Mobigel Spray 4% W/W Cutaneous Spray Solution
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Mobigel Spray
4% w/w cutaneous spray, solution
_Diclofenac sodium_
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 any further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you. Do 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 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 Mobigel Spray is and what it is used for
2. Before you use Mobigel Spray
3. How to use Mobigel Spray
4. Possible side effects
5. How to store Mobigel Spray
6. Further information
1. What Mobigel Spray is and what it is used for
Mobigel Spray contains the active substance diclofenac sodium, which belongs to the group of nonsteroidal anti-inflammatory drugs (NSAID). Mobigel Spray is used to relieve the acute pain and swelling affecting small or medium-sized joints and surrounding tissues.
2. Before you use Mobigel Spray
Do not use Mobigel Spray
• If you are allergic (hypersensitive) to diclofenac sodium, peanut, soya or any of the other ingredients of Mobigel Spray.
• If you have ever had an allergic reaction to aspirin (acetylsalicylic acid) or any other NSAID such as ibuprofen with difficulty in breathing, skin rash and runny nose.
• In the last three months of pregnancy - please see section on pregnancy and breast-feeding.
• On the breast area if you are breast-feeding.
• In children and adolescents under 14 years of age.
Take special care with Mobigel Spray
• If you have or have had stomach ulcers, liver or kidney problems, a tendency for bleeding or inflammatory bowel disease.
• If you have previously suffered from bronchial asthma or 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, in the genital area 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 Mobigel Spray.
• Do not sunbathe or use sunlamps whilst using this medicine.
• Discontinue use of Mobigel Spray if any skin rash develops.
• Do not cover the treated area with occlusive (waterproof or non breathable) bandages or plasters.
If you are not sure what to do, ask your doctor or pharmacist.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Speak to your doctor before you use Mobigel Spray:
• If you are taking tablets, capsules or suppositories for pain including any containing diclofenac sodium, acetylsalicylic acid or any other anti-inflammatory agent, as for example ibuprofen. The use of other NSAIDs (including acetylsalicylic acid or ibuprofen) at the same time as Mobigel 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 Mobigel Spray.
Mobigel Spray must not be used during the last 3 months of pregnancy, as it could harm your unborn child or cause problems at delivery.
Mobigel 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.
Mobigel Spray should only be used under medical advice, during breast-feeding as diclofenac sodium passes into breast milk in small amounts. However, Mobigel 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 Mobigel Spray has no influence on the ability to drive and use machines.
Important information about some of the ingredients of Mobigel Spray
This medicinal product contains:
• propylene glycol (E1520) which may cause mild localised skin irritation in some people
• peppermint oil which may cause allergic reactions
• soya, if you are allergic to peanut or soya, do not use this medicinal product.
Always use Mobigel Spray exactly as your doctor has told you. You should check with your doctor or
3. How to use Mobigel Spray
pharmacist if you are not sure.
• Adults and children aged 14 years and over: The usual dose is 4 to 5 strokes of Mobigel Spray applied 3 times daily. The number of strokes depends on the size of the affected area. The maximum number of pump strokes is 15 times daily. The maximum single dose should not exceed 5 pump strokes.
• Remove the protective cap.
• Apply the prescribed number of spray strokes onto the painful or swollen site.
• Mobigel Spray should be massaged gently into the skin. Wash your hands afterwards unless they are the site being treated.
• Wait until Mobigel Spray has dried before covering the skin with clothes or bandage. Take care as the spray can stain your clothes if wet.
• Discontinue treatment when your symptoms (pain and swelling) improve. Do not use for more than 7 days without consulting your doctor.
• If there is no improvement in your symptoms after 3 days, or if your symptoms worsen, talk to a doctor.
If you use more Mobigel Spray than you should
• If you use more of your medicine than you should wipe the surplus Mobigel Spray off with a tissue.
• If you swallow some of the spray inform your doctor immediately or go to the nearest hospital casualty. Take the bottle and this leaflet with you.
If you forget to use Mobigel Spray
• Use the spray as soon as you remember, but do not apply more than the recommended dose at once. 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 product, ask your doctor or pharmacist.
4. Possible Side Effects
Like all medicines, Mobigel Spray can cause side-effects, although not everybody gets them.
• Discontinue use of Mobigel Spray if any skin rash develops. Following the use of 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.
• If you experience any of the following signs of allergy, STOP using Mobigel 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).
• Some side effects are common (may affect between 1 and 10 in every 100 people):
Skin rash, itching, reddening or smarting of the skin.
• 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 the available data):
Application site reaction, dry skin, burning sensation.
If the product is used for a long time (longer than three weeks) and/or it is used on large areas of the skin, systemic side effects such as stomach pain and disorders, heartburn and kidney problems may occur.
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.
5. How to store Mobigel Spray
Keep out of the reach and sight of children.
Do not use Mobigel Spray after the expiry date which is 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 Mobigel Spray after 6 months after first opening.
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 Mobigel Spray contains
The active substance is diclofenac sodium 4 % (w/w).
The other ingredients are: isopropyl alcohol, soy bean lecithin, ethanol, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, disodium edetate, propylene glycol (E1520), peppermint oil, ascorbyl palmitate, hydrochloric acid 10 % (w/w) or sodium hydroxide 10 % (w/w) (for pH-adjustment) and purified water.
What Mobigel Spray looks like and contents of the pack
Mobigel Spray is a golden-yellow, transparent solution, which turns to a gel-like consistency after administration. Each bottle contains 7.5 g, 12.5 g or 25 g cutaneous spray, solution. Not all pack sizes may be marketed.
Marketing Authorisation Holder
MIKA Pharma GmbH,
Auestrasse 39, 67346 Speyer, Germany.
Manufacturer
Pharbil Waltrop GmbH, Im Wirrigen 25, 45731 Waltrop, Germany.
This leaflet was last revised in 06/2012.