REG0068357

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REG0068357

of the face, arms, or legs, especially on one side, or instances of slurred speech that last for less than 24 hours (these are called mini-strokes or strokes), involuntary movements of face, arms, or legs, ringing in ears, face oedema.)

•    Brain related disorder (Tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body). If you experience involuntary rhythmic movements of the tongue, mouth and face. Withdrawal of Risperidone may be needed.

•    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.

•    Heart related disorder (Abnormal electrical conduction of the heart, prolongation of the QT interval from your heart, drop in blood pressure after standing, low blood pressure, feeling dizzy after changing body position, abnormal electric activity tracing of the heart (ECG), abnormal heart rhythm, awareness of heart beating, heart rate increased or decreased)

Very common: affects more than 1 user in 10

Common: affects 1 to 10 users in 100

Uncommon: affects 1 to 10 users in 1,000

Rare: affects 1 to 10 users in 10,000

Very rare: affects less than 1 user in 10,000

Not known: frequency cannot be estimated from the

available data.

The following side effects may happen:

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

•    Parkinsonism.This is a medical term that includes many symptoms. Each individual symptom may occur less frequently than in 1 in 10 people. Parkinsonism includes: increase in saliva secretion or watery mouth, musculoskeletal stiffness, drooling, jerks when bending the limbs, slow, reduced or impaired body movements, no expression on the face, muscle tightness, stiff neck, muscle stiffness, small, shuffling, hurried steps and lack of normal arm movements when walking, persistent blinking in response to tapping of the forehead (an abnormal reflex)

•    Headache, difficulty falling or staying asleep.

•    Feeling sleepy, or less alert Common (affects 1 to 10 users in 100):

•    Drowsiness, fatigue, restlessness, inability to sit still, irritability, anxiety or nervous excitement, sleepiness, dizziness, poor attention, feeling exhausted, sleep disorder, depression, weakness

•    Vomiting, diarrhoea, constipation, nausea, increased appetite, abdominal pain or discomfort, sore throat, dry mouth, toothache

•    Weight increased, increase in body temperature, decreased appetite

•    Difficulty breathing, lung infection (pneumonia), flu, infection of the breathing passages, blurred vision, eye infection, nose congestion, nose bleeding, cough

•    Urinary tract infection, sinus infection, ear infection, bed wetting

•    Muscle spasm, involuntary movements of face or arms and legs, joint pain, back pain, swelling of arms and legs, pain in arms and legs, bone or muscle ache

•    Rash, skin redness

•    Fast beating heart, chest pain

•    Incontinence (lack of control) of urine

•    Risperidone can raise your levels of a hormone called “prolactin" found in 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..

•    Fall.

Uncommon (affects 1 to 10 users in 1000):

•    Excessive drinking of water, stool incontinence, excessive passing of gas, thirsty, very hard faeces, hoarseness or voice disorder

•    Lung infection caused by inhaling of food into the breathing passages, bladder infection, 'pink eye', sinus infection, viral infection, ear infection, tonsil infection, infection under the skin, eye infection, stomach or intestinal infection, eye discharge, yeast infection of nails, skin rash

•    Pain when passing urine, frequent passing of urine, inability to pass urine

•    Confused, disturbance in attention, low level of consciousness, excessive sleep, nervousness, elated mood (mania) , lack of energy and interest, nightmares

•    Diabetes or worsening of diabetes ,blood sugar increased, liver enzymes increased, white blood cell count decreased, low haemoglobin or red blood cell count (anaemia), increase in eosinophils (special white blood cells), blood creatinine phosphokinase increased, decrease in platelets (blood cells that help you stop bleeding)

•    Increased cholesterol in your blood

•    Muscle weakness, muscle pain, ear pain, neck pain, joint swelling, abnormal posture, joint stiffness, musculoskeletal chest pain, chest discomfort, sensation of spinning (vertigo)

•    Skin lesion, skin disorder, dry skin, intense itching of skin, acne, hair loss, skin inflammation caused by mites, skin discoloration, thickening of skin, flushing, reduced skin sensitivity to pain or touch, inflammation of oily skin

•    No menstruation, sexual dysfunction, erectile dysfunction, ejaculation disorder, breast discharge, breast pain, enlargement of breast in men, decreased sexual drive, irregular menstruation, vaginal discharge

•    Fainting, gait disturbance, sluggishness, decreased appetite resulting in malnutrition and low body weight, feeling 'out of sorts', balance disorder, allergy, oedema, speech disorder, chills, abnormal coordination

•    Painful oversensitivity to light, increased blood flow to the eye, eye swelling, dry eye, increase in tears

•    Breathing passage disorder, lung congestion, crackly lung noise, congestion of breathing passages, trouble speaking, difficulty swallowing, cough with sputum, coarse/whistling sound during breathing, flu-like illness, sinus congestion,

•    Convulsion (fits), fainting

•    Complete lack of taste

•    A restless urge to move parts of your body, balance disorder, abnormal coordination, dizziness upon standing, disturbance in attention, problems with speech, loss or abnormal sense of taste, reduced sensation of skin to pain and touch, a sensation of tingling, pricking, or numbness skin

•    Chills, an increase in body temperature

•    Feeling unwell, chest discomfort, feeling “out of sorts'" discomfort

•    Increased liver transaminases in your blood, increased GGT (a liver enzyme called gammagluta-myltransferase) in your blood, Increased liver enzymes in your blood

•    Procedural pain.

Rare (affects 1 to 10 users in 10,000):

•    Infection

•    Inability to reach orgasm, menstrual disorder

•    Dandruff

•    Drug allergy, coldness in arms and legs, lip swelling, lip inflammation

•    Glaucoma, reduced visual clarity, eyelid margin crusting, eye rolling

•    Lack of emotion

•    Change in consciousness with increased body temperature and twitching of muscles, oedema all over the body, drug withdrawal syndrome, body temperature decreased

•    Fast shallow breathing, trouble breathing during sleep, chronic otitis media

•    Obstruction of intestine,

•    Reduced blood flow to the brain

•    Decrease in white blood cells, inappropriate secretion of a hormone that controls urine volume

•    Breakdown of muscle fibers and pain in muscles (rhabdomyolysis), movement disorder, increase in heart

•    Coma due to uncontrolled diabetes

•    Yellowing of the skin and the eyes (jaundice)

•    Inflammation of the pancreas.

•    Dangerously excessive intake of water

•    Eye problems during cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) can happen if you take or have taken Risperidone. If you need to have cataract surgery, be sure to tell your doctor

•    Increased insulin (a hormone that controls blood sugar levels) in your blood

•    Blood clot in the legs, blood clot in the lungs

•    Swollen tongue, chapped lips, rash on skin related to

•    Priapism (a prolonged penile erection that may require surgical treatment)

•    A delay in menstrual periods, enlargement of the glands in your breasts, breast enlargement, discharge from the breasts

•    Hardening of the skin

Very rare (affects less than 1 user in 10,000):

•    Life threatening complications of uncontrolled diabetes.

•    Swelling beneath the surface of the skin with or without redness.

•    Lack of bowel muscle movement that causes blockage. Unknown frequency of occurrence (frequency cannot be estimated from the available data):

•    Severe allergic reaction resulting in difficulty in breathing and shock

•    No granulocytes (a type of white blood cell to help you against infection)

•    Prolonged and painful erection

Additional side effects in children and adolescents In general, side effects in children are expected to be similar to those in adults.

The following side effects were reported more often in children and adolescents (5 to 17 years) than in adults: feeling sleepy, or less alert, fatigue (tiredness), headache, increased appetite, vomiting, common cold symptoms, nasal congestion, abdominal pain, dizziness, cough, fever, tremor (shaking), diarrhoea, and incontinence (lack of control) of urine.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via theYellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

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HOW TO STORE RISPERIDONE

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

Do not use Risperidone after the expiry date which is stated on the outer packaging or bottle. The expiry date refers to the last day of the month.

Do not store above 25^oC.

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.

Contents of the pack and other Information

What Risperidone contains:

•    The active ingredient is risperidone.

•    Other ingredients are lactose monohydrate, sodium lauril sulfate, hypromellose (E464), macrogol 6000, macrogol 400, colloidal anhydrous silica, microcrystalline cellulose, pregelatinised starch, sodium starch glycolate (Type A) and magnesium stearate. The tablets contain the following colours:

•    0.5 mg tablets: iron oxide red (E172), iron oxide yellow (E172) and titanium dioxide (E171)

•    1 mg tablets: titanium dioxide (E171)

•    2 mg tablets: iron oxide red (E172), Iron oxide yellow (E172) and titanium dioxide (E171)

•    3 mg tablets: titanium dioxide (E171) and quinoline yellow aluminium lake (E104)

•    4 mg tablets: titanium dioxide (E171), quinoline yellow aluminium lake (E104), indigo carmine aluminium lake (E132) and iron oxide yellow (E172)

•    6 mg tablets: titanium dioxide (E171), iron oxide red (E172) and iron oxide yellow (E172).

What Risperidone looks like and the contents of the pack:

•    Risperidone 0.5 mg Film-Coated Tablets are brownish-red, round slightly arched tablets, with approx. 6.5 mm diameter and 3 mm thickness, debossed RIS 0.5 and scoreline on one side and scoreline on the other side

•    Risperidone 1 mg Film-Coated Tablets are white, round, slightly arched tablets, with approx. 8 mm diameter and

3.5    mm thickness, debossed RIS 1 and scoreline on one side and scoreline on the other side.

•    Risperidone 2 mg Film-Coated Tablets are tan, round, slightly arched tablets, with approx. 8 mm diameter and

3.5    mm thickness,debossed RIS 2 and scoreline on one side and scoreline on the other side

•    Risperidone 3 mg Film-Coated Tablets are yellow, round, slightly arched tablets, with approx. 9.5 mm diameter and 4 mm thickness, debossed RIS 3 and scoreline on one side and scoreline on the other side

•    Risperidone 4 mg Film-Coated Tablets are green, round, slightly arched tablets, with approx. 10.5 mm diameter and 4.5 mm thickness, debossed RIS 4 and scoreline on one side and scoreline on the other side

•    Risperidone 6 mg Film-Coated Tablets are tan, round, slightly arched tablets, with approx. 10.5 mm diameter and 4.5 mm thickness, debossed RIS 6 and scoreline on one side and scoreline on the other side

•    The 0.5 mg tablets are available in pack sizes of 10, 20 and 60 film-coated tablets

•    The 1 mg tablets are available in pack sizes of 6, 10, 20, 50, 60, 100, 100 (5x20 hospital pack) and 500 film-coated tablets

•    The 2 mg tablets are available in pack sizes of 10, 20, 50, 60, 100, 100 (5x20 hospital pack) and 500 film-coated tablets

•    The 3 mg tablets are available in pack sizes of 10, 20, 50, 60, 100, 100 (5x20 hospital pack) and 500 film-coated tablets

•    The 4 mg tablets are available in pack sizes of 10, 20, 30, 50, 60, 100, 100 (5x20 hospital pack) and 500 film-coated tablets

•    The 6 mg tablets are available in pack sizes of 7, 20, 28, 30, 50, 60, 100 and 100 (5x20 hospital pack) film-coated tablets.

Not all pack sizes may be marketed Marketing Authorisation Holder and Manufacturer The Marketing Authorisation holder and company responsible for manufacture isTEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised: May 2016

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