BYDUREON. 2 mg. flacon
BYDUREON is used in combination with these drugs for the treatment of diabetes: metformin, sulphonylureas, thiazolidinediones.
BYDUREON. 2 mg. flacon
BYDUREON WHAT IS AND WHAT IT IS USED FOR ?
BYDUREON is an injectable medicine used to improve glycemic control in adults with type 2 diabetes mellitus .
BYDUREON is used in combination with these drugs for the treatment of diabetes : metformin , sulphonylureas , thiazolidinediones . Your doctor BYDUREON appointed as an additional medicine to help control blood sugar levels. Continue to follow your diet and exercise.
You have diabetes because your body does not produce enough insulin to control the level of sugar in your blood or your body can not properly use insulin . BYDUREON helps your body to increase the production of insulin when blood sugar is high.
2 . BEFORE YOU USE BYDUREON
Do not use BYDUREON
- If you are allergic (hypersensitive) to exenatide or any of the other ingredients of BYDUREON, listed in Section 6 .
Take special care with BYDUREON
- When used in combination with a sulphonylurea , as can occur from low blood sugar ( hypoglycemia) . Check your blood sugar regularly. Ask your doctor or pharmacist if you are unsure if any of your other medicines contain a sulphonylurea .
- BYDUREON should not be used if you have type 1 diabetes or diabetic ketoacidosis.
- BYDUREON must be injected into the skin , and not in a vein or into a muscle .
- If you have severe problems with your stomach emptying (including gastroparesis ) or food digestion , the use of BYDUREON is not recommended. BYDUREON slows gastric emptying so food passes more slowly through your stomach .
- Tell your doctor if you have had pancreatitis ( see section 4 ) .
- If you lose weight too quickly (more than 1,5 kg per week ) , tell your doctor, as this can not be good for you.
- There is little experience with BYDUREON patients with kidney problems. The use of BYDUREON is not recommended if you have severe kidney disease or are on dialysis.
- There is no experience with BYDUREON in children and adolescents below 18 years and is therefore not recommended for use BYDUREON in this age group.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including warfarin medicines obtained without a prescription.
It is not recommended to BYDUREON with insulin and other drugs that are used to treat type 2 diabetes , which act like BYDUREON ( eg liraglutide and Byetta [ exenatide BID ] ) .
Use of BYDUREON with food and drink
BYDUREON Apply at any time of day, with or without food. Pregnancy and lactation
Women of childbearing potential must use contraception while being treated with BYDUREON. It is not known if BYDUREON may harm your unborn child. Tell your doctor if you think you are pregnant or planning to become pregnant as BYDUREON should not be used during pregnancy and during at least three months before conception.
It is not known if BYDUREON passes into breast milk . BYDUREON should not be used during lactation .
Ask your doctor or pharmacist before taking any medicine.
Driving and using machines
If you use BYDUREON in combination with a sulphonylurea , attenuation of blood sugar ( hypoglycemia) . Hypoglycemia may reduce your ability to concentrate. Please note this possible problem in all situations where you might put yourself and others at risk (eg driving a car or operating machinery) .
Important information about some of the ingredients of BYDUREON
This product contains less than 1 mmol sodium ( 23 mg) per dose , i.e. essentially sodium .
3 . HOW TO USE BYDUREON?
Always use BYDUREON just as you have been told your doctor or diabetes nurse . If you are not sure, ask your doctor, diabetes nurse or pharmacist.
BYDUREON 2 mg should be administered once a week , at any time of the day , with or without food.
BYDUREON is injected into the skin ( subcutaneous injection) in the abdomen , upper leg ( thigh) , or back of the hand ( arm) .
Each week you can use the same area of your body . But make sure that you choose a different injection site in the same area .
Regularly check your blood sugar, this is especially important if you are also using a sulphonylurea.
See the User Instructions provided in the carton to inject BYDUREON
Your healthcare professional should teach you how to inject BYDUREON, before using it for the first time .
Before you start , check that the liquid in the syringe is clear and free from particles . After mixing , use the suspension only if the mixture is a white to off-white and cloudy. If you see lumps of dry powder on the walls or bottom of the vial , the drug is not well mixed . Shake again until well mixed .
BYDUREON must be injected immediately after the mixing of the powder and the solvent.
For each injection, use a new needle and syringe after each use throw it away .
If you are not sure you got a full dose of BYDUREON
If you are not sure whether you got a full dose , do not inject another dose of BYDUREON, just apply it next week as planned .
If you use more than the amount of BYDUREON
If you use more than the amount of BYDUREON, may need medical treatment . More than the amount of BYDUREON may cause nausea , vomiting , dizziness, or symptoms of low blood sugar ( see section 4 ) .
If you forget to use BYDUREON
You have selected the day you plan to inject with BYDUREON. If you miss your shot at this day , do it as soon as you notice it . You can return to your chosen day if another injection is at least one day (24 hours) later. You can also change the selected day for injection. Do not take two injections on the same day.
If you stop using BYDUREON
If you feel you must stop using BYDUREON, please consult your doctor first . If you stop using BYDUREON, it can affect your blood sugar.
If you have any further questions on the use of this medicine, ask your doctor, diabetes nurse or pharmacist.
4 . POSSIBLE SIDE EFFECTS
Like all medicines , BYDUREON may cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined as follows :
- Very common (affects more than 1 user in 10)
- Common ( affects 1 to 10 users in 100)
- Uncommon (affects 1 to 10 of 1000 users)
- Rare ( affects 1 to 10 of 10 000 users)
- Very rare ( affects less than 1 in 10,000 users)
- Not known ( frequency can not be estimated from available data).
Severe allergic reactions ( anaphylaxis) ( not known ) .
You should immediately see your doctor if you experience symptoms such as:
• swelling of the face , tongue or throat
• difficulty in swallowing
• hives and difficulty breathing.
Cases of inflammation of the pancreas ( pancreatitis) have been reported rarely in patients taking a product that has the same active ingredient as BYDUREON. Pancreatitis can be a serious, potentially life-threatening disease .
• Tell your doctor if you have had pancreatitis, gallstones , alcoholism or very high triglycerides. These diseases may increase the risk of developing pancreatitis , or getting it again , whether or not taking BYDUREON.
• Call your doctor if you experience severe and persistent abdominal pain with or without vomiting, because you could have pancreatitis.
Very common side effects of BYDUREON
• nausea ( nausea is most common when first starting BYDUREON, but in most patients decrease with time )
• diarrhea or constipation
• reactions at the injection site
If you have a reaction at the injection site (redness , rash or itching), you can ask your doctor for something to help ease the signs or symptoms . Can you see or feel a small lump under the skin after injection, it will disappear after 4 to 8 weeks. You should not stop their treatment .
BYDUREON is used when a medicinal product containing a sulphonylurea may cause episodes of low blood sugar (hypoglycemia usually mild to moderate) . When using BYDUREON, you may need the dose of your sulphonylurea reduced. Signs and symptoms of low blood sugar may include headache, drowsiness , weakness, dizziness , confusion, irritability , hunger, fast heartbeat , sweating , and feeling jittery . Your doctor will advise you how to proceed in case of low blood sugar.
Common side effects of BYDUREON • dizziness
• fatigue (tiredness ) drowsiness
• pain in the stomach swelling
• indigestion burping
• flatulence heartburn decreased appetite
BYDUREON may reduce your appetite , the amount of food you eat , and your weight .
If you lose weight too quickly (more than 1,5 kg per week ) , tell your doctor, as this can not be good for you.
Uncommon side effects of BYDUREON or those with known:
• angioedema ( swelling of the face and throat)
• hypersensitivity ( rash , itching and swelling rapidly growing tissue in the neck, face, mouth or throat)
Moreover, some other observed adverse reactions in patients taking BYDUREON or product that has the same active ingredient as BYDUREON:
• unusual taste in the mouth Rare:
• reduction of the renal function
• dehydration, sometimes with reduced renal function
• hair loss
• changes in INR ( clotting study ) have been reported in concomitant use with warfarin.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet , please tell your doctor or pharmacist.
5 . HOW TO STORE BYDUREON?
Keep out of reach of children.
BYDUREON not use after the expiry date stated on the label and carton after " EXP" .
Store in the refrigerator. Do not freeze .
However , the kit may be stored for up to 4 weeks at 30 ° C before use. Store in the original package to protect from light. Discard any set of BYDUREON, which has been frozen .
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.
6 . ADDITIONAL INFORMATION
What does BYDUREON:
- The active substance is exenatide . Each vial contains 2 mg of exenatide .
- The other ingredients are:
- Powder in poly u , L-lactide -co- glycolide) and sucrose.
- As solvent : croscarmellose sodium, sodium chloride , polysorbate 20, sodium dihydrogen phosphate monohydrate, sodium phosphate dibasic heptahydrate , and water for injection.
BYDUREON looks like and contents of the pack
Powder and solvent for prolonged release suspension .
The powder is white to off-white , and the solution is clear, colorless to pale yellow or light brown solution.
Each unit dose kit consists of a vial containing 2 mg of exenatide powder , a pre-filled syringe containing 0,65 ml solvent vial , a connector and two injection needles . One needle replacement .
Packs of 4 single-dose kit and a pack of 3 packs of 4 single-dose kit. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Bristol-Myers Squibb / AstraZeneca EEIG