Promazine Hasco

Leaflet attached to the packaging: patient information

Promazine Hasco

25 mg, coated tablets

Promazine Hasco

50 mg, coated tablets

Promazine Hasco

100 mg, coated tablets
Promazine hydrochloride
Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their 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 the 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 the patient is 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 the patient has 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 the patient has 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, consult a 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, motor slowing, as well as parkinsonism);
• who have previously had extrapyramidal disorders and dyskinesias (paroxysmal, involuntary 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 diseases: arrhythmia or conditions predisposing to the development of cardiac rhythm disorders; cerebral thrombosis; coronary heart disease;
• with liver or kidney failure;
• with chronic and severe respiratory function disorders, such as asthma, emphysema, acute respiratory infections (possibility of developing or exacerbating symptoms of these disorders and worsening the patient's condition);
• with epilepsy or conditions predisposing to the development of epilepsy (possibility of developing seizures and worsening the patient's condition);
• in the elderly, especially during hot or cold weather (risk of excessive body temperature increase or decrease). 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 glaucoma with a narrow angle of anterior chamber narrowing in their medical history or family history;
• with hypothyroidism;
• with myasthenia gravis(a disease causing muscle weakness);
• with prostatic hyperplasia.

Before starting treatment, inform your doctor about the above situations.
The occurrence of unexplained fever during promazine treatment may be the first symptom of a malignant neuroleptic syndrome (symptoms: pallor, overheating, disturbances of the autonomic nervous system, disturbances of consciousness, muscle stiffness). If these symptoms occur, discontinue the medicine and contact your doctor immediately.
Promazine treatment 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 - contact your doctor immediately.

In patients treated with neuroleptics, very rare cardiac conduction disorders have been observed, manifested by a prolonged QT interval in the ECG. Therefore, patients at increased risk of developing so-called ventricular arrhythmias (e.g. with heart diseases, metabolic disorders, such as hypokalemia, hypocalcemia, or hypomagnesemia, malnutrition, alcohol abuse, or taking other medicines that prolong the QT interval), require special caution, especially in the initial phase of treatment.
Antipsychotic medicines may increase prolactin secretion in the brain (a hormone stimulating breast growth and milk production). Excess prolactin may cause menstrual disorders, infertility, galactorrhea, excessive hair growth in women, impotence in men, depression, and irritability.
Patients taking promazine should avoid exposure to the sun due to the risk of skin rash and abnormal skin pigmentation.
During long-term treatment with promazine, the doctor will recommend periodic monitoring of peripheral blood count, liver and heart function, and eye examinations.
In case of surgical procedures, inform your doctor about taking Promazine Hasco.
Very rarely, after sudden discontinuation of the medicine (especially after long-term use and in high doses), severe withdrawal symptoms may occur, such as nausea, vomiting, insomnia. It may also lead to a relapse of the disease and the occurrence of extrapyramidal symptoms.
Therefore, it is recommended to gradually discontinue the medicine.

Children

Promazine Hasco should not be taken in children.

Promazine Hasco and other medicines

Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
When taking Promazine Hasco with other medicines, including over-the-counter medicines, interactions may occur, leading to the development of side effects, including severe ones. Therefore, always inform your doctor about taking other medicines.
Do not give adrenaline to patients who have overdosed on promazine.
Promazine's effect on the central nervous system is enhanced by alcohol, barbiturates, sedatives, and opioid analgesics. This may lead to respiratory depression.
Concomitant use of promazine and 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 interfere with promazine absorption, such as medicines that reduce gastric acid secretion, medicines used to treat 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, motor slowing, restlessness, involuntary muscle contractions, and involuntary movements.
Promazine:

• reduces the effect of antidiabetic medicines,
• may interfere with the effect of antiepileptic medicines,
• may enhance the effect of most antihypertensive medicines,
• may have an opposing effect on certain medicines (amphetamines, levodopa, clonidine, guanethidine, or adrenaline),
• may have a toxic effect on the nervous system (combination of promazine with lithium salts may cause a malignant neuroleptic syndrome),
• when taken with certain antiarrhythmic, antidepressant, or 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, drink, or alcohol

Do 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, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Promazine Hasco during pregnancy, especially in the first trimester, unless the doctor considers promazine treatment necessary.
Breastfeeding
Taking Promazine Hasco during breastfeeding is contraindicated.
If the doctor considers promazine treatment necessary, do not breastfeed.

Driving and using machines

Do not drive or operate machines while taking Promazine Hasco.
Promazine may impair mental and physical ability (causing drowsiness) to the extent that it interferes with driving or operating machines.

Promazine Hasco contains lactose

Patients with lactose intolerance should be aware of this. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their 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/ 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

Take this medicine always as directed by your doctor. In case of doubts, consult a 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: should take half of the initial dose. 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.
Gradual dose increase should be observed. The doctor will closely monitor the treatment.

Taking a higher dose of Promazine Hasco than recommended

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

Missing a dose of Promazine Hasco

In case of missing a dose, take it as soon as possible and continue treatment as before. However, if it is close to the time of taking the next dose, skip the missed dose.
Do not take a double dose to make up for the missed dose.

Stopping Promazine Hasco treatment

Do not stop taking this medicine without prior consultation with your doctor.
In case of needing to stop treatment, the doctor will determine the appropriate course of action, depending on the individual patient's response to promazine treatment.
Promazine administration 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).
In case of any further doubts related to the use of this medicine, consult a 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 promazine treatment, with an unknown frequency (frequency cannot be estimated from the available data):

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

malignant neuroleptic syndrome (motor inhibition up to a state of stupor with significant 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 disturbances, depression.
• Immune system disorders: Angioedema (swelling of soft tissues of the face, lips, tongue, and sometimes with concurrent laryngeal edema that may cause breathing difficulties), bronchospasm, urticaria, anaphylactic reactions (rare, potentially life-threatening allergic reactions with symptoms such as: angioedema, urticaria, dyspnea, hypotension, tachycardia) (very 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 flutter, changes in the ECG.
• Endocrine disorders: Galactorrhea (milk secretion), gynecomastia (breast enlargement in men), menstrual disorders, hyperglycemia (elevated blood glucose), hypoglycemia (reduced blood glucose), glycosuria (glucose in the urine), impotence (erectile dysfunction), libido disorders (reduced sexual desire), increased thirst, weight gain.
• Blood and lymphatic system disorders: Granulocytopenia (reduced granulocyte count), agranulocytosis (lack of granulocytes), eosinophilia (increased eosinophil count), leukopenia (reduced leukocyte count), hemolytic anemia (rapid destruction of red blood cells) or aplastic anemia (reduced count of all blood cells), thrombocytopenia (reduced platelet count).
• Metabolic and nutritional disorders: Persistent constipation, sometimes leading to habitual constipation, very rarely: nausea and vomiting.
• Hepatobiliary disorders: Jaundice. If such a condition occurs, promazine should be discontinued and not taken 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 side effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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 helps to gather more information on the safety of the medicine.

5. How to store Promazine Hasco

Store the medicine at a temperature below 25°C.
Keep the blister pack in the outer packaging to protect it from light.
Keep the medicine 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. 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 Promazine Hasco contains

• 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 the coating ingredients: polyvinyl alcohol, talc, macrogol 3350, titanium dioxide (E 171). Additionally, the coating of Promazine Hasco 25 mg and Promazine Hasco 100 mg tablets contains 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 Promazine Hasco looks like and contents of the pack

Promazine Hasco 25 mg are yellow, round, biconvex, smooth coated tablets.
Promazine Hasco 50 mg are orange, round, biconvex, smooth coated tablets.
Promazine Hasco 100 mg are red, round, biconvex, smooth coated tablets.
PVC/PVDC/Aluminum blister pack in a cardboard box. One pack 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: