Active ingredient
- semaglutide
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: EU/1/20/1430/001, EU/1/20/1430/002, EU/1/20/1430/003, EU/1/20/1430/003, EU/1/20/1430/004, EU/1/20/1430/005, EU/1/20/1430/006, EU/1/20/1430/007, EU/1/20/1430/008, EU/1/20/1430/009, EU/1/20/1430/010.
Rybelsus
Package leaflet: Information for the patient
Rybelsus® 3 mg tablets
Rybelsus® 7 mg tablets
Rybelsus® 14 mg tablets
semaglutide
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Rybelsus® is and what it is used for
2. What you need to know before you take 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 that is used to lower blood sugar levels.
Rybelsus® is used to treat adults (aged 18 years and older) with type 2 diabetes when diet and exercise is not enough:
It is important that you continue with your diet and exercise plan as agreed with your doctor, pharmacist or nurse.
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.
2. What you need to know before you take Rybelsus®
Do not take Rybelsus®
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Rybelsus®.
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:
Stomach and gut problems
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:
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
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.
3. How to take Rybelsus®
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
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
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.
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)
Rare (may affect up to 1 in 1,000 people)
Other side effects
Very common (may affect more than 1 in 10 people)
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)
Uncommon (may affect up to 1 in 100 people)
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. You can also report side effects directly via
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store
By reporting side effects you can help provide more information on the safety of this medicine.
5. 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 expiry date refers to the last day of that month.
Store in the original package in order to protect from light and moisture. This medicine does not require any special temperature storage conditions.
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.
6. Contents of the pack and other information
What Rybelsus® contains
What Rybelsus® looks like and contents of the pack
Rybelsus® 3 mg tablets are white to light yellow and oval shaped (7.5 mm x 13.5 mm). They have ‘3’ on one side and ‘novo’ on the other side.
Rybelsus® 7 mg tablets are white to light yellow and oval shaped (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 and oval shaped (7.5 mm x 13.5 mm). They have ‘14’ on one side and ‘novo’ on the other side.
The 3 mg tablets are available in alu/alu blister cards in pack sizes of 10, 30, 60, 90 and 100 tablets.
The 7 mg and 14 mg tablets are available in alu/alu blister cards in pack sizes of 30, 60, 90 and 100 tablets.
Not all pack sizes may be marketed in your country.
Marketing Authorisation Holder and Manufacturer
This leaflet was last revised in 11/2020
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Rybelsus® is a trademark owned by Novo Nordisk A/S, Denmark
© 2020
Novo Nordisk A/S
3 City Place, Beehive Ring Road, Gatwick, West Sussex, RH6 0PA
+44 (0)1293 613555
+44 (0)845 600 5055
+44 (0)845 600 5055
+44 (0)1293 613535