Document: Risperidon Actavis film-coated tablet ENG PL change

• Risperidon Actavis film-coated tablet PL
• Risperidon Actavis film-coated tablet ENG PL

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Package leaflet: Information for the user

Risperidon Actavis 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg & 6 mg film-coated tablets

<or proposed name in territory concerned>

Risperidone

Read all of this leaflet carefully before you 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 further questions, ask your doctor or pharmacist.

• 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 or pharmacist. This includesany possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Risperidon Actavis is and what it is used for

2. What you need to know before you take Risperidon Actavis

3. How to take Risperidon Actavis

4. Possible side effects

5. How to store Risperidon Actavis

6. Contents of the pack and other information

Risperidon Actavis belongs to a group of medicines called ‘anti-psychotics’.

Risperidon Actavis is used to treat the following:

• Schizophrenia, where you may see, hear or feel things that are not there, believe things that are not true or feel unusually suspicious, or confused

• Mania, where you may feel very excited, elated, agitated, enthusiastic or hyperactive Mania occurs in an illness called “bipolar disorder”

• Short-term treatment (up to 6 weeks) of long-term aggression in people with Alzheimer’s dementia, who harm themselves or others. Alternative (non-drug) treatments should have been used previously

• Short-term treatment (up to 6 weeks) of long-term, aggression in intellectually disabled children (at least 5 years of age) and adolescents with conduct disorder.

2. What you need to know before you take Risperidon Actavis

Do not take Risperidon Actavis if:

• You are allergic to risperidone or any of the other ingredients of this medicine (listed in Section 6).

If you are not sure if the above applies to you, talk to your doctor or pharmacist before using Risperidon Actavis.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Risperidon Actavis if:

• You have a heart problem. Examples include an irregular heart rhythm or if you are prone to low blood pressure or if you are using medicines for your blood pressure. Risperidon Actavis may cause low blood pressure. Your dose may need to be adjusted

• You know of any factors which would favour you having a stroke, such as high blood pressure, cardiovascular disorder or blood vessel problems in the brain

• You have ever experienced involuntary movements of the tongue, mouth and face

• You have Parkinson’s disease or dementia

• 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)

• You are diabetic

• You have epilepsy

• You are a man and you have ever had a prolonged or painful erection If you experience this while taking Risperidon Actavis, contact your doctor straight away

• You have problems controlling your body temperature or overheating

• You have kidney problems

• You have liver problems

• You have an abnormally high level of the hormone prolactin in your blood or if you have a tumour, which is possibly dependent on prolactin.

• You or someone else in yourfamily has a history of blood clots, as antipsychoticshave been associated with formation of blood clots.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Risperidon Actavis.

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 Resperidon Actavis, your doctor may check your white blood cell counts.

Risperidon Actavis 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 mellitus have been seen with patients taking Resperidon Actavis, 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 lens (cataract), the pupil (the black circle in the middle of your eye) may not increase in size as needed. Also, the iris (the coloured part of the eye) may become floppy during surgery and that may lead to eye damage. If you are planning to have an operation on your eye, make sure you tell your eye doctor that you are taking this medicine.

Elderly people with dementia

In elderly patients with dementia, there is an increased risk of stroke. You should not take risperidone if you have dementia caused by stroke.

During treatment with risperidone you should frequently see your doctor.

Medical treatment should be sought straight away if you or your care-giver notice a sudden change in your mental state or sudden weakness or numbness of your face, arms or legs, especially on one side, or slurred speech, even for a short period of time. These may be signs of a stroke.

Children and adolescents

Before treatment is started in conduct disorder, other causes of aggressive behaviour should have been ruled out.

If during treatment with risperidone tiredness occurs, a change in the time of administration might improve attention difficulties.

Before treatment is started your, or your child’s body weight may be measured and it may be regularly monitored during treatment.

Other medicines and Risperidon Actavis

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

It is especially important to talk to your doctor or pharmacist if you are taking any of the following:

• Medicines that work on your brain such as to help you calm down (benzodiazepines) or some medicines for pain (opiates), medicines for allergy (some antihistamines), as risperidone may increase the sedative effect of all of these

• Medicines that may change the electrical activity of your heart, such as medicines for malaria, heart rhythm problems (such as quinidine), allergies (anti-histamines), some antidepressants or other medicines for mental problems

• Medicines that cause a slow heart beat

• Medicines that cause low blood potassium (e.g. certain diuretics)

• Medicines to treat elevated blood pressure. Risperidon Actavis can lower blood pressure

• Medicines for Parkinson's disease (such as levodopa)

• Water tablets (diuretics) used for heart problems or swelling of parts of your body due to a build up of too much fluid (such as furosemide or chlorothiazide). Risperidon Actavis taken by itself or with furosemide, may have an increased risk of stroke or death in elderly people with dementia.

The following medicines may reduce the effect of risperidone

• Rifampicin (a medicine for treating some infections)

• Carbamazepine, phenytoin (medicines for epilepsy)

• Phenobarbital

If you start or stop taking such medicines you may need a different dose of risperidone.

The following medicines may increase the effect of risperidone

• Quinidine (used for certain types of heart disease)

• Antidepressants such as paroxetine, fluoxetines, tricyclic antidepressants

• Medicines known as beta blockers (used to treat high blood pressure)

• Phenothiazines (e.g. used to treat psychosis or to calm down)

• Cimetidine, ranitidine (blockers of the acidity of stomach)

If you start or stop taking such medicines you may need a different dose of risperidone.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Risperidon Actavis.

Risperidon Actavis with food, drink and alcohol

You can take this medicine with or without food. You should avoid drinking alcohol when taking Risperidon Actavis.

Pregnancy, breast-feeding and fertility

• Ifyou 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 medicine.Your doctor will decide if you can take it.

• The following symptoms may occur in newborn babies, of mothers that have used Risperidon Actavis in the last trimester (last three months of their pregnancy): shaking, 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.

• Risperidon Actavis can raise your levels of a hormone called "prolactin" that may impact fertility in both men and women (see Possible side effects).

Driving and using machines

Dizziness, tiredness, and vision problems may occur during treatment with Risperidon Actavis. Do not drive or use any tools or machines without talking to your doctor first.

Risperidon Actavis contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Risperidon Actavis

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

The recommended dose is:

For the treatment of schizophrenia

Adults

• The usual starting dose is 2 mg per day, this may be increased to 4 mg per day on the second day

• Your dose may then be adjusted by your doctor depending on how you respond to the treatment

• Most people feel better with daily doses of 4 to 6 mg

• This total daily dose can be divided into either one or two doses a day. Your doctor will tell you which is the best for you.

Elderly people

• Your starting dose will normally be 0.5 mg twice a day

• Your dose may then be gradually increased by your doctor to 1 mg to 2 mg twice a day

• Your doctor will tell you which is the best for you.

For the treatment of mania

Adults

• Your starting dose will usually be 2 mg once a day

• Your dose may then be gradually adjusted by your doctor depending on how you respond to the treatment

• Most people feel better with doses of 1 to 6 mg once a day.

Elderly people

• Your starting dose will usually be 0.5 mg twice a day

• Your dose may then be gradually adjusted by your doctor to 1 mg to 2 mg twice a day depending on how much you respond to the treatment.

For the treatment of long-standing aggression in people with Alzheimer’s dementia

Adults (including elderly people)

• Your starting dose will normally be 0.25 mg twice a day

• Your dose may then be gradually adjusted by your doctor depending on how you respond to the treatment

• Most people feel better with 0.5 mg twice a day. Some patients may need 1 mg twice a day

• Treatment duration in patients with Alzheimer’s dementia should be not more than 6 weeks.

People with kidney or liver problems

Regardless of the disease to be treated, all starting doses and following doses of risperidone should be halved. Dose increases should be slower in these patients.

Risperidone should be used with caution in this patient group.

Use in children and adolescents

For the treatment of conduct disorder in children and adolescents

The dose will depend on your child’s weight:

For children who weigh less than 50 kg

• The starting dose will normally be 0.25 mg once a day

• The dose may be increased every other day in steps of 0.25 mg per day.

• The usual maintenance dose is 0.25 mg to 0.75 mg once a day.

For children who weigh 50 kg or more

• The starting dose will normally be 0.5 mg once a day

• The dose may be increased every other day in steps of 0.5 mg per day.

• The usual maintenance dose is 0.5 mg to 1.5 mg once a day.

Treatment duration in patients with conduct disorder should be not more than 6 weeks.

Children under 5 years old should not be treated with Risperidon Actavis for conduct disorder.

How to take Risperidon Actavis

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

Your doctor will tell you how much medicine to take and for how long. This will depend on your condition and varies from person to person. The amount of medicine you should take is explained under the ‘How much to take’ sub-heading below.

Risperidon Actavis film-coated tablets

• You should swallow your tablet with a drink of water

If you take more Risperidon Actavis than you should

• See a doctor right away. Take the medicine pack with you

• In case of overdose you may feel sleepy or tired, or have abnormal body movements, problems standing and walking, feel dizzy due to low blood pressure, or have abnormal heart beats or fits.

If you forget to take Risperidon Actavis

• If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue as usual. If you miss two or more doses, contact your doctor

• Do not take a double dose (two doses at the same time) to make up for a forgotten dose

If you stop taking Risperidon Actavis

You should not stop taking this medicine unless told to do so by your doctor. Your symptoms may return. If your doctor decides to stop this medicine, your dose may be decreased gradually over a few days.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately if you:

• Experience severe allergic reaction characterized by fever, swollen mouth, face, lip or tongue, shortness of breath, itching, skin rash or drop in blood pressure.

• 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 and difficulty breathing. If you notice any if 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 speech, even for a short period of time. These may be signs of a stroke

• Experience fever, severe muscle stiffness, sweating or a lowered level of consciousness (a disorder called “neuroleptic malignant syndrome). Immediate medical treatment may be needed.

• Are a man 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 risperidone may be needed

The following side effects may happen:

Very Common (affects more than 1 user in 10):

• Difficulty falling 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. 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.

• Feeling sleepy, or less alert

• Headache.

Common (affects 1 to 10 users in 100):

• Pneumonia, Infection of the chest (bronchitis), Common cold symptoms, Sinus infection Urinary tract infection Ear infection, Feeling like you have the flu

• Resperidon Actavis 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 they may include breast discomfort, leakage of milk from the breasts, missed menstrual periods, or other problems with your cycle.

• Weight gain, Increased appetite, Decreased appetite

Sleep disorder, Irritability, Depression, Anxiety, Restlessness with theinability to sit still.

• 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 writhing movements, or twitching.

• Tremor (shaking)

• Blurry vision, Eye infection or "pink eye"

• Rapid heart rate, High blood pressure, Shortness of breath

• Sore throat, Cough, Nosebleeds, Stuffy nose

• Abdominal pain, Abdominal discomfort, Vomiting, Nausea, Constipation, Diarrhea, Indigestion, Dry mouth, Toothache

• Rash, Skin redness

• Muscle spasms, Bone or muscle ache, Back pain, Joint pain

• Incontinence (lack of control) of urine

• Swelling of the body, arms or legs, Fever, Chest pain, Weakness, Fatigue (tiredness), Pain

• Fall.

Uncommon (affects1 to 10 usersin 1000):

• Infection ofthebreathingpassages, Bladderinfection,‘Eyeinfection,Tonsillitis,Fungalinfection of thenails, Infection oftheskin, An infectionconfinedtoa singleareaofskin orpartof thebody, Viral infection, Skininflammation caused bymites

• Decreaseinthetypeof whiteblood cellsthathelpto protectyou againstinfection,Whitebloodcell count decreased Decreasein platelets(blood cellsthathelp you stop bleeding), Anemia, Decreasein red bloodcells, Increaseineosinophils(atypeof whitebloodcell)in yourblood

• Allergicreaction

• Diabetesor worseningof diabetes, High blood sugar, Excessivedrinkingof water

• Weightloss, Lossof appetiteresultingin malnutritionand lowbodyweight

• Increased cholesterolin yourblood

• Elated mood (mania), Confusion,Decreased sexualdrive, Nervousness, Nightmares

• Tardivedyskinesia(twitchingor jerkingmovementsthatyou cannotcontrolin yourface,tongue, or otherpartsof yourbody).Tellyourdoctorimmediatelyifyou experienceinvoluntaryrhythmic movementsof thetongue,mouth and face.Withdrawalof Resperidon Actavismaybe needed,

• Suddenlossof bloodsupplyto brain (strokeor "mini"stroke)

• Unresponsiveto stimuli, Lossofconsciousness, Lowlevelof consciousness

• Convulsion(fits), Fainting

• Arestlessurgeto movepartsofyourbody, Balancedisorder, Abnormalcoordination, Dizzinessupon standing, Disturbancein attention, Problems with speech, Loss orabnormalsenseof taste, Reduced sensation ofskin to pain and touch, A sensationof tingling, pricking, or numbnessskin

• Oversensitivityof theeyesto light, Dryeye, Increasedtears, Rednessof theeyes

• Sensation of spinning(vertigo), Ringingin theears, Earpain

• Atrialfibrillation(anabnormalheartrhythm), An interruptionin conduction between theupperand lowerpartsoftheheart, Abnormalelectricalconduction of theheart, Prolongationof theQTinterval fromyourheart, Slowheartrate, Abnormalelectricaltracingof theheart(electrocardiogramor ECG), A flutteringor poundingfeelingin yourchest(palpitations)

• Lowblood pressure, Low blood pressureupon standing(consequently, somepeopletakingtaking Resperidon Actavismayfeelfaint, dizzy, or maypass outwhentheystand up orsitup suddenly, Flushing

• Pneumoniacaused byinhalingfood, Lungcongestion,Congestionof breathingpassages, Cracklylung sounds,Wheezing, Voicedisorder, Breathingpassagedisorder

• Stomach or intestinalinfection, Stoolincontinence,Veryhard stool, Difficultyswallowing, Excessive passingof gasor wind

• Hives (or"nettlerash"), Itching, Hairloss,Thickeningof skin, Eczema, Dryskin, Skin discoloration, Acne, Flaky, itchyscalp orskin, Skin disorder, Skinlesion

• An increaseof CPK(creatinephosphokinase)in yourblood,an enzymewhich issometimesreleased with musclebreakdown

• Abnormalposture,Jointstiffness,Jointswelling, Muscleweakness, Neckpain

• Frequentpassingof urine,Inabilityto passurine, Painwhen passingurine

• Erectiledysfunction, Ejaculation disorder

• Lossofmenstrualperiods,Missed menstrualperiodsorotherproblemswith yourcycle(females),

• Developmentof breastsinmen, Leakageof milkfromthebreasts, Sexualdysfunction,Breastpain, Breastdiscomfort,Vaginaldischarge

• Swellingof theface, mouth, eyes, orlips

• Chills, Anincreasein bodytemperature

• Achangein thewayyou walk

• Feelingthirsty, Feelingunwell, Chestdiscomfort,Feeling"outofsorts", Discomfort

• Increased livertransaminasesin yourblood, IncreasedGGT(aliverenzymecalledgamma- glutamyltransferase)in yourblood, Increased liverenzymesin yourblood

• Proceduralpain.

Rare(affects1 to 10 usersin 10,000):

• Infection

• Inappropriatesecretionof ahormonethatcontrolsurinevolume

• Sugarin theurine, Low blood sugar, High bloodtriglycerides(a fat)

• Lackof emotion, Inabilityto reach orgasm

• Neurolepticmalignantsyndrome(confusion, reduced orlossofconsciousness,high fever, and severe musclestiffness)

• Blood vesselproblemsin thebrain

• Comadue to uncontrolleddiabetes

• Shakingof thehead

• Glaucoma(increased pressurewithin theeyeball), Problemswith movementof youreyes, Eye rolling,Eyelid margin crusting

• Eyeproblemsduringcataractsurgery. Duringcataractsurgery, a conditioncalled intraoperativefloppy irissyndrome(IFIS)can happen ifyou takeorhavetaken Resperidon Actavis. Ifyou needtohavecataract surgery, be sureto tellyoureyedoctor ifyou takeorhavetaken thismedicine.

• Dangerouslylownumbersof acertain typeofwhiteblood cellneeded to fightinfectionin yourblood,

• Severeallergicreaction characterised by fever, swollenmouth, face,lip or tongue,shortnessof breath, itching, skin rash and sometimesdropin bloodpressure

• Dangerouslyexcessiveintakeof water

• Irregularheartbeat

• Blood clotinthelegs, Blood clotin thelungs

• Troublebreathingduringsleep (sleep apnea), Fast,shallowbreathing

• Inflammation of thepancreas, A blockagein thebowels

• Swollen tongue, Chappedlips, Rashon skinrelated todrug

• Dandruff

• Breakdown of musclefibersand painin muscles(rhabdomyolysis)

• Adelayin menstrualperiods, Enlargementof theglandsin yourbreasts, Breastenlargement, Dischargefromthebreasts

• Increased insulin(ahormonethatcontrolsblood sugarlevels)in yourblood

• Priapism(aprolonged penileerectionthatmayrequiresurgicaltreatment)

• Hardeningof theskin

• Adecreasein bodytemperature, Coldnessin armsand legs

• Symptomsof drugwithdrawal

• Yellowingof theskin and theeyes(jaundice).

Very rare(affectslessthan 1 user in 10,000):

• Lifethreateningcomplicationsof uncontrolled diabetes.

• Seriousallergicreaction with swellingthatmayinvolvethe throatand lead to difficultybreathing.

• Lack of bowel muscle movement that causes blockage.

Thefollowingsideeffecthasbeen seen withtheuseofanothermedicinecalled paliperidonethatisvery similartorisperidone, so thesecan also beexpected with Resperidon Actavis: Rapid heartbeatupon standing.

Additionalsideeffectsinchildren and adolescents

Ingeneral, sideeffectsin childrenareexpected to besimilarto thoseinadults.

Thefollowingsideeffectswerereported moreofteninchildren and adolescents(5to 17 years)than in adults:feelingsleepy, or less alert,fatigue (tiredness),headache,increased appetite, vomiting,common cold symptoms, nasal congestion, abdominalpain, dizziness, cough, fever,tremor(shaking), diarrhoea, and incontinence(lackof control)ofurine.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet.You can also report side effects directly via <to be completed nationally>. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Risperidone Actavis

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, carton, or tablet container after EXP. The expiry date refers to the last day of that month.

Film-coated tablets 0.25 mg and 0.5 mg:

Do not store above 25 C.

Film-coated tablets 1 mg, 2 mg, 3 mg, 4 mg and 6 mg:

No special storage precautions.

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 Risperidon Actavis contains

- The active substance is risperidone. Each Risperidon Actavis 0.25 mg film coated tablet contains 0.25 mg risperidone. Each Risperidon Actavis 0.5 mg film coated tablet contains 0.5 mg risperidone. Each Risperidon Actavis 1 mg film coated tablet contains 1 mg risperidone. Each Risperidon Actavis 2 mg film coated tablet contains 2 mg risperidone. Each Risperidon Actavis 3 mg film coated tablet contains 3 mg risperidone. Each Risperidon Actavis 4 mg film coated tablet contains 4 mg risperidone. Each Risperidon Actavis 6 mg film coated tablet contains 6 mg risperidone

- The other ingredients areTablet core: lactose, anhydrous, microcrystalline cellulose, pregelatinised starch, magnesium stearate; Film coat: hypromellose, macrogols, titanium dioxide (E 171). <[0.25 mg and 0.5 mg tablets also contain]> Iron oxide, yellow (E172)

What Risperidon Actavis looks like and contents of the pack

0.25 mg tablet: Light yellow, round, biconvex film-coated tablets, marked “T”, diameter 6 mm.

0.5 mg tablet: Light yellow, oval, biconvex, film-coated tablets, marked “T”, scored, 8 x 5 mm.

1 mg tablet: White, oval, biconvex film-coated tablets, marked “T1”, scored, 8x5 mm.

2 mg tablet: White, oval, biconvex film-coated tablets, marked “T2”, scored, 10x5 mm.

3mg tablet: White, oval, biconvex film-coated tablets, marked “T3”, scored, 11x6.5 mm.

4 mg tablet: White, oval, biconvex film-coated tablets, marked “T4”, scored, 14x7.5 mm.

6 mg tablet: White, oval, biconvex film-coated tablets, marked “T”, scored, 16x8.5 mm.

0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 6 mg tablets: The tablets can be divided into two equal parts.

Packaging:

Blister pack: 6, 10, 20, 28, 30, 50, 60, 98 and 100 tablets.

Plastic bottle: 100 and 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Actavis Group hf.

Reykjavíkurvegur 76-78

IS-220 Hafnarfjörður

Island

Manufacturer:

Actavis hf. (former Delta hf.)

Reykjavíkurvegi 78

PO Box 420

IS-222 Hafnarfjörður

Iceland

Actavis Ltd.

BT16 Bulebel Industrial Estate

Zeitun

Malta

Balkanpharma – Dupnitsa AD

3 Samokovsko Schosse Str.

Dupnitsa 2600

Bulgaria

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria: Risperidon Actavis 1 mg, 2 mg, 3 mg & 4 mg, Filmtabletten

Denmark: Risperidon Actavis 0.5 mg, 1 mg, 2 mg, 3 mg & 4 mg, filmovertrukne tabletter

Italy: Risperidone Actavis 1 mg, 2 mg, 3 mg & 4 mg, compresse rivestite con film

Netherlands: Risperidon Auro 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg & 6 mg, filmomhulde tabletten

Slovenia: Rispons 1 mg, 2 mg, 3 mg & 4 mg, filmsko obložene tablete

Spain: Risperidona Aurovitas 1 mg, 3 mg & 6 mg, comprimidos recubiertos con película EFG

Sweden: Risperidon Actavis 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg & 6 mg, filmdragerade tabletter

This leaflet was last revised in

2015-06-25