Polfergan

Leaflet attached to the packaging: information for the user

POLFERGAN, 5 mg/5 ml, syrup

Promethazine hydrochloride

Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Polfergan and what is it used for

Polfergan is a syrup containing promethazine hydrochloride as the active substance, which has antiallergic, sedative, and antiemetic effects. Polfergan is indicated for use in:

• symptomatic treatment of acute allergic skin reactions with severe itching;
• transfusion reactions; nausea, vomiting, and dizziness;
• motion sickness;
• short-term treatment of insomnia and restlessness after surgical procedures.

2. Important information before taking Polfergan

When not to take Polfergan:

• in coma;
• in the last trimester of pregnancy;
• during breastfeeding;
• in children under 2 years of age.

Polfergan should not be given at the same time as MAO inhibitors (medicines used to treat depression) and for 14 days after their withdrawal.

Warnings and precautions

Before starting treatment with Polfergan, you should consult a doctor or nurse if:

• the patient has any serious heart problems
• the patient has a history of heart disease or family history of heart disease
• the patient has an irregular heart rhythm.

Special caution should be exercised when taking Polfergan:

• in patients with asthma, bronchitis, bronchiectasis, as Polfergan may cause thickening of pulmonary secretions, leading to problems with expectoration;
• in patients with severe coronary artery disease, narrow-angle glaucoma, epilepsy, liver and kidney failure;
• in patients with urinary retention;
• in patients with prostatic hypertrophy;
• in patients with urethral stricture or duodenal obstruction.

Polfergan should not be used in children and adolescents with symptoms of Reye's syndrome. Polfergan may mask the symptoms of ototoxicity (toxic effect on the ear) caused by ototoxic drugs, e.g. salicylates. It may also delay the early diagnosis of intestinal obstruction or increased intracranial pressure by inhibiting vomiting. Polfergan syrup, 5 mg/5 ml, should not be taken for more than 7 days without consulting a doctor. You should talk to your doctor, even if the above warnings refer to past situations.

Children

Polfergan should not be used in children under 2 years of age. Elderly patients Elderly patients are at increased risk of adverse effects on the nervous system. Polfergan and other medicines You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. You should also tell your doctor or pharmacist about the following medicines you are taking or have recently taken:

• medicines that may affect heart rhythm (antipsychotic medicines, such as some phenothiazines (chlorpromazine, levomepromazine), benzamides (sulpiride, amisulpride, tiapride), pimozide, haloperidol, droperidol, citalopram, halofantrine, methadone, pentamidine, and moxifloxacin).

Polfergan enhances the sedative effect of central nervous system depressants, alcohol, barbiturates, sleeping pills, sedatives, other antihistamines, and tricyclic antidepressants. It enhances the effect of anticholinergic and antihypertensive medicines. Polfergan may cause false-positive or false-negative results in immunological pregnancy tests. You should stop taking Polfergan at least 72 hours before performing skin tests, as promethazine may inhibit the skin reaction to histamine and cause false-negative results. Pregnancy and breastfeeding 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. The medicine is contraindicated in the last trimester of pregnancy and during breastfeeding. Driving and using machines During treatment with Polfergan, you should not drive vehicles, operate machinery, or perform tasks that require full concentration and good motor skills (swimming, working at heights). Polfergan contains sucrose, sodium benzoate (E 211), ethanol, and sodium The medicine contains sucrose. If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine. 5 ml of syrup contains 4.25 g of sucrose, which corresponds to 0.4 carbohydrate exchange units (CEU). This should be taken into account in patients with diabetes. The medicine contains 0.3 mg of sodium benzoate (E 211) per 1 ml of syrup. Polfergan contains small amounts of alcohol (ethanol), which is a component of the flavor and aroma enhancer orange. This medicine contains 0.38 mg of alcohol (ethanol) per 5 ml of syrup. In the case of the maximum daily dose, the amount of alcohol is equivalent to:

• in adults:
• in allergic reactions - 3.8 mg of ethanol/50 ml, less than 1 ml of beer and less than 1 ml of wine,
• antiemetic - 5.7 mg of ethanol/75 ml, less than 1 ml of beer and less than 1 ml of wine,
• sedative - 1.9 mg of ethanol/25 ml, less than 1 ml of beer and less than 1 ml of wine,
• in children over 2 years of age:
• in allergic reactions - 0.0095 mg of ethanol/kg body weight, less than 1 ml of beer and less than 1 ml of wine,
• antiemetic - 0.038 mg of ethanol/kg body weight, less than 1 ml of beer and less than 1 ml of wine,
• nausea and dizziness - 0.038 mg of ethanol/kg body weight, less than 1 ml of beer and less than 1 ml of wine. The small amount of alcohol in this medicine will not cause noticeable effects.

The medicine contains less than 1 mmol (23 mg) of sodium per 1 ml of syrup, which means the medicine is considered "sodium-free".

3. How to take Polfergan

This medicine should always be taken according to the doctor's recommendations. In case of doubts, you should consult a doctor or pharmacist.

Administration in adults:

in allergic reactions - orally, once 25 ml before bedtime, maximum 50 ml per day in 2 or 3 divided doses, if necessary; antiemetic - orally, 12 to 25 ml every 6 to 8 hours, if necessary; sedative - orally, 25 ml in the evening before bedtime.

Administration in children over 2 years of age:

in allergic reactions - orally, 0.125 mg/kg body weight every 6 to 8 hours or 0.5 mg/kg body weight before bedtime, if necessary; antiemetic - orally, 0.25 to 0.5 mg/kg body weight every 6 to 8 hours, if necessary; nausea and dizziness - orally, 0.5 mg/kg body weight every 12 hours, if necessary. Do not exceed the adult dose. Polfergan should not be used in children under 2 years of age. 1 teaspoon = 5 ml of syrup If you take more Polfergan than you should Symptoms of severe overdose are varied. In children, symptoms of overdose are: excitement; clumsiness; lack of coordination; involuntary movements of limbs; hallucinations. In adults, symptoms of overdose are: drowsiness; coma. Both in children and adults, seizures may occur, which may be preceded by coma or excitement. Tachycardia may occur. After overdose of phenothiazines, prolonged QT interval and severe arrhythmias with a fatal outcome have been reported. Rarely, respiratory depression occurs. If you have taken more Polfergan than you should, you should immediately consult a doctor or pharmacist. In case of overdose, you should induce vomiting as soon as possible by administering ipecacuanha. Gastric lavage may be performed. Supportive treatment involves maintaining the function of the respiratory and circulatory systems. If seizures occur, you should administer diazepam or another appropriate anticonvulsant medicine. If you forget to take Polfergan If you miss a dose, you should take the recommended dose as soon as possible. However, if it is almost time for the next dose, you should not take the missed dose and continue treatment at the scheduled time. You should not take a double dose to make up for the missed dose. If you have any further doubts about taking this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Polfergan can cause side effects, although not everybody gets them. Possible side effects: drowsiness; dizziness; restlessness; headaches; nightmares; fatigue and disorientation. Anticholinergic side effects, such as blurred vision, dry mouth, and urinary retention, occur rarely. Infants are susceptible to anticholinergic effects of promethazine. In children, promethazine may cause paradoxical hyperactivity. Elderly patients are particularly susceptible to anticholinergic effects of promethazine. In elderly patients, promethazine may cause disorientation. Other side effects include: hives; rash; itching; loss of appetite; stomach upset; palpitations; hypotension; arrhythmias; extrapyramidal symptoms (muscle stiffness, facial rigidity, restlessness, involuntary movements); muscle spasms and single involuntary movements of the head and face. Rarely (in 1 to 10 patients per 10,000), the following side effects may occur: anaphylaxis (a type of allergic reaction that occurs immediately after administration of the allergen, characterized by, among other things, malaise, pallor, severe restlessness, feeling of pressure and pain in the head, tinnitus, vomiting, diarrhea, loss of consciousness); jaundice and abnormal blood count, including hemolytic anemia. There have also been reports of increased sensitivity to light. During treatment with promethazine, you should avoid strong sunlight. Side effects with unknown frequency (cannot be estimated from the available data) include:

• abnormal heart rhythm that affects its rhythm, including life-threatening arrhythmias;
• severe reaction with fever, muscle stiffness, changes in blood pressure, and coma (malignant neuroleptic syndrome);
• low platelet count (which may lead to bleeding and bruising);
• restlessness;
• hallucinations;
• aggression.

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 Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C 02-222 Warsaw Tel.: +48 22 49 21 301 Fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Polfergan

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and bottle after: "EXP". The expiry date refers to the last day of the month. Store in a temperature below 25°C. Store in the original packaging to protect from light. Shelf life after first opening the bottle: 1 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 pack and other information

What Polfergan contains

• The active substance of the medicine is promethazine hydrochloride. 5 ml of syrup contains 5 mg of promethazine hydrochloride.
• The other ingredients are: citric acid monohydrate, sodium benzoate (E 211), caramel, orange flavor and aroma enhancer (contains, among other things, ethanol, geraniol, and citral), sodium gentisate, sucrose, purified water.

What Polfergan looks like and contents of the pack

Brown syrup. The pack contains 150 ml of syrup. The bottle is made of brown glass type III with an aluminum cap with an LDPE seal and a guarantee ring, in a cardboard box or without a cardboard box. The bottle is made of orange PET with an HDPE cap and a guarantee ring, in a cardboard box or without a cardboard box. The bottle is made of orange PET with an aluminum cap with a PE seal and a guarantee ring, in a cardboard box or without a cardboard box.

Marketing authorization holder and manufacturer

Polfarmex S.A. ul. Józefów 9 99-300 Kutno Tel.: +48 24 357 44 44 Fax: +48 24 357 45 45 e-mail: [email protected]

Date of last revision of the leaflet: