Active ingredient
- liraglutide
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.
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/1/15/992/001, EU/1/15/992/002, EU/1/15/992/003.
Saxenda 6 mg/mL solution for injection in pre-filled pen
Package leaflet: Information for the patient
Saxenda® 6 mg/ml
Solution for injection in pre-filled pen
liraglutide
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1. What Saxenda® is and what it is used for
2. What you need to know before you use Saxenda®
3. How to use Saxenda®
4. Possible side effects
5. How to store Saxenda®
6. Contents of the pack and other information
1. What Saxenda® is and what it is used for
What Saxenda® is
Saxenda® is a weight loss medicine that contains the active substance liraglutide. It is similar to a natural occurring hormone called glucagon-like peptide-1 (GLP-1) that is released from the intestine after a meal. Saxenda® works by acting on receptors in the brain that control your appetite, causing you to feel fuller and less hungry. This may help you eat less food and reduce your body weight.
What Saxenda® is used for
Saxenda® is used for weight loss in addition to diet and exercise in adults aged 18 and above who have
BMI (Body Mass Index) is a measure of your weight in relation to your height.
You should only continue using Saxenda® if you have lost at least 5% of your initial body weight after 12 weeks on the 3 mg/day dose (see section 3). Consult your doctor before you continue.
Diet and exercise
Your doctor will start you on a diet and exercise programme. Stay on this programme while you are using Saxenda®.
2. What you need to know before you use Saxenda®
Do not use Saxenda®:
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Saxenda®.
The use of Saxenda® is not recommended if you have severe heart failure.
There is little experience with this medicine in patients of 75 years and older. It is not recommended if you are 75 years or older.
There is little experience with this medicine in patients with kidney problems. If you have kidney disease or are on dialysis, consult your doctor.
There is little experience with this medicine in patients with liver problems. If you have liver problems, consult your doctor.
This medicine is not recommended if you have a severe stomach or gut problem which results in delayed stomach emptying (called gastroparesis), or if you have an inflammatory bowel disease.
People with diabetes
If you have diabetes, do not use Saxenda® as a replacement for insulin.
Inflammation of the pancreas
Talk to your doctor if you have or have had a disease of the pancreas.
Inflamed gall bladder and gallstones
If you lose substantial weight, you are at a risk of gallstones and thereby inflamed gall bladder. Stop taking Saxenda® and contact a doctor immediately if you experience severe pain in your upper abdomen, usually worst on the right side under the ribs. The pain may be felt through to your back or right shoulder. See section 4.
Thyroid disease
If you have thyroid disease, including thyroid nodules and enlargement of the thyroid gland, consult your doctor.
Heart rate
Talk to your doctor if you have palpitations (you feel aware of your heartbeat) or if you have feelings of a racing heartbeat while at rest during Saxenda® treatment.
Loss of fluid and dehydration
When starting treatment with Saxenda®, you may lose body fluid or become dehydrated. This may be due to feeling sick (nausea), being sick (vomiting) and diarrhoea. It is important to avoid dehydration by drinking plenty of fluids. Talk to your doctor, pharmacist or nurse if you have any questions or concerns. See section 4.
Children and adolescents
Saxenda® should not be used in children and adolescents under 18 years of age. This is because the effects and safety of this medicine have not been studied in this age group.
Other medicines 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:
Pregnancy and breast-feeding
Do not use Saxenda® if you are pregnant, think that you might be pregnant or are planning to have a baby. This is because it is not known if Saxenda® may affect the baby.
Do not breast-feed if you are using Saxenda®. This is because it is not known if Saxenda® passes into breast milk.
Driving and using machines
Saxenda® is unlikely to affect your ability to drive and use machines.
Some patients may feel dizziness when taking Saxenda mainly during the first 3 months of treatment (see section ‘Possible side effects’). If you feel dizziness be extra careful while driving or using machines. If you need any further information, talk to your doctor.
Important information about some of the ingredients of Saxenda®
This medicine contains less than 1 mmol sodium (23 mg) per dose, that it is to say essentially ‘sodium-free’.
3. How to use Saxenda®
Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.
Your doctor will start you on a diet and exercise programme. Stay on this programme while you are using Saxenda®.
How much to inject
Your treatment will start at a low dose which will be gradually increased over the first five weeks of treatment.
Your doctor will tell you how much Saxenda® to use each week. Usually, you will be told to follow the table below.
Week Dose injected
Week 1 0.6 mg once a day
Week 2 1.2 mg once a day
Week 3 1.8 mg once a day
Week 4 2.4 mg once a day
Week 5 onwards 3.0 mg once a day
Once you reach the recommended dose of 3.0 mg in week 5 of treatment, keep using this dose until your treatment period ends. Do not increase your dose further.
Your doctor will assess your treatment on a regular basis.
How and when to use Saxenda®
Where to inject
Saxenda® is given as an injection under the skin (subcutaneous injection).
Detailed instructions for use are provided on the other side of this leaflet.
People with diabetes
Tell your doctor if you have diabetes. Your doctor may adjust the dose of your diabetes medicines to prevent you from getting low blood sugar.
If you use more Saxenda® than you should
If you use more Saxenda® than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. You may need medical treatment. The following effects may happen:
If you forget to use Saxenda®
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
Some severe allergic reactions (anaphylaxis) have been reported rarely in patients using Saxenda®. You should see your doctor straight away if you get symptoms such as breathing problems, swelling of face and throat and a fast heartbeat.
Cases of inflammation of the pancreas (pancreatitis) have been reported uncommonly in patients using Saxenda®. Pancreatitis is a serious, potentially life-threatening medical condition.
Stop taking Saxenda® and contact a doctor immediately if you notice any of the following serious side effects:
Other side effects
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 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
Ireland:
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Saxenda®
Keep this medicine out of the sight and 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 to 8°C). Do not freeze. Keep away from the freezer compartment.
Once you start using the pen:
You can keep the pen for 1 month when stored 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 you are not using the pen, keep the pen cap on in order to protect it from light.
Do not use this medicine if the solution is not clear and colourless or almost colourless.
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 Saxenda® contains
What Saxenda® looks like and contents of the pack
Saxenda® is supplied as a clear and colourless or almost colourless solution for injection in a pre-filled pen. Each pen contains 3 ml solution and is able to deliver doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg and 3.0 mg.
Saxenda® is available in pack sizes containing 1, 3 or 5 pens. Not all pack sizes may be marketed.
Needles are not included.
Marketing Authorisation Holder and Manufacturer
This leaflet was last revised in 09/2020
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Saxenda®, NovoFine® and NovoTwist® are trademarks owned by Novo Nordisk A/S, Denmark
© 2020
Novo Nordisk A/S
Instructions on how to use Saxenda® 6 mg/ml solution for injection in pre-filled pen
Please read these instructions carefully before using your Saxenda® pre-filled pen.
Do not use the pen without proper training from your doctor or nurse.
Start by checking your pen to make sure that it contains Saxenda® 6 mg/ml, then look at the illustrations below to get to know the different parts of your 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 help. Get help from a person with good eyesight who is trained to use the Saxenda® pre-filled pen.
Your pen is a pre-filled dial-a-dose pen. It contains 18 mg of liraglutide and delivers 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 a length of 8 mm and as thin as 32 G.
Needles are not included in the pack.
Important information
Pay special attention to these notes as they are important for safe use of the pen.
1 Prepare your pen with a new needle
Always use a new needle for each injection.
This may prevent blocked needles, contamination, infection and inaccurate dosing.
Never use a bent or damaged needle.
2 Check the flow
Always make sure that a drop appears at the needle tip before you use a new pen for the first time. This makes sure that the solution flows.
If no drop appears, you will not inject any medicine, even though the dose counter may move. This may indicate a blocked or damaged needle.
If you do not check the flow before your first injection with each new pen, you may not get the prescribed dose and the intended effect of Saxenda®.
3 Select your dose
Always use the dose counter and the dose pointer to see how many mg you have selected before injecting this medicine.
Do not count the pen clicks.
Do not use the pen scale. It only shows approximately how much solution is left in your pen.
Only doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3.0 mg must be selected with the dose selector. The selected dose must line up precisely with the dose pointer to ensure that you get a correct dose.
How much solution is left?
If you need more medicine than what is left in your pen
Only if trained or advised by your doctor or nurse, you may split your dose between your current pen and a new pen. Use a calculator to plan the doses as instructed by your doctor or nurse.
Be very careful to calculate correctly.
If you are not sure how to split your dose using two pens, then select and inject the dose you need with a new pen.
4 Inject your dose
Always watch the dose counter to know how many mg you inject. Hold the dose button down until the dose counter shows 0.
How to identify a blocked or damaged needle?
How to handle a blocked needle?
Change the needle as described in step 5 ‘After your injection’ and repeat all steps starting with step 1 ‘Prepare your pen with a new needle’. Make sure you select the full dose you need.
Never touch the dose counter when you inject. This can interrupt the injection.
5 After your injection
Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.
Always remove the needle from your pen after each injection.
This may prevent blocked needles, contamination, infection, leakage of solution and inaccurate dosing.
Further important information
Caring for your pen
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