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CLOPIXOL DEPOT 200 mg. 1 ml. 10 ampoules

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HOW DOES CLOPIXOL  DEPOT?
CLOPIXOL depot belongs to a group of drugs known as antipsychotics. These medicines act on nerve pathways in specific parts of the brain and help to correct certain chemical imbalances in the brain that prechinyavat symptoms of your illness.

WHAT IT IS USED CLOPIXOL DEPOT?
It is used to treat schizophrenia and similar psychoses. However, your doctor may prescribe Klopiksol depot and for other purposes.

HOW TO USE CLOPIXOL DEPOT?
A small volume is drawn into a syringe and administered intramuscularly into the buttocks. The drug is released slowly after administration of an injection as constant amounts thereof passing into the blood between injections.
ADULTS:
Usually 1-3 ml and the interval between injections will be between 1 and 4 weeks. If you need more than 2 ml of medicine, it would probably be applied to 2 seats.

PATIENTS OVER 65 YEARS OF AGE:
Usually doses close to the lower limit of the recommended dose range.

CHILDREN:
CLOPIXOL depot does not apply to children.
What is CLOPIXOL and what it is used
CLOPIXOL contains the active substance zuclopenthixol. CLOPIXOL belongs to a group of drugs known as antipsychotics (also called neuroleptics). These medicines act on nerve pathways in specific parts of the brain and help to correct certain chemical imbalances in the brain that cause the symptoms of your illness.
CLOPIXOL is used to treat schizophrenia and similar psychoses.
It is also used to treat mania and control of agitation and aggression in mentally disabled patients and elderly patients with dementia changes.
However, your doctor may prescribe Klopiksol and other purposes. Ask your doctor if you have any additional questions related to why you have been prescribed CLOPIXOL
2. What you need to know before taking CLOPIXOL
Do not take CLOPIXOL
• If you are allergic (hypersensitive) to zuclopenthixol or any of the other ingredients of this medicine (listed in section 6)
• If you have a disturbance of consciousness
Warnings and Precautions
Talk to your doctor or pharmacist before taking Klopiksol if you:
• have liver problems
• You have data on seizures or fits
• have diabetes (you may need adjustment of antidiabetic treatment)
• have an organic brain syndrome (which may result from poisoning with alcohol or organic solvents)
• you have a risk of stroke (eg smoking, hypertension)
• suffering from hypokalaemia or hypomagnesaemia (too little potassium or magnesium in your blood) or hereditary predisposition to such
• have his family history of cardiovascular disease
• use another antipsychotic
• You or someone in your family has a family history of blood clots, as medicines like these have been associated with blood clots
Children and adolescents
CLOPIXOL not recommended for this patient group.
Other medicines and CLOPIXOL
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines.
Tell your doctor or pharmacist if you are taking the following medicines:
• Tricyclic antidepressants
• guanethidine and similar drugs (used to lower blood pressure)
• Barbiturates and similar medicines (medicines that cause drowsiness)
• Medicines used for the treatment of epilepsy
• Levodopa and related drugs (used to treat Parkinson's disease)
• Metoclopramide (used to treat gastro-intestinal disorders)
• Piperazine (used for the treatment of tapeworms)
• Drugs that cause a disturbed water or salt balance (too little potassium or magnesium in your blood)
• Drugs that are known to increase the concentration of your blood CLOPIXOL
The following drugs should not be administered concurrently with CLOPIXOL
• Drugs that alter the rhythm of the heart (eg quinidine, amiodarone, sotalol, dofetilide, erythromycin, terfenadine, astemizole, gatifloxacin, moxifloxacin, cisapride, lithium)
• Other antipsychotic drugs (eg thioridazine)
Klopiksol with food, drinks and alcohol
Klopiksol can be taken with or without food
Klopiksol may enhance the sedative effects of alcohol making you more drowsy.
It is recommended not to drink alcohol during treatment with CLOPIXOL
Pregnancy, lactation and fertility
If you are pregnant or think you might be pregnant, tell your doctor CLOPIXOL should not be used during pregnancy unless clearly necessary.
pregnancy
If you are pregnant or think you may be pregnant, tell your doctor. Klopiksol should not be used during pregnancy unless clearly necessary.
The following symptoms may occur in newborn babies of mothers who have used Klopiksol in the last quarter (last three months of pregnancy): shaking, muscle stiffness and / or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.
breastfeeding
If you are breastfeeding, talk to your doctor. While breastfeeding, you should not take CLOPIXOL, as small amounts of the medicine can pass into breast milk.
Fertility
Animal studies have shown that Klopiksol affect fertility. Please ask your doctor for advice.
Driving and using machines
There is a risk of feeling drowsy and dizzy when using Klopiksol especially early in treatment.
If this happens do not drive or use any tools or machines until these effects wear off.
Klopiksol tablet contains lactose and hydrogenated castor oil.
If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.
Hydrogenated castor oil may cause stomach upset and diarrhea.
3. How to take CLOPIXOL
Always take CLOPIXOL just as you have been told your doctor. If you're not sure, ask your doctor or pharmacist.
The dose varies widely and depends on the severity of the disease.
The recommended dose is:
Adults
Schizophrenia, mania and other psychoses
The usual initial dose is between 10 mg and 50 mg daily. The dose can gradually be increased to 75 mg daily.
In some cases it may be necessary to use a much higher dose. The maximum dose is 150 mg per day.
The usual maintenance dose is 20-40 mg daily.
Agitation in mentally disabled patients
The usual dose is between 6 and 20 mg daily. If necessary, the dose may be increased up to 25-40 mg per day.
Risk patients.
Patients with liver complaints normally receive a dose closer to the lower end of the dosage range.
Use in children
Klopiksol not recommended for children.
If you have the impression that the effect of CLOPIXOL is too strong or too weak, talk to your doctor or pharmacist.
How and when to take Klopiksol
Take the tablets with water. Do not chew them.
At the beginning of the treatment, Klopiksol should be usually taken in 2 or 3 divided doses per day.
In Klopiksol supportive treatment can be administered as a single daily dose
Duration of treatment
Like other medications to treat psychosis may take several weeks to manifest fully the effects of these tablets.
Your doctor determines the duration of treatment.
Keep taking the tablets for as long as you by your doctor. Underlying disease may persist for a longer period of time and if you stop your treatment too early, the symptoms may reappear.
Never change the dose of the drug before you have talked to your doctor first.
If you take more than the amount Klopiksol
If you think you or anyone else may have taken too many tablets Klopiksol, contact your doctor or the nearest emergency department. Do this even if no signs of discomfort or poisoning. Take the pack with you Klopiksol to show the doctor or hospital.
Symptoms of overdose may include:
• Sleepiness
• Unconsciousness
• Muscle movements or stiffness
• Seizures
• Low blood pressure, weak pulse, fast heartbeat, pallor, restlessness
• High or low body temperature
• Changes in heart rhythm including irregular heart beat or slow heart rate were observed when Klopiksol overdose was concomitantly with other drugs known to affect the heart.
If you forget to take CLOPIXOL
If you forget to take appropriate dose, take the next one at the usual time. Do not take a double dose to make up the missed dose.
If you stop taking CLOPIXOL
Your doctor will decide when and how to end treatment with Klopiksol to avoid any unpleasant symptoms that might occur with sudden discontinuation (eg. Difficulty sleeping, muscle stiffness, malaise).
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, CLOPIXOL can cause side effects, although not everybody gets them.
If you experience any of these symptoms should immediately contact your doctor or go to hospital:
Uncommon (more than 1 in 1000, but at least 1 in 100 patients):
• Unusual movements of the mouth and tongue; this can be an early sign of a condition known as tardive dyskinesia.
Very rare (less than 1 in 10,000 patients):
• High fever, unusual stiffness of the muscles and changes in consciousness, especially if occurring with sweating and rapid heart beat; These symptoms may be signs of a rare condition called neuroleptic malignant syndrome has been reported with the use of different antipsychotics.
Very common (in 1 or more of 10 patients):
• sleepiness (somnolence), inability to sit still or remain motionless (akathisia), involuntary movements (hyperkinesia), slow or limited movements (hypokinesia)
• Dry mouth
Common (more than 1 in 100 patients but less than 1 in 10 patients):
• Heart palpitations (tachycardia), feeling faster, stronger or irregular heart beat (palpitations)
• Tremor, distorted or repetitive movements or abnormal postures due to sustained muscle contractions (dystonia), increased muscle stiffness (hypertension), dizziness, headache, feeling of tingling, pricking or numbness of the skin (paresthesia), disturbance in attention, amnesia, abnormal gait
• Difficulty to focus on objects close to the eye (accommodation disorder), disturbance of vision
• Sense of rotation or shake stationary body (vertigo)
• Blocking of the nasal passages (nasal congestion), difficulty in breathing or painful breathing (dyspnoea).
• Increased salivation (increased salivation), constipation, vomiting, digestive problems or discomfort in the upper abdomen (dyspepsia), diarrhea
• Violation of urination (micturition disorders), inability to urinate (urinary retention), increased volume of urine (polyuria)
• Increased sweating (hyperhidrosis), itching (pruritus)
• Muscle pain (myalgia)
• Increased appetite, weight gain
• Fatigue, weakness (asthenia), general feeling of discomfort and discomfort (malaise 'pain
• Sleepiness (insomnia), depression, anxiety, nervousness, abnormal dreams) reduced sex drive (decreased libido)
Uncommon (more than 1 in 1000, but less than 1 in 100 patients):
• Super-fast reflexes or excessive (hyper), irregular movements (dyskinesia), parkinsonism, fainting (syncope), inability to coordinate muscle activity (ataxia), speech disorder, decreased muscle tone (hypotonia), convulsions, migraine
• rotation of the eye (oculogyric crises), dilated pupils (mydriasis)
• Hypersensitivity to certain frequencies of sound or difficult tolerance to everyday sounds (hyperacusis), ringing in the ears (tinnitus)
• Abdominal pain, nausea, flatulence
• Rash, skin reaction due to sensitivity to light (photosensitivity reaction), pigmentation disorder, greasy, shiny and yellowish skin due to increased secretion of sebum (seborrhea), eczema or inflammation of the skin (dermatitis), subcutaneous bleeding, notable in red or purple spots on the skin (purpura)
• Muscle stiffness, inability to normally open the mouth (trismus), distortion of the neck and an unnatural position of the head (torticollis, torticollis, stiff neck)
• Decreased appetite, weight decreased
• Low blood pressure (hypotension), hot flush
• Thirst, abnormally low body temperature (hypothermia), fever (pyrexia)
• Abnormal liver function tests
• Sexual disturbances (delayed ejaculation, erection problems, women may experience an inability to achieve orgasm, vaginal dryness (vulvovaginal dryness))
• emphasized indifference to the environment (apathy), nightmares, increased sex drive (libido increased), confusional state
Rare (more than 1 in 10 000, but less than 1 in 1000 patients):
• Reduced number of platelets in the blood (thrombocytopenia), decreased neutrophil leukocytes (neutropenia), reduced leukocyte count (leukopenia), bone marrow toxicity (agranulocytosis)
• Increased level of prolactin in the blood (hyperprolactinemia)
• High blood sugar (hyperglycemia), impaired glucose tolerance, increased levels of blood fats (hyperlipidemia)
• hypersensitivity (hypersensitivity), acute systemic and severe allergic reaction (anaphylactic reaction)
• Development of breasts in men (gynecomastia), excessive milk production (galactorrhoea), lack of menstrual periods (amenorrhea), persistent painful erection of the penis, accompanied by sexual arousal or desire (priapism)
As with other drugs that act in a similar way to zuclopenthixol (the active ingredient of Klopiksol) have been rare reports of the following side effects:
• Extension of QT-interval (slow heart rate and changes in ECG)
• Irregular heartbeats (ventricular arrhythmias, ventricular fibrillation, ventricular tachycardia)
• Torsades de Pointes (a specific type of irregular heartbeat)
In rare cases irregular heart beats (arrhythmias) could lead to sudden death.
Blood clots in the veins, especially those in the legs (symptoms include redness and up) that can move through blood to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, seek immediate medical advice.
5. How to store CLOPIXOL
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
10 mg: Keep in the original packaging to protect from light.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medications * you no longer use. These measures will help to protect the environment
6. Contents of the pack and other information
What CLOPIXOL
The active substance is zuclopenthixol (as dihydrochloride).
Each tablet contains 10 mg CLOPIXOL zuclopenthixol.
The other ingredients are potato starch, lactose monohydrate, microcrystalline cellulose, copovidone, glycerol 85%, talc, hydrogenated castor oil and magnesium stearate.
Coating: Hypromellose 5 and macrogol 6000.
Coloring: Titanium dioxide (E171), red iron oxide (E172) and black iron oxide (E172).
CLOPIXOL looks like and contents of the pack
CLOPIXOL is available as 10 mg film-coated tablets (tablets).
Description CLOPIXOL
The tablets of 10 mg are round, biconvex, light red-brown film coated tablets.
CLOPIXOL film-coated tablets are available in blister packs or in tablet containers.
Not all pack sizes may be marketed.

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