Leaflet: information for the user

Risperidone Kern Pharma 1 mg/ml oral solution EFG

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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 and should not be given to other people
• even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Risperidone Kern Pharma and what it is used for

2. What you need to know before starting to take Risperidone Kern Pharma

3. How to take Risperidone Kern Pharma

4. Possible side effects

5. Storage of Risperidone Kern Pharma

6. Contents of the pack and additional information

Risperidona Kern Pharma belongs to a group of medications known as “antipsychotics”.

Risperidona Kern Pharma is used to treat the following:

• Schizophrenia, with which you may see, hear, or feel things that are not there, believe in something that is not true, or feel particularly suspicious or confused.
• Mania, with which you may feel very excited, elated, agitated, enthusiastic, or hyperactive. Mania appears in a disease called “bipolar disorder”.
• Short-term treatment (up to 6 weeks) of persistent aggression in people with Alzheimer's disease dementia, who harm themselves or others. They must have previously tried alternative non-pharmacological treatments.
• Short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children (at least 5 years of age), and adolescents with behavioral disorders.

Do not take Risperidona Kern Pharma

• If you are allergic (hypersensitive) to risperidona or any of the components of this medication (including those listed in section 6).

If you are unsure, consult your doctor or pharmacist before using Risperidona Kern Pharma.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Risperidona Kern Pharma if:

• You have any heart problems. Examples include heart rhythm disturbances, or if you are prone to having low blood pressure or if you are using medications for high blood pressure. Risperidona Kern Pharma may lower your blood pressure. You may need to have your dose adjusted.
• You know of any factor that may make you prone to having a stroke, such as high blood pressure, cardiovascular disease, or problems with blood vessels in the brain.
• You have Parkinson's disease or dementia.
• You are diabetic.
• You have epilepsy.
• You are male and have had a prolonged or painful erection at any time. If you experience this while taking Risperidona Kern Pharma, contact your doctor immediately.
• You have difficulty controlling your body temperature or feel excessive heat.
• You have kidney problems.
• You have liver problems.
• You have an abnormally high level of prolactin in your blood or if you have a tumor that may be dependent on prolactin.
• You or a family member has a history of blood clots, as these medications may be associated with their formation.

Consult your doctor immediately if you have

• Uncontrolled, involuntary movements of the tongue, mouth, or face. You may need to discontinue Risperidona Kern Pharma.
• Fever, severe muscle stiffness, sweating, or low levels of consciousness (a condition called "neuroleptic malignant syndrome"). You may need immediate medical treatment.

If you are unsure about whether the information above affects you, consult your doctor or pharmacist before using Risperidona Kern Pharma.

Risperidona Kern Pharma may cause you to gain weight.

Patients with advanced age and dementia

In patients with advanced age and dementia, there is an increased risk of stroke.

You should not take risperidona if you have dementia caused by a stroke.

During treatment with Risperidona Kern Pharma, you should see your doctor regularly.

If you or your caregiver notice a sudden change in your mental state or the sudden appearance of weakness or numbness in the face, arms, or legs, especially on one side, or if you are speaking in a confused manner, even for a short time, seek immediate medical treatment. This may be a sign of a stroke.

Children and adolescents

Other causes of aggressive behavior should be ruled out before starting treatment for conduct disorders.

If during treatment with risperidona you experience fatigue, changing the administration times may improve your difficulties with attention.

Taking Risperidona Kern Pharma with other medications

Inform your doctor or pharmacist that you are using or have recently used or may need to use any other medication.

It is especially important to speak with your doctor or pharmacist if you are taking any of the following products:

• Medications that act on your brain, such as those used to calm you (benzodiazepines), or some pain medications (opioids), allergy medications (some antihistamines), as risperidona may increase their sedative effect.
• Medications capable of modifying the electrical activity of your heart, such as those used for malaria, heart rhythm problems (such as quinidine), allergies (antihistamines), some antidepressants, or other medications for mental health problems.
• Medications that cause a slow heart rate.
• Medications that cause low potassium levels in the blood (for example: some diuretics).
• Medications for high blood pressure. Risperidona Kern Pharma may lower your blood pressure.
• Medications for Parkinson's disease (such as levodopa).
• Diuretics, which are used for heart problems or to treat swelling in some parts of the body due to fluid retention (such as furosemide or hydrochlorothiazide).

Risperidona Kern Pharma, taken alone or with furosemide, may increase the risk of stroke or death in elderly patients with dementia.

The following medications may reduce the effect of risperidona:

• Rifampicin (a medication for treating some infections).
• Carbamazepine, phenytoin (medications for epilepsy).
• Phenobarbital.

If you start or stop taking these medications, you may need a different dose of risperidona.

The following medications may increase the effect of risperidona:

• Quinidine (used for certain types of heart disease).
• Antidepressants such as paroxetine, fluoxetine, and tricyclic antidepressants.
• Medications known as beta blockers (used to treat high blood pressure).
• Phenothiazines (for example, used to treat psychosis or as sedatives).
• Cimetidine, ranitidine (gastric acid blockers).

If you start or stop taking these medications, you may need a different dose of risperidona.

If you are unsure about whether the information above affects you, consult your doctor or pharmacist before using Risperidona Kern Pharma.

Taking Risperidona Kern Pharma with food, drinks, and alcohol

You can take this medication with or without food. You should avoid consuming alcohol while taking Risperidona Kern Pharma.

Risperidona Kern Pharma 1 mg/ml oral solution should not be mixed with tea.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

• Newborns of mothers who have used risperidona in the last trimester of pregnancy may experience the following symptoms: tremors, muscle stiffness, and/or weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If your newborn experiences any of these symptoms, contact your doctor.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Risperidona may cause symptoms such as drowsiness, dizziness, or visual disturbances and may impair your reaction time. These effects, as well as the underlying condition, may make it difficult for you to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention until your doctor assesses your response to this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

How much to take:

For the treatment of schizophrenia

Adults

• The initial dose is 2 mg per day, which can be increased to 4 mg per day on the second day.
• Your doctor may adjust your dose based on how you respond to treatment.
• Most people feel better with daily doses of 4 mg to 6 mg.
• This total daily dose can be divided into one or two doses per day. Your doctor will tell you what is best for you.

Older adults

• The initial dose will usually be 0.5 mg, taken twice a day.
• Your doctor will later increase your dose gradually to 1 mg - 2 mg, taken twice a day.
• Your doctor will tell you what is best for you.

Children and adolescents

• Children and adolescents under 18 years old should not receive treatment with Risperidona Kern Pharma for schizophrenia.

For the treatment of mania

Adults

• The initial dose will usually be 2 mg, taken once a day.
• Your doctor may later adjust your dose gradually based on your response to treatment.
• Most people feel better with daily doses of 1 mg to 6 mg.

Older adults

• The initial dose will usually be 0.5 mg, taken twice a day.
• Your doctor may later adjust your dose gradually to 1 mg - 2 mg, taken twice a day based on your response to treatment.

Children and adolescents

• Children and adolescents under 18 years old should not receive treatment with Risperidona Kern Pharma for bipolar mania.

For the treatment of long-term aggression in people with Alzheimer's disease

Adults (including older adults)

• The initial dose will usually be 0.25 mg, taken twice a day.
• Your doctor may later change your dose gradually based on your response to treatment.
• Most people feel better with doses of 0.5 mg, taken twice a day. Some patients may need 1 mg, taken twice a day.
• The duration of treatment in patients with Alzheimer's disease should not exceed 6 weeks.

For the treatment of behavioral disorders in children and adolescents

The dose will depend on your child's weight:

If your child weighs less than 50 kg

• The initial dose will usually be 0.25 mg, taken once a day.
• The dose can be increased, one day yes and one day no, in increments of 0.25 mg per day.
• The usual maintenance dose is 0.25 mg to 0.75 mg, taken once a day.

If your child weighs 50 kg or more

• The initial dose will usually be 0.5 mg, taken once a day.
• The dose can be increased, one day yes and one day no, in increments of 0.5 mg per day.
• The usual maintenance dose is 0.5 mg to 1.5 mg, taken once a day.

The duration of treatment in patients with behavioral disorders should not exceed 6 weeks.

Children under 5 years old should not receive treatment with Risperidona Kern Pharma for behavioral disorders.

Patients with liver or kidney problems

Unless the disease being treated is taken into account, all initial doses and subsequent doses of risperidone should be reduced by half. Dose increases should be made more slowly in these patients.

Risperidone should be used with caution in this group of patients.

How to take Risperidona Kern Pharma:

Take Risperidona Kern Pharma exactly as your doctor has told you. Check with your doctor or pharmacist if you are unsure.

Your doctor will tell you how much medication you should take and for how long. This will depend on your illness and varies from person to person. The amount of medication you should take is explained earlier in the section "How much to take".

The solution comes with a syringe (pipette). Use only the syringe provided with this medication to measure the dose prescribed by your doctor. Measure the exact amount of medication you need. Pay attention when measuring a small dose, for example, for 0.25 mg it is necessary to measure 0.25 ml (a quarter of a milliliter); for 0.5 mg it is necessary to measure 0.5 ml (half a milliliter).

Follow these steps:

1. Remove the child-resistant cap. Push the plastic cap down, turning it at the same time against the direction of the clock (Figure 1).
2. Insert the pipette into the bottle.
3. Hold the lower ring and pull the upper ring up to the mark corresponding to the number of milliliters or mg you should administer (Figure 2).
4. Hold the lower ring and remove the pipette from the bottle (Figure 3).
5. Empty the pipette into a non-alcoholic drink that is not tea. Slide the upper ring down.
6. Close the bottle.
7. Wash the pipette with water and let it air dry.

If you take more Risperidona Kern Pharma than you should

• Go to your doctor immediately. Bring the medication packaging with you. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.
• In case of overdose, you may feel drowsy or tired, have abnormal body movements, have difficulty standing and walking, feel dizzy due to decreased blood pressure, or have abnormal heartbeats or convulsions.

If you forget to take Risperidona Kern Pharma

• If you forget to take a dose, take it as soon as you remember. But if it's almost time for your next dose, skip the missed one and continue as usual. If you forget two or more doses, contact your doctor.
• Do not take a double dose (two doses at once) to make up for the missed doses.

If you interrupt treatment with Risperidona Kern Pharma

Do not stop taking the treatment unless your doctor tells you to. Symptoms may reappear. If your doctor decides to stop treatment, your dose may be gradually reduced over a few days.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, Risperidona Kern Pharma may cause side effects, although not everyone will experience them.

Very common:affect more than 1 in 10 people

Common:affect between 1 and 10 in 100 people

Uncommon:affect between 1 and 10 in 1000 people

Rare:affect between 1 and 10 in 10,000 people

Very rare:affect less than 1 in 10,000 people

Unknown:the frequency cannot be estimated from available data

The following side effects may occur:

Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), these clots can move through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, go to your doctor immediately.

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

• Parkinsonism. It is a medical term that includes several symptoms. Each individual symptom may occur less frequently than 1 in 10 people. Parkinsonism includes: increased saliva secretion or a very wet mouth, muscle stiffness, drooling, pain when bending the limbs, slower, reduced, or difficult body movements, facial expressionlessness, muscle tension, torticollis, muscle stiffness, short and rapid steps, dragging the feet, and absence of normal arm movements, persistent blinking as a response to forehead taps (an abnormal reflex).
• Headache, difficulty staying or remaining asleep.

Common (affect between 1 and 10 in 100 people):

• Drowsiness, fatigue, tiredness, inability to remain calm, irritability, anxiety, drowsiness, dizziness, attention problems, feeling of exhaustion, sleep disturbance, tremor.
• Vomiting, diarrhea, constipation, nausea, increased appetite, abdominal pain or discomfort, sore throat, dry mouth.
• Weight gain, increased body temperature, decreased appetite.
• Respiratory difficulty, pneumonia, flu, respiratory tract infection, blurred vision, nasal congestion, nasal bleeding, cough.
• Urinary tract infection, bedwetting.
• Muscle cramps, involuntary movements of the face, arms, or legs, joint pain, back pain, swelling of arms and legs, pain in arms and legs.
• Rash, skin redness.
• Fast heart rate, chest pain.
• Increased prolactin concentration in the blood.

Uncommon (affect between 1 and 10 in 1000 people):

• Excessive water consumption, fecal incontinence, thirst, hard stools, hoarseness or voice disorder.
• Pneumonia caused by food passing through the respiratory tract, urinary tract infection, eye redness, sinusitis, viral infection, ear infection, tonsillitis, skin infection, eye infection, stomach infection, ocular secretion, fungal nail infection.
• Abnormal heart conduction, low blood pressure when standing, decreased blood pressure, sensation of dizziness when changing position, abnormal heart activity (ECG), abnormal heart rhythm, feeling heartbeats, fast or slow heart rate.
• Urinary incontinence, painful urination, frequent urination.
• Confusion, attention disorder, low level of consciousness, excessive sleep, nervousness, manic state, lack of energy and interest.
• Increased blood glucose, increased liver enzymes, decreased white blood cell count, decreased hemoglobin or red blood cell count (anemia), increased eosinophil count (special white blood cells), increased creatine phosphokinase, decreased platelet count (blood cells that help stop bleeding).
• Muscle weakness, muscle pain, ear pain, neck pain, joint swelling, abnormal posture, joint stiffness, chest muscle and bone pain, chest discomfort.
• Skin lesion, skin disorder, dry skin, intense itching, acne, hair loss, skin inflammation caused by mites, skin discoloration, skin thickening, flushing, reduced skin sensitivity to pain or touch, oily skin inflammation.
• Amenorrhea, sexual dysfunction, erectile dysfunction, ejaculation disorder, breast secretion, breast enlargement in males, decreased sexual desire, irregular menstruation, vaginal secretion.
• Loss of consciousness, gait disorder, inactivity, reduced appetite with malnutrition and weight loss, feeling unwell, balance disorder, allergy, edema, speech disorder, chills, coordination disorder.
• Photophobia, increased eye blood flow, eye swelling, dry eyes, increased tear production.
• Respiratory tract disorder, pulmonary congestion, lung crepitant sounds, respiratory tract congestion, speech difficulty, swallowing difficulty, cough with sputum, hoarse or hissing sound while breathing, pseudogripal disease, sinusitis.
• Loss of response to stimuli, loss of consciousness, sudden swelling of lips and eyes with difficulty breathing, sudden weakness or numbness of face, arms, or legs, especially on one side, or cases of confused speech lasting less than 24 hours (mini-stroke or cerebral attack), involuntary facial, arm, or leg movements, tinnitus, facial edema.

Rare (affect between 1 and 10 in 10,000 people):

• Inability to achieve orgasm, menstrual disorder.
• Dandruff.
• Medication allergy, coldness in arms and legs, lip swelling, lip inflammation.
• Glaucoma, decreased visual acuity, corneal crust formation, eye movement.
• Lack of emotions.
• Consciousness alteration with increased body temperature and muscle spasms, body-wide edema, medication withdrawal syndrome, decreased body temperature.
• Shallow and rapid breathing, respiratory problems during sleep, chronic otitis media.
• Intestinal obstruction.
• Decreased blood flow to the brain.
• Decreased white blood cell count, inadequate secretion of a hormone that controls urine volume.
• Muscle fiber rupture and muscle pain (rhabdomyolysis), movement disorder.
• Diabetes coma due to uncontrolled diabetes.
• Yellow skin and eye color (jaundice).
• Pancreatitis inflammation.

Very rare (affect less than 1 in 10,000 people):

• Life-threatening complications of uncontrolled diabetes.

Unknown frequency of side effects (the frequency cannot be estimated from available data):

• Severe allergic reaction leading to respiratory difficulty and shock.
• Absence of granulocytes (a type of white blood cell that helps fight infections).
• Prolonged and painful erection.
• Peligrosamente excessive water intake.

Risperidona long-acting injectable

The following side effects have been reported with the use of Risperidona long-acting injectable. If you experience any of the following side effects, talk to your doctor, even if you are not receiving long-acting Risperidona injections:

• Intestinal infection
• Subcutaneous abscess, skin tingling, skin numbness, skin inflammation
• Decreased white blood cell count, cells that help protect you from bacterial infections
• Depression
• Seizures
• Eye blinking
• Sensation of rotation or oscillation
• Slow heart rate, increased blood pressure
• Toothache, tongue spasm
• Gluteal pain
• Weight loss

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

Do not freeze. Store in the original packaging.

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

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Once the bottle is opened, unused portions should be discarded after 6 months.

Medications should not be disposed of through drains or trash. Deposit containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

Composition of Risperidona Kern Pharma

• The active ingredient is risperidone. Each ml of oral solution of Risperidona Kern Pharma contains 1 mg of risperidone.
• The other components are: benzoic acid (E-210), tartaric acid (E-334) and purified water.

Appearance of the product and content of the container

Transparent and colorless solution. Bottles of 30 ml and 100 ml with child-resistant cap and dosing syringe.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet: March 2025

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/