Promazine hasco

Package leaflet: Information for the patient

Promazine Hasco
25 mg, coated tablets
Promazine Hasco
50 mg, coated tablets
Promazine Hasco
100 mg, coated tablets
Promazini hydrochloridum
Please read all of this leaflet carefully before using this medicine, because 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 personally. 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 any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Promazine Hasco is and what it is 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 pack and other information

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

Promazine Hasco contains promethazine (in the form of hydrochloride).
Promethazine belongs to the group of neuroleptics. The drug has moderate sedative and antipsychotic effects, as well as weak anticonvulsant and antiemetic properties.

Indications

• Short-term adjunctive treatment of moderate to severe psychomotor agitation;
• Treatment of agitation and anxiety in elderly patients.

2. Important information before using Promazine Hasco

When Promazine Hasco must not be used

• 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 any of the following conditions or diseases: porphyria, phaeochromocytoma, severe liver or kidney failure, agranulocytosis (lack of granulocytes in the blood), severe circulatory failure, Parkinson's disease;
• if the patient has previously experienced the so-called neuroleptic malignant syndrome.

Do not use this medicine during breastfeeding.
Do not use this medicine in children.

Warnings and precautions

Before starting treatment with Promazine Hasco, discuss this with your doctor or pharmacist.

Exercise particular caution in patients:

• receiving long-term treatment with this medicine (risk of developing extrapyramidal disorders, such as increased muscle tension and tremors, muscle stiffness, gait disturbances, motor retardation, and drug-induced parkinsonism);
• with previous history of extrapyramidal disorders or dyskinesias (episodic, compulsive movements) – risk of symptom exacerbation and worsening of the patient's condition;
• receiving long-term treatment with phenothiazine derivatives (may cause so-called tardive dyskinesia – involuntary movements of facial muscles and tongue), especially in elderly patients. If such symptoms occur, treatment with promazine should be discontinued;
• with heart diseases: cardiac arrhythmia or conditions predisposing to cardiac rhythm disturbances; cerebral atherosclerosis; ischemic heart disease;
• with liver or kidney failure;
• with chronic and severe respiratory disorders, such as asthma, emphysema, or acute respiratory tract infections (risk of occurrence or worsening of symptoms and deterioration of the patient's condition);
• with epilepsy or conditions predisposing to seizures (risk of seizures and worsening of the patient's condition);
• in advanced age, particularly during hot or cold weather (risk of excessive increase or decrease in body temperature). Orthostatic hypotension may also occur in these patients, manifesting as dizziness upon standing from a lying or sitting position.

Avoid using this medicine in patients:

• with narrow-angle glaucoma, either in personal or family history;
• with hypothyroidism;
• with myasthenia gravis (a disease causing muscle weakness);
• with benign prostatic hyperplasia (enlarged prostate).

Before starting treatment, inform your doctor about any of the above-mentioned conditions.

Fever of unknown origin during treatment with promazine may be the first sign of neuroleptic malignant syndrome (symptoms: pallor, hyperthermia, autonomic nervous system disturbances, altered consciousness, muscle rigidity). If these symptoms occur, discontinue the medicine immediately and contact your doctor without delay.

Treatment with promazine may lead to disturbances in haematopoietic system function (agranulocytosis – lack of granulocytes in the blood). Unexplained infections or fever may indicate this condition – contact your doctor immediately.

Very rarely, cardiac rhythm disturbances have been observed in patients treated with neuroleptics, evident in ECG results as QT interval prolongation. Therefore, patients at increased risk of ventricular cardiac arrhythmias (e.g. due to heart disease, metabolic disturbances such as hypokalemia – low potassium levels in blood, hypocalcemia – low calcium levels in blood, or hypomagnesemia – low magnesium levels in blood, malnutrition, alcohol abuse, or treatment with other QT-prolonging drugs) require particularly careful monitoring, especially during the initial phase of treatment.

Antipsychotic drugs may increase prolactin secretion in the brain (a hormone stimulating mammary gland growth and milk production). Excess prolactin may cause menstrual disorders, infertility, acne, hirsutism in women, impotence in men, depression, and irritability.

Patients treated with promazine should avoid exposure to sunlight 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 monitoring of peripheral blood count, liver and heart function, and eye examinations.

If surgery is required, inform the doctor about the use of Promazine Hasco.

Very rarely, abrupt discontinuation of the medicine (especially after long-term use and high doses) may lead to severe withdrawal symptoms such as nausea, vomiting, and insomnia. There may also be a relapse of the illness and recurrence of extrapyramidal symptoms. Therefore, gradual discontinuation of the medicine is recommended.

Children

Promazine Hasco must not be used in children.

Promazine Hasco and other medicines

Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for use.

When Promazine Hasco is used concomitantly with other medicines, including over-the-counter drugs, mutual interactions may occur, leading to the development of adverse effects, including serious ones. Therefore, always inform your doctor about taking or intending to take other medicines.

Adrenaline must not be administered to patients who have overdosed on promazine.

The central nervous system effects of promazine are enhanced by alcohol, barbiturates, sedatives, hypnotics, and opioid analgesics. This may lead to respiratory disturbances.

Concomitant use of promazine and monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants may prolong and intensify the sedative and anticholinergic effects of promazine and these drugs. Increased anticholinergic effects may lead to constipation, heat stroke, etc.

Anticholinergic drugs (e.g. certain antidepressants and certain drugs used in Parkinson's disease treatment) may reduce the antipsychotic effect of promazine.

Some drugs interfere with promazine absorption, such as antacids, drugs used in Parkinson's disease, and lithium salts.

Unfavourable interactions between promazine and alcohol, guanethidine, and antidiabetic drugs have been observed.

After administration of neuroleptics (including promazine), extrapyramidal symptoms may occur, such as muscle rigidity, reduced facial expression, motor retardation, restlessness, involuntary muscle contractions, and involuntary movements.

Promazine:

• reduces response to antidiabetic drugs;
• may interfere with the action of antiepileptic drugs;
• may intensify the effect of most antihypertensive drugs;
• may act antagonistically to certain drugs (amphetamines, levodopa, clonidine, guanethidine, or adrenaline);
• may have neurotoxic effects (combination of promazine with lithium salts may lead to neuroleptic malignant syndrome);
• when used concomitantly with certain antiarrhythmic, antidepressant, or antipsychotic drugs, may increase the risk of arrhythmias;
• when used with other drugs that may cause bone marrow damage (e.g. carbamazepine, certain antibiotics, or cytostatics), increases the risk of agranulocytosis (lack of granulocytes in blood).

Promazine Hasco with food, drink or alcohol

Do not consume alcohol while taking Promazine Hasco.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy

Do not use Promazine Hasco during pregnancy, especially during the first trimester, unless, in the opinion of the doctor, treatment with promazine is necessary.

Breastfeeding

Use of Promazine Hasco during breastfeeding is contraindicated.
If, in the doctor's opinion, treatment with promazine is necessary, breastfeeding should not be continued.

Driving and operating machinery

While taking Promazine Hasco, patients should not drive or operate machinery.
Promazine may impair mental and physical performance (causing drowsiness) to an extent that may interfere with the ability to drive or operate machinery.

Promazine Hasco contains lactose

Patients with lactose intolerance should be aware of this. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

One Promazine Hasco 25 mg coated tablet contains 46.25 mg of monohydrated lactose.
One Promazine Hasco 50 mg coated tablet contains 92.5 mg of monohydrated lactose.
One Promazine Hasco 100 mg coated tablet contains 185 mg of monohydrated lactose.

Promazine Hasco contains quinoline yellow / sunset yellow / carmine red

The coatings of Promazine Hasco 25 mg and Promazine Hasco 100 mg tablets contain colouring agents: quinoline yellow (E 104) lake, carmine red A (E 124) lake.
The coating of Promazine Hasco 50 mg tablets contains colouring agents: quinoline yellow (E 104) lake, sunset yellow FCF (E 110) lake.
This medicine may cause allergic reactions.

3. How to use Promazine Hasco

This medicine should always be taken as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Promazine Hasco is administered orally.
Recommended dosage
Psychomotor agitation:
The usual dose is 100 mg to 200 mg of promazine, four times daily.
Treatment should be initiated with lower doses. The dose should then be gradually increased to
the optimal dose for the patient. Doses are usually administered at intervals of 6–8 hours.
Some patients may take a single daily dose of the medicine before bedtime.
Elderly patients: Start with half the initial dose. The physician will closely monitor the treatment.
Agitation and restlessness in elderly patients:
Initially 25 mg, then, if necessary, up to 50 mg four times daily.
The dose should be gradually increased. The physician will closely monitor the treatment.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.
Use of a higher than recommended dose of Promazine Hasco
In case of taking more than the recommended dose, seek immediate medical advice from your doctor or
pharmacist.
Taking more than the recommended dose may cause deep sleep, significant drop in blood pressure, and respiratory depression. Rarely, excitation may occur first, followed by coma, and ultimately generalized tonic-clonic seizures.
In case of promazine overdose, contact a doctor immediately.
Missed dose of Promazine Hasco
If a dose is missed, take it as soon as possible and continue treatment according to previous instructions. However, if it is almost time for the next dose, skip the missed dose.
Do not take a double dose to make up for a missed dose.
Stopping treatment with Promazine Hasco
Do not discontinue this medicine without first consulting your doctor.
If treatment needs to be discontinued, your doctor will determine the appropriate method based on the individual patient's response to promazine therapy.
Promazine administration should be stopped immediately only in the case of development of the so-called
neuroleptic malignant syndrome (see section 2 of the leaflet – Warnings and precautions) or in case of hypersensitivity (see section 2 of the leaflet – When not to use Promazine Hasco).
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
Adverse effects are rare; the most commonly observed adverse effects are
nervous system disorders.
The following adverse effects have been reported during the use of promazine, occurring with
unknown frequency (frequency cannot be estimated from the available data):

• Nervous system disorders: Parkinsonism (tremor, muscle rigidity, bradykinesia), akathisia (motor restlessness), acute dyskinesia syndrome (involuntary movements of limbs or the whole body), seizures, tardive dyskinesia or dystonic syndromes, hyperthermia (overheating of the body) or hypothermia (body cooling) (especially in elderly patients or those with hypothyroidism),
  malignant neuroleptic syndrome (motor retardation up to stupor, marked increase in skeletal muscle rigidity, tremor and single involuntary movements, tachycardia (rapid heartbeat), hyperthermia, large fluctuations in blood pressure, sweating, sialorrhea (excessive salivation), facial flushing, progressively worsening disturbances of consciousness up to coma, leukocytosis (increased number of white blood cells - leukocytes), dehydration, electrolyte disturbances); accommodation disorders, urinary retention, constipation, dryness of mucous membranes.

• Psychiatric disorders: Somnolence, reduced concentration, excessive motor inhibition, sleep disturbances, depression.

• Immune system disorders: Angioedema (swelling of soft tissues of the face, lips, tongue, sometimes with simultaneous swelling of the larynx, which may impair breathing), bronchospasm, urticaria, anaphylactic reactions (potentially life-threatening hypersensitivity reactions with symptoms such as: itching, urticaria, dyspnea, drop in blood pressure, rapid heartbeat) (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 drop in blood pressure upon standing).

• Cardiac disorders: Atrioventricular block, atrial rhythm disturbances, ventricular tachycardia (rapid heartbeat), ventricular fibrillation, changes in ECG recording.

• Endocrine disorders: Galactorrhea (milk secretion), gynaecomastia (enlargement of breast tissue in males), menstrual disorders, hyperglycaemia (increased blood glucose level), hypoglycaemia (decreased blood glucose level), glycosuria (presence of glucose in urine), impotence (erectile dysfunction), libido disorders (reduced sexual drive), increased thirst, weight gain.

• Blood and lymphatic system disorders: Granulocytopenia (reduced number of white blood cells - granulocytes in blood), agranulocytosis (absence of granulocytes in blood), eosinophilia (increased number of white blood cells - eosinophils in blood), leukopenia (reduced number of white blood cells - leukocytes in blood), haemolytic anaemia (rapid breakdown of red blood cells - erythrocytes) or aplastic anaemia (reduced number of all blood cells - erythrocytes, leukocytes, platelets), thrombocytopenia (reduced number of blood platelets).

• Metabolism and nutrition disorders: Severe constipation, sometimes leading to habitual constipation, very rarely: nausea and vomiting.

• Hepatobiliary disorders: Jaundice. If this condition occurs, promazine should be discontinued and not re-administered.

• Skin and subcutaneous tissue disorders: Allergic skin reactions, photosensitivity, pigmentary changes (skin discoloration, deposition of pigment in the cornea and retina).

• Reproductive system and breast disorders: Priapism (prolonged and painful penile erection).

• Respiratory, thoracic and mediastinal disorders: Respiratory depression in susceptible patients.

Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Effects of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: +48 22 4921 301, fax: +48 22 4921 309,
e-mail: [email protected].
Adverse effects can also be reported directly to the marketing authorization holder.
Reporting adverse effects helps to gather more information on the safety of the medicine.

5. How to store Promazine Hasco

Store the medicine below 25°C.
Keep the blister in the outer packaging to protect from light.
Store the medicine out of sight and out of 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Promazine Hasco contains

• The active substance is promazine hydrochloride. One coated tablet of Promazine Hasco 25 mg contains 25 mg of promazine hydrochloride. One coated tablet of Promazine Hasco 50 mg contains 50 mg of promazine hydrochloride. One coated tablet of Promazine Hasco 100 mg contains 100 mg of promazine hydrochloride.
• The other ingredients are: monohydrate lactose; pregelatinized corn starch; talc; povidone K 15/17; anhydrous colloidal silicon dioxide, magnesium stearate, and coating components: 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, carmine red A (E 124) lake. Additionally, the coating of Promazine Hasco 50 mg tablets contains quinoline yellow (E 104) lake, orange-yellow FCF (E 110) lake.

What Promazine Hasco looks like and contents of the pack
Promazine Hasco 25 mg are yellow, round, biconvex, smooth, film-coated tablets.
Promazine Hasco 50 mg are orange, round, biconvex, smooth, film-coated tablets.
Promazine Hasco 100 mg are red, round, biconvex, smooth, film-coated tablets.
PVC/PVDC/Aluminium blister packs in a cardboard box. One package contains 60 film-coated tablets.

Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żygrodzka 242 E

Product information
tel. (22) 742 00 22
email: [email protected]