Promazine Eg

Italy
Brand name Promazine Eg
Form drops, oral solution
Active substance / Dosage
PROMAZINE HYDROCHLORIDE
Prescription type Prescription only
ATC code
N05AA03
Registration number 044108
Manufacturer EG S.P.A.

Table of Contents

Patient Information Leaflet

PROMAZINE EG 4 g/100 ml oral drops, solution

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
  • If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4. Contents of this leaflet:
    1. What PROMAZINE EG is and what it is used for
    2. What you need to know before taking PROMAZINE EG
    3. How to take PROMAZINE EG
    4. Possible side effects
    5. How to store PROMAZINE EG
    6. Contents of the pack and other information

1. What PROMAZINE EG is and what it is used for

PROMAZINE EG contains the active substance promazine hydrochloride, which belongs to a group of
medicines called phenothiazines.
Promazine is indicated for the treatment of psychomotor agitation or aggressive behaviour. This medicine is also indicated for the treatment of schizophrenia and other mental disorders.

2. What you need to know before taking PROMAZINA EG

Do not take PROMAZINA EG:

  • if you are allergic to the active substance, to other medicines similar to the active substance, or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction may include skin rash, itching, or difficulty breathing;
  • if you have bone marrow depression. This means your immune system is not functioning normally. Your body will have more difficulty fighting infections;
  • if you have an adrenal gland tumor causing high blood pressure (pheochromocytoma);
  • if you have reduced sensory perception, drowsiness, lack of coordination, blurred vision, slurred speech, or decreased awareness of your surroundings (central nervous system depression). This medicine is not indicated for individuals in a state of coma.

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine.
Inform your doctor before taking PROMAZINA EG:

  • if you have previously experienced a blood disorder called agranulocytosis (reduction in the number of a type of white blood cells) caused by other medicines, because this medicine may cause blood disorders (haematological dyscrasia). Agranulocytosis may occur between the fourth and tenth week of treatment, with or without a decrease in all types of white blood cells (leucopenia). If you develop agranulocytosis or leucopenia during treatment, you must be closely monitored by your doctor and undergo periodic blood tests;
  • if you are taking anticancer medicines (antineoplastics), because this medicine may mask the toxic effects of certain drugs;
  • if you have circulatory problems (cardiovascular or cerebrovascular diseases), because this medicine may cause temporary blood pressure issues (orthostatic hypotension);
  • if you have a history of epilepsy or seizure disorders, as the seizure threshold may be lowered;
  • if you are at risk of increased body temperature, for example if you engage in intense physical activity, are exposed to high temperatures, take anticholinergic medicines, or are at risk of dehydration;
  • if you are elderly, especially if you suffer from advanced Alzheimer's dementia, as you may be more prone to esophageal motility disorders and breathing problems (e.g., aspiration pneumonia);
  • if you have had liver problems or jaundice (yellowing of the skin and whites of the eyes). If you develop liver problems during treatment with this medicine, your doctor should perform tests to monitor liver function. In case of severe liver problems, your doctor will discontinue treatment;
  • if you have had a stroke or are in a condition that may increase your risk of stroke;
  • if you have a history of heart problems or if someone in your family has or has had a heart condition called QT prolongation. In such cases, avoid taking other medicines known as neuroleptics (medicines used to treat certain mental disorders);
  • if you or a family member has a history of blood clotting disorders;
  • if you have or have previously had a condition of the eye called closed-angle glaucoma (characterized by increased intraocular pressure, accompanied by pain and blurred vision);
  • if you suffer from a bowel condition called paralytic ileus;
  • if you have Parkinson’s disease;
  • if you have a chronic disease causing muscle weakness and fatigue called myasthenia gravis;
  • if you have an enlarged prostate (a condition called prostatic hypertrophy).

Stop taking PROMAZINA EG and inform your doctor immediately if, during treatment with this medicine, you experience:

  • a group of symptoms including fever, muscle stiffness or fatigue, altered mental status, heart or blood pressure problems, or kidney problems, as these may indicate a potentially life-threatening condition called "Neuroleptic Malignant Syndrome";
  • a condition known as tardive dyskinesia, characterized by abnormal and involuntary body movements;
  • significant changes in mood, including suicidal thoughts.

Inform your doctor if, during treatment with PROMAZINA EG, you experience:

  • muscle tremors, constant need to move, or abnormal facial and body movements. Your doctor will decide whether to discontinue treatment or manage these symptoms with appropriate therapy.

During treatment with this medicine, avoid direct exposure to sunlight. This is because you may become more sensitive to strong sunlight while taking this medicine.
Your doctor should perform regular check-ups of your central nervous system, liver, bone marrow, eyes, and cardiovascular system during treatment with this medicine.
For individuals involved in sports, the use of medicines containing ethanol may result in a positive anti-doping test, depending on the alcohol concentration limits set by certain sports federations.

Other medicines and PROMAZINA EG
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines. This is because promazine may alter the effects of certain medicines, and some medicines may affect promazine.

Do not use this medicine if you are taking:

  • medicines that cause bone marrow depression;
  • medicines that affect heart rhythm (QT prolongation), as this increases the risk of heart problems (cardiac arrhythmias);
  • medicines that may alter blood electrolyte levels;
  • moxifloxacin, an antibiotic, as it increases the risk of heart problems (cardiac arrhythmias);
  • levodopa, a medicine used to treat Parkinson’s disease, as promazine may reduce the effect of levodopa.

Use this medicine with extreme caution and inform your doctor if you are taking:

  • other medicines used for mental disorders;
  • barbiturates, used to treat sleep disorders;
  • anxiolytics/hypnotics, used to treat anxiety;
  • anaesthetics, used during surgical procedures;
  • antihistamines, used to treat allergies;
  • analgesics, including opioid analgesics, used to treat pain. Indeed, using the above-mentioned medicines may enhance the effects of promazine on the central nervous system; this could lead to respiratory depression, central nervous system depression, and low blood pressure (hypotension).

Also use this medicine with extreme caution and inform your doctor if you are taking any of the following medicines:

  • anticonvulsant medicines, used to treat epilepsy and seizures: promazine may reduce the effectiveness of anticonvulsants;
  • succinylcholine, used during surgical procedures;
  • metrizamide, used as a contrast agent in radiological examinations of the spinal cord: concomitant use of promazine and metrizamide may increase the risk of seizures. Your doctor will ask you to stop taking promazine at least 48 hours before undergoing a spinal radiological examination and to resume taking promazine 24 hours after the examination;
  • lithium, used to treat certain mental disorders. If your doctor prescribes promazine while you are on lithium therapy, you must be closely monitored for the appearance of symptoms;
  • anticancer medicines (antineoplastics): promazine may reduce nausea and vomiting, which could mask the toxic effects of some of these medicines;
  • anticholinergics, medicines used to treat irritable bowel syndrome, asthma, or incontinence;
  • antacids, used to reduce stomach acidity, as they may reduce the absorption of promazine;
  • antihypertensives, used to treat high blood pressure. This medicine may cause darkening of urine, alter the results of certain laboratory tests (amylase, urobilinogen, uroporphyrins, porphobilinogens, and 5-hydroxy-indoleacetic acid tests), and give a false positive result in pregnancy tests.

PROMAZINA EG with food, drinks, and alcohol
PROMAZINA EG may enhance the depressant effects of alcohol when taken together. Avoid drinking alcoholic beverages during treatment with this medicine.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use this medicine if you are pregnant or breastfeeding unless your doctor considers it absolutely necessary.
Newborns whose mothers have taken promazine during the last trimester of pregnancy may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, feeding problems. If you notice any of these symptoms in your baby, inform your doctor immediately.

Driving and using machines
The use of PROMAZINA EG may affect your ability to drive or operate machinery. Avoid driving or using machinery if you experience sedation or drowsiness.

PROMAZINA EG contains sulphites, para-hydroxybenzoates, sorbitol, and alcohol

  • This medicine contains anhydrous sodium sulphite and potassium metabisulphite, which may rarely cause severe hypersensitivity reactions and bronchospasm.
  • This medicine contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate, which may cause allergic reactions (including delayed reactions).
  • This medicine contains sorbitol, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
  • This medicine contains small amounts of ethanol (alcohol), less than 100 mg per dose.

3. How to take PROMAZINA EG

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
PROMAZINA EG must be taken only by oral route. If the disease symptoms are acute and require rapid intervention, injectable formulations of promazine may be necessary. Please consult your doctor for further information.
PROMAZINA EG drops must be taken orally, diluted in water.
The recommended dose is 15 drops four times daily (120 mg per day), up to a maximum of 50 drops four times daily (400 mg per day).
Treatment will start with a lower dose of 10–15 drops daily (20–30 mg per day), taken in the evening; your doctor will increase the dose as needed.
When opening the bottle for the first time, you may notice a pungent odor (similar to burnt sugar) due to the release of sulfur dioxide, which acts by neutralizing oxygen to prevent degradation of the medicine.

Use in elderly patients
The recommended dose is 10–30 drops per day (20–60 mg per day), up to a maximum of 25 drops four times daily (200 mg per day).

Use in patients with liver problems
If you have liver problems, your doctor will determine the most appropriate dose for you.

Use in children and adolescents
PROMAZINA EG must not be used in children under 12 years of age.
The recommended dose in children over 12 years of age and in adolescents is 5–15 drops four times daily (20–60 mg per day), up to a maximum of 15 drops four times daily (120 mg per day).

If you take more PROMAZINA EG than you should
In case of accidental ingestion of an excessive dose of PROMAZINA EG, contact your doctor immediately or go to the nearest hospital.
After taking an excessive dose of PROMAZINA EG, you may experience the following symptoms:
difficulty breathing, central nervous system depression, confusion, inability to respond to stimuli, disturbances in perception or reasoning, low blood pressure, decreased body temperature, heart problems (increased heart rate, irregular heart rhythm, and myocardial ischemia—a pathological condition caused by reduced oxygen supply to the heart), movement disorders, seizures.

If you forget to take PROMAZINA EG
Do not take a double dose to make up for the missed dose.

If you stop taking PROMAZINA EG
Continue taking PROMAZINA EG for as long as your doctor tells you to. Your doctor will gradually reduce your dose. If you stop taking the medicine abruptly, you may experience the following withdrawal symptoms:

  • nausea and vomiting;
  • dizziness;
  • difficulty remaining still (restlessness);
  • tremors.

If you have any doubts about how to use this medicine, contact your doctor or pharmacist immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur:

  • some blood problems (agranulocytosis, neutropenia, leucopenia, eosinophilia, thrombocytopenia, aplastic anaemia, haemolytic anaemia) and coagulation disorders (disseminated intravascular coagulation);
  • thyroid problems (increased TSH levels);
  • loss of interest and motivation (apathy), confusion;
  • loss of coordination (ataxia), temporary loss of consciousness (syncope);
  • memory, language and attention disturbances (cognitive disorders);
  • a group of symptoms called Neuroleptic Malignant Syndrome, which includes: hyperpyrexia, slow movements or difficulty initiating movement (extrapyramidal symptoms), altered mental status, heart problems (arrhythmia, tachycardia) and blood pressure, marked sensation of fatigue or fainting, profuse sweating, rhabdomyolysis and acute renal failure;
  • heart problems (T-wave inversion, QT interval prolongation, ventricular arrhythmias such as torsades de pointes, ventricular tachycardia, ventricular fibrillation and cardiac arrest. Very rare cases of sudden death);
  • rapid and severe drop in blood pressure (hypovolemic shock);
  • breathing problems (respiratory failure);
  • severe liver problems (hepatitis, liver dysfunction), yellowing of the skin and eyes (jaundice), increased levels of certain liver enzymes (transaminases, alkaline phosphatase);
  • skin irritation (photosensitivity, dermatitis, erythema, purplish skin discoloration);
  • muscle problems such as injury (rhabdomyolysis) and muscle stiffness, marked increase in levels of a substance produced by muscles (creatine phosphokinase);
  • impaired kidney function (acute renal failure);
  • excessive increase in body temperature (hyperthermia) and fever;
  • allergic-type reactions (anaphylactic reactions), breathing difficulties (bronchospasm, laryngospasm), swelling due to fluid accumulation (laryngeal oedema);
  • increased blood sugar levels (hyperglycaemia) and presence of sugar in urine (glucosuria);
  • inability to fall asleep (insomnia), difficulty remaining still (restlessness), anxiety, mood changes (euphoric mood);
  • motor restlessness (akathisia), abnormal movements of the face and body (dystonia);
  • extrapyramidal symptoms, i.e. symptoms similar to Parkinson's disease such as tremors and stiffness (parkinsonism), slow movements or difficulty initiating movement, and involuntary movements mainly affecting facial and tongue muscles (tardive dyskinesia);
  • drowsiness, seizures, dizziness, sedation, profuse sweating;
  • vision disorders (blurred vision, lens deposits, corneal lesions, mydriasis, retinopathy);
  • sensation of dizziness upon standing due to a drop in blood pressure (orthostatic hypotension);
  • oesophageal disorders and respiratory tract inflammation (aspiration pneumonia);
  • constipation, dry mouth;
  • skin irritation (exfoliative dermatitis, photosensitivity, eczema, erythema, urticaria, skin pigmentation);
  • a condition characterised by red skin spots and bleeding (purpura);
  • skin rashes, joint disorders, connective tissue disorders and blood problems caused by an autoimmune disease (systemic lupus erythematosus);
  • difficulty urinating (urinary retention);
  • breast enlargement (gynaecomastia), sudden milk production (galactorrhoea), absence of menstrual periods (amenorrhoea) in women, menstrual cycle disturbances (menstrual disorders), inability to achieve or maintain an erection in men (erectile dysfunction);
  • increased or decreased body temperature, weight gain, swelling of the limbs due to fluid accumulation (peripheral oedema);
  • swelling, pain and redness in the legs caused by blood clot formation. Clots may travel through blood vessels to the lungs, causing chest pain and breathing difficulties: inform your doctor immediately if you experience these symptoms;
  • worsening of mental disorders (psychotic symptoms);
  • nausea, vomiting, dizziness, tremors and restlessness occurring when stopping the medicine abruptly (withdrawal symptoms);
  • overdose, intentional poisoning.

In elderly patients with dementia, a slight increase in the number of deaths has been reported among patients taking antipsychotics compared to those not taking them.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PROMAZINE EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton after "Exp.".
The expiry date refers to the last day of that month.
Do not store above 25 °C.
Keep the bottle tightly closed.
Store in the original packaging to protect the medicine from light and moisture.
The product should be used within 1 month of first opening the bottle.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What PROMAZINA EG contains

  • The active substance is promethazine hydrochloride. 100 ml of solution contain 4.51 g of promethazine hydrochloride, equivalent to 4 g of promethazine base.
  • The other ingredients are non-crystallizable liquid sorbitol, anhydrous sodium sulfite, potassium metabisulfite, sodium methyl p-hydroxybenzoate, sodium propyl p-hydroxybenzoate, ethanol 96%, purified water.

Description of the appearance of PROMAZINA EG and contents of the pack
30 ml bottle of oral solution with a dropper cap and child-resistant closure.
Marketing Authorization Holder
EG S.p.A., Via Pavia 6, 20136 Milan - Italy.
Responsible manufacturer for batch release
Mipharm S.p.A. - Via B. Quaranta 12 - 20141 Milan – Italy.