RISPERIDONE FARMALID 1 mg/ml ORAL SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

RisperidoneFarmalid1 mg/ml oral solution EFG

Read all of this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any of the side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Contents of the pack:

1. What is Risperidone Farmalid and what is it used for
2. Before taking Risperidone Farmalid
3. How to take Risperidone Farmalid
4. Possible side effects
5. Storage of Risperidone Farmalid
6. Further information

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

Risperidone Farmalid belongs to a group of medicines called "antipsychotics".

Risperidone is used to treat the following:

??Schizophrenia, where 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, 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, who may harm themselves or others. Other alternative treatments (non-pharmacological) should have been tried previously.

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

.

2. Before taking Risperidone Farmalid

Do not take RisperidoneFarmalidif:

??You are allergic (hypersensitive) to the active substance or any of the other ingredients of Risperidone Farmalid (listed in section 6 below).

If you are not sure, consult your doctor or pharmacist before taking Risperidone Farmalid.

Be careful with Risperidone Farmalid

Consult your doctor or pharmacist before taking Risperidone if:

• You have any heart problems. Examples include heart rhythm disturbances, or if you are prone to low blood pressure or if you are taking blood pressure medications. 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 disease, or problems with the blood vessels in the brain
• You have Parkinson's disease or dementia
• 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 blood clots

Consult your doctor immediately if you have:

• Involuntary rhythmic movements of the tongue, mouth, or face. It may be necessary to discontinue Risperidone
• Fever, severe muscle stiffness, sweating, or a low level of consciousness (a disease called "neuroleptic malignant syndrome"). You may need immediate medical treatment

If you are unsure about any of the above, consult your doctor or pharmacist before taking Risperidone Farmalid.

Risperidone may cause you to gain weight.

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 Risperidone, 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 your 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 you experience fatigue while taking risperidone, changing the administration times may improve your attention difficulties.

Use of other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any 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 products:

• 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 medicines 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)
• 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 for treating 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 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)

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 taking Risperidone Farmalid.

Taking Risperidone Farmalid with food and drinks

You can take this medicine with or without food. You should avoid consuming alcohol while taking Risperidone.

Pregnancy and breastfeeding

• Consult your doctor before taking Risperidone 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 Risperidone Farmalid in the last trimester of pregnancy may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding problems. If your newborn experiences any of these symptoms, contact your doctor.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

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

Important information about some of the ingredients of Risperidone Farmalid 1 mg/ml oral solution

Patients on low-sodium diets should note that this medicine contains 11.14 mg (0.48 mmol) of sodium per ml.

3. How to take Risperidone Farmalid

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 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 old 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.

??Later, your doctor may gradually adjust your dose 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.

??Later, your doctor may gradually adjust your dose to 1 mg - 2 mg, 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 elderly patients)

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

??Later, your doctor may gradually adjust your dose 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 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 they weigh less than 50 kg:

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

??The dose can be increased, every other day, 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 can be increased, every other day, 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 old 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.

How to take Risperidone Farmalid

Always take Risperidone Farmalid exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how much medicine to take and for how long. This will depend on your disease and may vary from person to person. The amount of medicine you should take is explained above in the "How much to take" section.

Risperidone Farmalid oral solution:

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 entire syringe from 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. Rinse the syringe with water and let it air dry.

If you take more Risperidone Farmalid 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 Risperidone Farmalid

??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 the same time) to make up for the missed doses.

If you stop taking Risperidone Farmalid

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, Risperidone can cause adverse effects, although not all people suffer from them.

Very frequent: affects more than 1 in 10 people

Frequent: affects between 1 and 10 in 100 people

Uncommon: affects between 1 and 10 in 1000 people

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

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

Unknown: frequency cannot be estimated from available data

The following side effects may appear:

Very frequent (affects more than 1 in 10 people)

??Parkinsonism. It is a medical term that includes several symptoms. Each individual symptom may occur with less frequency than 1 in 10 people. Parkinsonism includes: increased saliva secretion or very moist mouth, musculoskeletal stiffness, drooling, pain when bending limbs, slower, reduced, or difficult body movements, lack of facial expression, muscle tension, torticollis, muscle stiffness, short and rapid steps when walking, dragging feet, and absence of normal arm movements, persistent blinking in response to forehead tapping (an abnormal reflex).

??Headache, difficulty staying or falling asleep.

Frequent (affects between 1 and 10 in 100 people):

??Drowsiness, fatigue, tiredness, inability to stay still, irritability, anxiety,

??Somnolence, dizziness, attention problems, feeling of exhaustion, sleep disturbance

??Vomiting, diarrhea, constipation, nausea, increased appetite, abdominal pain or discomfort, sore throat, dry mouth

??Weight gain, increased body temperature, decreased appetite

??Breathing difficulties, lung infection (pneumonia), flu, respiratory tract infection, blurred vision, nasal congestion, nasal bleeding, cough

??Urinary tract infection, bedwetting

??Muscle cramps, involuntary movements of the face or arms and legs, joint pain, back pain, swelling of arms and legs, pain in arms and legs

??Rash, skin redness

??Rapid heartbeat, chest pain

??Increased prolactin hormone levels in the blood

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

??Excessive water consumption, fecal incontinence, thirst, very hard stools, hoarseness or voice disorder

??Lung infection caused by food passing into the airways, bladder infection, eye redness, sinusitis, viral infection, ear infection, tonsil infection, skin infection, eye infection, stomach infection, eye discharge, fungal nail infection,

??Abnormal heart electrical conduction, low blood pressure when standing up, decreased blood pressure, dizziness when changing position, abnormal heart electrical activity (ECG), irregular heartbeat, feeling heartbeats, rapid or slow heartbeat

??Urinary incontinence, pain when urinating, frequent urination

??Confusion, attention disorder, low level of consciousness, excessive sleepiness, nervousness, elevated mood (mania), 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 injury, skin disorder, skin dryness, intense itching, acne, hair loss

inflammation of the skin due to mites, skin discoloration, skin thickening, flushing, reduced skin sensitivity to pain or touch, fatty skin inflammation

??Absence of menstruation, sexual dysfunction, erectile dysfunction, ejaculation disorder, breast secretion, breast enlargement in males, decreased sexual desire, irregular menstruation, vaginal discharge

??Fainting, gait disorder, inactivity, reduced appetite with malnutrition and weight loss, feeling of "indisposition", balance disorder, allergy, edema, speech disorder, chills, coordination disorder

??Painful sensitivity to light, increased blood flow to the eye, eye swelling, eye dryness, increased tearing

??Respiratory tract disorder, lung congestion, lung crackling sounds, respiratory tract congestion, speech problems, difficulty swallowing, cough with sputum, wheezing or whistling sound when breathing, pseudocroup, sinusitis

??Unresponsiveness, loss of consciousness, sudden swelling of lips and eyes with breathing difficulties, sudden weakness or numbness of face, arms, or legs, especially on one side, or cases of confused speech lasting less than 24 hours (called mini-stroke or stroke), involuntary movements of face, arms, or legs, ringing in the ears, facial edema.

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

??Inability to reach orgasm, menstrual disorder

??Dandruff

??Drug allergy, coldness in arms and legs, lip swelling, lip inflammation

??Glaucoma, decreased visual acuity, crust formation on the eyelid margin, eye movement

??Absence of emotions.

??Altered consciousness with increased body temperature and muscle spasms, whole-body edema, drug withdrawal syndrome, decreased body temperature

??Rapid and shallow breathing, respiratory problems during sleep, chronic middle ear infection

??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

??Diabetic coma

??Yellowing of the skin and eyes (jaundice)

??Pancreatitis.

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

??Complications of uncontrolled diabetes, life-threatening

Unknown frequency of adverse effects (frequency cannot be estimated from available data)

??Severe allergic reaction leading to breathing difficulties and shock

??Absence of granulocytes (a type of white blood cell that helps fight infections)

??Prolonged and painful erection

??Excessive water intake

??Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), these clots can move through the bloodstream to the lungs, causing chest pain and breathing difficulties.

Risperidone Long-Acting Injectable

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

??Intestinal infection

??Abscess under the skin, tingling, pinching, or numbness of the skin, skin inflammation

??Decreased white blood cell count, cells that help protect against bacterial infections

??Depression

??Seizures

??Eye twitching

??Feeling of spinning or swaying

??Slow heartbeat, increased blood pressure

??Toothache, tongue spasm

??Buttock pain

??Weight loss.

If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

5. Conservation of Risperidone Farmalid

Do not store at a temperature above 30 °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 indicated month.

Once the bottle is opened, any unused portion should 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 unused medicines. This will help protect the environment.

6. Additional Information

Composition of Risperidone Farmalid

The active ingredient is risperidone.

Each milliliter of Risperidone Farmalid 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 Risperidone Farmalid and packaging content

The Risperidone Farmalid oral solution is transparent and slightly yellowish.

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

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

This prospectus was revised in 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/