InfoCons Consumer Protection informs you – Praluent – Package Leaflet

Before anything else

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor , pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 1. What Praluent is and what it is used for

What Praluent is

• Praluent contains the active substance alirocumab.
• Praluent is a monoclonal antibody (a type of specialised protein designed to attach to a target substance in the body ). Monoclonal antibodies are proteins that recognise and bind to other unique proteins. Alirocumab binds to PCSK9.

How Praluent works

Praluent helps lower your levels of “bad” cholesterol (also called “LDL cholesterol”). Praluent blocks a protein called PCSK9.

• PCSK9 is a protein secreted by liver cells.
• “Bad” cholesterol is normally removed from your blood by binding to specific “receptors” (docking stations) in your liver.
• PCSK9 lowers the number of these receptors in the liver – this causes your “bad” cholesterol to be higher than it should.
• By blocking PCSK9, Praluent increases the number of receptors available to help remove the “bad” cholesterol – this lowers your “bad” cholesterol levels.

What Praluent is used for

• Adults with high cholesterol levels in their blood (hypercholesterolaemia, heterozygous familial and non-familial, or mixed dyslipidaemia ) and children and adolescents 8 years of age and older with heterozygous familial hypercholesterolaemia (HeFH) .
• Adults with high cholesterol levels in their blood and with cardiovascular disease to reduce cardiovascular risk .

It is given:

• together with a statin (a commonly used medicine that treats high cholesterol) or other cholesterol lowering medicines, if the maximum dose of a statin does not lower levels of cholesterol sufficiently or,
• alone or together with other cholesterol lowering medicines when statins are not tolerated or cannot be used.

Continue to follow your cholesterol -lowering diet while taking this medicine.

⚠️ 2. What you need to know before you use Praluent

Do not use Praluent

• if you are allergic to alirocumab 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 Praluent.

If you develop a serious allergic reaction, stop using Praluent , talk to your doctor right away. Sometimes serious allergic reactions such as hypersensitivity , including angioedema (difficulties breathing , or swelling of the face, lips, throat or tongue ), nummular eczema ( reddish skin spots sometimes with blisters), and hypersensitivity vasculitis (which is a specific form of a hypersensitivity reaction with symptoms such as diarrhoea, with a rash, or purple -coloured skin spots on the skin ) have occurred. For allergic reactions that may occur while taking Praluent, see section 4.

Tell your doctor if you have kidney or liver disease before using this medicine, because Praluent has been studied in few patients with severe kidney disease and not in patients with severe liver disease.

Children and adolescents

Praluent should not be given to children under 8 years old because there is no experience using the medicine in this age group.

Other medicines and Praluent

Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.

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 or pharmacist for advice before using this medicine.

Praluent is not recommended during pregnancy or breast -feeding.

Driving and using machines

This medicine is not expected to have any effect on your ability to drive or use machines.

💊 3. How to use Praluent

Always use this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

How much to inject Your doctor will tell you which dose is right for you and how often to inject (75 mg or 150 mg once every 2 weeks, or 300 mg once every 4 weeks/monthly ). Your doctor will check your cholesterol levels and may adjust the dose (up or down) during treatment.

Always check the label of your syringe to make sure you have the right medicine and the right strength.

When to inject Inject Praluent once every 2 weeks (for the 75 mg or 150 mg dose), or once every 4 weeks/monthly (for the 300 mg dose). To give the 300 mg dose, two 150 mg injections should be given in a row at two different injection sites .

The pre -filled syringe is not intended for use in children and adolescents 8 years of age and older.

Before you inject Praluent should be allowed to warm to room temperature prior to use .

Read the detailed instructions for use leaflet before you inject Praluent.

Where to inject Praluent is injected under your skin into the thigh, abdomen or upper arm.

Read the detailed instructions for use leaflet on where to inject.

Learning how to use the pre -filled syringe Before you use the syringe for the first time, your doctor, pharmacist or nurse will show you how to inject Praluent.

• Always read the “Instructions for Use” provided in the box.
• Always use the syringe as described in the “Instructions for Use”.

If you use more Praluent than you should

If you use more Praluent than you should, talk to your doctor, pharmacist or nurse.

If you forget to use Praluent

If you miss a dose of Praluent, inject your missed dose as soon as you can. Then take your next dose at your regular scheduled time. This will keep you on the original schedule. If you are not sure when to inject Praluent, call your doctor, pharmacist or nurse .

If you stop using Praluent

Do not stop using Praluent without talking with your doctor. If you stop using Praluent, your cholesterol levels can 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.

If you develop a serious allergic reaction, stop using Praluent , talk to your doctor right away. Sometimes serious allergic reactions such as hypersensitivity (difficulties breathing), nummular eczema (reddish skin spots sometimes with blisters), and hypersensitivity vasculitis (which is a specific form of a hypersensitivity reaction with symptoms suc h as diarrhoea, with a rash, or purple -coloured skin spots on the skin) have occurred (may affect up to 1 in 1,000 people) .

Other side effects are

Common (may affect up to 1 in 10 people)

• redness , itching, swelling, pain /tenderness where the medicine was injected (local injection site reactions)
• upper respiratory tract signs or symptoms such as sore throat, running nose, sneezing
• itching (pruritus).

Rare (may affect up to 1 in 1,000 people)

• red and itchy raised bumps or hives (urticaria)

Not Known

The following side effects have been reported since the marketing of Praluent, but how often they occur is

not known

• flu-like illness
• difficulties breathing, or swelling of the face, lips, throat or tongue (angioedema) 106 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.

🌡️ 5. How to store Praluent

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 label and carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator ( 2°C to 8°C ). Do not freeze.

Keep the syringe in the outer carton in order to protect from light.

If needed, individual pre -filled syringes may be kept outside the refrigerator below 25°C for a maximum of 30 days. Protect from light. After removal from the refrigerator, Praluent must be used within 30 days or discarded.

Do not use this medicine if it looks discoloured or cloudy, or if it contains visible flakes or particles .

After use put the syringe into a puncture -resistant container. Ask your doctor, pharmacist or nurse how to throw away the container. Do not recycle the container.

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 Praluent contains

• The active substance is alirocumab.

Praluent 75 mg solution for injection in pre -filled syringe Each single -use syringe contains 75 milligrams of alirocumab.

Praluent 150 mg solution for injection in pre -filled syringe Each single -use syringe contains 150 milligrams of alirocumab.

• The other ingredients are histidine, sucrose, polysorbate 20 and water for injection s.

What Praluent looks like and contents of the pack

Praluent is a clear , colourless to pale yellow solution for injection that comes in a pre-filled syringe.

Praluent 75 mg solution for injection in pre -filled syringe Each pre -filled syringe with green plunger contains 1 ml of solution, delivering one single dose of 75 milligrams of alirocumab .

It is available in pack size of 1, 2 or 6 pre -filled syringes.

Praluent 150 mg solution for injection in pre -filled syringe Each pre -filled syringe with grey plunger contains 1 ml of solution, delivering one single dose of 150 milligrams of alirocumab .

It is available in pack size of 1, 2 or 6 pre -filled syringes.

107 Not all presentations and pack sizes may be marketed.

Marketing Authorisation Holder

Sanofi Winthrop Industrie 82 avenue Raspail 94250 Gentilly France

Manufacturer

Sanofi Winthrop Industrie 1051 Boulevard Industriel 76580 Le Trait France For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/ Belgique /Belgien Sanofi Belgium Tél/Tel: +32 (0)2 710 54 00 Lietuva Swixx Biopharma UAB Tel: +370 5 236 91 40 България Swixx Biopharma EOOD Тел.: +359 (0)2 4942 480 Luxembourg/Luxemburg Sanofi Belgium Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien) Česká republika Sanofi s.r.o.

Tel: +420 233 086 111 Magyarország SANOFI -AVENTIS Zrt.

Tel.: +36 1 505 0050 Danmark Sanofi A/S Tlf: +45 45 16 70 00 Malta Sanofi S.r.l.

Tel: + 39 02 39394275 Deutschland Sanofi -Aventis Deutschland GmbH Tel.: 0800 52 52 010 Tel. aus dem Ausland: +49 69 305 21 131 Nederland Sanofi B.V.

Tel: +31 20 245 4000 Eesti Swixx Biopharma OÜ Tel: +372 640 10 30 Norge sanofi -aventis Norge AS Tlf: +47 67 10 71 00 Ελλάδα Sanofi -Aventis Μονοπρόσωπη AEBE Τηλ: +30 210 900 16 00 Österreich sanofi -aventis GmbH Tel: +43 1 80 185 – 0 España sanofi -aventis, S.A Tel: +34 93 485 94 00 Polska Sanofi Sp. z o.o.

Tel.: +48 22 280 00 00 France Sanofi Winthrop Industrie Tél: 0 800 222 555 Appel depuis l’étranger : +33 1 57 63 23 23 Portugal Sanofi – Produtos Farmacêuticos, Lda.

Tel: +351 21 35 89 400 108 Hrvatska Swixx Biopharma d.o.o.

Tel: +385 1 2078 500 România Sanofi Romania SRL Tel: +40 (0) 21 317 31 36 Ireland sanofi -aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 00 Slovenija Swixx Biopharma d.o.o.

Tel: +386 1 235 51 00 Ísland Vistor hf.

Sími : +354 535 7000 Slovenská republika Swixx Biopharma s.r.o.

Tel: + 421 2 208 33 600 Italia Sanofi S. r.l.

Tel: 800 131212 (domande di tipo tecnico) 800 536389 (altre domande) Suomi/Finland Sanofi Oy Puh/Tel: +358 (0) 201 200 300 Κύπρος C.A. Papaellinas Ltd.

Τηλ: + 357 22 741741 Sverige Sanofi AB Tel: +46 (0)8 634 50 00 Latvija Swixx Biopharma SIA Tel: +371 6 616 47 50 United Kingdom (Northern Ireland) sanofi -aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2525

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/ 109 Praluent pre -filled syringe Instructions for use The parts of the Praluent syringe are shown in this picture.

Important information

• The medicine is injected under your skin and can be given by yourself or someone else (caregiver).
• This syringe can only be used for one single injection, and must be thrown away after use.
• This syringe is only for use in adults.

Do ✓ Keep the Praluent syringe out of the sight and reach of children. ✓ Read all of the instructions carefully before using the Praluent syringe. ✓ Follow these instructions every time you use a Praluent syringe.

Do not  Do not touch the needle.  Do not use the syringe if it has been dropped or damaged.  Do not use the syringe if the grey needle cap is missing or not securely attached.  Do not re -use a syringe.  Do not shake the syringe.  Do not freeze the syringe.  Do not expose syringe to direct sunlight.

Keep this leaflet. If you have questions, ask your doctor, pharmacist or nurse or call the local representative of the Marketing Authorization Holder on the package leaflet.

STEP A: G etting ready for an injection Before you start you will need:

• the Praluent syringe Syringe body Needle cap Needle Green plunger 110 • alcohol wipes
• cotton ball or gauze
• a puncture -resistant container (see Step B, 6) .

 Before you start.

• Take the syringe out of the packaging by holding the syringe body.

 Look at the label on the syringe.

• Check that you have the correct product and the correct dose (gr een plunger for 75 mg/ml).
• Check the use by date and do not use if this date has passed.
• Check the liquid is clear, colo urless to pale yellow and free from particles ; if not, do not use.
• Check that the syringe is not open or damaged.

 Let the syringe warm up at room temperature for 30 to 40 minutes.

• Do not heat the syringe, let it warm up on its own.
• Do not put the syringe back in the refrigerator.

 Prepare the injection site.

• Wash your hands with soap and water and dry with a towel.
• You can inject into your : o thigh o belly (except for the 5 cm area around your navel) o outer side of your upper arm (See picture).
• You can stand or sit to give yourself an injection.
• Clean skin in the injection area with an alcohol wipe.
• Do not use skin that is tender, hard, red or hot.
• Do not use any area near a visible vein.
• Use a different spot each time you inject.
• Do not in ject Praluent with other inject able medicines at the same spot.

STEP B: How to inject  After completing all steps in “ Step A: Getting ready for an injection ”, pull off the needle cap.

• Do not pull off the cap until you are ready to inject.
• Hold the syringe in the middle of the syringe body with the needle pointing away from you.
• Keep your hand away from the plunger.
• You may see air bubble (s). This is normal. Do not get rid of any air bubbles in the syringe before the injection.
• Do not put the grey cap back on.

 If needed pinch the skin.

• Use your thumb and first finger to pinch a fold of skin at the injection site.
• Hold the skin like this for the whole injection.

 Insert the needle into the fold of skin with a quick dart -like motion.

• Use a 90º angle if you can pinch 5 cm of skin.
• Use a 45° angle if you can only pinch 2 cm of skin.

Needle cap Plunger  Push the plunger down.

• Inject all of the solution by slowly and steadily pushing down the plunger.

 Before you remove the needle check the syringe is empty.

• Do not remove the syringe until it is completely empty.
• Pull the needle out of the skin at the same angle as it was inserted.
• Do not rub the skin after the injection.
• If you see any blood, press a cotton ball or gauze on the site until the bleeding stops.

 Throw away syringe and cap

• Do not put the grey needle cap back on.
• Do not re -use the syringe.
• Throw away syringe and cap into a puncture -resistant container immediately after use.
• Ask your doctor, pharmacist or nurse how to throw away the container .

113 • Always keep the container out of the sight and reach of children.

Praluent pre-filled s yringe Instructions for use The parts of the Praluent syringe are shown in this picture.

Important information

• The medicine is injected under your skin and can be given by yourself or someone else (caregiver).
• This syringe can only be used for one single injection, and must be thrown away after use.
• This syringe is only for use in adults.

Do ✓ Keep the Praluent syringe out of the sight and reach of children. ✓ Read all of the instructions carefully before using the Praluent syringe. ✓ Follow these instructions every time you use a Praluent syringe.

Do not  Do not touch the needle.  Do not use the syringe if it has been dropped or damaged.  Do not use the syringe if the grey needle cap is missing or not securely attached.  Do not re -use a syringe.  Do not shake the syringe.  Do not freeze the syringe.  Do not expose syringe to direct sunlight.

Keep this leaflet. If you have questions, ask your doctor, pharmacist or nurse or call the local representative of the Marketing Authorization Holder on the package leaflet.

STEP A: Getting ready for an injection Before you start you will need:

• the Praluent syringe Grey plunger Syringe body Needle cap Needle 115 • alcohol wipes
• cotton ball or gauze
• a puncture -resistant container (see Step B, 6) .

 Before you start.

• Take the syringe out of the packaging by holding the syringe body.

 Look at the label on the syringe.

• Check that you have the correct product and the correct dose (grey plunger for 150 mg/m l).
• Check the use by date and do not use if this date has passed.
• Check the liquid is clear, colo urless to pale yellow and free from particles ; if not, do not use.
• Check that the syringe is not open or damaged.

 Let the syringe warm up at room temperature for 30 to 40 minutes.

• Do not heat the syringe, let it warm up on its own.
• Do not put the syringe back in the refrigerator.

 Prepare the injection site.

• Wash your hands with soap and water and dry with a towel.
• You can inject into your : o thigh o belly (except for the 5 cm area around your navel) o outer side of your upper arm (See picture).
• You can stand or sit to give yourself an injection.
• Clean skin in the injection area with an alcohol wipe.
• Do not use skin that is tender, hard, red or hot.
• Do not use any area near a visible vein.
• Use a different spot each time you inject.
• Do not in ject Praluent with other inject able medicines at the same spot.

STEP B: How to inject  After completing all steps in “ Step A: Getting ready for an injection ”, pull off the needle cap .

• Do not pull off the cap until you are ready to inject.
• Hold the syringe in the middle of the syringe body with the needle pointing away from you.
• Keep your hand away from the plunger.
• You may see air bubble (s). This is normal. Do not get rid of any air bubbles in the syringe before the injection.
• Do not put the grey cap back on.

 If needed pinch the skin.

• Use your thumb and first finger to pinch a fold of skin at the injection site.
• Hold the skin like this for the whole injection.

 Insert the needle into the fold of skin with a quick dart -like motion.

• Use a 90º angle if you can pinch 5 cm of skin.
• Use a 45° angle if you can only pinch 2 cm of skin.

Needle cap Plunger  Push the plunger down.

• Inject all of the solution by slowly and steadily pushing down the plunger.

 Before you remove the needle check the syringe is empty.

• Do not remove the syringe until it is completely empty.
• Pull the needle out of the skin at the same angle as it was inserted.
• Do not rub the skin after the injection.
• If you see any blood, press a cotton ball or gauze on the site until the bleeding stops.

 Throw away syringe and cap

• Do not put the grey needle cap back on.
• Do not re -use the syringe.
• Throw away syringe and cap into a puncture -resistant container immediately after use.

118 • Ask your doctor, pharmacist or nurse how to throw away the container.

• Always keep the container out of the sight and reach of children.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Praluent (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/15/1031).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.