Patient Information Leaflet

NOVAPHERGAN 20 mg/g cream

Promethazine
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more advice or information, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:

What NOVAPHERGAN is and what it is used for
What you need to know before using NOVAPHERGAN
How to use NOVAPHERGAN
Possible side effects
How to store NOVAPHERGAN
Contents of the pack and other information

1. What NOVAPHERGAN is and what it is used for

This medicinal product contains the active substance promethazine, which belongs to a group of medicines called antihistamines.
NOVAPHERGAN works by relieving symptoms of skin irritation (itching, redness, burning), and is used to treat irritations caused by insect bites or excessive exposure to sunlight (sunburn).
Consult your doctor if you do not feel better or if you feel worse.

2. What you should know before using NOVAPHERGAN

Do not use NOVAPHERGAN

if you are allergic to promethazine, to other substances chemically similar to promethazine, or to any of the other ingredients of this medicine (listed in section 6);
if you currently have or have previously suffered from a skin disease characterized by inflammation (eczema);
if you have open, oozing wounds (oozing lesions);
if the patient is a child under 2 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using NOVAPHERGAN.
If you use the product for prolonged periods or for a purpose different from that stated in this leaflet, you may develop irritation (allergic sensitization reactions) which could worsen your condition. If this occurs, stop treatment with this medicine and inform your doctor, who will recommend an alternative therapy.
Do not apply this medicine to healing wounds for longer than 3–4 days.
If you are using NOVAPHERGAN to treat sunburn (solar erythema), avoid exposing the affected area to sunlight.
Stop treatment with this medicine if you notice the appearance of small pimples (skin rash), irritation, or burning.

Children
This medicine must not be used in children under 2 years of age.

Other medicines and NOVAPHERGAN
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
No interactions with other topical medicines are known.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Use this medicine only if strictly necessary and under direct medical supervision.

Driving and using machines
If you use high doses of this medicine or apply it over large areas of skin, absorption of the medicine may cause drowsiness. If this occurs, avoid driving and operating machinery.

NOVAPHERGAN contains methyl 4-hydroxybenzoate (E218) and propyl 4-hydroxybenzoate (E216)
This medicine contains methyl 4-hydroxybenzoate (E218) and propyl 4-hydroxybenzoate (E216), which may cause allergic reactions (including delayed reactions).

3. How to use NOVAPHERGAN

Use this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 2-3 applications per day.
Avoid applying the cream to large areas or for prolonged periods, and do not exceed the recommended doses.
If you use more NOVAPHERGAN than you should
Cases of overdose are not known.
In case of accidental ingestion or intake of an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to use NOVAPHERGAN
Do not apply a double dose to make up for the missed application.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

allergic reactions;
increased sensitivity of the skin to light (photosensitivity);
drowsiness, if high doses of this medicine are applied to large areas of skin.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NOVAPHERGAN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What NOVAPHERGAN contains

The active substance is promethazine hydrochloride. 1 g of cream contains 22.5 mg of promethazine hydrochloride, equivalent to 20 mg of promethazine.
The other components are: liquid paraffin, stearic acid, glycerol, xalifin 15, methyl p-hydroxybenzoate (E218), propyl p-hydroxybenzoate (E216), white wax, purified water, thiourea.

Description of the appearance of NOVAPHERGAN and contents of the pack
Pack containing one 30 g tube of cream.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Industria Farmaceutica NOVA ARGENTIA S.r.l., Via Carlo Porta, 49 – Gorgonzola (MI)
Manufacturer
Industria Farmaceutica NOVA ARGENTIA S.r.l., Via G. Pascoli, 1 - Gorgonzola – Milano – Italy