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DICLOFENAC DERMAPHARM 3% GEL

Active substance(s): DICLOFENAC SODIUM / DICLOFENAC SODIUM

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Package leaflet: Information for the user
Diclofenac Dermapharm 3% gel
Active substance: 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, 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 Dermapharm gel is and what it is used for
2.
What you need to know before you use Diclofenac Dermapharm gel
3.
How to use Diclofenac Dermapharm gel
4.
Possible side effects
5.
How to store Diclofenac Dermapharm gel
6.
Contents of the pack and other information

1.

What Diclofenac Dermapharm gel is and what it is used for

Diclofenac Dermapharm gel is a non-steroidal anti-inflammatory dermatological gel. Diclofenac
Dermapharm gel is applied to the skin to treat a skin problem known as actinic or solar keratosis
that is caused by long-term extensive sun exposure.
Actinic keratoses can be flat and scaly, or raised, rough, hard and warty. Diclofenac
Dermapharm gel should only be used for flat and scaly actinic keratoses, preferably on the face
and scalp.

2.

What you need to know before you use Diclofenac Dermapharm gel

Do not use Diclofenac Dermapharm gel





if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in
section 6).
if you have ever experienced an allergic reaction such as skin rash (nettle rash), breathing
problems (wheezing) or runny nose (allergic rhinitis) after taking aspirin or any other nonsteroidal anti-inflammatory medicinal products.
if you are in the final 3 months of your pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before using Diclofenac Dermapharm gel.

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The possibility of systemic adverse reactions following application of Diclofenac
Dermapharm gel cannot be excluded when the medicinal product is used on large areas of
skin and for a prolonged period of time. Consult your doctor if you:

have, or have had in the past, a stomach ulcer or bleeding from the stomach,

have heart, liver or kidney problems,

have any type of bleeding disorder or bruise easily.
Avoid direct sun exposure and the use of tanning salons when using Diclofenac Dermapharm
gel. If skin reactions occur, discontinue use of this medicinal product.
Do not apply to wounds, infected skin or inflammation of skin.
Do not allow Diclofenac Dermapharm ge to come into contact with your eyes or the inside
(mucosal lining) of your mouth or nose and do not swallow it.
Discontinue use of Diclofenac Dermapharm gel and consult your doctor if you develop a
wide-spread skin rash.
After applying products containing diclofenac on the skin you can use a permeable (nonocclusive) bandage. Do not use an airtight occlusive dressing.

Other medicines and Diclofenac Dermapharm gel
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might
take/use any other medicines.
Pregnancy and breast-feeding
If you are pregnant or think you may be pregnant, ask your doctor for advice before using
Diclofenac Dermapharm gel. Diclofenac Dermapharm gel should be used with caution during
the first six months of pregnancy but it must not be used during the last three months of
pregnancy.
Consult your doctor if you are breast-feeding. Diclofenac Dermapharm gel can be used with
caution whilst breast-feeding but it must not be used on the breasts.
If you are pregnant, planning to have a baby, or breast-feeding, and your doctor considers
treatment appropriate, Diclofenac Dermapharm gel must not be applied to an area of the skin
larger than a third of your body and must not be used for longer than three weeks.
Ask your doctor or pharmacist for advice before taking/using any medicine.
Driving and using machines
No specific precautions are necessary.

3.

How to use Diclofenac Dermapharm gel

 Diclofenac Dermapharm gel is not suitable for children.
 Always use Diclofenac Dermapharm gel exactly as your doctor has told you. Check with
your doctor if you are not sure.
 Pierce the aluminium membrane across the tube opening with the cap before use.
 Gently spread a small amount of gel onto the skin area to be treated. The amount of gel
needed will vary depending on the size of the area to be treated. Usually 0.5 grams of gel
(equivalent to about the size of a pea) will be enough for one area (5 cm x 5 cm). However,
not more than 8 grams should be used per day.

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 You can apply Diclofenac Dermapharm gel twice daily unless your doctor tells you
differently. You may notice a slight cooling effect when applying the gel onto your skin.
 The usual duration of treatment is 60 to 90 days. Maximum effect has been seen with
treatment times closer to 90 days. Complete healing may not occur for up to a month after
treatment has stopped.
 Wash your hands after applying the gel unless your hands are being treated.
If you use more Diclofenac Dermapharm gel than you should
Remove excess gel by washing with water.
If you forget to use Diclofenac Dermapharm gel
Continue to apply as directed but do not apply twice as much to make up for the missed
application.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you have any of the following side effects, stop using Diclofenac Dermapharm gel and
contact your doctor as soon as possible:
Skin rash (nettle rash), breathing problems (wheezing); swelling of the face; runny nose
(allergic rhinitis). These symptoms indicate that you may be allergic to Diclofenac Dermapharm
gel.
If any of the following common side effects are severe or last for more than a few days, you
should stop using Diclofenac Dermapharm gel and contact your doctor: itching, skin rash, skin
redness, inflammation, contact dermatitis, pain and blistering.
Other common side effects: (may affect up to 1 in 10 people)
Irritation or tingling at the site of treatment, conjunctivitis, allergy, a painful sensation when the
skin is touched, pins and needles, muscle stiffness, inflammation of the skin, eczema, dry skin,
swelling, skin rash (including scaling or blistering), sagging of the skin and skin ulcer.
Uncommon side effects: (may affect up to 1 in 100 people)
Eye pain, weeping/dry eyes, abdominal pain, diarrhoea, feeling sick, hair loss, facial swelling,
excessive bleeding or oily skin, a measles-like skin rash.
Rare side effects: (may affect up to 1 in 1,000 people)
Skin inflammation with large blisters
Very rare side effects: (may affect up to 1 in 10,000 people)
Bleeding from your stomach, kidney problems, breathing difficulties (asthma), all types of
hypersensitivity reactions (including nettle rash, rapid swelling of the skin and mucous
membranes), infected skin rash, skin sensitivity to sunlight.
Temporary hair discolouration at the application site has been reported. This is usually reversed
after stopping treatment.
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.

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You can also report side effects directly via the Yellow Card Scheme 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 Dermapharm gel

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 tube and carton after EXP.
The expiry date refers to the last day of that month.
Do not store above 25°C.
Shelf life once opened
Once the tube is opened, Diclofenac Dermapharm gel has a shelf life of 6 months.
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.

Contents of the pack and other information

What Diclofenac Dermapharm gel contains
The active substance is:
diclofenac sodium
1 g gel contains 30 mg diclofenac sodium.
The other ingredients are:
sodium hyaluronate; macrogol 400; benzyl alcohol; purified water
What Diclofenac Dermapharm gel looks like and contents of the pack
Diclofenac Dermapharm gel is a clear, transparent, colourless to yellowish gel and is supplied
in aluminium tubes containing 10 g, 25 g, 26 g, 30 g, 50 g, 60 g, or 90 g.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Dermapharm AG
Lil-Dagover-Ring 7
82031 Gruenwald
Germany
e-mail: service@dermapharm.de
Manufacturer
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany

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This medicinal product is authorised in the Member States of the EEA under the following
names:
Germany:
Diclofenac acis 30 mg/g Gel
Austria:
Diclofenac Dermapharm 3% Gel
Belgium:
Diclofenac Dermapharm 3% gel
Netherlands:
Diclofenac Na Dermapharm 3% gel
Italy:
Diclofenac Dermapharm 30 mg/g gel
Spain:
Diclofenaco Dermapharm 30 mg/g Gel
Czech Republic:
Diclofenac Dermapharm
Slovakia:
Diclofenac Dermapharm 3% gél
United Kingdom:
Diclofenac Dermapharm 3% gel

This leaflet was last revised in february 2017.

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Expand Transcript

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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