Diphergan

Patient Information Leaflet

DIPHERGAN, 25 mg, coated tablets
Promethazini hydrochloridum
Please read all of this leaflet before taking this medicine, because 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 ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others.
• It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 medicine which also has
sedative and antiemetic properties.
This medicine is used:

• 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 sedative in preoperative care in surgery and obstetrics;
• as an antiemetic agent, e.g. in kinetosis (motion sickness).

2. Important information before using Diphergan

When not to use Diphergan

• if the patient is allergic to promethazine or other phenothiazine derivatives, or to 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) 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;
• narrow-angle glaucoma (increased intraocular pressure);
• benign 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 exposure to sunlight.
Diphergan and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient intends to use.
Also inform your doctor or pharmacist if the patient is currently or recently taking 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 MAOI treatment.
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, while breastfeeding, or if pregnancy is suspected or planned, consult a doctor before using this medicine.
Pregnancy
Diphergan may be used during pregnancy only under medical supervision. It is not recommended to use Diphergan within 2 weeks preceding the expected delivery date.
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 disorientation.
These symptoms most commonly occur during the first few days of treatment.
Diphergan contains lactose and sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.
Diphergan contains cochineal red (E 124)
This medicine may cause allergic reactions.
Diphergan contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Diphergan

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
Your doctor will individually adjust the dosage for each patient. The dose depends on the indication,
patient's age and sensitivity to the drug.
Recommended dose
In allergic reactions:

• adults, including elderly patients, and children from 10 years of age: 25 mg once daily (preferably at bedtime), increasing if necessary up to a maximum of 25 mg twice daily;
• children from 5 to 10 years of age: 10 to 25 mg as a single dose (preferably at bedtime) 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: 25 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: 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 aged 5 years and older: use in the form of coated tablets (see above).
Taking more Diphergan than recommended
If you have taken too much Diphergan, contact your doctor immediately or go to the nearest hospital emergency department.
Missed dose of Diphergan
If a dose has been missed:

• in the treatment of allergies, 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 take a double dose to make up for a missed dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Central and peripheral nervous system disorders:

• drowsiness, dizziness and headache, nightmares, fatigue and disorientation, confusion, extrapyramidal reactions.
• motor restlessness, severe reaction with fever, muscle stiffness, changes 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, low blood pressure (hypotension), 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 head and facial movements resembling tics.

Immune system disorders:

• anaphylaxis; photosensitivity skin reactions have been reported; 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 effects of promethazine, whereas
older children may exhibit paradoxical hyperexcitability.
Elderly individuals are particularly susceptible to anticholinergic effects and confusion
induced by promethazine.
Adverse effects are usually mild and do not necessitate discontinuation of treatment. Some
of them resolve spontaneously over time.
Diagnostic investigations
Diphergan may affect the results of pregnancy and skin tests.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects 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 4921301
Fax: +48 22 4921309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Diphergan

Keep this medicine out of 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. Such measures 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 25 mg of promethazine hydrochloride.
The other ingredients are:

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

What Diphergan looks like and contents of the pack
Diphergan 25 mg is a red coated tablet.
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