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VOLTAROL ACTIVE 4% CUTANEOUS SPRAY

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145 mm

Pharma code 343

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 Voltarol Active Spray
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 3 days.
– If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Voltarol Active Spray is and what it is used for
2. Before you use Voltarol Active Spray
3. How to use Voltarol Active Spray
4. Possible side effects
5. How to store Voltarol Active Spray
6. Further information

For adolescents aged 14 years and over, if this product
is required for more than 7 days for pain relief or
if the symptoms worsen the patient/parents of the
adolescent is/are advised to consult a doctor.

1. What Voltarol Active Spray is and
what it is used for

Taking other medicines

2. Before you use Voltarol Active Spray
Do not use Voltarol Active Spray
• If you are allergic (hypersensitive) to diclofenac
sodium, peanut, soya or any of the other
ingredients of this medicine listed in Section 6 and
at the end of Section 2.
• If you have ever had an allergic reaction to
acetylsalicylic acid (aspirin) or any other NSAID
such as ibuprofen (skin rash, difficulty in breathing
or runny nose).
• If you are in the last 3 months of pregnancy
(see section Pregnancy and breast-feeding).
• Do not apply to the breast area if you are
breast-feeding.
• If you are below 14 years of age.

Pharma code 343

Take special care with Voltarol Active Spray
• If you have or have had stomach ulcers, liver
or kidney problems, a tendency for bleeding
or inflammatory bowel disease.
• If you have ever suffered from bronchial asthma
or any other 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 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 Voltarol Active Spray.
• Do not sunbathe or use sunlamps whilst using this
medicine.
• Discontinue use of Voltarol Active spray if any skin
rash develops.
• Do not cover the treated area with occlusive
(waterproof or non breathable) bandages or plasters.

If you are taking tablets, capsules or suppositories for pain
including any containing diclofenac sodium, acetylsalicylic
acid (aspirin) or any other anti-inflammatory agent, for
example ibuprofen. The use of other NSAID (including
acetylsalicylic acid or ibuprofen) at the same time as
Voltarol Active Spray 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 a woman who is trying to become pregnant
ask your doctor or pharmacist for advice before using
Voltarol Active spray.
Voltarol Active spray must not be used during the last
3 months of pregnancy, as it could harm your unborn
child or cause problems at delivery.
Voltarol Active spray 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.
Voltarol Active spray should only be used under
medical advice, during breast-feeding as diclofenac
sodium passes into breast milk in small amounts.
However, Voltarol Active spray should not be applied
on the breasts of nursing mothers nor elsewhere on
large areas of skin or for a prolonged period of time.
Consult your doctor or pharmacist for further information
if you are pregnant or breast-feeding.
Driving and using machines
Cutaneous application of Voltarol Active spray has no
influence on the ability to drive and use machines.
Important information about some of the
ingredients of Voltarol Active Spray
– Voltarol Active Spray contains
propylene glycol, which may cause mild localised
skin irritation in some people.
– Voltarol Active Spray contains
peppermint oil, which may cause allergic reactions.
– Voltarol Active Spray contains soya, if you are allergic
to peanut or soya, do not use this medicinal product.

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Children and adolescents
There are insufficient data on efficacy and safety
available for children and adolescents below 14 years
(see Do not use Voltarol Active Spray).

Tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.

8007.82.25/02

280 mm

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

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

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3. How to use Voltarol Active Spray

For adults and adolescents aged 14 years and over
– The usual dose is 4 to 5 pump strokes of Voltarol
Active Spray to be applied 3 times daily.
– The number of pump strokes you use depends on
the size of the affected area.
– The maximum daily dose is equivalent to 15 pump
strokes. The maximum single dose should not
exceed 5 pump strokes.
Voltarol Active Spray is for external use only (cutaneous
use). It must only be used on unbroken skin. It is
important to use Voltarol Active Spray correctly.
Follow the instructions carefully.
– Remove the protective cap.
– Apply the prescribed number of pump strokes in
an upright position of the bottle onto the painful or
swollen site.
– Voltarol Active Spray should be massaged gently
into the skin. Wash your hands afterwards unless
they are the site being treated.
– Wait until Voltarol Active Spray has dried before
covering the skin with clothes or a bandage. Whilst
wet it may stain your clothes.
Do not use a waterproof or non-breathable bandage.
– When the pain and swelling disappear stop using
the medicine.
– If there is no improvement in your symptoms after
3 days, talk to a doctor.
– If the symptoms improve but do not completely
disappear, do not continue using for more than
7 days without consulting a doctor.

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If you use more Voltarol Active Spray than you should
– If you use more of your medicine than you should wipe
the surplus Voltarol Active Spray off with a tissue.
– If you swallow some of the spray inform your doctor
immediately or go to the nearest hospital casualty
department. Take the bottle and this leaflet with you.
If you forget to use Voltarol Active Spray
– Use the spray as soon as you remember, but do not
apply more than the recommended dose.
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, Voltarol Active Spray can cause
side effects, although not everybody gets them.
Discontinue use of Voltarol Active Spray if any skin
rash develops. Following the use of other 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.

5. How to store Voltarol Active Spray
– Keep this medicine out of the reach and sight of
children.
– Do not use Voltarol Active Spray after the expiry
date stated on the carton and bottle after EXP. The
expiry date refers to the last day of that month.
– Store in the original package.
– Do not use Voltarol Active Spray after 6 months
after first opening.

6. Further information
What Voltarol Active Spray contains
– The active substance is diclofenac sodium. 1 g of
Voltarol Active Spray contains 40 mg of diclofenac
sodium. Each pump stroke delivers
8 mg of diclofenac sodium.
– The other ingredients are isopropyl alcohol,
soy bean lecithin, ethanol, disodium phosphate
dodecahydrate, sodium dihydrogen phosphate
dihydrate, disodium edetate, propylene glycol,
peppermint oil (contains menthol and cineole),
ascorbyl palmitate, hydrochloric acid 10% (w/w)
for pH adjustment, sodium hydroxide 10% (w/w)
for pH adjustment, purified water.
What Voltarol Active Spray looks like
and contents of the pack
Voltarol Active Spray is a golden-yellow, transparent
cutaneous spray, solution, which turns
to a gel-like consistency after administration.
Each bottle contains 12.5 g or 25 g cutaneous spray.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Novartis Consumer Health UK Limited
Wimblehurst Road, Horsham
West Sussex – RH12 5AB
United Kingdom
Manufacturer
Novartis Consumer Health UK Limited
Wimblehurst Road, Horsham
West Sussex – RH12 5AB
United Kingdom
This medicinal product is authorised in the Member
States of the EEA under the following names:
United Kingdom: Voltarol Active 4% w/w cutaneous
spray
Germany: Voltaren Spray
This leaflet was last approved in May 2012

8007.82.25/02
GB 921648

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Pharma code 343

If you experience any of the following signs of allergy,
STOP using Voltarol Active spray 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).
Other side effects which may occur are usually mild,
passing and harmless. If you are concerned, tell a doctor
or pharmacist.
Some side effects are common (may affect between
1 and 10 in every 100 people)
Skin rash, itching, reddening or smarting of the skin.

Pharma code 343

Always use this medicine exactly as described in this
leaflet or as your pharmacist has told you. You should
check with your doctor or pharmacist if you are not sure.

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 available data):
Application site reaction, dry skin, burning sensation
If topical NSAIDs are applied to areas of skin of more
than the equivalent of the lower arm or the size of
this leaflet and for more than 3 weeks continuously,
other side effects such as stomach pain and disorders,
heartburn and kidney problems may occur.
If you get any side effects which worry you (even
effects not listed in this leaflet), talk to 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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