Ficha técnica de Risperidona alter 1 mg comprimidos recubiertos con pelicula efg – Espanha

Como usar Risperidona alter 1 mg comprimidos recubiertos con pelicula efg

Introduction

Leaflet: information for the user

Risperidone Alter 1 mg film-coated tablets

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 and should not be given to others, even if they have the same symptoms, as it may harm them.
If you consider that any of the side effects you experience are serious or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

1. What Risperidone Alter 1 mg is and for what it is used

2. Before taking Risperidone Alter 1 mg

3. How to take Risperidone Alter 1 mg

4. Possible side effects

5. Storage of Risperidone Alter 1 mg

6. Additional information

1. What is RISPERIDONA ALTER 1 mg and what is it used for

Risperidona Alter belongs to a group of medicines called “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 people with Alzheimer's disease dementia, who harm themselves or others. They must have tried alternative non-pharmacological treatments 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 ALTER 1 mg

Do not take Risperidona Alter if:

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

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

Be especially careful with Risperidona Alter

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.
If you or a family member has a history of blood clots, these medications may be associated with their formation
If you know of any factor that may make you prone to having a stroke, such as high blood pressure, cardiovascular disease, 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

Consult your doctor immediately if you have:

Uncontrollable, involuntary 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 whether the information above affects you, consult your doctor or pharmacist before using Risperidona Alter.

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 stroke. Do not take risperidona if you have dementia caused by a stroke.

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 appearance 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 talk to your doctor or pharmacist if you take any of the following products:

Medications that act on 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 (for example: some diuretics)
Medications for high blood pressure. Risperidona may lower your 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 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 (stomach acid blockers)

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

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

Taking Risperidona Alter 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 in the last trimester of pregnancy may experience the following symptoms: trembling, muscle stiffness, and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If your newborn experiences any of the following 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 Alter 1 mg tablets

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to Take Risperidone Alter 1 mg

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 how you respond to treatment
Most people find relief with daily doses of 4 to 6 mg
This total daily dose may 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 Risperidona 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 based 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 based on your response to treatment

Children and adolescents

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

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

Adults (including older adults)

The initial dose will be 0.25 mg, taken twice a day, usually
Your doctor may later change your dose gradually based 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

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, 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 they weigh 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 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 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 Risperidona Alter

Take Risperidona Alter 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 to 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 Alter coated tablets

You should swallow the medicine with a glass of water

If you take more Risperidona Alter than you should

Go to your doctor immediately. Bring the medicine packaging 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, have difficulty standing and walking, feel dizzy due to decreased blood pressure, or have abnormal heartbeats or convulsions

If you forget to take Risperidona Alter

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 Risperidona Alter

Do 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

4. Possible Adverse Effects

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

Very common:affect more than 1 in 10 people

Common:affect between 1 in 100 and 1 in 10 people

Uncommon:affect between 1 in 1000 and 1 in 100 people

Rare:affect between 1 in 10,000 and 1 in 1000 people

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

Unknown:the frequency cannot be estimated from available data

The following side effects may occur:

Very common (affect 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 (affect between 1 in 100 and 1 in 10 people):

Drowsiness, fatigue, tiredness, inability to remain calm, irritability, anxiety, drowsiness, 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
Respiratory difficulty, pneumonia, flu, respiratory tract infection, blurred vision, nasal congestion, nasal bleeding, cough
Urinary tract infection, bedwetting
Muscle cramps, involuntary facial or arm and leg movements, joint pain, back pain, swelling of arms and legs, arm and leg pain
Rash, skin redness
Fast heart rate, chest pain
Increased prolactin concentration in the blood.

Uncommon (affect between 1 in 1000 and 1 in 100 people):

Excessive water consumption, fecal incontinence, thirst, hard stools, hoarseness or voice disorder
Pneumonia caused by food passing through 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 when standing, decreased blood pressure, feeling of dizziness when changing position, abnormal heart activity (ECG), abnormal heart rhythm, feeling 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, skin inflammation by mites, skin discoloration, skin thickening, flushing, reduced skin sensitivity to pain or touch, oily skin inflammation
Menstrual absence, sexual dysfunction, erectile dysfunction, ejaculation disorder, breast secretion, breast enlargement in males, decreased sexual desire, irregular menstruation, vaginal secretion
Loss of consciousness, gait disorder, inactivity, reduced appetite with malnutrition and weight loss, feeling unwell, balance disorder, allergy, edema, speech disorder, chills, coordination disorder
Light sensitivity, increased blood flow to the eye, eye swelling, dry eyes, increased tear production
Respiratory tract disorder, pulmonary congestion, lung crepitant sounds, respiratory tract congestion, speech difficulty, difficulty swallowing, cough with sputum, hoarse or hissing sound while breathing, pseudogripal disease, sinusitis
Loss of response to stimuli, loss of consciousness, sudden swelling of lips and eyes with respiratory difficulty, 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 facial, arm, or leg movements, tinnitus, facial edema.

Rare (affect between 1 in 10,000 and 1 in 1000 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-wide 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 eye color (jaundice)
Pancreatitis inflammation.

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

Life-threatening complications of uncontrolled diabetes

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

Severe allergic reaction leading to respiratory difficulty and shock
Absence of granulocytes (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. If you experience any of these symptoms, seek medical attention immediately.

Risperidone long-acting injectable

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

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
Gluteal 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.

5. Conservation of RISPERIDONA ALTER 1 mg

Do not store at a temperature above 30 °C.

Keep out of 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.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection point(or any other medication waste collection system) at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment

6. ADDITIONAL INFORMATION

Composition of Risperidona Alter

The active ingredient is risperidone.

Each film-coated tablet of Risperidona Alter contains 1 mg of risperidone.

The other components are:

Tablet core:

Lactose monohydrate, maize pregelatinized starch, microcrystalline cellulose, hydroxypropylmethylcellulose, sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate.

Coating:

Hydroxypropylmethylcellulose, titanium dioxide, and triacetin

Appearance of Risperidona Alter and contents of the package

The 1 mg risperidone film-coated tablets are round, white, biconvex, scored on one side. The score serves to divide into equal doses.

They are marketed in packages of 20 or 60 tablets.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

This leaflet was revised in September 2012

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

Quanto custa o Risperidona alter 1 mg comprimidos recubiertos con pelicula efg em Espanha em 2025?

O preço médio do Risperidona alter 1 mg comprimidos recubiertos con pelicula efg em julho de 2025 é de cerca de 2.73 EUR. Os valores podem variar consoante a região, a farmácia e a necessidade de receita. Confirme sempre com uma farmácia local ou fonte online para obter informações atualizadas.