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VOLTAROL 12 HOUR MEDICATED PATCH 140 MG MEDICATED PLASTER.

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Package leaf let: Inf ormation f or the user
Sophenoderm 140 mg medicated plaster
For use in adolescents from 16 years of age and adults.
Active substance: diclofenac sodium
Read all of this leaflet carefully before you start using this medicinal
product because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor
or pharmacist have told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
- You must talk to a doctor if you do not feel better or if you feel worse
after 7 days.

What is in this leaflet
1.
What Sophenoderm 140 mg medicated plaster is and what it is used for
2.
What you need to know before you use Sophenoderm 140 mg medicated plaster
3.
How to use Sophenoderm 140 mg medicated plaster
4.
Possible side effects
5.
How to store Sophenoderm 140 mg medicated plaster
6.
Contents of the pack and other information
1.

What Sophenoderm 140 mg medicated plaster is and what it is used for

Sophenoderm 140 mg medicated plaster is a medicine that relieves pain. It belongs to a group of
medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
Sophenoderm 140 mg medicated plaster is used for the local symptomatic and short term treatment of
pain associated with acute strains, sprains or bruises on the arms and legs as a result of injuries, e.g.
sports injuries in adolescents from 16 years of age and adults.
You must talk to a doctor if you do not feel better or if you feel worse after 7 days.
2.

What you need to know before you use Sophenoderm 140 mg medicated plaster

Do not use Sophenoderm 140 mg medicated plaster if you
are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6);
are allergic to any other non-steroidal anti-inflammatory drug (NSAID, e.g. acetylsalicylic
acid or ibuprofen);
have ever developed asthma attacks, hives or swelling and irritation inside the nose after
taking acetylsalicylic acid or any other NSAID;
are suffering from an active stomach or intestinal ulcer;
are in the last three months of pregnancy.
Sophenoderm 140 mg medicated plaster should not be used on injured skin (e.g. skin abrasions, cuts,
burns), infected skin or skin affected by exudative dermatitis or eczema;

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Warnings and precautions
Talk to your doctor or pharmacist before using Sophenoderm 140 mg medicated plaster
 if you notice a skin rash. If this happens, immediately remove the cutaneous patch and stop the
treatment.
 if you suffer from disorders of the kidneys, heart or liver, or if you suffer or have previously
suffered from a stomach or intestinal ulcer or intestinal inflammation or a tendency to
bleeding.
Consult a doctor or pharmacist before using Sophenoderm 140 mg medicated plaster if any of the
above mentioned applies to you.
Side effects can be reduced by using the lowest effective dose for the shortest possible period of time.
IMPORTANT precautions
 If symptoms persist for longer than 7 days, you should see a doctor.
 The cutaneous patch must not come into contact with or be applied to the eyes or mucous
membranes.
 Elderly patients should use Sophenoderm 140 mg medicated plaster with caution because they
are more likely to experience side effects.
After taking off the cutaneous patch, avoid exposing the treated area to direct sunlight or solarium
radiation in order to reduce the risk of sensitivity to light.
Do not use Sophenoderm 140 mg medicated plaster at the same time as any other diclofenaccontaining or other non-steroidal pain-relieving and anti-inflammatory medicines regardless of
whether these are used externally or taken by mouth.

Children and adolescents
Sophenoderm 140 mg medicated plaster should not be used in children and adolescents under 16 years
of age because no adequate experience is available for this age group.
Other medicines and Sophenoderm 140 mg medicated plaster
Please tell your doctor or pharmacist if you are taking or have recently taken or might take any other
medicines.
Provided that Sophenoderm 140 mg medicated plaster is used correctly, only a small amount of
diclofenac is absorbed into the body so that the interactions described for diclofenac-containing
medicines taken orally are unlikely to happen.

Pregnancy and breast-feeding
Pregnancy
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before using this medicine.
In the first and second trimesters of pregnancy or if you want to become pregnant, Sophenoderm 140
mg medicated plaster should be used only after talking to your doctor.
In the last trimester of pregnancy, Sophenoderm 140 mg medicated plaster must not be used because
an increased risk of complications for the mother and the child cannot be ruled out (see ”Do not use
Sophenoderm 140 mg medicated plaster”).

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Breast-feeding
Small quantities of diclofenac pass into the breast mild.
Talk to your doctor before using Sophenoderm 140 mg medicated plaster during breast-feeding. In any
case, if you are breast-feeding Sophenoderm 140 mg medicated plaster should not be applied directly
onto the breast area.
Driving and using machines
Sophenoderm 140 mg medicated plaster has no influence on your ability to drive and use machines.

3.

How to use Sophenoderm 140 mg medicated plaster

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told
you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one cutaneous patch twice daily.
Attach one cutaneous patch to the painful area twice daily, in the morning and in the evening. The
maximum total daily dose is 2 cutaneous patches, even if there is more than one injured area to be
treated. Treat only one painful area at once.
Use in children and adolescents
Sophenoderm 140 mg medicated plaster is not recommended for use in children and adolescents under
16 years of age. There are insufficient data of efficacy and safety available for children and
adolescents below 16 years (see section 2).
In adolescents aged 16 years and over, if this product is required for more than 7 days for pain relief
or if the symptoms worsen your child/you is/are advised to consult a doctor.

Method of administration
For treatment on the skin (cutaneous) use only. Do not take by mouth.
Instructions for use:
1. Cut the sachet along the dotted line and remove the cutaneous patch
To apply the patch:
2. Remove one of the two protective films.

3. Apply to the area to be treated and remove the remaining protective film.

4. Apply slight pressure with the palms of your hand until complete adhesion to the
skin is achieved.

To remove the patch:

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5. Moisten the patch with water and peel away an edge of the patch and pull smoothly away from the
skin.
6. To remove any product residues, wash the affected area with water gently rubbing the area with
your fingers using a circular movement.
If necessary, the cutaneous patch can be held in place using a net bandage.
Use the cutaneous patch only on intact non-diseased skin.
Do not use the cutaneous patch together with an air-tight (occlusive) bandage.
Do not wear it when bathing or showering.
You should not divide the cutaneous patch.
Duration of use
Do not use Sophenoderm 140 mg medicated plaster for longer than 7 days.
The use of this medicine for a longer period of time needs advice and must be discussed with a
doctor.
If you have the impression that the effect of Sophenoderm 140 mg medicated plaster is too strong or
too weak, please talk to your doctor or pharmacist.
If you use more Sophenoderm 140 mg medicated plaster than you should
Please tell your doctor if significant side effects occur after incorrect use of this medicine or accidental
overdose (e.g. in children). They will be able to advise you of any action that may need to be taken.
If you forget to use Sophenoderm 140 mg medicated plaster
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, pharmacist or nurse.

4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately and stop using the patch if you notice any of the following:
sudden itchy rash (hives); swelling of the hands, feet, ankles, face, lips, mouth or throat; difficulty
breathing; drop in blood pressure or weakness.
You may experience the following side effects:
Common side effects (may affect up to 1 in 10 people):
local skin reactions, such as skin redness, burning sensation, itching, inflamed skin redness, skin rash,
sometimes with pustules or wheals.
Very rare side effects: may affect up to 1 in 10,000 people:
hypersensitivity reactions or local allergic reactions (contact dermatitis).
In patients externally using drugs from the same drug group as diclofenac, there have been isolated
reports of generalised skin rash, hypersensitivity reactions such as swelling of the skin and mucous
membranes and anaphylactic-type reactions with acute circulatory regulation disorders and light
sensitivity reactions.
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Absorption of diclofenac into the body by the skin is very low compared to the drug concentration in
the blood following oral use of diclofenac. Therefore, the likelihood of side effects occurring in the
body as a whole (such as gastrointestinal or kidney disturbances or difficulty breathing) is very low.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet.

5.

How to store Sophenoderm 140 mg medicated plaster

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 outer carton and the sachet after
”EXP”. The expiry date refers to the last day of that month.
Store below 30°C.
Store in the original package in order to protect from desiccation and light.
Keep the sachet tightly closed in order to protect from desiccation and light.
Do not use Sophenoderm 140 mg medicated plaster if you notice that it is damaged.
Used patches should be folded in half with the sticky side inwards.
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 Sophenoderm 140 mg medicated plaster contains
The active substance is diclofenac sodium.
Each cutaneous patch contains 140 mg diclofenac sodium.
The other ingredients are:
Supporting layer:
Polyester non-woven fabric
Adhesive layer:
Basic butylated methacrylate coplymer
Copolymer acrylate vinyl acetate
PEG 12 stearate
Sorbitan oleate
Liner:
Mono silicone coated paper
What Sophenoderm 140 mg medicated plaster looks like and contents of the pack
Sophenoderm 140 mg medicated plaster are white 10x14 cm sized self-adhesive patches made of nonwoven fabric on one and paper on other side.
Sophenoderm 140 mg medicated plaster is available in packs of 2, 5 and 10 patches, each in a single
sachet.
Not all pack sizes may be marketed.

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Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Novartis Consumer Health UK Limited
Park view, Riverside Way
Watchmoor Park, Camberley
Surrey GU15 3YL
United Kingdom

Manufacturer:
Novartis Consumer Health GmbH
Zielstattstr. 40
81379 Munich
Germany
SPA Italiana Laboratori Bouty
Strada Statale n. 11 Padana Superiore, km 160
20060 Cassina de’ Pecchi (MI)
Italy
This medicinal product is authorised in the Member States of the EEA under the following
names:
DE: Diclofenac-Natrium Sophena 140 mg Wirkstoffhaltiges Pflaster
BE: Sophenoderm 140 mg pleister
CZ: Sophenoderm 140 mg léčivá náplast
DK: Diclofenac Sophena
EE: Sophenoderm 140 mg ravimplaaster
EL: Diclofenac Sophena Έμπλαστρο
FI: Diclofenac Sophena 140 mg lääkelaastari
HU: Diklofenák-nátrium Sophena 140 mg gyógyszeres tapasz
LT: Diclo 140 mg vaistinis pleistras
LV: Sophenoderm 140 mg ārstnieciskais plāksteris
NO: Diklofenak Sophena 140 mg medisinert patch
PT: Voltaren Plast, 140 mg emplastro medicamentoso
SE: Diclofenac Sophena
SK: Volatren liečivá náplasť
UK : Sophenoderm 140 mg medicated plaster
This leaflet was last revised in (02/2014)

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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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