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Saxenda 6 mg. / ml. 3 ml. 3 pen

Product Code: Saxenda 6 mg. / ml. 3 ml. 3 pen
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What Saxenda is and what it is used for
What is Saxenda
Saxenda is a weight loss medicine that contains the active substance liraglutide. It is similar to a naturally produced hormone called GLP-1, which is released from the gut after eating. Saxenda works by acting on receptors in the brain that control appetite, making you feel fuller and less hungry. This can help you eat less and lose weight.

What Saxenda is used for
Saxenda is used for weight loss in addition to diet and exercise in adults aged 18 and over who have

BMI 30 or more (obesity) or
BMI 27 and less than 30 (overweight) and weight-related health problems (such as diabetes, high blood pressure, blood fat abnormalities or sleep-disordered breathing problems called 'obstructive sleep apnea').
BMI (body mass index) is a measure of your weight relative to your height.

You should continue to use Saxenda only if you have lost at least 5% of your initial body weight after 12 weeks at a dose of 3 mg / day (see section 3). Consult your doctor before proceeding.

Diet and exercise
Your doctor will prescribe a diet and exercise program. Stick to it while using Saxenda.

2. What you need to know before you use Saxenda
Do not use Saxenda:
if you are allergic to liraglutide or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Ask your doctor, pharmacist or nurse for advice before using Saxenda.

Saxenda is not recommended if you have severe heart failure.

There is little experience with this drug in patients over 75 years of age. It is not recommended if you are 75 or older.
There is little experience with this drug in patients with kidney problems. If you have kidney disease or are on dialysis, talk to your doctor.

There is little experience with this drug in patients with liver problems. If you have liver problems, consult your doctor.

This medicine is not recommended if you have severe stomach or intestinal problems that lead to delayed gastric emptying (called gastroparesis) or inflammatory bowel disease.

People with diabetes
If you have diabetes, do not use Saxenda as an insulin substitute.

Inflammation of the pancreas
Talk to your doctor if you have or have had pancreatic disease.

Inflammation of the gallbladder or gallstones
If you lose a lot of weight, there is a risk of gallstones and, as a result, inflammation of the gallbladder. Stop using Saxenda and contact your doctor immediately if you experience severe pain in the upper abdomen, usually more severe on the right side, below the ribs. The pain may spread to the back or right shoulder. See point 4.

Thyroid disease
If you have thyroid disease, including nodules and an enlarged thyroid gland, consult your doctor.

Heartbeat
Talk to your doctor if you have palpitations (you feel your heart beating) or a strong heartbeat at rest during treatment with Saxenda.

Fluid loss and dehydration
When you start treatment with Saxenda, you may lose body fluids or become dehydrated. This may be due to nausea, vomiting or diarrhea. It is important to avoid dehydration by drinking enough fluids. Talk to your doctor, pharmacist or nurse if you have any further questions or concerns. See point 4.

Children and adolescents
Saxenda should not be used in children and adolescents under 18 years of age. The reason for this is that the effects of the drug have not been studied in this age group.

Other drugs and Saxenda
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor, pharmacist or nurse if:
you are taking medicines for diabetes called 'sulphonylureas' (such as glimepiride or glibenclamide) - your blood sugar level may drop (hypoglycaemia) when you take these medicines with Saxenda. Your doctor may adjust the dose of your antidiabetic medicine to protect you from lowering your blood sugar. See section 4 for warning signs of low blood sugar.
you are taking warfarin or other medicines by mouth that reduce blood clotting (anticoagulants). More frequent blood tests may be needed to determine the ability of your blood to clot.
Pregnancy and lactation
Do not use Saxenda if you are pregnant, think you may be pregnant, or are planning to become pregnant. The reason for this is that it is not known whether Saxenda can affect the fetus.

You should not breast-feed if you are using Saxenda. The reason for this is that it is not known whether Saxenda passes into breast milk.

Driving and using machines
Saxenda is unlikely to affect your ability to drive or use machines. If you need more information, talk to your doctor, pharmacist or nurse.

Important information about some of the ingredients of Saxenda
This medicine contains less than 1 mmol sodium (23 mg) per dose. This means that it contains virtually no sodium.

3. How to use Saxenda
Always use Saxenda exactly as your doctor has told you. If you are not sure, talk to your doctor, pharmacist or nurse. Your doctor will prescribe a diet and exercise program. Stick to it while using Saxenda.

How much to inject
Your treatment will start with a low dose and will gradually increase during the first five weeks.

When you first start using Saxenda, the starting dose is 0.6 mg once a day for at least one week.
You should increase your dose by 0.6 mg each week until you reach the recommended dose of 3.0 mg once a day.

Your doctor will tell you how much Saxenda to use each week. You will usually need to follow the table below.

Week 1 - 0.6 mg once daily;
Week 2 - 1.2 mg once daily;
Week 3 - 1.8 mg once daily;
Week 4 - 2.4 mg once daily;
Week 5 onwards - 3.0 mg once daily.
Once you reach the recommended dose of 3.0 mg in the 5th week of treatment, continue to use this dose until the end of the treatment period. Do not increase your dose further.

Your doctor will regularly evaluate your treatment.

How and when to use Saxenda
Before using the pen for the first time, your doctor or nurse will show you how to handle it.
You can use Saxenda at any time of the day, with or without food and drink.
Use Saxenda at about the same time each day - choose the one that works best for you.

Where to inject
Saxenda is injected under the skin (subcutaneous injection).
The most suitable injection sites are: the front of the waist (abdomen), the front of the thighs or the upper arm.
Do not inject into a vein or muscle.

Detailed instructions for use are given on the other page of this leaflet.

People with diabetes
Tell your doctor if you have diabetes. It can adjust the dose of your antidiabetic medicines to protect you from lowering your blood sugar.

Do not mix Saxenda with other medicines you inject (eg insulin).
Do not use Saxenda in combination with other medicines containing GLP-1 receptor agonists (such as exenatide or lixisenatide).

If you use more Saxenda than you should
If you use more Saxenda than you should, tell your doctor immediately or go to a hospital. Take the medicine pack with you. You may need medical attention. The following effects are possible:

nausea;
vomiting.
If you forget to use Saxenda
If you miss a dose and remember within 12 hours of the usual time you took the dose, inject it as soon as you remember.
However, if more than 12 hours have passed since you had to use Saxenda, skip the missed dose and inject your next dose the next day at the usual time.
Do not use a double dose or increase the dose the next day to make up for a forgotten dose.

If you stop using Saxenda
Do not stop using Saxenda without talking to your doctor.

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
Rare cases of some severe allergic reactions (anaphylaxis) have been reported in patients using Saxenda. You should see your doctor immediately, if any
Low blood sugar (hypoglycaemia). Warning signs of low blood sugar may come on suddenly and may include: cold sweat, cool pale skin, headache, palpitations, nausea, severe hunger; changes in vision, drowsiness, weakness; nervousness, anxiety, confusion, difficulty concentrating and trembling (tremor). Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs;
Increased pancreatic enzymes such as lipase and amylase.
Uncommon: may affect up to 1 in 100 people:

Fluid loss (dehydration). This is more likely to occur at the beginning of treatment and may be due to vomiting, nausea and diarrhea;
Inflammation of the gallbladder;
Allergic reactions, including skin rash;
General malaise;
Accelerated pulse.
Rare: may affect up to 1 in 1,000 people:

Decreased renal function;
Acute renal failure. Signs may include decreased urine output, a metallic taste in the mouth, and easy bruising.
5. How to store Saxenda
Keep out of reach of children.

Do not use Saxenda after the expiry date which is stated on the pen label and carton after 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 compartment.

Once you start using the pen:
You can store the pen for 1 month at a temperature below 30 ° C or in a refrigerator (2 ° C to 8 ° C). Do not freeze. Keep away from the freezer compartment.

When not in use, store the pen with the cap in place to protect it from light.

Do not use this medicine if the solution is not clear and colorless or almost colorless.

Do not throw away any medicines 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. Contents of the package and additional information

What Saxenda contains

The active substance is liraglutide. 1 ml of solution for injection contains 6 mg liraglutide. One pre-filled pen contains 18 mg liraglutide.
The other ingredients are: disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid and sodium hydroxide (for pH adjustment) and water for injections.
What Saxenda looks like and contents of the pack
Saxenda is a clear, colorless or almost colorless solution for injection in a pre-filled pen. Each pen contains 3 ml of solution and can deliver doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg and 3.0 mg.

Saxenda is available in packs of 1, 3 or 5 pens. Not all pack sizes may be marketed.

Needles are not included.
Instructions for use of Saxenda 6 mg / ml solution for injection in a pre-filled pen
Please read these instructions carefully before using the pre-filled Saxenda pen.
Do not use the pen without proper training from your doctor or nurse.
Start by checking the pen to make sure it contains Saxenda 6 mg / ml, then look at the illustrations below to see the different parts of the pen and needle.
If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without assistance. Seek help from a visually impaired person who has been trained to use the pre-filled Saxenda pen. This is a pre-filled pen with a choice of dose. It contains 18 mg liraglutide and releases doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg and 3.0 mg. Your pen is designed to be used with NovoFine or NovoTwist disposable needles up to 8 mm long and at least 32 G thick.
Needles are not included in the package.

Important information
Pay special attention to these notes, as they are important for the safe use of the pen.

1. Prepare your pen with a new needle
Check the name and color label of the pen to make sure it contains Saxenda. This is extremely important if you are using more than one type of medicine that is being injected. Using the wrong medicine can be dangerous to your health.
Remove the pen cap.
Make sure the solution in the pen is clear and colorless. Look out the window at the pen. If the solution looks cloudy, do not use the pen.
Take a new needle and remove the paper label.
Push the needle straight onto the pen. Twist until firm.
Remove the outer needle cap and keep it for later. You will need it after the injection to safely remove the needle from the pen.
Remove the inner needle cap and discard. If you try to put it back on, you may inadvertently prick the needle. A drop of the solution may appear on the tip of the needle. This is normal, but you should still check the leak if you are using a new pen for the first time.
Do not put a new needle on the pen until you are ready to inject the medicine.
Always use a new needle for each injection. This can prevent clogging of the needles, contamination, infection and inaccurate dosing.

Never use a crooked or damaged needle.
2. Check for leaks
Check the leak with each new pen before the first injection. If you are already using the pen, go to step 3 "Selecting the dose".
Turn the dose selector until the dose counter shows the leak check symbol.
Hold the pen with the needle pointing up.
Press and hold the dose knob until the dose counter returns to 0. The number 0 must be aligned with the dose arrow.
A drop of solution should appear on the tip of the needle.
A small drop may remain on the tip of the needle, but it will not be injected.
If a drop does not appear, repeat step 2 "Check for leaks" up to 6 times. If there is still no drop, change the needle and repeat step 2 "Check for leaks" once more.
If a drop has not yet appeared, discard the pen and use a new one.
Always make sure that a drop appears on the tip of the needle before using a new pen for the first time. This ensures that the solution flows.
If a drop does not appear, you will not inject any amount of the medicine, although the dose counter may move. This may mean that the needle is clogged or damaged.
If you do not check the leak before the first injection with each new pen, you may not get the prescribed dose and the desired effect of Saxenda.
3. Dose selection
Turn the dose selector until the dose counter shows your dose (0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3.0 mg).
If you have selected the wrong dose, you can turn the selector forwards or backwards until the correct dose is reached.
A maximum of 3.0 mg can be selected with the stylus.
The dose selector changes the dose. Only the dose counter and arrow will show how many mg per dose you have chosen.
You can dial up to 3.0 mg per dose. When the pen contains less than 3.0 mg, the dose counter stops before 3.0 is displayed.
The dose selector clicks differently when rotating forwards, backwards or when the number of mg remaining is exceeded. Do not count the clicks of the pen.
Always use the dose counter and dose arrow to see how many mg you have chosen before injecting the medicine.
Do not count the clicks of the pen. Do not use the pen scale. It shows only approximately how much solution is left in the pen.
Only doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3.0 mg should be selected with the dose selector. The selected dose should be directly opposite the arrow to ensure that the correct dose is administered.
How much solution is left?
The rock

 

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