Risperidone Sandoz GmbH: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

RISPERIDONE SANDOZ GMBH 1 mg/ml oral solution

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Risperidone Sandoz GmbH is and what it is used for
What you need to know before taking Risperidone Sandoz GmbH
How to take Risperidone Sandoz GmbH
Possible side effects
How to store Risperidone Sandoz GmbH
Contents of the pack and other information

1. What Risperidone Sandoz GmbH is and what it is used for

Risperidone Sandoz GmbH contains the active substance risperidone. It belongs to a group of medicines
called "antipsychotics".
Risperidone Sandoz GmbH is used to treat:

Schizophrenia, a condition in which you may see, hear, or feel things that are not there, believe things that are not true, or feel unusually suspicious or confused
Mania, a condition in which you may feel highly excited, euphoric, restless, elated, or hyperactive. Mania occurs as part of an illness called "bipolar disorder"
Short-term treatment (up to 6 weeks) of persistent aggression in patients with Alzheimer's dementia who are at risk of harming themselves or others. Non-pharmacological alternatives should have been considered before treatment
Short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children (aged 5 years and older) and adolescents with conduct disorder.

Risperidone Sandoz GmbH can help relieve the symptoms of the illness and prevent their recurrence.

2. What you need to know before taking Risperidone Sandoz GmbH

Do not take Risperidone Sandoz GmbH if:

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

If you are unsure whether any of the conditions listed above apply to you, talk to your doctor or pharmacist before using Risperidone Sandoz GmbH.
Warnings and precautions
Talk to your doctor or pharmacist before taking Risperidone Sandoz GmbH if:

You have a heart condition. Examples include an irregular heartbeat, or if you tend to have low blood pressure, or if you are taking medicines for blood pressure. Risperidone Sandoz GmbH may cause a drop in blood pressure. Your dose may need adjustment.
You are aware of any factors that could put you at risk of stroke, such as high blood pressure, cardiovascular disorders, or cerebrovascular disorders.
You have previously experienced involuntary movements of the tongue, mouth, or face.
You have had a condition whose symptoms included fever, muscle stiffness, sweating, or reduced level of consciousness (also known as Neuroleptic Malignant Syndrome).
You suffer from Parkinson's disease or dementia.
You know you have previously had low levels of white blood cells in your blood (whether or not caused by other medicines).
You have diabetes.
You suffer from epilepsy.
You are a man and have previously experienced prolonged or painful erection.
You have difficulty controlling your body temperature or excessive overheating.
You have kidney problems.
You have liver problems.
You have abnormally high levels of the hormone prolactin in your blood or have a tumour that may be dependent on prolactin.
You or someone in your family has a history of blood clots (thrombosis), as antipsychotic medicines such as risperidone have been associated with blood clot formation.

If you are unsure whether any of the conditions listed above apply to you, talk to your doctor or pharmacist before using Risperidone Sandoz GmbH.
Since a dangerously low number of a certain type of white blood cells necessary to fight infections in the blood has been observed very rarely in patients taking risperidone, your doctor may monitor your white blood cell count.
Risperidone may cause weight gain. A significant increase in weight may negatively affect your health. Your doctor should regularly monitor your body weight.
Since the onset of diabetes mellitus or worsening of pre-existing diabetes mellitus has been observed in patients taking risperidone, your doctor should check for high blood glucose levels. Blood glucose levels should be monitored regularly in patients with pre-existing diabetes mellitus.
Risperidone often increases levels of a hormone called "prolactin". This may cause unwanted effects such as menstrual disorders and fertility problems in women, and breast enlargement in men (see section “Possible side effects”). If such side effects occur, assessment of prolactin levels in the blood is recommended.
During eye surgery for cataract (clouding of the lens), the pupil (the black circle in the center of your eye) may not dilate as required. In addition, the iris (the coloured part of the eye) may become floppy during surgery, which could cause eye damage. If you are planning eye surgery, make sure to inform your ophthalmologist that you are taking this medicine.
Elderly patients with dementia
In elderly patients with dementia, there is an increased risk of stroke. If your dementia is caused by stroke, you must not take risperidone.
During treatment with risperidone, you should see your doctor frequently.
If you or the person caring for you notice a sudden change in your mental state, sudden weakness or numbness of the face, arms or legs, particularly on one side of the body, or slurred speech, even if only for a short time, you must seek immediate medical help. These could be signs of a stroke.
Children and adolescents
Before starting treatment for behavioural disorder, other causes of aggressive behaviour should be ruled out.
Before starting treatment, your body weight, or that of your child, should be measured and carefully monitored during treatment.
If fatigue occurs during treatment with risperidone, changing the time of administration of the medicine may improve attention difficulties.
A small, inconclusive study reported increased height in children taking risperidone, but it is not known whether this is a drug effect or due to some other reason.
Other medicines and Risperidone Sandoz GmbH
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is particularly important to inform your doctor or pharmacist if you are taking any of the following:

Medicines acting on your brain to help you calm down (benzodiazepines), or certain pain medicines (opioids), or allergy medicines (some antihistamines), as risperidone may increase the sedative effects of these medicines.
Medicines that may alter the electrical activity of your heart, such as medicines for malaria, medicines for heart rhythm disorders, for allergies (antihistamines), certain antidepressants, or other medicines for mental disorders.
Medicines that cause a slowing of the heart rate.
Medicines that cause low potassium levels in the blood (such as certain diuretics).
Medicines for high blood pressure. Risperidone Sandoz GmbH may cause a drop in blood pressure.
Medicines for Parkinson’s disease (such as levodopa).
Medicines for urination (diuretics), used for heart conditions or swelling of body parts due to fluid accumulation (such as furosemide or chlorothiazide). Risperidone Sandoz GmbH, taken alone or with furosemide, may increase the risk of stroke or death in elderly patients with dementia.
Medicines that increase the activity of the central nervous system (psychostimulants, such as methylphenidate).

The following medicines may reduce the effect of risperidone

Rifampicin (a medicine used to treat certain infections)
Carbamazepine, phenytoin (medicines for epilepsy)
Phenobarbital. If you start or stop taking these medicines, you may need a different dose of risperidone.

The following medicines may increase the effect of risperidone

Quinidine (used for certain heart conditions)
Antidepressants such as paroxetine, fluoxetine, tricyclic antidepressants
Medicines known as beta-blockers (used to treat high blood pressure)
Phenothiazines (used to treat psychosis or as sedatives)
Cimetidine, ranitidine (stomach acid blockers)
Itraconazole and ketoconazole (medicines used to treat fungal infections)
Some medicines used in the treatment of HIV/AIDS, such as ritonavir
Verapamil, a medicine used to treat high blood pressure and/or abnormal heart rhythm
Sertraline and fluvoxamine, medicines used to treat depression and other psychiatric disorders.

If you start or stop taking any of these medicines, you may need a different dose of risperidone.
If you are unsure whether any of the conditions listed above apply to you, talk to your doctor or pharmacist before using Risperidone Sandoz GmbH.
Risperidone Sandoz GmbH with food, drinks and alcohol
During treatment with Risperidone Sandoz GmbH, you should avoid drinking alcohol. Risperidone Sandoz GmbH oral solution must not be mixed with tea.
Pregnancy, breast-feeding and fertility

If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breast-feeding, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether you can use it.
The following symptoms may occur in newborns of mothers who have used risperidone during the third trimester (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, feeding problems (difficulty feeding). If your baby shows any of these symptoms, contact your doctor or paediatrician immediately.
Risperidone Sandoz GmbH may increase levels of a hormone called "prolactin" which may affect fertility (see section 4 “Possible side effects”).

Driving and using machines
During treatment with Risperidone Sandoz GmbH, dizziness, tiredness, and vision problems may occur. Do not drive or operate tools or machinery without first discussing this with your doctor.
Risperidone Sandoz GmbH contains benzoic acid
This medicine contains 2.0 mg of benzoic acid per ml of solution. Benzoic acid may increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks).

3. How to take Risperidone Sandoz GmbH

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is as follows:
For the treatment of schizophrenia
Adults

The usual starting dose is generally 2 ml of oral solution (2 mg of risperidone) per day, which may be increased to 4 ml of oral solution (4 mg of risperidone) daily from the second day
Your doctor may then increase the dose depending on how you respond to treatment
Most people feel better with daily doses between 4 and 6 ml of oral solution (4 to 6 mg of risperidone)
The total daily dose may be taken as a single dose or divided into two doses. Your doctor will tell you which option is best for you

Elderly patients

The usual starting dose is generally 0.5 ml of oral solution (0.5 mg of risperidone) twice daily
Your doctor may then gradually increase the dose up to 1–2 ml of oral solution (1–2 mg of risperidone) twice daily
Your doctor will tell you the best way for you

For the treatment of mania
Adults

The usual starting dose is generally 2 ml of oral solution (2 mg of risperidone) once daily
Your doctor may then gradually adjust the dose depending on your response to treatment
Most people feel better with doses between 1 and 6 ml of oral solution (1–6 mg of risperidone) once daily
Elderly patients The usual starting dose is generally 0.5 ml of oral solution (0.5 mg of risperidone) twice daily
Your doctor may then gradually adjust the dose up to 1–2 ml of oral solution (1–2 mg of risperidone) twice daily, depending on your response to treatment

For the treatment of persistent aggression in patients with Alzheimer's dementia
Adults (including elderly patients)

The usual starting dose is generally 0.25 ml of oral solution (0.25 mg of risperidone) twice daily
Your doctor may then gradually adjust the dose depending on your response to treatment
Most patients feel better with 0.5 ml of oral solution (0.5 mg of risperidone) twice daily. Some patients may require 1 ml of oral solution (1 mg of risperidone) twice daily
The duration of treatment in patients with Alzheimer's dementia should not exceed 6 weeks

Patients with kidney or liver problems
Regardless of the condition being treated, all initial and subsequent doses of risperidone must be halved. Dose increases should be made more slowly in these patients. Risperidone must be used with caution in this patient group.
Children and adolescents
Children and adolescents under 18 years of age must not be treated with Risperidone Sandoz GmbH for schizophrenia or mania.
For the treatment of conduct disorder, the dose will depend on your child's weight:
For children weighing less than 50 kg:

The usual starting dose is generally 0.25 ml of oral solution (0.25 mg of risperidone) once daily
The dose may be increased every other day in increments of 0.25 ml of oral solution (0.25 mg of risperidone) per day
The usual maintenance dose ranges between 0.25 ml and 0.75 ml of oral solution (0.25 to 0.75 mg of risperidone) once daily

For children weighing 50 kg or more:

The usual starting dose is generally 0.5 ml of oral solution (0.5 mg of risperidone) once daily
The dose may be increased every other day in increments of 0.5 ml of oral solution (0.5 mg of risperidone) per day
The usual maintenance dose ranges between 0.5 ml and 1.5 ml (0.5 to 1.5 mg of risperidone) once daily. The duration of treatment in patients with conduct disorder should not exceed 6 weeks.

Children under 5 years of age must not be treated with Risperidone Sandoz GmbH for conduct disorder.
Method of administration
Risperidone Sandoz GmbH is for oral use.
Take the medicine with a glass of water.
Risperidone Sandoz GmbH may be taken with or without food.
Opening the bottle and handling the dosing pipette
Each bottle is supplied with a dosing pipette. The bottle has a child-resistant cap.

Open the cap by pressing it firmly downwards and turning it counterclockwise.
Insert the pipette into the bottle. To measure the dose, firmly hold the pipette by the lower ring with one hand and, with the other hand, pull the upper ring upwards until the exact amount of medicine to be taken (e.g. ml or mg) is visible in the pipette.
Holding the lower ring firmly, carefully remove the entire dosing pipette from the bottle. Empty the contents of the pipette into a glass containing a drink (non-alcoholic and not black or green tea), by pushing down the upper ring. Drink immediately until the glass is empty.
Close the bottle and rinse the empty pipette with water.

If you take more Risperidone Sandoz GmbH than you should

Contact your doctor immediately. Take the medicine package with you.
In case of overdose, you may feel drowsy or tired, have unusual body movements, problems standing or walking, dizziness due to low blood pressure, or an irregular heartbeat or seizures.

If you forget to take Risperidone Sandoz GmbH

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and continue as usual. If you forget two or more doses, contact your doctor.
Do not take a double dose (two doses together) to make up for a forgotten dose.

If you stop taking Risperidone Sandoz GmbH
Do not stop taking this medicine unless your doctor tells you to. Your symptoms may return. If your doctor decides to stop this medicine, your dose may be gradually reduced over several days.
If you have any further questions about 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.
Immediately inform your doctor if you experience any of the following serious side effects:

Uncommon: may affect up to 1 in 100 people

Tardive dyskinesia (involuntary spasms or jerky movements of the face, tongue or other parts of the body). Contact your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth or face. Discontinuation of risperidone may be necessary.
Sudden change in mental state or sudden weakness or numbness of the face, arms or legs, particularly on one side, or slurred speech, even for a brief period. These may be signs of stroke or "mini" stroke caused by sudden loss of blood flow to the brain. This risk is higher if you have dementia.
Rare: may affect up to 1 in 1,000 people
Neuroleptic malignant syndrome (confusion, reduced or loss of consciousness, high fever and severe muscle stiffness). Immediate medical treatment may be required.
Priapism (prolonged and painful erection which may require surgical treatment)
Very rare: may affect up to 1 in 10,000 people
Life-threatening complications of uncontrolled diabetes
Severe allergic reaction with swelling that may involve the throat and lead to breathing difficulties
Not known: frequency cannot be estimated from the available data
Blood clots in the veins, particularly in the legs (symptoms include swelling, pain and redness in the legs), which may travel through the bloodstream to the lungs, causing chest pain and breathing difficulties. If you notice any of these symptoms, consult your doctor immediately.

The following side effects may occur

Very common: may affect more than 1 in 10 people

Difficulty falling asleep or staying asleep.
Parkinsonism: this condition may include: slow or impaired body movements, sensation of muscle stiffness or tightness (causing jerky movements), and sometimes a feeling of movement starting and stopping. Other signs of parkinsonism include shuffling gait, resting tremor, increased saliva and/or drooling, and reduced facial expression.
Feeling sleepy or reduced alertness.
Headache.

Common: may affect up to 1 in 10 people

Pneumonia, chest infection (bronchitis), cold symptoms, sinusitis.
Urinary tract infection.
Ear infection, feeling as if you have the flu.
Increased levels of a hormone called “prolactin” detected in a blood test (which may or may not cause symptoms). Symptoms due to high prolactin levels do not commonly occur and may include: (in men) breast enlargement, difficulty achieving or maintaining erections, decreased sexual desire or other sexual dysfunction; (in women) breast tenderness, milk discharge from the breasts, missed menstrual periods or other menstrual problems or fertility issues.
Weight gain, increased appetite, decreased appetite.
Sleep disturbances, irritability, depression, anxiety, agitation.
Dystonia: this is a condition involving slow or prolonged involuntary muscle contractions. While it may affect any part of the body (resulting in abnormal posture), dystonia often involves the facial muscles, including abnormal eye, mouth, tongue or jaw movements.
Dizziness.
Dyskinesia: this is a condition involving involuntary muscle movements and may include repetitive, jerky or twisting movements or spasms.
Tremor (shaking).
Blurred vision, eye infection or conjunctivitis.
Rapid heartbeat, high blood pressure, shortness of breath.
Sore throat, cough, nosebleed, nasal congestion.
Abdominal pain, abdominal discomfort, vomiting, nausea, constipation, diarrhoea, indigestion, dry mouth, toothache.
Rash, skin redness.
Muscle spasms, bone or muscle pain, back pain, joint pain.
Urinary incontinence (lack of control).
Swelling of the body, arms or legs, fever, chest pain, weakness, fatigue (tiredness), pain.
Falls.

Uncommon: may affect up to 1 in 100 people

Respiratory tract infection, bladder infection, eye infection, tonsillitis, fungal nail infection, skin infection, infection of a single skin area or body part, viral infection, skin inflammation caused by mites.
Decrease in blood of a type of white blood cells that helps protect the body from infections.
Reduced number of white blood cells, reduced platelets (blood cells that help stop bleeding), anaemia, reduced number of red blood cells, increased eosinophils (a specific type of white blood cells) in the blood.
Allergic reaction.
Diabetes or worsening of diabetes, high blood sugar levels, excessive water intake, weight loss, loss of appetite resulting in malnutrition and low body weight.
Increased cholesterol in the blood.
Euphoria (mania), confusion, reduced sexual drive, nervousness, nightmares.
Tardive dyskinesia (involuntary spasms or jerky movements of the face, tongue or other parts of the body). Contact your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth and face. Discontinuation of Risperidone Sandoz GmbH may be necessary.
Sudden loss of blood flow to the brain (stroke or "mini" stroke).
Lack of response to stimuli, loss of consciousness, reduced level of consciousness.
Seizures (fits), fainting.
Sudden urge to move a part of the body, balance disorders, abnormal coordination, dizziness when standing up, attention disturbance, language problems, loss or altered sense of taste, reduced skin sensitivity to pain and touch, tingling, prickling or numbness of the skin.
Light sensitivity of the eyes, dry eyes, increased tearing, eye redness.
Sensation of spinning (vertigo), ringing in the ears, ear pain.
Atrial fibrillation (abnormal heart rhythm), interruption of electrical conduction between upper and lower parts of the heart, abnormal heart electrical conduction, QT interval prolongation on ECG, slow heart rate, abnormal heart electrical trace (electrocardiogram or ECG), sensation of rapid heartbeat or pounding in the chest (palpitations).
Low blood pressure, low blood pressure when standing up (as a result, some patients taking risperidone may feel faint, dizzy or may faint when standing up or sitting down suddenly), hot flushes.
Pneumonia caused by inhalation of food, lung congestion, respiratory tract congestion, rattling sounds in the lungs, wheezing, voice problems, respiratory disorders.
Stomach or intestinal infection, faecal incontinence, very hard stools, difficulty swallowing, excessive passing of gas or air.
Hives, itching, hair loss, skin thickening, eczema, dry skin, skin discolouration, acne, scalp or skin flaking and itching, skin disorder, skin lesion.
Increased levels of CPK (creatine phosphokinase) in the blood, an enzyme sometimes released when muscle damage occurs.
Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain.
Frequent urination, inability to urinate, pain during urination.
Erectile dysfunction, ejaculation disorders.
Loss of menstrual cycle, absence of menstrual cycle or menstrual problems (females).
Breast development in males, milk discharge from breasts, sexual dysfunction, breast pain, breast discomfort, vaginal discharge.
Swelling of the face, mouth, eyes or lips.
Chills, increased body temperature.
Change in walking pattern.
Thirst, feeling unwell, chest pain, feeling down, discomfort.
Increased liver transaminases in the blood, increased GGT in the blood (a liver enzyme called gamma-glutamyltransferase), increased liver enzymes in the blood.
Procedural pain.

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

Infection.
Inappropriate secretion of the hormone controlling urine volume.
Sleepwalking.
Sleep-related eating disorder.
Sugar in urine.
Low blood sugar, elevated triglyceride levels (a type of fat).
Inability to move or react while awake (catatonia).
Lack of emotion, inability to achieve orgasm.
Problems with brain blood vessels.
Coma due to uncontrolled diabetes.
Head shaking.
Glaucoma (increased pressure inside the eyeball), eye movement problems, eye rotation, crusting at the eyelid margin.
Eye problems during cataract surgery. During cataract surgery, a condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur if you are taking or have taken risperidone. If you are scheduled for cataract surgery, make sure to inform your doctor if you are taking or have taken this medicine.
Dangerously low number of a certain type of white blood cells in the blood needed to fight infections.
Severe allergic reaction characterised by fever, swelling of the mouth, face, lips or tongue, breathing difficulty, itching, rash and sometimes low blood pressure.
Dangerously excessive water intake.
Irregular heartbeat.
Blood clots in the legs, blood clots in the lungs.
Breathing problems during sleep (sleep apnoea), rapid and shallow breathing.
Inflammation of the pancreas.
Colon obstruction.
Swelling of the tongue, chapped lips, drug rash.
Dandruff.
Muscle fibre rupture and muscle pain (rhabdomyolysis).
Delay in menstrual cycle, enlargement of mammary glands, breast enlargement, milk discharge from breasts.
Increased insulin levels (a hormone that controls blood sugar levels).
Skin hardening.
Very low body temperature, cold arms and legs.
Drug withdrawal syndrome.
Yellowing of the skin and eyes (jaundice).

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

Lack of intestinal muscle movement causing blockage.

The following side effects have been observed with the use of another medicine called paliperidone, which is very similar to risperidone, so these effects may also be expected with Risperidone Sandoz GmbH: rapid heartbeat when standing up.

Additional side effects in children and adolescents
In general, the type of side effects expected in children is expected to be similar to that observed in adults.
The following side effects have been reported more frequently in children and adolescents (aged 5 to 17 years) compared to adults: feeling sleepy or less alert, fatigue, headache, increased appetite, vomiting, common cold symptoms, nasal congestion, abdominal pain, dizziness, cough, fever, tremor (shaking), diarrhoea and urinary incontinence (loss of control).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Risperidone Sandoz GmbH

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the bottle
after "Exp.". The expiry date refers to the last day of the month.
Do not freeze.
Do not use Risperidone Sandoz GmbH after 6 months from the first opening of the bottle.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Risperidone Sandoz GmbH contains
The active substance is risperidone.
Each ml of oral solution contains 1 mg of risperidone.
The other components are benzoic acid (E 210), purified water.

Description of the appearance of Risperidone Sandoz GmbH and pack contents
Risperidone Sandoz GmbH 1 mg/ml oral solution is a clear, colourless solution.
It is available in brown glass bottles with a white child-resistant plastic closure, containing 30 ml, 60 ml, 100 ml or 120 ml of oral solution. A dosing pipette with a pipette holder is supplied with the bottle.
It is possible that not all pack sizes will be marketed.

Marketing Authorization Holder and Manufacturer:
SANDOZ GMBH – Biochemiestrasse 10 – 6250 Kundl (Austria)
Italian Representative: Sandoz Spa – Largo U. Boccioni, 1 – 21040 Origgio (VA)

Responsible manufacturer for batch release:

Salutas Pharma GmbH - Otto von Guericke Allee 1 - 39179 Barleben - Germany
LEK Pharmaceuticals d.d. - Verovskova 57 - 1526 Ljubljana - Slovenia

This leaflet was last revised on