medicines you take by mouth or inject, such as insulin.
It is important that you continue to follow your diet and exercise plan as agreed with your doctor, pharmacist or nurse.
What is type 2 diabetes?
Type 2 diabetes is a disease in which your body does not produce enough insulin, and the insulin your body produces does not lower your blood sugar as well as it should.
In some cases, your body may produce too much blood sugar. If your blood sugar rises and stays high for an extended period of time, it can lead to harmful effects, such as heart problems, kidney disease, eye damage, and poor circulation in the extremities. Therefore, it is important to keep your blood sugar levels within normal limits.
2. What you need to know before you take Rybelsus
Do not take Rybelsus
if you are allergic to semaglutide or any of the other ingredients of this
medicine (listed in point 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Rybelsus.
To improve the traceability of biological medicinal products, write down the name and batch number (printed on the carton and blister) of the medicine you are taking and provide this information when reporting any side effects.
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 at all);
develop diabetic ketoacidosis. It is a complication of diabetes occurring with high
blood sugar, difficulty breathing, confusion, excessive thirst, sweet smelling breath, or a sweet or metallic taste in the mouth.
Stomach or intestinal problems
You may have nausea or vomiting, or have diarrhea during treatment with this medicine. These side effects can cause dehydration (loss of fluids).
It is important to 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 prolonged stomach pain, which may be due to inflammation of the pancreas
If you have severe and prolonged pain in the stomach area, see a doctor immediately, as it may be a sign of inflammation of the pancreas (acute pancreatitis).
Low blood sugar (hypoglycemia)
Taking sulphonylureas or insulin with Rybelsus may increase the risk of low blood sugar levels (hypoglycaemia). See point 4 on warning signs of low blood sugar.
Your doctor may order you to have your blood sugar levels tested. In this way, it will be possible to determine whether the dose of the sulphonylurea or the insulin should be changed to reduce the risk of low blood sugar levels.
Eye disease due to diabetes (retinopathy)
Rapid improvement in blood sugar control may lead to temporary worsening of diabetic eye disease. If you have eye disease due to diabetes and eye problems develop while taking this medicine, talk to your doctor.
Response to treatment
If the response to semaglutide treatment is poorer than expected, this may be due to poor absorption, due to absorption variability and low absolute bioavailability.
You must follow the instructions given in point 3 to achieve the optimal effect of semaglutide.
Children and adolescents
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
You should tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, you should 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 hormone levels if you are taking Rybelsus together with levothyroxine.
warfarin or similar medicines taken by mouth to reduce blood clotting (oral anticoagulants). You may need frequent blood tests to check how quickly your blood clots
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor before using this medicine.
This medicine should not be used during pregnancy because it is not known whether it affects the fetus. Therefore, it is recommended that you use contraception while taking this medicine. If you wish to become pregnant, discuss with your doctor how to change your treatment, as you must 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 may 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.
Driving and using machines
If you use this medicine in combination with sulphonylureas or insulin, your blood sugar may drop (hypoglycaemia), making it difficult for you to concentrate. Do not drive or operate machinery if you develop signs of low blood sugar. See section 2 "Warnings and precautions" for information about the increased risk of low blood sugar, and section 4 for the warning signs of low blood sugar. Talk to your doctor for more information.
Rybelsus contains sodium
This medicine contains 23 mg of sodium (main component of table/table salt) in each tablet. This amount is equivalent to 1% of the recommended maximum daily dietary intake of sodium for an adult.
3. How to take Rybelsus
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
How much to take
The starting dose is one 3 mg tablet once a day for a period of 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 on a dose of 7 mg once a day.
Your doctor will prescribe the amount that is right for you. Do not change the dose unless your doctor tells you to do so. It is not recommended that you take two 7 mg tablets to get the effect of one 14 mg tablet as this has not been studied.
Taking the medicine
Take the Rybelsus tablet on an empty stomach at any time of the day.
Swallow the Rybelsus tablet whole with a sip of water (up to 120 ml). The tablet should not be split, crushed or chewed as it is not known whether this affects the absorption of semaglutide.
After taking the Rybelsus tablet, wait at least 30 minutes before the first food or drink of the day or before taking other oral medicinal products. Waiting less than 30 minutes reduces the absorption of semaglutide.
If you have taken more Rybelsus than you should
If you have taken more than the required dose of Rybelsus, inform your doctor immediately.
You may experience side effects such as nausea.
If you forget to take Rybelsus
If you forget to take a dose, skip the missed dose and just take your usual dose the next day.
If you have stopped taking Rybelsus
Do not stop using this medicine without telling your doctor. If you stop it, your blood sugar level may rise.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. 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 eye disease due to diabetes (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 should get medical help immediately and tell your doctor right away if you experience symptoms such as breathing problems, swelling of the face and throat, wheezing, fast heart rate, pale and cold skin, feeling dizzy or weak.
inflammation of the pancreas (acute pancreatitis), in which there may be severe pain in
stomach and back that does not pass. You should see a doctor immediately if you experience such symptoms.
Other side effects
Very common (may affect more than 1 in 10 people)
nausea - this usually goes away with time;
diarrhea - this usually goes away with time;
low blood sugar (hypoglycaemia) when this medicine is used together with medicines that contain a sulphonylurea or insulin. Your doctor may reduce the dose of these medicines before you start using this medicine.
The warning signs of low blood sugar can appear suddenly. These may include: cold sweat, cool pale skin, headache, fast heart rate, nausea or extreme hunger, vision changes
Uncommon (may affect up to 1 in 100 people)
5. How to store Rybelsus
Keep out of the 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 corresponds to the last day of the specified month.
Store in the original package to protect from light and moisture. This medicine does not require special temperature storage conditions.
Do not dispose of medicines down the drain or in the household waste container.
Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What Rybelsus contains
Active substance: semaglutide. Each tablet contains 3, 7 or 14 mg of semaglutide.
Other ingredients: salcaprosate sodium, povidone K90, microcrystalline cellulose, magnesium stearate.
What Rybelsus looks like and contents of the pack
Rybelsus 3 mg tablets are white to light yellow, oval in shape (7.5 mm x 13.5 mm). They have the inscription "3" on one side and "novo" on the other side.
Rybelsus 7 mg tablets are white to light yellow, oval in shape (7.5 mm x 13.5 mm). They have "7" on one side and "novo" on the other side.
Rybelsus 14 mg tablets are white to light yellow, oval in shape (7.5 mm x 13.5 mm). They are marked "14" on one side and "novo" on the other.
The 3 mg, 7 mg and 14 mg tablets are available in Al/Al blisters in packs of 10, 30, 60, 90 and 100 tablets.
Not all types of packaging can be marketed in your country.
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