NAPROXEN 12 mg /G Gel

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. NAPROXEN HASCO
3. 12 mg/g (1.2%), gel
   1. Read the leaflet carefully before using the medicine, as it contains
   2. Table of contents of the leaflet
4. What is Naproxen HASCO and what is it used for
5. Important information before using Naproxen HASCO
   1. When not to use Naproxen HASCO
   2. Warnings and precautions
   3. Children
   4. Naproxen HASCO and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and operating machinery
   7. Naproxen HASCO contains propylene glycol
   8. Naproxen HASCO contains methyl parahydroxybenzoate
6. How to use Naproxen HASCO
   1. Using a higher dose of Naproxen HASCO than recommended
7. Possible side effects
8. How to store Naproxen HASCO
9. Package contents and other information
   1. What Naproxen HASCO contains
   2. What Naproxen HASCO looks like and what the packaging contains
   3. Marketing authorization holder and manufacturer

Leaflet attached to the packaging: patient information

NAPROXEN HASCO

12 mg/g (1.2%), gel

Naproxen sodium

Read the 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 patient leaflet or as directed by
a doctor, pharmacist, or nurse.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse, they should contact their 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. Package contents and other information

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

The medicine is intended for use on the skin. The active substance of Naproxen HASCO is
naproxen, which has analgesic and anti-inflammatory effects. Levomenthol 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 mildly irritating properties, causes beneficial,
reflexive vasodilation of blood vessels.
The medicine is used locally for analgesic and anti-inflammatory purposes 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 the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• if there is hypersensitivity to other non-steroidal 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

Before starting to use Naproxen HASCO, the patient should discuss it with their doctor, pharmacist, or
nurse.
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Patients with gastrointestinal ulcers and bleeding ulcers should be cautious due to the possibility of
naproxen absorption into the bloodstream.
After applying the gel to the skin, hands should be washed thoroughly.
Contact between the medicine and the eyes or mucous membranes should be avoided. If the gel gets
into the eyes or onto mucous membranes, it should be rinsed off with plenty of water.
The medicine should not be used on damaged skin, open wounds, or skin inflammatory conditions.
During treatment and for 2 weeks after its completion, direct sunlight (including solarium) should be
avoided.
The medicine should be used with caution:

• in cases of a history of allergic reactions (rash, itching, redness) during treatment with non-steroidal anti-inflammatory drugs;
• when used on large areas of skin for a long time, as there is a possibility of systemic side effects. If the above symptoms occur, the medicine should be discontinued. The patient should consult their doctor, even if the above warnings refer to past situations.

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.

Children

The medicine should not be used in children under 3 years of age.

Naproxen HASCO and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they 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 increases 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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 occurs when using Naproxen HASCO on the skin.
Naproxen HASCO should not be used during the last 3 months of pregnancy.
Naproxen HASCO should not be used during the first 6 months of pregnancy, unless it is absolutely necessary and recommended by a doctor. If treatment is necessary during this period, the smallest possible dose should be taken for the shortest possible time.
The medicine should not be used during breastfeeding. Naproxen passes into breast milk.

Driving and operating machinery

The medicine does not affect the ability to drive vehicles or operate machinery.
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Naproxen HASCO contains propylene glycol

The medicine may cause skin irritation.

Naproxen HASCO contains methyl parahydroxybenzoate

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

3. How to use Naproxen HASCO

This medicine should always be used exactly as described in the patient leaflet or as directed by
a doctor, pharmacist, or nurse. If in doubt, the patient should consult their doctor, pharmacist, or nurse.
The medicine is for use on the skin.
The medicine should be applied 4 to 5 times a day to the painful area and gently massaged in. On
a skin surface of approximately 7 cm x 7 cm, a 1 cm long strip of gel should be used.
After applying the gel to the skin, hands should be washed thoroughly, unless the treatment includes them.
If redness and skin irritation occur, the use of the medicine should be discontinued until the symptoms resolve. If the symptoms do not resolve, the patient should consult their doctor.

Using a higher dose of Naproxen HASCO than recommended

When using naproxen topically, no overdose symptoms are known. However, due to improper use or accidental ingestion, systemic side effects may occur. In such a case, the doctor will apply the appropriate treatment for non-steroidal anti-inflammatory drug poisoning.
In case of accidental ingestion (e.g., by a child), the patient should contact their doctor.

4. Possible side effects

Like all medicines, Naproxen HASCO can cause side effects, although not everybody gets them.
After using the medicine, local skin reactions may occur: hypersensitivity, redness, irritation, usually resolving after discontinuation of 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). Photosensitivity reactions are possible. Rarely, erythema, itching, or burning may occur. If shortness of breath or skin changes occur, the use of the medicine should be discontinued immediately, and the patient should consult their doctor or go to the nearest hospital.
Reporting side effects
If any side effects occur, including any possible side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. 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.: 22 49 21 301, fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.
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5. How to store Naproxen HASCO

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

6. Package contents and other information

What Naproxen HASCO contains

• The active substance of the medicine is naproxen sodium. 1 g of gel contains 12 mg of naproxen sodium.
• The other ingredients (excipients) are: carbomer 5984, sodium hydroxide 30%, levomenthol, chloral hydrate, propylene glycol, methyl parahydroxybenzoate, purified water.

What Naproxen HASCO looks like and what the packaging contains

The gel is homogeneous, white or yellowish, with a minty smell.
One packaging of the medicine contains 50 g of gel.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicine information
tel.: 22 742 00 22
e-mail: [email protected]
Date of last update of the leaflet:08/2024
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