Paliperidona alter 6 mg comprimidos de liberacion prolongada efg
Introduction
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 doubts, consult your doctor, pharmacist, or nurse.
-This medicine has been prescribed only for you and should not be given 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, 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
1. What is Paliperidone Altra and what is it used for
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2. What you need to know before starting Paliperidone Altra
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 monitored foranychange in 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 and musclerigidity (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 have beencaused
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 may make youmoreproneto a reduction in bloodarterial.
- if you haveepilepsia.
-if you have any swallowing, stomach, or intestinal disorders that reduce your ability to swallowfoodsordigest them with normal intestinalmovements.
- if you have diseases associated withdiarrhea.
- if you have problems with yourriñón.
- if you have problems with yourhigado.
- 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 that may bedependenton prolactin.
-if you or a family member has a history of blood clots, as antipsychotics are associated with theformationofclots.
If you have any of these conditions, please consult your doctor as you may need a dose adjustment ormonitoring.
Due to the fact that in very rare cases, a dangerously low number of a type of white blood cellsnecessaryto combat infections in the blood has been observed in patients treated with paliperidone, yourdoctormaycomplecheck the number of whiteblancas.
Paliperidone may cause you to gain weight. A significant weight gain can negatively affect yourhealth.
Your doctor will regularly monitor your weight.
In patients treated with paliperidone, diabetes mellitus or worsening of pre-existing diabetes mellitushasbeenobserved. Your doctor should check for signs of increased blood sugar.Inpacientswith pre-existing diabetes mellitus should regularly monitor blood sugar.
During eye surgery for cataracts, the pupil (the black circle in the middle of the eye) may not dilateasnufficientlyas needed. Additionally, the iris (the colored part of the eye) may become flaccid during surgery andcausedamageto the eye.Sinceyoureareplaningto have eye surgery, make sure to inform your ophthalmologist that you are using thismedicament.
Children andadolescents
Paliperidone should not be administered to children and adolescents under 15 years old for thetreatmentofschizophrenia.
Paliperidone should not be administered to children and adolescents under 18 years old for thetreatmentofbipolardisorderadeschizoaffective.
This is because it is unknown whether paliperidone is safe or effective in this age group.
Othermedicines and paliperidone
Inform your doctor or pharmacist if you are using or have recently usedothermedicaments.
Abnormalities in heart function may occur when this medication is taken with other medications forritmcontrolofheartor other medications such as antihistamines, antimalarials, orantipsychótics.
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 medication withothermedicamentsthat alsoreducebloodpressureyres.
This medication may reduce the effect of medications for Parkinson's disease and restless legssyndrome(e.g.,levodopa).
The effects of this medication may be affected if you take medications that influence the speed ofintestinalmovement(e.g.,metoclopramida).
Consider reducing the dose of this medication when it is taken withvalproato.
It is not recommended to use risperidone oral with this medication as this combination may increaseadverseeffects.
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 or plan to become pregnant,consultyyourdoctoror pharmacist before taking thismedicament.
You should not take this medication during pregnancy unless you have discussed it with your doctor.
The following symptoms may occur in newborn babies, from mothers who have been treated withpaliperidonein the last trimester of pregnancy (last three months of your pregnancy):templor,rigideness,debility,agitation,pressureon,anddifficultyinfeeding.
You should not take this medication during lactation.
Driving and use ofmachinery
During treatment with this medication, dizziness and vision problems (see section 4, PossibleAdverseFfects)mayappeareinonenamatically,forexample,example,oroperateavehicle.
Paliperidone contains sodium
This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially “sodium-free”
3. How to Take Paliperidone Altra
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. Telephone: 91 562 04 20 indicating the medication and the amount ingested.You may experience drowsiness, dizziness, 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.
4. Possible Adverse Effects
Like all medicines, this medicine can cause side effects, although not everyone will 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 experience any of these symptoms, seek medical advice.
• Dementia and 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 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.
• Uncontrollable, rhythmic movements of the tongue, mouth, and face. You may need to discontinue paliperidone.
• 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 (known as anaphylaxis).
Very common: may 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 reinitiated. Other signs of parkinsonism include walking slowly dragging the feet, tremors while descending stairs, increased saliva and/or drooling, and loss of facial expression.
- Inquietude
- Feeling drowsy or less attentive
- Headache
Common side effects: may affect up to 1 in 10 patients:
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, or continuous muscle contraction. Although it can affect any part of the body (and may cause abnormal postures), dyskinesia most commonly affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or mandible.
- Dizziness
- Infection of the chest (bronchitis), symptoms of a common cold, infection of the nose, infection of the urinary tract, feeling like you have a lump in your throat
- Weight gain, increased appetite, weight loss, decreased appetite
- Euphoria (mania), irritability, depression, anxiety
- Dyskinesia: A disease that involves involuntary, slow, Keep this medication out of the sight and reach of children. Do not usethis medication after the expiration date that appears on the blister packinthebox after CAD. The expiration date is the last day of the month that isindicated. Blister packs: Store in the original packaging to protect it from moisture. This medication does not require any special storage temperature. Medicinesshould not be disposed of through drains or in the trash. Dispose of the containers and medicines that you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacistcómodispose of the containers and medicines that you no longer need. By doing so, you will helpprotect the environment. Composition of Paliperidone Alter The active ingredient 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, iron oxide red (E172). Intermediate tablet coating Hydroxypropylcellulose Permeable coating Cellulose acetate, macrogol 4000 Ph.Eur Coating 6CP hypromellose, titanium dioxide, talc, propylene glycol, iron oxide red (E172) (for the 9 mg dose), iron oxide yellow (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/5. Conservation of Paliperidone Alter
6. Contents of the packaging and additional information
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