Package leaflet: Information for the patient

Olfen hydrogel, 10 mg/g, gel
Diclofenacum natricum
Please read this 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, 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 not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if your condition worsens after 7 days, consult your doctor.

Leaflet contents

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

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

Olfen hydrogel is a topical gel intended for application to the skin. The active substance,
diclofenac, belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). Due to its water-alcohol base, Olfen hydrogel also has a soothing and cooling effect.
The medicine acts as an analgesic, anti-inflammatory and anti-edematous agent.
It is used locally for the treatment of:

Adults and adolescents over 14 years of age:

inflammatory traumatic conditions of tendons, ligaments, muscles and joints (e.g. resulting from sprains, strains or contusions),
back pain,
localized inflammatory conditions of soft tissues such as tendinitis, tennis elbow, bursitis, periarthritis.

Adults (over 18 years of age):

localized and mild forms of osteoarthritis.

2. Information before using Olfen hydrogel

When not to use Olfen hydrogel

if the patient is allergic to diclofenac, other non-steroidal 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), blistering skin rash or
urticaria, facial or tongue swelling, nasal mucosa inflammation (rhinitis),
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, Olfen hydrogel must not be used.
Warnings and precautions
Before starting to use Olfen hydrogel, discuss it with a doctor or pharmacist.

Do not apply the medicine on damaged skin, open wounds or rashes. Discontinue use if a skin rash appears after application.
Do not use more medicine than recommended or for a longer period than advised, unless directed by a doctor.
Olfen hydrogel is intended for external use only. Do not use it in the mouth. Avoid contact of the gel with eyes. If the medicine gets into the eyes, rinse thoroughly with clean water and contact a doctor or pharmacist.
Concurrent use of bandages, commonly used for sprains, is acceptable, but occlusive (airtight) bandages must not be used.
Keep the medicine out of sight and reach of children.

If in any doubt, consult a doctor or pharmacist before using Olfen hydrogel.
Children and adolescents
Due to insufficient data on efficacy and safety, Olfen hydrogel must not be used in children and adolescents under 14 years of age.
In adolescents over 14 years of age, if the medicine needs to be used for longer than 7 days for pain treatment or if symptoms worsen, the patient should contact a doctor.
Olfen hydrogel and other medicines
Inform your doctor or pharmacist about all prescription medicines or over-the-counter medicines currently used or recently used, as well as any medicines the patient plans to take.
Pregnancy, breastfeeding and fertility
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.
Do not use Olfen hydrogel 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, do not use Olfen hydrogel unless necessary and specifically recommended by a doctor. If use is required, the lowest effective dose should be used for the shortest possible duration.
When administered orally (e.g. tablets), adverse effects on the unborn child may occur. It is unknown whether the same risk applies to Olfen hydrogel when applied to the skin.
During breastfeeding, Olfen hydrogel may be used only on medical advice, as diclofenac passes into breast milk in small amounts. In such cases, the medicine must not be applied to the breast area of breastfeeding women, nor to large skin areas or for prolonged periods.
Driving and operating machinery
The use of 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 information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Olfen hydrogel should be applied topically to the skin three or four times daily. Gently spread the gel on the skin without rubbing it in. The amount of gel should be adjusted according to the size of the affected area: 2 g to 4 g of Olfen hydrogel (an amount corresponding to the size of a cherry up to a walnut) is sufficient.
When applying the gel, the patient may notice a slight cooling effect.
Olfen hydrogel is intended for topical use on the skin only.
After applying the medicine:

Wipe hands with a tissue and then wash them, unless the hands themselves are the treated area. The used tissue should be disposed of in a household waste container, not flushed down the toilet, to prevent the product from entering the sewage system.
Wait several minutes for the gel to dry on the skin before applying a dressing or a breathable bandage. If a shower or bath is needed, apply the product afterwards.

Do not use 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 directed by a doctor.

Use the lowest recommended dose for the shortest possible duration.
If pain and swelling do not improve within 7 days, or if symptoms worsen, consult your doctor.
Use of more Olfen hydrogel than recommended
If too much gel has been applied, remove the excess with a tissue. In case of accidental ingestion of the gel, seek immediate medical advice.
Missed dose of Olfen hydrogel
If a dose is missed, apply the medicine as soon as remembered, then continue as directed. Do not use a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Some adverse reactions occurring rarely or very rarely may be serious.
If any of the symptoms listed below occur, which may be signs of
hypersensitivity, stop using the medicine immediately, contact your doctor or
go to the nearest hospital:

Rare (may occur in up to 1 in 1,000 patients): skin rash with or without blisters, urticaria.
Very rare (may occur in up to 1 in 10,000 patients): wheezing, shortness of breath or feeling of tightness in the chest (asthma), swelling of the face, lips, tongue or throat.

Other adverse reactions
Other adverse reactions that may occur during the use of Olfen hydrożel are
usually mild and transient. If any of the listed symptoms occur, inform your doctor or
pharmacist as soon as possible.

Common (may occur in up to 1 in 10 patients): skin rash, itching, redness or burning sensation of the skin.
Very rare (may occur in up to 1 in 10,000 patients): increased sensitivity of the skin to sunlight. Symptoms of photosensitivity include sunburn with itching, swelling and blistering.
Frequency not known (frequency cannot be estimated from available data): burning sensation at the application site, dry skin.

If any of the adverse symptoms worsen or if any adverse symptoms not listed in this leaflet occur,
inform your doctor or pharmacist.
The risk of adverse reactions is higher when diclofenac is used over large
areas of skin and over a long period of time.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, tell your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions can also be reported to the marketing authorisation holder.

5. How to store Olfen hydrogel

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following: "Expiry date (EXP)" or "EXP". The expiry date refers to the last day of the stated month. The batch number is indicated on the packaging after: "Batch number (Lot)" or "Lot".
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Olfen hydrogel contains
The active substance is sodium diclofenac.
1 g of gel contains 10 mg of sodium diclofenac.
Other ingredients are: isopropyl adipate, lactic acid, isopropyl alcohol, sodium metabisulfite, hydroxypropylcellulose, hydroxyethylcellulose, purified water.

What Olfen hydrogel looks like and contents of the pack
Olfen hydrogel is a colourless to light yellow, transparent gel with a characteristic odour, contained in an aluminium tube within a cardboard box.
Available pack sizes:
50 g tube
100 g tube

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva B.V.
Swensweg 5,
2031 GA Haarlem,
The Netherlands

Manufacturer
Merckle GmbH,
Ludwig-Merckle-Str. 3
89143 Blaubeuren
Germany
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80,
31-546 Kraków
Poland

For further information about this medicine, contact the local representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o.
tel. +48 22 345 93 00