Promazine Hasco

Leaflet included in the packaging: patient information

Promazine Hasco

25 mg, coated tablets

Promazine Hasco

50 mg, coated tablets

Promazine Hasco

100 mg, coated tablets
Promazine hydrochloride
You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Promazine Hasco and what is it used for
• 2. Important information before taking Promazine Hasco
• 3. How to take Promazine Hasco
• 4. Possible side effects
• 5. How to store Promazine Hasco
• 6. Contents of the packaging and other information

1. What is Promazine Hasco and what is it used for

Promazine Hasco contains promazine (in the form of hydrochloride).
Promazine belongs to a group of neuroleptics. The medicine has a moderate sedative and antipsychotic effect, as well as a weak antiemetic effect.
Indications for use

• Short-term supportive treatment of moderate or severe psychomotor agitation;
• Treatment of agitation and anxiety in the elderly.

2. Important information before taking Promazine Hasco

When not to take Promazine Hasco

• if you are allergic to the active substance (promazine) or to other phenothiazine derivatives or to any of the other ingredients of this medicine listed in section 6;
• if you have the following conditions or diseases: porphyria, pheochromocytoma, severe liver or kidney failure, so-called agranulocytosis (lack of granulocytes in the blood); severe circulatory failure, Parkinson's disease,
• if you have experienced a so-called malignant neuroleptic syndrome.

Do not take the medicine during breastfeeding.
Do not take the medicine in children.

Warnings and precautions

Before starting treatment with Promazine Hasco, you should discuss it with your doctor or pharmacist.
Particular caution should be exercised in patients:

• who have been taking this medicine for a long time (possibility of developing extrapyramidal disorders, i.e. increased muscle tension and tremors, muscle stiffness, gait disturbances, slowed movement, as well as drug-induced parkinsonism);
• who have previously had extrapyramidal disorders and dyskinesias (paroxysmal, compulsive movements) - possibility of exacerbating symptoms and worsening the patient's condition;
• who have been taking phenothiazine derivatives for a long time (may cause so-called late dyskinesias - involuntary movements of the face and tongue muscles), especially in the elderly. If such symptoms occur, treatment with promazine should be discontinued;
• with heart disease: cardiac arrhythmia or conditions predisposing to the occurrence of cardiac rhythm disorders; cerebral thrombosis; coronary heart disease;
• with liver or kidney failure;
• with chronic and severe respiratory function disorders, i.e. asthma, emphysema, acute respiratory infections (possibility of occurrence or exacerbation of symptoms of these disorders and worsening of the patient's condition);
• with epilepsy or conditions predisposing to the occurrence of epilepsy (possibility of seizures and worsening of the patient's condition);
• in the elderly, especially during hot or cold weather (risk of excessive increase or decrease in body temperature). In these patients, so-called orthostatic hypotension may also occur, manifested by dizziness when getting up from a lying or sitting position.

Avoid taking the medicine in patients:

• with narrow-angle glaucoma diagnosed in their medical history or family history;
• with hypothyroidism;
• with myasthenia gravis (a disease causing muscle weakness);
• with prostatic hyperplasia.

Before starting treatment, you should inform your doctor about the above-mentioned situations.
The occurrence of unexplained fever during treatment with promazine may be the first symptom of a malignant neuroleptic syndrome (symptoms: pallor, overheating of the body, disturbances of the autonomic nervous system, disturbances of consciousness, muscle stiffness). If these symptoms occur, you should stop taking the medicine and contact your doctor immediately.
Treatment with promazine may lead to blood system disorders (agranulocytosis

• lack of granulocytes in the blood). This may be indicated by the occurrence of unexplained infection or fever - you should contact your doctor immediately.

In patients treated with neuroleptics, very rare cardiac conduction disorders have been observed, manifesting in ECG results as a prolonged QT interval. Therefore, patients at increased risk of developing so-called ventricular arrhythmias (e.g. with heart disease, metabolic disorders, such as hypokalemia - decreased potassium levels in the blood, hypocalcemia - decreased calcium levels in the blood or hypomagnesemia - decreased magnesium levels in the blood, malnutrition, alcohol abuse, taking other medicines that prolong the QT interval), require particularly cautious treatment, especially in the initial phase.
Antipsychotic medicines may increase the secretion of prolactin in the brain (a hormone stimulating the growth of breast glands and milk production). Excess prolactin may cause menstrual disorders, infertility, galactorrhea, excessive hair growth in women, impotence in men, depressive states, irritability.
Patients taking promazine should avoid exposure to the sun due to the risk of skin rash and abnormal pigment deposition in the skin.
During long-term treatment with promazine, your doctor will recommend periodic checks of peripheral blood count, liver and heart function, as well as eye examinations.
If surgery is necessary, you should inform your doctor about taking Promazine Hasco.
Very rarely, after sudden withdrawal of the medicine (especially when taken for a long time and in high doses), severe withdrawal symptoms may occur, in the form of nausea, vomiting, insomnia. It is also possible for the disease to recur and for extrapyramidal symptoms to occur.
Therefore, it is recommended to gradually discontinue the medicine.

Children

Promazine Hasco should not be taken in children.

Promazine Hasco and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as about medicines you plan to take.
When taking Promazine Hasco with other medicines, including those available without a prescription, interactions may occur, leading to the development of side effects, including severe ones. Therefore, you should always inform your doctor about taking or planning to take other medicines.
Adrenaline should not be administered to patients who have overdosed on promazine.
Promazine's effect on the central nervous system is enhanced by alcohol, barbiturates, sedatives and hypnotics, as well as opioid analgesics. This may lead to respiratory disorders.
Concomitant use of promazine and so-called monoamine oxidase inhibitors or tricyclic antidepressants may prolong and enhance the sedative and anticholinergic effects of promazine and these medicines. Enhanced anticholinergic effect may lead to constipation, heat stroke, etc.
Anticholinergic medicines (e.g. some antidepressants and some medicines used to treat Parkinson's disease) may weaken the antipsychotic effect of promazine.
Some medicines may disrupt the absorption of promazine, such as medicines that reduce gastric acid secretion, medicines used in Parkinson's disease, and lithium salts.
Adverse interactions of promazine with alcohol, guanethidine, and antidiabetic medicines have been observed.
After taking neuroleptics (including promazine), so-called extrapyramidal symptoms may occur, such as muscle stiffness, facial rigidity, slowed movement, restlessness, involuntary muscle spasms, and involuntary movements.

• Promazine reduces the effect of antidiabetic medicines,
• may disrupt the effect of antiepileptic medicines,
• may enhance the effect of most antihypertensive medicines,
• may act antagonistically to some medicines (amphetamine, levodopa, clonidine, guanethidine, or adrenaline),
• may act toxically on the nervous system (combination of promazine with lithium salts may cause the development of a malignant neuroleptic syndrome),
• when taken with certain antiarrhythmic, antidepressant, and antipsychotic medicines, may increase the risk of developing arrhythmias,
• when taken with other medicines that may cause bone marrow damage (e.g. carbamazepine or certain antibiotics and cytostatics), increases the risk of developing agranulocytosis (lack of granulocytes in the blood).

Promazine Hasco with food, drinks, or alcohol

You should not drink alcohol while taking Promazine Hasco.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Promazine Hasco during pregnancy, especially in the first trimester, unless your doctor considers promazine treatment necessary.
Breastfeeding
Taking Promazine Hasco during breastfeeding is contraindicated.
If your doctor considers promazine treatment necessary, you should not breastfeed.

Driving and using machines

You should not drive vehicles or operate machines while taking Promazine Hasco.
Promazine may impair mental and physical ability (causing drowsiness) to the extent that it makes driving or operating machines difficult.

Promazine Hasco contains lactose

People with lactose intolerance should be aware of this. If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.
One Promazine Hasco 25 mg coated tablet contains 46.25 mg of lactose monohydrate.
One Promazine Hasco 50 mg coated tablet contains 92.5 mg of lactose monohydrate.
One Promazine Hasco 100 mg coated tablet contains 185 mg of lactose monohydrate.
Promazine Hasco contains yellow quinoline/chinoline/orange/carmoisine
The coating of Promazine Hasco 25 mg and Promazine Hasco 100 mg tablets contains the dyes: quinoline yellow (E 104) lake, carmoisine (E 124) lake.
The coating of Promazine Hasco 50 mg tablets contains the dyes: quinoline yellow (E 104) lake, sunset yellow FCF (E 110) lake.
The medicine may cause allergic reactions.

3. How to take Promazine Hasco

This medicine should always be taken according to your doctor's instructions. If you are unsure, you should consult your doctor or pharmacist.
The medicine is taken orally.
Recommended dose
Psychomotor agitation:
Usually, 100 mg to 200 mg of promazine is taken four times a day.
Treatment should be started with smaller doses. The dose is then gradually increased to the optimal dose for the patient. The intervals between doses are usually 6-8 hours.
Some patients may take the daily dose once, before bedtime.
Elderly patients: the initial dose should be halved. The doctor will closely monitor the treatment.
Agitation and anxiety in the elderly:
Initially 25 mg, then, if necessary, up to 50 mg four times a day.
You should follow the gradual increase in the dose of the medicine. The doctor will closely monitor the treatment.
If you feel that the effect of the medicine is too strong or too weak, you should consult your doctor.

Taking a higher dose of Promazine Hasco than recommended

If you have taken a higher dose of the medicine than recommended, you should immediately consult your doctor or pharmacist.
Taking a higher dose of the medicine than recommended may cause deep sleep, significant drop in blood pressure, and slowed breathing. Rarely, it may first cause agitation, then coma, and eventually generalized tonic-clonic seizures.
In case of promazine overdose, you should immediately contact your doctor.

Missing a dose of Promazine Hasco

If you miss a dose, you should take it as soon as possible and continue treatment according to the previous instructions. However, if it is almost time for the next dose, you should skip the missed dose.
You should not take a double dose to make up for the missed dose.

Stopping treatment with Promazine Hasco

You should not stop taking this medicine without first consulting your doctor.
If treatment needs to be discontinued, your doctor will determine the appropriate course of action, depending on the individual patient's response to promazine treatment.
Promazine should be discontinued immediately only in case of a malignant neuroleptic syndrome (see section 2 of the leaflet - Warnings and precautions) or in case of hypersensitivity (see section 2 of the leaflet - When not to take Promazine Hasco).
If you have any further questions about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are rare, and the most common side effects observed are nervous system disorders.
The following side effects have been reported during treatment with promazine, with an unknown frequency (frequency cannot be estimated from the available data):

• -Nervous system disorders: Parkinsonism (tremors, muscle tension, slowed movements), akathisia (motor agitation), acute dystonic syndrome (involuntary movements of the limbs or the whole body), seizures, late dyskinesias or dystonic syndromes, hyperthermia, i.e. overheating of the body or hypothermia, i.e. cooling of the body (especially in the elderly or with hypothyroidism),

malignant neuroleptic syndrome (motor inhibition up to a state of stupor with significant increase in muscle tension, tremors, and single involuntary movements, tachycardia, hyperthermia, large fluctuations in blood pressure, sweating, salivation, flushing of the face, increasing disturbances of consciousness up to a coma, leukocytosis, dehydration, electrolyte disturbances); accommodation disorders, urinary retention, constipation, dryness of mucous membranes.

• Psychiatric disorders: Drowsiness, decreased concentration, excessive motor inhibition, sleep disorders, depression.
• Immune system disorders: Angioedema (swelling of the mucous membranes of the face, lips, tongue, and sometimes with concurrent laryngeal edema, which can make breathing difficult), bronchospasm, urticaria, anaphylactic reactions (rare, potentially life-threatening allergic reactions with symptoms such as angioedema, urticaria, dyspnea, hypotension, tachycardia) (extremely rare), systemic lupus erythematosus (an autoimmune disease characterized by a butterfly-shaped rash on the face).
• Vascular disorders: Hypotension (especially at the beginning of treatment), orthostatic hypotension (excessive decrease in blood pressure when standing up).
• Cardiac disorders: Atrioventricular block, supraventricular arrhythmias, ventricular tachycardia, ventricular fibrillation, changes in ECG.
• Endocrine disorders: Galactorrhea, gynecomastia, menstrual disorders, hyperglycemia, hypoglycemia, glycosuria, impotence, decreased libido, increased thirst, weight gain.
• Blood and lymphatic system disorders: Granulocytopenia, agranulocytosis, eosinophilia, leukopenia, hemolytic or aplastic anemia, thrombocytopenia.
• Metabolic and nutritional disorders: Persistent constipation, sometimes leading to habitual constipation, rarely: nausea and vomiting.
• Hepatobiliary disorders: Jaundice. If such a condition occurs, promazine should be discontinued and not administered again.
• Skin and subcutaneous tissue disorders: Allergic skin reactions, photosensitivity, pigmentation changes (skin discoloration, pigment deposition in the cornea and retina of the eye).
• Reproductive system and breast disorders: Priapism (prolonged and painful erection).
• Respiratory, thoracic, and mediastinal disorders: Respiratory depression in sensitive patients.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw,
phone: +48 22 49 21 301, fax: +48 22 49 21 309,
e-mail: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Promazine Hasco

The medicine should be stored at a temperature below 25°C.
The blister should be stored in the outer packaging to protect it from light.
The medicine should be kept out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What does Promazine Hasco contain

• The active substance of the medicine is promazine hydrochloride. One Promazine Hasco 25 mg coated tablet contains 25 mg of promazine hydrochloride. One Promazine Hasco 50 mg coated tablet contains 50 mg of promazine hydrochloride. One Promazine Hasco 100 mg coated tablet contains 100 mg of promazine hydrochloride.
• The other ingredients are: lactose monohydrate; maize starch; talc; Povidone K 15/17; colloidal silica; magnesium stearate; and coating ingredients: polyvinyl alcohol, talc, macrogol 3350, titanium dioxide (E 171). Additionally, the coatings of Promazine Hasco 25 mg and Promazine Hasco 100 mg tablets contain quinoline yellow (E 104) lake, carmoisine (E 124) lake. Additionally, the coating of Promazine Hasco 50 mg tablets contains quinoline yellow (E 104) lake, sunset yellow FCF (E 110) lake.

What does Promazine Hasco look like and what does the packaging contain

Promazine Hasco 25 mg are round, biconvex, smooth, yellow coated tablets.
Promazine Hasco 50 mg are round, biconvex, smooth, orange coated tablets.
Promazine Hasco 100 mg are round, biconvex, smooth, red coated tablets.
PVC/PVDC/Aluminum blister in a cardboard box. One packaging of the medicine contains 60 coated tablets.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Information about the medicine

phone: (22) 742 00 22
e-mail: informacjaoleku@hasco-lek.pl

Date of the last update of the leaflet: