Package leaflet: Information for the patient

NAPROXEN HASCO 100 mg/g (10%) gel
( Naproxenum )
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by the
physician or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse, consult your doctor.

Table of contents

What Naproxen HASCO is and what it is used for
Important information before using Naproxen HASCO
How to use Naproxen HASCO
Possible side effects
How to store Naproxen HASCO
Contents of the pack and other information

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

This medicine is intended for topical application.
The active substance in Naproxen HASCO is naproxen, which has analgesic and anti-inflammatory effects.
Levomenthol produces a cooling sensation on the skin and acts as a local anesthetic, causing local vasodilation and facilitating the penetration of naproxen into diseased tissues.
Chloral hydrate, due to its mild irritant properties, induces beneficial reflex vasodilation.

Indications
The medicine is used topically for analgesic and anti-inflammatory treatment of muscle and joint pain:

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

2. Important information before using Naproxen HASCO

When not to use Naproxen HASCO

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

Warnings and precautions
Caution should be exercised in patients with gastrointestinal ulcers or bleeding tendencies due to the possibility of systemic absorption of naproxen.
After applying the gel to the skin, hands should be washed thoroughly.
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Avoid contact of the medicine with eyes and mucous membranes. If the gel comes into contact with eyes or mucous membranes, remove it immediately by rinsing abundantly with water.
Do not apply to damaged skin, open wounds, or inflamed skin conditions.
During treatment and for 2 weeks after treatment ends, avoid direct sunlight (including solarium use).
Use Naproxen HASCO with caution:

if there has been a history of allergic reactions (rash, itching, redness) during treatment with nonsteroidal anti-inflammatory drugs;
when used over large skin areas for prolonged periods, due to the risk of systemic adverse reactions. If any of the above symptoms occur, discontinue use of the medicine. Consult a doctor, even if these warnings refer to conditions experienced in the past.

Children
Do not use in children under 3 years of age.
Use of Naproxen HASCO in patients with impaired kidney and/or liver function
Exercise particular caution when using Naproxen HASCO in patients with liver and/or kidney impairment due to the possibility of systemic absorption of naproxen.
Naproxen HASCO and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
No interactions have been observed so far between topically applied naproxen and other medicines. However, when the medicine is used long-term over large skin areas, such interactions cannot be completely ruled out.
With oral use of naproxen, the following interactions have been observed:

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

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Oral formulations (e.g. tablets) of naproxen may cause adverse 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.
Naproxen HASCO should not be used during the first 6 months of pregnancy unless absolutely necessary and recommended by a doctor. If treatment is required during this period, the lowest possible dose should be used for the shortest possible duration.
Do not use this medicine during breastfeeding. Naproxen passes into breast milk.
Driving and operating machinery
There is no data available on adverse effects following naproxen application that may affect the ability to drive or operate machinery.
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Naproxen HASCO contains propylene glycol
This medicine may cause skin irritation.
Naproxen HASCO contains methyl parahydroxybenzoate and propyl parahydroxybenzoate
This medicine may cause allergic reactions (delayed-type reactions possible).

3. How to use Naproxen HASCO

This medicine should always be used exactly as described in the patient information leaflet or as directed by a physician or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is for topical application to the skin.
Apply the gel 4 to 5 times daily to the affected area and gently massage in.
For an area of skin approximately 7 cm by 7 cm, use a strip of gel 1 cm in length.
After applying the gel, hands should be washed thoroughly unless they are the area being treated.
If redness or skin irritation occurs, discontinue use of the medicine until symptoms resolve. If symptoms persist, consult a doctor.
Use of a higher than recommended dose of Naproxen HASCO
After topical application of naproxen at a concentration of 10%, symptoms of overdose are not known.
However, improper use or accidental ingestion may lead to systemic adverse effects. In such cases, the physician will initiate therapeutic measures appropriate for poisoning with non-steroidal anti-inflammatory drugs.
In case of accidental ingestion (e.g., by a child), contact a doctor immediately.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
After application of the medicine, local skin reactions may occur: hypersensitivity, redness,
irritation, which usually resolve after discontinuation of the medicine.
With prolonged use over large areas of skin, adverse effects resulting from systemic action of naproxen may occur (e.g. nausea, diarrhoea, drowsiness, headache, hypersensitivity reactions). Photosensitivity reactions are possible. Rarely, erythema, itching, or burning sensation may occur.
If dyspnoea or skin changes occur, use of the medicine should be stopped immediately, and medical advice should be sought from a doctor or the nearest hospital.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Adverse effects can also be reported to the Marketing Authorisation Holder.
By reporting adverse effects, additional information regarding the safety of the medicine can be collected.
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5. How to store Naproxen HASCO

Store in a tightly closed container, at a temperature below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or in household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Naproxen HASCO contains

The active substance is naproxen. 1 g of gel contains 100 mg of naproxen.
The other ingredients are: carbomer 5984, sodium hydroxide 30%, levomenthol, 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 g or 100 g of gel.
Marketing authorisation holder and manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicine information
tel. + 48 (22) 742 00 22
e-mail: [email protected]
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