LYXUMIA 20 mcg. 3 ml. 2 PEN

SANOFI AVENTIS
LYXUMIA 20 mcg. 3 ml. 2 PEN
€ 145.00
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What is Lyxumia and what it is used
Lyxumia contains the active substance liksizenatid.
Lyxumia medicine for injection, which is used to help the body to control the blood glucose level when the blood glucose is high. It is used in adult patients with type 2 diabetes mellitus.

Lyxumia is used together with other medicines for diabetes when they are not enough to control blood sugar. These may include:
oral antidiabetic drugs (eg. metformin, pioglitazone, sulfonylureas);
basal insulin, insulin type, which operates throughout the day.

2. What you should know before using Lyxumia
Do not use Lyxumia:
if you are allergic to liksizenatid or any of the other ingredients of this medicine (listed in section 6).
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before using Lyxumia, if:
have type 1 diabetes or diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose, because there is not enough insulin), as this medicine is not suitable for you;
have or have had inflammation of the pancreas (pancreatitis);
have a severe problem with the stomach or intestine, such as disease of the stomach muscles, called "gastroparesis", which leads to delayed gastric emptying;
have severe kidney disease or are on dialysis, since the use of this medicine is not recommended;
also taking a sulphonylurea or basal insulin. This is because you can get low blood sugar (hypoglycemia). Your doctor may want to monitor your blood sugar and then decide to reduce the dose of basal insulin or sulphonylurea. Lyxumia should not be used in combination with a basal insulin and a sulphonylurea;
taking other medicines, as there are other drugs, eg. antibiotics or gastro-resistant tablets or capsules should not remain too long in the stomach (see section "Other medicines and Lyxumia");
have fluid loss / dehydration, eg. with vomiting, nausea and diarrhea. It is important to avoid dehydration by taking enough fluids, especially when starting treatment with Lyxumia;
suffer from heart problems that can cause shortness of breath or swelling of the ankles, as experience in this population is limited.
Children and adolescents
There is no experience with Lyxumia in children and adolescents under the age of 18 years is therefore not recommended for use Lyxumia in this age group.

Other medicines and Lyxumia
Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.
The effect of some drugs taken orally, can be affected by Lyxumia.
Some drugs, eg. antibiotics or gastroresistant tablets or capsules that must not remain too long in the stomach, must be taken at least one hour before or four hours after injection of Lyxumia.

Pregnancy and lactation
Lyxumia should not be used in pregnancy. It is not known whether Lyxumia can cause damage to the unborn child.
Lyxumia should not be used during breastfeeding. It is not known whether Lyxumia passes into breast milk.
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.

Driving and using machines
If you use Lyxumia sulphonylurea or basal insulin may get low blood sugar (hypoglycemia). This can affect your ability to concentrate and you may feel dizzy or drowsy. If this happens, do not drive or operate any tools or machines.

Important information about some of the ingredients of Lyxumia
This product contains less than 1 mmol sodium (23 mg) per dose, ie practically does not contain sodium.
This drug contains metacresol, which may cause allergic reactions.

3. How to use Lyxumia
Always use this medicine exactly as prescribed by your doctor, pharmacist or nurse. If you are not sure, ask your doctor, pharmacist or nurse.

How to inject
The starting dose is 10 micrograms once daily for the first 14 days - injected with a green pen;
The dose will then be 20 micrograms once daily - using a purple pen.
When to inject
Inject with Lyxumia one hour before any of the meals for the day. Preferably Lyxumia be injected before the same meal every day, when you choose the most convenient meal for your injection.

Where to inject
Inject with Lyxumia in the skin (subcutaneously), stomach area (abdomen), upper leg (thigh), or upper arm.

How to use pre-filled pens
Before using the pen for the first time, your doctor or nurse will show you how to inject yourself with Lyxumia.
Always read the "instructions for use" in the package;
Always use the pen as described in these "Instructions for Use".
Other important information about the use of pre-filled pens
The "instructions for use" for more information on how to use the pen. The most important things are:
Always use a new needle for each injection. Dispose of needles after each use;
Only use needles that are compatible for use with pen Lyxumia (see "Instructions for Use");
You must activate your pen Lyxumia, before using it for the first time. This is to make sure that it works properly and that the dose of your first injection is correct;
If you think your pen Lyxumia may be damaged, do not use it. Get a new one. Do not attempt to repair the pen.
If you use more than the amount Lyxumia
If you use more than the amount of Lyxumia, inform your doctor immediately.
If you used a higher dose Lyxumia, you may experience nausea or vomiting.

If you forget to use Lyxumia
If you miss a dose Lyxumia, it can inject an hour before the next meal.
Do not use two doses on the same day to make up for a missed injection.

If you stop using Lyxumia
Do not stop taking Lyxumia, without talking to your doctor. If you stop using Lyxumia, your blood sugar 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.
Some severe allergic reactions (eg. Anaphylaxis) have been reported uncommonly in patients receiving Lyxumia. You should seek immediate medical attention if you experience symptoms such as swollen face, tongue or throat, causing difficulty breathing.

Stop taking Lyxumia and immediately contact a doctor if you notice any of these serious side effects:
Strong and prolonged pain in the abdomen (stomach area), which can spread to the back, nausea and vomiting, as this may be a sign of inflammation of the pancreas (pancreatitis).
The most common side effects reported with Lyxumia, which may affect more than 1 in 10 people (very common) were nausea and vomiting. These adverse reactions were mostly mild and usually disappear with time.

Other very common side effects reported with Lyxumia:
diarrhea;
headache;
Low blood sugar (hypoglycemia), especially when Lyxumia used with insulin or sulphonylureas. Warning signs of low blood sugar may include cold sweats, cool pale skin, headache, sleepiness, weakness, dizziness, confusion or irritability, feeling hunger, fast heartbeat and nervousness. Your doctor will advise you what to do if you get low blood sugar. This is more likely to happen if you are also taking a sulphonylurea or basal insulin. Your doctor may reduce the dose of these medications before you start using Lyxumia.
Common side effects may affect up to 1 in 10 users:
Flu (influenza);
Cold (infection of the upper respiratory tract);
dizziness;
Indigestion (dyspepsia);
Back pain;
cystitis;
Viral infection;
Low blood sugar (Lyxumia when used with metformin);
drowsiness;
Reactions at the injection site (such as itchy).
Uncommon side effects may affect up to 1 in 100 users:
Hives (urticaria).
Adverse event reporting
If you get any side effects, tell your doctor, pharmacist or nurse. This includes any possible effects not listed in this leaflet. You can also report adverse events directly through the national reporting system. As reported adverse reactions, you can do your bit to get more information on the safety of this medicine.

5. How to store Lyxumia
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the pen label and carton respectively after "EXP" and "EXP". The expiry date refers to the last day of that month.

Before first use
Store in a refrigerator (2 ° C-8 ° C). Do not freeze. Keep away from the freezer.

During use of the pen
The pen can be used for 14 days when stored at temperatures below 30 ° C. Do not freeze. Do not store with needle attached. When not using the pen cap must be put back on the pen in order to protect from light.

Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information
What Lyxumia
The active substance is liksizenatid.
Each dose contains 10 Lyxumia 10 micrograms liksizenatid (50 micrograms per ml).
Each dose contains 20 Lyxumia liksizenatid 20 micrograms (100 micrograms per ml).

The other ingredients are: glycerol 85%, sodium acetate trihydrate, methionine, m-cresol, hydrochloric acid (to adjust pH), sodium hydroxide solution (to adjust pH) and water for injections.

Lyxumia looks like and contents of the pack
Lyxumia is clear and colorless solution for injection (injection) filled in a glass cartridge within a pre-filled pen.
Each green pen Lyxumia contains 3 ml solution, delivering 14 doses of 10 micrograms Lyxumia 10. Pack 1 pre-filled pen.
Each purple pen Lyxumia contains 3 ml solution, delivering 14 doses of 20 micrograms Lyxumia 20. Pack with 1, 2 or 6 pre-filled pens.
Not all pack sizes may be marketed in your country.
Package is also available for the initiation of treatment, for use during the first 28 days of treatment. Packaging treatment initiation contain a green pen Lyxumia 10 micrograms and a purple pen Lyxumia 20 micrograms.
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