Paliperidone Alter 9 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paliperidona Alter 3 mg prolonged-release tablets EFG

Paliperidona Alter 6 mg prolonged-release tablets EFG

Paliperidona Alter 9 mg prolonged-release tablets EFG

Read this entire leaflet carefully before you start taking this medicine because 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, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Paliperidona Alter is and what it is used for

Paliperidona contains the active substance paliperidone, which belongs to a class of medications called antipsychotics.

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

Schizophrenia is a disorder that causes symptoms such as hearing, seeing, or feeling things that do not exist, having false beliefs, excessive distrust, withdrawing into oneself, speaking incoherently, and impaired planning of behaviour and emotional expression. People with this disorder may also feel depressed, anxious, guilty, or tense.

Paliperidone is also used to treat schizoaffective disorder in adults.

Schizoaffective disorder is a mental condition in which a person experiences several of the symptoms of schizophrenia (listed in the previous paragraph) together with mood disorder symptoms (feelings of euphoria, sadness, agitation, distractibility, insomnia, pressured speech, loss of interest in everyday activities, excessive or insufficient sleep, excessive or reduced food intake, and recurrent suicidal thoughts).

Paliperidone may help relieve the symptoms of your illness and prevent them from returning.

2. What you need to know before starting Paliperidona Alter

Do not take paliperidone

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting paliperidone.

• Patients with schizoaffective disorder treated with this medicine should be closely monitored for a possible shift from manic symptoms to depressive symptoms.

• This medicine has not been studied in elderly patients with dementia. However, elderly patients with dementia who are treated with similar medicines 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 body temperature and muscle rigidity (also known as Neuroleptic Malignant Syndrome).

• if you have ever experienced abnormal movements of the tongue or face (Tardive Dyskinesia).

You should be aware that these two disorders may be caused by this type of medicine.

• if you have previously had low levels of white blood cells in the blood (which may or may not have been caused by other medicines).
• if you have diabetes or are prone to diabetes.
• if you have heart disease or are receiving treatment for heart conditions that could make you more susceptible to a drop in blood pressure.
• if you have epilepsy.
• if you have a swallowing disorder, or stomach or intestinal problems that reduce your ability to swallow food or digest it with normal intestinal movements.
• if you have conditions associated with diarrhea.
• if you have kidney problems.
• if you have liver problems.
• if you experience prolonged and/or painful erection.
• if you have difficulty regulating body temperature or are overheated.
• if you have abnormally high levels of prolactin hormone in the blood or have a tumor that may be prolactin-dependent.
• if you or someone in your family has a history of blood clots, as antipsychotics have been associated with blood clot formation.

If you have any of these conditions, please consult your doctor, as a dose adjustment or monitoring may be necessary.

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

Paliperidone may cause weight gain. Significant weight gain can negatively affect your health. Your doctor will regularly monitor your weight.

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

During eye surgery for lens clouding (cataracts), the pupil (the black circle in the center of the eye) may not dilate as needed. In addition, the iris (the colored part of the eye) may become floppy during surgery, which could cause eye damage. If you are considering eye surgery, make sure to inform your ophthalmologist that you are taking this medicine.

Children and adolescents

Paliperidone must not be given to children and adolescents under 15 years of age for the treatment of schizophrenia.

Paliperidone must not be given to children and adolescents under 18 years of age for the treatment of schizoaffective disorder.

This is because it is unknown whether paliperidone is safe or effective in this age group.

Other medicines and paliperidone

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

Abnormalities in the heart's electrical function may occur when this medicine is taken together with other medicines used to control heart rhythm or other medicines such as antihistamines, antimalarials, or antipsychotics.

Since this medicine acts mainly in the brain, it may interact with other medicines (or alcohol) that also act on the brain, due to additive effects on brain function.

This medicine may lower blood pressure, so caution is needed if taken together with other medicines that also lower blood pressure.

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

The effects of this medicine may be altered if taken with medicines that affect intestinal motility (e.g., metoclopramide).

Dose reduction of this medicine should be considered when administered concomitantly with valproate.

The use of oral risperidone together with this medicine is not recommended, as this combination may lead to an increase in adverse effects.

Taking paliperidone with alcohol

You should avoid consuming alcohol during treatment with this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

Do not take this medicine during pregnancy unless you have discussed it with your doctor.

The following symptoms may occur in newborn babies whose mothers were treated with paliperidone during the third trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, contact your doctor immediately.

Do not take this medicine during breastfeeding.

Driving and using machines

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

Paliperidona Alter contains sodium

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

3. How to take Paliperidona Alter

Follow exactly the instructions for using this medicine as given by your doctor, pharmacist, or nurse.

Use in adults

The recommended dose in adults is 6 mg once daily in the morning. Your doctor may increase or decrease your dose within the dosage range of 3 mg to 12 mg once daily for schizophrenia, or 6 mg to 12 mg once daily for schizoaffective disorder. This depends on how well the medicine works for you.

Use in adolescents

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

For adolescents weighing 51 kg or more, the dose may be increased within the range of 6 mg to 12 mg once daily.

For adolescents weighing less than 51 kg, the dose may be increased to 6 mg once daily.

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

How and when to take paliperidone

This medicine must be taken by mouth, swallowed whole with water or other liquids. Do not chew, break, or crush the tablet.

This medicine should be taken in the morning with breakfast or on an empty stomach, but always in the same way each day. Do not alternate between taking the medicine one day with breakfast and the next day on an empty stomach.

The active substance, paliperidona, dissolves after swallowing, and the tablet coating is eliminated from the body in the faeces.

Patients with kidney problems

Your doctor may adjust the dose of this medicine depending on your kidney function.

Elderly patients

Your doctor may reduce your dose if you have reduced kidney function.

If you take more paliperidone than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist or go to the nearest hospital immediately, or call the Toxicology Information Service. Telephone: 91 562 04 20, indicating the medicine and the amount ingested. You may experience drowsiness, fatigue, abnormal body movements, difficulty standing and walking, dizziness due to low blood pressure, and changes in heart rhythm.

If you forget to take paliperidona

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

If you stop taking paliperidona

Do not stop taking this medicine, as you will lose the benefits of treatment. You should not stop taking this medicine unless instructed by your doctor, as your symptoms may return.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Tell your doctor immediately if:

• You develop blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical advice immediately.
• You have dementia and experience a sudden change in mental status or sudden weakness or numbness of the face, arms, or legs—especially on one side—or have difficulty speaking, even briefly. These may be signs of a stroke.
• You develop fever, muscle stiffness, sweating, or decreased level of consciousness (a disorder known as "Neuroleptic Malignant Syndrome"). Immediate medical treatment may be required.
• You are male and experience a prolonged or painful erection. This is known as priapism. Immediate medical treatment may be needed.
• You experience involuntary rhythmic movements of the tongue, mouth, or face. Discontinuation of paliperidone may be necessary.
• You have a severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, itching, skin rash, and sometimes a drop in blood pressure (i.e., an "anaphylactic reaction").

Very common: may affect more than 1 in 10 patients

• Difficulty falling or staying asleep
• Parkinsonism: This condition may include slow or altered movement, a sensation of muscle stiffness or tightness (resulting in jerky movements), and sometimes a feeling of "freezing" of movement that then restarts. Other signs of parkinsonism include shuffling while walking slowly, resting tremor, increased saliva and/or drooling, and reduced facial expressiveness.
• Restlessness
• Feeling drowsy or less alert
• Headache

Common adverse effects: may affect up to 1 in 10 patients

• Chest infection (bronchitis), symptoms of a common cold, nasal infection, urinary tract infection, feeling as if you have the flu
• Weight gain, increased appetite, weight loss, decreased appetite
• Euphoria (mania), irritability, depression, anxiety
• Dystonia: A condition involving involuntary, slow, or sustained muscle contractions. Although any part of the body may be affected (and may lead to abnormal postures), dystonia frequently affects facial muscles, including abnormal eye, mouth, tongue, or jaw movements.
• Dizziness
• Dyskinesia: A condition involving involuntary muscle movements, which may include repetitive, spasmodic, or twisting movements or spasms
• Tremor (agitation)
• Blurred vision
• Conduction disturbances between the upper and lower parts of the heart, abnormalities in the heart's electrical conduction, QT interval prolongation in the heart, slow heartbeat, rapid heartbeat
• Decreased blood pressure upon standing (as a result, some people taking paliperidona may feel weak, dizzy, or lose consciousness when standing up or sitting down suddenly), increased blood pressure
• Sore throat, cough, nasal congestion
• Abdominal pain or discomfort, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache
• Increased liver transaminases in the blood
• Itching, skin rash
• Bone or muscle pain, back pain, joint pain
• Absence of menstrual periods
• Fever, weakness, fatigue (tiredness)

Uncommon adverse effects: may affect up to 1 in 100 patients

• Pneumonia, respiratory tract infection, bladder infection, ear infection, tonsillitis
• Decreased number of white blood cells, decreased platelets (blood cells that help stop bleeding), anemia, decreased number of red blood cells
• Paliperidone may increase levels of a hormone called "prolactin" detectable in blood tests (which may or may not cause symptoms). When symptoms of elevated prolactin occur, they may include: (in men) breast swelling, difficulty achieving or maintaining erections or other sexual dysfunction; (in women) breast discomfort, milk secretion from the breasts, absence of menstrual periods, or other menstrual cycle problems
• Diabetes or worsening of diabetes, increased blood sugar, increased waist circumference, loss of appetite leading to malnutrition and reduced body weight, increased blood triglycerides (a type of fat)
• Sleep disorder, confusion, decreased sexual desire, inability to achieve orgasm, nervousness, nightmares
• Tardive dyskinesia (spasms or uncontrollable spasmodic movements of the face, tongue, or other body parts). Inform your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth, or face. Discontinuation of paliperidone may be necessary.
• Seizures (epileptic fits), fainting, restlessness causing body movements, dizziness upon standing, attention disturbances, speech problems, loss or alteration of taste, decreased skin sensitivity to pain or touch, tingling, prickling, or numbness of the skin
• Light sensitivity of the eyes, eye infection, or "red eye," dry eyes
• Sensation of spinning (vertigo), ringing in the ears, ear pain
• Irregular heartbeat, abnormal electrical activity of the heart (electrocardiogram or ECG), fluttering or pounding sensation in the chest (palpitations)
• Decreased blood pressure
• Shortness of breath, gasping, nosebleeds
• Swelling of the tongue, stomach or intestinal infection, difficulty swallowing, excess gas or flatulence
• Increased GGT (a liver enzyme called gamma-glutamyl transferase) in blood, increased liver enzymes in blood
• Hives (or "urticaria"), hair loss, eczema, acne
• Increased CPK (creatine phosphokinase) in blood, an enzyme sometimes released during muscle breakdown, muscle spasms, joint stiffness, joint swelling, muscle weakness, neck pain
• Urinary incontinence (loss of control), frequent urination, inability to pass urine, painful urination
• Erectile dysfunction, ejaculation disorder
• Absence of menstrual periods or other cycle problems (in women), milk secretion from the breasts, sexual dysfunction, breast pain, breast discomfort
• Swelling of the face, mouth, eyes, or lips; swelling of the body, arms, or legs
• Chills, increased body temperature
• Change in walking pattern
• Feeling thirsty
• Chest pain, chest discomfort, feeling unwell
• Falls

Rare adverse effects: may affect up to 1 in 1,000 patients

• Eye infection, fungal nail infection, skin infection, skin inflammation caused by mites
• Dangerously low levels of a type of white blood cell needed to fight infections
• Decreased levels 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, itching, skin rash, and sometimes a drop in blood pressure; allergic reaction
• Sugar in the urine
• Inappropriate secretion of a hormone that controls urine volume
• Life-threatening complications of uncontrolled diabetes
• Dangerously excessive water intake, low blood sugar, excessive water intake, increased blood cholesterol
• Sleepwalking
• Absence of emotions
• Neuroleptic malignant syndrome (confusion, decreased or loss of consciousness, high fever, and severe muscle rigidity)
• Loss of consciousness, balance disorder, abnormal coordination
• Problems with blood vessels in the brain, coma due to uncontrolled diabetes, unresponsiveness to stimuli, decreased level of consciousness, head tremor
• Glaucoma (increased pressure in the eyeball), increased tearing, eye redness, eye movement problems, eye rolling
• Atrial fibrillation (abnormal heart rhythm), rapid heartbeat upon standing
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which may travel through blood vessels to the lungs causing chest pain and breathing difficulties. If you experience any of these symptoms, seek medical help immediately.
• Decreased oxygen in parts of the body (due to reduced blood flow), flushing
• Breathing problems during sleep (sleep apnea), rapid, shallow breathing
• Pneumonia caused by aspiration of food, respiratory congestion, voice disorder
• Intestinal obstruction, fecal incontin ence, very hard stools, absence of intestinal movement causing obstruction
• Yellowing of the skin and eyes (jaundice)
• Pancreatitis (inflammation of the pancreas)
• Severe allergic reaction with swelling, which may affect the throat and cause breathing difficulties
• Thickening of the skin, dry skin, skin redness, skin discoloration, scaly and itchy skin or scalp, dandruff
• Muscle fiber breakdown and muscle pain (rhabdomyolysis), postural abnormalities
• Priapism (a prolonged erection that may require surgical treatment)
• Breast development in males, enlargement of mammary glands, milk secretion from the breasts, vaginal secretion
• Delayed menstrual periods, breast enlargement
• Very low body temperature, decreased body temperature
• Medication withdrawal symptoms

Not known: frequency cannot be estimated from available data

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

The following adverse effects have occurred with the use of another medicine called risperidone, which is very similar to paliperidone, and therefore may also be expected with paliperidona: sleep-related eating disorder, other types of blood vessel problems in the brain, and crackling lung sounds. Eye problems may also occur during cataract surgery. During cataract surgery, a disturbance called intraoperative floppy iris syndrome (IFIS) may occur if you are taking or have taken paliperidone. If you need cataract surgery, make sure to inform your ophthalmologist if you are taking or have taken this medicine.

Additional adverse effects in adolescents

Adolescents generally experienced adverse effects similar to those seen in adults, except for the following effects, which occurred more frequently:

• Feeling drowsy or less alert
• Parkinsonism: This condition may include slow or altered movement, a sensation of muscle stiffness or tightness (resulting in jerky movements), and sometimes a feeling of "freezing" of movement that then restarts. Other signs of parkinsonism include shuffling while walking slowly, resting tremor, increased saliva and/or drooling, and reduced facial expressiveness.
• Weight gain
• Symptoms of the common cold
• Restlessness
• Tremor (agitation)
• Stomach pain
• Milk secretion from the breasts in girls
• Breast swelling in boys
• Acne
• Speech problems
• Stomach or intestinal infection
• Nosebleeds
• Ear infection
• High blood triglycerides (a type of fat)
• Sensation of movement (vertigo)

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Paliperidone Alter

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

Do not use this medicine after the expiry date stated on the blister and the carton after EXP. The expiry date is the last day of the month indicated.

Blister packs: Store in the original packaging to protect from moisture.

This medicine does not require any special storage temperature conditions.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If in doubt, please ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paliperidona Alter

The active substance is paliperidone.

Each 3 mg prolonged-release tablet of Paliperidona Alter contains 3 mg of paliperidone.

Each 6 mg prolonged-release tablet of Paliperidona Alter contains 6 mg of paliperidone.

Each 9 mg prolonged-release tablet of Paliperidona Alter contains 9 mg of paliperidone.

The other components are:

Core

Macrogol 200 000, macrogol 7000 000, butylhydroxytoluene, povidone K30, sodium chloride, microcrystalline cellulose PH102, magnesium stearate, red iron oxide (E172).

Intermediate tablet coating

Hydroxypropylcellulose

Semi-permeable coating

Cellulose acetate, macrogol 4000 Ph.Eur

Coating

Hypromellose 6CP, titanium dioxide, talc, propylene glycol, red iron oxide (E172) (for the 9 mg dose), yellow iron oxide (for the 6 mg dose)

Printing ink

Shellac, black iron oxide (E172).

Appearance of the product and contents of the pack

The 3 mg prolonged-release tablets of Paliperidona Alter are round, biconvex, white to greyish in colour, possibly with an irregular surface, printed with the mark "P3" on one side of the tablet.

The 6 mg prolonged-release tablets of Paliperidona Alter are round, biconvex, brownish-yellow in colour, possibly with an irregular surface, printed with the mark "P6" on one side of the tablet.

The 9 mg prolonged-release tablets of Paliperidona Alter are round, biconvex, pink in colour, possibly with an irregular surface, printed with the mark "P9" on one side of the tablet.

The tablets are supplied in blisters packed in cartons of 28 tablets.

Marketing Authorisation Holder

Laboratorios Alter S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Manufacturer

Krka, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Date of the most recent revision of this leaflet: July 2018

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/