INVEGA 3 mg Extended-Release Tablets

Зміст інструкції

1. INVEGA 3 mg prolonged-release tablets, 6 mg prolonged-release tablets, 9 mg prolonged-release tablets, 12 mg prolonged-release tablets
   1. What is INVEGA and what is it used for
   2. What you need to know before you take INVEGA
   3. How to take INVEGA
   4. Possible side effects
   5. How to store INVEGA
   6. Contents of the pack and other information

INVEGA 3 mg prolonged-release tablets, 6 mg prolonged-release tablets, 9 mg prolonged-release tablets, 12 mg prolonged-release tablets

Paliperidone

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What INVEGA is and what it is used for
• 2. What you need to know before you take INVEGA
• 3. How to take INVEGA
• 4. Possible side effects
• 5. How to store INVEGA
• 6. Contents of the pack and other information

1. What is INVEGA and what is it used for

INVEGA contains the active substance paliperidone which belongs to the class of antipsychotic drugs.
INVEGA is used for the treatment of schizophrenia in adults and adolescents starting from 15
years of age.
Schizophrenia is a disorder whose symptoms include: hearing sounds or voices, seeing or perceiving things
that are not present, having false beliefs or being unusually suspicious, having a
tendency to isolate oneself, making incoherent speech and flattening of behaviour and emotions. People with this disorder may also feel depressed, anxious, guilty or tense.
INVEGA is also used to treat schizoaffective disorder in adults.
Schizoaffective disorder is a mental condition in which a person experiences a combination of
symptoms of schizophrenia (as indicated above) in addition to symptoms related to mood disorders
(excitement, sadness, agitation, distraction, drowsiness, talkativeness, loss of interest in daily
activities, sleeping too much or too little, eating too much or too little and recurrent suicidal thoughts).
INVEGA can help to relieve the symptoms of the disease and stop their recurrence.

2. What you need to know before you take INVEGA

Do not take INVEGA

• if you are allergic to paliperidone, risperidone or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• Talk to your doctor, pharmacist or nurse before taking INVEGA. Patients with schizoaffective disorder treated with this medicine should be carefully monitored for a potential shift from manic to depressive symptoms.
• This medicine has not been studied in elderly patients with dementia. However, elderly patients with dementia, who are being treated with other similar types of medicines, may be at an increased risk of stroke or death (see section 4, Possible side effects).
• If you have Parkinson's disease or dementia.
• If you have ever been diagnosed with an illness whose symptoms include increased temperature and muscle rigidity (also called Neuroleptic Malignant Syndrome).
• If you have ever had abnormal movements of the tongue or face (Tardive Dyskinesia). You should know that both of these conditions can be caused by this type of drug.
• If you are aware of having had low levels of white blood cells in the past (whether or not they were caused by other medicines).
• If you have diabetes or are predisposed to diabetes.
• If you have heart problems or are taking medication for heart problems that tends to lower your blood pressure.
• If you suffer from epilepsy.
• If you have difficulty swallowing, or have stomach or intestinal problems that reduce your ability to swallow or expel food through normal intestinal movements.
• If you have conditions associated with diarrhoea.
• If you have kidney problems.
• If you have liver problems.
• If you have a prolonged and/or painful erection.
• If you have difficulty controlling your internal body temperature or conditions of excessive heat.
• If you have an abnormally high level of the prolactin hormone in your blood or if you have a possible prolactin-dependent tumour.
• If you or someone in your family has a history of blood clot formation (thrombosis),

If you have any of these conditions, talk to your doctor so they can assess whether it is
necessary to adjust the dosage or monitor you for a certain period.
Because a dangerously low number of a certain type of white blood cells needed to fight infections in the
blood has been observed very rarely in patients taking INVEGA, your doctor may check the count of
white blood cells in your blood.
INVEGA can cause weight gain. Significant weight gain can
negatively affect your health. Your doctor should check your weight regularly.
Because diabetes mellitus or worsening of
pre-existing diabetes mellitus has been observed in patients taking INVEGA, your doctor should check for
high blood sugar levels. Blood glucose levels should be monitored regularly in patients with
pre-existing diabetes mellitus.
During an eye operation for cataracts (clouding of the lens), the pupil (the black circle in the
centre of your eye) may not increase in size as needed. In addition, the iris (the coloured part of the
eye) may become floppy during surgery and this can cause damage
to the eye. If you are planning to have an eye operation, be sure to inform
your ophthalmologist that you are taking this medicine.

Children and adolescents
INVEGA should not be used in children and adolescents under the age of 15 years for the treatment of
schizophrenia.
INVEGA should not be used in children and adolescents under the age of 18 years for the
treatment of schizoaffective disorder.
This is because it is not known whether INVEGA is safe or effective in these age groups.

Other medicines and INVEGA
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines.
When the medicine is taken with some medicines for the heart that control the heartbeat or
some other medicines such as antihistamines, antimalarials or other antipsychotics, abnormalities in
heart electrical activity may occur.
Because this medicine acts primarily on the brain, interference with
other drugs (or alcohol) that act on the brain may occur, due to the additive effect on brain function.
Because this medicine can lower blood pressure, be careful when taking
this medicine with other medicines that lower blood pressure.
This medicine may reduce the effect of medicines used to treat Parkinson's disease and
restless legs syndrome (e.g. levodopa).
The effects of this medicine may be affected if you are taking medicines that affect
the speed of intestinal movements (e.g. metoclopramide).
Consider a reduction in dosage for this medicine when this medicine is
administered in conjunction with valproate.
The concomitant use of oral risperidone with this medicine is not recommended as the
combination of the two medicines could lead to greater side effects.
INVEGA should be used with caution with medicines that increase the activity of the central nervous
system (stimulants such as methylphenidate).

INVEGA with alcohol
Avoid drinking alcohol while taking this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. You should not
take this medicine during pregnancy unless you have discussed it with your doctor. The
following symptoms may occur in newborns of mothers who have used paliperidone in the last
trimester (last three months of pregnancy): tremor, stiffness and/or muscle weakness, drowsiness,
agitation, breathing problems, and difficulty feeding. If your baby develops any of these
symptoms, you may need to contact your doctor.
Avoid breastfeeding while taking this medicine.

Driving and using machines
Dizziness and vision problems may occur during treatment with this medicine (see
section 4, Possible side effects). This should be taken into account in cases where complete
vigilance is required, e.g., when driving a car or using machinery.

The 3 mg INVEGA tablets contain lactose
The 3 mg tablets of this medicine contain lactose, a type of sugar. If your doctor has
told you that you have an intolerance to certain sugars, contact them before taking this medicine.

Invega contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is practically
“sodium-free”.

3. How to take INVEGA

Take this medicine exactly as your doctor, pharmacist or nurse instructs.

Use in adults
The recommended dose in adults is 6 mg once a day, to be taken in the morning. The dose may
be increased or decreased by your doctor within the range of 3 mg to 12 mg once a day for schizophrenia or from 6 mg to 12 mg once a day for schizoaffective disorder. This
depends on how the medicine works for you.

Use in adolescents
The recommended starting dose for the treatment of schizophrenia in adolescents aged 15 years and over,
is 3 mg once a day, to be taken in the morning.
For adolescents weighing 51 kg or more, the dose may be increased within the range of 6 mg to 12
mg once a day.
For adolescents weighing less than 51 kg, the dose may be increased to 6 mg once a day.
The doctor will decide the appropriate dose for you. The dose you take depends on how the medicine works for
you.

How and when to take INVEGA
This medicine must be taken orally, the tablet must be swallowed whole with water or
other liquids. It must not be chewed, divided, or crushed.
This medicine should be taken every morning with breakfast or on an empty stomach, but in
the same way each day. Do not alternate taking the medicine one day on an empty stomach and the next with a
full stomach.
The active ingredient, paliperidone, dissolves once swallowed and the tablet shell is
eliminated from the body as waste.

Patients with kidney problems
Based on your kidney function, your doctor may adjust the dose of this medicine.

Elderly
The doctor may reduce the dose of the medicine in case of decreased kidney function.

If you take more INVEGA than you should
Contact your doctor immediately. You may experience drowsiness, fatigue, abnormal movements of the
body, problems maintaining an upright position and walking, dizziness caused by low
blood pressure and abnormal heartbeats.

If you forget to take INVEGA
Do not take a double dose to make up for the missed dose. If you miss a tablet, take the
next dose the following day. If you miss two or more doses, contact your doctor.

If you stop taking INVEGA
Do not stop taking INVEGA as you will lose the effects of the medicine. You should not stop
taking the medicine unless your doctor tells you to, as symptoms may
reappear.
If you have any further questions about taking this medicine, ask your doctor, pharmacist or
nurse

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Tell your doctor immediately if:

• You think you have blood clots in the veins, particularly in the legs (symptoms include swelling, pain and redness in the legs), which can move along the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, consult your doctor immediately.
• You suffer from dementia and notice a sudden change in your mental state or a sudden weakness or numbness of the face, arms or legs, especially on one side, or if your speech is incomprehensible, even for a short period. These may be signs of a stroke.
• You have a fever, muscle stiffness, sweating or reduced level of consciousness (a condition called “Neuroleptic Malignant Syndrome”). Immediate medical treatment may be necessary.
• You are male and have a prolonged or painful erection. This condition is called priapism. Immediate medical treatment may be necessary.
• You have involuntary rhythmic movements of the tongue, mouth and face. It may be necessary to stop paliperidone
• You experience a severe allergic reaction, characterized by fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, skin rash and sometimes a drop in blood pressure (corresponding to an “anaphylactic reaction”).

Very common: may affect more than 1 in 10 users

• difficulty falling asleep or staying asleep
• parkinsonism. This condition may include: slow or impaired body movements, a feeling of stiffness or tension in the muscles (making movements jerky), and sometimes a feeling of movement that stops and then restarts. Other signs of parkinsonism include, walking slowly dragging your feet, resting tremor, increased saliva and/or loss of saliva, and a loss of facial expression
• restlessness
• feeling sleepy or reduced alertness
• headache.

Common side effects: may affect up to 1 in 10 users

• chest infection (bronchitis), common cold symptoms, sinusitis, urinary tract infection, feeling as if you have the flu
• weight gain, increased appetite, weight loss, decreased appetite
• elevated mood (mania), irritability, depression, anxiety
• dystonia: this is a condition involving slow or prolonged involuntary muscle contraction. While it can involve any part of the body (resulting in an abnormal posture), dystonia often involves the muscles of the face, including abnormal movements of the eyes, mouth, tongue or jaw.
• dizziness
• dyskinesia: this is a condition involving involuntary muscle movements and may include repetitive, jerky or contorted movements or spasms.
• tremor
• blurred vision
• an interruption of the conduction of the heart between the upper and lower parts of the heart, abnormal electrical conduction of the heart, prolongation of the QT interval of the heart, slow heart rate, rapid heart rate
• low blood pressure when getting up (consequently, some patients taking INVEGA may feel faint, dizzy or may faint when getting up or sitting down suddenly), high blood pressure
• sore throat, cough, nasal congestion
• abdominal pain or discomfort, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache
• increased liver transaminases in the blood
• itching, skin rash
• bone or muscle pain, back pain, joint pain
• loss of menstrual cycle
• fever, weakness, fatigue

Uncommon side effects: may affect up to 1 in 100 users

• pneumonia, respiratory tract infection, bladder infection, ear infection, tonsillitis
• decreased white blood cell count, decreased platelets (blood cells that help stop bleeding), anemia, decreased red blood cells in the blood
• INVEGA may increase the levels of a hormone called “prolactin” found in a blood test (which may or may not cause symptoms). When symptoms due to a high level of prolactin occur, these may include: (in men) breast enlargement, difficulty having or maintaining an erection or other sexual dysfunction, (in women) breast discomfort, milk leakage from the breasts, loss of menstrual cycle or other problems with the cycle
• diabetes or worsening of diabetes, high blood sugar level, increased waist circumference, loss of appetite resulting in malnutrition and low body weight, high levels of triglycerides (a fat)
• sleep disorders, confusion, reduced sexual drive, inability to achieve orgasm, nervousness, nightmares
• tardive dyskinesia (spasms or jerking movements that you cannot control, of the face, tongue or other parts of the body). Tell your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth and face. It may be necessary to stop taking INVEGA
• seizures (convulsions), fainting, an urgent need to move a part of the body, dizziness when getting up, attention disorder, speech problems, loss or abnormal sense of taste, reduced sensitivity of the skin to pain and touch, a sensation of tingling, prickling or numbness of the skin
• hypersensitivity of the eyes to light, eye infection or “slightly red”, dry eyes
• sensation of spinning (vertigo), ringing in the ears, ear pain
• irregular heartbeat, abnormal heart tracing (electrocardiogram or ECG), a sensation of a fast or pounding heartbeat (palpitations)
• low blood pressure
• shortness of breath, wheezing, nosebleeds
• swelling of the tongue, infection of the stomach or intestines, difficulty swallowing, excessive passing of gas or air
• increased GGT in the blood (a liver enzyme called gamma-glutamyltransferase), increased liver enzymes in the blood
• skin rash (or hives), hair loss, eczema, acne
• an increase in CPK (creatine phosphokinase) in the blood, an enzyme that is sometimes released when there is muscle damage, muscle spasms, joint stiffness, joint swelling, muscle weakness, neck pain
• incontinence (loss of control) of urine, frequent urination, inability to urinate, pain during urination
• erectile dysfunction, ejaculation disorders
• loss of menstrual cycle or problems with the cycle (females), milk leakage from the breasts, sexual dysfunction, breast pain, breast discomfort
• swelling of the face, mouth, eyes or lips, swelling of the body, arms or legs
• chills, increased body temperature
• change in the way you walk
• feeling thirsty
• chest pain, chest discomfort, feeling unwell
• falls

Rare side effects: may affect up to 1 in 1,000 users

• eye infection, fungal nail infection, skin infection, skin inflammation caused by mites
• dangerously low number of a certain type of white blood cells in the blood needed to fight infections
• decrease in the blood of a type of white blood cells that helps protect the body from infections, increased eosinophils (a type of white blood cell)
• severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, lack of breath, itching, skin rash and sometimes a drop in blood pressure, allergic reaction
• sugar in the urine
• inappropriate secretion of the hormone that controls urine volume
• complications leading to life-threatening diabetes,
• dangerously excessive intake of water, decreased blood sugar, drinking water in an excessive manner, increased cholesterol in the blood
• sleepwalking
• absence of movements or responses when awake (catatonia)
• lack of emotion
• neuroleptic malignant syndrome (confusion, reduction or loss of consciousness, high fever and severe muscle stiffness)
• loss of consciousness, balance disorders, abnormal coordination
• problems with blood vessels in the brain, coma caused by uncontrolled diabetes, unresponsiveness to stimuli, head tremor
• glaucoma (increased pressure inside the eyeball), increased tearing, redness of the eyes, problems with eye movement, rolling of the eyes to the back of the head
• atrial fibrillation (an abnormal heart rhythm), fast heartbeat when getting up
• blood clots in the veins, particularly in the legs (symptoms include swelling, pain and redness in the legs), which can move along the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, consult your doctor immediately.
• decreased level of oxygen in parts of the body (because of decreased blood flow), hot flashes
• sleep breathing problems (sleep apnea), rapid and shallow breathing
• pneumonia caused by inhalation of food, congestion of the airways, problems with voice
• intestinal blockage, fecal incontinence, hard stools, lack of intestinal muscle movement causing blockage
• yellowing of the skin and eyes (jaundice)
• inflammation of the pancreas
• severe allergic reaction with swelling that can involve the throat and lead to difficulty breathing
• thickening of the skin, dry skin, redness of the skin, altered skin color, scaly and itchy scalp or skin, dandruff
• breakdown of muscle fibers and muscle pain (rhabdomyolysis), abnormal posture
• priapism (a prolonged erection of the penis that may require surgical treatment)
• development of breast tissue in men, enlargement of the mammary glands, leakage from the breasts, vaginal discharge
• a delay in the menstrual cycle, breast enlargement
• very low body temperature, a decrease in body temperature
• withdrawal symptoms from the medicine

Not known: frequency cannot be estimated from available data

• pulmonary congestion
• increased levels of insulin (a hormone that controls blood sugar levels) in the blood

The following side effects have been observed with the use of another medicine called risperidone
which is very similar to paliperidone, so these effects may be expected also with INVEGA:
eating disorder related to sleep, other types of problems with blood vessels in the brain, crackling
sounds in the lungs and severe or life-threatening skin rash with blisters and peeling of the skin that
can start inside and around the mouth, nose, eyes and genitals and spread to other areas of the body
(Stevens-Johnson syndrome / toxic epidermal necrolysis). Eye problems may also occur during cataract
surgery. During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) may occur
if you take or have taken INVEGA. If you are to have cataract surgery, make sure to tell your doctor if
you take or have taken this medicine.

Other side effects in adolescents
The side effects generally experienced by adolescents are similar to those observed in
adults, except for those reported below which have been observed more commonly:

• feeling sleepy or less alert
• parkinsonism: this condition may include: slow or impaired movements, a feeling of stiffness or tension in the muscles (making movements jerky) and sometimes also a feeling of movement that stops and then restarts. Other signs of parkinsonism include walking slowly dragging your feet, resting tremor, increased saliva and/or loss of saliva and a loss of facial expression
• weight gain
• common cold symptoms
• restlessness
• tremor
• stomach pain
• milk leakage from the breasts in girls
• breast swelling in boys
• acne
• speech problems
• stomach or intestinal infection
• nosebleeds
• ear infection
• high levels of triglycerides (a fat) in the blood
• sensation of spinning (dizziness)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or
nurse. You can also report side effects directly through 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 INVEGA

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 blister/bottle and on the packaging
after EXP. The expiry date refers to the last day of the month.
Bottles: Do not store at a temperature above 30  C. Keep the bottle tightly closed to
protect the medicine from moisture.
Blisters: Do not store at a temperature above 30  C. Keep the blister in its original
packaging to protect the medicine from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What INVEGA contains
The active ingredient is paliperidone
Each INVEGA 3 mg extended-release tablet contains 3 mg of paliperidone.
Each INVEGA 6 mg extended-release tablet contains 6 mg of paliperidone.
Each INVEGA 9 mg extended-release tablet contains 9 mg of paliperidone.
Each INVEGA 12 mg extended-release tablet contains 12 mg of paliperidone.
The other ingredients are:
Tablet core coating:
Polyethylene oxide 200K
Sodium chloride
Povidone (K29-32)
Stearic acid
Butylated hydroxytoluene (E321)
Iron oxide (yellow) (E172) (only in 3 mg and 12 mg tablets)
Polyethylene oxide 7000K
Iron oxide (red) (E172)
Hydroxyethyl cellulose
Polyethylene glycol 3350
Cellulose acetate
Iron oxide (black) (E172) (only in 9 mg tablets)
Colored coating:
Hypromellose
Titanium dioxide (E171)
Polyethylene glycol 400 (only in 6, 9 and 12 mg tablets)
Iron oxide (yellow) (E172) (only in 6 mg and 12 mg tablets)
Iron oxide (red) (E172) (only in 6 mg and 9 mg tablets)
Lactose monohydrate (only in 3 mg tablets)
Triacetin (only in 3 mg tablets)
Carnauba wax
Printing ink:
Iron oxide (black) (E172)
Propylene glycol
Hypromellose

Description of the appearance of INVEGA and contents of the pack
INVEGA extended-release tablets are capsule-shaped. The 3 mg tablets
are white with the printing “PAL 3”, the 6 mg tablets are beige with the printing “PAL 6”, the
9 mg tablets are pink with the printing “PAL 9” and the 12 mg tablets are dark yellow with the
printing “PAL 12”. All tablets are available in the following formats:

• Bottles: the tablets are supplied in white plastic bottles with a child-resistant closure .Each bottle contains 30 tablets or 350 tablets. Each bottle contains two sachets of silica gel, to absorb moisture and keep the tablets dry.
• Blisters: the tablets are supplied in blisters packaged in boxes of 14, 28, 49, 56 and 98 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer
Janssen-Cilag SpA
Via C. Janssen
04100 Borgo San Michele
Latina
Italy
For further information on INVEGA, contact the local representative of the marketing authorisation
holder:

België/Belgique/Belgien
Janssen-Cilag NV
Tel/Tél: +32 14 64 94 11
[email protected]

Lietuva
UAB "JOHNSON & JOHNSON"
Tel: +370 5 278 68 88
[email protected]

България
„Джонсън & Джонсън България” ЕООД
Тел.:+359 2 489 94 00
[email protected]

Luxembourg/Luxemburg
Janssen-Cilag NV
Tél/Tel: +32 14 64 94 11
[email protected]

Česká republika
Janssen-Cilag s.r.o.
Tel:+420 227 012 227

Magyarország
Janssen-Cilag Kft.
Tel.: +36 1 884 2858
[email protected]

Danmark
Janssen-Cilag A/S
Tlf.: +45 45 94 82 82
[email protected]

Malta
AM MANGION LTD
Tel: +356 2397 6000

Deutschland
Janssen-Cilag GmbH
Tel: 0800 086 9247 / +49 2137 955 6955
[email protected]

Nederland
Janssen-Cilag B.V.
Tel: +31 76 711 1111
[email protected]

Eesti
UAB "JOHNSON & JOHNSON" Eesti filiaal
Tel: +372 617 7410
[email protected]

Norge
Janssen-Cilag AS
Tlf: +47 24 12 65 00
[email protected]

Ελλάδα
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη
Α.Ε.Β.Ε.
Tηλ: +30 210 80 90 000

Österreich
Janssen-Cilag Pharma GmbH
Tel: +43 1 610 300

España
Janssen-Cilag, S.A.
Tel: +34 91 722 81 00
[email protected]

Polska
Janssen-Cilag Polska Sp. z o.o.
Tel.: +48 22 237 60 00

France
Janssen-Cilag
Tél: 0 800 25 50 75 / +33 1 55 00 40 03
[email protected]

Portugal
Janssen-Cilag Farmacêutica, Lda.
Tel: +351 214 368 600

Hrvatska
Johnson & Johnson S.E. d.o.o.
Tel: +385 1 6610 700
[email protected]

România
Johnson & Johnson România SRL
Tel: +40 21 207 1800

Ireland
Janssen Sciences Ireland UC
Tel: 1 800 709 122
[email protected]

Slovenija
Johnson & Johnson d.o.o.
Tel: +386 1 401 18 00
[email protected]

Ísland
Janssen-Cilag AB
c/o Vistor hf.
Sími: +354 535 7000
[email protected]

Slovenská republika
Johnson & Johnson, s.r.o.
Tel: +421 232 408 400

Italia
Janssen-Cilag SpA
Tel: 800.688.777 / +39 02 2510 1
[email protected]

Suomi/Finland
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300
[email protected]

Κύπρος
Βαρνάβας Χατζηπαναγής Λτδ
Tηλ: +357 22 207 700

Sverige
Janssen-Cilag AB
Tel: +46 8 626 50 00
[email protected]

Latvija
UAB "JOHNSON & JOHNSON" filiāle Latvijā
Tel: +371 6789 3561
[email protected]

United Kingdom (Northern Ireland)
Janssen Sciences Ireland UC
Tel: +44 1 494 567 444
[email protected]

Other sources of information:
More detailed information on this medicine is available on the website of the European Medicines
Agency https://www.ema.europa.eu.