Risperidone Codramol 1 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Risperidona Codramol 1 mg/ml oral solution EFG

risperidone

Read the entire 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 must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Risperidona Codramol is and what it is used for
2. What you need to know before taking Risperidona Codramol
3. How to take Risperidona Codramol
4. Possible side effects
5. How to store Risperidona Codramol
6. Contents of the pack and other information

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

Risperidone Codramol belongs to a group of medicines known as "antipsychotics".

Risperidone is used to treat the following:

??Schizophrenia, a condition in which you may see, hear, or feel things that are not there, believe things that are not true, or feel particularly suspicious or confused

??Mania, a condition in which you may feel overly excited, elated, agitated, enthusiastic, or hyperactive. Mania occurs in an illness called "bipolar disorder"

??Short-term treatment (up to 6 weeks) of persistent aggression in patients with Alzheimer-type dementia who are a danger to themselves or others. Alternative non-pharmacological treatments should have been attempted previously.

??Short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children (aged at least 5 years) and adolescents with conduct disorders

Risperidone Codramol can help reduce the symptoms of your illness and help prevent them from returning.

2. What you need to know before taking Risperidona Codramol

Do not take Risperidona Codramol if:

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

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Risperidona if:

• You have any heart problems. Examples include irregular heart rhythms, or if you are prone to low blood pressure, or if you are taking medicines for blood pressure. Risperidone may reduce blood pressure. You may need your dose adjusted.
• You have any risk factor that may make you prone to stroke, such as high blood pressure, cardiovascular disease, or blood vessel problems in the brain.
• You have ever experienced involuntary movements of the tongue, mouth, or face.
• You have ever had symptoms including fever, muscle stiffness, sweating, or decreased level of consciousness (also known as Neuroleptic Malignant Syndrome).
• You have Parkinson's disease or dementia.
• You have previously had low levels of white blood cells (which may or may not have been caused by other medicines).
• You are diabetic.
• You have epilepsy.
• You are a man and have ever had a prolonged or painful erection. If this occurs while taking Risperidona, contact your doctor immediately.
• You have difficulty regulating your body temperature or feel excessive heat.
• You have kidney problems.
• You have liver problems.
• You have abnormally high levels of the hormone prolactin in your blood, or if you have a tumor that may be prolactin-dependent.
• You or someone in your family has a history of blood clots, as these medicines may be associated with blood clot formation.

If you are unsure whether the above applies to you, consult your doctor or pharmacist before using Risperidona Codramol.

Very rarely, patients treated with Risperdal have developed a dangerously low number of a type of white blood cell needed to fight infections. Your doctor may monitor your white blood cell count.

Risperdal may cause weight gain. A significant increase in weight may negatively affect your health. Your doctor will regularly monitor your weight.

Since cases of diabetes mellitus or worsening of pre-existing diabetes mellitus have been observed in patients taking Risperdal, your doctor should check for signs of elevated blood sugar. In patients with pre-existing diabetes mellitus, blood sugar levels should be monitored regularly.

Risperdal frequently increases levels of a hormone called prolactin. This may cause adverse effects such as menstrual disorders or fertility problems in women, or breast enlargement in men (see Possible side effects). If these adverse effects occur, evaluation of prolactin levels in the blood is recommended.

During eye surgery for lens clouding (cataracts), the pupil (the black circle in the center of the eye) may not dilate as needed. In addition, the iris (the colored part of the eye) may become floppy during surgery, which could lead to eye damage. If you are considering eye surgery, make sure to inform your ophthalmologist that you are using this medicine.

Elderly patients with dementia

In elderly patients with dementia, there is an increased risk of stroke. You should not take risperidone if your dementia is caused by a stroke.

During treatment with Risperidona, you should see your doctor frequently.

If you or your caregiver notice a sudden change in your mental state, or sudden onset of weakness or numbness in the face, arms, or legs—especially on one side—or if you experience confusion or slurred speech, even briefly, seek immediate medical attention. These may be signs of a stroke.

Children and adolescents

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

If you experience fatigue during treatment with risperidone, changing the time of administration may improve difficulties with attention.

Before starting treatment, your weight or your child’s weight may be measured and should be monitored regularly during treatment.

A small, inconclusive study has reported increased height in children taking risperidone, but it is unknown whether this is a drug effect or due to another reason.

Other medicines and Risperidona Codramol

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription and herbal products.

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

• Medicines that act on the brain, such as those used to calm you (benzodiazepines), or some pain medicines (opioids), or allergy medicines (some antihistamines), as risperidone may increase their sedative effect.
• Medicines that can alter the electrical activity of your heart, such as those used for malaria, heart rhythm disorders (e.g., quinidine), allergies (antihistamines), some antidepressants, or other medicines for mental disorders.
• Medicines that cause a slow heart rate.
• Medicines that cause low potassium levels in the blood (e.g., certain diuretics).
• Medicines for high blood pressure. Risperidona may lower blood pressure.
• Medicines for Parkinson’s disease (e.g., levodopa).
• Medicines that increase central nervous system activity (psychostimulants, such as methylphenidate).
• Diuretics used for heart problems or to treat swelling in parts of the body due to fluid retention (e.g., furosemide or chlorothiazide). Risperidona, taken alone or 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 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 types of heart disease).
• Antidepressants such as paroxetine, fluoxetine, and tricyclic antidepressants.
• Medicines known as beta-blockers (used to treat high blood pressure).
• Phenothiazines (e.g., used to treat psychosis or as sedatives).
• Cimetidine, ranitidine (stomach acid blockers).
• Itraconazole and ketoconazole (medicines used to treat fungal infections).
• Some medicines used to treat 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 these medicines, you may need a different dose of risperidone.

If you are unsure whether the above applies to you, consult your doctor or pharmacist before using Risperidona Codramol.

Use of Risperidona Codramol with food, drinks, and alcohol

You may take this medicine with or without food. You should avoid consuming alcohol while taking Risperidona.

Pregnancy, breastfeeding, and fertility

• Consult your doctor before using Risperidona if you are pregnant, trying to become pregnant, or breastfeeding. Your doctor will decide whether you can take it.
• Newborns of mothers who have used Risperidona Codramol during the last trimester of pregnancy may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your newborn shows any of these symptoms, contact your doctor.

Risperidona Codramol may increase levels of a hormone called “prolactin” which may affect fertility (see Possible side effects).

Driving and using machines

Dizziness, fatigue, and vision problems have been observed during treatment with Risperidona. Do not drive or operate tools or machinery without first consulting your doctor.

Important information about some of the components of Risperidona Codramol 1 mg/ml oral solution
This medicine contains less than 23 mg of sodium (1 mmol) per ml; this is essentially “sodium-free”.

3. How to take Risperidone Codramol

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is as follows:

For the treatment of schizophrenia

Adults

??The initial dose is 2 mg per day; this may be increased to 4 mg per day on the second day.

??Your doctor may adjust your dose depending on how you respond to treatment.

??Most people improve with daily doses of 4 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.

Elderly patients

??The initial dose is normally 0.5 mg twice daily.

??Later, your doctor may gradually increase your dose to 1 mg – 2 mg twice daily.

??Your doctor will tell you what is best for you.

Children and adolescents

??Children and adolescents under 18 years of age must not be treated with Risperidone for schizophrenia.

For the treatment of mania

Adults

??The initial dose is normally 2 mg once daily.

??Later, your doctor may gradually adjust your dose depending on your response to treatment.

??Most people improve with daily doses of 1 to 6 mg.

Elderly patients

??The initial dose is normally 0.5 mg twice daily.

??Later, your doctor may gradually adjust your dose to 1 mg – 2 mg twice daily, depending on your response to treatment.

Children and adolescents

??Children and adolescents under 18 years of age must not be treated with Risperidone for bipolar mania.

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

Adults (including elderly patients)

??The initial dose is normally 0.25 mg twice daily.

??Later, your doctor may gradually change your dose depending on your response to treatment.

??Most people improve with doses of 0.5 mg twice daily. Some patients may require 1 mg twice daily.

??The duration of treatment in patients with Alzheimer-type 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 Codramol for schizophrenia or mania.

For the treatment of behavioural 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 is normally 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 mg to 0.75 mg once daily.

If your child weighs 50 kg or more:

??The initial dose is normally 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 mg to 1.5 mg once daily.

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

Children under 5 years of age must not be treated with risperidone for behavioural disorders.

Patients with liver or kidney problems

Regardless of the condition being treated, all initial and subsequent risperidone doses should be halved. Dose increases should be made more slowly in these patients.

Risperidone should be used with caution in this patient group.

Method of administration

FOR ORAL USE

Instructions for opening the bottle and using the dosing syringe:

100 ml and 30 ml bottles:

The solution comes with a syringe. Use only the syringe supplied with this medicine to measure the dose prescribed by your doctor. Measure the exact dose of medicine you need. Pay close attention when measuring a small dose; for example, for 0.25 mg, you must measure 0.25 ml (a quarter millilitre); for 0.5 mg, you must measure 0.5 ml (half a millilitre).

Follow these steps:

1. Remove the child-resistant cap. Push down on the plastic cap while turning it counterclockwise (Figure 1).
2. Insert the syringe into the bottle.
3. Holding the lower ring, pull the upper ring up to the mark corresponding to the number of millilitres or mg to be administered (Figure 2).
4. Holding the lower ring, remove the entire syringe from the bottle (Figure 3).
5. Empty the syringe into a non-alcoholic drink (not tea). Slide the upper ring down.
6. Close the bottle.
7. Rinse the syringe with water and allow it to air dry.

If you take more Risperidone Codramol than you should

??Seek medical help immediately. Take the medicine container with you. You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount taken.

??In case of overdose, you may feel drowsy or tired, experience abnormal body movements, have difficulty standing or walking, feel dizzy due to low blood pressure, or have abnormal heartbeats or seizures.

If you forget to take Risperidone Codramol

??If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose and continue with your regular schedule.

??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 forgotten doses.

If you stop taking Risperidone Codramol

Do not stop taking this medicine unless your doctor tells you to. Symptoms may return. If your doctor decides to stop treatment, your dose may be gradually reduced over several days.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Immediately inform your doctor if you experience any of the following uncommon adverse effects (may affect up to 1 in 100 patients):

• You have dementia and experience a sudden change in your mental state or sudden weakness or numbness of the face, arms, or legs, especially on one side, or have difficulty speaking, even for a short period of time. These may be signs of a stroke.

• You develop tardive dyskinesia (uncontrollable spasms or twitching movements of the face, tongue, or other parts of the body). Inform your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth, or face. Discontinuation of Risperdal may be necessary.

Immediately inform your doctor if you experience any of the following rare adverse effects (may affect up to 1 in 1,000 patients):

• You develop blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which may travel through blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical advice immediately.

• You develop fever, muscle stiffness, sweating, or decreased level of consciousness (a condition known as "Neuroleptic Malignant Syndrome"). Immediate medical treatment may be required.

• You are a man and experience a prolonged or painful erection. This is known as priapism. Immediate medical treatment may be required.

• You experience a severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, itching, skin rash, or low blood pressure.

The following side effects may also occur:

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

?? Parkinsonism. This condition may include slow or altered movement, a sensation of muscle stiffness or tightness (causing jerky movements), and sometimes a "freezing" of movement that later restarts. Other signs of parkinsonism include shuffling gait, resting tremor, increased saliva and/or drooling, and reduced facial expression.

?? Headache, difficulty falling or staying asleep.

?? Feeling drowsy or less alert.

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

? Pneumonia, chest infection (bronchitis), symptoms of a common cold, sinusitis, urinary tract infection, ear infection, feeling as if you have the flu.

? Increased levels of a hormone called "prolactin" detected in blood tests (which may or may not cause symptoms). Symptoms of elevated prolactin occur rarely and may include, in men, breast swelling, difficulty achieving or maintaining erections, decreased sexual desire, or other sexual dysfunctions. In women, symptoms may include breast discomfort, milk secretion from the breasts, loss of menstrual periods, or other menstrual cycle problems or fertility issues.

? Weight gain, increased appetite, decreased appetite.

? Sleep disorders, irritability, depression, anxiety, restlessness.

? Dystonia: A condition involving involuntary, slow, or sustained muscle contractions. Although any part of the body may be affected (and may result in abnormal postures), dystonia frequently affects facial muscles, including abnormal eye, mouth, tongue, or jaw movements.

? Dizziness.

? Dyskinesia: A condition involving involuntary muscle movements and may include repetitive, twitching, twisting, or spasmodic movements.

? Tremor (agitation).

? Blurred vision, eye infection, or "red eye."

? Rapid heartbeat, increased blood pressure, shortness of breath.

? Sore throat, cough, nosebleeds, nasal congestion.

? Abdominal pain, abdominal discomfort, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache.

? Skin rash, redness of the skin.

? Muscle spasms, bone or muscle pain, back pain, joint pain.

? Urinary incontinence (loss of bladder control).

? Swelling of the body, arms, or legs, fever, chest pain, weakness, fatigue (tiredness), pain.

? Falls.

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

? Respiratory tract infection, bladder infection, eye infection, tonsillitis, fungal nail infection, skin infection, localized infection in a single area of skin or body part, viral infection, skin inflammation caused by mites.

? Decreased levels of a type of white blood cell that helps fight infections, decreased number of white blood cells, decreased platelets (blood cells that help stop bleeding), anemia, decreased red blood cells, increased number of eosinophils (a type of white blood cell) in the blood.

? Allergic reaction.

? Diabetes or worsening of diabetes, high blood sugar, excessive water intake.

? Weight loss, loss of appetite leading to malnutrition and reduced body weight.

? Increased cholesterol in the blood.

? Euphoria (mania), confusion, decreased sexual desire, nervousness, nightmares.

? Lack of response to stimuli, loss of consciousness, decreased level of consciousness.

? Seizures (epileptic fits), fainting.

? Restlessness causing movement of body parts, balance disorder, abnormal coordination, dizziness upon standing, difficulty concentrating, speech problems, loss or changes in taste, decreased skin sensitivity to pain or touch, tingling, prickling, or numbness of the skin.

? Light sensitivity of the eyes, dry eyes, increased tearing, redness of the eyes.

? Sensation of spinning (vertigo), ringing in the ears, ear pain.

? Atrial fibrillation (abnormal heart rhythm), interruption of conduction between upper and lower parts of the heart, abnormal electrical activity of the heart, QT interval prolongation on the electrocardiogram (ECG), slow heartbeat, abnormal electrical conduction of the heart (ECG), sensation of fluttering or pounding in the chest (palpitations).

? Decreased blood pressure, decreased blood pressure upon standing—consequently, some people taking Risperdal may feel weakness, dizziness, or loss of consciousness when standing up or sitting up suddenly, flushing.

? Pneumonia caused by aspiration of food, pulmonary congestion, respiratory congestion, crackling sounds in the lungs, wheezing, voice disorder, breathing difficulty.

? Stomach or intestinal infection, fecal incontinence, very hard stools, difficulty swallowing, excess gas or flatulence.

? Hives (or "urticaria"), itching, hair loss, skin thickening, eczema, dry skin, skin discoloration, acne, scaly and itchy scalp or skin, skin disorder, skin lesion.

? Increased CPK (creatine phosphokinase) in blood, an enzyme sometimes released during muscle breakdown.

? Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain.

? Frequent urination, inability to urinate, pain during urination.

? Erectile dysfunction, ejaculation disorder.

? Loss of menstruation, missed periods, or other menstrual cycle problems (women).

? Breast development in men, milk secretion from the 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 sensation, feeling unwell, chest discomfort, feeling "under the weather," malaise.

? Increased liver transaminases in blood, increased GGT (a liver enzyme called gamma-glutamyltransferase) in blood, increased liver enzymes in blood.

? Procedure-related pain.

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

? Infection.

? Inappropriate secretion of a hormone that controls urine volume.

? Sleepwalking.

? Sleep-related eating disorder.

? Sugar in urine, low blood sugar, increased blood triglycerides (a type of fat).

? Absence of emotions, inability to achieve orgasm.

? Lack of movement or response while awake (catatonia).

? Problems with blood vessels in the brain.

? Coma due to uncontrolled diabetes.

? Head agitation.

? Glaucoma (increased pressure in the eyeball), problems with eye movement, eye rolling, crusts on the eyelid margin.

? Eye problems during cataract surgery. During cataract surgery, a disturbance called intraoperative floppy iris syndrome (IFIS) may occur if you are taking or have taken Risperdal. If you need to undergo cataract surgery, make sure to inform your ophthalmologist if you are taking or have taken this medicine.

? Dangerously low levels of a type of white blood cell needed to fight infections in the blood.

? Dangerously excessive water intake.

? Irregular heartbeat.

? Breathing problems during sleep (sleep apnea), rapid, shallow breathing.

? Pancreatitis, intestinal obstruction.

? Swelling of the tongue, cracked lips, drug-related skin rash.

? Dandruff.

? Muscle fiber breakdown and muscle pain (rhabdomyolysis).

? Delayed menstrual periods, increased mammary glands, breast enlargement, milk secretion from the breasts.

? Increased insulin (a hormone that controls blood sugar levels) in blood.

? Skin hardening.

? Decreased body temperature, coldness in arms and legs.

? Medication withdrawal syndrome.

? Yellowing of the skin and eyes (jaundice).

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

? Life-threatening complications of uncontrolled diabetes.

? Severe allergic reaction with swelling, which may affect the throat and cause breathing difficulties.

? Lack of movement in intestinal muscles causing obstruction.

The following adverse effect has been reported with the use of another medicine called paliperidone, which is very similar to risperidone; therefore, it is also expected to occur with Risperdal: rapid heartbeat upon standing.

Other adverse effects in children and adolescents

In general, adverse effects in children are expected to be similar to those seen in adults. The following adverse effects were reported more frequently in children and adolescents (5 to 17 years) than in adults: feeling drowsy or less alert, fatigue (tiredness), headache, increased appetite, vomiting, symptoms of common cold, nasal congestion, abdominal pain, dizziness, cough, fever, tremor (shakiness), diarrhea, and urinary incontinence (lack of bladder control).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Risperidone Codramol

Do not store above 30 °C.

Do not store below 15 °C.

Do not freeze.

Keep in the original packaging.

Keep out of the reach and sight of children.

Do not use after the expiry date stated on the container, following EXP. The expiry date refers to the last day of the month indicated.

Once the bottle has been opened, any unused portion must be discarded after 3 months.

Medicines must not be disposed of via wastewater or household waste. Return empty containers and any medicines you no longer need to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of containers and unwanted medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Risperidone Codramol

The active substance is risperidone.

Each millilitre of Risperidone Codramol oral solution contains 1 mg of risperidone.

The other components are: Sodium chloride, domiphen bromide, anhydrous citric acid, disodium phosphate dodecahydrate, lemon flavour, and purified water.

Appearance of Risperidone Codramol and contents of the pack

Risperidone Codramol oral solution is clear and slightly yellowish.

The oral solution is available in 30 ml or 100 ml containers.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Farmalider, S.A.

Aragoneses, 15

28108 Alcobendas (Madrid)

Manufacturer

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94

28802 Alcalá de Henares, Madrid

Spain

Or

Medinfar Manufacturing, S.A.

Parque Industrial Armando Martins Tavares

Rua Outeiro Da Armada, 5

Condeixa-a-Nova, 3150-194, Sebal

Portugal

Date of the most recent revision of this leaflet: March 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/