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 because it contains important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4
What is in this leaflet:
1. What Mobigel® Spray is and what it is used for
2. What you need to know before you use Mobigel® Spray
3. How to use Mobigel® Spray
4. Possible side effects
5. How to store Mobigel® Spray
6. Contents of the pack and otherinformation
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. What you need to know 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 this medicine (listed in section 6).
• 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.
Warnings and precautions
Talk to your doctor or pharmacist before using 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.
Other medicines and Mobigel® Spray
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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 pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
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.
Driving and using machines
Cutaneous application of Mobigel® Spray has no influence on the ability to drive and use machines. Mobigel® Spray 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.
3. How to use Mobigel® Spray
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
• Adults and children aged 14 years and over: The recommended 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 in an upright position of the bottle 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 medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side-effects, although not everybody gets them.
• 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 10,000people).
• Wheezing, shortness of breath or feeling of tightness in the chest (asthma) (may affect less than 1 in every 10,000people).
• Swelling of the face, lips, tongue or throat (may affect less than 1 in every 10,000people).
• 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.
o Some side effects are common (may affect between 1 and 10 in every 100 people):
Skin rash, itching, reddening or smarting of the skin.
o 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.
o 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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at website : www .mhra.gov .uk/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
5. How to store Mobigel® Spray
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label, 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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicinesyou no longer use. These measures will help protect the environment.
6. Contents of the pack and other 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 medicinal product is authorised in the Member States of the EEA under the following names:
|
United Kingdom |
Mobigel Spray cutaneous spray, solution |
|
Czech Republic |
DIKY 4% |
|
Finland |
Eeze 4% spray gel |
|
France |
Synthoflex 4%; solution pour pulverisation cutanee |
|
Poland |
Diky 4% |
|
Portugal |
Diclospray |
|
Slovakia |
DIKY 4% Spray Gel |
This leaflet was last revised in February 2015.
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