Diphergan

Leaflet attached to the packaging: patient information

DIPHERGAN, 5 mg/5 ml, syrup

Promethazine hydrochloride

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

• You should keep this leaflet, so 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.
• 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 is Diphergan and what is it used for
• 2. Important information before taking Diphergan
• 3. How to take Diphergan
• 4. Possible side effects
• 5. How to store Diphergan
• 6. Contents of the packaging and other information

1. What is Diphergan and what is it used for

Diphergan in the form of a syrup contains promethazine hydrochloride, which has antihistamine, sedative, and antiemetic effects.

Indications for use:

• allergic diseases: hay fever, conjunctivitis, mild skin changes, dermatographism;
• motion sickness;
• sedative before and after surgical procedures;
• as a supplementary medicine in the treatment of postoperative pain.

2. Important information before taking Diphergan

When not to take Diphergan:

• if the patient is allergic to promethazine or any of the other ingredients of this medicine (listed in section 6);
• in a coma;
• if the patient has experienced inhibition of the central nervous system;
• if the patient is being treated with monoamine oxidase inhibitors (MAOIs) and for 14 days after stopping these medicines;
• in children under 2 years of age.

Warnings and precautions

Before starting to take Diphergan, you should consult a doctor or nurse if:

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

Use with caution in:

• glaucoma;
• epilepsy (lowers the seizure threshold);
• urethral stricture;
• prostate hypertrophy;
• liver failure;
• duodenal obstruction;
• gastric ulcer;
• bronchial asthma;
• bronchitis;
• bronchiectasis;
• severe coronary artery disease;
• renal failure.

The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

Diphergan 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. Diphergan enhances the effects of: painkillers, barbiturates, and the depressant effects of narcotics. Diphergan shows synergism (mutual enhancement of effects) with: neuroleptics, alcohol, and parasympatholytics. Hypotension caused by promethazine should not be treated with adrenaline, as promethazine hydrochloride may reverse the vasoconstrictive effect of adrenaline. You should also tell your doctor or pharmacist about any of the following medicines you are currently taking or have recently taken:

• medicines that may affect heart rhythm.

Pregnancy, breastfeeding, and fertility

In pregnancy and during breastfeeding, or if you suspect you are pregnant, or if you plan to become pregnant, you should consult a doctor before taking this medicine. Pregnancy Diphergan syrup may only be used during pregnancy if absolutely necessary. Breastfeeding The medicine passes into breast milk and may cause drowsiness in the newborn - use during breastfeeding is only allowed after consulting a doctor.

Driving and operating machinery

Diphergan may impair psychophysical abilities, the ability to drive vehicles, and operate machinery. You should use it with caution.

The medicine contains sucrose.

If you have previously been diagnosed with intolerance to some sugars, you should consult a doctor before taking the medicine. The medicine contains 7.93 g of sucrose in 10 ml of syrup. This should be taken into account in patients with diabetes.

The medicine contains sodium metabisulfite (E 223).

The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

The medicine contains sodium benzoate (E 211).

The medicine contains 15 mg of benzoic acid sodium salt (sodium benzoate (E 211)) in every 100 ml of syrup, which corresponds to 0.75 mg in 5 ml of syrup.

The medicine contains ethanol.

This medicine contains 42 mg of alcohol (ethanol) in every 50 ml of syrup. The amount of alcohol in 50 ml of this medicine is equivalent to less than 1.1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not have noticeable effects.

The medicine contains sodium.

The medicine contains less than 1 mmol (23 mg) of sodium per 5 ml of syrup, which means the medicine is considered "sodium-free".

3. How to take Diphergan

This medicine should always be taken according to the doctor's recommendations. If you have any doubts, you should consult a doctor or pharmacist.

Recommended dose

In allergic diseases:

• adults: 10 mg (10 ml syrup) 2-4 times a day, before meals and before bedtime;
• children from 2 to 12 years: 0.125 mg per kg of body weight every 4 to 6 hours.

Anti-emetic:

• adults: 25 mg once (25 ml syrup), then 10 mg to 25 mg (10 ml to 25 ml syrup) every 4 to 6 hours;
• children from 2 to 12 years: 0.25 mg to 0.50 mg per kg of body weight every 4 to 6 hours.

In motion sickness (nausea, dizziness):

• adults: 25 mg once (25 ml syrup) 30 minutes to 1 hour before travel, the dose can be repeated 8-12 hours later;
• children from 2 to 12 years: 0.25 mg to 0.50 mg per kg of body weight every 12 hours.

Sedative:

• adults: 25 mg to 50 mg (25 ml to 50 ml syrup) once;
• children from 2 to 12 years: 0.50 mg to 1 mg per kg of body weight once.

Note:

When dosing children, do not exceed half of the adult dose.

Taking a higher dose of Diphergan than recommended.

In case of overdose - induce vomiting and immediately call a doctor.

In case of overdose, promethazine hydrochloride may cause respiratory arrest, coma, extrapyramidal symptoms (symptoms of parkinsonism), hallucinations, increased muscle tone, urinary retention, cholinergic symptoms (ocular, cardiac), and anaphylactic symptoms with urticaria. A change in urine color to red (sometimes due to hematuria) has been observed with promethazine overdose. As an antidote, caffeine, amphetamine, and gastric lavage should be administered. Hypotension caused by promethazine should not be treated with adrenaline; instead, norepinephrine or phenylephrine should be used. If you have any further doubts about the use of this medicine, you should consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. 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 Respiratory, thoracic, and mediastinal disordersFrequency not known: dry mouth and thickening of mucus in the airways, which may cause wheezing, hoarseness, and coughing. Rare: xerostomia (dry mouth), drying of the airways. Cardiac disordersFrequency not known: decrease in blood pressure, tachycardia, abnormal electrical activity of the heart affecting its rhythm, including life-threatening arrhythmias. Rare: arrhythmias, increased blood pressure. Eye disordersFrequency not known: vision disturbances (blurred, double vision, pupil dilation), hypersensitivity to light. Renal and urinary disordersRare: changes in the kidneys, dysuria (pain and burning during urination). Nervous system disordersFrequency not known: depression or stimulation of the central nervous system (more often stimulation and hallucinations), restlessness, severe reaction with fever, muscle stiffness, changes in blood pressure, and coma (neuroleptic malignant syndrome). Hepatobiliary disordersRare: changes in the liver. General disorders and administration site conditionsFrequency not known: changes in body temperature regulation (fever). Skin and subcutaneous tissue disordersFrequency not known: facial flushing. Psychiatric disordersFrequency not known: hallucinations, aggression. Blood and lymphatic system disordersFrequency not known: low platelet count (which may lead to bleeding and bruising). InvestigationsMay cause false (positive or negative) results of immunological pregnancy tests, may increase blood glucose levels, hypokalemia.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 the medicine.

5. How to store Diphergan

The medicine should be stored out of sight and reach of children. Store at a temperature below 25°C. Do not store in the refrigerator or freeze. Before use, check the expiration date of the medicine on the packaging. Do not use this medicine after the expiration date stated on the box and bottle. The expiration date refers to the last day of the specified 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. Shelf life after first opening: 2.5 months.

6. Contents of the packaging and other information

What Diphergan contains

The active substance of the medicine is promethazine hydrochloride. 5 ml of syrup contains 5 mg of promethazine hydrochloride. The excipients are: ammoniacal caramel (E 150c), sucrose, sodium benzoate (E 211), sodium metabisulfite (E 223), ascorbic acid, diluted hydrochloric acid, orange essence (contains ethanol, linalool, d-limonene), and purified water.

What Diphergan looks like and what the pack contains

Diphergan syrup is a dark, brown-red liquid with a sweet taste and orange odor. The bottle made of brown glass is closed with a white aluminum cap with a measuring cup made of PP with a capacity of 15 ml (scaled 2.5 ml, 5 ml, 7.5 ml, 10 ml, 12.5 ml, 15 ml), in a cardboard box. 150 ml

Marketing authorization holder

Bausch Health Ireland Limited 3013 Lake Drive Citywest Business Campus Dublin 24, D24PPT3 Ireland

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o. ul. Krzywa 2 95-030 Rzgów

Date of last revision of the leaflet: