Diphergan

Package leaflet: Information for the patient

DIPHERGAN, 10 mg, coated tablets
Promethazini hydrochloridum
Please read the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others.
• The medicine may harm another person, even if their symptoms appear identical.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse immediately. See section 4.

Table of contents

1. What Diphergan is and what it is 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 Diphergan is and what it is used for

Diphergan is a potent, long-acting antihistamine with additional sedative and antiemetic properties.
This medicine is indicated:

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

2. Important information before using Diphergan

When not to use Diphergan:

• if the patient is allergic to promethazine, 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 enzyme inhibitors (MAOIs), or within 14 days after discontinuation of such treatment;
• 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 personal or family history of heart disease;
• the patient has an irregular heartbeat. Inform the doctor about the following conditions, which may affect the safety of patients treated with Diphergan:
• pregnancy;
• breastfeeding;
• asthma, bronchitis, or bronchiectasis;
• severe coronary heart disease;
• epilepsy;
• renal or hepatic impairment;
• diabetes;
• narrow-angle glaucoma (increased intraocular pressure);
• prostate enlargement;
• difficulty in passing urine or gastric obstruction;
• presence of 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, direct exposure to sunlight should be avoided.
Diphergan and other medicines
Tell your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient intends to use.
You should also inform your doctor or pharmacist if the patient is currently or recently taking any of the following medicines:

• medicines that may affect heart rhythm.

Do not use Diphergan together with monoamine oxidase inhibitors (MAOIs) or within 14 days after discontinuation of MAOIs.
Diphergan enhances the effects of anticholinergic drugs, tricyclic antidepressants, sedatives, or hypnotics.
Diphergan and alcohol
Do not drink alcohol during treatment with Diphergan.
Pregnancy, breastfeeding and effects on fertility
During pregnancy, breastfeeding, if pregnancy is suspected, or when planning pregnancy, consult a doctor before using this medicine.
Pregnancy
Diphergan may be used during pregnancy only under medical supervision. Use of Diphergan is not recommended during the 2 weeks preceding the expected date of delivery.
Breastfeeding
Diphergan may 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 disturbances in orientation.
These symptoms most commonly occur during the first few days of treatment.
The medicine contains lactose and sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains Sunset Yellow FCF (E 110)
The medicine may cause allergic reactions.
The medicine contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means the medicine is considered "sodium-free".

3. How to use Diphergan

This medicine should always be used as directed by a physician. If in doubt, consult a doctor or pharmacist.
The dosage is individually adjusted by the physician according to the indication, patient's age, and sensitivity to the drug.
Recommended dosage
In allergic reactions:

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

For prevention of motion sickness symptoms:

• adults, including elderly patients, and children from 10 years of age: 20 to 25 mg the night before travel. If necessary, repeat the dose after 6–8 hours;
• children from 5 to 10 years of age: 10 mg the night before travel. If necessary, repeat the dose after 6–8 hours.

For preoperative preparation:

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

Use in children and adolescents
Do not use in children under 2 years of age.
Use in children aged 2 to 5 years: use Diphergan in syrup form.
Use in children over 5 years of age: see above.
Accidental overdose of Diphergan
In case of overdose, seek immediate medical advice from a doctor or go to the emergency department of the nearest hospital.
Missed dose of Diphergan
If a dose has been missed:

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

Stopping Diphergan
If you have any further doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Nervous system disorders:

• drowsiness, dizziness and headache, nightmares, fatigue and disorientation, confusion, extrapyramidal reactions.
• motor restlessness, severe reaction with fever, muscle stiffness, change in blood pressure and coma (neuroleptic malignant syndrome) - frequency unknown (cannot be estimated from available data).

Eye disorders:

• visual disturbances.

Gastrointestinal disorders:

• dry mouth, gastric irritation.

Renal and urinary disorders:

• urinary retention.

Metabolism and nutrition disorders:

• anorexia.

Cardiac disorders:

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

Musculoskeletal and connective tissue disorders:

• muscle spasms and involuntary movements of the head and face resembling tics.

Immune system disorders:

• anaphylaxis, photosensitivity skin reactions have been reported. Exposure to strong sunlight should be avoided during treatment.

Blood and lymphatic system disorders:

• blood abnormalities, including haemolytic anaemia.
• low platelet count (which may lead to bleeding and bruising) - frequency unknown (cannot be estimated from available data).

Hepatobiliary disorders:

• jaundice.

Psychiatric disorders:

• hallucinations, aggression - frequency unknown (cannot be estimated from available data).

Infants show susceptibility to the anticholinergic effect of promethazine, whereas
older children may exhibit paradoxical hyperexcitability.
Elderly individuals are particularly susceptible to the anticholinergic effects and confusion
induced by promethazine.
Adverse reactions are usually mild and do not require discontinuation of treatment. Some of them
resolve spontaneously over time.
Diagnostics: Diphergan may interfere with pregnancy and skin tests.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Diphergan

Keep this medicine out of the sight and reach of children.
Store below 25°C. Keep 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 stated month.
Medicines must 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 coated tablet contains 10 mg of promethazine hydrochloride.
The other ingredients are:

• core of the coated tablet: monohydrate lactose, potato starch, sucrose, gelatin, talc, sodium saccharin, magnesium stearate.
• coating of the coated 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 are orange-coloured coated tablets.
The pack contains 20 tablets.
Marketing Authorisation 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