Diclofenac sodium nutra essential

Diclofenac sodium Nutra Essential, 40 mg/mL, cutaneous spray, solution
Diclofenacum natricum
Please read the entire 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 the doctor or pharmacist.

• Keep this leaflet for possible future reference.
• If advice or additional information is needed, consult a pharmacist.
• If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.

Leaflet contents:

1. What Diclofenac sodium Nutra Essential is and what it is used for
2. Important information before using Diclofenac sodium Nutra Essential
3. How to use Diclofenac sodium Nutra Essential
4. Possible adverse effects
5. How to store Diclofenac sodium Nutra Essential
6. Contents of the pack and other information

1. What Diclofenac sodium Nutra Essential is and what it is used for

Diclofenac sodium Nutra Essential contains the active substance diclofenac sodium, which belongs
to the group of non-steroidal anti-inflammatory drugs (NSAIDs), and is intended for application to the affected skin area.
This medicine is used in adults and adolescents over 14 years of age for short-term local symptomatic treatment of mild to moderate pain and inflammation following acute, blunt injuries of small and medium-sized joints and surrounding tissues.
If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.

2. Important information before using Diclofenac sodium Nutra Essential

When not to use Diclofenac sodium Nutra Essential

• If the patient is allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6).
• If the patient is allergic to peanuts or soya, because the medicine contains soya lecithin.
• If the patient has ever experienced an allergic reaction with breathing difficulties (asthma), skin rash, runny nose, or swelling of the face or tongue after taking any medicine used to treat pain, fever, or inflammation, such as ibuprofen or acetylsalicylic acid (also used as an anticoagulant).
• On open wounds, inflamed or infected skin, or on eczema or mucous membranes.
• During the third trimester of pregnancy – see section "Pregnancy and breastfeeding".

Warnings and precautions
Before starting treatment with Diclofenac sodium Nutra Essential, discuss this with your doctor or pharmacist.

• If the patient has previously been diagnosed with bronchial asthma or allergies.
• If the aerosol accidentally gets into the eyes, rinse them thoroughly with clean water and inform your doctor.
• Never swallow Diclofenac sodium Nutra Essential.
• Discontinue use of Diclofenac sodium Nutra Essential if any skin rash appears after application.
• Do not cover the treated area of skin with dressings or occlusive (waterproof or non-breathable) plasters.
• Do not expose treated areas to sunlight or use sunlamps.

It cannot be ruled out that systemic adverse effects may occur when Diclofenac sodium Nutra Essential is used over large areas of skin and for prolonged periods. Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
Hazard: This medicine is highly flammable. Store away from heat sources, hot surfaces, sparks, open flames, and other sources of ignition.

Children and adolescents
Do not use this medicine in children and adolescents under 14 years of age.

Diclofenac sodium Nutra Essential and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Before using Diclofenac sodium Nutra Essential, discuss with your doctor:

• If the patient is taking any medicines containing diclofenac, acetylsalicylic acid, or any other NSAID, such as ibuprofen.

Using other NSAIDs (including acetylsalicylic acid or ibuprofen) together with Diclofenac sodium Nutra Essential may increase the risk of adverse effects.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Do not use Diclofenac sodium Nutra Essential during the third trimester of pregnancy, as it may increase the risk of complications for both mother and newborn.

Diclofenac sodium Nutra Essential should only be used on medical advice during the first 6 months of pregnancy. In such cases, the lowest effective dose for the shortest possible duration should be used.

After oral administration of Diclofenac sodium Nutra Essential (e.g. tablets), adverse effects may occur in the unborn child. It is not known whether the same risk applies when Diclofenac sodium Nutra Essential is applied to the skin/oral cavity.

Breastfeeding
Do not use Diclofenac sodium Nutra Essential during breastfeeding unless otherwise advised by a doctor.

Diclofenac sodium Nutra Essential should not be applied to the breasts of nursing mothers or to large areas of skin for prolonged periods.

Driving and operating machinery
Topical application of Diclofenac sodium Nutra Essential does not affect the ability to drive or operate machinery.

Diclofenac sodium Nutra Essential contains propylene glycol (E1520), ethanol, and soya lecithin:
This medicine contains 30 mg of propylene glycol (E1520) per pump actuation.
This medicine contains 6.65 mg of alcohol (ethanol) per pump actuation.
This medicine contains soya oil. Do not use this medicine if you have been diagnosed with hypersensitivity to peanuts or soya.

3. How to use Diclofenac sodium Nutra Essential

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.
The recommended dose is:
Adults and adolescents over 14 years of age:
Apply 4–5 sprays 3 times daily at regular intervals. The number of sprays depends on the size of the affected skin area. The maximum single dose must not exceed 5 sprays. The maximum daily dose is 15 sprays.
Treatment may be discontinued when symptoms (pain and swelling) have resolved.
Do not use this medicine for longer than 7 days without prior consultation with a doctor.
Consult a doctor if symptoms worsen or do not improve after 3 days of treatment.
Use in children and adolescents:
Do not use in children and adolescents under 14 years of age.
Method of application:
Diclofenac sodium Nutra Essential is intended for topical use only.
Follow these instructions:

• Remove the transparent protective cap from the spray pump.
• Before first use, prime the pump by pressing it four times to activate it, which will release the contents. Incomplete priming may result in a lower dose being delivered during the first application.
• Wash and dry the painful area. Apply the spray to the affected parts of the body and gently rub into the skin. After application, wipe hands with a paper towel and then wash them, unless the hands themselves are the treated area.
• In case of accidental application of too much spray, wipe off the excess with a paper towel.
• Dispose of the paper towel in household waste to prevent unused product from entering the aquatic environment.
• Allow the spray to dry on the skin for several minutes before applying a bandage.

Wash and dry the Apply to the skin area Gently massage to
painful skin surface to be treated stimulate absorption
Use of more than the recommended dose of Diclofenac sodium Nutra Essential
If more medicine is used than recommended, wipe off the excess with a tissue.
In case of accidental ingestion of the spray, contact a doctor immediately or go to the nearest hospital. Take the bottle and this leaflet with you.
Missed dose of Diclofenac sodium Nutra Essential
If you miss a dose of this medicinal product when it is needed, apply the solution as soon as possible and continue treatment as before. Do not use a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everybody experiences them.
Discontinue use of Diclofenac sodium Nutra Essential if any skin rash occurs.
When topical (on the skin) medicines containing diclofenac are used, allergic reactions at the application site are commonly reported: skin rashes, itching, redness, burning, or peeling of the skin.
Some rare and very rare adverse effects can be serious:
If any of the following symptoms of allergy occur, stop using Diclofenac sodium Nutra Essential immediately and seek medical advice without delay.

• Rare (may occur in no more than 1 in 1,000 people): Skin rash with blisters.
• Very rare (may occur in no more than 1 in 10,000 people): Wheezing, shortness of breath, or feeling of tightness in the chest (asthma). Hypersensitivity reactions, including urticaria (red welts, raised itchy and burning lumps). Swelling of the face, lips, tongue, or throat. Other adverse effects may also occur, although they are usually mild and temporary. Any such occurrence should be reported promptly to a doctor or pharmacist.
• Common (may occur in no more than 1 in 10 patients): Skin rash, itching, redness, or burning sensation after applying the medicine.
• Uncommon (may occur in no more than 1 in 100 people): Dandruff-like scaling, dry skin, swelling.
• Very rare (may occur in no more than 1 in 10,000 people): Skin may become more sensitive to sunlight (photosensitivity). Possible symptoms include sunburn with itching, swelling, and blisters. Pustular rash. Gastrointestinal disturbances.
• Systemic adverse effects, such as stomach pain and disturbances, heartburn, liver or kidney disorders, and hypersensitivity reactions, may occur if the medicine is used long-term or over large areas of skin.

Reporting of adverse effects
If any adverse effects occur in patients, including any possible adverse effects not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Diclofenac sodium Nutra Essential

Keep this medicine out of sight and reach of children.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the cardboard box and bottle after EXP. The expiry date refers to the last day of the stated month.
Do not use this medicine after 6 months from first opening.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices will help protect the environment.

6. Contents of the packaging and other information

Active substance of Diclofenac sodium Nutra Essential:

• The active substance is diclofenac sodium. Each mL of aerosol solution for skin application (corresponding to 5 pump actuations) contains 40 mg of sodium diclofenac. Each pump dose (0.2 mL of solution) contains 8 mg of sodium diclofenac.

• Other components of the medicine are: propylene glycol (E 1520), isopropyl alcohol, Phospholipon 90G (containing phosphatidylcholine derived from soybean lecithin and lysophosphatidylcholine, non-polar lipids and tocopherol), ethanol 96%, disodium phosphate, sodium dihydrogen phosphate dihydrate, disodium edetate, ascorbyl palmitate, peppermint essential oil, hydrochloric acid diluted to adjust pH, sodium hydroxide 10% to adjust pH, and purified water.

What Diclofenac sodium Nutra Essential looks like and contents of the pack:
Diclofenac sodium Nutra Essential is a yellowish solution.
A 30 ml amber glass bottle containing 25 g of solution for skin spray, equivalent to 125 pump actuations, fitted with a polypropylene spray pump and a polyethylene dip tube.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel.: +48 22 364 61 01

Manufacturer
Medinfar Manufacturing, S.A.
Parque Industrial Armando Martins Tavares,
Rua Outeiro da Armada, 5,
3150-194 Condeixa-a-Nova
Portugal
FARMALIDER, S.A.
Calle Aragoneses 2,
28108 Alcobendas, Madrid
Spain