InfoCons Consumer Protection informs you – Invega – Package Leaflet

Before anything else

Read all of this leaflet carefully before you start taking this medicine because it contains important inf ormation 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.

What is i n this leaflet :

1. What INVEGA is and what it is used for 2. What you need to know b efore 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

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

INVEGA contains the active substance paliperido ne which belongs to the class of antipsychotic medicines .

INVEGA is used to treat schizophrenia in adults and in adolescents aged 15 years and older.

Schizophrenia is a disorder with symptoms such as hearing things, seeing or sensing things that are not there, mistaken beliefs, unusual suspiciousness, becoming withdrawn, incoherent speech, and behaviour and emotional flatness. People with this disorder may also feel depressed, anxious, guilty, or tense.

INVEGA is also used to treat schizoaffective disord er in adults.

Schizoaffective disorder is a mental condition in which a person experiences a combination of schizophrenia symptoms (as listed above) in addition to mood disorder symptoms (feeling very high, feeling sad, feeling agitated, distracted, sleep lessness, talkativeness, losing interest in everyday activities, sleeping too much or too little, eating too much or too little, and recurrent thoughts of suicide).

INVEGA can help alleviate the symptoms of your disease and stop your symptoms from coming back.

⚠️ 2. What you need to know before you take I NVEGA

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 .

40- Patients with schizoaffective disorder treated with this medicine should be carefully monitored for a potential switch from manic to depressive symptoms.

• This medicine has not been studied in elderly patients with dementia. H owever, elderly patients with dementia, who are treated with other similar types of medicine, may have 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 diagnose d with a condition whose symptoms include high temperature and muscle stiffness (also known as Neuroleptic Malignant Syndrome).
• if you have ever experienced abnormal movements of the tongue or face (Tardive Dyskinesia).

You should be aware that both of the se conditions may be caused by this type of medicine.

• if you know that you have had low levels of white blood cells in the past (which may or may not have been caused by other medicines).
• if you are diabetic or prone to diabetes.
• if you have heart disease or heart disease treatment that makes you prone to low blood pressure.
• if you have epilepsy.
• if you have a swallowing, stomach or intestinal disorder that reduces your ability to swallow or pass foods by normal bowel movements.
• if you have diseases associa ted with diarrhoea .
• if you have kidney problems .
• if you have liver problems .
• if you have prolonged and/or painful erection.
• if you have difficulty controlling core body temperature or overheating.
• if you have an abnormally high level of the hormone prolact in in your blood or if you have a possible prolactin -dependent tumour.
• if you or someone else in your family has a history of blood clots, as antipsychotics have been associated with formation of blood clots.

If you have any of these conditions, please ta lk to your doctor as he/she may want to adjust your dose or monitor you for a while.

As dangerously low numbers of a certain type of white blood cell needed to fight infection in your blood has been seen very rarely with patients taking INVEGA, your docto r may check your white blood cell counts.

INVEGA may cause you to gain weight. Significant weight gain may adversely affect your health.

Your doctor should regularly measure your body weight.

As diabetes mellitus or worsening of pre -existing diabetes mel litus have been seen with patients taking INVEGA , your doctor should check for signs of high blood sugar. In patients with pre -existing diabetes mellitus blood glucose should be monitored regularly.

During an operation on the eye for cloudiness of the len s (cataract), the pupil (the black circle in the middle of your eye) may not increase in size as needed. Also, the iris (the colo ured part of the eye) may become floppy during surgery and that may lead to eye damage . If you are planning to have an operatio n on your eye, make sure you tell your eye doctor that you are taking this medicine.

Children and adolescents

INVEGA is not for use in children and adolescents under 15 years for the treatment of schizophrenia .

INVEGA is not for use in children and adole scents who are under 18years for the treatment of schizoaffective disorder .

This is because it is not known if 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.

41Abnormalities of electrical function in the heart may occur when this medicine is taken with certain heart medicines that control heart rhythm, or some other types of medicines such as antihistamines, antimalarials, or other anti psychotics.

Since this medicine works primarily in the brain, interference from other medicines (or alcohol) that work in the brain could occur due to additive effect on brain function.

Since this medicine can lower blood pressure, care should be taken w hen this medicine is taken with other medicines that lower blood pressure.

This medicine can reduce the effect of medicines against Parkinson’s disease and restless legs syndrome (e.g., levodopa).

The effects of this medicine may be affected if you are t aking medicines that affect the speed of movement in the gut (e.g., metoclopramide).

Dosage reduction for this medicine should be considered when this medicine is co-administered with valproate.

The use of oral risperidone together with this medicine is not recommended as the combination of the two medicines may lead to increased side effects.

INVEGA should be used with caution with medicines that increase the activity of the central nervous system (psychostimulants such as methylphenidate) .

INVEGA with alcohol Alcohol should be avoided when taking this medicine .

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 taking this medicin e.You should not take this medicine during pregnancy unless this has been discussed with your doctor. The following symptoms may occur in newborn babies of mothers that have used paliperidone in the last trimester (last three months of their pregnancy): s haking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.

You should not breastfeed when taking this medicine .

Driving a nd using machines Dizziness and vision problems may occur during treatment with this medicine (see section 4, possible side effects). This should be considered in cases where full alertness is required, e.g., when driving a car or handling machine s.

The 3 mgtablet of INVEGA contains lactose

The 3 mgtablet of this medicine contains lactose, a type of sugar. If you have been told by a doctor that you have an intolerance to some sugars, contact your doctor before taking this medicin e.

INVEGA contains sodiu m

This medicine contains less than 1 mmol sodium (23 mg) per tablet , that is to say essentially ‘sodium -free’ .

💊 3. How to take INVEGA

Take this medicine exactly as the doctor, pharmacist or nurse has told you to .

42Use in adults The recommended dose in ad ults is 6 mgonce a day taken in the morning . The dose may be increased or decreased by your doctor within the dose range of 3 mgto 12 mgonce a day for schizophrenia or 6mgto 12 mgonce a day for schizoaffective disorder . This depends on how well the m edicine works for you.

Use in adolescents The recommended starting dose for treating schizophrenia in adolescents 15 years and older is 3 mg once a day taken in the morning.

For adolescents weighing 51 kg or more the dose may be increased within the rang e of 6 mgto 12 mg once a day.

For adolescents weighing less than 51 kgthe dose may be increased to 6 mgonce a day.

Your doctor will decide how much to give you. The amount you take depends on how well the medicine works for you.

How and when to take INVEGA This medicine must be taken by mouth, swallowed whole with water or other liquids. It must not be chewed, broken, or crushed.

This medicine should be taken every morning with breakfast or without breakfast, but in the same way every day. Do not alt ernate between taking this medicine with breakfast one day and without having breakfast the next day.

The active ingredient, paliperidone, dissolves once swallowed and the tablet shell is passed out of the body as waste.

Patients with kidney problems Your doctor may adjust your dose of this medicine based upon your kidney function.

Elderly Your doctor may reduce your dose of medicine if your kidney function is reduced.

If you take more INVEGA than you should

Contact your doctor right away. You may exper ience sleepiness, tiredness, abnormal body movements, problems with standing and walking, dizziness from low blood pressure, and abnormal heart beats.

If you forget to take INVEGA

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

If you stop INVEGA Do not stop taking this medicine since y ou will lose the effects of the medicine. You should not stop this medicine unless told to do so by your doctor as your symptoms may return.

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, althoug h not everybody gets them.

43Tell your doctor immediately if you:  experience blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs causing chest pain a nd difficulty breathing. If you notice any of these symptoms seek medical advice immediately .  have dementia and experience a sudden change in your mental state or sudden weakness or numbness of your face, arms or legs, especially on one side, or slurred sp eech, even for a short period of time. These may be signs of a stroke .  experience fever, muscle stiffness, sweating or a lowered level of consciousness (a disorder called “Neuroleptic Malignant Syndrome”). Immediate medical treatment may be needed .  are a m an and experience prolonged or painful erection. This is called priapism. Immediate medical treatment may be needed .  experience involuntary rhythmic movements of the tongue, mouth and face. Withdrawal of paliperidone may be needed .  experience a severe alle rgic reaction characterised by fever, swollen mouth, face, lip or tongue, shortness of breath, itching, skin rash and sometimes drop in blood pressure (amounting to an ‘anaphylactic reaction’).

Very common: may affect more than 1 in 10 people

 difficulty f alling or staying asleep  parkinsonism: This condition may include slow or impaired movement, sensation of stiffness or tightness of the muscles (making your movements jerky), and sometimes even a sensation of movement “freezing up” and then restarting. Oth er signs of parkinsonism include a slow shuffling walk, a tremor while at rest, increased saliva and/or drooling, and a loss of expression on the face .  restlessness  feeling sleepy or less alert  headache .

Common side effects : may affect up to 1 in 10 peopl e

 infection of the chest (bronchitis), common cold symptom s,sinus infection , urinary tract infection, feeling like you have the flu  weight gain, increased appetite , weight loss, decreased appetite  elated mood (mania), irritability, depression, anxiety  dystonia: This is a condition involving slow or sustained involuntary contraction of muscles.

While it can involve any part of the body (and may result in abnormal posture), dystonia often involves 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 can include repetitive, spastic or wr ithing movements, or twitching .  tremor (shaking)  blurry vision  an interruption in conduction between the uppe r and lower parts of the heart, abnormal ele ctrical conduction of the heart, prolongation of the QT interval from your heart, slow heart rate, rapid heart rate  low blood pressure upon standing (consequently, some people taking INVEGA may feel faint, dizzy, or may pass out when they stand up or sit up suddenly ),high blood pressure  sore throat, cough, stuffy nose  abdominal pain , abdominal discomfort, vomiting, nausea, constipation, diarrhoea, indigestion, dry mouth, toothache  increased liver transaminases in your blood  itching , rash  bone or muscle ache, back pain , joint pain  loss of menstrual periods  fever, weakness, fatigue (tiredness) .

44Uncommon side effects : may affect up to 1 in 100 people  pneumonia, infection of the breathing passages, bladder infection, ear infection, tonsillitis  white blood cell count decreased, decrease in platelets (blood cells that help you stop bleeding), anaemia , decrease in red blood cells  INVEGA can raise your levels of a hormone called “prolactin” found on a blood test (which may or may not cause symptoms). When symptoms of high prolactin occur, they may include: (in men) breast swelling, difficulty in getting or maintaining erections, or other sexual dysfunction, (in women) breast discomfort, leakage of milk from the breasts, mi ssed menstrual periods, or other problems with your cycle .  diabetes or worsening diabetes, high blood sugar, increased waist size, loss of appetite resulting in malnutrition and low body weight, h igh blood triglycerides (a fat)  sleep disorder, confusion, d ecreased sexual drive, inability to reach orgasm, nervousness, nightmares  tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body). Tell your doctor immediately if you experience involunt ary rhythmic movements of the tongue, mouth and face. Withdrawal of INVEGA may be needed .  convulsion (fits), fainting, arestless urge to move parts of your body, dizziness upon standing , disturbance in attention, problems with speech, l oss or abnormal sen se of taste ,reduced sensation of skin to pain and touch , a sensation of tingling, pricking, or numbness of skin  oversensitivity of the eyes to light, eye infection or “pink eye” ,dry eye  a sensation of spinning (vertigo), ringing in the ears, e ar pain  irregular heartbeat ,abnormal electrical tracing of the heart (electrocardiogram or ECG) ,a fluttering or pounding feeling in your chest (palpitations)  low blood pressure  shortness of breath ,wheezing ,nosebleeds  swollen tongue, s tomach or intestinal infectio n,difficulty swallowing ,excessive passing of gas or wind  increased GGT (a liver enzyme called gamma -glutamyltransferase) in your blood, increa sed liver enzymes in your blood  hives (or “nettle rash”), hair loss, eczema, acne  an increase of CPK (creatine p hosphokinase) in your blood, an enzyme which is sometimes released with muscle breakdown ,muscle spasms , joint stiffness, joint swelling ,muscle weakness ,neck pain  incontinence (lack of control) of urine ,frequent passing of urine ,inability to pass urine ,pain when passing urine  erectile dysfunction , ejaculation disorder  missed menstrual periods or other problems with your cycle (females), l eakage of milk from the breasts ,sexual dysfunction, b reast pain, breast discomfort  swelling of the face, mouth, eye s, or lips ,swelling of the body, arms or legs  chills, an increase in body temperature  a change in the way you walk  feeling thirsty  chest pain, chest discomfort, feeling unwell  fall.

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

 eye infection, fungal infection of the nails ,infection of the skin ,skin inflammation caused by mites  dangerously low numbers of a certain type of white blood cell needed to fight infection in your blood  decrease in the type of white blood cells that help to protect you ag ainst infection ,increase in eosinophils (a type of white blood cell) in your blood  severe allergic reaction characterised by fever, swollen mouth, face, lip or tongue, shortness of breath, itching, skin rash and sometimes drop in blood pressure ,allergic reaction  sugar in the urine 45 inappropriate secretion of a hormone that controls urine volume  life-threatening complications of uncontrolled diabetes  dangerously excessive intake of water ,low blood sugar ,excessive drinking of water, increased cholesterol i n your blood  sleep walking  not moving or responding while awake (catatonia)  lack of emotion  neuroleptic malignant syndrome (confusion, reduced or loss of consciousness, high fever, and severe muscle stiffness)  loss of consciousness ,balance disorder, abnor mal coordination  blood vessel problems in the brain ,coma due to uncontrolled diabetes , unresponsive to stimuli , low level of consciousness ,shaking of the head  glaucoma (increased pressure within the eyeball), increased tears, redness of the eyes, problem s with movement of your eyes, eye rolling  atrial fibrillation (an abnormal heart rhythm), rapid heartbeat upon standing  blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms seek medical advice immediately  decreased oxygen in parts of your body (because of decreased blood flow), flushing  trouble breathing during sleep (sle ep apnea) ,fast, shallow breathing  pneumonia caused by inhaling food, congestion of breathing passages, voice disorder  ablockage in the bowels ,stool incontinence , very hard stool, lack of bowel muscle movement that causes blockage  yellowing of the skin a nd the eyes (jaundice)  inflammation of the pancreas  serious allergic reaction with swelling that may involve the throat and lead to difficulty breathing  thickening of the skin, dry skin, skin redness ,skin discolo uration , flaky itchy scalp or skin, dandruf f  breakdown of muscle fibers and pain in muscles (rhabdomyolysis) ,abnormal posture  priapism (a prolonged penile erection that may require surgical treatment)  development of breasts in men ,enlargement of the glands in your breasts ,discharge from the breasts,vaginal discharge  adelay in menstrual periods ,breast enlargement  very low body temperature ,adecrease in body temperature  symptoms of drug withdrawal .

Not known : frequency cannot be estimated from the available data

 lung congestion  increased insul in (a hormone that controls blood sugar levels) in your blood .

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

Additional side effects in adolescents

Adolescents generally experienced side effects that were similar to those seen in adults except the following side effects were seen more commonly:  feeling sleepy or less alert 46 parkinsonism: This condition may include slow or impaired movement, sensation of stiffness or tightness of the muscles (making your movements jerky), and sometimes even a sensation of movement “freezin g up” and then restarting. Other signs of parkinsonism include a slow shuffling walk, a tremor while at rest, increased saliva and/or drooling, and a loss of expression on the face .  weight gain  common cold symptoms  restlessness  tremor (shaking)  stomach pain  leaking milk from the breasts in girls  breast swelling in boys  acne  problems with speech  stomach or intestinal infection  nose bleeds  ear infection  high blood triglycerides (a fat)  sensation of spinning (vertigo) .

Reporting of side effects

If you get an y side effects, talk to y our doctor, pharmacist or nurse. This includes an y possible side effects not listed in this leaflet. You can also report side effects directl y via the national reporting s ystem listed i nAppendix V. By reporting side effe cts you can help provide more information on the safet y 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 carton after EXP . The expiry date refers to the last day of that month.

Bottles: Do not store above 30°C. Keep the bottle tightly closed in order to protect from moisture.

Blisters: Do not store above 30°C. Store in the original package in order to protect from moisture.

Do not throw away any m edicines via wastewater or household w aste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

📦 6. Contents of the pack and other information

What INVE GA contains

The active substance is paliperidone Each INVEGA 3 mgprolonged -release tablet contains 3 mgof paliperidone.

Each INVEGA 6 mgprolonged -release tablet co ntains 6 mgof paliperidone.

Each INVEGA 9 mgprolonged -release tablet contains 9 mgof pa liperidone.

Each INVEGA 12 mgprolonged -release tablet contains 12 mgof paliperidone.

The other ingredients are:

Coated tablet core:

Polyethylene oxide 200K Sodium chloride Povidone (K29 -32) Stearic acid 47Butyl hydroxytoluene (E321) Ferric Oxide (Yellow) (E172) (3, 12 mgtablet only) Polyeth ylene Oxide 7000K Ferric Oxide (Red) (E172) Hydroxyethyl Cellulose Polyethylene glycol 3350 Cellulose acetate Iron oxide (Black) (E172) (9 mgtablet only) Colour overcoat:

Hypromellose Titanium dioxide (E171) Polyethyl ene glycol 400 (6, 9 and 12 mgtablet only) Ferric Oxide (Yellow) (E172) (6, 12 mgtablet only) Ferric Oxide (Red) (E172) ( 6, 9 mgtablet only) Lactose monohydrate (3 mgtablet only) Triacetin (3 mgtablet only) Carnauba wax Printing ink:

Iron oxide (Bla ck) (E172) Propylene glycol Hypromellose

What INVEGA looks like and contents of the pack

INVEGA prolonged -release tablets are capsule shaped. The 3 mgtablets are white and printed with “PAL 3”, the 6 mgtablets are beige and printed with “PAL 6”, the 9 mgtablets are pink and printed with “PAL 9”, and the 12 mgtablets are dark yellow and printed with “PAL 12”. All tablets are available in the following pack sizes:

• Bottles: The tablets are supplied in a plastic bottle with a child -resistant plastic cap. Each bottle

contains either 30tablets or 350tablets. Each bottle contains two silica gel pouches which are provided to absorb moi sture and keep the tablets dry.

• Blisters: The tablets are supplied in blisters packed in cartons of 14, 28, 49, 56, and 98tablets.

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 04100Borgo San Michele Latina Italy 48For any information about this medicine , please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Janssen -Cilag NV Tel/Tél: +32 14 64 94 11 [email protected] UAB “JOHNSON & JOHNSON ” Tel: +370 5 278 68 88 [email protected] България „Джонсън & Джонсън България” ЕООД Тел.:+359 2 489 94 00 [email protected]/Luxemburg Janssen -Cilag NV Tél/Tel: +32 14 64 94 11 [email protected] Česká republika Janssen -Cilag s.r.o.

Tel:+420 227 012 227Magyarország Janssen -Cilag Kft.

Tel.:+36 1 884 2858 [email protected] Danmark Janssen -Cilag A/S Tlf.: +45 4594 8282 [email protected] AM MANGION LTD Tel: +356 2397 6000 Deutschland Janssen -Cilag GmbH Tel: 0800 086 9247 / +49 2137 955 6955 [email protected] Janssen -Cilag B.V.

Tel: +31 76 711 1111 [email protected] Eesti UAB “JOHNSON & JOHNSON “Eesti filiaal Tel: + 372617 7410 [email protected] 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 000Österreich Janssen -Cilag Pharma GmbH Tel: +43 1 610 300 España Janssen -Cilag , S.A.

Tel: +34 91 722 81 00 [email protected] Janssen -Cilag Polska Sp. z o.o.

Tel.: +48 22 237 60 00 France Janssen -Cilag Tél: 0800 25 50 75 / +33 1 55 00 40 03 [email protected] Janssen -Cilag Farmacêutica, Lda.

Tel: +351 214 368 600 Hrvatska Johnson & Johnson S.E. d.o.o.

Tel: +385 1 6610 700 [email protected]ân ia Johnson & Johnson România SRL Tel: +40 21 207 1800 49Ireland Janssen Sciences Ireland UC Tel: 1 800 709 122 [email protected] Johnson & Johnson d.o.o.

Tel: +386 1 401 18 00 [email protected] Ísland Janssen -Cilag AB c/o Visto r hf.

Sími: +354 535 7000 [email protected]á 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]/Finland Janssen -Cilag Oy Puh/Tel: +358 207 531 300 [email protected] Κύπρος Βαρνάβας Χατζηπαναγής Λτδ Tηλ: +357 22 207 700Sverige Janssen -Cilag AB Tfn: +46 8 626 50 00 [email protected] Latvija UAB “JOHNSON & JOHNSON “filiāle Latvijā Tel: +371 678 93561 [email protected] Kingdom (Northern Ireland) Janssen Sciences Ireland UC Tel: +44 1 494 567 444 [email protected]

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu .

📄 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 Invega (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/07/395).

⚠️ 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.