Promazin jelfa

Package leaflet: Information for the patient

PROMAZIN JELFA, 25 mg, coated tablets
PROMAZIN JELFA, 50 mg, coated tablets
PROMAZIN JELFA, 100 mg, coated tablets
Promazini hydrochloridum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents:

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

1. What Promazin Jelfa is and what it is used for

Promazin Jelfa contains promazini hydrochloridum as the active substance, which belongs to the group of neuroleptics. The medicine 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 taking Promazin Jelfa

When not to take Promazin Jelfa:

• if the patient is allergic to the active substance, other phenothiazine derivatives, or any of the other ingredients of this medicine (listed in section 6);
• if the patient is in a coma;
• if the patient has a chromaffin tumor (pheochromocytoma);
• if the patient has severe liver or kidney failure;
• if the patient has agranulocytosis (lack of granulocytes in the blood);
• if the patient has severe circulatory failure;
• if the patient has Parkinson's disease;
• if the patient has previously experienced neuroleptic malignant syndrome;
• if the woman is breastfeeding.

The medicine should not be used in children.
Warnings and precautions
Before starting treatment with Promazin Jelfa, discuss this with your doctor, pharmacist, or nurse.
Exercise particular caution in patients:

• receiving long-term treatment with this medicine due to the risk of developing extrapyramidal disorders, including drug-induced parkinsonism (increased muscle tension, slowed movements, tremor);
• with a history of extrapyramidal disorders or dyskinesias (episodic, involuntary movements), due to a high risk of worsening these disorders; long-term use of phenothiazine derivatives may cause tardive dyskinesia (involuntary movements of facial muscles and tongue), especially in elderly patients – if dyskinesias occur, promazine should be discontinued;
• with heart disease, cardiac arrhythmia, or conditions predisposing to heart rhythm disturbances;
• with cerebral arteriosclerosis or ischemic heart disease;
• with liver or kidney dysfunction (severe impairment is a contraindication for using the medicine);
• with chronic and severe respiratory disorders, in patients with asthma, emphysema, or acute respiratory tract infections, due to the risk of worsening or provoking symptoms of these conditions by promazine;
• with epilepsy or conditions predisposing to seizures, due to the risk of promazine lowering the seizure threshold;
• in elderly patients, especially during hot or cold weather, due to the risk of hyper- or hypothermia (excessive increase or decrease in body temperature). Orthostatic hypotension causing dizziness upon standing from a lying or sitting position may particularly occur in these patients.

Avoid using the medicine in patients:

• with a history or family history of narrow-angle glaucoma;
• with hypothyroidism;
• with myasthenia gravis (a disease causing muscle weakness);
• with benign prostatic hyperplasia.

Before starting treatment, inform the doctor about the above-mentioned conditions.
If unexplained fever occurs, treatment must be discontinued and the cause established, as it may be the first sign of neuroleptic malignant syndrome (symptoms: pallor, hyperthermia, autonomic nervous system disturbances, altered consciousness, muscle rigidity). If these symptoms occur, contact your doctor immediately.
Very rarely, abrupt discontinuation of the medicine (especially after long-term use of high doses) may lead to acute withdrawal symptoms such as nausea, vomiting, and insomnia. A relapse of the illness may also occur, along with extrapyramidal symptoms. Therefore, gradual discontinuation of the medicine is recommended.
Agranulocytosis (lack of granulocytes in the blood) may occur during treatment with phenothiazine derivatives. Therefore, regular blood tests are recommended. The occurrence of unexplained infection or fever may indicate hematopoietic system disorders – a blood test should be performed immediately.
Cases of QT interval prolongation on ECG have been reported in patients treated with neuroleptics, although very rarely. Nevertheless, patients at increased risk of ventricular arrhythmias (e.g., those with heart disease, metabolic disorders such as hypokalemia – decreased potassium levels in blood, hypocalcemia – decreased calcium levels in blood, or hypomagnesemia – decreased magnesium levels in blood, malnourished patients, alcohol abusers, or those treated with other QT-prolonging drugs) require particularly careful monitoring, especially during the initial phase of treatment.
Antipsychotic medicines may increase prolactin secretion in the brain (a hormone stimulating breast gland growth and milk production).
Patients treated with promazine should avoid exposure to sunlight due to the risk of skin rash and pigment deposition in the skin.
During long-term treatment with Promazin Jelfa, periodic monitoring of peripheral blood count, liver and heart function, and eye examinations should be performed.
If surgery is required, inform the doctor about the use of Promazin Jelfa.
Children and adolescents
The medicine should not be used in children.
Promazin Jelfa and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines planned for use.
When Promazin Jelfa is used concomitantly with other medicines, including over-the-counter medicines, mutual interactions may occur, leading to adverse effects, including severe 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 depressant effect of promazine is enhanced by alcohol, barbiturates, sedatives, hypnotics, and opioid analgesics. This may lead to respiratory disturbances.
Concomitant use of promazine with monoamine oxidase inhibitors or tricyclic antidepressants may result in prolonged and intensified sedative and anticholinergic effects of promazine and these medicines. Increased anticholinergic effects may lead to constipation, heat stroke, etc.
Anticholinergic medicines (e.g., certain antidepressants and certain medicines used in Parkinson's disease treatment) may reduce the antipsychotic effect of promazine.
Some medicines interfere with neuroleptic absorption, e.g., medicines that neutralize gastric acid, medicines used in Parkinson's disease, and lithium.
Clinically significant adverse interactions between promazine and alcohol, guanethidine, and antidiabetic medicines have been observed.
After administration of neuroleptics, including promazine, extrapyramidal symptoms may occur, such as: muscle rigidity, reduced facial expression, slowed movement, motor restlessness, involuntary muscle contractions, and involuntary movements. In such cases, to reduce extrapyramidal symptoms, anticholinergic medicines effective against parkinsonism are recommended instead of levodopa.
Promazine:

• reduces the response to antidiabetic medicines, thus increasing their dosage may be necessary;
• may interfere with the action of anticonvulsant medicines;
• may enhance the effect of most antihypertensive medicines;
• may act antagonistically to certain medicines, including amphetamine, levodopa, clonidine, guanethidine, and adrenaline;
• may act neurotoxically and cause neuroleptic malignant syndrome in patients treated concomitantly with neuroleptics and lithium;
• when used together with other medicines that prolong the QT interval on ECG, such as certain antiarrhythmic, antidepressant, and other antipsychotic medicines, may increase the risk of developing arrhythmias;
• when used with other medicines that may cause bone marrow damage, such as carbamazepine or certain antibiotics and cytostatics, increases the risk of agranulocytosis.

Promazin Jelfa and alcohol
Alcohol should not be consumed during treatment with Promazin Jelfa.
Pregnancy, breastfeeding, and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have children, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Promazin Jelfa should not be used during pregnancy, especially in the first trimester, unless in the doctor's opinion treatment with promazine is necessary.
Breastfeeding
Use of Promazin Jelfa during breastfeeding is contraindicated. If its use is necessary, breastfeeding should be discontinued.
Driving and operating machinery
Promazine may impair mental and physical performance (causing drowsiness) to an extent that may hinder driving or operating moving machinery; therefore, patients treated with promazine should not perform these activities.
Promazin Jelfa contains monohydrate lactose, quinoline yellow (E 104) (only 25 mg tablets),
sunset yellow (E 110) (only 50 mg tablets), carmine red (E 124) (only 100 mg tablets).
If the patient has been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking Promazin Jelfa.
The medicine may cause allergic reactions.

3. How to take Promazin Jelfa

This medicine should always be taken exactly as directed by the doctor. In case of doubts, consult
your doctor or pharmacist.
Psychomotor agitation
Recommended dose: usually 100 mg to 200 mg 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 6-8 hour intervals.
Some patients may take a single daily dose of the medicine before bedtime.
Elderly patients: half the initial dose should be used. Treatment must be conducted
under strict medical supervision.
Agitation and restlessness
Recommended dose:
elderly patients: initially 25 mg, then, if necessary, up to 50 mg four times daily. The dose should be
gradually increased. Treatment must be conducted under strict medical supervision.
If you feel that the effect of Promazin Jelfa is too strong or too weak, consult your doctor.
Taking more Promazin Jelfa than recommended
Taking more than the recommended dose of Promazin Jelfa may cause deep sleep, a significant
drop in blood pressure, and slowed breathing.
In rare cases, agitation may occur first, followed by coma, and eventually generalized tonic-clonic seizures.
In case of overdose, contact your doctor immediately.
Missing a dose of Promazin Jelfa
If you miss a dose of Promazin Jelfa, 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 Promazin Jelfa
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions are rare; the most commonly observed adverse reactions are
nervous system disorders.
Adverse reactions may occur with the following frequencies:
very common: more than 1 in 10 people
common: 1 to 10 in 100 people
uncommon: 1 to 10 in 1,000 people
rare: 1 to 10 in 10,000 people
very rare: less than 1 in 10,000 people
frequency not known: frequency cannot be estimated from the available data

Nervous system disorders
Frequency not known: parkinsonism resolving after dose reduction or administration of anticholinergic drugs, akathisia, acute dyskinetic syndrome, seizures, tardive dyskinesia or dystonic syndromes (especially in patients treated long-term, following abrupt discontinuation of the drug or significant dose reduction), hyperthermia (especially during hot and humid weather or when antiparkinsonian drugs are used concomitantly) or hypothermia (especially in elderly patients or those with hypothyroidism), neuroleptic malignant syndrome (motor retardation up to stupor, marked increase in skeletal muscle rigidity, tremor, and single involuntary movements, tachycardia, hyperthermia, large fluctuations in blood pressure, vegetative disturbances – sweating, salivation, facial flushing; progressive disturbances of consciousness up to coma, leukocytosis, dehydration, electrolyte disturbances); accommodation disorders, urinary retention, constipation, dryness of mucous membranes.

Psychiatric disorders
Frequency not known: drowsiness, impaired concentration, excessive motor inhibition, sleep disturbances, depression.

Immune system disorders
Frequency not known: angioedema, bronchospasm, urticaria, anaphylactic reactions (very rare), systemic lupus erythematosus.

Vascular disorders
Frequency not known: hypotension (especially at the beginning of treatment), orthostatic drops in blood pressure.

Cardiac disorders
Frequency not known: atrioventricular block, atrial arrhythmias, ventricular tachycardia, ventricular fibrillation, ECG changes: flattening or inversion of the T wave, prolongation of the PQ and QT intervals, and appearance of the U wave.

Endocrine disorders
Frequency not known: galactorrhea, gynecomastia, menstrual disorders, hyper- and hypoglycemia, glycosuria, impotence, libido disorders, increased thirst, weight gain.

Blood and lymphatic system disorders
Frequency not known: granulocytopenia, agranulocytosis, eosinophilia, leukopenia, hemolytic or aplastic anemia, thrombocytopenia.

Metabolism and nutrition disorders
Frequency not known: troublesome constipation (related to the anticholinergic effect of the drug), sometimes leading to habitual constipation; nausea and vomiting very rarely.

Hepatobiliary disorders
Frequency not known: cholestatic jaundice (usually between the 2nd and 4th week of treatment) caused by spasm of the bile ducts due to hypersensitivity mechanism. Symptoms resemble viral hepatitis, and laboratory tests indicate mechanical origin. If such a condition occurs, promazine must be discontinued and not re-administered.

Skin and subcutaneous tissue disorders
Frequency not known: allergic skin reactions, photosensitivity, pigmentary changes (skin discoloration, deposition of pigment in the cornea and retina of the eye).

Reproductive system and breast disorders
Frequency not known: priapism

Respiratory, thoracic and mediastinal disorders
Frequency not known: respiratory depression in sensitive patients

Reporting of adverse reactions
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
Al. Jerozolimskie 181c
02-222 Warsaw
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions allows the collection of further information on the safety of using the medicine.

5. How to store Promazin Jelfa

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container and cardboard packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Proper disposal helps protect the environment.

6. Package contents and other information
What Promazin Jelfa contains

• The active substance is promazine hydrochloride.
  Promazin Jelfa, 25 mg: One film-coated tablet contains 25 mg of promazine hydrochloride.
  Promazin Jelfa, 50 mg: One film-coated tablet contains 50 mg of promazine hydrochloride.
  Promazin Jelfa, 100 mg: One film-coated tablet contains 100 mg of promazine hydrochloride.
• Other ingredients: monohydrate lactose, corn starch, gelatin, stearic acid, anhydrous colloidal silicon dioxide, talc, sodium saccharin, sucrose, arabic gum, and quinoline yellow (E 104) (only in Promazin Jelfa, 25 mg), orange yellow (E 110) (only in Promazin Jelfa, 50 mg), cochineal red (E 124) (only in Promazin Jelfa, 100 mg).

What Promazin Jelfa looks like and pack contents
Promazin Jelfa, 25 mg, film-coated tablets
Yellow, round, biconvex film-coated tablets.
Promazin Jelfa, 50 mg, film-coated tablets
Orange, round, biconvex film-coated tablets.
Promazin Jelfa, 100 mg, film-coated tablets
Red, round, biconvex film-coated tablets.

Promazin Jelfa, 25 mg, film-coated tablets: PP/PE container in a cardboard box.
60 tablets (1 container with 60 tablets)
Promazin Jelfa, 50 mg, film-coated tablets: PP/PE container in a cardboard box.
60 tablets (1 container with 60 tablets)
Promazin Jelfa, 100 mg, film-coated tablets: PP/PE container in a cardboard box.
60 tablets (1 container with 60 tablets)

Marketing Authorisation Holder:
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer:
Przedsiębiorstwo Farmaceutyczne Jelfa SA
58-500 Jelenia Góra, ul. Wincentego Pola 21
tel.: (75) 643-31-02
fax: (075) 752-44-55
e-mail: [email protected]