Prospect: information for the user

OKEDI 100 mg, powder and solvent for prolonged-release injectable suspension

risperidone

Read this prospect carefully before starting to use this medication, as it contains important information for you.

•Keep this prospect, as you may need to read it again.

•If you have any doubts, consult your doctor or pharmacist.

•This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

•If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is OKEDI and for what it is used

2.What you need to know before starting to use OKEDI

3.How to use OKEDI

4.Possible adverse effects

5.Storage of OKEDI

6.Contents of the package and additional information

OKEDI contains the active ingredient risperidone, which belongs to a group of medicines called "antipsychotics".

OKEDI is used in adult patients to treat schizophrenia, a disorder in which you may see, hear or feel things that are not there, believe things that are not true or feel unusually suspicious or confused.

OKEDI is indicated for patients who have shown tolerance and effectiveness to oral risperidone (e.g., tablets).

OKEDI may help alleviate the symptoms of the disease and prevent them from recurring.

No use OKEDI:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use OKEDI if:

•You have heart problems. Examples include irregular heart rhythm, if you are prone to having low blood pressure or if you are using blood pressure medications. OKEDI may cause low blood pressure. It may be necessary to adjust the dose.

•You know you have any factor that would make you more prone to suffering a stroke, such as high blood pressure, cardiovascular disorder or problems in the blood vessels of the brain.

•You have ever had involuntary movements of the tongue, mouth and face.

•You have ever had an illness whose symptoms include high temperature, muscle rigidity, sweating or reduced level of consciousness (also known as malignant neuroleptic syndrome).

•You have Parkinson's disease.

•You have dementia.

•You know you have had low white blood cell counts (which may have been caused by other medications or not).

•You are diabetic.

•You have epilepsy.

•You are male and have ever had a prolonged or painful erection.

•You have problems controlling your body temperature or feel excessive heat.

•You have kidney problems.

•You have liver problems.

•You have an abnormally high concentration of the prolactin hormone in the blood or a tumor that may depend on prolactin.

•You or a family member has a history of blood clots, as antipsychotics have been associated with the formation of blood clots.

If you are unsure whether the above options apply to your case, consult your doctor or pharmacist before starting to use risperidone oral or OKEDI.

During treatment

Very rarely in patients taking risperidone, there have been observed dangerously low counts of a type of white blood cell necessary to fight infections in the blood. Therefore, your doctor may need to control your white blood cell counts before and during treatment.

Although you may have previously tolerated risperidone oral, in rare cases allergic reactions may occur after receiving OKEDI injections. Seek immediate medical assistance if you have a rash, swelling of the throat, itching or respiratory problems, as they may be signs of a severe allergic reaction.

OKEDI may cause weight gain. Significant weight gain can negatively affect your health. Your doctor should weigh you periodically.

In patients using OKEDI, diabetes mellitus or the worsening of pre-existing diabetes mellitus has been observed. Therefore, your doctor should perform tests to detect signs of high blood sugar levels. In patients with pre-existing diabetes mellitus, blood glucose levels should be controlled periodically.

OKEDI normally increases the concentrations of a hormone called "prolactin". This can cause adverse effects, such as menstrual disorders or fertility problems in women, and breast inflammation in men (see section 4, "Possible adverse effects"). If these adverse effects occur, it is recommended to evaluate the prolactin blood concentration.

During eye surgery for cataract formation, problems may arise that can cause eye damage. If you plan to undergo eye surgery, make sure to inform your ophthalmologist that you are using this medication.

Children and adolescents

Do not administer this medication to children and adolescents under 18 years old.

Other medications and OKEDI

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 talk to your doctor or pharmacist if you are taking any of the following:

•Medications that act on the brain, such as to calm down (benzodiazepines) or some pain medications (opioids), for allergies (some antihistamines), as OKEDI may increase the sedative effect of all of them.

•Medications that may modify the heart's electrical activity, such as medications to treat malaria, heart rhythm problems, allergies (antihistamines), some antidepressants or other medications for mental health problems.

•Medications that slow down heart rate.

•Medications that generate low potassium levels in the blood (such as certain diuretics).

•Medications to treat high blood pressure. OKEDI may reduce blood pressure.

•Medications for Parkinson's disease (such as levodopa).

•Medications that increase the activity of the central nervous system (psychoestimulants, such as methylphenidate).

•Diuretics used to treat heart problems or swelling of parts of the body due to the accumulation of excess fluid (e.g., furosemide or chlorothiazide). OKEDI, in monotherapy or combined with furosemide, may increase the risk of stroke or death in elderly people with dementia.

The following medications may reduce the effect of risperidone:

•Rifampicin (a medication to treat some infections).

•Carbamazepine, phenytoin (medications for epilepsy).

•Fenobarbital.

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

The following medications may increase the effect of risperidone:

•Quinidine (used to treat certain types of heart disease).

•Antidepressants (such as paroxetine, fluoxetine, tricyclic antidepressants).

•Beta-blockers (used to treat high blood pressure).

•Fenothiazines (used to treat psychosis or to calm down).

•Cimetidine, ranitidine (acid blockers).

•Itraconazole and ketoconazole (medications to treat fungal infections).

•Certain medications for HIV/AIDS treatment, such as ritonavir.

•Verapamil, used to treat high blood pressure and/or heart rhythm problems.

•Sertraline and fluvoxamine, medications to treat depression and other psychiatric disorders.

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

If you are unsure whether the above options apply to your case, consult your doctor or pharmacist before starting to use OKEDI.

Use of OKEDI with food, drinks and alcohol

You should avoid consuming alcohol when using OKEDI.

Pregnancy, breastfeeding and fertility

•If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication. Your doctor will decide if you can use it.

•The following symptoms may appear in newborns of mothers who have used risperidone during the last trimester (last three months of pregnancy): tremor, muscle rigidity and/or weakness, drowsiness, agitation, respiratory problems and difficulty feeding. If your baby shows any of these symptoms, you may need to consult your doctor.

•OKEDI may increase the concentrations of a hormone called "prolactin" that can affect fertility (see section 4, "Possible adverse effects").

Driving and using machines

During treatment with OKEDI, dizziness, fatigue and visual problems may occur. Do not drive or use any tools or machines without first consulting your doctor.

A healthcare professional will administer OKEDI through an intramuscular injection in the arm or buttock every 28 days. Injections should be alternated between the right and left sides.

The recommended dose is 75 mg every 28 days, but a higher dose of 100 mg every 28 days may be necessary. Your doctor will decide which dose of OKEDI is right for you.

If you are currently receiving treatment with other antipsychotics other than risperidone, but have previously used risperidone, you should start taking risperidone orally at least 6 days before starting treatment with OKEDI.

If you have never taken any form of risperidone, you should start taking risperidone orally at least 14 days before starting treatment with OKEDI. Your doctor will determine the duration of the risperidone oral administration period.

If you have kidney problems

OKEDI is not recommended for patients with moderate to severe renal insufficiency.

If you take more OKEDI than you should

•Consult a doctor immediately.

•You may feel drowsy or tired, have abnormal body movements, have trouble staying upright and walking, have dizziness due to low blood pressure, or have abnormal heartbeats or seizures.

If you stop treatment with OKEDI

You will lose the effects of the medication. Do not stop treatment with this medication unless your doctor tells you to, as symptoms may reappear.

It is essential that you do not miss your scheduled appointments every 28 days when you are supposed to receive the injections of this medication. If you cannot attend an appointment, make sure to notify your doctor immediately to schedule another date for the injection.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Consult a doctor or go immediately to the nearest emergency service if you experience the following rare side effect (may affect up to 1 in 100 people):

•You have tardive dyskinesia (involuntary movements or tics in the face, tongue, or other parts of the body that you cannot control).

Consult a doctor or go immediately to the nearest emergency service if you experience any of the following rare side effects (may affect up to 1 in 1000 people):

•You have blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the legs), which can move through the blood vessels to the lungs and cause chest pain and difficulty breathing.

•You have a fever, muscle stiffness, sweating, or reduced level of consciousness (a condition known as "neuroleptic malignant syndrome").

•As a male, you have a prolonged or painful erection, known as priapism.

•You have a severe allergic reaction characterized by fever; swelling of the mouth, face, lip, or tongue; difficulty breathing; itching; skin rash or decreased blood pressure (anaphylactic or angioedema reaction). Although you may have previously tolerated oral risperidone, in rare cases, allergic reactions may occur after receiving OKEDI injections.

•Your urine is dark brown or red, or you have significantly decreased urine output along with muscle weakness or difficulty moving your arms and legs. These may be signs of rhabdomyolysis (rapid muscle damage).

•You have weakness or drowsiness, fever, chills, or mouth sores. These may be signs of a very low white blood cell count (a type of white blood cell that helps fight infections).

Other side effects may also occur:

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

•Difficulty falling asleep or staying asleep.

•Parkinsonism: movement disorders that may include slow or impaired movements, feeling of stiffness or muscle tension, and, in some cases, a feeling that movements "freeze" and then you can move again. Other signs include slow walking, resting tremor, increased salivation or drooling, and loss of facial expression.

•Headache.

Common side effects (may affect up to 1 in 10 people):

•Pneumonia (lung infection), bronchitis (infection of the main airways of the lungs), sinus infection, urinary tract infection, ear infection, flu, pseudogripal symptoms, sore throat, cough, nasal congestion, fever, eye infection, or conjunctivitis.

•Increased concentrations of a hormone called "prolactin" that is detected in a blood test. The symptoms of high prolactin levels are rare and in men may include breast enlargement, difficulty getting or maintaining erections, and decreased libido. In women, they may include milk secretion from the breasts, menstrual disorders, absence of menstrual periods, absence of ovulation, fertility problems.

•Weight gain, increased or decreased appetite.

•Sleep disorder, irritability, depression, anxiety, feeling drowsy or less alert.

•Dystonia (involuntary contraction of muscles that generate repetitive, slow, or abnormal postures), dyskinesia (another disorder that affects involuntary muscle movements, including repetitive, spasmodic, or twisting movements, or tics).

•Tremor (agitation), muscle spasms, bone or muscle pain, back pain, joint pain, falls.

•Blurred vision.

•Urinary incontinence (involuntary loss of urine).

•Fast heart rate, high blood pressure, shortness of breath.

•Abdominal pain, discomfort, vomiting, nausea, dizziness, constipation, diarrhea, indigestion, dry mouth, toothache.

•Rash, skin redness, reaction at the injection site (which includes discomfort, pain, redness, or swelling), swelling of the body, arms, or legs, chest pain, lack of energy and strength, fatigue, pain.

Rare side effects (may affect up to 1 in 100 people):

•Urinary tract infection, tonsillitis, fungal nail infection, deep skin infection, viral infection, skin inflammation caused by mites.

•Reduced or increased white blood cell count in the blood, decreased platelets (blood cells that help stop bleeding), anemia or decreased hematocrit (reduced red blood cells), elevated creatine phosphokinase in the blood, elevated liver enzymes in the blood.

•Low blood pressure, decreased blood pressure after standing, skin redness, cerebral ischemia (insufficient blood flow to the brain).

•Diabetes, elevated blood sugar, excessive water consumption, excessive sugar in the urine, low blood sugar, elevated insulin in the blood.

•Mania (euphoric mood), confusion, decreased libido, nervousness, nightmares.

•Loss of consciousness, convulsion (epileptic crisis), feeling of everything spinning (vertigo), tinnitus, ear pain.

•Urge to move parts of the body constantly, balance disorder, abnormal coordination, attention deficit, speech problems, loss or alteration of taste, reduced skin sensitivity to pain and touch, feeling of tingling, pinching, or numbness of the skin.

•Irregular and often rapid heart rate, slow heart rate, abnormal electrocardiogram (test that measures the electrical activity of heartbeats), palpitations (feeling of fluttering or pulsations in the chest), interruption of conduction between the upper and lower parts of the heart.

•Respiratory tract congestion, wheezing (asperous or sibilant sound during breathing), nasal hemorrhages.

•Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain, abnormal gait, thirst, feeling unwell, chest or general discomfort, feeling down.

•Stomach or intestinal irritation or infection, fecal incontinence, difficulty swallowing, excessive gas or flatulence, frequent urination, inability to urinate, painful urination.

•Absence of menstrual periods or other menstrual cycle problems, breast milk secretion, sexual dysfunction, breast pain or discomfort, vaginal secretion, erectile dysfunction, ejaculation disorder, male breast development.

•Urticaria, skin thickening, skin disorder, intense skin itching, hair loss, eczema (skin areas that become inflamed, itchy, cracked, and rough), dry skin, skin color change, acne, seborrheic dermatitis (red, scaly, greasy, itchy, and inflamed skin), skin injury.

•Light sensitivity of the eyes, dry eyes, increased tear production.

•Allergic reaction, chills.

Rare side effects (may affect up to 1 in 1000 people):

•Infection.

•Inadequate secretion of the hormone that controls urine volume, excessively excessive water consumption, excessive sugar in the urine, low blood sugar, elevated insulin in the blood.

•Absence of response to stimulation, catatonia (not moving or responding while awake), reduced level of consciousness, somnambulism, sleep-related eating disorder, difficulty breathing during sleep (sleep apnea), rapid shallow breathing, pulmonary infection caused by inhalation of food into the airways, pulmonary congestion, respiratory tract disorder, voice disorder, crepitant lung sounds, absence of emotion, inability to achieve orgasm.

•Cerebral vascular problems, coma due to uncontrolled diabetes, involuntary head tremor.

•Glaucoma (increased intraocular pressure), eye movement problems, eye rotation, crust/inflammation at the eyelid margin, eye problems during cataract surgery.

•Pancreatitis, intestinal obstruction.

•Swollen tongue, cracked lips, dandruff, jaundice (yellow skin and eyes), skin hardening.

•Enlarged breast, breast congestion (hard, swollen, and painful breasts due to excessive milk production).

•Low body temperature, feeling cold in arms and legs.

•Withdrawal symptoms from medications (also in newborns).

Very rare side effects (may affect up to 1 in 10,000 people):

•Potentially fatal complications of uncontrolled diabetes.

•Absence of intestinal muscle movement that causes obstruction.

Unknown frequency: cannot be estimated from available data

• Severe or potentially fatal skin rash with blisters and skin peeling that may start around the mouth, nose, eyes, genitals, and spread to other parts of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis).

Reporting 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 national notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information about 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 box, aluminum foil packets, or syringe labels after (CAD). The expiration date is the last day of the month indicated.

Store below 30 °C. Store in the original packaging to protect it from moisture.

Use OKEDI immediately after reconstitution.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of containers and medications that you no longer need. This will help protect the environment.

OKEDI Composition

The active ingredient is risperidone.

Only the powder syringe contains the active ingredient. Once reconstituted, the amount of risperidone administered is 100 mg.

The other components are:

Powder syringe: poly(D,L-lactide-co-glycolide).

Preloaded syringe with solvent: dimethylsulfoxide.

Product appearance and packaging contents

Each box of the OKEDI powder and solvent kit for prolonged-release injectable suspension contains:

• A foil pouch with a preloaded syringe containing powder (the active ingredient, risperidone, is inside the powder) and a silica gel desiccant sachet. The powder is loose, white to off-white.
• A foil pouch with a preloaded syringe containing the solvent and a silica gel desiccant sachet. The preloaded syringe with solvent contains a transparent solution and has blue-colored wings.
• A sterile 2-inch (0.90 × 51 mm [20G]) needle for intramuscular injection with a safety guard for gluteal administration.
• A sterile 1-inch (0.80 × 25 mm [21G]) needle for intramuscular injection with a safety guard for deltoid muscle administration.

Marketing Authorization Holder and Responsible Manufacturer

Laboratorios Farmacéuticos Rovi, S.A.

Julián Camarillo, 35

28037 Madrid

Spain

For more information about this medication, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet: May 20, 23.

This information is intended solely for healthcare professionals

INSTRUCTIONS FOR HEALTHCARE PROFESSIONALS

OKEDI 100 mg, powder and solvent for prolonged-release injectable suspension

Important information

To ensure the correct administration of OKEDI, please pay close attention to these step-by-step instructions.

Use the provided components

The components included in the OKEDI powder and solvent kit are designed specifically for use with OKEDI. OKEDI should only be reconstituted with the solvent provided in the kit.

Do not substituteANY component of the kit.

Administer the dose immediately after reconstitution. Only for intramuscular use after reconstitution.

Correct administration

Ensure that the entire contents of the reconstituted syringe are administered to ensure the administration of the indicated dose of OKEDI.

Single-use device

1.VERIFY THE CONTENT

On a clean surface, open the sachets and discard the desiccant.

The OKEDI kit contains the following:

• A foil pouch with a preloaded syringe containing OKEDI, with a white plunger rod and white-colored wings. The syringe is marked with.

• A foil pouch with DISOLVENT for the OKEDI syringe, with a transparent plunger rod and blue-colored wings. The syringe is marked with

•Two needles for administration (21G, 1 inch for deltoid muscle [green cap] and 20G, 2 inches for gluteal administration [yellow cap]).

Discard the kit if any of the components are damaged.

If you observe any foreign particlesy/or variation in appearance, do not administer OKEDI.

1.1 Inspect the solvent syringe

ENSURE that the contents of the solvent syringe flow normally as a liquid.

The solvent freezes below 19°C.

If it is frozen or partially frozen, before proceeding, allow it to thaw by placing it in contact with your hands or leaving it at room temperature until it flows like a liquid again.

1.2 Release the powder from the syringe

TAP the OKEDI syringe to release any possible powder plug near the cap.

2.CONNECT THE SYRINGES

2.1 Remove the caps from the syringes in a vertical position

Hold both syringes invertical position to prevent product loss.

REMOVE the cap from the solvent syringe.

TURN the cap and REMOVE it from the powder syringe.

2.2 Connect the syringes

Place the solvent syringe S with the blue-colored wings on top of the powder syringe R, or tilt it slightly when connecting.

TURN the syringes together until you feel aslight resistance.

Ensure the powder syringe R is in a vertical position to prevent product loss.

3.MIX THE CONTENT

STOP AND READ THIS SECTION BEFORE STARTING OR YOU MAY RECONSTITUTE THE MEDICINE INCORRECTLY.

•PRESS VIGOROUSLYTHEcontents of the solvent into the powder syringe.

•DO NOT WAIT for the powder to become dampand start mixing the contentsRAPIDLY,pressing the plungers rapidly and alternately about 100 times (2 times per second, approximately 1 minute).

•ENSURE that the medicine passes from one syringe to the otherto mix correctly:the medicine is viscous and should make forcewhen pressing the plunger rods.

Mixpressing at least100 timesalternately

Ensure the medicine passes from one syringe to the other

Whenthe medicine is mixed correctly, the appearance will bea uniform white to yellowish suspension andthick consistency.

Once reconstituted, prepare the injection syringe immediately to avoid loss of homogeneity.

4.PREPARE THE INJECTION SYRINGE

4.1 Transfer the medicine

APPLY a downward pressure on the plunger rodRand transfer all the contents to the syringeSwith the blue-colored wings.

Ensure all the contents have been transferred.

4.2 Separate the syringes

Once all the medicine has been transferred, separate the syringes by unscrewing them.

OKEDI should beadministered immediately to avoid loss of homogeneity.

4.3 Place the sterile needle with safety guard

SELECT the correct needle:

• Deltoid muscle: 21G, 1 inch for deltoid muscle (green cap).

• Gluteal administration: 20G, 2 inches for gluteal administration (yellow cap).

PLACE it by turning it clockwise.Do not overtighten.

4.4 Remove air bubbles

REMOVE the safety guard from the needle and remove any excess air (only large bubbles) from the syringe cylinder.

DO NOT expel any medicine

If you see medicine at the needle tip, pull the plunger back slightly to avoid dripping medicine.

5.ADMINISTER AND DISPOSE

5.1 Inject the medicine

INSERT the needle completely into the muscle.DO NOT ADMINISTER BY ANY OTHER ROUTE.

THICK MEDICINE, INJECT IT SLOWLY AND CONSTANTLY. ENSURE IT IS ALL INJECTED.

•The injection time is longer than usual due to the viscosity of the medicine.

•Wait a few seconds before removing the needle.

•Avoid accidental injection into a blood vessel.

5.2 Dispose of the medicine

COVER the needle by applying pressure to the safety guard with your finger or a flat surface, and dispose of it immediately in a safe sharps container.