Leaflet: information for the user

Risperidona Codramol 1 mg/ml oral solution EFG

risperidona

Read this leaflet carefully before you start taking this medicine, as 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 others, 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 Risperidona Codramol and what it is used for

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

3. How to take Risperidona Codramol

4. Possible side effects

5. Storage of Risperidona Codramol

6. Contents of the pack and additional information

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

Risperidona 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 individuals with Alzheimer's disease, who harm themselves or others. Alternative non-pharmacological treatments must have been tried previously.

??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

Risperidona Codramol may help reduce the symptoms of your illness and prevent them from returning.

Do not take Risperidona Codramol if:

???????You are allergic to risperidona or to any of the other components of this medication (including those listed in section 6).

If you are unsure, 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 heart rhythm disturbances, or if you are prone to having low blood pressure or if you use medications for high blood pressure. Risperidona 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 heart attack, such as high blood pressure, cardiovascular diseases, or problems with 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 level of consciousness (also known as Malignant Neuroleptic Syndrome)
• You have Parkinson's disease or dementia
• If you have had low white blood cell counts in the past (which may or may not have been caused by other medications)
• You are diabetic
• You have epilepsy
• Are male and have ever had a prolonged or painful erection. If you experience this while taking Risperidona, 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

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

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

Risperdal may cause you to gain weight. Significant weight gain may negatively affect your health. 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 frequently increases levels of a hormone called prolactin. This may cause adverse effects such as menstrual disorders or fertility problems in women or breast swelling in men (see Possible Adverse Effects). If these adverse effects appear, it is recommended that blood prolactin levels be evaluated.

During cataract surgery in the eye, the pupil (the black circle in the middle of the eye) may not dilate as needed. Additionally, the iris (the colored part of the eye) may become flaccid during surgery and this may cause eye damage. If you are planning eye surgery, be sure to inform your ophthalmologist that you are taking this medication.

Patients with advanced age and dementia

In patients with advanced age and dementia, there is an increased risk of having a stroke. Do not take risperidona 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 if you speak confusedly, even for a short time, seek medical treatment immediately. This 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 risperidona you experience fatigue, changing the administration times may improve your difficulties with attention.

Before starting treatment, your weight or that of your child may be measured, and this should be regularly monitored during treatment.

A small, inconclusive study has reported an increase in the height of children taking risperidona, but it is unknown whether this is a side effect of the medication or due to another reason.

Other medications and Risperidona Codramol

Inform your doctor or pharmacist if you are using or have recently used other medications, 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:

• Medications that act on your brain, such as those used to calm you down (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 may lower blood pressure
• Medications for Parkinson's disease (such as levodopa)
• Medications that increase the activity of the central nervous system (psychoestimulants, such as methylphenidate)Diuretics, used for heart problems or to treat swelling in some parts of the body due to fluid retention (such as furosemide or chlorothiazide). Risperidona, 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)
• Itraconazole and ketoconazole (medications used to treat fungal infections)
• Some medications used to treat HIV/AIDS, such as ritonavir
• Verapamil, a medication used to treat high blood pressure and/or abnormal heart rhythm
• Sertraline and fluvoxamine, medications used to treat depression and other psychiatric disorders.

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

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

Use of Risperidona Codramol with food, drinks, and alcohol

You can take this medication 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 if you can take it
• Newborns of mothers who have used Risperidona Codramol in the last trimester of pregnancy may experience the following symptoms: tremors, muscle stiffness, weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If your newborn experiences any of these symptoms, contact your doctor.

Risperidona codramol may increase levels of a hormone called "prolactin" that may affect fertility (see Possible Adverse Effects).

Driving and operating machinery

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

Important information about some components of Risperidona Codramol 1 mg/ml oral solutionThis medication contains less than 23 mg of sodium (1 mmol) per ml; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as 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 find relief 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

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 Risperidone 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 depending on your response to treatment

Most people find relief with daily doses of 1 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, depending on your response to treatment

Children and adolescents

Children and adolescents under 18 years old should not receive treatment with Risperidone 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 depending on your response to treatment

Most people find relief 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

Use in children and adolescents

Children and adolescents under 18 years old should not receive treatment with Risperidone for schizophrenia or mania

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 may 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 may 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 risperidone 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 to half. Dose increases should be made more slowly in these patients.

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

Administration form

ORAL ROUTE

Instructions for opening the bottle and using the dosing syringe:

100 and 30 ml bottles:

The solution comes with a syringe. Use only the syringe provided with this medication to measure the dose prescribed by your doctor. Measure the exact dose of medication you need. Be careful when 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 at the same time against the direction of the clock (Figure 1)
2. Insert the syringe into the bottle
3. Holding the lower ring, pull the upper ring down to the mark corresponding to the number of milliliters or mg you should administer (Figure 2)
4. Holding the lower ring, pull the syringe out of the bottle (Figure 3)
5. Empty the syringe into a non-alcoholic drink that is not tea. Slide the upper ring down
6. Close the bottle
7. Wash the syringe with water and let it air dry.

If you take more Risperidone Codramol 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.

??You may feel drowsy or tired, experience abnormal body movements, have trouble staying upright and walking, feel dizzy due to decreased blood pressure, or have irregular heartbeats or convulsions.

If you forget to take Risperidone Codramol

??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 Risperidone Codramol

You should 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, this medicine can cause side effects, although not everyone will experience themInform your doctor immediately if you experience any of the following rare side 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 in the face, arms, or legs, especially on one side, or difficulty speaking, even for a short period of time. These may be signs of a stroke

even during a short period of time

• You experience tardive dyskinesia (involuntary spasms or 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. You may need to stop taking

Risperdal

Inform your doctor immediately if you experience any of the following rare side 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 may travel 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 level of consciousness (a condition known as "Neuroleptic Malignant Syndrome"). You may need immediate medical treatment

consciousness

• You are a man and experience a prolonged or painful erection. This is known as priapism. 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 a drop in blood pressure. Other possible side effects include:

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

??Parkinsonism. This disease may include slow or altered movement, a feeling of stiffness or tension in the muscles (making sudden movements) and sometimes a feeling of "freezing" of movement that is later reinitiated. Other signs of parkinsonism include walking slowly with a dragging gait, tremors at rest, increased saliva and/or drooling, and loss of facial expression.

??Headache, difficulty staying or falling asleep.

??Feeling drowsy or less alert

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

?Pneumonia, chest infection (bronchitis), common cold symptoms, sinusitis, urinary tract infection, ear infection, feeling like you have the flu

?Weight gain, increased appetite, decreased appetite

?Sleep disturbances, irritability, depression, anxiety, restlessness

?Dystonia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dystonia often affects the facial muscles, 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

?Tremor (agitation)

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

?Fast heart rate, increased blood pressure, labored breathing

?Throat pain, 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

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

?Falls

Rare side effects (may affect up to 1 in 100 people):

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

?Decreased white blood cell count, decreased white blood cell count, decreased platelet count, anemia, decreased red blood cell count, increased eosinophil count in the blood

?Allergic reaction

?Diabetes or worsening of diabetes, high blood sugar, 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 crises), fainting

?Anxiety that causes movement of parts of the body, balance disorder, abnormal coordination, dizziness when standing up, attention disorder, speech problems, loss or alteration of taste, decreased skin sensitivity to pain or touch, feeling of pins and needles, numbness, or tingling of the skin

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

?Sensation 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, abnormal heart activity, prolonged QT interval in the heart, slow heart rate, abnormal heart conduction (electrocardiogram or ECG), sensation 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 standing up or sitting down, flushing

?Pneumonia caused by aspiration of food, pulmonary congestion, respiratory tract congestion, crepitant sounds of the lungs, wheezing, voice disorder, difficulty breathing

?Gastrointestinal infection, fecal incontinence, very hard stools, difficulty swallowing, excessive gas or flatulence

?Hives (urticaria), itching, hair loss, skin thickening, eczema, dry skin, skin discoloration, acne, scaly skin or scalp with itching, skin disorder, skin injury

?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 menstrual cycle problems (women)

?Male breast development, milk secretion by the breasts, sexual dysfunction, breast pain, breast discomfort, vaginal discharge

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

?Chills, increased body temperature

?Change in gait

?Sensation of thirst, feeling unwell, chest discomfort, feeling "off," feeling unwell

?Increased liver enzymes 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 side effects (may affect up to 1 in 1,000 people):

?Infection

?Incorrect secretion of a hormone that controls urine volume

?Somnambulism

?Sleep-related eating disorder

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

?Lack of emotions, inability to achieve orgasm

?Lack of movement or response while awake (catatonia)

?Problems with blood vessels in the brain

?Diabetic coma due to uncontrolled diabetes

?Head agitation

?Glaucoma (increased pressure in the eyeball), eye movement problems, eye rotation, crusts on the edge of the eyelid

?Eye problems during cataract surgery. During cataract surgery, there may be an alteration called intraoperative floppy iris syndrome (IFIS) 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 medication

?Very low count of a type of white blood cell necessary to fight infections in the blood

?Excessive water intake

?Irregular heartbeat

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

?Pancreatitis, intestinal obstruction

?Swelling of the tongue, cracked lips, skin rash related to the medication

?Dandruff

?Muscle fiber rupture and muscle pain (rhabdomyolysis)

?Delayed menstrual periods, breast enlargement, breast secretion

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

?Skin hardening

?Decreased body temperature, coldness in arms and legs

?Medication withdrawal syndrome

?Yellow skin and eyes (jaundice).

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

?Complications of uncontrolled diabetes, life-threatening

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

?Lack of movement of the intestinal muscles, causing obstruction

The following side effect has appeared with the use of another medication called paliperidone, which is very similar to risperidone, so it is also expected to appear with Risperdal: Fast heart rate when standing up

Other side effects in children and adolescents

In general, it is expected that side effects in children will be similar to those that appeared in adults. The following side 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, common cold symptoms, nasal congestion, abdominal pain, dizziness, cough, fever, tremors, diarrhea, and urinary incontinence

Reporting side effects

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

Do not store at a temperature above 86 °F (30 °C).

Do not store at a temperature below 59 °F (15 ºC).

Do not freeze.

Keep in the original packaging.

Keep out of the reach and sight of children.

Do not use 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 3 months.

Medicines should not be disposed of through drains or in the trash. Dispose of containers and unused

medicines that you no longer need at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. By doing so, you will help protect the environment...

Composition of Risperidona Codramol

The active ingredient is risperidone.

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

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

Appearance of Risperidona Codramol and contents of the packaging

Risperidona Codramol oral solution is transparent and slightly yellowish.

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

Holder of the Marketing Authorization and Responsible for Manufacturing

Holder of the marketing authorization

Farmalider, S.A.

Aragoneses, 15

28108 Alcobendas (Madrid)

Responsible for manufacturing

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

Last review date of this leaflet: March 2025

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