Risperidone Qualigen 6 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Risperidona Qualigen 6 mg Film-coated Tablets EFG

Risperidone

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Leaflet Contents:

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

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

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

Risperidona Qualigen is used to treat the following:

• Schizophrenia, a condition in which you may see, hear, or feel things that are not there, believe things that are not true, or feel particularly suspicious or confused.
• Mania, a condition in which you may feel overly excited, elated, agitated, enthusiastic, or hyperactive.

Mania occurs in a disorder called "bipolar disorder".

• Short-term treatment (up to 6 weeks) of persistent aggression in patients with Alzheimer-type dementia who are harming themselves or others. Alternative non-pharmacological treatments should have been attempted previously.
• Short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children (aged at least 5 years) and adolescents with conduct disorders.

2. What you need to know before taking Risperidona Qualigen

Do not take Risperidona Qualigen:

• If you are allergic to risperidone or to any of the other components of this medicine (listed in section 6).

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

Warnings and Precautions

Talk to your doctor or pharmacist before starting Risperidona Qualigen.

• If you have any heart problems. Examples include irregular heartbeat, or if you are prone to low blood pressure, or if you are taking medicines for blood pressure. Risperidona Qualigen may lower blood pressure. You may need your dose adjusted.
• You are aware of any factor that may make you prone to stroke, such as high blood pressure, cardiovascular disease, or blood vessel problems in the brain.
• You have Parkinson's disease or dementia.
• You are diabetic.
• You have epilepsy.
• You are male and have ever experienced a prolonged or painful erection. If this occurs while taking Risperidona Qualigen, 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 abnormally high levels of prolactin hormone in your blood, or if you have a tumor that may be prolactin-dependent.
• You or a family member have a history of blood clots, as these medicines may be associated with blood clot formation.

Contact your doctor immediately if you experience:

• Involuntary rhythmic movements of the tongue, mouth, or face. It may be necessary to discontinue Risperidona Qualigen.
• Fever, severe muscle stiffness, sweating, or decreased level of consciousness (a condition called "neuroleptic malignant syndrome"). You may need immediate medical treatment. If you are unsure whether the above applies to you, consult your doctor or pharmacist before using Risperidona Qualigen.

Risperidona Qualigen may cause weight gain.

Elderly patients with dementia

In elderly patients with dementia, there is an increased risk of stroke. You should not take risperidone if your dementia is caused by a stroke.

During treatment with Risperidona Qualigen, you should see your doctor regularly.

If you or your caregiver notice a sudden change in your mental state or sudden onset of weakness or numbness in the face, arms, or legs—especially on one side—or slurred speech, even if brief, seek immediate medical attention. These may be signs of a stroke.

Children and adolescents

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

If you experience fatigue during treatment with risperidone, changing the time of administration may improve difficulties with attention.

Taking Risperidona Qualigen with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

It is especially important to 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 (benzodiazepines), or certain pain medicines (opioids), or allergy medicines (some antihistamines), as risperidone may increase their sedative effect.
• Medicines that can alter the electrical activity of your heart, such as those used for malaria, heart rhythm disorders (e.g., quinidine), allergies (antihistamines), some antidepressants, or other medicines for mental disorders.
• Medicines that cause a slow heartbeat.
• Medicines that cause low potassium levels in the blood (e.g., certain diuretics).
• Medicines for high blood pressure. Risperidona Qualigen may lower blood pressure.
• Medicines for Parkinson's disease (e.g., levodopa).
• Diuretics used for heart problems or to treat swelling in parts of the body due to fluid retention (e.g., furosemide or chlorothiazide). Risperidona Qualigen, taken alone or with furosemide, may increase the risk of stroke or death in elderly patients with dementia.

The following medicines may reduce the effect of risperidone:

• Rifampicin (a medicine used to treat certain 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 heart conditions)
• 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 whether the above applies to you, consult your doctor or pharmacist before using Risperidona Qualigen.

Taking Risperidona Qualigen with food, drinks, and alcohol

You may take this medicine with or without food. You should avoid consuming alcohol while taking Risperidona Qualigen.

Pregnancy and breastfeeding

• If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
• Newborns whose mothers have used Risperidona Qualigen during the last trimester of pregnancy may experience symptoms such as tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your newborn shows any of these symptoms, contact your doctor.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Risperidona Qualigen may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce reaction time. These effects, as well as the underlying illness itself, may impair your ability to drive or operate machinery. Therefore, do not drive or operate machinery, or engage in any activity requiring special alertness, until your doctor has assessed your response to this medicine.

Risperidona Qualigen contains lactose and sodium

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him or her before taking this medicine.

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

3. How to take Risperidone Qualigen

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

How much to take

For the treatment of schizophrenia

Adults

• The initial dose is 2 mg per day; this 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 improve 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.

Elderly patients

• The initial dose is normally 0.5 mg twice daily.
• Later, your doctor may gradually increase your dose to 1–2 mg twice daily.
• Your doctor will tell you what is best for you.

Children and adolescents

• Children and adolescents under 18 years of age should not be treated with Risperidone Qualigen for schizophrenia.

For the treatment of mania

Adults

• The initial dose is normally 2 mg once daily.
• Your doctor may gradually adjust your dose depending on your response to treatment.
• Most people improve with daily doses of 1 to 6 mg.

Elderly patients

• The initial dose is normally 0.5 mg twice daily.
• Later, your doctor may gradually adjust your dose to 1–2 mg twice daily depending on your response to treatment.

Children and adolescents

• Children and adolescents under 18 years of age should not be treated with Risperidone Qualigen for bipolar mania.

For the long-term treatment of aggression in patients with Alzheimer-type dementia

Adults (including elderly patients)

• The initial dose is normally 0.25 mg twice daily.
• Your doctor may gradually adjust your dose depending on your response to treatment.
• Most people improve with doses of 0.5 mg twice daily. Some patients may require 1 mg twice daily.
• The duration of treatment in patients with Alzheimer-type dementia should not exceed 6 weeks.

For the treatment of behavioural disorders in children and adolescents

The dose will depend on your child's weight:

If weighing less than 50 kg

• The initial dose is normally 0.25 mg once daily.
• The dose may 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 daily.

If weighing 50 kg or more

• The initial dose is normally 0.5 mg once daily.
• The dose may 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 daily.

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

Children under 5 years of age should not be treated with Risperidone Qualigen for behavioural disorders.

Patients with liver or kidney problems

Regardless of the condition 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 patient group.

How to take Risperidone Qualigen

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 above under the heading “How much to take”.

Swallow the medicine with a glass of water.

If you take more Risperidone Qualigen than you should

• In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.
• In case of overdose, you may feel drowsy or tired, experience abnormal body movements, have difficulty standing or walking, feel dizzy due to a drop in blood pressure, or have irregular heartbeats or seizures.

If you forget to take Risperidone Qualigen

• If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose and continue with your regular schedule. If you miss two or more doses, contact your doctor.

• Do not take a double dose (two doses at once) to make up for a missed dose.

If you stop taking Risperidone Qualigen

Do not stop taking this medicine unless instructed by your doctor. Symptoms may return. If your doctor decides to discontinue treatment, your dose may be gradually reduced over several days.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Risperidone Qualigen can cause adverse effects, although not everyone experiences them.

Tell your doctor immediately if you experience:

Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg). These clots may travel through blood vessels to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek immediate medical attention.

Very common: may affect more than 1 in 10 people
Common: may affect between 1 and 10 in 100 people
Uncommon: may affect between 1 and 10 in 1,000 people
Rare: may affect between 1 and 10 in 10,000 people
Very rare: may affect fewer than 1 in 10,000 people
Not known: frequency cannot be estimated from available data

The following side effects may occur:

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

• Parkinsonism. This 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 very wet mouth, musculoskeletal rigidity, drooling, pain when bending limbs, slower, reduced, or difficult body movements, lack of facial expression, muscle tightness, torticollis, muscle stiffness, short, rapid steps when walking with shuffling feet, absence of normal arm movements, persistent blinking in response to tapping the forehead (an abnormal reflex)
• Headache, difficulty falling or staying asleep

Common (may affect between 1 and 10 in 100 people)

• Drowsiness, fatigue, tiredness, inability to remain still, irritability, anxiety, somnolence, dizziness, attention problems, feeling of exhaustion, sleep disturbances, tremor
• Vomiting, diarrhea, constipation, nausea, increased appetite, abdominal pain or discomfort, sore throat, dry mouth
• Weight gain, increased body temperature, decreased appetite
• Breathing difficulty, lung infection (pneumonia), flu, respiratory tract infection, blurred vision, nasal congestion, nosebleed, 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
• Rapid heartbeat, chest pain
• Increased blood concentration of the hormone prolactin

Uncommon (may affect between 1 and 10 in 1,000 people)

• Excessive water intake, fecal incontinence, thirst, very hard stools, hoarseness or voice disorder
• Lung infection caused by food entering the airways, bladder infection, eye redness, sinusitis, viral infection, ear infection, tonsillitis, skin infection, eye infection, stomach infection, eye discharge, fungal nail infection
• Abnormality in the heart's electrical conduction, drop in blood pressure upon standing, low blood pressure, dizziness when changing position, abnormal heart electrical activity (ECG), abnormal heart rhythm, awareness of heartbeat, fast or slow heartbeat
• Urinary incontinence, painful urination, frequent urination
• Confusion, attention disorder, reduced level of consciousness, excessive sleepiness, restlessness, elevated mood (mania), lack of energy and interest
• Increased blood glucose, increased liver enzymes, decreased number of white blood cells, decreased hemoglobin or number of red blood cells (anemia), increased number of eosinophils (a type of white blood cell), increased creatine phosphokinase, decreased number of platelets (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, dry skin, severe itching, acne, hair loss, skin inflammation due to mites, skin discoloration, skin thickening, flushing, reduced skin sensitivity to pain or touch, greasy skin inflammation
• Absence of menstruation, sexual dysfunction, erectile dysfunction, ejaculation disorder, breast discharge, breast enlargement in males, decreased sexual desire, irregular menstruation, vaginal discharge
• Fainting, gait disturbance, inactivity, reduced appetite with malnutrition and weight loss, feeling of "being unwell", balance disorder, allergy, edema, speech disorder, chills, coordination problems
• Painful sensitivity to light, increased blood flow to the eye, eye swelling, dry eyes, increased tearing
• Respiratory tract disorder, pulmonary congestion, crackling lung sounds, respiratory tract congestion, speech problems, difficulty swallowing, cough with sputum, hoarse or wheezing breathing sounds, pseudoinfluenza illness, sinusitis
• Absence of response to stimuli, loss of consciousness, sudden swelling of lips and eyes with breathing difficulty, sudden weakness or numbness of face, arms or legs, especially on one side, or episodes 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 (may affect between 1 and 10 in 10,000 people)

• Inability to achieve orgasm, menstrual disorder
• Dandruff
• Drug allergy, coldness in arms and legs, lip swelling, lip inflammation
• Glaucoma, decreased visual acuity, crust formation at the edge of the eyelid, eye movement disorder
• Absence of emotions
• Altered consciousness with increased body temperature and muscle spasms, body-wide edema, drug withdrawal syndrome, decreased body temperature
• Rapid and shallow breathing, breathing problems during sleep, chronic middle ear infection
• Intestinal obstruction
• Decreased blood flow to the brain
• Decreased number of white blood cells, inappropriate secretion of a hormone controlling urine volume
• Muscle fiber rupture and muscle pain (rhabdomyolysis), movement disorder
• Coma due to uncontrolled diabetes
• Yellowing of the skin and eyes (jaundice)
• Inflammation of the pancreas

Very rare (may affect fewer than 1 in 10,000 people)

• Life-threatening complications of uncontrolled diabetes

Adverse effects with unknown frequency (frequency cannot be estimated from available data)

• Severe allergic reaction leading to breathing difficulty and shock
• Absence of granulocytes (a type of white blood cell that helps fight infections)
• Prolonged and painful erection
• Dangerously excessive water intake
• Blood clots in veins, especially in the legs (symptoms include swelling, pain, and redness in the leg). These clots may travel through blood vessels to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek immediate medical attention.

A small increase in the number of deaths has been reported in elderly patients with dementia treated with antipsychotics, compared to those not receiving this treatment.

Long-acting injectable risperidone

The following adverse effects have been reported with the use of long-acting injectable risperidone.

If you experience any of the following effects, speak to your doctor, even if you are not receiving long-acting risperidone injections:

• Intestinal infection
• Skin abscess, tingling, prickling, or numbness of the skin, skin inflammation
• Decreased number of white blood cells, cells that help protect you from bacterial infections
• Depression
• Seizures
• Eye twitching
• Sensation of spinning or oscillation
• Slow heartbeat, increased blood pressure
• Toothache, tongue spasm
• Buttock pain
• Weight loss

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines, Website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Risperidone Qualigen

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging, following EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Risperidone Qualigen

• The active substance is risperidone. Each Risperidone Qualigen 6 mg coated tablet contains 6 milligrams of risperidone.
• The other components are: anhydrous lactose, corn starch, pregelatinized corn starch, sodium lauryl sulfate, microcrystalline cellulose (E 460i), sodium croscarmellose (E 468), colloidal hydrated silica, magnesium stearate (E 572), hypromellose (E 464), titanium dioxide (E 171), red iron oxide (E 172), and macrogol 400.

Appearance of the product and contents of the pack

Risperidone Qualigen 6 mg film-coated tablets are oblong, biconvex, salmon-coloured tablets, with the inscription “6” on one side.

They are marketed in packs of 30 or 60 film-coated tablets.

Some pack sizes may not be commercialized.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain.

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain.

Date of the most recent review of this leaflet: July 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) www.aemps.gob.es