Prospect: information for the patient

Paliperidone TAD3 mg prolonged-release tablets EFG

Paliperidone TAD6 mg prolonged-release tablets EFG

Paliperidone TAD9 mg prolonged-release tablets EFG

Read this prospect carefully before starting to take this medicine, 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 medicine has been prescribed only for you, and you should not give it to other people 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 Paliperidone TAD and what it is used for

2.What you need to know before starting to take Paliperidone TAD

3.How to take Paliperidone TAD

4.Possible adverse effects

5.Storage of Paliperidone TAD

6.Contents of the pack and additional information

Paliperidone contains the active ingredient paliperidone, which belongs to the class ofmedicamentosantipsicóticos.

Paliperidone is used to treat schizophrenia in adults and adolescents aged 15 years and older.

Schizophrenia is a disorder that causes symptoms that include hearing, seeing or feeling things thatdonotexist, holding false beliefs, having an abnormal distrust, withdrawing into oneself,speaking incoherently and flattening of behavior and emotion. People with this disorder may also feeldepressed,anxious,guiltyotensions.

Paliperidone is also used to treat schizoaffective disorder in adults.

Schizoaffective disorder is a mental condition in which the person experiences several of the symptoms ofschizophrenia(enumeratedin the previous paragraph) plus symptoms of mood disorder (feeling of euphoria, sadness, agitation, beingdistracted, insomnia, excessive or reduced sleep, excessive or reduced food intake, and recurrent thoughts ofsuicidedo).

Paliperidone may help alleviate the symptoms of your illness and prevent it from recurring.

Do not takepaliperidone

-if you are allergic to paliperidone, risperidone, or any of the other ingredients in thismedicine(listed in section6)

Warnings andprecautions

Consult your doctor or pharmacist before starting to take paliperidone..

• Patients with schizoaffective disorder treated with this medication should be closely monitored for a change in manic symptoms to depressive symptoms.
• This medication has not been studied in elderly patients with dementia. However, elderly patients with dementia who are treated with similar medications may have an increased risk of stroke or death (see section 4, Possible side effects).
• if you have Parkinson's disease or dementia.
• if you have ever been diagnosed with a condition characterized by high temperature and muscle rigidity (also known as Neuroleptic Malignant Syndrome). If you have ever experienced abnormal tongue or facial movements (Tardive Dyskinesia). You should know that these two conditions may be caused by this type of medication.
• if you have had low white blood cell counts in the past (which may or may not have been caused by other medications).
• if you are diabetic or have a tendency to develop diabetes.
• if you have any heart disease or if you are receiving treatment for heart diseases that may make you more prone to a drop in blood pressure.
• if you have epilepsy.
• if you have any swallowing, stomach, or intestinal disorders that reduce your ability to swallow food or digest it normally.
• if you have diseases associated with diarrhea.
• if you have kidney problems.
• if you have liver problems.
• if you have a prolonged and painful erection.
• if you have difficulty controlling your body temperature or are overheated.
• 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 antipsychotics are associated with blood clot formation.

If you have any of these conditions, please consult your doctor as it may benecessaryor a dose adjustment or monitoring during atimeperiod.

Because in very rare cases, a dangerously low number of a type of white blood cells necessary to fight infections in the blood has been observed in patients treated with paliperidone, your doctor may check the number of white blood cells.

Paliperidone may cause you to gain weight. A significant weight gain canafectarnegatively on your health. Your doctor will regularly monitor yourweight.

In patients treated with paliperidone, diabetes mellitus or worsening of existing diabetes mellitus has been observed. Your doctor should check for signs of increased blood sugar.In patients with pre-existing diabetes mellitus, blood sugar should be regularly monitored.

During cataract surgery in the eye, the pupil (the small circle in the middle of the eye) may not dilate as needed. Additionally, the iris (the colored part of the eye) may become flaccid during surgery and this may cause eye damage.If you are planning to have eye surgery, be sure to inform your ophthalmologist thatyouareusing thismedicine.

Children andadolescents

Paliperidone should not be administered to children and adolescents under 15 years old for the treatment ofschizophrenia.

Paliperidone should not be administered to children and adolescents under 18 years old for the treatment ofschizoaffectivedisorderos.

This is because the safety and efficacy of paliperidone in this age group are unknown.

Other medications and paliperidone

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any othermedicamento.

Abnormalities in heart function may occur when this medication is taken with other medications for heart rhythm control or other medications such as antihistamines, antimalarials, orantipsicótics.

Since this medication primarily acts on the brain, this medication may interfere with other medications (or alcohol) that also act on it, due to the sum of effects onbrainfunction.

This medication may lower blood pressure, so you should be careful if you take this medication with other medications that alsoreducebloodpressure.

This medication may reduce the effect of medications for Parkinson's disease and restless legs syndrome (e.g.,levodopa).

The effects of this medication may be affected if you take medications that influence the speed of intestinal movement (e.g.,metoclopramida).

Reduction of this medication dose should be considered when administered withvalproato.

The use of oral risperidone with this medication is not recommended as thiscombinationmayprovocaneanindeadverses.

Paliperidone TAD should be used with caution with medications that increase the activity of the central nervous system (psychoestimulants such as metilphenidato).

Paliperidone withalcohol

You should avoid consuming alcohol during treatment with thismedicine.

Pregnancy andlactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using thismedicine.

You should not take this medication during pregnancy unless you have discussed it with yourmédico.

The following symptoms may occur in newborn babies of mothers who have been treated with paliperidone in the last trimester of pregnancy (last three months of pregnancy):templor,rigidenessand/ordebilitymuscleness,somnolencessians,problemsing,and/ordifficulyingtoedanorbaby.

You should not breastfeed your baby while taking this medication.

Driving and use ofmachinery

During treatment with this medication, dizziness and vision problems (see section 4, Possible side effects) may occur. This should be taken into account when requiring maximum attention, for example, when driving or operatingmachinery.

Paliperidone TAD contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Use in adults

The recommended dose in adults is 6 mg once a day in the morning. Your doctor may increase or decrease it within the dosing interval of 3 mg to 12 mg once a day in case of schizophrenia or 6 mg to 12 mg once a day in case of schizoaffective disorder. This depends on how well the medication works for you.

Use in adolescents and children

The recommended starting dose for the treatment of schizophrenia in adolescents aged 15 years or older is 3 mg once a day taken in the morning.

For adolescents weighing 51 kg or more, the dose can be increased within the interval of 6 mg to 12 mg once a day.

For adolescents weighing less than 51 kg, the dose can be increased to 6 mg once a day.

Your doctor will decide how much to administer to you. The amount you take depends on how well the medication works for you.

How and when to take paliperidone

This medication should be taken by mouth, swallowed whole with water or other liquids. It should not be chewed, broken, or crushed.

This medication should be taken in the mornings with breakfast or on an empty stomach, but in the same way every day. Do not alternate between taking the medication with breakfast and on an empty stomach the next day.

The active ingredient, paliperidone, dissolves once swallowed, and the coating of the tablet is eliminated from the body by the kidneys.

Patients with kidney problems

Your doctor may adjust the dose of this medication according to your kidney function.

Patients of advanced age

Your doctor may reduce your medication dose if your kidney function is reduced.

If you take more paliperidone than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or go to the nearest hospital immediately, or call the Toxicological Information Service. Phone: 91 562 04 20 indicating the medication and the amount ingested. You may experience drowsiness, confusion, abnormal body movements, difficulty staying upright and walking, dizziness due to reduced blood pressure, and alterations in heartbeats.

If you forgot to take paliperidone

Do not take a double dose to compensate for the missed doses. If you forget a dose, take the next dose the next day. If you forget two or more doses, contact your doctor.

If you interrupt the treatment with paliperidone

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

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

Like all medicines, this medicine can cause side effects, althoughnotall people experience them.

Inform your doctor immediately if you experience any of the following:

• Present blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can travel through the blood vessels to the lungs causing chest pain and difficulty breathing. If you experience any of these symptoms, seek medical advice.
• You have dementia and experience a sudden change in your mental state or sudden weakness or numbness in the face, arms, or legs, especially on one side, or difficulty speaking even for a short period of time. These may be signs of a heart attack.
• You experience fever, muscle stiffness, sweating, or a decrease in consciousness (a condition known as "Neuroleptic Malignant Syndrome"). You may need medical treatment.
• You are a man and experience a prolonged or painful erection. This is known as priapism. You may need medical treatment.
• You experience involuntary rhythmic movements of the tongue, mouth, and face. You may need to discontinue paliperidone.
• You experience a severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, hives, skin rash, and sometimes a decrease in blood pressure (i.e., anaphylactic reaction).

Very common side effects: can affect more than 1 in 10 patients

• Difficulty staying or falling asleep
• Parkinsonism: This disease can include slow or altered movement, a feeling of stiffness or tension in the muscles (making sudden movements) and sometimes a feeling of "freezing" of movement that is then restarted. Other signs of parkinsonism include walking slowly dragging the feet, trembling while descending stairs, increased saliva and/or drooling, and loss of facial expression.
• Insomnia
• Feeling drowsy or less alert
• Abdominal pain

Common side effects: can affect up to 1 in 10 patients

• Respiratory tract infection (bronchitis), common cold symptoms, urinary tract infection, feeling like you have a lump in your throat
• Weight gain, increased appetite, weight loss, decreased appetite
• Euphoria (mania), irritability, depression, anxiety
• Dystonia: A condition that involves involuntary slow or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dystonia often affects the facial muscles, including abnormal movements of the eyes, mouth, tongue, or mandible.
• Dizziness
• Dyskinesia: A condition that involves involuntary muscle movements and can include repetitive, spasmodic, or twisting movements, or spasms
• Tremor (agitation)
• Blurred vision
• Abnormal heart rhythm, anomalies in heart electrical activity (electrocardiogram or ECG), sensation of fluttering or pounding in the chest (palpitations)
• Decreased blood pressure when standing (resulting in some people taking paliperidone feeling weak, dizzy, or losing consciousness when standing or sitting suddenly), increased blood pressure
• Sore throat, cough, congestion
• Abdominal pain, nausea, vomiting, constipation, diarrhea, indigestion, dry mouth, toothache
• Increased liver enzymes in the blood (gamma-glutamyltransferase or GGT)
• Itching, skin rash
• Bone or muscle pain, back pain, joint pain
• Loss of menstrual periods
• Fever, weakness, fatigue (cansaço)

Rare side effects: can affect up to 1 in 1,000 patients

• Eye infection, fungal infection of the nails, skin infection, inflammation of the skin caused by bacteria

• Very low count of a type of white blood cell necessary for fighting infections
• Decreased count of a type of white blood cell that helps fight infections, increased eosinophils (a type of white blood cell) in the blood
• Severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, hives, skin rash, and sometimes a decrease in blood pressure (i.e., anaphylactic reaction)
• High blood sugar
• Incorrect secretion of a hormone that controls urine volume
• Complications of uncontrolled diabetes with a risk to life
• Excessive water intake, decreased blood sugar, excessive water intake, increased cholesterol in the blood
• Somnambulism
• Not moving or responding while awake (catatonia)
• Absence of emotions
• Neuroleptic malignant syndrome (confusion, decreased or lost consciousness, high fever, and severe muscle rigidity)
• Loss of consciousness, balance, and coordination disorders
• Problems with blood vessels in the brain, coma due to uncontrolled diabetes, decreased response to stimuli, decreased level of consciousness, tremor of the face
• Glaucoma (increased pressure in the eyeball), increased tear production, redness of the eyes, problems with eye movement, eye rotation
• Atrial fibrillation (abnormal heart rhythm), rapid heart rate when standing
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can travel through the blood vessels to the lungs causing chest pain and difficulty breathing. If you experience any of these symptoms, seek medical advice.
• Decreased oxygen in parts of the body (due to decreased blood flow), flushing
• Respiratory problems during sleep (sleep apnea), rapid breathing, superficial breathing
• Pneumonia caused by aspiration of food, respiratory tract congestion, voice disorder
• Intestinal obstruction, fecal incontinence, hard stools, absence of intestinal movement causing obstruction
• Yellow skin and eyes (ictericia)
• Inflammation of the pancreas
• Severe allergic reaction with swelling, which can affect the throat causing difficulty breathing
• Thickening of the skin, dry skin, redness of the skin, skin or scalp discoloration, scaly skin with itching, eczema
• Muscle fiber rupture and muscle pain (rhabdomyolysis), anomaly in the posture
• Priapism (prolonged erection that may require surgical treatment)
• Development of breasts in men, increased breast gland size, milk secretion by the breasts, vaginal secretion
• Delayed menstrual periods, increased breast size
• Very low body temperature, decreased body temperature
• Withdrawal symptoms from the medication

Unknown: their frequency cannot be estimated from the available data

• Pulmonary congestion
• Increased insulin (a hormone that controls blood sugar levels) in the blood

The following side effects have appeared with the use of another medication called risperidone, which is very similar to paliperidone, so it is also expected to appear with paliperidone: eating disorder related to sleep, other types of blood vessel problems in the brain, crepitant sounds from the lungs, and severe or fatal skin rash with blisters and peeling of the skin that can start in the mouth, nose, eyes, and genitals and spread to other parts of the body (Stevens-Johnson syndrome/toxic epidermal necrolysis). Other eye problems may also occur during cataract surgery. During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) may occur if you are taking or have taken paliperidone. If you need to undergo cataract surgery, make sure to inform your ophthalmologist if you are taking or have taken this medication.

Additional side effects in adolescents

Adolescents generally experienced side effects similar to those found in adults, except for the following side effects that were detected more frequently:

• Feeling drowsy or less alert
• Parkinsonism: This disease can include slow or altered movement, a feeling of stiffness or tension in the muscles (making sudden movements) and sometimes a feeling of "freezing" of movement that is then restarted. Other signs of parkinsonism include walking slowly dragging the feet, trembling while descending stairs, increased saliva and/or drooling, and loss of facial expression.
• Tremor while descending stairs
• Average weight gain
• Common cold symptoms
• Insomnia
• Tremor (agitation)
• Abdominal pain
• Milk secretion by the breasts in girls
• Swelling of the breasts in boys
• Acne
• Speech problems
• Stomach or intestinal infection
• Nosebleeds
• Ear infection
• High triglycerides in the blood (a type of fat)
• Sensation of movement (vertigo)

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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://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.

Store in the original packaging to protect it from moisture.

This medication does not require any special storage temperature.

Do not dispose of medications through drains or trash. Deposit empty containers and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of empty containers and unused medications. This will help protect the environment.

Paliperidone TAD Composition

• The active ingredient is paliperidone.
• Each prolonged-release tablet contains 3 mg, 6 mg or 9 mg of paliperidone.

-The other components are:

Core: macrogol 200 000, macrogol 7 000 000, macrogol 4000, hydroxybutyltoluene, povidone, sodium chloride, microcrystalline cellulose, magnesium stearate, red iron oxide (E172), hydroxypropylcellulose and cellulose acetate.

Coating: hypromellose, titanium dioxide (E171), talc, propylene glycol, yellow iron oxide (E172) – only for 6 mg tablets and red iron oxide (E172) – only for 9 mg tablets.

Printed ink: shellac, black iron oxide (E172) and propylene glycol. See section 2 “Paliperidone TAD contains sodium”.

Appearance of the product and contents of the pack

3 mg: Film-coated, biconvex, round, white to light grey tablets with a possible irregular surface and printed with the mark P3 on one side of the tablet. Diameter: approximately 9 mm.

6 mg: Film-coated, biconvex, round, yellowish-brown tablets with a possible irregular surface and printed with the mark P6 on one side of the tablet. Diameter: approximately 9 mm.

9 mg: Film-coated, biconvex, round, pale pink tablets with a possible irregular surface and printed with the mark P9 on one side of the tablet. Diameter: approximately 9 mm.

Paliperidone TAD are available in packs of 14x1, 28x1 and 56x1 prolonged-release tablets in blister packs.

Only some pack sizes may be marketed.

Marketing Authorisation Holder

TAD Pharma GmbH, Heinz-Lohmann‑Straße 5, 27472 Cuxhaven, Germany

Manufacturer

KRKA d.d. Novo mesto

Smarjeska cesta 6

8501 Novo mesto

Slovenia

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, 28108 Alcobendas, Madrid, Spain

This medicine is authorised in the member states of the European Economic Area with the following names:

Last review date of this leaflet:April 2024

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