Promazin Ielfa

Leaflet attached to the packaging: patient information

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

You should 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 doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the 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 packaging 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 a moderate sedative and antipsychotic effect, as well as a weak antiemetic and antihistamine 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 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 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 had a malignant neuroleptic syndrome;
• if the patient is breastfeeding.

This medicine should not be used in children.

Warnings and precautions

Before starting treatment with Promazin Jelfa, you should 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, spasmodic 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 cerebrovascular disease or 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 hyperthermia or hypothermia (excessive increase or decrease in body temperature). In these patients, orthostatic hypotension may occur, manifested by dizziness when getting up from a lying or sitting position.

The medicine should not be used in patients:

• with a history of narrow-angle glaucoma or a family history of glaucoma;
• 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.
In case of unexplained fever, treatment should be discontinued and its cause determined, 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 - you should immediately have a blood test.
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, or taking 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).

Promazine-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 recommended to periodically monitor the peripheral blood picture, liver and heart function, and perform eye examinations.
In case of the need for surgical intervention, you should 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

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
In case of concomitant use of Promazin Jelfa with other medicines, including over-the-counter medicines, interactions may occur, leading to the occurrence of side effects, including serious 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 sedative 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.
During concomitant use of promazine and monoamine oxidase inhibitors or tricyclic antidepressants, prolongation and enhancement of promazine's sedative and anticholinergic effects may occur. Enhancement of the 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 promazine's antipsychotic effect.
Some 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 the use of 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 counteract parkinsonism.
Promazine:

• reduces the response to antidiabetic medicines, which may require an increase in their dosage;
• may disrupt the effect of antiepileptic medicines;
• may enhance the effect of most antihypertensive medicines;
• may have an opposing effect on certain medicines, including amphetamine, levodopa, clonidine, guanethidine, and adrenaline;
• may have a toxic effect on the nervous system and cause a malignant neuroleptic syndrome in patients treated 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 certain antibiotics and cytostatics, increases the risk of agranulocytosis.

Promazin Jelfa and alcohol

You should 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, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
Promazin Jelfa should not be used during pregnancy, especially in the first trimester, unless the doctor considers promazine treatment necessary.
Breastfeeding
Using Promazin Jelfa during breastfeeding is contraindicated. If its use is necessary, you should not breastfeed.

Driving and using machines

Promazine may impair mental and physical abilities (causing drowsiness) to the extent that it interferes with driving vehicles 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, you should contact your doctor before taking Promazin Jelfa.
The medicine may cause allergic reactions.

3. How to take Promazin Jelfa

This medicine should always be taken according to the doctor's recommendations. If you have any doubts, you should consult 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: the initial dose should be halved. Treatment should be carried out under close medical supervision.
Agitation and anxiety
Recommended dose:
elderly patients: initially 25 mg, then, if necessary, up to 50 mg four times a day. The dose of the medicine 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, you should 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, you should immediately contact your doctor.

Missing a dose of Promazin Jelfa

If you miss a dose of Promazin Jelfa, you should take it as soon as possible and continue treatment according to the previous recommendations. 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 Promazin Jelfa

If you have any further doubts about the use of this medicine, you should consult your doctor, pharmacist, or nurse.

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 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 the available data
Nervous system disorders
Frequency not known: parkinsonism that disappears after reducing the dose or administering anticholinergic medicines, akathisia, acute dystonic syndrome, seizures, late dyskinesias or dystonic syndromes (especially in patients treated for a long time, after sudden discontinuation of the medicine or significant reduction in dose), hyperthermia (especially in hot and humid weather or when using medicines against parkinsonism) or hypothermia (especially in the elderly or with hypothyroidism) malignant neuroleptic syndrome (motor inhibition up to stupor with significant increase in muscle tension, tremors, and single involuntary movements, tachycardia, hyperthermia, large fluctuations in blood pressure, vegetative disorders - sweating, salivation, facial flushing; progressive disorders of consciousness up to coma, leukocytosis, dehydration, electrolyte disorders); disorders of accommodation, 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: galactorrhoea, gynaecomastia, menstrual disorders, hyper- and hypoglycaemia, glycosuria, impotence, libido disorders, increased thirst, weight gain.
Blood and lymphatic system disorders
Frequency not known: granulocytopenia, agranulocytosis, eosinophilia, leucopenia, haemolytic or aplastic anaemia, thrombocytopenia.
Metabolic and nutritional disorders
Frequency not known: troublesome constipation (related to the anticholinergic effect of the medicine) 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 a spasm of the bile ducts with 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 any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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 gather more information on the safety of this medicine.

5. How to store Promazin Jelfa

Store in a temperature below 25°C.
The medicine should be stored in a place that is out of 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. 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 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, corn starch, gelatin, stearic acid, colloidal silica, talc, sodium saccharin, sucrose, arabic gum, and quinoline yellow (E 104) (only Promazin Jelfa, 25 mg), orange yellow (E 110) (only Promazin Jelfa, 50 mg), and erythrosine (E 124) (only Promazin Jelfa, 100 mg).

What Promazin Jelfa looks like and what the pack contains

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 cardboard box.
60 pieces (1 container of 60 pieces)
Promazin Jelfa, 50 mg, sugar-coated tablets: PP/PE container in a cardboard box.
60 pieces (1 container of 60 pieces)
Promazin Jelfa, 100 mg, sugar-coated tablets: PP/PE container in a cardboard box.
60 pieces (1 container of 60 pieces)

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: jelfa@jelfa.com.pl

Date of last revision of the leaflet: