RISPERIDONE CODRAMOL 1 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Risperidona Codramol 1 mg/ml Oral Solution EFG

Risperidone

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

Risperidona Codramol belongs to a group of medicines called "antipsychotics".

Risperidone is used to treat:

Schizophrenia, where you may see, hear, or feel things that are not there, believe in something that is not true, or feel unusually suspicious or confused.

Mania, where you may feel very excited, elated, agitated, enthusiastic, or hyperactive. Mania occurs in a disease called "bipolar disorder".

Short-term treatment (up to 6 weeks) of persistent aggression in people with Alzheimer's disease-type dementia, who may harm themselves or others. Other non-pharmacological treatments should have been tried before.

Short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children and adolescents with behavioral disorders.

Risperidona Codramol may help to decrease the symptoms of your illness and prevent them from coming back.

2. What you need to know before you take Risperidona Codramol

Do not take Risperidona Codramol if:

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

If you are not sure, consult your doctor or pharmacist before using Risperidona Codramol.

Warnings and precautions

Consult your doctor or pharmacist before taking Risperidona if:

• You have any heart problems. Examples include heartbeat disturbances, or if you are prone to having low blood pressure or if you use medications for blood pressure. Risperidone 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 diseases, or problems with the blood vessels in the brain.
• You have ever had involuntary movements of the tongue, mouth, and face.
• You have ever had symptoms that include fever, muscle stiffness, sweating, or a decrease in the level of consciousness (also known as Neuroleptic Malignant Syndrome).
• You have Parkinson's disease or dementia.
• If you have had low levels of white blood cells in the past (which may or may not have been caused by other medications).
• You are diabetic.
• You have epilepsy.
• You are male and have ever had a prolonged or painful erection. If you experience this while taking Risperidone, contact your doctor immediately.
• You have problems controlling your body temperature or feel excessive heat.
• You have kidney problems.
• You have liver problems.
• You have an abnormally high level of the hormone prolactin in your blood or if you have a tumor that may be dependent on prolactin.
• You or a family member have a history of blood clots, as these medications may be associated with the formation of clots.

If you are unsure about any of the above, consult your doctor or pharmacist before using Risperidona Codramol.

Because very rare cases of a dangerously low number of a type of white blood cell necessary to fight infections in the blood have been observed in patients treated with Risperdal, your doctor may check your white blood cell count.

Risperdal may cause you to gain weight. A significant increase in weight can affect your health unfavorably. Your doctor will regularly monitor your weight.

Because diabetes mellitus or worsening of pre-existing diabetes mellitus has been seen in patients taking Risperdal, your doctor should check for signs of elevated blood sugar. In patients with pre-existing diabetes mellitus, blood sugar should be regularly monitored.

Risperdal often increases the levels of a hormone called prolactin. This can cause side effects such as menstrual disorders or fertility problems in women or breast swelling in men (see Possible side effects). If these side effects appear, it is recommended to evaluate the levels of prolactin in the blood.

During eye surgery for cataracts, the pupil (the black circle in the middle of the eye) may not increase in size as needed. Additionally, the iris (the colored part of the eye) may become flaccid during surgery, which can cause eye damage. If you are considering eye surgery, make sure to inform your ophthalmologist that you are using this medication.

Elderly patients with dementia

In elderly patients with dementia, there is an increased risk of having a stroke. You should not take risperidone if you have dementia 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 the sudden appearance of weakness or numbness in the face, arms, or legs, especially on one side, or confused speech, even if only for a short time, seek medical attention immediately. It may be a sign of a stroke.

Children and adolescents

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

If during treatment with risperidone you experience fatigue, changing the administration hours may improve your difficulties in paying attention.

Before starting treatment, your weight or your child's weight may be measured and followed regularly during treatment.

A small, inconclusive study has reported an increase in height in children who took 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 using or have recently used other medicines, including those obtained without a prescription and herbal products.

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

• Medicines that act on your brain, such as those used to calm you down (benzodiazepines) or some pain medications (opioids), allergy medications (some antihistamines), as risperidone may increase their sedative effect.
• Medicines that can change 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 problems.
• Medicines that cause a slow heartbeat.
• Medicines that cause low potassium levels in the blood (such as some diuretics).
• Medicines for high blood pressure. Risperidone may lower your blood pressure.
• Medicines for Parkinson's disease (such as levodopa).
• Medicines that increase the activity of the central nervous system (psychostimulants, such as methylphenidate).
• Diuretics, which are used for heart problems or to treat swelling of some parts of the body due to fluid retention (such as furosemide or chlorothiazide). Risperidone, taken alone or with furosemide, may increase the risk of stroke or death in elderly patients with dementia.

The following medicines may decrease the effect of risperidone:

• Rifampicin (a medicine used to treat some 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 diseases).
• 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 about any of the above, consult your doctor or pharmacist before using Risperidona Codramol.

Using Risperidona Codramol with food, drinks, and alcohol

You can 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 are breastfeeding. Your doctor will decide if you can take it.
• Newborns of mothers who have used Risperidona Codramol in the last trimester of pregnancy may present with the following symptoms: tremors, muscle stiffness, and/or weakness, drowsiness, agitation, breathing problems, and feeding problems. If your newborn presents with any of these symptoms, contact your doctor.

Risperidona codramol may increase the levels of a hormone called "prolactin" that can 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 machines without consulting your doctor first.

Important information about some of the ingredients of Risperidona Codramol 1 mg/ml Oral Solution

This medicine contains less than 23 mg of sodium (1 mmol) per ml; it is essentially "sodium-free".

3. How to take Risperidona Codramol

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of 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, which 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 feel better 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 indicate what is best for you.

Elderly patients

The initial dose will normally be 0.5 mg, twice a day.

Later, your doctor may gradually increase your dose to 1 mg - 2 mg, twice a day.

Your doctor will indicate what is best for you.

Children and adolescents

Children and adolescents under 18 years of age should not receive treatment with Risperidone for schizophrenia.

For the treatment of mania

Adults

The initial dose will normally be 2 mg, once a day.

Your doctor may adjust your dose gradually depending on your response to treatment.

Most people feel better with daily doses of 1 to 6 mg.

Elderly patients

The initial dose will normally be 0.5 mg, twice a day.

Your doctor may adjust your dose gradually to 1 mg - 2 mg, twice a day, depending on your response to treatment.

Children and adolescents

Children and adolescents under 18 years of age should not receive treatment with Risperidone for bipolar mania.

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

Adults (including elderly patients)

The initial dose will normally be 0.25 mg, twice a day.

Your doctor may adjust your dose gradually depending on your response to treatment.

Most people feel better with doses of 0.5 mg, twice a day. Some patients may need 1 mg, twice a day.

The duration of treatment in patients with Alzheimer's disease-type dementia should not exceed 6 weeks.

Use in children and adolescents

Children and adolescents under 18 years of age should not receive treatment with Risperidona codramol for schizophrenia or mania.

For the treatment of behavioral disorders in children and adolescents

The dose depends on your child's weight:

If they weigh less than 50 kg:

The initial dose will normally be 0.25 mg, once a day.

The dose may be increased, one day yes and one day no, in increments of 0.25 mg per day.

The normal maintenance dose is 0.25 mg to 0.75 mg, once a day.

If they weigh 50 kg or more:

The initial dose will normally be 0.5 mg, once a day.

The dose may be increased, one day yes and one day no, in increments of 0.5 mg per day.

The normal maintenance dose is 0.5 mg to 1.5 mg, once a day.

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

Children under 5 years of age should not receive treatment with risperidone for behavioral disorders.

Patients with liver or kidney problems

Regardless of the disease being treated, all initial 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.

Method of administration

ORAL USE

Instructions for opening the bottle and using the dosing syringe:

100 and 30 ml packaging:

The solution comes with a syringe. Use only the syringe provided with this medicine to measure the prescribed dose. Measure the exact dose of the medicine you need. Pay attention to measuring a small dose, for example, for 0.25 mg you need to measure 0.25 ml (a quarter of a milliliter); for 0.5 mg you need to measure 0.5 ml (half a milliliter).

Follow these steps:

1. Remove the child-resistant cap. Push the plastic cap down, 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 that corresponds to the number of milliliters or mg you should administer (Figure 2).
4. Holding the lower ring, remove the syringe from the bottle (Figure 3).
5. Empty the syringe into a non-alcoholic beverage that is not tea. Slide the upper ring down.
6. Close the bottle.
7. Rinse the syringe with water and let it air dry.

If you take more Risperidona Codramol than you should

Go to the doctor immediately. Take the medicine package with you. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

In case of overdose, you may feel drowsy or tired, have abnormal body movements, problems standing and walking, dizziness due to low blood pressure, or have abnormal heartbeats or convulsions.

If you forget to take Risperidona Codramol

If you forget to take a dose, take it as soon as you remember. But if it is close to the time of 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 at once) to make up for missed doses.

If you stop taking Risperidona Codramol

Do not stop taking the treatment unless your doctor tells you to. The symptoms may come back. If your doctor decides to stop the treatment, your dose may be gradually decreased over a few days.

If you have any other 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 all people suffer from them Inform your doctor immediately if you experience any of the following rare 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 during a short period. They can be signs of a stroke

• You experience tardive dyskinesia (involuntary spasms or twitching movements that cannot be controlled in the face, tongue, or other parts of the body). Inform your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth, and face. It may be necessary to withdraw

Risperdal

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

• You experience blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can circulate through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical advice immediately
• You experience fever, muscle stiffness, sweating, or a decrease in the level of consciousness (a condition known as "Neuroleptic Malignant Syndrome"). You may need immediate medical treatment

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.

Also, the following side effects may appear:

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

> Parkinsonism. This disease may include slow or altered movement, feeling of stiffness or tension in the muscles (making sudden movements) and sometimes a feeling of "freezing" of movement that then restarts. Other signs of parkinsonism include walking slowly, dragging feet, tremors at rest, increased saliva and/or drooling, and loss of facial expressiveness.

> Headache, difficulty staying or falling asleep.

> Feeling drowsy or less attentive

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 like you have the flu

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

? Weight gain, increased appetite, decreased appetite

? Sleep disorders, irritability, depression, anxiety, restlessness

? Dystonia: It is a disease that involves involuntary, slow, or continuous contraction of the muscles. Although any part of the body can be affected (and can cause abnormal postures), dystonia often affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or jaw

? Dizziness

? Dyskinesia: This disease involves involuntary muscle movements and may include repetitive, spasmodic, or twisting movements, or spasms

? Tremors (shaking)

? Blurred vision, eye infections, or "red eye"

? Rapid heartbeat, increased blood pressure, shortness of breath

? Sore throat, cough, nasal bleeding, nasal congestion

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

? Rash, skin redness

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

? Urinary incontinence (loss of 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 infection of the nails, skin infection, localized infection in a single area of the skin or body part, viral infection, skin inflammation caused by mites

? Decrease in a type of white blood cell that helps fight infections, decrease in the number of white blood cells, decrease in platelets (blood cells that help stop bleeding), anemia, decrease in red blood cells, increase in the number of eosinophils (a type of white blood cell) in the blood

? Allergic reaction

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

? Weight loss, loss of appetite that causes malnutrition and weight loss

? 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

? A restlessness that causes movement of body parts, balance disorder, abnormal coordination, dizziness when standing up, attention problems, speech problems, loss or alteration of taste, decreased skin sensitivity to pain or touch, sensation of tingling, pinching, or numbness of the skin

? Increased sensitivity of the eyes to light, dry eyes, increased tearing, redness of the eyes

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

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

? Decreased blood pressure, decreased blood pressure when standing up, as a result, some people taking Risperdal may feel weakness, dizziness, or loss of consciousness when getting up or sitting down suddenly, flushing

? Aspiration pneumonia, pulmonary congestion, respiratory tract congestion, crackling sounds in the lungs, wheezing, voice disorder, breathing difficulties

? 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 skin or scalp, skin disorder, skin lesion

? Increased CPK (creatine phosphokinase) in the blood, an enzyme that is sometimes released with muscle breakdown

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

? Frequent urination, inability to urinate, painful urination

? Erectile dysfunction, ejaculation disorder

? Loss of menstruation, loss of menstrual periods, or other problems with the cycle (in women)

? Development of breasts in men, milk secretion from the breasts, sexual dysfunction, breast pain, breast discomfort, vaginal discharge

? Swelling of the face, mouth, eyes, or lips

? Chills, a rise in body temperature

? Change in gait

? Feeling of thirst, feeling of discomfort, chest discomfort, feeling "unwell", discomfort

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

? Pain due to the procedure.

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 the urine, decreased blood sugar, increased triglycerides in the blood (a type of fat)

? Lack of emotions, inability to reach orgasm

? Lack of movement or response while awake (catatonia)

? Problems in the blood vessels of the brain

? Coma due to uncontrolled diabetes

? Head shaking

? Glaucoma (increased eye pressure), problems with eye movement, eye rotation, crusts on 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 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 number of a type of white blood cell necessary to fight infections in the blood

? Dangerously excessive water intake

? Irregular heartbeat

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

? Pancreatitis, intestinal obstruction

? Tongue swelling, cracked lips, skin rash related to the medicine

? Dandruff

? Muscle fiber breakdown and muscle pain (rhabdomyolysis)

? Delayed menstrual periods, breast enlargement, breast swelling, milk secretion from the breasts

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

? Skin hardening

? Decreased body temperature, coldness in arms and legs

? Drug withdrawal syndrome

? Yellowing of the skin and eyes (jaundice).

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

? Complications of uncontrolled diabetes, life-threatening

? Severe allergic reaction with swelling, which can affect the throat, causing difficulty breathing

? Lack of movement of the intestinal muscles that causes obstruction.

The following adverse effect has appeared with the use of another medicine called paliperidone, which is very similar to risperidone, so it is also expected to appear with Risperdal: Rapid heartbeat when standing up.

Other adverse effects in children and adolescents

In general, it is expected that the adverse effects in children will be similar to those that appeared 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 attentive, fatigue (tiredness), headache, increased appetite, vomiting, common cold symptoms, nasal congestion, abdominal pain, dizziness, cough, fever, tremors (shaking), diarrhea, and urinary incontinence (loss of control).

Reporting of adverse effects

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

5. Storage of Risperidona 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 expiration date shown on the packaging, after CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and unused medicines in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Risperidona Codramol

The active ingredient is risperidone.

Each milliliter of Risperidona Codramol oral solution contains 1 mg of risperidone.

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

Appearance of Risperidona Codramol and package contents

The Risperidona Codramol oral solution is transparent and slightly yellowish.

The oral solution is marketed in 30 ml or 100 ml bottles.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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

O

Medinfar Manufacturing, S.A.

Parque Industrial Armando Martins Tavares

Rua Outeiro Da Armada, 5

Condeixa-a-Nova, 3150-194, Sebal

Portugal

Date of the last revision of this leaflet: March 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/