Diphergan

Package Leaflet: Information for the Patient

DIPHERGAN, 25 mg, effervescent tablets

Promethazine hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, 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 not listed in this leaflet, they should inform 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. Package contents and other information

1. What is Diphergan and what is it used for

Diphergan is a strong antihistamine with a long duration of action, also exhibiting sedative and antiemetic effects.
The medicine is used:

• for symptomatic treatment of allergic conditions of the upper respiratory tract and skin, including allergic rhinitis, urticaria, and anaphylactic reactions to drugs and foreign proteins;
• as an adjunct to preoperative sedation of patients in surgery and obstetrics;
• as an antiemetic, e.g., in kinetosis (motion sickness).

2. Important information before taking Diphergan

When not to take Diphergan

• if the patient is allergic to promethazine or 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 central nervous system depression, regardless of its cause;
• if the patient is being treated with monoamine oxidase inhibitors (MAOIs) and for 14 days after stopping MAOIs;
• in children under 2 years of age.

Warnings and precautions

Before starting treatment with Diphergan, 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. Inform the doctor about the following cases that affect the safety of the patient taking Diphergan:
• pregnancy;
• breastfeeding;
• asthma, bronchitis, or bronchiectasis, severe coronary artery disease;
• epilepsy;
• renal or hepatic insufficiency;
• glaucoma with a narrow angle of filtration (increased intraocular pressure);
• prostatic hyperplasia;
• difficulty urinating or gastric obstruction;
• symptoms indicating Reye's syndrome in children and adolescents (diarrhea, rapid breathing, vomiting, fever, seizures).

The medicine may cause allergic reactions.
During treatment with Diphergan, avoid direct sun exposure.

Diphergan and other medicines

Inform the doctor or pharmacist about all medicines currently being taken or recently taken, as well as any medicines the patient plans to take.
Also, inform the doctor or pharmacist about any of the following medicines being taken:

• medicines that may affect heart rhythm.

Do not take Diphergan with monoamine oxidase inhibitors (MAOIs) or for 14 days after stopping MAOIs.
Diphergan enhances the effects of anticholinergic, tricyclic antidepressant, sedative, or hypnotic medicines.

Diphergan and alcohol

Do not drink alcohol while taking Diphergan.

Pregnancy, breastfeeding, and fertility

In pregnancy, during breastfeeding, or if pregnancy is suspected, or if the patient is planning to become pregnant, consult a doctor before taking this medicine.
Pregnancy
Diphergan should only be used during pregnancy under medical supervision. It is not recommended to use Diphergan during the last 2 weeks before the planned delivery date.
Breastfeeding
Diphergan can be used during breastfeeding only under medical supervision.

Driving and operating machinery

Do not drive or operate machinery, as the medicine may cause drowsiness, dizziness, and disorientation.
These symptoms occur most frequently during the first few days of treatment.

Diphergan contains lactose and sucrose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medicine.

Diphergan contains cochineal red (E 124)

The medicine may cause allergic reactions.

Diphergan contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per effervescent tablet, which means it is considered "sodium-free".

3. How to take Diphergan

Always take this medicine exactly as prescribed by the doctor. In case of doubts, consult a doctor or pharmacist.
The doctor will adjust the dosage individually for each patient, depending on the indications, the patient's age, and their sensitivity to the medicine.

Recommended dose

In allergic reactions:

• adults, including the elderly, and children over 10 years: 25 mg once a day (preferably at night), increasing to a maximum of 25 mg twice a day if necessary;
• children from 5 to 10 years: 10 to 25 mg once (preferably at night) or 5 to 10 mg twice a day, up to a maximum of 25 mg per day;

In preventing motion sickness:

• adults, including the elderly, and children over 10 years: 25 mg at night before the trip; if necessary, the dose can be repeated after 6-8 hours;

In preparing the patient for surgery:

• adults and children over 10 years: 25 to 50 mg 1 hour before the procedure;
• children from 5 to 10 years: 25 mg 1 hour before the procedure.

Use in children and adolescents

Do not use in children under 2 years of age.
Use in children from 2 to 5 years: use Diphergan in the form of syrup.
Use in children from 5 years: use in the form of effervescent tablets (see above).

Taking a higher dose of Diphergan than recommended

In case of taking too high a dose, immediately contact a doctor or go to the emergency room at the nearest hospital.

Missing a dose of Diphergan

If a dose is missed:

• in the treatment of allergies, take it as soon as possible and continue with the previous dosage;
• in cases of restlessness and insomnia, omit this dose and take the next one the following evening; Do not take a double dose to make up for the missed dose.

Stopping treatment with Diphergan

In case of any further doubts about taking this medicine, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Diphergan can cause side effects, although not everybody gets them.
Nervous system disorders:

• drowsiness, dizziness, and headaches, nightmares, fatigue, and disorientation, confusion, extrapyramidal reactions.
• restlessness, severe reaction with fever, muscle stiffness, blood pressure changes, and coma (malignant neuroleptic syndrome) - frequency not known (cannot be estimated from the available data).

Eye disorders:

• vision disturbances.

Gastrointestinal disorders:

• dry mouth, stomach irritation.

Renal and urinary disorders:

• urinary retention.

Metabolic and nutritional disorders:

• anorexia.

Cardiac disorders:

• palpitations, low blood pressure (hypotension), arrhythmia.
• abnormal heart electrical activity affecting heart rhythm, including life-threatening arrhythmias - frequency not known (cannot be estimated from the available data).

Musculoskeletal and connective tissue disorders:

• muscle cramps and movements of the head and face resembling tics.

Immune system disorders:

• anaphylaxis, photosensitivity reactions have been reported, avoid strong sunlight during treatment.

Blood and lymphatic system disorders:

• abnormal blood counts, including hemolytic anemia.
• low platelet count (which may lead to bleeding and bruising) - frequency not known (cannot be estimated from the available data).

Hepatobiliary disorders:

• jaundice.

Psychiatric disorders:

• hallucinations, aggression - frequency not known (cannot be estimated from the available data).

Infants are susceptible to the anticholinergic effects of promethazine, while older children may exhibit paradoxical hyperactivity.
The elderly are particularly susceptible to the anticholinergic effects and confusion caused by promethazine.
Side effects are usually mild and do not require discontinuation of treatment. Some of them may disappear on their own over time.
Diagnostic tests
Diphergan may affect the results of pregnancy tests and skin tests.

Reporting side effects

If any side effects occur, including any not listed in the leaflet, inform the 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
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Diphergan

Keep the medicine out of sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Diphergan contains

The active substance of the medicine is promethazine hydrochloride. One effervescent tablet contains 25 mg of promethazine hydrochloride.
The other ingredients are:

• effervescent tablet core: lactose monohydrate, potato starch, sucrose, gelatin, talc, sodium saccharin, magnesium stearate.
• effervescent tablet coating: sucrose, talc, gum arabic, cochineal red (E 124), Capol 1295 (a mixture of carnauba wax and beeswax).

What Diphergan looks like and what the package contains

Diphergan 25 mg are red effervescent tablets.
The package contains 20 tablets.

Marketing authorization 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
Date of last revision of the leaflet:March 2025