Package Insert: Information for the User

Arketin 1 mg Film-Coated Tablets EFG

Risperidone

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

Arketin 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 (up to 6 weeks) treatment 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 (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 Arketin:

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

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

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Arketin.

• If you have any heart problems. Examples include heart rhythm disturbances, or if you are prone to having low blood pressure or if you are taking blood pressure medications. Arketin may lower blood pressure. You may need to have your dose adjusted.
• If you have any risk factors for having a stroke, such as high blood pressure, cardiovascular disease, or problems with blood vessels in the brain.
• If you have Parkinson's disease or dementia.
• If you are diabetic.
• If you have epilepsy.
• If you are a male and have had a prolonged or painful erection. If you experience this while taking Arketin, contact your doctor immediately.
• If you have difficulty controlling your body temperature or feel excessive heat.
• If you have kidney problems.
• If you have liver problems.
• If you have an abnormally high level of prolactin in your blood or if you have a tumor that may be dependent on prolactin.
• If you or a family member has a history of blood clots, as these medications may be associated with their formation.

Consult your doctor immediately if you have:

• Involuntary rhythmic movements of the tongue, mouth, or face. You may need to discontinue Arketin.
• 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 what you have read affects you, consult your doctor or pharmacist before using Arketin.

Arketin may cause weight gain.

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 risperidone if you have dementia caused by a stroke.

You should see your doctor frequently during treatment with Arketin.

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 are speaking 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 risperidone you experience fatigue, changing the administration times may improve your difficulties with attention.

Taking Arketin with other medications

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

It is especially important to speak with your doctor or pharmacist if you are taking 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 risperidone 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. Arketin 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). Arketin, 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 risperidone:

• 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 risperidone.

The following medications may increase the effect of risperidone:

• 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 risperidone.

If you are unsure about whether what you have read affects you, consult your doctor or pharmacist before using Arketin.

Taking Arketin with food, drinks, and alcohol

You can take this medication with or without food. You should avoid consuming alcohol while taking Arketin.

Pregnancy and breastfeeding

• If you are pregnant, or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.
• Newborns of mothers who have used Arketin 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

Arketin may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may impair your reaction time. These effects, as well as the underlying condition, may make it difficult for you to drive vehicles or operate machinery. Therefore, do not drive or operate machinery, or engage in other activities that require special attention, until your doctor assesses your response to this medication.

Arketin contains lactose and sodium.

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.

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of 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, which can 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 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 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 - 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 Arketin 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 feel 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 - 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 Arketin 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, twice a day.
• Your doctor may later change your dose gradually based 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 usually be 0.25 mg, once a day.
• The dose can 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 can 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 Arketin 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 Arketin

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

You should swallow the medication with a glass of water.

If you take more Arketin than you should

• In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.
• In case of overdose, you may feel drowsy or tired, have abnormal body movements, have trouble staying upright and walking, feel dizzy due to decreased blood pressure, or have abnormal heartbeats or convulsions.

If you forget to take Arketin

• 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 missed doses.

If you interrupt treatment with Arketin

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 medication, ask your doctor or pharmacist.

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

Inform 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 can move through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, go to your doctor immediately.

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

Unknown: the frequency cannot be estimated from available data

The following side effects may occur:

Very common (may affectmore 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 saliva secretion or a very wet mouth, muscular skeletal rigidity, drooling, pain when bending the limbs, slower, reduced, or difficult body movements, facial expressionlessness, muscle tension, torticollis, muscle rigidity, 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 falling or staying asleep

Common (may affectbetween 1 and 10 in 100 people):

• Drowsiness, fatigue, tiredness, inability to remain calm, irritability, anxiety, drowsiness, dizziness, attention problems, feeling of exhaustion, sleep disturbance, tremor
• 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, arm and leg swelling, arm and leg pain
• Rash, skin redness
• Fast heart rate, chest pain
• Increased prolactin hormone concentration in the blood

Uncommon (may affectbetween 1 and 10 in 1,000 people):

• Excessive water consumption, fecal incontinence, thirst, hard stools, hoarseness or voice disorder.
• Pneumonia caused by food passing 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, low blood pressure when standing, decreased blood pressure, feeling of dizziness when changing position, abnormal heart activity (ECG), irregular heart rhythm, feeling of heartbeats, fast or slow heart rate.
• Urinary incontinence, painful urination, frequent urination
• Confusion, attention disorder, low 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 caused 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 men, 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 when breathing, pseudogripal disease, sinusitis
• Loss 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 stroke), involuntary facial, arm, or leg movements, tinnitus, facial edema

Rare (may affectbetween 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-wide edema, medication withdrawal syndrome, decreased body temperature
• Fast and shallow breathing, respiratory problems during sleep, chronic otitis media
• 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 (may affectfewer 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
• Blood clots in 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, go to your doctor immediately.

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

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
• Buttock pain

• Weight loss.

Reporting of 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 the Vigilance of Medicinal Products for Human Use, Website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Arketin

• The active ingredient is risperidone. Each coated tablet of Arketin 1 mg contains 1 milligram of risperidone.
• The other components are: anhydrous lactose, cornstarch, pregelatinized cornstarch, sodium lauryl sulfate, microcrystalline cellulose (E 460i), sodium croscarmellose (E 468), hydrated colloidal silica, magnesium stearate (E 572), hypromellose (E 464), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), and macrogol 400.

Appearance of the product and contents of the packaging

The coated tablets with a 1 mg film of Arketin are oblong, biconvex, orange in color, with the inscription “1” on one face and a groove on the other. The tablet can be divided into two equal halves.

They are marketed in packaging of 20 or 60 coated tablets.

Some packaging sizes may not be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of marketing authorization

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Responsible for manufacturing

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Last review date of this leaflet: July 2021

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