Promazine Doc Generici

Patient Information Leaflet

PROMAZINA DOC 4 g/100 ml oral drops, solution

Generic medicine
Please read this leaflet carefully before you start taking this medicine, as 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 others, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4. Contents of this leaflet:
  1. What PROMAZINA DOC is and what it is used for
  2. What you need to know before taking PROMAZINA DOC
  3. How to take PROMAZINA DOC
  4. Possible side effects
  5. How to store PROMAZINA DOC
  6. Contents of the pack and other information

1. What PROMAZINA DOC is and what it is used for

PROMAZINA DOC 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 should know before taking PROMAZINA DOC

Do not take PROMAZINA DOC:

• 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 that 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 reduced awareness of your surroundings (central nervous system depression). This medicine is not indicated for individuals in a coma.

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

• if you have previously experienced a blood disorder called agranulocytosis (a decrease in the number of a type of white blood cells) caused by other medicines, because this medicine may cause blood disorders (hematological dyscrasia). Agranulocytosis may occur between the fourth and tenth week of treatment, with or without a decrease in all types of white blood cells (leukopenia). If you develop agranulocytosis or leukopenia during treatment, you must be closely monitored by your doctor and undergo periodic blood tests;
• if you are taking medicines for the treatment of certain tumors (antineoplastic agents), because this medicine may mask the toxic effects of some of these medicines;
• if you have circulatory problems (cardiovascular or cerebrovascular diseases), because this medicine may cause temporary blood pressure problems (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 have engaged in intense physical activity, have been exposed to high temperatures, are taking 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. If severe liver problems occur, your doctor will discontinue treatment with this medicine;
• if you have had a stroke or are in a condition that increases 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 this case, 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 pressure in the eye, accompanied by pain and blurred vision);
• if you suffer from a bowel condition called paralytic ileus;
• if you have Parkinson’s disease;
• if you suffer from 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 DOC and contact your doctor immediately if, during treatment with this medicine, you experience:

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

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

• muscle tremors, constant need to move, or abnormal movements of the face and body. 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 this medicine may increase your sensitivity to strong sunlight.
Your doctor should perform regular monitoring of the central nervous system, liver, bone marrow, eyes, and cardiovascular system during treatment with this medicine.

Other medicines and PROMAZINA DOC
Inform your doctor or pharmacist if you are 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 induce bone marrow depression;
• medicines that alter heart rhythm (QT prolongation), as this increases the risk of heart problems (cardiac arrhythmias);
• medicines that may alter electrolyte levels in the blood;
• 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 effectiveness of levodopa.

Use this medicine with great 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;
• anesthetics, 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 great 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 for 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 radiological examination of the spinal cord 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;
• medicines used to treat tumors (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 the urine, may alter the results of certain laboratory tests (amylase, urobilinogen, uroporphyrins, porphobilinogens, and 5-hydroxy-indoleacetic acid tests), and may give a false positive result in pregnancy tests.

PROMAZINA DOC with food, drinks, and alcohol
PROMAZINA DOC 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, are planning to become pregnant, or are 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 of mothers who have used promazine during the third 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, contact your doctor immediately.

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

PROMAZINA DOC contains sulfites, para-hydroxybenzoates, sorbitol, alcohol, and sodium

• This medicine contains sodium sulfite and potassium metabisulfite, 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 51 g of sorbitol in 100 ml of solution. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before you (or your child) take this medicine.
• This medicine contains 377 mg of alcohol (ethanol) in 100 ml of solution. 8 ml of this medicine (200 drops) are equivalent to less than 1 ml of beer or wine. The small amount of alcohol in this medicine will not produce significant effects.
• This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially "sodium-free".

3. How to take PROMAZINA DOC

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
PROMAZINA DOC may only be taken orally. If disease symptoms are acute and require rapid intervention, injectable formulations of promazine may be necessary. Please consult your doctor for further information.
PROMAZINA DOC drops must be taken orally, diluted in water.
The recommended dose is 15 drops four times a day (120 mg per day), up to a maximum of 50 drops four times a day (400 mg per day).
Treatment will begin with a lower dose of 10–15 drops per day (20–30 mg per day), taken in the evening; your doctor will increase the dose as needed.
When opening the bottle, you may notice a pungent odor (similar to burnt sugar) due to the release of sulfur dioxide, which acts to neutralize oxygen and 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 a day (200 mg per day).

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

Use in children and adolescents
PROMAZINA DOC 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 a day (20–60 mg per day), up to a maximum of 15 drops four times a day (120 mg per day).

If you take more PROMAZINA DOC than you should
In case of accidental ingestion or overdose of PROMAZINA DOC, contact your doctor immediately or go to the nearest hospital.
After taking an excessive dose of PROMAZINA DOC, 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, lowered 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 DOC
Do not take a double dose to make up for the missed dose.

If you stop taking PROMAZINA DOC
Continue taking PROMAZINA DOC for as long as your doctor instructs. Your doctor will gradually reduce your dose before stopping. 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 questions about the use of this medicine, consult 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 disorders (agranulocytosis, neutropenia, leukopenia, eosinophilia, thrombocytopenia, aplastic anaemia, haemolytic anaemia) and coagulation problems (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 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, hepatic dysfunction), yellowing of the skin and eyes (jaundice), increased levels of certain liver enzymes (transaminases, alkaline phosphatase);
• skin irritation (photosensitivity, dermatitis, erythema, purplish skin discolouration);
• 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 caused by fluid accumulation (laryngeal oedema);
• increased blood sugar levels (hyperglycaemia) and presence of sugar in urine (glucosuria);
• inability to fall asleep (insomnia), difficulty staying still (restlessness), anxiety, mood changes (euphoric mood);
• restlessness in movement (akathisia), abnormal movements of the face and body (dystonia);
• extrapyramidal symptoms, i.e. symptoms similar to Parkinson's disease such as tremors and rigidity (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 disturbances (blurred vision, lens deposits, corneal lesions, mydriasis, retinopathy);
• sensation of dizziness when standing up due to a drop in blood pressure (orthostatic hypotension);
• oesophageal disorders and inflammation of the respiratory tract (aspiration pneumonia);
• constipation (stipsis), dry mouth (xerostomia);
• skin irritation (exfoliative dermatitis, photosensitivity, eczema, erythema, urticaria, skin pigmentation);
• a disease 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 erection in men (erectile dysfunction);
• increased or decreased body temperature, weight gain, swelling of extremities due to fluid accumulation (peripheral oedema);
• swelling, pain and redness in the legs caused by blood clots. 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 who did not.
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 DOC

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 packaging 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 no longer in use. This will help protect the environment.

6. Pack contents and other information

What PROMAZINA DOC contains

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

Description of the appearance of PROMAZINA DOC and pack contents
30 ml bottle of oral solution, equipped with a dropper cap with child-resistant closure.
Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan – Italy.
Responsible manufacturer for batch release
Mipharm S.p.A. - Via B. Quaranta 12 - 20141 Milan – Italy.