Diphergan

Patient Information Leaflet

DIPHERGAN, 5 mg/5 ml, syrup
Promethazini hydrochloridum
Please read the entire leaflet before using this medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others.
• This medicine may harm others, even if their symptoms are similar.
• If the patient experiences 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 syrup contains promethazine hydrochloride, which has antihistaminic,
sedative, and antiemetic properties.

Indications:

• Allergic conditions: hay fever, conjunctivitis, mild skin manifestations, dermographism;
• Motion sickness;
• Pre- and post-operative sedation;
• As an adjunctive treatment in postoperative pain management.

2. Important information before using Diphergan

When not to use Diphergan:

• if the patient is allergic to promethazine or any of the other ingredients of this medicine (listed in section 6);
• in coma;
• if the patient has central nervous system depression;
• 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 irregular heartbeat.

Use with caution in:

• glaucoma;
• epilepsy (lowers the seizure threshold);
• urinary tract obstruction;
• benign prostatic hyperplasia;
• hepatic insufficiency;
• pyloric stenosis;
• peptic ulcer;
• bronchial asthma;
• bronchitis;
• bronchiectasis;
• severe coronary artery disease;
• renal failure.

The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.
Diphergan with other medicines
Inform your doctor or pharmacist about all medicines currently used or recently taken,
as well as any medicines the patient intends to use.
Diphergan enhances the effect of: analgesics, barbiturates, and the depressant effect of
narcotics.
Diphergan shows synergy (mutual enhancement of effect) with: neuroleptics,
alcohol, and parasympatholytics.
Hypotension caused by promethazine must not be treated with adrenaline (epinephrine), because
promethazine hydrochloride may reverse the pressor effects of adrenaline.
You should also inform your doctor or pharmacist if the patient is currently or recently taking the following medicines:

• medicines that may affect heart rhythm.

Pregnancy, breastfeeding and fertility
During pregnancy and breastfeeding, or if pregnancy is suspected, or when planning pregnancy,
consult a doctor before using this medicine.
Pregnancy
Diphergan syrup may be used during pregnancy only if clearly necessary.
Breastfeeding
The medicine passes into breast milk and may cause drowsiness in the newborn – use during
breastfeeding is acceptable only after consultation with a doctor.
Driving and operating machinery
Diphergan may impair psycho-physical performance, ability to drive vehicles and operate machinery. Use with caution.
The medicine contains 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 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 salt (sodium benzoate (E 211)) in each 100 ml of syrup, equivalent to 0.75 mg in 5 ml of syrup.
The medicine contains ethanol.
This medicine contains 42 mg of alcohol (ethanol) in each 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 cause 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 use Diphergan

This medicine should always be used according to the doctor's instructions. In case of doubts, consult
your doctor or pharmacist.
Recommended dose
In allergic conditions:

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

As an antiemetic:

• adults: 25 mg as a single dose (25 ml of syrup), followed by 10 mg to 25 mg (10 ml to 25 ml of 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 as a single dose (25 ml of syrup) half an hour to one hour before travel; the dose may 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.

As a sedative:

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

Note:
In pediatric dosing, the dose should not exceed half of the adult dose.
Taking more than the recommended dose of Diphergan.
In case of overdose – induce vomiting and call a doctor immediately.
In overdose, promethazine hydrochloride may cause respiratory depression,
cerebral coma, extrapyramidal symptoms (choreiform symptoms), hallucinations, increased muscle
tone, urinary retention, cholinergic symptoms (ocular, cardiac), anaphylactic symptoms
with urticaria. Red discoloration of urine (sometimes due to hematuria) has been observed in cases of promethazine overdose.
As antidotes, administer caffeine, amphetamine, and perform gastric lavage.
Hypotension caused by promethazine must not be treated with adrenaline; use
noradrenaline or phenylephrine instead.
If you have any further doubts regarding 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.
Adverse effects may occur with the following frequency:
very common: more than 1 in 10 people
common: 1 to 10 in 100 people
uncommon: 1 to 10 in 1,000 people
rare: 1 to 10 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 disorders
Frequency not known: dryness of the mouth and thickening of mucus in the airways, which may cause wheezing, noisy breathing, and gasping.
Rare: xerostomia (dry mouth), drying of the airways.

Cardiac disorders
Frequency not known: low blood pressure, tachycardia, abnormal electrical activity of the heart affecting its rhythm, including life-threatening arrhythmias.
Rare: cardiac arrhythmias, increased arterial blood pressure.

Eye disorders
Frequency not known: visual disturbances (blurred vision, double vision, pupil dilation), photophobia (sensitivity to light).

Renal and urinary disorders
Rare: kidney changes, dysuria (pain and burning during urination).

Nervous system disorders
Frequency not known: depression or central nervous system stimulation (more commonly stimulation and hallucinations), motor restlessness, severe reaction with fever, muscle stiffness, changes in blood pressure, and coma (neuroleptic malignant syndrome).

Hepatobiliary disorders
Rare: liver changes.

General disorders and administration site conditions
Frequency not known: disturbances in body temperature regulation (fever).

Skin and subcutaneous tissue disorders
Frequency not known: facial flushing.

Psychiatric disorders
Frequency not known: hallucinations, aggression.

Blood and lymphatic system disorders
Frequency not known: low platelet count (which may lead to bleeding and bruising).

Investigations
May interfere with (give false positive or false negative results) immunological pregnancy tests, may increase blood glucose levels, hypokalaemia.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
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 this medicine.

5. How to store Diphergan

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Do not store in a refrigerator or freeze.
Check the expiry date stated on the packaging before use.
Do not use this medicine after the expiry date shown on the carton and bottle.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.
Shelf-life after first use: 2.5 months.

6. Contents of the pack and other information

What Diphergan contains
The active substance is promethazine hydrochloride. 5 ml of syrup contains 5 mg of promethazine hydrochloride.
The other ingredients are: ammonium caramel (E 150c), sucrose, sodium benzoate (E 211), sodium metabisulphite (E 223), ascorbic acid, diluted hydrochloric acid, orange flavour (containing ethanol, linalool, d-limonene) and purified water.

What Diphergan looks like and contents of the pack
Diphergan syrup is a dark brown-red solution with a sweet taste and orange odour.
Brown glass bottle with a white aluminium screw cap, with a polypropylene (PP) measuring cup of 15 ml capacity (graduated at 2.5 ml, 5 ml, 7.5 ml, 10 ml, 12.5 ml, 15 ml), in a cardboard box.
150 ml

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

Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
Krzywa 2 Street
95-030 Rzgow
Poland