Haloperidol 10 amp. 5 mg. 1 ml.

WHAT haloperidol SOPHARMA AND WHAT IT IS USED

Haloperidol Sopharma solution for injection contains the active substance haloperidol, which refers to a group of medicines called antipsychotics . He suppressed excitement and hallucinations causing calming and drowsiness. Possesses pronounced depressing effect vomiting .
It is used to treat psychiatric disorders occurring with confusion, hallucinations, causeless fear, fragmented thoughts, inappropriate behavior , Rampage , to suppress nausea and vomiting of various origins.

2 . BEFORE YOU USE haloperidol SOPHARMA

Do not use Haloperidol Sopharma

- If you are allergic (hypersensitive ) to the active substance or to any of the ingredients of Haloperidol Sopharma ;

- In the presence in the patient of delayed reactions , drowsiness and dizziness as a result of disease, the use of drugs or alcohol in patients with Parkinson 's disease ;

- When a heart disease violations of normal heartbeat , severe slow heartbeat , concomitant antiarrhythmic products , in patients with severe renal or hepatic disease ; during pregnancy and lactation .

Take special care with Haloperidol Sopharma

Before starting treatment with Haloperidol Sopharma Tell your doctor if any of the following diseases or conditions :

- Heart problems , cases of sudden death of a member of your family, cerebral hemorrhage ;
depression ;

- Kidney or liver disease , glaucoma ( increased eye pressure) ;

- Epilepsy or other diseases in which you received seizures disorders in thyroid gland tumors of the adrenal gland ( pheochromocytoma ) ;

- Taking diuretics ( water pills ) , antiarrhythmics (medicines to treat abnormal heart rhythms ) , Parkinson products;

- Drink alcohol or treated for alcoholism , aged 65 years;

- Tell your doctor if you or someone in your family has in the past had problems with blood clotting ( blood clots ) as drugs such as haloperidol may lead to blood clots ;

- Before starting treatment with haloperidol ECG monitoring is recommended in all patients , especially those with evidence of impaired cardiac status;

- It is recommended to control the levels of electrolytes in the blood, particularly in patients who are treated with diuretics .

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Especially, tell your doctor if you are taking the following medicines as haloperidol can alter their activity or, conversely, they can modify their effects when used together :
- Sedatives or hypnotics ;
- Antipsychotics or neuroleptics ;

- Antiarrhythmics ( quinidine , procainamide , amiodarone , sotalol ) ;

- Tetratsiklnchni or tricyclic antidepressants ( medicines for treating depression ) , such as amitriptyline , maprotiline ;

- Medicines to lower blood pressure by guanethidine or methyldopa ;

- Drugs that are used for severe allergic reactions, such as epinephrine ;

- Drugs to treat parkinsonism , and levodopa ;

- Painkillers ;

- As anticoagulant phenindione ;

- Antidepressants ( fluoxetine, paroxetine ) ;

- Drugs to treat malaria ( quinine , mefloquine ) ;

- Anxiolytics ( buspirone ) ;

- Drugs to treat epilepsy (phenytoin , phenobarbital ), medicines for allergy ( terfenadine ) ;

- Antimicrobials ( sparfloxacin , moxifloxacin , erythromycin ) and drugs for treating tuberculosis ( rifampicin ), water tablets ( diuretics ), antifungal drugs (ketoconazole ) ;

- Monitoring of the concentration of lithium during concomitant use of haloperidol and lithium salts (used to treat some mental disorders) .

Use of Haloperidol Sopharma with food and drink

Not recommended for use of alcohol or drugs containing alcohol during treatment with Haloperidol Sofarma .

Pregnancy and lactation

Ask your doctor or pharmacist before taking any medicine. Haloperidol Sopharma crosses the placenta. Application is not recommended during pregnancy , as it is not proven its safety .
The following symptoms may occur in newborn infants of mothers who had used haloperidol in the last quarter ( last three months of pregnancy) : tremors, muscle stiffness and / or weakness , drowsiness , agitation, breathing problems, and difficulty in fed . If your baby develops any of these symptoms you may need to contact your doctor
Sopharma haloperidol is excreted in human milk. Not recommended during breast-feeding because it may cause side effects in the infant.

Driving and using machines

When treated with Haloperidol Sopharma should refrain from activities requiring alertness and speed of psychomotor reactions. Not recommended for driving or operating machinery.

3 . HOW TO USE haloperidol SOPHARMA ?

Always use Haloperidol Sopharma exactly as your doctor tells you . If you are not sure, ask your doctor or pharmacist.

Haloperidol Sopharma solution for injection is administered intramuscularly or intravenously by a physician or other qualified medical personnel. The dosage and duration of treatment is determined by the attending physician , depending upon the nature and severity of the condition and the tolerance of the product.

If you use more than the amount of Haloperidol Sopharma

When introducing Sofarma Haloperidol injection solution in high doses may occur movement disorders sharp decrease in blood pressure , drowsiness, occasionally convulsions . In very high doses of haloperidol Sopharma solution for injection can cause respiratory depression, comatose , a sharp drop in blood pressure to the onset of shock . Possible disturbances of cardiac rhythm. Treatment of overdosage is symptomatic and is directed at maintaining vital functions.

If you forget to use Haloperidol Sopharma

Do not take a double dose to make up .

If you stop taking Haloperidol Sopharma

Suspension of the treatment should be carried out by gradually reducing the dose , since abruptly suspension may lead to recurrence of the disease symptoms .

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

4 . POSSIBLE SIDE EFFECTS

Like all medicines, Sopharma Haloperidol injection can cause side effects, although not everybody gets them.
Tell your doctor immediately if you notice sudden swelling of the face or throat , hives (known as hives) , irritation , redness or blistering of the skin. These may be signs of a severe allergic reaction that occurs in a small number of patients. Rarely observed neuroleptic malignant syndrome, which is expressed by increased heart rate, changes in blood pressure, sweating, rapid breathing, muscle stiffness , loss of consciousness, coma. Can be observed irregular heartbeat (arrhythmia ), which in some cases can lead to sudden cardiac arrest . Cases of sudden death have been reported rarely in elderly patients receiving haloperidol. In some cases it may be observed sudden movements , slowness , muscle stiffness, tremors and anxiety . Salivation , twitching or abnormal movements of the tongue, face , mouth, jaw or throat , abnormal eye movements can be observed in some patients. In these cases it may be necessary to add additional treatment . Very often there is a headache , feelings of agitation, trouble sleeping .
Other adverse reactions occurred more frequently are: tremors, rigid posture, mask-like face , disorder of movement and coordination , restlessness , anxiety, drowsiness , dizziness when standing due to low blood pressure , hallucinations, blurred vision . Less commonly occur develop jaundice or mild dysfunction of the liver , confusion, decrease the number of white blood cells, which can lead to frequent infections , seizures or convulsions , difficulty breathing or wheezing , hormonal disorders that may lead to : weight changes , sexual disorders , menstrual disorders , breast swelling , abnormal secretion of milk.
Rarely seen trismus (difficulty opening the mouth) . Very often , a decrease of blood platelets, which may lead to easy bleeding or bruising , fluid retention , affecting the brain , which may lead to weakness , fatigue and confusion . Other adverse reactions observed in patients treated with haloperidol include: rash, dry mouth, slow movements , nausea, vomiting , constipation, urinary retention, reactions at the injection site , increased skin sensitivity to light, excessive sweating , increased or decreased body temperature, swelling of ankles , inflammation and flaking of the skin, low blood sugar, ECG changes. Blood clots in the veins especially in the legs ( symptoms include swelling , pain and redness ) can reach the lungs , causing chest pain and difficulty breathing . If you notice any of these symptoms, seek medical attention immediately . In elderly patients with dementia is treated with antipsychotics , has been observed an increase in death compared with those who did not receive such treatment.

If any of the side effects gets serious, or you notice other effects not listed in this leaflet , please tell your doctor or pharmacist.

5 . HOW TO STORE haloperidol SOPHARMA

Store in the original package to protect from light at a temperature below 25 ° C.
Do not freeze !
Keep out of reach of children.
Do not use Haloperidol Sopharma solution for injection after the expiry date stated on the carton and vial . The expiry date refers to the last day of that month.
Do not use Haloperidol Sopharma solution for injection if you notice the presence of sediment, particulate matter and discoloration of the solution.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.

6 . ADDITIONAL INFORMATION
What does Haloperidol Sopharma ?

The active substance is 5 mg of haloperidol in 1 ml of solution for injection . Other ingredients are: lactic acid, and water for injection.

Looks like Haloperidol Sopharma and contents of the pack ?

Clear, colorless solution for injection 1 ml in colorless glass vials mark opening ( point). Opening ampoules by pressing the thumb on the label on the neck of the ampoule.
10 ampoules in blister of PVC folio of 1 or 10 blisters in a carton with leaflet.

Marketing Authorisation Holder and Manufacturer

Sopharma
Iliensko Shosse 16 , 1220 Sofia, Bulgaria

Dosage and method of administration of Haloperidol Sopharma solution for injection

The dosage and duration of treatment is determined individually according to the nature and severity of the disease and patient tolerance to the product. Haloperidol has to be administered at a minimum dose sufficient to control the clinical manifestations. After the acute symptoms are recommended to continue treatment with oral agents . psychosis

In acute psychoses haloperidol apply 2-5 mg deep intramuscular . If necessary, the dose may be repeated at hourly intervals, or in 4-8 hour intervals , until a control of the condition . The maximum daily dose is 15-20 mg (3-4 ampoules ) . For rapid response of acute psychoses Haloperidol can be administered intravenously , slowly , at 5 mg per minute. The dose can be repeated after 30 minutes. Alternatively, the dose may be diluted in 30-50 ml infusion solution and administered intravenously as an infusion over 30 minutes. Nausea and vomiting

By 1 ampoule ( 5 mg) deep intramuscularly. The dose may also be administered in intravenous infusion. Elderly (over 65 years)

In adults recommended dose reductions due to delayed metabolism of haloperidol and increased risk of extrapyramidal symptoms. Treatment should be initiated with HA from the usual dose followed by titration to optimal effect . children

Parenteral administration of haloperidol in children is not recommended. Discontinuation of therapy

Cessation of haloperidol treatment should be carried out by gradual dose reduction , since abruptly stopping can lead to a recurrence of psychotic symptoms.