Norvir 100 mg powder for oral suspension: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Norvir 100 mg powder for oral suspension

ritonavir

Read the entire leaflet carefully before you or your child start taking this medicine, because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you (or your child) only. Do not give it to others, even if they have the same symptoms as you, because it could harm them.
If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.

Contents of the leaflet:

What Norvir is and what it is used for
What you need to know before you or your child take Norvir
How to take Norvir
Possible side effects
How to store Norvir
Contents of the pack and other information

1. What Norvir is and what it is used for

Norvir contains the active substance ritonavir. Norvir is a protease inhibitor used to control HIV infection. Norvir is used in combination with other anti-HIV (antiretroviral) medicines to control HIV infection. Your doctor will discuss with you the most appropriate combination of medicines for you.

Norvir is used in children from 2 years of age, adolescents, and adults infected with HIV, the virus that causes AIDS.

2. What you need to know before you or your child take Norvir

Do not take Norvir

if you are allergic to ritonavir or any of the other components of this medicine (see section 6).
if you have severe liver disease.
if you are currently taking any of the following medicines:
astemizole or terfenadine (normally used to treat allergy symptoms – these medicines may be purchased without a prescription);
amiodarone, bepridil, dronedarone, encainide, flecainide, propafenone, quinidine (used to correct irregular heartbeats);
dihydroergotamine, ergotamine (used to treat migraine headaches);
ergonovine, methylergonovine (used to stop bleeding that may occur after childbirth or abortion);
clorazepate, diazepam, estazolam, flurazepam, triazolam, or oral midazolam (taken by mouth) (used to help you sleep and/or relieve anxiety);
clozapine, pimozide (used to treat abnormal thoughts or feelings);
quetiapine (used to treat schizophrenia, bipolar disorder, and major depressive disorder);
lurasidone (used to treat depression);
ranolazine (used to treat chronic chest pain [angina pectoris]);
meperidine, piroxicam, propoxyphene (used to relieve pain);
cisapride (used to relieve certain stomach pains);
rifabutin (used to prevent/treat certain infections)*;
voriconazole (used to treat fungal infections)*;
simvastatin, lovastatin (used to lower blood cholesterol);
neratinib (used to treat breast cancer);
lomitapide (used to lower blood cholesterol);
alfuzosin (used to treat enlarged prostate);
fusidic acid (used to treat bacterial infections);
sildenafil if you have a lung disease called pulmonary arterial hypertension that makes breathing difficult. Patients without this condition may use sildenafil for impotence (erectile dysfunction) under the supervision of their doctor (see section Use of Norvir with other medicines );
avanafil or vardenafil (used to treat impotence);
colchicine (used to treat gout) if you have liver and/or kidney problems (see section Use of Norvir with other medicines );
products containing St. John’s wort (Hypericum perforatum), as they may cause Norvir to stop working properly. St. John’s wort is often used in herbal remedies that you can buy yourself.

*Your doctor may decide that you can take rifabutin and/or voriconazole with a boosted (lower) dose of Norvir, but a full dose of Norvir must not be taken together with these medicines.

If you are currently taking any of these medicines, ask your doctor whether you could switch your medication while taking Norvir.

For use of other medicines requiring special care, refer to the list included in the section “Taking Norvir with other medicines”.

Warnings and precautions

Talk to your doctor before starting Norvir.

Important information

If you take Norvir together with other antiretroviral medicines, it is important that you read the patient information leaflets of these other medicines carefully. These leaflets may contain additional important information about situations in which you should avoid taking Norvir. If you have further questions about Norvir (ritonavir) or any other prescribed medicines, consult your doctor or pharmacist.
Norvir does not cure HIV infection or AIDS.
People taking Norvir may still develop infections or other diseases related to HIV or AIDS. It is therefore important that you remain under medical supervision while taking Norvir.
Although effective antiretroviral treatment reduces the risk of transmission, you may still transmit HIV to others while taking this medicine. Consult your doctor about which precautions are necessary to avoid infecting other people.

Tell your doctor if you have or have had:

A history of liver disease.
Hepatitis B or C and are being treated with a combination of antiretroviral medicines, as you may have a higher risk of serious and potentially life-threatening side effects due to liver effects. You may need blood tests to monitor liver function.
Haemophilia, as there have been reports of increased bleeding in haemophilia patients treated with this type of medicine (protease inhibitors). The reason for this is unknown. You may need additional medication to help blood clotting (factor VIII) to control any bleeding.
Erectile dysfunction, as medicines used to treat erectile dysfunction may cause hypotension and prolonged erection.
Diabetes, as there have been cases of worsening or development of diabetes (diabetes mellitus) in some patients taking protease inhibitors.
Kidney (renal) disease, as your doctor may need to adjust the dose of other medicines you are taking (such as protease inhibitors).

Tell your doctor if you experience:

Diarrhea or vomiting that does not improve (persistent), as this may reduce the effectiveness of your medicines.
Dizziness (nausea), vomiting, or stomach pain, as these may be signs of inflammation of the pancreas (pancreatitis). Some patients taking Norvir may develop problems with the pancreas. Inform your doctor as soon as possible if this applies to you.
Signs of infection – inform your doctor immediately. Some patients with advanced HIV infection (AIDS) who start anti-HIV treatment may develop symptoms of past infections, even if they were unaware of having them. This is believed to occur because the body's immune response improves and begins to fight these infections.

In addition to opportunistic infections, you may also develop autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) after starting treatment for your HIV infection. Autoimmune disorders may appear several months after starting treatment. If you notice any signs of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and moving up the trunk, palpitations, tremors, or hyperactivity, please inform your doctor immediately to receive appropriate treatment.

Joint stiffness, discomfort, and pain (especially in the hip, knee, and shoulder) and difficulty moving, inform your doctor, as this may be a sign of a condition that can destroy bone (osteonecrosis). Some patients taking antiretroviral medicines may develop this condition.
Muscle pain, discomfort, or weakness, particularly when combined with antiretroviral therapy including protease inhibitors and nucleoside analogues. Rarely, these muscle disorders have been severe (see section 4. Possible side effects).
Dizziness, lightheadedness, fainting, or irregular heartbeat. Some patients taking Norvir may experience changes in the electrocardiogram (ECG). Inform your doctor if you have any heart or electrical conduction problems.
If you have other health problems, consult your doctor as soon as possible.

Children and adolescents

The use of Norvir is not recommended in children under 2 years of age.

Use of Norvir with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. There are some medicines you must not take if you are taking Norvir. These are listed in section 2 under the heading “Do not take Norvir”. There are some medicines that can only be taken under certain circumstances, as described below.

The following precautions apply when Norvir is used at full dose. However, these precautions may also be necessary when Norvir is taken at low (boosting) doses with other medicines.

Inform your doctor if you are taking any of the medicines listed below, as special precautions are required.

Sildenafil or tadalafil for impotence (erectile dysfunction). The dose and/or frequency of use of these medicines must be reduced to avoid hypotension and prolonged erection. You must not take Norvir with sildenafil if you also have pulmonary arterial hypertension (see section 2. What you need to know before you or your child take Norvir). Inform your doctor if you are taking tadalafil for the treatment of pulmonary arterial hypertension.
Colchicine (for gout), as Norvir may increase blood levels of this medicine. You must not take Norvir with colchicine if you have liver and/or kidney problems (see also “Do not take Norvir” above).
Digoxin (a heart medicine). To prevent heart problems, your doctor may need to adjust the dose of digoxin and monitor you while you are taking digoxin and Norvir.
Hormonal contraceptives containing ethinyl estradiol, as Norvir may reduce the effectiveness of these medicines. It is recommended to use a condom or another non-hormonal contraceptive method instead. You may also experience irregular uterine bleeding if you take this type of hormonal contraceptive with Norvir.
Atorvastatin or rosuvastatin (for high cholesterol), as Norvir may increase blood levels of these medicines. Inform your doctor before taking cholesterol-lowering medicines with Norvir (see “Do not take Norvir” above).
Steroids (e.g., dexamethasone, fluticasone propionate, prednisolone, triamcinolone), as Norvir may increase blood levels of these medicines, which could lead to Cushing’s syndrome (development of a rounded face) and reduced cortisol hormone production. Your doctor may want to reduce the steroid dose or monitor side effects more closely.
Trazodone (a medicine for depression), as adverse effects such as nausea, dizziness, low blood pressure, and fainting may occur when taken with Norvir.
Rifampicin and saquinavir (used for tuberculosis and HIV, respectively), as they may cause serious liver damage when taken with Norvir.
Bosentan, riociguat (used for pulmonary arterial hypertension), as blood levels of these medicines may increase when taken with Norvir.

Some medicines must not be combined with Norvir because their effects may increase or decrease when taken together. In some cases, your doctor may need to perform certain tests, adjust doses, or monitor you regularly. Therefore, you must inform your doctor if you are taking any medicine, including those you have purchased yourself or herbal products, although it is particularly important to mention the following:

amphetamines or amphetamine derivatives;
antibiotics (e.g., erythromycin, clarithromycin);
cancer treatments (e.g., abemaciclib, afatinib, apalutamide, ceritinib, encorafenib, dasatinib, ibrutinib, nilotinib, venetoclax, vincristine, vinblastine);
anticoagulants (e.g., rivaroxaban, vorapaxar, warfarin);
antidepressants (e.g., amitriptyline, desipramine, fluoxetine, imipramine, nefazodone, nortriptyline, paroxetine, sertraline, trazodone);
antifungals (e.g., ketoconazole, itraconazole);
antihistamines (e.g., loratadine, fexofenadine);
antiretroviral medicines including HIV protease inhibitors (amprenavir, atazanavir, darunavir, fosamprenavir, indinavir, nelfinavir, saquinavir, tipranavir), and non-nucleoside reverse transcriptase inhibitors (NNRTIs) (delavirdine, efavirenz, nevirapine), and others (didanosine, maraviroc, raltegravir, zidovudine);
tuberculosis medicines (bedaquiline and delamanid);
antiviral medicines used to treat chronic hepatitis C virus (HCV) infection in adults (e.g., glecaprevir/pibrentasvir and simeprevir);
medicines for anxiety, buspirone;
medicines for asthma, theophylline, salmeterol;
atovaquone, a medicine used to treat certain types of pneumonia and malaria;
buprenorphine, a medicine used for chronic pain;
bupropion, a medicine used to quit smoking;
medicines for epilepsy (e.g., carbamazepine, divalproex, lamotrigine, phenytoin);
medicines for the heart (e.g., digoxin, disopyramide, mexiletine, and calcium channel blockers such as amlodipine, diltiazem, and nifedipine);
medicines affecting the immune system (e.g., cyclosporine, tacrolimus, everolimus);
levothyroxine (used to treat thyroid problems);
morphine and morphine derivatives used to treat severe pain (methadone, fentanyl);
sleeping pills (e.g., alprazolam, zolpidem) and also midazolam administered by injection;
tranquilizers (e.g., haloperidol, risperidone, thioridazine);
colchicine, treatment for gout.

There are some medicines you must not take with Norvir. These are listed earlier in section 2. “Do not take Norvir.”

Taking Norvir with food and drink

See section 3.

Pregnancy and breastfeeding

It is very important that you consult your doctor if you think you are pregnant or are planning to become pregnant.

There is a large amount of information on the use of ritonavir (the active substance in Norvir) during pregnancy. In general, pregnant women have received low (boosting) doses of ritonavir together with other protease inhibitors after the first three months of pregnancy. Norvir does not appear to increase the risk of birth defects compared to the general population.

Norvir can pass into breast milk. To avoid transmission of infection, HIV-positive mothers must not breastfeed their infants.

Driving and using machines

Norvir may cause dizziness. If you experience these effects, do not drive or operate machinery.

3. How to take Norvir

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts. Take this medicine once or twice daily, every day, with food.

For doses corresponding to exact multiples of 100 mg (100, 200, 300, 400, 500, or 600 mg), mix the entire contents of each sachet with soft food (apple sauce or custard) or mix with a small amount of liquid (water, chocolate milk, or infant formula), and consume the entire mixture.

For doses less than 100 mg, or doses between multiples of 100 mg, mix the entire contents of the sachet with liquid and then administer the appropriate volume in ml using the oral dosing syringe, as directed by your doctor.

For administration through a feeding tube, follow the instructions in the section “How do I prepare the correct dose of Norvir oral powder mixed with liquid?”

Use water to mix this medicine and follow the feeding tube instructions for administering the medicine.

The recommended doses of Norvir are:

when Norvir is used to boost the effect of other anti-HIV medicines, the usual adult dose is 1 to 2 sachets once or twice daily. For further information on dosing recommendations, including those for children, refer to the package leaflet of the anti-HIV medicines taken in combination with Norvir.
if your doctor prescribes a full dose, adults may start with 3 sachets in the morning and 3 sachets 12 hours later, gradually increasing over a period of up to 14 days to reach the full dose of 6 sachets twice daily. Children (2–12 years) will start at a lower dose and increase gradually to the maximum dose allowed for their body size.

Your doctor will determine the appropriate dose you should take.

You must take Norvir every day to control HIV, regardless of whether you feel better. If any side effect prevents you from taking Norvir as prescribed, inform your doctor immediately. During episodes of diarrhoea, your doctor may decide that additional monitoring is needed.

Always keep an adequate supply of Norvir available to avoid running out. When travelling or if you need to stay in hospital, make sure you have enough Norvir to last until you can obtain more.

Norvir oral powder has an aftertaste that lingers. To help mask the taste, you may take peanut butter, chocolate-hazelnut cream, or blackcurrant syrup immediately after taking the dose.

Prepare only one dose at a time, using the correct number of sachets. When mixing the powder with food or liquid, make sure to take the full dose within two hours of preparation. Do not mix Norvir with anything else unless you have first consulted your doctor or pharmacist.

How do I prepare the correct dose of Norvir oral powder mixed with food (full sachet)?

Follow the instructions below:

Figure 1	Step 1. Before preparing the Norvir dose, gather the necessary supplies (see Figure 1). Step 2. Check your prescription for the number of packets needed for your dose, or consult your doctor or pharmacist.

Figure 2	Step 3. Place one small spoonful of soft food (applesauce or vanilla pudding) into a glass (see Figure 2).

Figure 3	Step 4. Open the packet by tearing the top (see Figure 3).

Figure 4	Step 5. Pour ALL of the powder from the packet onto the food (see Figure 4).

Figure 5	Step 6. Mix thoroughly (see Figure 5).
	Step 7. Serve the food to the patient.
Figure 6	Step 8. All of the food served must be taken (see Figure 6). If any powder residue remains in the glass, add more spoonfuls of food and serve them to the patient. Use within 2 hours.

Figure 7	Step 9. Discard the empty packet in the trash. Clean and dry the dose preparation surface. Wash the spoon and glass immediately with water and dishwashing soap (see Figure 7). Rinse and allow to air dry.

How do I prepare the correct dose of Norvir powder for oral suspension mixed with liquids?

Follow the instructions below:

Figure 1	What do you need? Before mixing the Norvir dose, gather the supplies shown in Figure 1. You may need to use more than one packet for each dose. Check your prescribed dose on the label of the package or consult your doctor or pharmacist if you are unsure. If more than one packet is needed for your dose, repeat all steps for each packet.

	Using the syringe Reading the scale Each milliliter (ml) is marked as a number with a long line Each 0.2 ml is shown as a smaller line between the numbers. Check the syringe before each use A new syringe will be needed if: the syringe cannot be cleaned scale markings cannot be read the plunger cannot be moved the syringe is damaged or leaks liquid

Figure 2	Step 1. Fill the syringe Push the plunger completely to the bottom of the syringe. Place the tip of the syringe into the liquid. Slowly pull the plunger out until it reaches the 10 ml mark on the syringe (see Figure 2).

Figure 3	Step 2. Move bubbles to the tip of the syringe Hold the syringe with the tip pointing upward. Tap the syringe gently with your other hand. This will move the bubbles toward the tip. Pull the plunger down slightly. Be careful not to remove the plunger from the syringe. <4>Tap the syringe again. This will help remove bubbles and ensure all of them move to the tip (see Figure 3).

Figure 4	Step 3. Measure the liquid Keep the syringe with the tip pointing upward. Slowly push the plunger up until the top of the plunger reaches the 9.4 ml mark, which will expel any air bubbles from the syringe (see Figure 4).

Figure 5	Step 4. Empty the syringe a. Slowly push the plunger to empty the liquid from the syringe into the mixing cup (see Figure 5).

Figure 6	Step 5. Pour the powder into the cup Open the packet by tearing the top. <2>Empty all the powder into the mixing cup.<3>Make sure the packet is empty. Be careful not to spill powder outside the cup (see Figure 6).

Figure 7	Step 6. Mix the powder with the liquid Fully close the cup with the screw cap and shake vigorously for at least 90 seconds until all lumps dissolve. <2>Check that no powder lumps remain; if they do, continue shaking until they disappear.<3>The liquid may appear cloudy; this is normal.<4>Let the liquid stand for 10 minutes so that most bubbles disappear.<5>You may see some small bubbles on the surface of the liquid. This is normal (see Figure 7).
Figure 8	Step 7. Fill the syringe Push the plunger to the bottom of the syringe. <2>Place the tip of the syringe at the bottom of the cup.<3>Slowly pull the plunger out until it reaches the 10 ml mark on the syringe. Try not to draw bubbles into the syringe (see Figure 8).

Figure 9	Step 8. Move bubbles to the tip of the syringe Hold the syringe with the tip pointing upward. <2>Tap the syringe gently with your other hand to move bubbles toward the tip.<3>Pull the plunger down slightly. Be careful not to remove the plunger from the syringe.<4>Tap the syringe again. This will help remove bubbles and ensure all move to the tip (see Figure 9).<5>Push the plunger until a small amount of liquid appears at the tip of the syringe.<6>If large air bubbles remain, empty the liquid from the syringe back into the cup and restart from Step 7.

Figure 10	Step 9. Measure the dose Check your prescribed dose in ml on the package label. If you are unsure, consult your doctor or pharmacist. <2>Place the tip of the syringe into the mixing cup and slowly pull the plunger to the ml mark corresponding to your dose (see Figure 10).<3>If you draw too much liquid, start again from Step 7. Be careful not to spill liquid from the mixing cup.

Figure 11	Step 10. Administer the dose to the patient Place the tip of the syringe inside the cheek. <2>Slowly push the plunger to deliver the full dose (see Figure 11).<3>Administer the complete dose to the patient within 2 hours of opening the packet.

	Step 11. (If needed) If more than one packet is required, repeat the entire process from the beginning.

	Step 12. After finishing Dispose of the empty packet and any remaining medication in the mixing cup in the trash. <2>Remove the plunger from the syringe.<3>Wash the plunger, mixing cup, and cup lid by hand with hot water and dish soap. Rinse with water and air dry. Do not wash these items in the dishwasher.<4>Clean and dry the surface where you prepared the dose.

If you take more Norvir than you should

If you take too much Norvir, you may experience numbness, tingling, or a prickling sensation. If you realize you have taken more Norvir than you should, contact your doctor or the nearest hospital emergency department immediately.

If you forget to take Norvir

If you forget to take a dose, take it as soon as possible. If it is almost time for your next dose, take only one dose. Do not take a double dose to make up for a missed dose.

If you stop taking Norvir

Even if you feel well, do not stop taking Norvir without consulting your doctor. If you take Norvir as directed, you are more likely to delay the development of resistance to this medicine.

4. Possible adverse effects

During HIV treatment, there may be an increase in weight and in blood glucose and lipid levels. This may be partly related to the recovery of health, lifestyle, and, in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor these changes.

Like all medicines, Norvir can cause adverse effects, although not everyone experiences them. When Norvir is used with other antiretroviral medicines, the adverse effects may also depend on these other medicines. Therefore, it is very important that you read carefully the adverse reactions section of the package leaflet of these medicines.

Very common: may affect more than 1 in 10 people

upper or lower stomach discomfort
vomiting
diarrhea (may be severe)
upset stomach (nausea)
flushing, feeling of warmth
headache
dizziness
sore throat
cough
stomach discomfort or indigestion

tingling or numbness in the hands, feet, or around the lips and mouth
weakness or fatigue
unpleasant taste in the mouth
nerve damage that may lead to weakness and pain
itching
rash
pain in the joints and back

Frequent: may affect up to 1 in every 10 people

allergic reactions, including skin rashes (redness, swelling, itching), severe swelling of the skin and other tissues
difficulty sleeping (insomnia)
anxiety
increased cholesterol
increased triglycerides
gout
stomach bleeding
liver inflammation and yellowing of the skin and whites of the eyes
increased urination
reduced kidney function
seizures (fits)
low platelet levels in blood
thirst (dehydration)
abnormally heavy periods

gas (flatulence)
loss of appetite
mouth sores
muscle pain, tenderness, or weakness
fever
weight loss

laboratory test results: changes in blood test results (such as chemical levels and blood counts)
confusion
difficulty concentrating
fainting
blurred vision
swelling of hands and feet
high blood pressure
low blood pressure and feeling faint when standing up
coldness in hands and feet
acne

Uncommon: may affect up to 1 in 100 people

heart attack
diabetes

kidney failure

Rare: may affect up to 1 in 1,000 people

serious or life-threatening skin reactions, including blistering (Stevens-Johnson syndrome and toxic epidermal necrolysis)

serious allergic reaction (anaphylaxis)

high blood sugar levels

Inform your doctor if you feel dizzy (nausea), are vomiting, or have stomach pain, as these may be symptoms of pancreatitis. Also inform your doctor if you experience joint stiffness, discomfort, and pain (especially in the hip, knee, and shoulder) and difficulty moving, as this could be a sign of osteonecrosis. See section 2. What you need to know before you or your child take Norvir.

There have been cases of increased bleeding in patients with haemophilia A and B during treatment with this or other protease inhibitors. If this happens to you, consult your doctor immediately.

Abnormal liver function tests, hepatitis (inflammation of the liver), and, rarely, jaundice have been reported in patients taking Norvir. Some individuals had other illnesses or were taking other medications. Some people with liver disease or hepatitis may have worsened.

Cases of muscle pain, discomfort, or weakness have been reported, particularly when cholesterol-lowering medications are taken in combination with combination antiretroviral therapy, including protease inhibitors and nucleoside analogues. In rare cases, these muscle disorders were severe (rhabdomyolysis). If you experience unexplained or persistent muscle pain, stop taking the medication and contact your doctor as soon as possible or go to the nearest hospital emergency department.

Inform your doctor immediately if, after taking Norvir, you experience any symptoms that might suggest an allergic reaction, such as rash, hives, or difficulty breathing.

If you consider any of the side effects you experience to be severe or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist, go to emergency services, or, if urgent, seek immediate medical help.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Norvir

Keep this medicine out of the sight and reach of children.

Do not use Norvir powder for oral suspension solution after the expiry date stated on the sachet and on the outer packaging. The expiry date refers to the last day of the month indicated.

Norvir powder for oral suspension solution should be stored below 30°C.

Medicines should not be disposed of via wastewater.

Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Norvir

The active substance is ritonavir. Each Norvir sachet contains 100 mg of ritonavir.
The other components are: copovidone, sorbitan laurate, colloidal anhydrous silica.

Nature and contents of the container

Norvir oral solution powder is supplied in individual sachets containing 100 mg of ritonavir. Each pack contains 30 sachets, 1 mixing cup, and 2 oral dosing syringes.

Some pack sizes may not be marketed.

Norvir is also available as film-coated tablets containing 100 mg of ritonavir.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany

Manufacturer

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen,

Germany

AbbVie Logistics B.V.,

Zuiderzeelaan 53,

8017 JV Zwolle,

The Netherlands

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder.

Belgium/Belgium/Belgium

AbbVie SA

Tel/Tel: +32 10 477811

Lithuania

AbbVie UAB

Tel: +370 5 205 3023

Bulgaria

AbbVie EOOD

Tel.: +359 2 90 30 430

Luxembourg/Luxembourg

AbbVie SA

Belgium/Belgium

Tel/Tel: +32 10 477811

Czech Republic

AbbVie s.r.o.

Tel: +420 233 098 111

Hungary

AbbVie Kft.

Tel.: +36 1 455 8600

Denmark

AbbVie A/S

Tlf: +45 72 30-20-28

Malta

V.J.Salomone Pharma Limited

Tel: +356 22983201

Germany

AbbVie Deutschland GmbH & Co. KG

Tel: 00800 222843 33 (toll-free)

Tel: +49 (0) 611 / 1720-0

Netherlands

AbbVie B.V.

Tel: +31 (0)88 322 2843

Estonia

AbbVie Biopharmaceuticals GmbH Estonia branch

Tel: +372 623 1011

Norway

AbbVie AS

Tlf: +47 67 81 80 00

Greece

AbbVie PHARMACEUTICALS S.A.

Tel: +30 214 4165 555

Austria

AbbVie GmbH

Tel: +43 1 20589-0

Spain

AbbVie Spain, S.L.U.

Tel: +34 91 384 09 10

Poland

AbbVie Polska Sp. z o.o.

Tel.: +48 22 372 78 00

France

AbbVie

Tél: +33 (0)1 45 60 13 00

Portugal

AbbVie, Lda.

Tel: +351 (0)21 1908400

Croatia

AbbVie d.o.o.

Tel: +385 (0)1 5625 501

Romania

AbbVie S.R.L.

Tel: +40 21 529 30 35

Ireland

AbbVie Limited

Tel: +353 (0)1 4287900

Slovenia

AbbVie Biofarmacevtska družba d.o.o.

Tel: +386 (1)32 08 060

Iceland

Vistor hf.

Tel: +354 535 7000

Slovakia

AbbVie s.r.o.

Tel: +421 2 5050 0777

Italy

AbbVie S.r.l.

Tel: +39 06 928921

Finland

AbbVie Oy

Puh/Tel: +358 (0) 10 2411 200

Cyprus

Lifepharma (Z.A.M.) Ltd

Tel: +357 22 34 74 40

Sweden

AbbVie AB

Tel: +46 (0)8 684 44 600

Latvia

AbbVie SIA

Tel: +371 67605000

United Kingdom

AbbVie Ltd

Tel: +44 (0)1628 561090

This patient information has been reviewed in

Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu