Document: leaflet MAH BRAND_PL 00030-0447 change

• leaflet MAH BRAND_PL 00030-0447
• leaflet MAH BRAND_PL 44673-0160

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Read all of this leaflet carefully because it contains important information for you.

Always use Voltarol 12 Hour Emulgel 2.32% Gel exactly as described in this leaflet. You should check with your doctor or pharmacist if you are not sure.

•    This medicine is available without prescription. However, you still need to use Voltarol 12 Hour Emulgel carefully to get the best results from it. Note that this leaflet is revised on a regular basis with the latest information on your medicine.

Please refer to the date at the end of the leaflet.

•    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 signs of illness worsen or do not improve after 7 days.

•    If you get any side effects which worry you (even side effects not listed in this leaflet), talk to your doctor or pharmacist.

In this leaflet

1.    What Voltarol 12 Hour Emulgel is and what it is used for

2.    What you need to know about Voltarol 12 Hour Emulgel

3.    How to use Voltarol 12 Hour Emulgel

4.    Possible side effects

5.    How to store Voltarol 12 Hour Emulgel

6.    What is in the pack and further information

1.    What Voltarol 12 Hour Emulgel is and what it is used for

Voltarol 12 Hour Emulgel contains the active substance diclofenac which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It is specially formulated for rubbing into the skin. Voltarol 12 Hour Emulgel is used to relieve pain and reduce inflammation and swelling in a number of painful conditions affecting the joints and muscles.

Voltarol 12 Hour Emulgel can be used to treat: muscle and joint injuries (e.g. sprains, strains, bruises, backache, sports injuries), relieving pain and helping recovery back to normal function; tendonitis (e.g. tennis elbow), swelling around elbow or knee;

Voltarol 12 Hour Emulgel is intended for use in adults and children aged over 14 years.

2.    What you need to know about Voltarol 12 Hour Emulgel

Do not use Voltarol 12 Hour Emulgel if you:

•    are allergic (hypersensitive) to diclofenac or other medicines used to treat pain, fever or inflammation, such as ibuprofen or aspirin (a substance also used to prevent blood clotting), or any of the other ingredients of this medicine (see Section 6 and end of Section 2). If you are not sure, ask your doctor or pharmacist.

Symptoms of an allergic reaction may include: wheezing or shortness of breath (asthma); skin rash with blisters or hives; swelling of the face or tongue; runny nose.

•    are using any other medicine containing diclofenac or are taking oral NSAIDs such as aspirin or ibuprofen.

•    have severe joint pain of recent onset that is not related to an injury or period of overuse.

•    feel ill, have a temperature or any other symptoms that accompany the pain.

•    are in the last 3 months of pregnancy.

If any of these apply to you, do not use Voltarol 12 Hour Emulgel.

Take special care with Voltarol 12 hour Emulgel

•    Do not apply the gel to skin that has (i) a rash or eczema (ii) cuts or open wounds. Stop the treatment if a skin rash develops after applying the product. Avoid applying on large areas of skin and over a prolonged period of time, unless under medical advice.

•    Voltarol 12 Hour Emulgel is for external use only.

Do not use it in the mouth. Do not swallow it.

Wash your hands after use unless they are the area to be treated. Be careful not to get Voltarol 12 Hour Emulgel in your eyes. If this happens, rinse your eyes well with clean water.

See your doctor or pharmacist if any discomfort persists.

•    A brace or wrap commonly used for injuries like sprains can be used, but do not use the gel under airtight (plastic) bandages.

•    If you have or have ever had asthma speak to your doctor or pharmacist before using the gel.

•    If you have a stomach or duodenal ulcer (or a history of), tell your doctor or pharmacist before using the gel.

If you have any questions, talk to your doctor or pharmacist before using Voltarol 12 Hour Emulgel

This medicine is not recommended for use in children under 14 years of age.

Taking other medicines with Voltarol 12 Hour Emulgel

Please tell your doctor or pharmacist if you are taking, or have recently taken, or want to start taking any other medicines, including those obtained without a medical prescription.

Pregnancy and breast-feeding

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.

Voltarol 12 Hour Emulgel must not be used during the last 3 months of pregnancy, as it could harm your unborn child or cause problems at delivery. Voltarol 12 Hour Emulgel 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 12 Hour Emulgel should only be used under medical advice during breast-feeding as diclofenac passes into breast milk in small amounts. However, Voltarol 12 hour Emulgel 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 breastfeeding.

Effects of other ingredients (excipients)

Voltarol 12 Hour Emulgel contains:

•    propylene glycol, which may cause a mild localised skin irritation in some people.