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DICLOFENAC SODIUM 3% W/W GEL

Active substance(s): DICLOFENAC SODIUM

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Solaraze® 3% Gel

2850
29.04.16[3]

(diclofenac sodium)
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you personally and you should not
pass it on to others. It may harm them, even if their symptoms are the
same as yours.
- If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine will be referred to as Solaraze throughout the leaflet.
In this leaflet:
1. What Solaraze is and what it is used for
2. Before you use Solaraze
3. How to use Solaraze
4. Possible side effects
5. How to store Solaraze
6. Further information
1. WHAT SOLARAZE IS AND WHAT IT IS USED FOR
Solaraze is a non-steroidal anti-inflammatory dermatological gel. When
applied to the skin, Solaraze gel is used to treat a skin problem known as
actinic or solar keratosis that is caused by long-term sun exposure.
2. BEFORE YOU USE SOLARAZE
Do not use Solaraze
- If you are allergic to diclofenac or any of the ingredients in Solaraze.
- If you have had an allergic reaction such as skin rash (nettle rash),
breathing difficulties (wheezing) or runny nose (allergic rhinitis) after taking
aspirin or any other non-steroidal anti-inflammatory agents.
- If you are in the final 3 months of your pregnancy.
Take special care with Solaraze
- The possibility of systemic side effects from application of Solaraze cannot
be excluded if the product is used on large areas of skin and over a
prolonged period. Consult your doctor if:
- you have, or have had in the past, a stomach ulcer or bleeding from the
stomach.
- you have heart, liver or kidney problems.
- you have any type of bleeding disorder or bruise very easily.
- Avoid sun exposure, including tanning salons, when using Solaraze. If
skin reactions occur, discontinue use.
- Do not apply to skin wounds, infected skin or dermatitis.
- Do not allow Solaraze to come into contact with your eyes or the inside of
your nose or mouth and do not swallow it. If Solaraze has accidentally
been swallowed, consult a doctor immediately.
- Discontinue Solaraze and consult your doctor if you develop a widespread skin rash.
- After applying products containing diclofenac on the skin you can use a
permeable (non-occlusive) bandage. Do not use an airtight occlusive
dressing.
Pregnancy/Breastfeeding
Speak to your doctor if you are, or could be pregnant. Solaraze should be
used with caution during the first six months of pregnancy but must not be
used during the last three months of pregnancy.
Consult your doctor if you are breastfeeding. Solaraze can be used whilst
breastfeeding with caution but should not be used on the breasts.
If you are pregnant, trying to get pregnant, or breastfeeding, and your doctor
considers treatment appropriate, Solaraze must not be applied to an area of
the skin larger than about a third of your body and must not be used for
longer than three weeks. Ask your doctor or pharmacist for advice before
taking or using any medicine.
3. HOW TO USE SOLARAZE
- Solaraze is not suitable for children.
- Use the gel as directed by your doctor.
- Pierce the aluminium membrane across the tube opening with the cap
before using.
- Gently smooth a small amount of gel onto the skin over the area to be
treated. The amount of gel needed will vary depending upon the size of
the area to be treated. Usually 0.5 grams of gel (about the size of a pea)
will be enough for one area (5cm x 5cm) but not more than 8 grams
should be used per day.
- You can apply Solaraze twice daily unless your doctor tells you differently.
You may notice a slight cooling effect when you smooth the gel onto your
skin.
- The usual period of treatment is 60-90 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 Solaraze than you should
Remove the excess gel by washing with water.
If you forget to use Solaraze
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, Solaraze can have side effects although not everybody
gets them.
If you have any of the following side effects, stop using Solaraze and
contact your doctor as soon as possible:
Skin rash (nettle rash); breathing difficulties (wheezing); swelling of the face;
runny nose (allergic rhinitis). These symptoms indicate that you may be
allergic to Solaraze.
If any of the following common side effects are severe or last for more than
a few days you should stop using Solaraze and contact your doctor: itching,
rash, skin redness, inflammation, contact dermatitis, pain and blistering.
Other common side effects: (occur in between 1 and 10 out of every 100
patients)
Irritation or tingling at the site of treatment, conjunctivitis, allergy, a painful
sensation when the skin is touched, pins and needles, muscle stiffness,
dermatitis, eczema, dry skin, swelling, rash (including scaly or blistering),
sagging of the skin, and skin ulcer.
Uncommon side effects: (occur in between 1 and 10 out of every 1,000
patients)
Eye pain, weeping/dry eyes, pain in the abdomen, diarrhoea, feeling sick,
hair loss, facial swelling, excessive bleeding or oily skin, a measles-like
rash.
Rare side effects: (occur in between 1 and 10 out of every 10,000 patients)
Dermatitis with large blisters.
Very rare side effects: (occur in fewer than 1 in 10,000 patients)
Bleeding from your stomach, problems with your kidneys, breathing
difficulties (asthma), infected skin rash, skin sensitivity to sunlight.
Temporary hair discolouration at the application site has been reported. This
is usually reversed on stopping treatment.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
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 SOLARAZE
Keep Solaraze out of the sight and reach of children.
Do not use after the expiry date on the tube and carton. The date refers to
the last date of that month.
Do not store above 25°C.
Shelf life after opening: 6 months.
If your gel becomes discoloured or shows any other signs of deterioration,
please ask your doctor or pharmacist before using your medicine.
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. FURTHER INFORMATION
What Solaraze contains
- Each gram of gel contains the equivalent of 30mg diclofenac sodium (the
active substance).
- The gel also contains sodium hyaluronate, benzyl alcohol, macrogol
monomethyl ether 350 and purified water.
What Solaraze looks like and contents of the pack
Solaraze gel is a clear, transparent, colourless or pale yellow gel packed in
tubes containing 25 grams, 2 x 25 grams or 4 x 25 grams of product.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by Almirall Hermal GmbH, Scholtzstrasse 3, D-21465
Reinbek, Germany. Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middesex, HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/2850

Leaflet revision and issue date (Ref) 29.04.16[3]
Solaraze is a trademark of Almirall S.A.

Diclofenac sodium 3% w/w Gel

2850
29.04.16[3]

PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you personally and you should not
pass it on to others. It may harm them, even if their symptoms are the
same as yours.
- If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine will be referred to as Diclofenac sodium throughout the leaflet.
In this leaflet:
1. What Diclofenac sodium is and what it is used for
2. Before you use Diclofenac sodium
3. How to use Diclofenac sodium
4. Possible side effects
5. How to store Diclofenac sodium
6. Further information
1. WHAT DICLOFENAC SODIUM IS AND WHAT IT IS USED FOR
Diclofenac sodium is a non-steroidal anti-inflammatory dermatological gel.
When applied to the skin, Diclofenac sodium gel is used to treat a skin
problem known as actinic or solar keratosis that is caused by long-term sun
exposure.

If you use more Diclofenac sodium than you should
Remove the excess gel by washing with water.
If you forget to use Diclofenac sodium
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, Diclofenac sodium can have side effects although not
everybody gets them.
If you have any of the following side effects, stop using Diclofenac
sodium and contact your doctor as soon as possible:
Skin rash (nettle rash); breathing difficulties (wheezing); swelling of the face;
runny nose (allergic rhinitis). These symptoms indicate that you may be
allergic to Diclofenac sodium.
If any of the following common side effects are severe or last for more than
a few days you should stop using Diclofenac sodium and contact your
doctor: itching, rash, skin redness, inflammation, contact dermatitis, pain
and blistering.
Other common side effects: (occur in between 1 and 10 out of every 100
patients)
Irritation or tingling at the site of treatment, conjunctivitis, allergy, a painful
sensation when the skin is touched, pins and needles, muscle stiffness,
dermatitis, eczema, dry skin, swelling, rash (including scaly or blistering),
sagging of the skin, and skin ulcer.

2. BEFORE YOU USE DICLOFENAC SODIUM
Do not use Diclofenac sodium
- If you are allergic to diclofenac or any of the ingredients in Diclofenac
sodium.
- If you have had an allergic reaction such as skin rash (nettle rash),
breathing difficulties (wheezing) or runny nose (allergic rhinitis) after taking
aspirin or any other non-steroidal anti-inflammatory agents.
- If you are in the final 3 months of your pregnancy.

Uncommon side effects: (occur in between 1 and 10 out of every 1,000
patients)
Eye pain, weeping/dry eyes, pain in the abdomen, diarrhoea, feeling sick,
hair loss, facial swelling, excessive bleeding or oily skin, a measles-like
rash.

Take special care with Diclofenac sodium
- The possibility of systemic side effects from application of Diclofenac
sodium cannot be excluded if the product is used on large areas of skin
and over a prolonged period. Consult your doctor if:
- you have, or have had in the past, a stomach ulcer or bleeding from the
stomach.
- you have heart, liver or kidney problems.
- you have any type of bleeding disorder or bruise very easily.
- Avoid sun exposure, including tanning salons, when using Diclofenac
sodium. If skin reactions occur, discontinue use.
- Do not apply to skin wounds, infected skin or dermatitis.
- Do not allow Diclofenac sodium to come into contact with your eyes or the
inside of your nose or mouth and do not swallow it. If Diclofenac sodium
has accidentally been swallowed, consult a doctor immediately.
- Discontinue Diclofenac sodium 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 (non-occlusive) bandage. Do not use an airtight occlusive dressing.

Very rare side effects: (occur in fewer than 1 in 10,000 patients)
Bleeding from your stomach, problems with your kidneys, breathing
difficulties (asthma), infected skin rash, skin sensitivity to sunlight.
Temporary hair discolouration at the application site has been reported. This
is usually reversed on stopping treatment.

Pregnancy/Breastfeeding
Speak to your doctor if you are, or could be pregnant. Diclofenac sodium
should be used with caution during the first six months of pregnancy but
must not be used during the last three months of pregnancy.
Consult your doctor if you are breastfeeding. Diclofenac sodium can be used
whilst breastfeeding with caution but should not be used on the breasts.
If you are pregnant, trying to get pregnant, or breastfeeding, and your doctor
considers treatment appropriate, Diclofenac sodium must not be applied to
an area of the skin larger than about a third of your body and must not be
used for longer than three weeks. Ask your doctor or pharmacist for advice
before taking or using any medicine.
3. HOW TO USE DICLOFENAC SODIUM
- Diclofenac sodium is not suitable for children.
- Use the gel as directed by your doctor.
- Pierce the aluminium membrane across the tube opening with the cap
before using.
- Gently smooth a small amount of gel onto the skin over the area to be
treated. The amount of gel needed will vary depending upon the size of
the area to be treated. Usually 0.5 grams of gel (about the size of a pea)
will be enough for one area (5cm x 5cm) but not more than 8 grams
should be used per day.
- You can apply Diclofenac sodium twice daily unless your doctor tells you
differently. You may notice a slight cooling effect when you smooth the gel
onto your skin.
- The usual period of treatment is 60-90 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.

Rare side effects: (occur in between 1 and 10 out of every 10,000 patients)
Dermatitis with large blisters.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
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
Keep Diclofenac sodium out of the sight and reach of children.
Do not use after the expiry date on the tube and carton. The date refers to
the last date of that month.
Do not store above 25°C.
Shelf life after opening: 6 months.
If your gel becomes discoloured or shows any other signs of deterioration,
please ask your doctor or pharmacist before using your medicine.
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. FURTHER INFORMATION
What Diclofenac sodium contains
- Each gram of gel contains the equivalent of 30mg diclofenac sodium (the
active substance).
- The gel also contains sodium hyaluronate, benzyl alcohol, macrogol
monomethyl ether 350 and purified water.
What Diclofenac sodium looks like and contents of the pack
Diclofenac sodium gel is a clear, transparent, colourless or pale yellow gel
packed in tubes containing 25 grams, 2 x 25 grams or 4 x 25 grams of
product.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by Almirall Hermal GmbH, Scholtzstrasse 3, D-21465
Reinbek, Germany. Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middesex, HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/2850

Leaflet revision and issue date (Ref) 29.04.16[3]

Expand view ⇕

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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