Diclofenac Kern Pharma 11.6 mg/g gel

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Diclofenac Kern Pharma 11.6 mg/g gel

Diethylamine diclofenac

Read the entire leaflet carefully before you start using this medicine because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 7 days.

Contents of the leaflet:

1. What Diclofenac Kern Pharma is and what it is used for
2. What you need to know before using Diclofenac Kern Pharma
3. How to use Diclofenac Kern Pharma
4. Possible adverse effects
5. How to store Diclofenac Kern Pharma
6. Contents of the pack and other information

1. What Diclofenac Kern Pharma is and what it is used for

Diclofenac diethylamine, the active substance of this medicine, belongs to the group of non-steroidal anti-inflammatory drugs and acts as a local analgesic and anti-inflammatory.

Diclofenac Kern Pharma is indicated in adults and adolescents over 14 years of age for local relief of mild and occasional pain and inflammation caused by:

• minor bruises, blows, strains,
• torticollis or other muscle spasms,
• lumbago (back pain),
• mild sprains resulting from twisting injuries.

You should consult a doctor if your condition worsens or does not improve after 7 days.

2. What you need to know before starting to use Diclofenac Kern Pharma

Do not use Diclofenac Kern Pharma

• if you are allergic to diclofenac or to any of the other ingredients of this medicine (listed in section 6),
• if you have ever had an allergic reaction to diclofenac or to any other medicine used to treat pain, fever, or inflammation, such as ibuprofen or acetylsalicylic acid (also used to prevent blood clotting). If you are unsure, consult your doctor or pharmacist,
• if you are in the last three months of pregnancy,
• if you are under 14 years of age,
• do not apply on wounds, eczematous lesions, mucous membranes, or burns.

If you think you may be allergic, consult your doctor.

Warnings and precautions

• Do not apply to areas of skin where there are cuts or open wounds, to mucous membranes, or to eczema or areas of skin with a rash.
• Avoid contact of Diclofenac Kern Pharma with the eyes. If contact occurs, rinse the eyes thoroughly with clean water. Consult your doctor or pharmacist if you experience any subsequent discomfort.
• Do not use occlusive dressings.
• Do not apply over large areas. Use only on the affected area.
• Do not apply Diclofenac Kern Pharma simultaneously to the same area where other medicinal products have been applied.
• Do not ingest this medicine or use it in the mouth. Diclofenac Kern Pharma is for external use only. Consult your doctor or pharmacist in case of accidental ingestion.
• Treated areas must not be exposed to sunlight (even when cloudy) or to ultraviolet radiation lamps (UVA rays).

Consult your doctor or pharmacist before starting to use Diclofenac Kern Pharma.

Children and adolescents

This medicine is not recommended for use in children and adolescents under 14 years of age, due to insufficient data on safety and efficacy.

Use in elderly patients

Diclofenac Kern Pharma may be used in patients over 65 years of age.

Use of Diclofenac Kern Pharma with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and lactation

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Diclofenac Kern Pharma must not be used during the last three months of pregnancy. It should also not be used during the first six months of pregnancy unless strictly necessary and recommended by your doctor. If treatment is required during this period, the lowest possible dose for the shortest possible duration should be used. Oral formulations (e.g., tablets) of diclofenac may cause adverse reactions in the fetus. It is unknown whether this same risk applies to Diclofenac Kern Pharma when used on the skin.

Lactation

Consult your doctor or pharmacist before using any medication.

During breastfeeding, do not use Diclofenac Kern Pharma except on the advice of your doctor.

Under no circumstances should it be applied directly to the breast area.

Driving and use of machines

No effects on the ability to drive or operate machinery have been reported with external use on the skin.

Diclofenac Kern Pharma contains propylene glycol (E-1520)

This medicine contains 50 mg of propylene glycol per gram of gel.

3. How to use Diclofenac Kern Pharma

Follow exactly the instructions for use provided in this leaflet or those given by your doctor. If in doubt, consult your doctor or pharmacist.

This medicine is for application on the skin (cutaneous use).

The recommended dose is:

Adults and adolescents over 14 years of age

Apply a small amount of gel 3 or 4 times a day to the inflamed or painful area.

The amount of gel will vary depending on the size of the affected area (normally, an amount similar in size to a cherry or a walnut will be sufficient).

Use in children and adolescents under 14 years of age

This medicine is not recommended for use in children and adolescents under 14 years of age due to insufficient data on safety and efficacy.

Instructions for use:

• For first use of the tube, unscrew the cap. Insert the back end of the cap into the seal closing the tube. Turn the cap to pierce the seal and open the tube.
• Spread a thin layer of the gel over the painful and inflamed area of skin with a gentle massage.
• Close the tube properly after use.
• Wash your hands after applying the gel.

If pain or swelling worsens or persists after 7 days of treatment, consult your doctor.

If you use more Diclofenac Kern Pharma than you should

If you accidentally ingest Diclofenac Kern Pharma or use it over a large area of skin for a prolonged period, adverse reactions may occur similar to those seen with oral diclofenac (e.g. tablets).

The main symptoms of overdose are: gastrointestinal or renal disorders and difficulty breathing. Nausea, vomiting, abdominal pain, and decreased level of consciousness may occur.

If you have applied too much of the medicine, it is recommended to remove it by washing the affected area thoroughly with water or by wiping off the excess.

In case of accidental ingestion, go immediately to a medical center or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the name of the medicine and the amount ingested.

If you forget to use Diclofenac Kern Pharma

If you forget to apply this medicine at the scheduled time, apply the gel as soon as possible and continue treatment as normal.

Do not apply a double dose to make up for missed doses.

If you stop using Diclofenac Kern Pharma

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Some rare and very rare adverse effects can be serious.

If you experience any of the following signs of allergy, stop using Diclofenac Kern Pharma and consult your doctor or pharmacist immediately:

• Rare (may affect between 1 and 10 in 10,000 patients): Skin rash accompanied by blisters; urticaria (red, raised rashes, often with itching and burning sensation).
• Very rare (may affect less than 1 in 10,000 patients): Difficulty breathing or feeling of pressure in the chest (asthma); swelling of the face, lips, tongue, or throat.

Non-serious adverse effects:

Other adverse effects may occur, but these are usually mild and transient in duration. If you notice any of them, consult your doctor or pharmacist as soon as possible.

• Frequent (may affect between 1 and 10 in 100 patients): Rash, itching, redness, or stinging on the skin after using the product.
• Very rare (may affect less than 1 in 10,000 patients): The skin may become more sensitive to sunlight (photosensitivity). Symptoms include sunburn with itching, swelling, and blisters.
• Frequency not known (cannot be estimated from available data): Burning sensation at the site of application, dry skin.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines at https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Diclofenac Kern Pharma

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

Do not store above 30°C.

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

After opening, discard the tube with any remaining gel after 12 months.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Diclofenac Kern Pharma 11.6 mg/g

• The active substance is diethylamine diclofenac. Each gram of gel contains 11.6 mg of diethylamine diclofenac (equivalent to 10 mg of sodium diclofenac).
• The other components (excipients) are: propylene glycol (E-1520), isopropyl alcohol, diethylamine, liquid paraffin, polyoxyethylene alkyl ether, carbomer 934P NF, coco-caprylate/caprate, cream perfume 1876601, purified water.

Appearance of the medicinal product and contents of the pack

Diclofenac Kern Pharma 11.6 mg/g gel is a white, viscous gel. It is packaged in an aluminum tube with a screw cap.

The medicine is available in tubes containing 60 and 100 grams of gel.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the most recent revision of this leaflet: May 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/.