Olfen hidrozhel

Leaflet attached to the packaging: patient information

Olfen hydrogel, 10 mg/g, gel

Diclofenac 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 this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

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

1. What is Olfen hydrogel and what is it used for

Olfen hydrogel is a gel for topical application to the skin. The active substance of the medicine, diclofenac, belongs to a group of medicines known as nonsteroidal anti-inflammatory drugs (NSAIDs). Due to its water-alcohol base, Olfen hydrogel also has a soothing and cooling effect.

The medicine has analgesic, anti-inflammatory, and anti-edema effects.

It is used for local treatment of:

Adults and adolescents over 14 years of age:

• post-traumatic inflammatory conditions of tendons, ligaments, muscles, and joints (e.g., resulting from sprains, strains, or bruises),
• back pain,
• limited inflammatory conditions of soft tissues, such as tendonitis, tennis elbow, bursitis, or periarthritis.

Adults (over 18 years of age)

• mild and limited forms of osteoarthritis.

2. Important information before using Olfen hydrogel

When not to use Olfen hydrogel

• if the patient is hypersensitive to diclofenac, other nonsteroidal anti-inflammatory drugs used to treat pain, fever, or inflammation, such as ibuprofen or acetylsalicylic acid, or

any of the other ingredients of this medicine (listed in section 6). In case of doubt, consult a doctor or pharmacist. Symptoms of hypersensitivity to the medicine may include: wheezing or shortness of breath (asthma), skin rash with blisters or hives, swelling of the face or tongue, rhinitis (hay fever),

• during the last three months of pregnancy,
• in children and adolescents under 14 years of age.

If any of the above statements apply to the patient, they should not use Olfen hydrogel.

Warnings and precautions

Before starting to use Olfen hydrogel, the patient should discuss it with their doctor or pharmacist.

• The medicine should not be applied to damaged skin, open wounds, or skin eruptions. The patient should stop using the medicine if a skin rash appears after its use.
• The patient should not use more of the medicine than recommended or for a longer period than recommended, unless advised to do so by a doctor.
• Olfen hydrogel is for external use only. It should not be used in the mouth. The patient should avoid contact with the eyes. If the medicine gets into the eyes, they should be rinsed with clean water, and the patient should consult a doctor or pharmacist.
• Concomitant bandaging, usually used in cases of sprains, may be used, but it should not be airtight.
• The medicine should be kept out of sight and reach of children.

In case of any doubts, the patient should consult a doctor or pharmacist before using Olfen hydrogel.

Children and adolescents

Since there is insufficient data on the efficacy and safety of using Olfen hydrogel in children and adolescents under 14 years of age, the medicine should not be used in this age group.

In adolescents over 14 years of age, if the medicine needs to be used for more than 7 days to treat pain or if the symptoms worsen, the patient should consult a doctor.

Olfen hydrogel and other medicines

The patient should inform their doctor or pharmacist about all prescription or non-prescription medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.

Olfen hydrogel should not be used during the last three months of pregnancy, as it may harm the unborn child or cause difficulties during delivery.

During the first six months of pregnancy, Olfen hydrogel should not be used unless it is necessary and recommended by a doctor. If use is necessary, the patient should use the smallest possible dose for the shortest possible time.

After oral administration (e.g., tablets), side effects may occur in the unborn child. It is not known if the same risk applies to Olfen hydrogel when used on the skin.

During breastfeeding, Olfen hydrogel may be used only on the advice of a doctor, as diclofenac passes into breast milk in small amounts. In such cases, the medicine should not be applied to the breast area of breastfeeding women or to large areas of skin or for extended periods.

Driving and using machines

Using Olfen hydrogel does not affect the ability to drive or operate machinery.

3. How to use Olfen hydrogel

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

In case of doubts, the patient should consult a doctor or pharmacist.

Olfen hydrogel should be applied topically to the skin three or four times a day. The amount of gel should be adjusted to the size of the affected area: 2 g to 4 g of Olfen hydrogel (an amount equivalent to the size of a cherry or a walnut) is sufficient.

When applying the gel, the patient may notice a slight cooling effect. Olfen hydrogel is for use on the skin only.

After application, the patient should wash their hands unless they are the area being treated.

After using the medicine, the patient should:

• Wipe their hands with a tissue and then wash them, unless they are the area being treated. The used tissue should be disposed of in the trash.
• Wait for the medicine to dry completely before taking a bath.

Do notuse the medicine for longer than:

• In adults and adolescents over 14 years of age: 14 days for muscle and joint injuries (sprains, strains, or bruises) and tendonitis.
• In adults (over 18 years of age): 21 days for pain associated with osteoarthritis, unless otherwise advised by a doctor.

Use the smallest possible dose for the shortest possible time.

If pain and swelling do not improve within 7 days or worsen, the patient should consult a doctor.

Using more than the recommended dose of Olfen hydrogel

In case of using too much of the medicine, the excess should be removed with a tissue. If the gel is swallowed, the patient should contact a doctor immediately.

Missing a dose of Olfen hydrogel

If a dose is missed, the patient should use the medicine as soon as they remember, and then continue with the recommended dosing schedule. The patient should not use a double dose to make up for the missed dose.

In case of any further doubts about using the medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Olfen hydrogel can cause side effects, although not everybody gets them.

Some side effects that occur rarely or very rarely can be serious.

If any of the following symptoms occur, which may be symptoms of an allergic reaction, the patient should stop using the medicine immediately, consult a doctor, or go to the nearest hospital:

• Rare (occurring in less than 1 in 10,000 people using the medicine):Skin rash with blisters or without blisters, hives.
• Very rare (occurring in less than 1 in 10,000 people using the medicine):Wheezing, shortness of breath, or feeling of tightness in the chest (asthma), swelling of the face, lips, tongue, or throat.

Other side effects

Other side effects that may occur when using Olfen hydrogel are usually mild and temporary. If the patient experiences any of the following symptoms, they should inform their doctor or pharmacist as soon as possible.

• Common (occurring in less than 1 in 100 people using the medicine):Skin rash, itching, redness, or burning of the skin.
• Very rare (occurring in less than 1 in 10,000 people using the medicine):Increased sensitivity of the skin to sunlight. Symptoms of hypersensitivity include sunburn with itching, swelling, and blisters.
• Frequency not known (frequency cannot be estimated from the available data):burning sensation at the application site, dry skin.

If any of the side effects worsen or if the patient experiences any side effects not listed in this leaflet, they should inform their doctor or pharmacist.

The risk of side effects is higher when using diclofenac on large areas of skin and for a long period.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C, 02-222 Warsaw

Tel: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

By reporting side effects, more information can be gathered on the safety of the medicine.

Side effects can also be reported to the marketing authorization holder.

5. How to store Olfen hydrogel

The medicine should be kept out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after "Expiry date" or "EXP". The expiry date refers to the last day of the month stated.

The batch number on the packaging is stated after "Batch number" or "Lot".

Store in a temperature below 25°C.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Olfen hydrogel contains

The active substance of the medicine is diclofenac sodium.

1 g of gel contains 10 mg of diclofenac sodium.

Other ingredients of the medicine are: isopropyl adipate, lactic acid, isopropyl alcohol, sodium metabisulfite, hydroxypropyl cellulose, hydroxyethyl cellulose, purified water.

What Olfen hydrogel looks like and contents of the packaging

Olfen hydrogel is a colorless to light yellow, transparent gel with a characteristic odor, in an aluminum tube in a cardboard box.

Available packaging:

50 g tube

100 g tube

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva B.V.

Swensweg 5,

2031 GA Haarlem,

Netherlands

Manufacturer

Merckle GmbH,

Ludwig-Merckle-Str. 3

89143 Blaubeuren

Germany

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80,

31-546 Kraków