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SOLEVE SUNBURN RELIEF

Active substance(s): IBUPROFEN / ISOPROPYL MYRISTATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
SUNBURN RELIEF
CUTANEOUS EMULSION
ibuprofen 1% w/w
isopropyl myristate 10% w/w

Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to use Soleve carefully to get the
best results from it. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more
information or advice. You must contact a doctor if your symptoms worsen or do not improve after a few days.
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.

1. WHAT SOLEVE IS AND WHAT
IT IS USED FOR
• Soleve is a lotion applied to mild to moderately
sunburnt skin to relieve the pain of the sunburn
and to moisturise the skin.
• Mild to moderately sunburnt skin is red and sore.
It is warm to the touch even after attempts to cool
it with water or by moving into the shade.
• Soleve is not a sunscreen or sunblock
and will not protect your skin from the sun.
• Avoid sunburn: excessive exposure to sun may
cause skin cancer.
• Soleve is recommended for use by adults, the
elderly and children over the age of 12 years.
• There are two types of active ingredient
in this product:

Ibuprofen is one of a group of medicines known
as Non-Steroidal Anti-Inflammatory Drug (NSAIDs).
It works by relieving pain.

Isopropyl myristate is an emollient which
soothes and moisturises your skin by trapping
moisture in the skin.

2. BEFORE YOU USE SOLEVE
Do not use Soleve:
• if the sunburn is severe. Seek medical advice
immediately if you have symptoms of severe
sunburn including blistered skin, intense pain,
intolerance of any contact with clothing, fever,
chills, feeling sick and extreme exhaustion or
lack of energy, seek medical advice;
• if a large proportion of the body surface is
involved. As a general guide, seek medical advice
immediately if more than one tenth (1/10) of a
child’s body surface (e.g. more than the equivalent
area of the forehead, plus shoulders and tops of
both arms), or if more than one fifth (1/5) of an
adult’s body surface (e.g. more than the equivalent
area of both thighs and knees, plus shoulders and
tops of both arms) has been burned.
• if you are allergic (hypersensitive) to ibuprofen,
isopropyl myristate or any of the other ingredients
of Soleve listed in Section 6;
• if you are asthmatic, or suffer from rhinitis
(allergic runny nose) or urticaria (hives) and have
ever had a bad reaction to aspirin, ibuprofen or
other NSAIDs in the past;
• if you are pregnant or breast-feeding;
• on infected, diseased, broken or damaged skin
(this includes skin with sunburn blisters);
• on children under 12 years (parents should seek
advice from a doctor or pharmacist if anyone under
this age is sunburnt);
Before applying this product for the first time,
make sure it is suitable for you to use.
Because Soleve is applied directly to the skin, there is
less risk of the complications that sometimes occur
when ibuprofen (or a similar anti-inflammatory painkiller)
is taken by mouth. However, in rare cases you may be
at more risk of complications:
• if you have a stomach ulcer (also called a peptic
or gastric ulcer);

• if you have ever had kidney problems;
• if you have ever had asthma;
• if you have ever had a bad reaction to aspirin
or ibuprofen taken by mouth.
If any of the previous warnings apply to you,
only use this product on advice from your
doctor or pharmacist.
Take special care when using this product.
• Soleve is not a sunscreen or sunblock
and will not protect your skin from the sun.
• Do not expose the treated areas to the
sun until they are completely better.
• Soleve is for short-term use to relieve sunburn and
should not be used as a general aftersun lotion.
• Use it only on the skin.
• Keep the lotion away from the eyes, nostrils and mouth.
Using other medicines
• Interaction between Soleve and blood pressure
lowering drugs and anticoagulants (medicines that
stop blood clotting) is possible, in theory, although
very unlikely. If you would like more advice about
this, speak to your doctor or pharmacist.
• Do not use Soleve lotion at the same time as any
other medicines (including medicines obtained
without prescription) containing ibuprofen, aspirin
or any other NSAIDs.
• Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines including other medicines obtained
without prescription.
Pregnancy and breast-feeding
You should not use Soleve if you are pregnant
or breast-feeding.
Driving and using machinery
Using this product is not known to affect
your ability to drive or use machinery.

3. HOW TO USE SOLEVE
To use the lotion (for adults, the elderly
and children over 12 years old):
• Use as soon as possible after the first sign of
sunburn. Lightly apply the lotion to the affected
areas and massage gently into the skin.
• Use the lotion at regular intervals, up to
eight times a day, leaving at least two
hours between applications.
• The lotion spreads very easily (a little goes
a long way) and you will not need to apply
very much. The amount needed depends on
the area which is sunburnt, but as a very rough
guide, an amount ranging from a 1 penny piece
to a 2 penny piece will usually be sufficient.
• Do not apply more than 12 ml at a time, or more
than 100 ml a day. As a guide, one and a half
capfuls is approximately 12 ml.
• Wash hands after use, unless treating them.
• The lotion is designed to resist being washed
off whilst swimming or bathing.
• Use the lotion for a maximum of two to
three days, by which time your symptoms
should have subsided.
• If your symptoms worsen, or continue for more
than a few days, you should consult a doctor
or pharmacist.
• Where Soleve is used on children, it should
always be applied by an adult.
If the lotion comes into contact with broken
skin or gets into the eyes, nostrils or mouth
• The product may cause irritation if it comes
into contact with broken skin or gets into the
continued...

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1. What Soleve is and what it is used for
2. Before you use Soleve
3. How to use Soleve
4. Possible side effects
5. How to store Soleve
6. Further information
7. General advice on responsible behaviour in the sun

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In this leaflet:

Like all medicines, Soleve can cause side effects,
although not everybody gets them. If any side effect
gets worse, or if you notice any not listed in this leaflet,
please tell your doctor or pharmacist.
Occasionally, because sunburnt skin is tender, the
initial application of Soleve to sunburnt skin may be
associated with a temporary sensation of tingling or
stinging, but this should subside after a few minutes.
Treatment should be stopped if tingling/stinging
persists.
Occasionally, mild skin rashes, itching or irritation
can occur where it is applied, particularly where
exposed to excessive sunlight (photosensitivity).
If this is unacceptable,or persists, stop using the
product and tell your pharmacist.
Very rarely, the following side effects can happen
with ibuprofen, although these are extremely
uncommon with products such as Soleve that
are applied to the skin.
If you experience any of the following, stop using
Soleve immediately, and get medical advice:
• Allergic reactions (particularly in people who have
a history of asthma or allergic problems), such as:
• unexplained runny nose and watery eyes, or,
in more serious cases asthma or aggravated
asthma involving breathing difficulties, wheezing
or chest tightness;
• generalised allergic skin reactions involving itch,
swelling, inflammation, redness and perhaps
blistering and light sensitivity;
• other more serious generalised allergic reactions
possibly involving unexplained nausea and
vomiting, swollen eyes, face or tongue, difficulty
swallowing, dizziness or light-headedness.
Unconsciousness could perhaps occur in the
most serious cases.
• Kidney problems (particularly in people who
have a history of kidney disease), such as:
• decreased urine volume;
• loss of appetite / weight loss;
• swelling of the abdomen.
• Problems with the digestive system
(particularly in people who have a history
of stomach ulcers etc), such as:
• stomach pain;
• heartburn / indigestion.
If any side effects get serious or don’t go away, get
medical advice.
If you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
Tanning and peeling of the skin are normal reactions
to sunburn and may occur 4 to 7 days after being burnt.
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 SOLEVE
• Keep it out of the sight and reach of children.
• Always replace the cap tightly after use.
• Do not store the product above 25°C.

Do not use after the expiry date shown on the
bottle and the carton. The expiry date refers to
the last day of that month.
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 Soleve contains
The active ingredients are ibuprofen (1% w/w)
and isopropyl myristate (10% w/w).
The other ingredients are coconut oil, carbomers,
sorbitan laurate, 2-diethylaminoethanol, phenoxyethanol
and purified water.
What Soleve looks like and contents
of the pack
• The product is a white lotion (emulsion).
• It is available in bottles containing 100 ml.
The Marketing Authorisation holder is
Diomed Developments Limited, Tatmore Place,
Gosmore, Hitchin, Herts, SG4 7QR, UK.
The Manufacturer is DDD Limited,
94 Rickmansworth Road, Watford, Herts,
WD18 7JJ, UK.
The Distributor is DDD Limited,
94 Rickmansworth Road, Watford, Herts,
WD18 7JJ, UK.

7. RESPONSIBLE BEHAVIOUR
IN THE SUN
• If you do get burnt, avoid further exposure
to the sun until the signs and symptoms have
subsided completely. This may take two to
three days.
• Too much exposure to the sun in a hot and/or
humid environment can cause heat stroke
even if the skin is not sunburnt. If the patient
develops a high temperature, is confused or
weak, or has convulsions, you must consult
a doctor immediately.
• Children are especially vulnerable to the harmful
effects of the sun. If a baby or small child has
been sunburnt, you must get medical advice.
• Excessive exposure to the sun damages and ages
the skin. Prolonged, unprotected exposure to the
sun is also linked to skin cancer, which may take
more than 20 years to appear.
• Children and people with fair skin who burn easily
are especially vulnerable to the harmful effects of
the sun.
• It is very important to protect the skin against
sun damage.
• Spend time in the shade between 11am and 3pm.

Sun protection should be applied thickly
at least 30 minutes before sun exposure.
• Sun protection should be at least SPF 30
and should block both UVA and UVB rays.
• Sun protection should be re-applied regularly,
especially after swimming.

Sunglasses should be worn to protect the eyes,
and should have UV filters.
• The face and scalp burn readily, so wear a hat
with a brim.
• Cover easily burnt areas such as the shoulders
and upper arms.
• There are many situations where you can get burnt
without realising it. Clouds, wind and parasols reduce
the sensation of heat, but have only a limited effect
on the amount of harmful UV rays reaching the skin,
and you can still get burnt while on or in the water.
• Your skin may have been sun-damaged before you
realised it. The pain and redness of sunburn take
several hours (up to a day) to develop fully and
are likely to get worse after being first noticed,
even if you take corrective measures, such as
keeping out of the sun and treating the sunburn.
This leaflet was last revised in May 2015.
To listen to or request a copy of this leaflet in
Braille, large print or audio, please call free of
charge: 0800 198 5000 (UK only).
Please be ready to give the following information:
Soleve, 00173/0167. This is a service provided by
the Royal National Institute of Blind People (RNIB).

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4. POSSIBLE SIDE EFFECTS










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eyes, nostrils or mouth. If this happens, rinse the
affected areas with plenty of water. If rinsing
one eye, take care to avoid washing product
into the other eye. If irritation persists, tell your
doctor or pharmacist.
If the lotion is accidentally swallowed
• If the lotion is swallowed by a baby or young
child, contact a doctor or hospital straight away.
• For adults, if the lotion is swallowed and you
experience any symptoms such as headache,
vomiting, drowsiness or dizziness, contact a
doctor or hospital straight away.
If you forget to use this product
Do not apply a double amount of Soleve to make
up for a forgotten application. Apply it when you
remember, then allow at least 2 hours before the next
application. If you have any further questions on the
use of this product, ask your doctor or pharmacist.

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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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