Naproxen Hasco

Package Leaflet: Information for the Patient

NAPROXEN HASCO 100 mg/g (10%) Gel

(Naproxen)

Read the package leaflet carefully before using the medicine, as it contains

important information for the patient.
This medicine should always be used exactly as described in the package leaflet or as advised by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or further information, you should ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If you do not feel better or if you feel worse, you should contact your doctor.

Table of Contents of the Leaflet

• 1. What is Naproxen HASCO and what is it used for
• 2. Important information before using Naproxen HASCO
• 3. How to use Naproxen HASCO
• 4. Possible side effects
• 5. How to store Naproxen HASCO
• 6. Contents of the pack and other information

1. What is Naproxen HASCO and what is it used for

This medicine is intended for use on the skin.
The active substance of Naproxen HASCO is naproxen, which has analgesic and anti-inflammatory effects. Menthol causes a cooling sensation on the skin and has a local anesthetic effect, causing local vasodilation and facilitating the penetration of naproxen into diseased tissues. Chloral hydrate, due to its slightly irritating properties, causes beneficial, reflexive vasodilation.

Indications

The medicine is used locally for analgesic and anti-inflammatory effects in muscle and joint pain:

• in degenerative joint disease;
• in soft tissue injuries;
• in joint and tendon injuries.

2. Important information before using Naproxen HASCO

When not to use Naproxen HASCO

• if you are allergic to naproxen or any of the other ingredients of this medicine (listed in section 6);
• if you are hypersensitive to other nonsteroidal anti-inflammatory drugs (e.g., acetylsalicylic acid);
• if you are in the third trimester of pregnancy;
• in children under 3 years of age.

Warnings and precautions

In patients with gastrointestinal ulcers and bleeding, caution should be exercised due to the possibility of naproxen absorption into the bloodstream.
After applying the gel to the skin, wash your hands thoroughly.
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You should avoid contact between the medicine and your eyes and mucous membranes. If the gel gets into your eyes or onto your mucous membranes, rinse it off with plenty of water.
Do not use on damaged skin, open wounds, or skin inflammation.
During treatment and for 2 weeks after stopping treatment, you should avoid direct sunlight (including sunbeds).
The medicine should be used with caution:

• in cases of a history of allergic reactions (rash, itching, redness) during treatment with nonsteroidal anti-inflammatory drugs;
• when used on large areas of skin for extended periods, as there is a possibility of systemic side effects. If the above symptoms occur, you should stop using the medicine. You should consult your doctor, even if the above warnings refer to past situations.

Children

Do not use in children under 3 years of age.

Using Naproxen HASCO in patients with kidney and/or liver function disorders

Particular caution should be exercised when using Naproxen HASCO in patients with liver and/or kidney failure due to the possibility of naproxen absorption into the bloodstream.

Naproxen HASCO and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
So far, no interactions have been observed between naproxen applied topically to the skin and other medicines. However, in the case of long-term use of the medicine on large areas of skin, it cannot be entirely ruled out that such interactions may occur.
In the case of oral administration of naproxen, it has been observed that:

• ethanol enhances the effect of naproxen;
• naproxen enhances the effect of acetylsalicylic acid, phenytoin, and hydantoin, oral anticoagulants from the coumarin group, and enhances the toxic effect of methotrexate;
• naproxen inhibits the effect of furosemide and other diuretics;
• sodium bicarbonate and probenecid increase the concentration of naproxen in serum.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Oral forms (e.g., tablets) of naproxen may cause side effects in the unborn child. It is not known whether the same risk applies when using Naproxen HASCO on the skin.
Do not use Naproxen HASCO during the last 3 months of pregnancy.
Do not use Naproxen HASCO during the first 6 months of pregnancy, unless it is absolutely necessary and recommended by your doctor. If treatment is necessary during this period, you should take the smallest possible dose for the shortest possible time.
Do not use Naproxen HASCO while breastfeeding. Naproxen passes into breast milk.

Driving and using machines

There are no data on side effects after using naproxen that may affect the ability to drive and use machines.
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Naproxen HASCO contains propylene glycol

The medicine may cause skin irritation.

Naproxen HASCO contains methyl parahydroxybenzoate and propyl parahydroxybenzoate

The medicine may cause allergic reactions (possible late reactions).

3. How to use Naproxen HASCO

This medicine should always be used exactly as described in the package leaflet or as advised by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.
The medicine is for topical use on the skin.
The medicine should be applied 4 to 5 times a day to the painful area and gently massaged in.
A 1 cm long strip of gel is applied to a skin area of approximately 7 cm x 7 cm.
After applying the gel to the skin, you should wash your hands thoroughly, unless the treatment involves your hands.
If redness and skin irritation occur, you should stop using the medicine until the symptoms disappear. If the symptoms do not disappear, you should consult your doctor.

Using a higher dose of Naproxen HASCO than recommended

After topical application of naproxen at a concentration of 10%, no overdose symptoms are known.
However, due to improper use or accidental ingestion, it is possible for systemic side effects to occur. In such a case, your doctor will apply the appropriate treatment for nonsteroidal anti-inflammatory drug poisoning.
In case of accidental ingestion (e.g., by a child), you should contact your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
After using the medicine, local skin reactions may occur: hypersensitivity, redness, irritation, usually disappearing after stopping the medicine.
In the case of long-term use on large areas of skin, side effects may occur due to the systemic effect of naproxen (e.g., nausea, diarrhea, drowsiness, headaches, hypersensitivity reactions). Sensitization to light is possible. Rarely, rash, itching, or burning may occur. If you experience shortness of breath or skin changes, you should stop using the medicine immediately, consult your doctor, or go to the nearest hospital.
Reporting side effects
If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw
tel.: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.
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5. How to store Naproxen HASCO

Store in a closed package, at a temperature below 25°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Naproxen HASCO contains

• The active substance of the medicine is naproxen. 1 g of gel contains 100 mg of naproxen.
• The other ingredients are: carbomer 5984, sodium hydroxide 30%, menthol, chloral hydrate, propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water.

What Naproxen HASCO looks like and contents of the pack

Naproxen HASCO is a gel.
One package contains 50 or 100 g of gel.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Information about the medicine
tel. +48 (22) 742 00 22
e-mail: informacjaoleku@hasco-lek.pl
Date of last revision of the leaflet:08/2024
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