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Haloperidol-Grindeks 5 mg/ml solution for injection Haloperidolum Read this leaflet carefully before you start taking this medicine as it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they have the same signs of illness as you. - If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Haloperidol-Grindeks is and what it is used for 2. What you need to know before taking Haloperidol-Grindeks 3. How to take Haloperidol-Grindeks 4. Possible side effects 5. How to store Haloperidol-Grindeks 6. Contents of the pack and other information 1. What Haloperidol-Grindeks is and what it is used for Haloperidol-Grindeks is an effective antipsychotic medicine that helps relieve anxiety and various psychotic disorders. The medicine also has an antiemetic effect, but at low doses - a mild sedative effect. Compared to other antipsychotics, Haloperidol-Grindeks rarely causes drowsiness. This medicine is used in the following cases: - Schizophrenia - Treatment and prevention of relapse, - Other psychoses, especially paranoia, - Mania and hypomania, - Behavioral disorders in children, aggression in adult patients, hyperactivity and self-harm in patients with intellectual disability or organic brain damage, - As an adjunct for short-term treatment of moderate to severe psychomotor agitation or uncontrolled impulsive behavior, - Nausea and vomiting in cases where traditional remedies are not sufficiently effective. 2. What you need to know before taking Haloperidol-Grindeks Do not take Haloperidol-Grindeks: - if you are allergic to haloperidol, other neuroleptics of the same group (butyrophenones) and/or any other ingredients of this medicine, - in a comatose state or severe central nervous system (CNS) depression caused by alcohol or other drugs, - if you have Parkinson's disease, - if you have nerve damage (basal ganglia), - if you have clinically significant impairment of heart function (e.g., recent acute myocardial infarction, decompensated heart failure, arrhythmias treated with class IA and III antiarrhythmics), - prolonged QT interval (shown as a pathological curve on an electrocardiogram), - if you have had ventricular arrhythmia or torsades de pointes in the past, - if you have untreated hypokalemia (low potassium level in the blood), - in combination with other medicines that prolong the QT interval. Warnings and precautions Talk to your doctor or nurse before taking Haloperidol-Grindeks. When taking Haloperidol-Grindeks, you must follow all doctor's recommendations to avoid adverse events. It should be taken into account that side effects are more common in elderly patients. Taking Haloperidol-Grindeks can rarely cause the following dangerous side effects (see also section 4): - Neuroleptic Malignant Syndrome (NMS), characterized by a sharp increase in body temperature of unknown origin, paleness, increased sweating, muscle rigidity, heart rate and consciousness disorders; - Tardive dyskinesia, mainly characterized by rhythmic involuntary movements of the face, tongue, mouth or jaw, - Severe allergic (anaphylactoid) reactions (hives, itching, redness, swelling of the face, lips, tongue or throat, difficulty breathing, sudden swelling of the hands, feet or ankles, rapid drop in blood pressure). If any of the above symptoms appear, stop taking this medicine and consult your doctor immediately. Before starting this medicine, tell your doctor if you have: - heart disease (or if a family member has died suddenly from heart disease), - problems with liver and kidneys, - problems with the thyroid gland, - epilepsy, brain damage or alcohol dependence, - adrenal gland tumor (pheochromocytoma), breast tumor, - if you or a family member has a blood clot in a vein, as blood clots have been observed with this type of medicine (see section 4). Before or during treatment, the doctor may examine your heart's electrical activity (ECG). Regular monitoring of blood tests (especially blood levels of potassium, magnesium, and calcium) is recommended. In individual cases, liver function tests may be necessary. This medicine should be used with caution in patients with cerebrovascular diseases, subarachnoid (under the brain membrane) hemorrhage, hematopoietic disorders or metabolic disorders (low blood levels of potassium, calcium, and magnesium, starvation). Caution is also advised in the following diseases or conditions: glaucoma, severe respiratory failure, diabetes mellitus, myasthenia gravis (severe muscle weakness), paralytic intestinal obstruction (intestinal obstruction), enlarged prostate, urinary retention, if jaundice has been observed before or if lithium is used concurrently. It should be noted that the antiemetic effect of Haloperidol-Grindeks sometimes masks the symptoms of certain gastrointestinal (obstructive) diseases or overdose of other medications. It is not recommended to change the dose of the medicine or suddenly stop taking Haloperidol-Grindeks without the doctor's permission! If stopped suddenly, hand tremors, involuntary movements of the tongue, mouth or jaw may occur. Thus, the dose should be reduced gradually, according to the doctor's recommendations. Before any surgical interventions and dental procedures, the doctor should be informed about taking Haloperidol-Grindeks. When using this medication, it is recommended to avoid hot places (e.g., sauna) or intense sunlight, as well as heavy physical activity that can cause overheating of the body. Sometimes, dry mouth, inflammation of the mouth, bleeding from the oral mucosa are observed during treatment with this medication, so oral hygiene is recommended. Chewing gum can be used to prevent dry mouth. In case of depression, Haloperidol-Grindeks should be used together with other antidepressants. Anti-doping warning. Intravenous infusions are prohibited, except for infusions legally administered in a hospital or for clinical research purposes. Children The safety of using Haloperidol-Grindeks in children has not been established (see also Haloperidol-Grindeks contains benzyl alcohol). Other medicines and Haloperidol-Grindeks Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. This is especially important if you are taking: - Lithium-containing medication. In some cases, a combination of these medications may lead to brain dysfunction (encephalopathy) and extrapyramidal disorders. If signs of neurotoxicity (confusion, disorientation, headache, drowsiness) or extrapyramidal disorders appear, the use of both drugs should be stopped immediately. - Medicines affecting heart function (e.g., quinidine, amiodarone). If Haloperidol-Grindeks is used with medicines that suppress central nervous system activity (sedatives and hypnotics, strong painkillers, etc.) or with alcohol, its suppressive effect may increase. There are reports of stimulant effects on the central nervous system when combined with methyldopa. Use with the analgesic tramadol may increase the risk of seizures. Haloperidol-Grindeks may reduce the effect of epinephrine (adrenaline) and other medicines in this group, as well as the blood pressure-lowering effect of guanethidine and other so-called adreno-blockers. When used with anticholinergics (e.g., atropine group medications), antihistamines (e.g., anti-allergy medications) or antiparkinsonian drugs, the risk of developing side effects of haloperidol (anticholinergic effects) increases. The simultaneous use of Haloperidol-Grindeks with anticonvulsants may change the frequency and type of seizures. Carbamazepine, phenobarbital, rifampicin, and possibly memantine can weaken the effect of Haloperidol-Grindeks. Dose adjustment may be necessary. Combination with Haloperidol-Grindeks may increase the side effects of some antidepressants (tricyclics) and may reduce the antiparkinsonian effect of levodopa. The use of amantadine or metoclopramide with Haloperidol-Grindeks increases the risk of extrapyramidal side effects (Parkinson-like symptoms). Quinidine, buspirone, fluoxetine, venlafaxine, sertraline, paroxetine, and fluvoxamine can enhance the effect of haloperidol. Dose adjustment may be necessary. It has been reported that haloperidol can reduce the effect of the anticoagulant phenindione. Erythromycin in combination with Haloperidol-Grindeks increases the risk of cardiac (ventricular) arrhythmias. Taking Haloperidol-Grindeks with antiarrhythmics also increases the risk of arrhythmias. Combination with indomethacin may cause significant drowsiness. The use of Haloperidol-Grindeks with sulfonylurea group antidiabetic drugs (e.g., glimepiride, glibenclamide) may increase blood glucose levels. Haloperidol-Grindeks solution should not be mixed in the same syringe or infusion system with phenytoin or heparin, as a precipitate will form. Haloperidol-Grindeks with food, drinks and alcohol Alcohol should not be consumed during treatment. Pregnancy and breastfeeding If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Haloperidol-Grindeks is not recommended during pregnancy or when planning pregnancy and should only be used if the expected benefit outweighs the potential risk to the mother and fetus. If you become pregnant or think you may be pregnant, you should contact your doctor immediately to stop treatment. The use of Haloperidol-Grindeks during breastfeeding is not allowed, as this medicine is excreted in breast milk. If the mother requires treatment, breastfeeding should be discontinued. Driving and operating machinery Haloperidol-Grindeks can affect your ability to react, as it can cause weakness, drowsiness, dizziness, and extrapyramidal disorders. When using Haloperidol-Grindeks, you should avoid work that requires concentration and quick reactions (e.g., work involving technical equipment, driving a vehicle). Haloperidol-Grindeks contains benzyl alcohol This preparation contains 8 mg/ml of benzyl alcohol. The medicine should not be used in premature and newborn infants. This medicine can cause toxic and allergic reactions in newborns and children up to 3 years of age. 3. How to take Haloperidol-Grindeks Always take this medicine exactly as prescribed by your doctor. If you are unsure, check with your doctor or pharmacist. Haloperidol injections are usually used when rapid symptom relief is needed or when the medicine cannot be taken orally due to the patient's health condition. The dose is determined by the doctor individually, depending on the patient's age, severity of the disease, and previous experience with neuroleptics. Haloperidol-Grindeks solution for injection can be administered intramuscularly (IM) or intravenously (IV). Adults In case of acute agitation, 2-10 mg is administered intramuscularly in patients with moderate symptoms. The injection can be repeated at intervals of 4-8 hours between administrations until the drug can be taken orally. Haloperidol-Grindeks can also be administered intravenously. The maximum daily dose is 18 mg. In some cases, in severely ill patients, the initial dose may be 18 mg. Nausea and vomiting: 0.5-2 mg of haloperidol intramuscularly daily. In elderly and weakened patients, as well as those who have developed side reactions to neuroleptics, lower doses should be used. In such cases, the doctor recommends using half of the usual starting dose. The dose is gradually increased until optimal therapeutic effect is achieved. Use in children Injections are not recommended for children (see also Haloperidol-Grindeks contains benzyl alcohol). If you take more Haloperidol-Grindeks than you should If you overdose, severe symptoms of extrapyramidal disorders may occur (see section 4), including dizziness, low blood pressure, lethargy, and drowsiness. Heart rhythm disturbances (arrhythmia) may occur. In case of worsening condition, respiratory depression and a sharp drop in blood pressure leading to shock may occur. High blood pressure and seizures may also occur. In case of overdose, seek medical attention immediately! If you forget to take Haloperidol-Grindeks Do not take a double dose to make up for a missed injection. If you stop taking Haloperidol-Grindeks If you stop taking it abruptly, you may experience hand tremors, involuntary movements of the tongue, mouth or jaw (see section 2, Warnings and precautions). Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Rare (may affect up to 1 in 1000 people), but serious side effects include tardive dyskinesia, neuroleptic malignant syndrome, and severe allergic (anaphylactoid) reactions (see also Warnings and precautions). Stop using this medicine and seek medical help immediately if: - Rhythmic involuntary movements of the tongue, face, mouth or jaw appear suddenly (mild involuntary tongue movements may be the first signs of tardive dyskinesia), - High body temperature, increased sweating, muscle rigidity, decreased heart rate and consciousness appear, - Swelling of the face, lips, tongue and throat, itching, hives, redness, swelling of the hands, feet or ankles, difficulty breathing or a rapid drop in blood pressure appear suddenly; - You have blood clots in your veins, especially in the leg veins (which manifests as burning sensation in the leg, pain and redness). Blood clots can travel through the blood vessels and reach the lungs, causing chest pain and difficulty breathing. The frequency of other possible side effects is as follows: Common side effects (may affect up to 1 in 10 people): - Extrapyramidal symptoms (tremor, muscle stiffness, increased salivation, slow or uncontrolled (spastic) movements, akathisia in patients with thyrotoxicosis, acute eyelid spasms, blinking, tremors of facial, neck and limb muscles, eye movement disorders, laryngeal spasms). These side effects usually disappear when the dose is reduced or stopped. Antiparkinsonian drugs can be used if necessary. In such cases, the doctor should be informed to adjust the treatment; - Low blood pressure, decrease in blood pressure when changing body position from horizontal to vertical (orthostatic hypotension), - Constipation, dry mouth, nausea, vomiting, loss of appetite, indigestion, - Weight gain or loss. Uncommon (may affect up to 1 in 100 people): - Increased heart rate (especially in elderly patients). Rare (may affect up to 1 in 1000 people): - Headache, dizziness, epileptic seizures, - Drowsiness or insomnia, confusion, depression, pronounced calmness or, conversely, anxiety, worsening of psychotic symptoms, - Heart rhythm disturbances (ventricular arrhythmia), - Hyperprolactinemia (increased level of prolactin hormone in the blood), - Urinary retention, - Skin rash, urticaria, increased sensitivity to light (especially sunlight), - Galactorrhea (spontaneous milk discharge from the mammary glands), gynecomastia (enlargement of breast tissue in men), menstrual cycle disorders, erectile or ejaculation disorders, painful erection, - Increased body temperature, swelling not related to NMS. Very rare side effects (may affect up to 1 in 10,000 people): - Changes in blood composition (decreased granulocytes, platelets, and leukocytes in the blood), - Hypersensitivity reactions, anaphylaxis (severe allergic reaction). Unknown (cannot be estimated from available data): - Prolonged QT interval, torsades de pointes arrhythmia, cardiac arrest. The probability of the mentioned side effects is higher with high doses of haloperidol, as well as in patients prone to heart rhythm disturbances, - Blood clots in veins (see section 4), - Disorders related to the secretion of antidiuretic hormone (ADH), - Hypoglycemia (low blood sugar level), - Blurred vision, - Transient liver function disorders, jaundice, cholestatic hepatitis, - Exfoliative dermatitis, erythema multiforme, changes in skin pigmentation, increased sweating, - Reactions at the injection site, low body temperature, sudden death. A slightly increased number of deaths has been observed in elderly patients with dementia taking antipsychotics compared to those not taking antipsychotics. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. By reporting side effects, you can help provide more information about the safety of this medicine. 5. How to store Haloperidol-Grindeks Do not store above 25 ºC. Store in the original packaging to protect from light. Keep this medicine out of the reach and sight of children. Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of that month. Do not dispose of any medicines in household waste or down the drain. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Haloperidol-Grindeks contains - The active substance is haloperidol (Haloperidolum). 1 ml of solution for injection contains 5 mg of haloperidol. - Other ingredients are benzyl alcohol, lactic acid (for pH adjustment), chlorobutanol hemihydrate, water for injection. What Haloperidol-Grindeks looks like and contents of the pack A clear, colorless liquid with a specific odor. 1 ml of solution in a colorless glass ampoule with a break line or point. 5 ampoules are placed in a liner. 1 liner is placed in a cardboard box. Also see: Spperidol 5mg/ml 1ml 50 ampoules
