Promazin Ielfa

Package Leaflet: Information for the Patient

PROMAZIN JELFA, 25 mg, sugar-coated tablets
PROMAZIN JELFA, 50 mg, sugar-coated tablets
PROMAZIN JELFA, 100 mg, sugar-coated tablets
Promazine Hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet:

• 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 package and other information

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

Promazin Jelfa contains the active substance promazine hydrochloride, which belongs to the group of neuroleptics. The medicine has moderate sedative and antipsychotic effects, as well as weak antiemetic and antihistamine effects.
Indications for use:

• short-term supportive treatment of moderate or severe psychomotor agitation;
• treatment of agitation and restlessness in the elderly.

2. Important information before taking Promazin Jelfa

When not to take Promazin Jelfa:

• if you are allergic to the active substance, other phenothiazine derivatives, or any of the other ingredients of this medicine (listed in section 6);
• if you are in a coma;
• if you have a pheochromocytoma;
• if you have severe liver or kidney failure;
• if you have agranulocytosis (lack of granulocytes in the blood);
• if you have severe circulatory failure;
• if you have Parkinson's disease;
• if you have had a malignant neuroleptic syndrome;
• if you are breastfeeding.

This medicine should not be used in children.

Warnings and precautions

Before starting treatment with Promazin Jelfa, discuss it with your doctor, pharmacist, or nurse.
Particular caution should be exercised in patients:

• who have been taking this medicine for a long time, due to the possibility of developing extrapyramidal disorders, including drug-induced parkinsonism (increased muscle tension, slowed movements, tremors);
• with a history of extrapyramidal disorders or dyskinesias (involuntary movements), due to the high risk of exacerbating these disorders; long-term use of phenothiazine derivatives may cause late dyskinesias (involuntary movements of the face and tongue), especially in the elderly - if dyskinesias occur, promazine should be discontinued;
• with heart disease, arrhythmias, or conditions predisposing to cardiac arrhythmias;
• with cerebral atherosclerosis, coronary heart disease;
• with liver or kidney failure (severe failure is a contraindication to the use of the medicine);
• with chronic and severe respiratory disorders, in patients with asthma, bronchitis, acute respiratory infections, due to the possibility of exacerbating or provoking symptoms of these disorders;
• with epilepsy or conditions predisposing to epilepsy, due to the possibility of lowering the seizure threshold by promazine;
• in the elderly, especially in hot or cold weather, due to the risk of developing hyperthermia or hypothermia (excessive increase or decrease in body temperature). In these patients, orthostatic hypotension may occur, manifested by dizziness when standing up from a lying or sitting position.

Avoid using the medicine in patients:

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

Before starting treatment, inform your doctor about the above situations.
In case of unexplained fever, it is necessary to discontinue treatment and determine its cause, as it may be the first symptom of a malignant neuroleptic syndrome (symptoms: pallor, overheating, autonomic nervous system disorders, consciousness disorders, muscle stiffness). If these symptoms occur, you should immediately contact your doctor.
Very rarely, after sudden discontinuation of the medicine (especially after long-term use of high doses), acute withdrawal symptoms may occur, such as nausea, vomiting, insomnia. There may also be a relapse of the disease and extrapyramidal symptoms. Therefore, it is recommended to gradually discontinue the medicine.
During treatment with phenothiazine derivatives, agranulocytosis (lack of granulocytes in the blood) may occur. Therefore, regular blood tests are recommended. The occurrence of unexplained infection or fever may indicate a disorder of the hematopoietic system - immediate blood tests should be performed.
In patients treated with neuroleptics, cases of prolonged QT interval in the ECG have been reported, which occurred very rarely. Nevertheless, patients with an increased risk of developing 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, malnourished, alcohol-abusing, treated with other medicines that prolong the QT interval) require particularly cautious treatment, especially in the initial phase.
Antipsychotic medicines may increase prolactin secretion in the brain (a hormone that stimulates breast growth and milk production).

Promazin Jelfa-treated patients should avoid exposure to the sun due to the risk of skin rash and pigment deposition in the skin.
In long-term treatment with Promazin Jelfa, it is necessary to periodically monitor the peripheral blood picture, liver and heart function, and perform eye examinations.
In case of planned surgery, inform your doctor about the use of Promazin Jelfa.

Children and Adolescents

The medicine should not be used in children.

Promazin Jelfa and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
When using Promazin Jelfa with other medicines, including over-the-counter medicines, interactions may occur, leading to side effects, including serious ones. Therefore, always inform your doctor about taking or planning to take other medicines.
Do not administer adrenaline to patients who have overdosed on promazine.
Promazine's inhibitory effect on the central nervous system is enhanced by alcohol, barbiturates, and sedative and hypnotic medicines, as well as opioid analgesics. Respiratory disorders may occur.
When promazine is used concomitantly with monoamine oxidase inhibitors or tricyclic antidepressants, prolonged and enhanced sedative and anticholinergic effects of promazine and these medicines may occur. 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 reduce the antipsychotic effect of promazine.
Certain medicines may disrupt the absorption of neuroleptics, such as antacids, medicines used to treat Parkinson's disease, and lithium.
Clinically significant adverse interactions of promazine with alcohol, guanethidine, and antidiabetic medicines have been observed.
After using neuroleptics, including promazine, extrapyramidal symptoms may occur, such as muscle stiffness, facial rigidity, slowed movements, restlessness, involuntary muscle contractions, and involuntary movements. In this case, instead of levodopa, it is recommended to administer anticholinergic medicines that act against parkinsonism.
Promazine:

• reduces the response to antidiabetic medicines, and therefore, their dosage may need to be increased;
• may disrupt the action of antiepileptic medicines;
• may enhance the action of most antihypertensive medicines;
• may act antagonistically to some medicines, including amphetamine, levodopa, clonidine, guanethidine, and adrenaline;
• may act toxically on the nervous system and cause a malignant neuroleptic syndrome in patients treated concomitantly with neuroleptics and lithium;
• and other neuroleptics used concomitantly with medicines that prolong the QT interval in the ECG, such as some antiarrhythmic, antidepressant, and other antipsychotic medicines, may increase the risk of developing arrhythmias;
• used with other medicines that may cause bone marrow damage, such as carbamazepine or some antibiotics and cytostatics, increases the risk of developing agranulocytosis.

Promazin Jelfa and Alcohol

Do not consume alcohol while taking Promazin Jelfa.

Pregnancy, Breastfeeding, and Fertility

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 Promazin Jelfa during pregnancy, especially in the first trimester, unless your doctor considers promazine treatment necessary.
Breastfeeding
Using Promazin Jelfa during breastfeeding is contraindicated. If necessary, do not breastfeed.

Driving and Operating Machines

Promazine may impair mental and physical abilities (causing drowsiness) to the extent that it interferes with driving or operating moving machinery, and therefore, patients treated with promazine should not perform these activities.

Promazin Jelfa Contains

tablets 100 mg).
If you have been told that you have an intolerance to some sugars, contact your doctor before taking Promazin Jelfa.
The medicine may cause allergic reactions.

3. How to Take Promazin Jelfa

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Psychomotor agitation
Recommended dose: usually 100 mg to 200 mg four times a day.
Treatment should be started with smaller doses. Then, the dose is gradually increased to the optimal dose for the patient. The intervals between doses are usually 6-8 hours.
Some patients may take a single daily dose of the medicine, before bedtime.
Elderly patients: should start with half the initial dose. Treatment should be carried out under close medical supervision.
Agitation and restlessness
Recommended dose:
elderly patients: initially 25 mg, then, if necessary, up to 50 mg four times a day. The dose should be gradually increased. Treatment should be carried out under close medical supervision.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Taking a Higher Dose of Promazin Jelfa than Recommended

Taking a higher dose of Promazin Jelfa than recommended may cause deep sleep, significant decrease in blood pressure, and slowed breathing.
In rare cases, it may first cause agitation, then coma, and finally 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 as before. However, if it is almost time for the next dose, skip the missed dose.
Do not take a double dose to make up for the missed dose.

Stopping Treatment with Promazin Jelfa

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medicines, Promazin Jelfa can cause side effects, although not everybody gets them.
Side effects are rare, and the most commonly observed side effects are nervous system disorders.
Side effects may occur with the following frequency:
very common: more than 1 in 10 people
common: 1 in 10 to 1 in 100 people
uncommon: 1 in 100 to 1 in 1,000 people
rare: 1 in 1,000 to 1 in 10,000 people
very rare: less than 1 in 10,000 people
frequency not known: frequency cannot be estimated from available data
Nervous System Disorders
Frequency not known: parkinsonism that resolves after dose reduction or administration of anticholinergic medicines, akathisia, acute dystonic syndrome, seizures, late dyskinesias or dystonic syndromes (especially in patients treated long-term, after sudden discontinuation of the medicine or significant dose reduction), hyperthermia (especially in hot and humid weather or when taking antiparkinsonian medicines) or hypothermia (especially in the elderly or with hypothyroidism) malignant neuroleptic syndrome (motor inhibition up to stupor with significant increase in muscle tone, tremors, and single involuntary movements, tachycardia, hyperthermia, large fluctuations in blood pressure, autonomic disorders - sweating, salivation, facial flushing; progressive disorders of consciousness up to coma, leukocytosis, dehydration, electrolyte disorders); accommodation disorders, urinary retention, constipation, dryness of mucous membranes.
Psychiatric Disorders
Frequency not known: drowsiness, impaired concentration, excessive motor inhibition, sleep disorders, depression.
Immune System Disorders:
Frequency not known: angioedema, bronchospasm, urticaria, anaphylactic reactions (extremely rare), systemic lupus erythematosus.
Vascular Disorders
Frequency not known: hypotension (especially at the beginning of treatment), orthostatic decreases in blood pressure.
Cardiac Disorders
Frequency not known: atrioventricular block, atrial arrhythmias, ventricular tachycardia, ventricular fibrillation, changes in ECG: flattening or inversion of the T wave, prolongation of the PQ and QT intervals, and the appearance of a 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.
Metabolic and Nutritional Disorders
Frequency not known: troublesome constipation (related to the anticholinergic effect of the medicine) sometimes leading to habitual constipation, very rarely nausea and vomiting.
Hepatobiliary Disorders
Frequency not known: obstructive jaundice (usually between 2 and 4 weeks of treatment) caused by contraction of the bile ducts due to an allergic mechanism. The symptoms resemble viral hepatitis, and laboratory tests indicate a mechanical origin. If such a condition occurs, promazine should be discontinued and not administered again.
Skin and Subcutaneous Tissue Disorders
Frequency not known: allergic skin reactions, hypersensitivity to light, pigmentary changes (skin discoloration, pigment deposition 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 Side Effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.
Jerozolimskie Avenue 181c
02-222 Warsaw
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Promazin Jelfa

Store in a temperature 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 carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Package and Other Information

What Promazin Jelfa Contains

• The active substance of the medicine is promazine hydrochloride. Promazin Jelfa, 25 mg: 1 sugar-coated tablet contains 25 mg of promazine hydrochloride; Promazin Jelfa, 50 mg: 1 sugar-coated tablet contains 50 mg of promazine hydrochloride; Promazin Jelfa, 100 mg: 1 sugar-coated tablet contains 100 mg of promazine hydrochloride.
• Other ingredients are: lactose monohydrate, cornstarch, gelatin, stearic acid, colloidal silicon dioxide, talc, sodium saccharin, sucrose, gum arabic, and quinoline yellow (E 104) (only Promazin Jelfa, 25 mg), orange yellow (E 110) (only Promazin Jelfa, 50 mg), and crimson lake (E 124) (only Promazin Jelfa, 100 mg).

What Promazin Jelfa Looks Like and Contents of the Package

Promazin Jelfa, 25 mg, sugar-coated tablets
Yellow, round, biconvex sugar-coated tablets.
Promazin Jelfa, 50 mg, sugar-coated tablets
Orange, round, biconvex sugar-coated tablets.
Promazin Jelfa, 100 mg, sugar-coated tablets
Red, round, biconvex sugar-coated tablets.
Promazin Jelfa, 25 mg, sugar-coated tablets: PP/PE container in a carton box.
60 pieces (1 container of 60 pieces)
Promazin Jelfa, 50 mg, sugar-coated tablets: PP/PE container in a carton box.
60 pieces (1 container of 60 pieces)
Promazin Jelfa, 100 mg, sugar-coated tablets: PP/PE container in a carton box.
60 pieces (1 container of 60 pieces)

Marketing Authorization 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: jelfa@jelfa.com.pl

Date of last revision of the leaflet: