XENOPALAN 100 mg. 50 tablets

XENOPALAN 100 mg. 50 tablets
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What Xenopalan and what it is used
Xenopalan is an antipsychotic (sometimes called neuroleptic) medication and belongs to a group of medicines known as dibenzodiazepini.
Xenopalan is used to treat schizophrenia in people who either received at least two other antipsychotic drugs without taking into account special therapeutic response or were intolerant to other antipsychotics because of side effects.
Xenopalan is also used to treat severe thought disturbances in patients with Parkinson's disease, where other therapies were unsuccessful.

2. What you need to know before taking Xenopalan
Do not take Xenopalan:
if you are allergic to clozapine or any of the other ingredients of this medicine (listed in section 6);
If you are unable to undergo regular blood tests;
if you have had low white blood cells (including after taking clozapine), unless it was after cancer treatment. Clozapine can reduce the number of white blood cells in the body, and these cells are important for fighting infection;
if you have or have had a disease of the bone marrow;
if you suffer from uncontrolled epilepsy (seizures);
if you have problems with alcohol or drug abuse, for example. drugs;
if you had a sudden stop circulation (circulatory collapse) or slowing of brain functions (unconscious);
if you have severe heart disease, or kidney problems;
if you have symptoms of active liver disease, such as nausea, anorexia or jaundice (yellowing of the skin), or liver failure;
if you suffer from loss of bowel activity, which causes severe constipation (paralytic ileus);
if currently you are taking drugs known to reduce the effect of white blood cells, including drugs that decrease bone marrow function (see. section "Other drugs and Xenopalan");
if you are being treated or have been treated with depot injections of antipsychotics with prolonged action.
Warnings and Precautions
Check whether any warnings listed below applies to you or is true for you in the past.
Contact your doctor immediately:
if you have flu-like symptoms, or any kind of infection. This may be indicative of the low number of white blood cells;
if you have a history of cardiac illness or abnormal cardiac findings. You should consult a specialist to conduct further investigations to decide whether you can take clozapine;
if you have just started taking clozapine, or if you are taking other antipsychotic drugs. Increased risk of lowering blood pressure with possible loss of consciousness. In these cases, your doctor will carefully monitor your blood pressure;
if you have any of the following symptoms: unexplained fatigue, shortness of breath or breathing faster than normal, rapid and irregular heartbeat. This may be indicative of heart disease;
if you suffer from liver disease. There should be regular monitoring of liver function;
If you have high intraocular pressure (glaucoma);
if you suffer from diabetes. Clozapine may worsen your diabetes;
if have difficulty urinating due to enlargement of the prostate gland;
if you suffer from (controlled) epilepsy (seizures). You should take a lower dose of clozapine;
if you have a fever, possibly combined with muscle stiffness, tremors, rapid breathing and / or drowsiness. These symptoms may be indicative of a serious neurological disorder (neuroleptic malignant syndrome);
if you suffer from constipation;
if you or someone in your family has a history of blood clots, as medicines like it have been associated with formation of blood clots.
Blood tests
Before starting treatment with clozapine will be a blood test to make sure that you take this medicine.
You will have regular blood tests while still taking clozapine and for four weeks after stopping treatment. Your doctor will tell you when and where you will be doing research. They will be doing every week during the first few months, but can later be reduced to a study by two weeks. After being treated with clozapine for a year or more, it may need to give you blood tests once every four weeks. Important for you to know that for safety reasons, if you miss these studies. Your doctor can not prescribe more pills. For this reason, your help is very important.
Before starting treatment your doctor will perform a physical examination. It can make you an electrocardiogram (ECG) to check the condition of your heart, but only if it is necessary for you, or unless you are concerned.
In case of surgery or for some reason your mobility is limited for a long time, discuss with your doctor the fact that you are taking clozapine. When it may have an increased risk of thromboembolism (blood clot in the veins).

Elderly patients may be more susceptible to the occurrence of these adverse reactions during treatment with clozapine: fainting or dizziness when changing the position of the body, dizziness, rapid heartbeat, urinary retention and constipation.

Other medicines and Xenopalan
The effects of other medicines can be affected by clozapine. On the other hand, it may interfere with the effect of clozapine.

Do not take Xenopalan with:
drugs which reduce the number of white blood cells in your body (drugs that inhibit the function of the bone marrow) as certain antibiotics (eg., chloramphenicol, sulfonamides like cotrimoxazole), some analgesics (e. pyrazolone, analgesics such as phenylbutazone), drugs for the treatment of epilepsy (carbamazepine), drugs used to treat inflammation of the joints (penicillamine), drugs for chemotherapy (cytotoxic agents) and long-acting drugs for the treatment of psychiatric disorders, administered in the form of injection. Clozapine may enhance the effect of these drugs to reduce the number of blood cells in your body.
Ksenopalan may be reacted with:
agents that slow down normal brain function (depressants of the central nervous system), such as alcohol, narcotics, tranquilizers, special group of drugs for the treatment of depression, called monoamine oxidase inhibitors (MAO inhibitors) and sedatives (such as benzodiazepines). Clozapine may enhance the effects of alcohol and drugs mentioned. It may feel drowsy / decrease of consciousness and difficulty in movement. There is an increased risk of sudden heart failure or sudden stop breathing;
group of drugs known as anticholinergics, including muscle relaxants, anti-asthma drugs, and anti-Parkinsonian drugs. Ksenopalan may enhance the effects of these drugs and therefore side effects;
drugs for the treatment of low blood pressure such as adrenaline and noradrenaline. Clozapine may enhance the effect of these medicines, which can lead to very low blood pressure;
medicines for heart and vascular diseases such as warfarin and digoxin. Clozapine may increase the concentration of these medications in the blood;
phenytoin, a drug used to treat epilepsy. This medicine can reduce the concentration of clozapine in the blood;
lithium. There is an increased risk of serious neurological disorder called neuroleptic malignant syndrome;
medicines used to treat allergies or hay fever (antihistamines). Clozapine enhances the effect of these drugs;
certain drugs used for treatment of gastric ulcers, such as omeprazole. These drugs may decrease the concentration of clozapine in the blood;
drugs for the treatment of depression (such as fluvoxamine), ciprofloxacin (a drug used to treat severe and life threatening bacterial infections), and caffeine. These medicines may increase the concentration of clozapine in blood.
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any of the drugs listed above or other drugs.

Xenopalan with food and drink
Taking food and drink does not affect treatment with clozapine. During treatment with clozapine should not consume alcohol.
Tell your doctor if you smoke and how often you take drinks containing caffeine (coffee, tea, colas). Sudden changes in your habits regarding smoking and the consumption of beverages containing caffeine may also alter the effects of clozapine.

Pregnancy and lactation
There are limited data on the use of clozapine in pregnant women.
Always tell your doctor if you are pregnant or intend to become pregnant. It will assess whether you can take clozapine.
You should not breast-feed while taking clozapine, as it may pass into your baby through your breast milk.

Women of childbearing potential
During treatment with clozapine may occur at irregular menstrual cycles or missed periods. Regular menstruation may be restarted when switching from treatment with other antipsychotics to clozapine therapy. You need to take adequate measures to prevent unwanted pregnancy during treatment with this medicine.
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.

Driving and using machines
While receiving clozapine should not drive or use any tools or machines, especially during the first weeks of treatment as clozapine cause drowsiness or dizziness.

Xenopalan tablets contain the milk sugar lactose. If your doctor has told you that you have an intolerance to some sugars, such as lactose, contact your doctor before taking this product.

3. How to take Xenopalan
Always take this medicine exactly as you have been told by your doctor. If you're not sure, ask your doctor or pharmacist.
Tablets (parts of the tablets) should be swallowed whole with some liquid. It can take clozapine before or after meals. Must not consume alcohol while being treated with clozapine.
Children and adolescents under 16 years of age should not take clozapine.

Treatment of Schizophrenia
The usual daily dose clozapine is between 200 mg and 450 mg. This dose is constructed gently for 2 to 3 weeks.
Treatment is started with half a tablet of 25 mg (12,5 mg) once or twice a day for the first day. Your doctor will slowly increase the dose by 25 to 50 mg daily, until reaching the lowest effective dose. It may need further dose increase with increases of 50 to 100 mg at intervals of one or half a week. The maximum dose is 900 mg daily.
In elderly patients, treatment should be initiated at a lower dose of 12,5 mg single day, with a consequent increase in the dose of 25 mg daily.
It can take clozapine irregularly divided doses throughout the day, and the dose at bedtime was higher. If your daily dose exceeds 200 mg, you need to take it once daily in the evening.
Treatment should continue for at least six months.
Consult your doctor or pharmacist when you resume the symptoms but do not stop taking clozapine until your doctor tells you.

Treatment of severe thought disturbances in patients with Parkinson's disease and a
The usual daily dose of clozapine is usually between 25 and 37,7 mg. This dose is constructed gently for 2 weeks. Treatment usually begins with a half tablet of 25 mg (12,5 mg) in the evening. Your doctor will slowly increase the dose by 12,5 mg maximum twice a week, until the lowest effective dose. It will control your blood pressure during the first weeks of treatment to assess whether it is safe dose escalation.
The maximum daily dose is 100 mg. You should take clozapine single night.

If you take more dose Ksenopalan
Immediately contact your doctor or pharmacist or go to the nearest hospital. Take this leaflet and other tablets to show them to your doctor or pharmacist.
It may feel rapid or irregular heartbeat, dizziness, fatigue, confusion, increased salivation, expansion of the dark part of the eye, blurred vision, seizures, abnormal movements, low blood pressure, difficulty breathing (choking or slow breathing), dizziness / loss of consciousness to imagine things that are not there (hallucinations), agitation, delirium and coma.
You must be monitored closely for at least 5 days because some side effects can occur with a lag.

If you forget to take Xenopalan
Do not take a double dose to make up the missed dose. Skip the missed dose and take the next tablet at the usual time.
If it's been more than two days since you took the last dose of clozapine consult your doctor before taking any more tablets. Your treatment should start again with 12,5 mg, taken once or twice daily with subsequent dose escalation carefully.

If you stop taking Xenopalan
Do not stop taking your tablets just because you feel better. It is important to continue taking clozapine as long as you have been told by your doctor. You should not stop taking clozapine suddenly. Your dose should be carefully reduced over a period of 1-2 weeks; Your doctor will give you relevant information about it.

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

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious. These side effects are uncommon (e. Occurring in more than 1 in 1000, but less than 1 in 100 persons).

Immediately contact your doctor if you experience:
flu-like symptoms or infections. This may indicate a decrease in white blood cells in your body (agranulocytosis);
fever, muscle rigidity, tremor, rapid breathing and drowsiness. These events may indicate a life-threatening condition called neuroleptic malignant syndrome.
Blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel along the blood vessels to the lungs causing chest pain and breathing difficulties. If you notice any of these symptoms seek medical advice immediately.

Other side effects
Very common (occurring in more than 1 in 10 people):
dizziness, somnolence, sedation;
rapid heartbeat;
Common (occurring in more than 1 in 100 but less than 1 in 10 people):
changes in the values of certain white blood cells (neutropenia, eosinophilia, leukocytosis, leukopenia);
weight gain;
blurred vision;
seizures, convulsions, seizures;
sense of restlessness and hyperactivity, abnormal movements;
changes in the electrocardiogram (ECG);
high blood pressure, dizziness or darken the eyes, especially when getting up from a lying or sitting position, sudden loss of consciousness;
urinary incontinence, problems with emptying of the bladder;
fatigue, chills, sweating and abnormal body temperature;
feeling sick, vomiting, loss of appetite, dry mouth;
elevated levels of liver enzymes.
Rare (occurring in more than 1 in 10 000, but less than 1 of 1 000):
elevated levels of blood glucose, diabetes;
restlessness, agitation;
confusion, delirium;
inflammation of the heart membrane and fluid accumulation around the heart;
abnormal heart rhythm;
a low level of red blood cells (anemia);
sudden stopping of blood circulation;
blood clots (thromboembolism);
jams consumed food;
difficulty swallowing;
inflammation of the liver (hepatitis), causing yellowing of the skin, itching and dark urine, inflammation of the pancreas, causing abdominal pain;
elevated levels of the enzyme creatine in the blood.
Very rare (occurring in less than 1 in 10,000 people)
complications due to uncontrolled elevated blood sugar (eg. ketoacidosis or coma);
very high levels of circulating fat (triglycerides) and blood cholesterol, high blood sugar levels;
involuntary movements, which also occur after discontinuation of the drug, changes in the number of platelets;
cardiac disorders;
sudden cardiac arrest function;
slowing or stopping breathing;
enlargement of the salivary glands;
loss of bowel activity, which leads to severe constipation;
sudden destruction of liver cells;
inflammation of the kidneys;
prolonged or painful erection;
Sudden unexpected death;
skin reactions.
Adverse event reporting
If you get any side effects, contact your doctor, pharmacist or nurse. This includes all listed in this leaflet.
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