Rispolept 1 mg, 2 mg, 3 mg and 4 mg film-coated tablets – risperidone for schizophrenia, mania and short-term treatment of aggression

Rispolept is the original Janssen medicine from the group of antipsychotics, containing risperidone. It is used to treat schizophrenia, mania in bipolar disorder and, short-term, persistent aggression in certain patient groups.

The medicine is available as film-coated tablets of 1 mg, 2 mg, 3 mg and 4 mg risperidone. It helps relieve the symptoms of the disease and can stop them from coming back.

What is Rispolept used for and how should it be taken?

Basic information about the medicine

What is Rispolept used for?

According to the package leaflet, Rispolept is used to treat:

• schizophrenia – a condition in which a person may see, hear or feel things that are not there, believe things that are not true or feel unusually suspicious or confused;
• mania in bipolar disorder – a state of marked excitement, elation, energy or overactivity;
• long-term aggression in patients with Alzheimer’s dementia who harm themselves or others – short-term (up to 6 weeks), after non-drug approaches have been tried;
• long-term aggression in children aged 5 and over with below-average intellectual functioning and in adolescents with conduct disorder – short-term (up to 6 weeks).

How is Rispolept taken and dosed?

• Schizophrenia – adults: the usual starting dose is 2 mg on day one, which may be increased to 4 mg on day two. Most patients feel better on 4 mg to 6 mg a day, as one or two doses. Elderly: start with 0.5 mg twice daily, gradually up to 1–2 mg twice daily.
• Mania – adults: the usual starting dose is 2 mg once daily; most patients feel better on 1 mg to 6 mg once daily. Elderly: start with 0.5 mg twice daily, gradually up to 1–2 mg twice daily.
• Aggression in Alzheimer’s dementia (including elderly): start with 0.25 mg twice daily; usually 0.5 mg twice daily, in some patients 1 mg twice daily; treatment should not last longer than 6 weeks.
• Conduct disorder in children and adolescents: under 50 kg – start with 0.25 mg once daily, maintenance 0.25–0.75 mg daily; 50 kg and over – start with 0.5 mg once daily, maintenance 0.5–1.5 mg daily; treatment should not last longer than 6 weeks.
• For doses of 0.25 mg and 0.5 mg an available medicine of a suitable form and strength is used – according to the leaflet, e.g. Rispolept oral solution 1 mg/mL (0.25 mL = 0.25 mg).
• Impaired kidney or liver function: all starting and maintenance doses are halved and the dose is increased more slowly.
• Swallow the tablet with water; it can be taken with or without food. The score line on the tablet only helps to break it if you have difficulty swallowing it whole – it is not intended for dividing into two equal doses.

Special patient groups

• Children and adolescents under 18: not recommended for schizophrenia and mania; for conduct disorder not used in children under 5. Other causes of aggressive behaviour should be ruled out before treatment, and body weight is monitored at the start and regularly during treatment.
• Elderly patients: lower starting doses; in dementia there is an increased risk of stroke – the medicine must not be taken for dementia caused by stroke.
• Impaired kidney or liver function: doses are halved and caution is needed.

Contraindications – when the medicine must not be used

• allergy (hypersensitivity) to risperidone or any of the excipients.

Precautions and warnings

• heart disease, irregular heartbeat, tendency to low blood pressure or use of blood pressure medicines – the medicine may lower blood pressure;
• risk factors for stroke (high blood pressure, cardiovascular disease, disease of the blood vessels of the brain);
• previous involuntary movements of the tongue, mouth or face, or neuroleptic malignant syndrome (high fever, muscle stiffness, sweating, reduced consciousness);
• Parkinson’s disease or dementia; epilepsy;
• previous low white blood cell count – your doctor may request blood tests;
• diabetes – the medicine may cause or worsen diabetes, so blood sugar is checked;
• weight gain – your doctor monitors body weight periodically;
• raised prolactin or a prolactin-dependent tumour (possible menstrual problems, fertility problems, breast enlargement in men);
• history of prolonged and painful erection (priapism);
• problems with body temperature control or overheating;
• kidney or liver disease;
• personal or family history of blood clots;
• planned cataract surgery – tell your eye doctor (possible “floppy iris” syndrome);
• the medicine contains lactose and less than 1 mmol sodium per dose; the 2 mg tablet contains the colour Orange Yellow S (E110), which may cause allergic reactions.

Interactions with other medicines, food and drink

Tell your doctor or pharmacist about all medicines you take, including herbal and non-prescription medicines, especially:

• sedatives (benzodiazepines), opioid painkillers and antihistamines – risperidone may increase their sedative effect;
• medicines that affect the electrical activity of the heart (antimalarials, antiarrhythmics, antihistamines, some antidepressants and other psychiatric medicines), medicines that slow the heart and medicines that lower potassium (some diuretics);
• blood pressure medicines – possible additional fall in blood pressure;
• medicines for Parkinson’s disease (levodopa) and psychostimulants (methylphenidate);
• diuretics (furosemide, chlorothiazide) – in elderly patients with dementia, increased risk of stroke or death;
• may reduce the effect: rifampicin, carbamazepine, phenytoin, phenobarbital;
• may increase the effect: quinidine, paroxetine, fluoxetine, tricyclic antidepressants, beta-blockers, phenothiazines, cimetidine, ranitidine, itraconazole, ketoconazole, ritonavir, verapamil, sertraline, fluvoxamine;
• alcohol – avoid it during treatment.

Pregnancy and breastfeeding

• Pregnancy and breastfeeding: if you are pregnant, planning a pregnancy or breastfeeding, talk to your doctor – they will decide whether you can take the medicine.
• Newborns of mothers who took risperidone in the last trimester may develop shaking, muscle stiffness or weakness, sleepiness, agitation, breathing problems and feeding difficulties.
• Risperidone may increase prolactin, which may affect fertility.

Driving and using machines

• Dizziness, tiredness and vision problems may occur during treatment. Do not drive or use machines before talking to your doctor.

Possible side effects

• Contact your doctor immediately (uncommon): in dementia, sudden change in mental state, weakness or numbness of the face, arms or legs (especially on one side) or slurred speech (possible stroke); involuntary rhythmic movements of the tongue, mouth or face (tardive dyskinesia).
• Contact your doctor immediately (rare): blood clot in the leg veins (swelling, pain, redness), chest pain and difficulty breathing; fever, muscle stiffness, sweating or reduced consciousness (neuroleptic malignant syndrome); prolonged painful erection; severe allergic reaction.
• Very common: difficulty falling or staying asleep, parkinsonism (slow movements, stiffness, tremor, drooling, mask-like face), sleepiness or reduced alertness, headache.
• Common: infections (lungs, sinuses, urinary tract, ear), cold symptoms, increased prolactin, weight gain, increased or decreased appetite, sleep disorder, irritability, depression, anxiety, restlessness, dystonia, dizziness, dyskinesia, tremor, blurred vision, fast heartbeat, high blood pressure, cough, nosebleeds, abdominal pain and discomfort, nausea, vomiting, constipation, diarrhoea, dry mouth, toothache, rash, muscle and joint cramps and pain, inability to hold urine, swelling, fever, weakness, tiredness, falls.
• Uncommon: among others diabetes or worsening of diabetes, raised cholesterol, reduced white blood cells and platelets, drop in blood pressure on standing with fainting, heart rhythm disorders (including QT prolongation), convulsions, dry eye, hair loss, difficulty swallowing, sexual dysfunction and absent periods.
• Rare and very rare: among others severely reduced white blood cells, glaucoma, pancreatitis, bowel obstruction, rhabdomyolysis, jaundice, low body temperature, life-threatening complications of uncontrolled diabetes; frequency not known: Stevens-Johnson syndrome and toxic epidermal necrolysis.
• Children and adolescents more often than adults have sleepiness, tiredness, headache, increased appetite, vomiting, cold symptoms, abdominal pain, dizziness, cough, fever, tremor, diarrhoea and inability to hold urine.

Overdose, missed dose and stopping treatment

• Overdose: contact a doctor, pharmacist or the nearest healthcare facility immediately and take the pack with you. Signs may include sleepiness, tiredness, uncontrolled movements, difficulty standing or walking, dizziness due to low blood pressure, fast heartbeat or convulsions.
• Missed dose: take it as soon as possible; if it is almost time for the next dose, continue with your usual schedule. If you have missed two or more doses, contact your doctor. Never take a double dose.
• Stopping treatment: do not stop before the end of the prescribed treatment, even if you feel better; if your doctor decides to stop, the dose is reduced gradually over several days.

Related information

Weight gain is a common side effect of risperidone, and the doctor advises regular weight monitoring; for weighing yourself at home, see also the category Digital scales – products in this category do not replace the medicine prescribed for you.

Composition, pack and manufacturer

• active substance: risperidone – 1 mg, 2 mg, 3 mg or 4 mg per film-coated tablet;
• excipients – core: lactose monohydrate; maize starch; microcrystalline cellulose (E460); hypromellose (E464); magnesium stearate; colloidal anhydrous silica; sodium lauryl sulfate;
• film coating: hypromellose (E464) and propylene glycol (E490); for 2 mg, 3 mg and 4 mg also talc (E553B) and titanium dioxide (E171); colours: 2 mg – Orange Yellow S (E110); 3 mg – Quinoline Yellow (E104); 4 mg – Quinoline Yellow (E104) and indigotindisulfonate (E132);
• appearance: oblong biconvex tablets marked “Ris” and the strength – 1 mg white, 2 mg light orange, 3 mg yellow, 4 mg green;
• pack: 2 PVC/LDPE/PVDC-aluminium blisters of 10 film-coated tablets (20 tablets) for each strength;
• manufacturer: Janssen-Cilag S.p.A., Via C. Janssen, Borgo San Michele, Latina, Italy; marketing authorisation holder: Janssen-Cilag Kft Representative Office Belgrade, Omladinskih brigada 88b, New Belgrade.

Storage

• store below 30 °C in the original package, protected from light;
• shelf life: 3 years;
• keep out of the sight and reach of children; return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

Can I break a Rispolept tablet in half?

According to the leaflet, the score line only makes swallowing easier and is not intended for dividing the tablet into two equal doses. If you need a lower dose, your doctor will prescribe a suitable strength or the oral solution.

Does Rispolept cause weight gain?

Yes, weight gain and increased appetite are common side effects. Your doctor may advise you to weigh yourself regularly.

Can I drink alcohol with Rispolept?

No. According to the leaflet, alcohol should be avoided while taking the medicine.

What if I forget to take Rispolept?

Take the dose as soon as you remember, unless it is already time for the next one – then skip the missed dose. Do not take a double dose, and if you miss two or more doses, consult your doctor.

Sources

• ALIMS – Package leaflet Rispolept 1 mg, 2 mg, 3 mg and 4 mg film-coated tablets (PIL, Serbian, 10/2024)
• ALIMS – Summary of product characteristics Rispolept film-coated tablets (SmPC, Serbian)

Date sources were checked: 25.10.2026.