DIKLOFENAK 10 mg /G Gel

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Diklofenak Perrigo, 10 mg/g, Gel
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
3. What is Diklofenak Perrigo and what is it used for
4. Important information before using Diklofenak Perrigo
   1. When not to use Diklofenak Perrigo
   2. Warnings and precautions
   3. When to be particularly cautious when using Diklofenak Perrigo
   4. Diklofenak Perrigo and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Important information about some components of Diklofenak Perrigo
5. How to use Diklofenak Perrigo
   1. Adults and adolescents over 12 years of age
   2. Using a higher dose of Diklofenak Perrigo than recommended
   3. Missing a dose of Diklofenak Perrigo
6. Possible side effects
   1. Reporting side effects
7. How to store Diklofenak Perrigo
8. Contents of the pack and other information
   1. What Diklofenak Perrigo contains
   2. What Diklofenak Perrigo looks like and contents of the pack
   3. Marketing authorization holder and manufacturer

Package Leaflet: Information for the User

Diklofenak Perrigo, 10 mg/g, Gel

Diclofenac Sodium

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

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including any not listed in this package leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If after 7 days there is no improvement or you feel worse, you should contact a doctor.

Table of Contents of the Package Leaflet

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

1. What is Diklofenak Perrigo and what is it used for

Diklofenak Perrigo has analgesic, anti-inflammatory, and anti-edematous effects. The active substance of the medicine – diclofenac – belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs). Due to its water-alcohol base, Diklofenak Perrigo also has a soothing and cooling effect.
The medicine is used topically on the skin:

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

The medicine is intended for adults and adolescents.

2. Important information before using Diklofenak Perrigo

When not to use Diklofenak Perrigo

• if the patient has been diagnosed with hypersensitivity (allergy) to diclofenac, propylene glycol, or any other component of Diklofenak Perrigo;
• if the patient has experienced asthma attacks (shortness of breath), hives, or rhinitis after using acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (e.g., ibuprofen);
• in children under 12 years of age;
• during the last three months of pregnancy.

Warnings and precautions

Before starting to use Diklofenak Perrigo, discuss it with a doctor, pharmacist, or nurse.

When to be particularly cautious when using Diklofenak Perrigo

• when applying the gel to large areas of skin or during prolonged use, as systemic side effects may occur;
• the medicine should only be applied to undamaged skin;
• avoid contact with eyes and mucous membranes (e.g., mouth);
• after applying the gel, you can put on bandages or dressings commonly used for sprains, but without airtight layers.

Diklofenak Perrigo and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, including those available without a prescription.
After applying the gel to the skin, the amount of medicine that is absorbed into the blood is small, so the likelihood of interactions with other medicines is low.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before using this medicine.
Do not use Diklofenak Perrigo during the last three months of pregnancy. During the first six months of pregnancy, do not use Diklofenak Perrigo unless it is necessary and recommended by a doctor. If use is necessary, the smallest dose should be used for the shortest time.
After oral administration of diclofenac-containing medicines (e.g., tablets), side effects may occur in the unborn child. It is not known if this risk also applies to Diklofenak Perrigo when used on the skin.
It is not recommended to use Diklofenak Perrigo during breastfeeding.
If use during breastfeeding is necessary, do not apply the medicine to the breast skin, large areas, or for a long time.

Driving and using machines

Using Diklofenak Perrigo does not affect driving or operating machinery.

Important information about some components of Diklofenak Perrigo

The medicine contains 50 mg of propylene glycol per 1 gram of gel. Propylene glycol may cause skin irritation.

3. How to use Diklofenak Perrigo

The gel is used topically on the skin.
Diklofenak Perrigo is intended for use on the skin only.
Do not swallow the medicine.
To open the tube, unscrew the cap and tear off the aluminum protective membrane from the tube outlet.

Adults and adolescents over 12 years of age

Diklofenak Perrigo should be applied topically to the skin, 3 to 4 times a day, gently rubbing into the affected area. The amount of gel used should be adjusted to the size of the affected area: 2 g to 4 g (the amount of gel the size of a cherry to the size of a walnut) is sufficient to treat an area of approximately 400 cm to 800 cm.
After applying the medicine, close the tube tightly, wipe your hands with a paper towel, and then wash them, unless your hands are the area being treated.
If too much gel is accidentally applied, the excess should be wiped off with a paper towel.
Dispose of the used paper towel in a household waste bin to prevent the unused medicine from entering the water environment.
Before applying a bandage, let the gel dry on the skin for a few minutes.
Do not use the medicine for more than 14 days for sprains and soft tissue inflammation or for more than 21 days for pain associated with arthritis, unless otherwise directed by a doctor. If symptoms do not improve within 7 days of using the gel or worsen, consult a doctor.

Using a higher dose of Diklofenak Perrigo than recommended

Do not increase the recommended dose of Diklofenak Perrigo without consulting a doctor.
Overdose of the medicine is unlikely due to the small absorption of diclofenac when used topically.
If the medicine is accidentally swallowed and side effects occur, contact a doctor as soon as possible.

Missing a dose of Diklofenak Perrigo

Do not use a double dose to make up for a missed dose.
If you have any further questions about using this medicine, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Diklofenak Perrigo can cause side effects, although not everybody gets them.
Side effects include mild and transient skin symptoms at the application site.
In very rare cases, allergic reactions may occur.
If any of the following symptoms occur, which may be signs of an allergic reaction, stop using the medicine and consult a doctor immediately.
Side effects are ranked according to frequency, using the following terms:

• common (may affect 1 to 10 people in 100);
• uncommon (may affect 1 to 10 people in 10,000);
• very rare (may affect less than 1 person in 10,000);

Common:
rash, eruption, redness, skin inflammation (including contact dermatitis),
itching
Uncommon: blistering skin inflammation
Very rare: papular rash, hypersensitivity, edema, asthma, photosensitivity reaction (symptoms of hypersensitivity are sunburn with itching, edema, and blisters)

Reporting side effects

If you experience any side effects, including any not listed in this package leaflet, tell your 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
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: +48 22 49 21 301,
fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the use of this medicine.

5. How to store Diklofenak Perrigo

Keep the medicine out of the sight and reach of children.
There are no special precautions for storage.
Do not use Diklofenak Perrigo after the expiration date stated on the tube and carton.
Medicines should 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 Diklofenak Perrigo contains

• The active substance of the medicine is diclofenac sodium. 1 g of gel contains 10 mg of diclofenac sodium.
• The other ingredients of the medicine are carbomer, macrogol ether cetostearyl, diethylamine, isopropyl alcohol, propylene glycol, liquid paraffin, lavender oil, lemon oil, cocoyl caproyl caprate, purified water.

What Diklofenak Perrigo looks like and contents of the pack

A tube containing 40 g, 50 g, 75 g, or 100 g of gel, together with the patient package leaflet, in a carton.

Marketing authorization holder and manufacturer

Marketing authorization holder
Perrigo Poland Sp. z o.o. [+logo of the marketing authorization holder]
ul. Domaniewska 48
02-672 Warsaw
Tel.: +48 (22) 852 55 51
Manufacturer
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
Date of last revision of the package leaflet: