Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - rybelsus

Document Subject

Generated Narrative: MedicinalProductDefinition mpb74140ab033fc1249f12696486a5f0cd

identifier: http://ema.europa.eu/identifier/EU/1/20/1430/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Rybelsus 3 mg tablets

type: Full name

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part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-b74140ab033fc1249f12696486a5f0cd

identifier: http://ema.europa.eu/identifier/EU/1/20/1430/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - rybelsus

Attesters

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

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:

• on its own when you cannot use metformin (another diabetes medicine) or
• with other medicines for diabetes when the other medicines are not enough to control your blood sugar levels. These may be medicines you take by mouth or inject such as insulin.

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.

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 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:

• 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.

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 at any time of the day.
• 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.

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 the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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.

What Rybelsus contains

• The active substance is semaglutide. Each tablet contains 3, 7 or 14 mg semaglutide.
• The other ingredients are salcaprozate sodium, povidone K90, cellulose microcrystalline, magnesium stearate.

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, 7 mg and 14 mg tablets are available in alu/alu blister cards in pack sizes of 10, 30, 60, and 100 tablets. .

Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder and Manufacturer Novo Nordisk A/S Novo All
DK-2880 Bagsv rd Denmark

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: