PACKAGE LEAFLET: INFORMATION FOR THE USER

Risperidone Sandoz 1 mg film-coated tablets, 2 mg film-coated tablets, 3 mg film-coated tablets, 4 mg film-coated tablets

Generic 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, ask 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

schizophrenia, due to which you may see, hear or feel things that do not exist, believe things that are not true, or feel unusually suspicious or confused
mania, due to which you may feel highly excited, euphoric, restless, enthusiastic or hyperactive. Mania occurs in a condition called "bipolar disorder"
short-term treatment (up to 6 weeks) of persistent aggression in people with Alzheimer's dementia who harm themselves or others. Previously, alternative (non-pharmacological) treatments should have been used.
short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children (at least 5 years of age) and adolescents with behavioural disorder

Risperidone Sandoz can relieve the symptoms of your illness and helps prevent the symptoms from returning.

2. What you should know before taking Risperidone Sandoz

Do not take Risperidone Sandoz:

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 the above applies to you, consult your doctor or pharmacist before taking Risperidone Sandoz.
Warnings and precautions
Talk to your doctor or pharmacist before taking Risperidone Sandoz if:

you suffer from heart problems. For example, if you have an irregular heartbeat, are prone to low blood pressure, or are taking medicines for blood pressure. Risperidone Sandoz may cause a drop in blood pressure. A dose adjustment may be necessary.
you are aware of risk factors for stroke, such as high blood pressure, cardiovascular disorders, or blood vessel disorders in the brain.
you have ever experienced involuntary movements of the tongue, mouth, or face.
you have ever had a condition whose symptoms include high body temperature, muscle stiffness, sweating, or reduced level of consciousness (also known as neuroleptic malignant syndrome).
you have Parkinson's disease or dementia with Parkinsonism.
you know you have previously had low levels of white blood cells (which may have been caused or worsened by other medicines).
you are diabetic.
you suffer from epilepsy.
you are male and have ever experienced painful or prolonged erection.
you suffer from problems with body temperature control or 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 related to prolactin.
you or someone in your family has a history of blood clots, as antipsychotics have been associated with blood clot formation.

If you are unsure whether any of these conditions apply to you, consult your doctor or pharmacist before taking Risperidone Sandoz.
Very rarely, patients taking Risperidone Sandoz have experienced dangerously low levels of a certain type of white blood cells needed to fight infection. Your doctor may monitor your white blood cell count.
Risperidone Sandoz may cause weight gain. A significant increase in body weight may negatively affect your health. Your doctor should regularly measure your body weight.
Cases of diabetes mellitus or worsening of pre-existing diabetes mellitus have been observed in patients taking Risperidone Sandoz. Your doctor should check for high blood sugar levels.
In patients with pre-existing diabetes mellitus, blood glucose should be monitored regularly.
During eye surgery for lens opacity (cataract), the pupil (the black circle in the center of the eye) may not dilate as required. Additionally, the iris (the coloured part of the eye) may become floppy during surgery, potentially causing eye damage. If you are scheduled for eye surgery, 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. You must not take risperidone if your dementia is caused by stroke.
During treatment with risperidone, you should consult your doctor frequently.
Immediate medical treatment is required if you or your caregiver notice a sudden change in your mental state, sudden weakness or numbness of the face, arms or legs (especially on one side), or sudden speech difficulties, even if brief. These may be signs of a stroke.
Children and adolescents
Before starting treatment for behavioural disorder, other possible causes of aggressive behaviour should be ruled out.
If tiredness occurs during treatment with risperidone, changing the time of administration may improve attention-related problems.
Before starting treatment, your body weight or that of your child should be measured and regularly monitored during treatment.
Other medicines and Risperidone Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is particularly important that you inform your doctor or pharmacist if you are taking any of the following medicines:

medicines acting on the brain to calm the patient (benzodiazepines), or certain painkillers (opioids), or antiallergic medicines (some antihistamines), as risperidone may increase their sedative effect.
medicines that may alter the electrical activity of the heart, such as antimalarial drugs, medicines for heart rhythm disorders, antiallergic medicines (antihistamines), certain antidepressants, or other medicines used to treat mental disorders.
medicines that cause a slowing of the heartbeat.
medicines that cause low potassium levels in the blood (such as certain diuretics).
medicines used to treat high blood pressure. Risperidone Sandoz may lower blood pressure.
medicines used to treat Parkinson's disease (such as levodopa).
diuretics used for heart problems or to treat swelling in certain body parts due to excess fluid accumulation (such as furosemide or chlorothiazide). Risperidone Sandoz, alone or in combination with furosemide, may increase the risk of stroke or death in elderly patients with dementia.

The following medicines may reduce the effect of risperidone:

rifampicin (a medicine used to treat certain infections).
carbamazepine, phenytoin (medicines used to treat epilepsy).
phenobarbital.

If you start or stop treatment with these 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, tricyclic antidepressants.
medicines called beta-blockers (used to treat high blood pressure).
phenothiazines (such as medicines used to treat psychosis or for sedation).
cimetidine, ranitidine (stomach acid blockers).

If you start or stop treatment with these medicines, you may need a different dose of risperidone.
If you are unsure whether any of these situations apply to you, consult your doctor or pharmacist before taking Risperidone Sandoz.
Risperidone Sandoz with food, drinks and alcohol
You may take Risperidone Sandoz with or without food. During treatment with Risperidone Sandoz, avoid alcoholic beverages.
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 taking this medicine. Your doctor will decide whether you can take this medicine.
The following symptoms may occur in newborns whose mothers took Risperidone Sandoz during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, you may need to contact your doctor.
Risperidone Sandoz 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, dizziness, tiredness, and vision disturbances may occur. Do not drive or operate tools or machines without first consulting your doctor.
Risperidone Sandoz contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Risperidone Sandoz

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will tell you how much medicine to take and for how long. These factors depend on your condition and may vary from person to person.

Recommended dose:

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 doctor may then adjust the dose depending on your response to treatment.
Most people feel better with daily doses of 4–6 mg.
This total daily dose may be divided into one or two doses per day. Your doctor will tell you which dosing schedule is most suitable for you.

Elderly patients

The usual starting dose is generally 0.5 mg twice daily.
Your doctor may gradually increase the dose up to 1–2 mg twice daily.
Your doctor will tell you which dosing schedule is most suitable for you.

For the treatment of mania

Adults

The usual starting dose is 2 mg once daily.
Your doctor may then adjust the dose depending on your response to treatment.
Most people feel better with doses of 1–6 mg once daily.

Elderly patients

The usual starting dose is generally 0.5 mg twice daily.
Your doctor may gradually increase the dose up to 1–2 mg twice daily, depending on your response to treatment.

For the long-term treatment of aggression in patients with Alzheimer’s dementia

Adults (including elderly patients)

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

Use in children and adolescents

Children and adolescents under 18 years of age must not be treated with Risperidone Sandoz for schizophrenia or mania.
For the treatment of behavioural disorder, the dose will depend on the child's body weight:

For children weighing less than 50 kg

The usual starting dose is 0.25 mg once daily.
The dose may be increased every other day in increments of 0.25 mg per day.
The usual maintenance dose is 0.25–0.75 mg once daily.

For children weighing 50 kg or more

The usual starting dose is 0.5 mg once daily.
The dose may be increased every other day in increments of 0.5 mg per day.
The usual maintenance dose is 0.5–1.5 mg 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 for behavioural disorder.

Patients with renal or hepatic impairment
Regardless of the condition being treated, all initial and subsequent doses of risperidone should be halved. Dose increases in these patients should be made more gradually. Risperidone should be used with caution in this patient group.

Method of administration
For oral use.
Swallow the tablet with a glass of water.

If you take more Risperidone Sandoz than you should

Contact a doctor immediately. Take the medicine package with you.
In case of overdose, you may experience drowsiness or fatigue, abnormal body movements, difficulty standing or walking, dizziness due to low blood pressure, abnormal heartbeats, or seizures.

If you forget to take Risperidone Sandoz

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule. If you miss two or more doses, consult 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 Risperidone Sandoz

Do not stop treatment unless instructed by your doctor. Your symptoms may return.

If your doctor decides to discontinue the medicine, they will do so by gradually reducing the dose over several days.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Tell your doctor immediately if you

develop blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness in the legs), which may travel through the blood vessels to the lungs causing chest pain and breathing difficulties. If you notice any of these symptoms, tell your doctor immediately.
experience dementia or a sudden change in mental state, or sudden weakness or numbness in the face, arms or legs, particularly on one side, or difficulty speaking, even for a brief period. These may be signs of a stroke.
experience fever, muscle stiffness, sweating or reduced level of consciousness (a condition called "neuroleptic malignant syndrome"). Immediate medical treatment may be required.
are male and experience a prolonged and painful erection. This is called priapism. Immediate medical treatment may be required.
experience involuntary rhythmic movements of the tongue, mouth or face. Discontinuation of risperidone therapy may be necessary.
experience a severe allergic reaction characterised by fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, rash or low blood pressure.

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 includes: slow or altered movement, feeling of muscle stiffness or tension (leading to jerky movements), and sometimes a sensation of "frozen" movement that then restarts. Other signs of parkinsonism include slow shuffling gait, resting tremor, increased saliva and/or drooling, and reduced facial expression.
Feeling drowsy or lacking alertness
Headache.

Common (may affect up to 1 in 10 people)

Pneumonia, chest infection (bronchitis), common cold symptoms, sinusitis, urinary tract infection, ear infections, feeling of influenza
Risperidone may increase levels of a hormone called "prolactin" seen in a blood test (which may or may not cause symptoms). When symptoms of high prolactin occur, these may include breast enlargement in men, difficulty achieving or maintaining an erection, or other sexual dysfunction. In women, symptoms may include breast pain, milk discharge from the breasts, absence of menstrual periods, or other menstrual cycle problems.
Weight gain, increased appetite, decreased appetite
Sleep disturbances, irritability, depression, anxiety, agitation
Dystonia: this is a condition involving involuntary, slow or sustained muscle contractions. While it may affect any part of the body (and may cause abnormal posture), dystonia often involves 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 contractions.
Tremor (shaking)
Blurred vision, eye infections or conjunctivitis
Rapid heart rate, high blood pressure, shortness of breath
Sore throat, cough, nosebleeds, blocked nose
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
Incontinence (lack of control over urine)
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 infections, bladder infections, eye infections, tonsillitis, fungal nail infections, skin infections, a localized skin infection or infection confined to one body area, viral infection, skin inflammation caused by mites
Decrease in the type of white blood cells that help protect against infections, decrease in white blood cell count, decrease in platelets (blood cells that help stop bleeding), anaemia, decrease in red blood cells, increase in eosinophils (a type of white blood cell) in the blood
Allergic reaction
Diabetes or worsening of diabetes, high blood sugar, drinking excessive amounts of water
Weight loss, loss of appetite leading to malnutrition and low body weight
Increased cholesterol in the blood
Elevated mood (mania), confusion, decreased sexual desire, nervousness, nightmares
- Tardive dyskinesia (spasms or jerky movements of the face, tongue, or other body parts that cannot be controlled). Contact your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth or face. Discontinuation of treatment with risperidone may be necessary.
- Sudden loss of blood flow to the brain (stroke or "mini" stroke)
Lack of response to stimuli, loss of consciousness, low level of consciousness
Seizures (fits), fainting
An urgent need to move parts of the body, balance disorders, abnormal coordination, dizziness when standing, attention disturbances, language problems,

loss or altered sense of taste, reduced skin sensation to pain and touch, a
tingling, prickling or numbness sensation of the skin

Light sensitivity of the eyes, dry eyes, increased tearing, eye redness
Feeling dizzy (vertigo), ringing in the ears, ear pain
Atrial fibrillation (an abnormal heart rhythm), interruption in conduction between upper and lower parts of the heart, abnormal electrical conduction of the heart, QT interval prolongation on the heart, low heart rate, abnormal heart electrical trace (electrocardiogram or ECG), pounding or pounding sensation in the chest (palpitations)
Low blood pressure, low blood pressure when standing (as a result, some people taking risperidone may feel weak, dizzy, or faint when standing up or sitting down suddenly), hot flushes
Pneumonia caused by inhalation of food, lung congestion, respiratory congestion, rattling sound in the lungs, shortness of breath, voice disorders, breathing disorders
Stomach or intestinal infections, 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 itching, skin disorders, skin lesions
Increased CPK (creatine phosphokinase) in the blood, an enzyme sometimes released during muscle breakdown
Abnormal posture, joint stiffness, swelling, muscle weakness, neck pain
Frequent urination, inability to urinate, pain during urination
Erectile dysfunction, ejaculation disorders
Loss of menstrual periods, missed periods or other menstrual cycle problems (females)
Breast development in men, milk discharge from breasts, sexual dysfunction, breast pain, breast disorder, vaginal discharge
Swelling of the face, mouth, eyes or lips
Chills, increased body temperature
Change in the way of walking
Feeling thirsty, feeling unwell, chest pain, feeling of low mood, discomfort
Increased liver transaminases in the blood, increased GGT (an enzyme called gamma-glutamyltransferase) in the blood, increased liver enzymes in the blood
Procedural pain

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

Infection
Inappropriate secretion of a hormone controlling urine volume
Sugar in urine, low blood sugar, high triglyceride levels in the blood (a fat)
Lack of emotions, inability to reach orgasm
- Neuroleptic malignant syndrome (confusion, reduced or loss of consciousness, high fever and severe muscle rigidity).
Blood vessel problems in the brain
Coma due to uncontrolled diabetes
Dizziness
Glaucoma (increased pressure inside the eyeball), eye movement problems, sensation of eye spinning, crust formation 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 need cataract surgery, make sure to inform your doctor if you are taking or have taken this medicine.
Dangerously low count of a certain type of white blood cells needed to fight infection in the blood
Severe allergic reaction characterised by fever, swollen mouth, face, lips or tongue, shortness of breath, itching, rash and sometimes low blood pressure
Dangerous excessive water intake
Irregular heartbeat
- Blood clots in the legs, blood clots in the lungs
Breathing problems during sleep (sleep apnoea), rapid breathing, shallow breathing
Inflammation of the pancreas, intestinal blockage
Swelling of the tongue, chapped lips, drug rash on the skin
Dandruff
Muscle fibre breakdown and muscle pain (rhabdomyolysis)
Delayed menstrual periods, enlargement of mammary glands, breast enlargement, breast secretion
Increased insulin (a hormone controlling blood sugar levels) in the blood
• Priapism (a prolonged erection that may require surgical treatment)
Skin hardening
Decreased body temperature, coldness in arms and legs
Withdrawal symptoms
Yellowing of the skin and eyes (jaundice).

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

Life-threatening complications of uncontrolled diabetes
- Severe allergic reactions with swelling that may involve the throat and lead to breathing difficulties. Lack of intestinal movement causing a blockage.

The following side effect has been reported with the use of another medicine called
paliperidone, which is very similar to risperidone, and so may also be expected with
this medicine: rapid heartbeat when standing up.
Other side effects in children and adolescents
In general, side effects in children should be similar to those in adults.
The following side effects have been reported more frequently in children and adolescents (5–17 years) than in adults: feeling drowsy or lacking alertness, fatigue (tiredness), headache, increased appetite, vomiting, cold symptoms, nasal congestion, abdominal pain, dizziness, cough, fever, tremor (shakiness), diarrhoea, and incontinence (lack of control) of urine.
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
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Risperidone Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging, blister, and tablet container, following the word "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Risperidone Sandoz contains
The active substance is risperidone.
Each film-coated tablet of Risperidone Sandoz contains 1, 2, 3, or 4 mg of risperidone.
The excipients are as follows:
Core
Monohydrate lactose, microcrystalline cellulose (E460), pregelatinized corn starch,
sodium croscarmellose, sodium lauryl sulfate, anhydrous colloidal silica, magnesium stearate (E470b).
Coating
Risperidone Sandoz 1 mg film-coated tablets:
hypromellose (E464), titanium dioxide (E171), polyethylene glycol (400)
Risperidone Sandoz 2 mg film-coated tablets:
hypromellose (E464), titanium dioxide (E171), polyethylene glycol (400), iron oxide red (E172)
Risperidone Sandoz 3 mg film-coated tablets:
hypromellose (E464), titanium dioxide (E171), polyethylene glycol (400), quinoline yellow aluminium lake (E104)
Risperidone Sandoz 4 mg film-coated tablets:
hydroxypropylcellulose (E463), hypromellose (E464), titanium dioxide (E171), red iron oxide (E172),
black iron oxide (E172)

Description of the appearance of Risperidone Sandoz and package contents
Risperidone Sandoz 1 mg film-coated tablets: white, biconvex, oblong tablets with a score line on one side.
Risperidone Sandoz 2 mg film-coated tablets: pink, biconvex, oblong tablets with a score line on both sides.
Risperidone Sandoz 3 mg film-coated tablets: yellow, biconvex, oblong tablets with a score line on one side.
Risperidone Sandoz 4 mg film-coated tablets: dark pink, biconvex, oblong tablets with a score line on both sides.
Risperidone Sandoz may be packaged in PVC/PE/PVDC/Alu blisters or in PP tablet containers with LDPE caps.

Pack sizes
Blister packs: 6, 10, 20, 30, 50, 60, 100, 100x1 and 250 film-coated tablets
Bottles: 6, 10, 20, 30, 50, 60, 100 and 250 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A. – Largo U. Boccioni, 1 – 21040 Origgio (VA)

Responsible manufacturer for batch release
Lek Pharmaceuticals d.d. - Verovskova 57 - 1526 Ljubljana – Slovenia
Sandoz GmbH - Biochemiestrasse 10 - 6250 Kundl – Austria
S.C. Sandoz S.r.l - 7a Livezeni street - 540472 Targu Mures – Romania

This medicinal product has been authorized in EEA member states under the following names:
Denmark: Risperidon Sandoz 1/2/3/4 mg filmovertrukne tabletter
Finland: Risperidon Sandoz 1/2/3/4 mg tabletti, kalvopäällysteinen
Italy: Risperidone Sandoz 1/2/3/4 mg compresse rivestite con film
Norway: Risperidon Sandoz 1/2/3/4 mg filmdrasjert tablett
Sweden: Risperidon Sandoz 1/2/3/4 mg filmdragerad tablett
United Kingdom: Risperidone 1 mg/2 mg/3 mg/4 mg Tablets