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DICLOFENAC SODIUM SPRAY GEL 4% W/W CUTANEOUS SPRAY SOLUTION

Active substance(s): DICLOFENAC SODIUM

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Diclofenac Sodium Spray Gel 4%

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Diclofenac Sodium Spray Gel 4%w/w cutaneous spray, solution
Diclofenac sodium
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
·
Keep this leaflet. You may need to read it again.
·
If you have any further questions, please ask your doctor or pharmacist.
·
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
·
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4
What is in this leaflet:
1.
What Diclofenac Sodium Spray Gel is and what it is used for
2.
What you need to know before you use Diclofenac Sodium Spray Gel
3.
How to use Diclofenac Sodium Spray Gel
4.
Possible side effects
5.
How to store Diclofenac Sodium Spray Gel
6.
Content of the pack and other information

1.

What Diclofenac Sodium Spray Gel is and what it is used for

Diclofenac Sodium Spray Gel contains the active substance diclofenac sodium, which belongs to the
group of non-steroidal anti-inflammatory drugs (NSAID). Diclofenac Sodium Spray Gel is used to
relieve the acute pain and swelling affecting small or medium-sized joints and surrounding tissues.

2.

What you need to know before you use Diclofenac Sodium Spray Gel

Do not use Diclofenac Sodium Spray Gel

If you are allergic (hypersensitive) to diclofenac sodium, peanut, soya or any of the other
ingredients of Diclofenac Sodium Spray Gel (listed in section 6).

If you have ever had an allergic reaction to aspirin (acetylsalicylic acid) or any other NSAID
such as ibuprofen with difficulty in breathing, skin rash and runny nose.

In the last three months of pregnancy – please see section on pregnancy and breast-feeding.

On the breast area if you are breast-feeding.

In children and adolescents under 14 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before using Diclofenac Sodium Spray Gel

If you have or have had stomach ulcers, liver or kidney problems, a tendency for bleeding or
inflammatory bowel disease.

If you have previously suffered from bronchial asthma or allergies.

Avoid applying on large areas of skin and over a prolonged period of time, unless under medical
advice.

Do not use in eyes, nose or mouth, in the genital area and on open wounds or infected skin
areas. If you accidentally get some spray into your eyes rinse thoroughly with clear water and
inform your doctor.

Never swallow Diclofenac Sodium Spray Gel.

Do not sunbathe or use sunlamps whilst using this medicine.

Discontinue use of Diclofenac Sodium Spray Gel if any skin rash develops.

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Do not cover the treated area with occlusive (waterproof or non breathable) bandages or
plasters.

If you are not sure what to do, ask your doctor or pharmacist.

Other medicines and Diclofenac Sodium Spray Gel
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Speak to your doctor before you use Diclofenac Sodium Spray Gel:

If you are taking tablets, capsules or suppositories for pain including any containing diclofenac
sodium, acetylsalicylic acid (aspirin) or any other anti-inflammatory agent, as for example ibuprofen.
The use of other NSAID (including acetylsalicylic acid or ibuprofen) at the same time as Diclofenac
Sodium Spray Gel may increase the risk of side effects.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.
Diclofenac Sodium Spray Gel must not be used during the last 3 months of pregnancy, as it could
harm your unborn child or cause problems at delivery.
Diclofenac Sodium Spray Gel should only be used under medical advice during the first 6 months of
pregnancy and the dose should be kept as low and duration of treatment as short as possible.
Diclofenac Sodium Spray Gel should only be used under medical advice, during breast-feeding as
diclofenac sodium passes into breast milk in small amounts. However, Diclofenac Sodium Spray Gel
should not be applied on the breasts of nursing mothers nor elsewhere on large areas of skin or for a
prolonged period of time.
Driving and using machines
Cutaneous application of Diclofenac Sodium Spray Gel has no influence on the ability to drive and use
machines.
Diclofenac Sodium Spray Gel contains
This medicinal product contains:
 propylene glycol (E1520) which may cause mild localised skin irritation in some people,
 peppermint oil which may cause allergic reactions,
 soya, if you are allergic to peanut or soya, do not use this medicinal product.

3.

How to use Diclofenac Sodium Spray Gel

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.



Remove the protective cap.
Hold the bottle in an upright position and use as directed onto the painful or swollen site.


Apply the recommended number of spray strokes
Adults and children aged 14 years and over: The recommended dose is 4 to 5 strokes of Diclofenac
Sodium Spray Gel applied 3 times daily. The number of strokes depends on the size of the affected

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area. The maximum number of pump strokes is 15 times daily. The maximum single dose should not
exceed 5 pump strokes.

Diclofenac Sodium Spray Gel should be massaged gently into the skin. Wash your hands
afterwards unless they are the site being treated.

Wait until Diclofenac Sodium Spray Gel has dried before covering the skin with clothes or
bandage. Take care as the spray can stain your clothes if wet.

Discontinue treatment when your symptoms (pain and swelling) improve.
Do not use for more than 7 days without consulting your doctor.

If there is no improvement in your symptoms after 3 days, or if your symptoms worsen, talk to a
doctor.
If you use more Diclofenac Sodium Spray Gel than you should



If you use more of your medicine than you should wipe the surplus Diclofenac Sodium Spray
Gel off with a tissue.
If you swallow some of the spray inform your doctor immediately or go to the nearest hospital
casualty. Take the bottle and this leaflet with you.

If you forget to use Diclofenac Sodium Spray Gel



Use the spray as soon as you remember, but do not apply more than the recommended dose at
once. Then carry on as before.
Do not use a double dose to make up for a forgotten dose.

If you have any further questions on 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.
 Discontinue use of Diclofenac Sodium Spray Gel if any skin rash develops. Following the use of
topical (applied to the skin) diclofenac preparations reactions at the site of application have been
reported commonly. These include rashes, itching, reddening, burning sensations or scaling of the
skin.
 If you experience any of the following signs of allergy, STOP using Diclofenac Sodium Spray
Gel and tell a doctor or pharmacist immediately:
 Skin rash with blisters; hives (may affect between 1 and 10 in every 10,000 people).
 Wheezing, shortness of breath or feeling of tightness in the chest (asthma) (may affect
less than 1 in every 10,000 people).
 Swelling of the face, lips, tongue or throat (may affect less than 1 in every 10,000 people).


Some side effects are common (may affect between 1 and 10 in every 100 people):
Skin rash, itching, reddening or smarting of the skin.



Some side effects are very rare (may affect less than 1 in every 10,000 people):
The skin may be more sensitive to the sun. Possible signs are sunburn with itching, swelling and
blistering.



Some side effects have unknown frequency (frequency of occurrence in patients cannot be
estimated from the available data):
Application site reaction, dry skin, burning sensation

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If the product is used for a long time (longer than three weeks) and/or it is used on large areas of the
skin, systemic side effects such as stomach pain and disorders, heartburn and kidney problems may
occur.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at website
:www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on
the safety of this medicine.

5.

How to store Diclofenac Sodium Spray Gel

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label, carton and bottle after EXP.
The expiry date refers to the last day of that month.
Store in the original package.
Do not use Diclofenac Sodium Spray Gel after 6 months after first opening.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.

6.
Content of the pack and other information
What Diclofenac Sodium Spray Gel contains
The active substance is diclofenac sodium 4 % (w/w).
The other ingredients are: isopropyl alcohol, soy bean lecithin, ethanol, disodium phosphate
dodecahydrate, sodium dihydrogen phosphate dihydrate, disodium edetate, propylene glycol (E1520),
peppermint oil, ascorbyl palmitate, hydrochloric acid 10 % (w/w) or sodium hydroxide 10 % (w/w)
(for pH-adjustment) and purified water.
What Diclofenac Sodium Spray Gel looks like and contents of the pack
Diclofenac Sodium Spray Gel is a golden-yellow, transparent solution, which turns to a gel-like
consistency after administration. Each bottle contains 7.5 g, 12.5 g or 25 g cutaneous spray, solution.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
MIKA Pharma GmbH Auestraße 39, 67346 Speyer, Germany
Manufacturer
Pharbil Waltrop GmbH,
Im Wirrigen 25
45731 Waltrop, Germany.
This medicinal product is authorised in the Member States of the EEA under the
following names:
United Kingdom
Diclofenac Sodium Spray
Gel 4% cutaneous spray,
solution
Ireland
Difene 4% Spray Gel

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Estonia

DicloFlex,
40mg/g,
nahasprei, lahus

Latvia

DicloFlex 4% uz ādas
izsmidzināms
aerosols,
šķīdums

Lithuania

DicloFlex
4%
purškalas, tirpalas

Hungary

Doloflex 4% külsőleges
oldatos spray

Slovenia

DicloFlex
40
mg/g
dermalno pršilo, raztopina

This leaflet was last revised in February 2015.

odos

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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