Prospect: information for the user

Paliperidone Alter 3 mg prolonged-release tablets EFG

Paliperidone Alter 6 mg prolonged-release tablets EFG

Paliperidone Alter 9 mg prolonged-release tablets EFG

Read this prospect carefully before starting to take the medicine because it contains important information for you.

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

-If you have any questions, consult your doctor, pharmacist, or nurse.

-This medicine has been prescribed only for you and should not be given 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, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

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

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

3. How to take Paliperidone Alter

4. Possible adverse effects

5. Storage of Paliperidone Alter

6. Contents of the pack and additional information

Paliperidonecontineelprincipioactivopaliperidonaquepertenecealaclasedemedicamentosantipsicóticos.

Paliperidoneseusaparatratarlaesquizofreniaenadultosyadolescentesde15añosdeedadenadelante.

Laesquizofreniaesuntrastornoqueprovocasíntomasqueconsistenenoír,verosentircosasquenoexisten,tenercreenciaserróneas,tenerunadesconfianzafueradelonormal,encerrarseensímismo,hablaincoherenteyaplanamientodelaconducta ylaemotividad.Laspersonasquepadecenestetrastornotambiénsepuedensentirdeprimidas,ansiosas,culpablesotensas.

Paliperidoneseusatambiénparatratareltrastornoesquizoafectivoenadultos.

Eltrastornoesquizoafectivoesunaafecciónmentalporlaquelapersonaexperimentavariosdelossíntomasdelaesquizofrenia(enumeradosenelpárrafoanterior)ademsdesíntomasdetrastornodelánimo(sensacióndeeuforia,detristeza,deagitación,estadodistraído,insomnio,verborrea,pérdidadeinterésenactividadescotidianas,suenfermedayevitarquereaparezcan,suenoexcesivooescaso,ingestiónexcesivaoescasadealimentosypensamientosrecurrentesdesuicidio).

Paliperidonepuedeayudaraaliviarlossíntomasdesuenfermedayevitarquereaparezcan.

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, pharmacist, or nurse before starting to take paliperidone.

- Patients with bipolar disorder treated with this medication should be closely monitoredfora potential change from manic symptoms to depressive symptoms.

-This medication has not been studied in elderly patients with dementia. However, elderly patientswithdementia who are treated with other medications may have an increased risk of stroke or death(see section 4, Possible Adverse Effects).

- if you have Parkinson's disease ordementia.

-if you have ever been diagnosed with a condition whose symptoms are high temperature andmuscular rigidity (also known as Neuroleptic Malignant Syndrome).

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

You should know that these two conditions may be caused by this type ofmedicament.

- if you have had low levels of white blood cells in the past (which may or may not havesido

been caused by othermedicamentos)

- if you are diabetic or have a tendency todiabetes.

-if you have any heart disease or if you are receiving treatment for heart diseases that maymakeyyou more prone to a reduction in bloodarterial.

- if you haveepilepsia.

-if you have any swallowing, stomach, or intestinal disorders that reduce your ability toswallowfood or digest it with normal intestinalmovements.

- if you have diseases associated withdiarrea.

- if you have problems withriñón.

- if you have problems withhígado.

- if you have an erection that lasts for a long time and/or isdolorosa.

- if you have difficulty controlling your body temperature or areacalorado.

-if you have an abnormally high level of prolactin in your blood or if you have a tumor thatmaybebedependentontheprolactina.

-if you or a family member has a history of blood clots, as antipsychotics are associated withbloodclotformation.

If you have any of these conditions, please consult your doctor as you may need a dose adjustmentormonitoring.

Due to the rare occurrence of a dangerously low number of a type of white blood cells necessaryforfighting infections in the blood, your doctor may check the number of whiteblancas.

Paliperidone may cause you to gain weight. Significant weight gain can have a negative impact onyourhealth.

Your doctor will regularly monitor yourweight.

In patients treated with paliperidone, diabetes mellitus or worsening of existing diabetes mellitushasbeenobserved.Your doctor should check for signs of increased blood sugar.In patients with pre-existing diabetes mellitus, blood sugar should be regularlymonitored.

During eye surgery for cataracts, the pupil may not dilate as needed. Additionally, the iris maybeccomeflaciddduringsurgery and this may cause eye damage.Please inform your ophthalmologist that you are taking thismedicament.

Children andadolescents

Paliperidone should not be administered to children and adolescents under 15 years of age for thetreatmentofschizophrenia.

Paliperidone should not be administered to children and adolescents under 18 years of age for thetreatmentofbipolardisorder.

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

Othermedicines and paliperidone

Please inform your doctor or pharmacist if you are using or have recently usedother medicaments.

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

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

This medication may reduce blood pressure, so you should be careful if you take this medicationwithosemedicamentsthatalsoreducebloodpressure.

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

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

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

It is not recommended to use risperidone oral with this medication as this combination mayprovokeanincreasedeffects.

Paliperidone and alcohol

You should avoid consuming alcohol during treatment with thismedicament.

Pregnancy andlactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor orpharmaceuticantorebefore taking thismedicament.

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

The following symptoms may occur in newborn babies whose mothers were treated withpaliperidoneinthelasttrimesterofpregnancy(the last three months of pregnancy):templor,rigideness and/or muscle weakness, somnolence, agitation, breathing problems, and difficultyinfeeding.If your baby develops any of these symptoms, please contact your doctor.

You should not take this medication during lactation.

Driving and operatingmachinery

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

Paliperidone Alter contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentiallysodiumfree

Follow exactly the administration instructions of this medication indicated by your doctor, pharmacist or nurse.

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 from 15 years of age 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. Do not chew, break or crush it.

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 one day with breakfast and the next day on an empty stomach.

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 with liver problems

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

Overdose

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 cardiac arrhythmias.

Missed dose

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.

Discontinuation of 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 questions about the use of this medication, ask your doctor, pharmacist 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:

• 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 notice any of these symptoms, seek medical advice.

• Dementia and a sudden change in your mental state or sudden weakness or numbness of 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 stroke.

• Fever, muscle stiffness, sweating, or a decrease in consciousness (a condition known as "Neuroleptic Malignant Syndrome"). You may need medical treatment.

• Men who experience a prolonged or painful erection. This is known as priapism. You may need medical treatment.

• Involuntary rhythmic movements of the tongue, mouth, and face. You may need to stop taking this medicine.

• A severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, itching, skin rash, and sometimes a decrease in blood pressure (known as "anaphylactic reaction").

Very common: may affect more than 1 in 10 people

- 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 reinitiated. Other signs of parkinsonism include walking slowly dragging the feet, trembling while descending stairs, increased saliva and/or drooling, and loss of facial expression.

- Inquietude

- Feeling drowsy or less attentive

- Back pain

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

- Chest infection (bronchitis), common cold symptoms, nasal infection, 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: This disease 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.

- Mareos

- Dyskinesia: This disease involves involuntary muscle movements and can include repetitive, spasmodic, or twisting movements, or spasms

- Trembling (agitation)

- Blurred vision

- Abnormal heart rhythm, heart conduction abnormalities, prolonged QT interval in the heart, irregular heartbeat, rapid heartbeat

- Decreased blood pressure when standing up (as a result, some people taking paliperidone may feel weakness, dizziness, or loss of consciousness when standing up or sitting down suddenly), increased blood pressure

- Sore throat, cough, congestion

- Abdominal pain, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache

- Increased liver enzymes in the blood

- Itching, skin rash

- Back pain, muscle pain, joint pain

- Loss of menstrual periods

- Fever, weakness, fatigue (cansa)

- Pneumonia, respiratory tract infection, urinary tract infection, ear infection, angina

- Decreased white blood cell count, decreased platelet count (a type of blood cell that helps stop bleeding), anemia, decreased red blood cell count

- Paliperidone may increase levels of a hormone called "prolactin" that is detected in blood tests (which may or may not cause symptoms). When symptoms of increased prolactin appear, they may include: (in men) breast swelling, difficulty getting or maintaining erections, or other sexual dysfunction, (in women) breast discomfort, milk secretion by the breasts, loss of menstrual periods, or other menstrual cycle problems.

- Diabetes or worsening of diabetes, increased blood sugar, increased circumference of the waist, loss of appetite causing malnutrition and weight loss, increased triglycerides in the blood (a type of fat)

- Sleep disorder, confusion, decreased sexual desire, inability to achieve orgasm, nervousness, pesadillas

- Dyskinesia tardía (spasms or involuntary movements that cannot be controlled in the face, tongue, or other parts of the body). Inform your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth, or face. You may need to stop taking paliperidone.

- Seizures (epileptic crises), fainting, restlessness that causes movement of parts of the body, dizziness when standing up, altered attention, speech problems, loss or alteration of taste, decreased sensitivity of the skin to pain or touch, sensation of pins and needles, numbness, or tingling of the skin

- Increased sensitivity of the eyes to light, eye infection, or "red eye," dry eyes

- Feeling like everything is spinning (vertigo), ringing in the ears, ear pain

- Irregular heartbeat, abnormal heart activity (electrocardiogram or ECG), sensation of fluttering or pounding in the chest (palpitations)

- Decreased blood pressure

- Interrupted breathing, gasping, nasal bleeding

- Swelling of the tongue, stomach or intestinal infection, difficulty swallowing, excessive gas or flatulence

- Increased GGT (a liver enzyme called gamma-glutamiltransferase) in the blood, increased liver enzymes in the blood

- Hives (urticaria), hair loss, eczema, acne

- Increased CPK (creatine phosphokinase) in the blood, an enzyme that sometimes is released with muscle breakdown, muscle spasms, joint stiffness, swelling of the joints, muscle weakness, muscle pain

- Urinary incontinence, frequent urination, inability to urinate, painful urination

- Erectile dysfunction, sexual dysfunction

- Loss of menstrual periods or other menstrual cycle problems (women), milk secretion by the breasts, sexual dysfunction, breast pain, breast discomfort

- Swelling of the face, mouth, eyes, or lips, swelling of the body, arms, or legs

- Chills, high body temperature

- Change in the way you walk

- Feeling of sedation

- Chest pain, chest discomfort, feeling of malaise

- Falls

Rare side effects: may affect up to 1 in 1,000 people

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

- Peligrosamente low count of a type of white blood cell necessary for combat 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, itching, skin rash, and sometimes decreased blood pressure, anaphylactic reaction

- Sugar in the urine

- Inappropriate secretion of a hormone that controls urine volume

- Complications of uncontrolled diabetes with risk to life

- Peligrosamente excessive water intake, decreased blood sugar, excessive water intake, increased cholesterol in the blood

- Somnambulismo

- Absence of emotions

- Neuroleptic malignant syndrome (confusion, decreased or lost consciousness, high fever, and severe muscle stiffness)

- Loss of consciousness, balance disorder, coordination abnormality

- Problems in the blood vessels of the brain, coma due to uncontrolled diabetes, response to stimuli, decreased level of consciousness, tremor of the face

- Glaucoma (increased pressure of the eyeball), increased tear production, redness of the eyes, eye movement problems, eye rotation

- Atrial fibrillation (abnormal heart rhythm), rapid heartbeat when standing up

- 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 notice 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, caspa

- Muscle fiber rupture and muscle pain (rhabdomyolysis), abnormal posture

- Priapismo (prolonged erection that may require surgical treatment)

- Development of breasts in men, increased breast tissue, milk secretion by the breasts, vaginal secretion

- Delayed menstrual periods, increased breast size

- Low body temperature, decreased body temperature

- Symptoms of withdrawal from the medication

Unknown: their frequency cannot be estimated from available data

- Congestion of the lungs

- 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: sleep-related eating disorder, other types of cerebrovascular problems, and crepitant sounds from the lungs. Other eye problems may also appear 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 attentive

• 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 reinitiated. Other signs of parkinsonism include walking slowly dragging the feet, trembling while descending stairs, increased saliva and/or drooling, and loss of facial expression.

• Weight gain

• Common cold symptoms

• Inquietude

• Trembling (agitation)

• Back pain

• Milk secretion by the breasts in girls

• Breast swelling in boys

• Acne

• Speech problems

• Stomach or intestinal infection

• Nasal hemorrhages

• Ear infection

• High triglycerides in the blood (a type of fat)

• Sensation of movement (vertigo)

Reporting of side effects

If you experience side effects, consult your doctor, pharmacist, or nurse, even if the side effects do not appear in this leaflet. 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 blister pack in thebox after CAD. The expiration date is the last day of the month indicated.

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

This medication does not require any special storage temperature.

Medicines should not be disposed of through drains or trash. Dispose of containers and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacisthowtodisposeofthecontainersandmedicationsyounolongerneed. This will help protect the environment.

Composition of Paliperidone Alter

The active principle is paliperidone.

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

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

Each prolonged-release tablet of 9 mg 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

Permeable coating

Cellulose acetate, macrogol 4000 Ph.Eur

Coating

6CP hypromellose, 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, iron oxide black (E172).

Appearance of the product and contents of the package

The prolonged-release tablets of Paliperidona Alter 3 mg are round, biconvex tablets of white to grayish color with a possible irregular surface and printed with the mark P3 on one side of the tablet.

The prolonged-release tablets of Paliperidona Alter 6 mg are round, biconvex tablets of yellowish-brown color with a possible irregular surface and printed with the mark P6 on one side of the tablet.

The prolonged-release tablets of Paliperidona Alter 9 mg are round, biconvex tablets of pink color with a possible irregular surface and printed with the mark P9 on one side of the tablet.

The tablets are provided in blisters packaged in boxes of 28 tablets.

Marketing Authorization Holder

Laboratorios Alter S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Responsible for manufacturing

Krka, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Last review date of this leaflet:July 2018

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