Diphergan

Leaflet attached to the packaging: patient information

DIPHERGAN, 10 mg, effervescent tablets

Promethazine hydrochloride

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others.
• The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your 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 pack 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 having a sedative and antiemetic effect.
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 you are allergic to promethazine, other phenothiazine derivatives, or any of the other ingredients of this medicine (listed in section 6);
• if you are in a coma;
• if you have central nervous system depression, regardless of its cause;
• if you are 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 taking Diphergan, tell your doctor or nurse if:

• you have any serious heart problems
• you have a history of heart disease or a family history of heart disease
• you have an irregular heartbeat. You should inform your 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;
• diabetes;
• glaucoma with a narrow angle of filtration (increased pressure in the eyeball);
• prostatic hypertrophy;
• 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

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Also, tell your doctor or pharmacist about any of the following medicines you are taking or have recently 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

If you are pregnant, breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Pregnancy
Diphergan should only be used during pregnancy if your doctor considers it necessary. It is not recommended to take Diphergan during the last 2 weeks before the planned delivery date.
Breastfeeding
Diphergan can be used during breastfeeding only if your doctor considers it necessary.

Driving and using machines

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

The medicine contains lactose and sucrose

If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking the medicine.

The medicine contains orange yellow (E 110)

The medicine may cause allergic reactions.

The medicine 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 your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Your doctor will adjust the dose individually for each patient, depending on the indications, age, and sensitivity to the medicine.

Recommended dose

In allergic reactions:

• adults, including the elderly, and children over 10 years: initially 10 mg twice a day. If necessary, the dose can be gradually increased to the optimal dose for the patient, up to 20 mg three times a day;
• children from 5 to 10 years: 10 to 25 mg as a single dose or 5 to 10 mg twice a day. Maximum 25 mg per day.

In the prevention of motion sickness:

• adults, including the elderly, and children over 10 years: 20 to 25 mg at night before the trip. If necessary, the dose can be repeated after 6-8 hours;
• children from 5 to 10 years: 10 mg at night before the trip. If necessary, the dose can be repeated after 6-8 hours

In preparation for surgery:

• adults and children over 10 years: 25 to 50 mg one hour before the procedure;
• children from 5 to 10 years: 20 to 25 mg one hour before the procedure.

Use in children and adolescents

Do not use in children under 2 years.
Use in children from 2 to 5 years: use Diphergan in the form of a syrup.
Use in children over 5 years: see above.

Overdose

If you have taken more than the recommended dose, contact your doctor or go to the emergency room immediately.

Missed dose

If you miss a dose:

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

Stopping treatment

If you have any further questions about taking this medicine, ask your 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, changes in blood pressure, 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, hypotension (low blood pressure), arrhythmia.
• abnormal electrical activity of the heart affecting its 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. During treatment, avoid strong sunlight.

Blood and lymphatic system disorders:

• abnormal blood count, 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 you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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
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 this medicine.

5. How to store Diphergan

Keep the medicine out of the reach and sight 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 your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Diphergan contains

The active substance is promethazine hydrochloride. One effervescent tablet contains 10 mg of promethazine hydrochloride.
The other ingredients are:

• core of the effervescent tablet: lactose monohydrate, potato starch, sucrose, gelatin, talc, sodium saccharin, magnesium stearate.
• coating of the effervescent tablet: sucrose, talc, gum arabic, orange yellow (E 110), Capol 1295 (a mixture of carnauba wax and beeswax).

What Diphergan looks like and contents of the pack

Diphergan 10 mg is an orange-colored effervescent tablet.
The pack contains 20 effervescent 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