40 mg / g 
diclofenac sodium

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. This medicine is available without a prescription.

  • Save this information, you may need to read it again.
  • Contact the pharmacy staff if you need more information or advice.
  • If this medicine has been obtained without a prescription, you must contact your doctor if your symptoms worsen or do not improve within 7 days.
  • If this medicine has been prescribed for you, do not give it to others. It may harm them, even if they show symptoms similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4

In this leaflet you will find information about: 
1. What Eeze cutaneous spray is and what it is used for 
2. What you need to know before using Eeze cutaneous spray 
3. How to use Eeze cutaneous spray 
4. Possible side effects 
5. How to take Eeze cutaneous spray must be stored 
6. Package contents and other information

1. What Eeze cutaneous spray is and what it is used for

The active substance, diclofenac sodium, belongs to the group of non-steroidal anti-inflammatory drugs ( NSAIDs ). Diclofenac relieves pain and has an anti-inflammatory effect.

Eeze cutaneous spray is used for mild to moderate pain in connection with the muscle and joint injuries.

Eeze cutaneous spray is a solution that has a gel-like consistency when sprayed on the skin. The spray is only intended for external use.

Diclofenac sodium contained in Eeze cutaneous spray may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Eeze cutaneous spray

Do not use Eeze cutaneous spray

  • if you are allergic to diclofenac sodium or any of the other ingredients of this medicine (listed in section 6).
  • if you have had an allergic reaction to acetylsalicylic acid or any other anti-inflammatory drug ( NSAID ). Symptoms of an allergic reaction may include difficulty breathing, rash or runny nose.
  • during the last three months of pregnancy.
  • if you have eczema, acne, infections, or open sores in the treatment area.

Eeze cutaneous spray should not be used by children and adolescents under 14 years of age.

Warnings and cautions

Talk to your doctor or pharmacist before using Eeze cutaneous spray

  • if you have or have had stomach ulcers, or have impaired heart, liver, or kidney function.
  • if you have previously had asthma or allergic disease.
  • Avoid getting the spray in the eyes, mouth, or on other mucous membranes. Never swallow the medicine. If you accidentally spray your eyes, rinse thoroughly with water and consult a doctor.
  • avoid direct sun and solarium, e.g. by covering the treated area with clothing, during the treatment and for at least two weeks thereafter.
  • stop treatment if you get a rash.

The risk of side effects increases over time. Therefore, do not use the spray for longer than the recommended treatment time.

Do not use the spray together with airtight bandages. When sprained, the joint can be wound, but not so hard that the blood circulation is restricted.

Treatment with Eeze cutaneous spray should be avoided by women who are planning to become pregnant or are pregnant.

If this medicine and another NSAID are used at the same time, the risk of side effects may increase.

If you are not sure, talk to your doctor or pharmacist.

Other medicines and Eeze cutaneous spray

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

Pregnancy and breastfeeding

Treatment during any part of the pregnancy should only be done after a doctor’s prescription. Eeze cutaneous spray should not be used during the last three months of pregnancy.

It is not known whether diclofenac is excreted in human milk. Always consult a physician before treatment with Eeze cutaneous spray. The spray must not be applied to the breasts of breastfeeding women.

Driving and using machines

Eeze cutaneous spray does not affect your ability to drive or use machines.

Eeze cutaneous spray contains propylene glycol, peppermint oil, and anhydrous ethanol.

Eeze cutaneous spray contains peppermint oil which can cause allergic reactions.

This medicine contains 150 mg of propylene glycol per gram. Propylene glycol may cause skin irritation.

This medicine contains 33.3 mg of alcohol ( ethanol ) per gram (3.3% w / w). It can cause a burning sensation on damaged skin.

3. How to use Eeze cutaneous spray

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Dose one is determined by the doctor, who adjusts it individually for you. Dosage one and the duration of treatment are determined depending on the pain condition.

If this medicine has not been prescribed for you, use Eeze cutaneous spray according to the instructions below. Ask your doctor or pharmacist if you are unsure.

Adults and adolescents over 14 years:

  • The usual dose is 4-5 sprays 3 times a day on the painful or swollen area. Maximum 15 sprays per day.
  • The spray gets a gel-like consistency when it gets on the skin. Gently massage alone into the skin. Wash your hands afterward if it is not the hands that are being treated.
  • Wait until the gel has dried before putting on clothes or bandages.
  • If no improvement in symptoms occurs after 7 days of treatment, consult a physician.
  • End treatment when the symptoms (pain and swelling) have returned. The treatment time should not exceed 14 days for adults or 7 days for adolescents over 14 years without a doctor’s prescription.

If you have used too much Eeze cutaneous spray

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to use Eeze cutaneous spray

Use the spray as soon as you remember, but do not take a double dose to compensate for the dose you forgot. Then continue dosing one as before.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects are usually mild and transient skin reactions at the treatment site. In rare cases, allergic reactions may occur.

Stop using Eeze cutaneous spray and contact a doctor immediately if you get any of the following symptoms ( angioedema ):

  • swelling of the face, tongue, or throat
  • difficulty swallowing
  • hives and difficulty breathing

Very rare (may affect up to 1 in 10,000 people): Rash, itching, reddening of the skin, swelling,g and blistering of the skin where the gel is applied. Allergic skin reactions, difficulty breathing. Angioedema (swelling of the skin and mucous membranes, eg on the face and finger joints). An ant crawls and involuntary muscle movements. Sensitivity to sunlight.

5. How to store Eeze cutaneous spray

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. dat. The expiration date is the last day of the specified month.

Opened packaging must be used within 6 months.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is diclofenac sodium. 1 gram of cutaneous spray contains 40 mg of diclofenac sodium.
  • The other ingredients are isopropyl alcohol, soy lecithin, anhydrous ethanol, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, disodium edetate, propylene glycol, peppermint oil, ascorbyl palmitate, hydrochloric acid, sodium hydroxide, and purified water.

What the medicine looks like and the contents of the pack

Eeze cutaneous spray gel is a golden yellow, transparent solution that has a gel-like consistency when sprayed on the skin.

Pack sizes of 12.5 g and 25 g are non-prescription and 2×25 g are prescription-only.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Meda OTC AB, Box 906, 170 09 Solna

Manufacturer

Pharbil Waltrop GmbH, 45731 Waltrop, Germany

Muhammad Nadeem

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