OLFEN gel 10mg , 100 g (3.5 oz) for Pain Relief

Package leaflet: information for the user Olfen 1% gel diclofenac sodium

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

Do not throw this leaflet away as you may need to read it again. If you want to know more or consult, ask your pharmacist.

If you experience side effects (even if they are not listed in this leaflet), contact your doctor or pharmacist.

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

Olfen 1% gel is a pain reliever. It belongs to a group of medicines called non-steroidal anti-inflammatory drugs.

If your condition has not improved or even worsened within 7 days, consult a doctor.

2. What you need to know before taking Olfen.

Use of Olfen is prohibited: if you are allergic to the active substance or any auxiliary substance of this medicine;

If you are allergic to other medicines for pain, fever or inflammation, such as ibuprofen or acetylsalicylic acid (this medicine is used prophylactically against the formation of blood clots).

If in doubt, ask your doctor or pharmacist. Symptoms of an allergic reaction caused by this medicine: shortness of breath or difficulty breathing (asthma), hives or blisters on the skin, swelling of the face or tongue, runny nose; if you are pregnant in the last three months; children and adolescents under 14 years of age.

Warnings and precautions. Talk to your doctor or pharmacist before taking Olfen if: you have or have had bronchial asthma or allergies, you have had bronchospasm (contraction of the bronchial muscles) which made it difficult to breathe.

You have impaired kidney, heart or liver function, or have or have had a stomach ulcer, inflammation of the bowels or a tendency to bleed.

Do not apply Olfen gel to a large area of the skin, do not use it for too long, because then the chance of unwanted effects increases.

If skin rash occurs, discontinue treatment immediately. Do not use Olfen gel on damaged skin (e.g. scrapes, cuts, and burns); infected or eczema damaged skin.

Do not apply Olfen gel to the eyes or mucous membranes (e.g. mouth, nose, genitals) or allow Olfen gel to come into contact with them.

If you accidentally get Olfen gel in your eyes, immediately wash your eyes with clean water and consult a doctor. Elderly patients should use Olfen gel with caution, as these patients are more likely to experience adverse events.

Olfen gel is intended for use on the skin and should not be swallowed.

Protect the treated skin area from direct sunlight or tanning beds to reduce the risk of photosensitivity.

Olfen gel should not be used with airtight dressings.

For children and teenagers Olfen gel is prohibited for use by children and adolescents under the age of 14.

Other medicines and Olfen Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, or if you are not sure.

When Olfen gel is applied to the skin, the systemic absorption of diclofenac is very low, so this interaction is unlikely.

If you use Olfen gel together with anti-inflammatory and pain relievers such as acetylsalicylic acid/aspirin or other such as ibuprofen, the risk of adverse effects may increase.

Pregnancy and breastfeeding. If you are pregnant, breast-feeding, think you may be pregnant, or are planning to become pregnant, then talk to your doctor or pharmacist before taking this medicine.

Olfen gel should not be used during the last three months of pregnancy, as it may harm the unborn baby or cause problems during childbirth.

Olfen gel can be used during the first 6 months of pregnancy only under the supervision of a doctor, the lowest possible dose of the drug must be used and the duration of treatment must be as short as possible.

Olfen gel can be used during breastfeeding only with the permission of the doctor, since a small amount of diclofenac passes into breast milk.

If Olfen gel must be used, it should not be applied to the breasts or large areas of skin and should not be used for a long time.

Driving and machine control.

Olfen gel applied to the skin does not affect the ability to drive or operate machinery.

3. How to use Olfen?

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

If in doubt, ask your doctor or pharmacist. For adults and adolescents over 14 years of age after assessing the size of the damaged area, 2 - 4 g of gel (1 - 2 fingernail-sized balls of ointment) are applied to the skin 3 - 4 times a day.

Do not exceed the daily dose - 16 g of gel. Gently spread the gel on the skin, do not rub it.

Wash your hands afterwards.

Do not swallow this medicine.

How long to use Olfen gel?

Do not use Olfen gel for more than 14 days for adults and 7 days for adolescents without first consulting a doctor.

If after 7 days you do not feel better or the condition worsens, consult a doctor.

For children and adolescents under 14 years of age. Since there are insufficient data on the safety and effectiveness of Olfen gel in children and adolescents under 14 years of age, its use in children of this age is prohibited.

Elderly patients and patients with impaired liver or kidney function.

There are no special dosage recommendations for elderly patients or people with liver or kidney failure.

If you think that Olfen gel works too strongly or too weakly, tell your doctor or pharmacist.

What to do if you overdose on Olfen?

If you have used more medicine than you need, wipe off the excess gel with a cloth.

If swallowed, seek immediate medical attention or go to the nearest hospital emergency department.

Take the medicine tube and this package leaflet with you.

If you forget to take Olfen.

Use the gel as soon as you remember, but do not apply more than the recommended single dose.

Continue to use as before. Do not take a double dose to make up for a missed dose.

When you stop taking Olfen If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If Olfen gel is used on a large area of the skin or for too long, there is a greater chance of unwanted effects.

Immediately inform the doctor and stop using the gel if you notice at least one of the following phenomena: sudden blistering skin rash (hives);

Difficulty breathing, swelling of hands, feet, ankles, face, lips, mouth or throat; blood pressure drops or weakness occurs.

You may experience these side effects.

Common side effects (may affect up to 1 in 10 people): skin rash, eczema, reddening of the skin, dermatitis (including contact dermatitis), and swelling of the skin, itching and burning sensation.

Uncommon side effects (may affect up to 1 in 100 people): Anaphylactic reaction (severe acute allergic reaction).

Rare side effects (may affect up to 1 in 1,000 people): skin rash with blisters.

Very rare side effects (may affect up to 1 in 10,000 people): Hypersensitivity reactions (including urticarial), angioedema (including angioedema), bullous rash, asthma, severe eczema, rash with ulceration, photosensitivity.

Side effects with an unknown frequency (cannot be estimated from the available data): dry skin.

5. How to store Olfen?

Keep this medicine out of the sight and reach of children.

Store at a temperature not exceeding 25 °C. Do not use this medicine after the expiry date which is stated on the carton after EXP and on the tube after EXP.

The drug is suitable for use until the last day of the indicated month. Medicines must not be disposed of in the sewer or with household waste.

Ask your pharmacist how to dispose of unnecessary medicines.

These measures will help protect the environment.