PATIENT INFORMATION LEAFLET

RisperidoneFarmalid1 mg/ml oral solution EFG

Read this leaflet carefully before you start taking the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If you think you have suffered a side effect, you can help us by reporting it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

1. What Risperidone Farmalid is and what it is 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

Risperidona Farmalid 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 condition called “bipolar disorder”

??Short-term (up to 6 weeks) treatment of persistent aggression in individuals with Alzheimer's disease type dementia, who harm themselves or others. Alternative non-pharmacological treatments must have been tried previously.

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

.

Do not take RisperidonaFarmalidif:

You are allergic (hypersensitive) to the active ingredient or any of the components of Risperidona Farmalid (listed in section 6 below).

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

Be especially careful with Risperidona Farmalid

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 low blood pressure or if you are taking blood pressure medications. Risperidona may lower your blood pressure. You may need to adjust your dose.
• 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 Parkinson's disease or dementia
• You are diabetic
• You have epilepsy
• You are a male and have had a prolonged or painful erection at any time. 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

Seek immediate medical attention if you have:

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

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

Risperidona may cause you to gain weight.

Patients with advanced age and dementia

In patients with advanced age and dementia, there is an increased risk of having a heart attack. Do not take risperidona if you have dementia caused by a heart attack.

You should see your doctor frequently during treatment with Risperidona.

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

Children and adolescents

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

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

Use of other medications

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 speak with your doctor or pharmacist if you take any of the following products:

• Medications that affect your brain, such as those used to calm 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 (e.g., some diuretics)
• Medications for high blood pressure. Risperidona may lower blood pressure
• Medications for Parkinson's disease (such as levodopa)
• 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 certain 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 (e.g., used to treat psychosis or as sedatives)
• Cimetidine, ranitidine (stomach acid blockers)

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

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

Taking Risperidona Farmalid with food and drinks

You can take this medication with or without food. Avoid consuming alcohol while taking Risperidona.

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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 Farmalid 1 mg/ml oral solution

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

How much to take

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 based on your response to treatment

??Most people find they do 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 tell you what is best for you

Older adults

??The initial dose will usually be 0.5 mg, twice a day

??Your doctor will later increase your dose gradually to 1 mg - 2 mg, twice a day

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

Children and adolescents

??Children and adolescents under 18 years old should not receive treatment with Risperidona for schizophrenia

For the treatment of mania

Adults

??The initial dose will usually be 2 mg, once a day

??Your doctor may later adjust your dose gradually based on your response to treatment

??Most people find they do better with daily doses of 1 to 6 mg

Older adults

??The initial dose will usually be 0.5 mg, twice a day

??Your doctor may later adjust your dose gradually to 1 mg - 2 mg, twice a day based on your response to treatment

Children and adolescents

??Children and adolescents under 18 years old should not receive treatment with Risperidona for mania bipolar

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

Adults (including older adults)

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

??Your doctor may later change your dose gradually based on your response to treatment

??Most people find they do 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 type dementia 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 usually 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 usual maintenance dose is 0.25 mg to 0.75 mg, once a day

If they weigh 50 kg or more:

??The initial dose will usually 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 usual 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 risperidona 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 risperidona should be reduced by half. Dose increases should be made more slowly in these patients.

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

How to take Risperidona Farmalid

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

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

Risperidona Farmalid oral solution:

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

Follow these steps:

1. Remove the child-resistant cap. Push the plastic cap down, turning it at the same time against the direction of the clock (Figure 1)
2. Insert the syringe into the bottle
3. Hold the lower ring and pull the upper ring down to the mark corresponding to the number of milliliters or mg you should administer (Figure 2)
4. Hold the lower ring and 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 Risperidona Farmalid than you should

??Go to your doctor immediately. Bring the medicine packaging with you. You can also call the Toxicological 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, have trouble standing and walking, feel dizzy due to decreased blood pressure, or have abnormal heartbeats or convulsions.

If you forget to take Risperidona Farmalid

??If you forget to take a dose, take it as soon as you remember. But if it is 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 compensate for the missed doses.

If you interrupt treatment with Risperidona Farmalid

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 medications, Risperidone may cause side effects, although not everyone will experience them.

Very common: affects more than 1 in 10 people

Common: affects between 1 and 10 in 100 people

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

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

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

Unknown: the frequency cannot be estimated from available data

The following side effects may occur:

Very common (affects more than 1 in 10 people)

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

??Headache, difficulty staying or remaining asleep.

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

??Drowsiness, fatigue, tiredness, inability to remain calm, 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

??Difficulty breathing, pneumonia, flu, respiratory tract infection, blurred vision, nasal congestion, nasal bleeding, cough

??Urinary tract infection, bedwetting

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

??Rash, skin redness

??Fast heart rate, chest pain

??Increased concentration of prolactin hormone in the blood

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

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

??Pneumonia caused by aspiration into the respiratory tract, urinary tract infection, eye redness, sinusitis, viral infection, ear infection, tonsillitis, skin infection, eye infection, stomach infection, ocular secretion, fungal nail infection,

??Abnormal heart conduction, decreased blood pressure upon standing, decreased blood pressure, sensation of dizziness when changing position, abnormal heart activity (ECG), abnormal heart rhythm, feeling of heartbeats, fast or slow heart rate

??Urinary incontinence, painful urination, frequent urination

??Confusion, attention disorder, decreased level of consciousness, excessive sleep, nervousness, manic state, lack of energy and interest

??Increased blood glucose, increased liver enzymes, decreased white blood cell count, decreased hemoglobin or red blood cell count (anemia), increased eosinophil count (special white blood cells), increased creatine phosphokinase, decreased platelet count (blood cells that help stop bleeding)

??Muscle weakness, muscle pain, ear pain, neck pain, joint swelling, abnormal posture, joint stiffness, chest muscle and bone pain, chest discomfort

??Skin lesion, skin disorder, dry skin, intense itching, acne, hair loss

??Inflammation of the skin by mites, skin discoloration, skin thickening, blushing, reduced skin sensitivity to pain or touch, oily skin inflammation

??Menstrual absence, sexual dysfunction, erectile dysfunction, ejaculation disorder, breast secretion,male breast enlargement, decreased sexual desire, irregular menstruation, vaginal secretion

??Loss of consciousness, gait disorder, inactivity, reduced appetite with malnutrition and weight loss, feeling of“discomfort”, balance disorder, allergy, edema, speech disorder, chills, coordination anomaly

??Light sensitivity, increased blood flow to the eye, eye swelling, dry eyes, increased tear production

??Respiratory tract disorder, pulmonary congestion, lung crepitus, respiratory tract congestion, speech difficulty, swallowing difficulty, cough with sputum, hoarse or hissing sound while breathing, pseudogripal disease, sinusitis

??Lack of response to stimuli, loss of consciousness, sudden swelling of lips and eyes with difficulty breathing, sudden weakness or numbness of face, arms, or legs, especially on one side, or cases of confused speech lasting less than 24 hours (mini-stroke or cerebral attack), involuntary movements of the face, arms, or legs, tinnitus, facial edema.

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

??Inability to achieve orgasm, menstrual disorder

??Dandruff

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

??Glaucoma, decreased visual acuity, corneal crust formation, eye movement

??Lack of emotions.

??Consciousness alteration with increased body temperature and muscle spasms, body edema, medication withdrawal syndrome, decreased body temperature

??Shallow and rapid 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

??Diabetes coma due to uncontrolled diabetes

??Yellow skin and eyes (jaundice)

??Pancreatitis inflammation.

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

??Life-threatening complications of uncontrolled diabetes

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

??Severe allergic reaction leading to respiratory difficulty and shock

??Granulocyte absence (a type of white blood cell that helps fight infections)

??Prolonged and painful erection

??Excessive water intake

??Clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), these clots can move through the blood vessels to the lungs, causing chest pain and difficulty breathing.

Risperidone long-acting injectable

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

??Intestinal infection

??Subcutaneous abscess, skin tingling, skin pinching, or numbness, skin inflammation

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

??Depression

??Seizures

??Eye blinking

??Sensation of rotation or oscillation

??Slow heart rate, increased blood pressure

??Toothache, tongue spasm

??Buttock pain

??Weight loss.

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Do not store above 86 °F (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 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. Deposit the containers and unused

medicines at the SIGRE collection 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 Farmalid

The active ingredient is risperidone.

Each milliliter of oral solution of Risperidona Farmalid 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 Farmalid and packaging contents

The oral solution of Risperidona Farmalid 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

This leaflet was revised in 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/