ARKETIN 3 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Arketin 3 mg Film-Coated Tablets EFG

Risperidone

Contents of the Package Leaflet:

1. What is Arketin and what is it used for
2. What you need to know before you take Arketin
3. How to take Arketin
4. Possible side effects
5. Storage of Arketin
6. Contents of the pack and further information

1. What is Arketin and what is it used for

Arketin belongs to a group of medicines called "antipsychotics".

Arketin is used to treat the following:

• Schizophrenia, where you may see, hear, or feel things that are not there, believe in things that are not true, or feel unusually 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 harm themselves or others. Other non-pharmacological treatments must have been tried before.
• 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. What you need to know before you take Arketin

Do not take Arketin:

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

If you are not sure, consult your doctor or pharmacist before taking 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 medicines for blood pressure. Arketin can lower blood pressure. You may need to have your dose adjusted.
• 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 the blood vessels in the brain.
• If you have Parkinson's disease or dementia.
• If you are diabetic.
• If you have epilepsy.
• If you are male and have ever had a prolonged or painful erection. If you experience this while taking Arketin, contact your doctor immediately.
• If you have problems 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 the hormone prolactin in your blood or if you have a tumor that may be dependent on prolactin.
• If you or a family member have a history of blood clots, these medicines may be associated with the formation of clots.

Consult your doctor immediately if you have:

• Involuntary rhythmic movements of the tongue, mouth, or face. It may be necessary to discontinue Arketin.
• 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 the above, consult your doctor or pharmacist before taking Arketin.

Arketin 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 Arketin, 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 the 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.

Taking Arketin with other medicines

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

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 medicines (opioids), allergy medicines (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. Arketin can lower 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). Arketin, 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 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 heart diseases)
• 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 the above, consult your doctor or pharmacist before taking Arketin.

Taking Arketin with food, drinks, and alcohol

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

Pregnancy and breastfeeding

• If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.
• Newborns of mothers who have used Arketin in the last trimester of pregnancy may present with the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding problems. If your newborn presents with any of these symptoms, contact your doctor.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Arketin can cause symptoms such as drowsiness, dizziness, or changes in vision, and can reduce your reaction ability. These effects, as well as the disease itself, can make it difficult for you to drive vehicles or operate machines. Therefore, do not drive or operate machines, or engage in other activities that require special attention, until your doctor assesses your response to this medicine.

Arketin contains lactose and sodium.

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

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

3. How to take Arketin

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, 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 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 1-2 mg, twice a day.
• Your doctor will indicate what is best for you.

Children and adolescents

• Children and adolescents under 18 years of age should not receive treatment with Arketin for schizophrenia.

For the treatment of mania

Adults

• The initial dose will normally be 2 mg, once a day.
• Later, your doctor may adjust your dose gradually 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 adjust your dose gradually to 1-2 mg, twice a day, depending on your response to treatment.

Children and adolescents

• Children and adolescents under 18 years of age should not receive treatment with Arketin for bipolar mania.

For the long-term treatment of 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 change your dose gradually 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 depends 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, one day yes and one day no, 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, one day yes and one day no, 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 of age should not receive treatment with Arketin 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 Arketin

Your doctor will tell you how much medicine you should 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.

You should swallow the medicine 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 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 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 dose 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 stop taking Arketin

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 medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Arketin can cause adverse effects, although not all people suffer from them.

Report immediately to your doctor if you present:

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 present any of these symptoms, go immediately to your doctor.

Very frequent: can affect more than 1 in 10 people

Frequent: can affect between 1 and 10 in 100 people

Infrequent: can affect between 1 and 10 in 1000 people

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

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

Unknown: the frequency cannot be estimated from the available data

The following side effects may appear:

Very frequent (can affect 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 humid 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 as a response to forehead tapping (an abnormal reflex)
• Headache, difficulty staying or remaining asleep

Frequent (can 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 disturbance, tremor
• Vomiting, diarrhea, constipation, nausea, increased appetite, abdominal pain or discomfort, sore throat, dry mouth
• Weight gain, increased body temperature, decreased appetite
• Difficulty breathing, 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
• Fast heartbeat, chest pain
• Increased concentration of the prolactin hormone in the blood

Infrequent (can affect 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, infection under the skin, eye infection, stomach infection, eye discharge, fungal infection of the nails
• Anomaly in the electrical conduction of the heart, drop in blood pressure when standing up, decrease in blood pressure, feeling of dizziness when changing position, anomaly in the electrical activity of the heart (ECG), abnormal heart rhythm, feeling the heartbeats, fast 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 number of white blood cells, decreased hemoglobin or number of red blood cells (anemia), increased number of eosinophils (special white blood cells), 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, pain in the muscles and bones of the chest, chest discomfort
• Skin injury, skin disorder, dry skin, intense itching, acne, hair loss, skin inflammation caused by 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, increased breast size 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 anomaly
• Painful sensitivity to light, increased blood flow to the eye, eye swelling, dry eyes, 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
• Absence 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 that last less than 24 hours (called mini-stroke or stroke), involuntary movements of face, arms, or legs, ringing in the ears, facial edema

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

• Difficulty reaching orgasm, menstrual disorder
• Dandruff
• Drug allergy, coldness in arms and legs, lip swelling, lip inflammation
• Glaucoma, decreased visual acuity, crust formation on the eyelid edge, eye movement
• Absence of emotions
• Altered consciousness with increased body temperature and muscle spasms, edema throughout the body, 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 number of white blood cells, inadequate secretion of a hormone that controls urine volume
• Muscle fiber rupture and muscle pain (rhabdomyolysis), movement disorder
• Diabetic coma due to uncontrolled diabetes
• Yellowing of the skin and eyes (jaundice)
• Pancreatitis.

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

• Complications of uncontrolled diabetes, with risk to life

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

• Severe allergic reaction leading to difficulty breathing 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 can move through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you present any of these symptoms, go immediately to your doctor.

A small increase in the number of deaths has been reported in elderly patients with dementia treated with antipsychotics, compared to those who do not receive 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, talk to your doctor, even if you do not receive treatment with long-acting risperidone injections:

• Intestinal infection
• Abscess under the skin, tingling, pinching, or numbness of the skin, skin inflammation
• Decreased number of white blood cells, cells that help protect against bacterial infections
• Depression
• Seizures
• Eye twitching
• Feeling of spinning or swaying
• Slow heartbeat, increased blood pressure
• Toothache, tongue spasm
• Pain in the buttocks

• Weight loss.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, Website: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Arketin

Keep this medicine out of sight and reach of children.

Do not use this medicine 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 thrown away through the sewers or in the trash. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Arketin

• The active ingredient is risperidone. Each coated tablet of Arketin 3 mg contains 3 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), hydrated colloidal silica, magnesium stearate (E 572), hypromellose (E464), titanium dioxide (E 171), yellow iron oxide (E 172), and macrogol 400.

Appearance of the Product and Package Contents

The 3 mg Arketin film-coated tablets are oblong, biconvex, yellow, with the inscription "3" on one side and a score line on the other. The tablet can be divided into two equal halves.

They are marketed in packages of 20 or 60 film-coated tablets.

Some package sizes may not be marketed.

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)

Date of the Last Revision of this Prospectus: July 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es