Risperidon Mylan

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Package leaflet: Information for the patient

Risperidon Mylan 3 mg Orodispersible Tablets

Risperidon Mylan 4 mg Orodispersible Tablets

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 includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Risperidon Mylanis and what it is used for

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

3. How to take Risperidon Mylan

4. Possible side effects

5. How to store Risperidon Mylan

6. Contents of the pack and other information

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

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

Risperidon Mylan 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 Mylan

Do not take Risperidon Mylan

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Risperidon Mylan:

if you have a heart problem. Examples include if you have a weakness of the heart muscle (heart failure), have had a heart attack, if you are prone to low blood pressure or if you are taking medicines for your blood pressure. Risperidone may cause low blood pressure. Your dose may need to be adjusted

if you, or someone else in your family, have a history of an irregular heart rhythm, as medicines like this medicine have been associated with potentially serious changes in heart rhythm

if 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

if you know of any factors which would favour you developing a blood clot, such as you smoke, or have smoked, or if you are likely to be immobile for a prolonged period (e.g. after surgery or illness)
if you or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots
if you have, or have had, low numbers of white blood cells in the blood including if this has happened after taking other medicines
if you have ever experienced involuntary movements of the tongue, mouth and face
if you have ever had a condition whose symptoms include high temperature, muscle stiffness, sweating, or a lowered level of consciousness (also known as Neuroleptic Malignant Syndrome)

if you have Parkinson’s disease or dementia, including dementia with Lewy bodies
if you are diabetic, or are at risk of developing diabetes (you may have raised levels of sugar in the blood)
if you have epilepsy
if you are a man and you have ever had a prolonged or painful erection If you experience this while taking risperidone, contact your doctor straight away
if you have problems controlling your body temperature, are prone to overheating, or are, or may be, exposed to very high temperatures or strenuous exercise

if you are, or become during treatment, dehydrated, or have a low blood volume (hypovolaemia)
if you have low levels of potassium or magnesium in the blood

if you have kidney problems
if you have liver problems
if 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.

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

During treatment

Risperidone can cause changes in the number of white blood cells, which help fight infection, therefore before and during treatment your doctor may carry out blood tests.

Risperidone may cause you to gain weight. Significant weight gain may adversely affect your health. Your doctor should regularly measure your body weight.

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

Risperidone commonly raises levels of a hormone called "prolactin". This may cause side effects such as menstrual disorders or fertility problems in women, breast swelling in men, low sex drive, impotence, and milky secretion from the breasts (see section 4 “Possible side effects”). If such side effects occur, evaluation of the prolactin level in the blood is recommended.

If you are due to have surgery on your eye, tell your doctor or hospital staff that you are taking this medicine. During cataract (a clouding of the lens of the eye) surgery, this medicine may affect the pupil or the iris (coloured part of the eye) which could lead to eye damage.

Elderly people with dementia

In elderly patients with dementia, there is an increased risk of strokeor mini-stroke (also known as atransient ischaemic attack or TIA). 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, vision problems 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.

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

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

A small and inconclusive study has reported an increase in height in children who took risperidone, but whether this is an effect of the drug or due to some other reason is not known.

Other medicines and Risperidon Mylan

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 health conditions
Medicines that cause a slow heart beat
Medicines that cause low blood potassium or magnesium (e.g. certain diuretics)
Medicines to treat elevated blood pressure. Risperidone 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). Risperidone 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, fluoxetine, sertraline and fluvoxamine, 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)
Itraconazole and ketoconazole (medicines for treating fungal infections)
Certain medicines used in the treatment of HIV/AIDS, such as ritonavir.

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 Mylan.

Risperidon Mylan with alcohol

You should avoid drinking alcohol when taking Risperidon Mylan.

Pregnancy, breast-feeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you, or your partner take this medicine.

The following symptoms may occur in newborn babies, of mothers that have used Risperidon Mylanin 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.

Risperidone can raise your levels of a hormone called “prolactin” that may impact fertility in both female and male patients (see section 4 “Possible side effects”).

Driving and using machines

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

Risperidon Mylan contains aspartame and sorbitol

Risperidon Mylan orodispersible tablets contain aspartame (E951) which is a source of phenylalanine. May be harmful for people with phenylketonuria.

Risperidon Mylan orodispersible tablets contain sorbitol also. 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 Mylan

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

How much to take

For the treatment of schizophrenia

Adults

The recommended 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 dose is the best for you.

Elderly people

Your recommended 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 dose is the best for you.

Use in children and adolescents

Children and adolescents under 18 years old should not be treated with risperidone for schizophrenia.

For the treatment of mania

Adults

Your recommended 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 recommended 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 you respond to the treatment.

Use in children and adolescents

Children and adolescents under 18 years old should not be treated with risperidone for bipolar mania.

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

Adults (including elderly people)

Your recommended 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.

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 recommended 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 recommended maintenance dose is 0.25 mg to 0.75 mg once a day.

For children who weigh 50 kg or more

The recommended 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 recommended 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 risperidone for conduct disorder.

People with kidney or liver problems

Regardless of why you are taking this medicine, 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.

How to take Risperidon Mylan

Risperidon Mylan can be taken with or without food.

Only remove a tablet from the blister when it is time to take your medicine.

Hold the blister at the edges and separate one blister cell from the rest of the blister by gently tearing along the perforations around it.

Peel open a blister to expose the tablet.
Do not push the tablet through the foil because it may break.

Remove the tablet from the blister with dry hands.

Place the tablet on your tongue straight away. The tablet will begin disintegrating within seconds. It can then be swallowed with or without water.

If you take more Risperidon Mylan 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 Mylan

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 Mylan

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.

Contact your doctor immediately or go to a hospital emergency department if you experience any of the following:

Common (may affect up to 1 in 10 people):

Serious lung infections such as pneumonia – you may have a very high temperature, cough up phlegm which may be bloody or frothy and feel very unwell.

Uncommon (may affect up to 1 in 100 people):

Sudden weakness or numbness of the face, arms, or legs, especially on one side, or instances of vision problems or slurred speech that last for less than 24 hours. These may be signs of a mini-stroke (TIA), stroke or reduced blood flow to the brain
An abnormal heart rhythm, such as fluttering of the heart (fibrillation) or very slow or abnormal heart beat (heart block). These may be caused by abnormal electrical conduction of the heart and may be seen as abnormal electrical activity tracing of the heart (ECG). In some cases this can be life threatening
If you are unresponsive to stimuli, have a low level of consciousness or fall unconscious, or experience fits (convulsions)
Involuntary rhythmic movements of the tongue, mouth and face. Withdrawal of risperidone may be needed
Infections with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/mouth, or urinary problems. Risperidone may cause a severe reduction in the number of white blood cells and your resistance to infection may be decreased. A blood test will be taken to check for a possible reduction of white blood cells (neutropenia, agranulocytosis). It is important to tell your doctor that you are taking this medicine
Inability to urinate or incomplete emptying of the bladder.

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

A severe allergic reaction resulting in difficulty breathing and shock, sudden swelling of the lips, eyes, face, tongue or throat; difficulty swallowing; hives; drop in blood pressure
Unexplained muscle pain, muscle cramps or muscle weakness (rhabdomyolysis)
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
Fever, muscle stiffness, sweating or a lowered level of consciousness (a disorder called “Neuroleptic Malignant Syndrome”)
Prolonged or painful erection. This is called priapism

Severe pain in the stomach which reaches round through the back. This may be a sign of inflammation of the pancreas.

Very rare (may affect up to 1 in 10,000 people):

If you are diabetic and experience loss of appetite, unexplained weight loss, nausea, vomiting, stomach pain, difficulty breathing, slow heart beat, unusual muscle pain or feeling weak, tired or uncomfortable. These may be signs of a rare life-threatening complication of uncontrolled diabetes called diabetic ketoacidosis.

The following side effects may also occur:

Very common (may affect more than 1 in 10 people):

Parkinsonism. 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, drowsiness, sleepiness.

Common (may affect up to 1 in 10 people):

Fatigue, restlessness, inability to sit still
Anxiety, depression, irritability, dizziness, feeling exhausted, sleep disorder
Vomiting, diarrhoea, constipation, nausea, heartburn or indigestion, abdominal pain or discomfort, sore throat, dry mouth, toothache
Weight increased, increased appetite, decreased appetite
Shortness of breath
Flu, common cold symptoms, infection of the chest (bronchitis), sinus infections, urinary tract infection, infections of the ear, infection or allergic reactions of the eye which can produce a sticky discharge
Blurred vision
Nose or sinus congestion, nose bleeding, cough
Inability to control when passing urine (incontinence)
Shaking (tremor) or twitching muscles
Dystonia: 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
Dyskinesia: a condition involving involuntary muscle movements, and can include repetitive, jerky or writhing movements, or twitching
Fluid retention in the body (e.g. swelling of arms and legs)
Rash, skin redness
Fast beating heart, chest pain, high blood pressure
Fever
Other pain
Fall
Raised levels of a hormone called “prolactin” seen 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.

Uncommon (may affect up to 1 in 100 people):

Increased cholesterol in your blood
Excessive drinking of water, thirst
Stool incontinence, wind
Bladder infection, viral and other infection, tonsil infection, infection of the breathing passages, stomach infection, yeast infection of nails
Congestion of the sinuses or breathing passages
Drop in blood pressure after standing, low blood pressure, increase in body temperature, feeling dizzy after changing body position, awareness of heart beating, heart rate decreased
Pain when passing urine, frequent passing of urine
Confusion, disturbance in attention
Nightmares, nervousness, elated mood (mania)
Blood sugar increased, liver enzymes increased, 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)

Development of diabetes – a condition where the body is unable to control blood sugar levels correctly. You may feel very thirsty yet pass lots of urine, have an increased appetite yet feel tired and lethargic

Muscle weakness, excessive restlessness associated with muscle spasms and tremor, abnormal coordination
Ear pain, neck pain
Joint swelling, abnormal posture, joint stiffness
Chest discomfort
Skin lesion, skin disorder, dry skin, intense itching of skin, nettle rash, acne, hair loss, eczema, skin inflammation caused by mites, skin discoloration, thickening of skin, flushing, pins and needles like sensations, reduced skin sensitivity to pain or touch, inflammation of oily skin
No menstruation, sexual dysfunction, erectile dysfunction, ejaculation disorder, unusual secretion of breast milk, enlargement of breast in men, breast pain or discomfort, decreased sexual drive, irregular or delayed menstruation, vaginal discharge
Fainting, gait disturbance
Weight decreased, decreased appetite resulting in malnutrition and low body weight, taste disturbance, feeling ‘out of sorts’ or abnormal, balance disorder
Allergy
Chills
Painful oversensitivity to light, increased blood flow to the eye, dry eye, increase in tears
Crackly lung noise, speech disorder, trouble speaking, difficulty swallowing, coarse/whistling sound during breathing

Inhale food into the breathing passages causing an infection, or have congestion of the lung (e.g. due to a build-up of phlegm)

Infection under the skin, normally in the fatty layers of the thigh and buttock (cellulitis)
Severe constipation, which may be due to an obstruction of intestine or a severe hardening and compaction of the faeces
Ringing in ears, sensation of spinning and dizziness (vertigo)
Face oedema.

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

Inability to reach orgasm, breast enlargement or swollen, hot, tender breasts, breast discharge
Dandruff
Coldness in arms and legs
Tongue swelling, lip inflammation
Hardening of parts of the body e.g. skin
Eyelid margin crusting, eye rolling, problems with eye movement, complications during cataract surgery
Increased pressure in the eye (glaucoma), which can cause problems with vision and longer term serious problems with eyesight
A lower than normal level of sodium in the blood, which may make you feel weak and confused with aching of muscles. This may be due to inappropriate secretion of a hormone (ADH) that causes the body to retain water and dilute the blood, reducing the amount of sodium
Dangerously excessive intake of water
Lack of emotion

Shaking, muscle stiffness, and/or weakness, sleepiness, agitation and breathing problems. These may be signs of drug withdrawal syndrome which can occur if you suddenly stop taking this medicine
Signs of drug withdrawal and feeding difficulties in newborn babies (see section 2 “Pregnancy and breast-feeding”)
Body temperature decreased

Fast shallow breathing, trouble breathing during sleep
Tremor of the head
Yellowing of the skin and the eyes (jaundice)
Presence of blood sugar (glucose) in the urine, low blood sugar, raised levels of insulin or fats (triglycerides) in the blood.

Very rare (may affect up to 1 in 10,000 people):

Blockage of bowel (persistent constipation with swollen stomach and vomiting)

The following side effect has been seen with the use of another medicine called paliperidone that is very similar to risperidone, so these can also be expected with Risperidon Mylan: Rapid heartbeat upon standing.

Elderly people

In elderly patients with dementia, a small increase in the number of deaths has been reported for patients taking antipsychotics compared with those not receiving antipsychotics.

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, dizziness
Abdominal pain, increased appetite, vomiting, diarrhoea
Common cold symptoms, nasal congestion, cough, fever, tremor (shaking)
Incontinence (lack of control) of urine, which may cause bed wetting.

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 Mylan

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 and outer carton after EXP.The expiry date refers to the last day of that month.

Store in the original blister in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Risperidon Mylan contains

The active substance is risperidone. Each orodispersible tablet contains 3 mg or 4 mg risperidone.
The other ingredients are mannitol, basic butylated methacrylate copolymer, povidone K25, microcrystalline cellulose, low-substituted hydroxypropylcellulose, aspartame (E951), crospovidone, red iron oxide (E172), spearmint flavour (containing in particular sorbitol

(E420)), peppermint flavour (containing in particular sorbitol (E420)), levomenthol, calcium silicate, magnesium stearate.

What Risperidon Mylan looks like and contents of the pack

Round, slightly convex, pink marbled orodispersible tablets.

Pack sizes of 10, 14, 20, 28, 30, 56, 60, 84, 90, 100, 180 and 200orodispersible tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

[To be completed nationally].

Manufacturer

Krka, d.d.,

Šmarješka cesta 6

8501 Novo mesto

Slovenia

McDermott Laboratories Ltd t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate, Grange Road

Dublin 13

Ireland

Mylan Hungary Kft.

H-2900, Komárom, Mylan utca 1,

Hungary

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

Bulgaria Risperidon Generics orodispersible tablets

Greece Risperidone/Generics orodispersible tablets

Portugal Risperidona Mylan

Sweden Risperidon Mylan munsonderfallande tablett

The Netherlands Risperidon SmeltTab Mylan orodispergeerbare tabletten

United Kingdom Risperidone Oral Dispersible Tablets

This leaflet was last revised in 2016-09-22