Spraymik 4% Cutaneous Spray
PACKAGE LEAFLET: INFORMATION FOR THE USER
SPRAYMIK 4% cutaneous spray
Diclofenac Sodium
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 SPRAYMIK 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 SPRAYMIK is and what it is used for
2. Before you use SPRAYMIK
3. How to use SPRAYMIK
4. Possible side effects
5. How to store SPRAYMIK
6. Further information
1. WHAT SPRAYMIK IS AND WHAT IT IS USED FOR
SPRAYMIK contains the active substance diclofenac sodium, which belongs to the group of nonsteroidal anti-inflammatory drugs (NSAID). SPRAYMIK is used to relieve the acute pain and swelling affecting small or medium-sized joints and surrounding tissues.
2. BEFORE YOU USE SPRAYMIK
Do not use SPRAYMIK
• 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 on ‘Pregnancy and breast-feeding’).
• Do not apply to the breast area if you are breast-feeding.
• If you are below 14 years of age.
Take special care with SPRAYMIK
• 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 SPRAYMIK.
• Do not sunbathe or use sunlamps whilst using this medicine.
• Discontinue use of SPRAYMIK if any skin rash develops.
• Do not cover the treated area with occlusive (waterproof or non breathable) bandages or plasters.
Children and adolescents
There are insufficient data on efficacy and safety available for children and adolescents below 14 years (see “Do not use SPRAYMIK”).
For adolescents aged14 years and over, if this product is required for more than 7 days for pain relief or if symptoms worsen the patient/parents of the adolescent is/are advised to consult a doctor.
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.
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 SPRAYMIK 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 SPRAYMIK.
SPRAYMIK must not be used during the last 3 months of pregnancy, as it could harm your unborn child or cause problems at delivery.
SPRAYMIK 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.
SPRAYMIK should only be used under medical advice, during breast-feeding as diclofenac sodium passes into breast milk in small amounts. However, SPRAYMIK 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 SPRAYMIK has no influence on the ability to drive and use machines. Important information about some of the ingredients of SPRAYMIK
- SPRAYMIK contains propylene glycol, which may cause mild localized skin irritation in some people.
- SPRAYMIK contains peppermint oil, which may cause allergic reactions.
- SPRAYMIK contains soya, if you allergic to peanut or soya, do not use this medicinal product.
3. HOW TO USE SPRAYMIK
Always use this medicine 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.
For adults and adolescents aged 14 years and over
- The usual dose is 4 to 5 pump strokes of SPRAYMIK 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.
SPRAYMIK is for external use only (cutaneous use). It must only be used on unbroken skin. It is
important to use SPRAYMIK 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.
- SPRAYMIK should be massaged gently into the skin. Wash your hands afterwards unless they are the site being treated.
- Wait until SPRAYMIK 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.
If you use more SPRAYMIK than you should
- If you use more of your medicine than you should wipe the surplus SPRAYMIK 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 SPRAYMIK
- 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, SPRAYMIK can cause side effects, although not everybody gets them.
Discontinue use of SPRAYMIK 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.
If you experience any of the following signs of allergy, STOP using SPRAYMIK 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.
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 estimatedfrom 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.
5. HOW TO STORE SPRAYMIK
- Keep this medicine out of the reach and sight of children.
- Do not use SPRAYMIK 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 SPRAYMIK after 6 months after first opening.
6. FURTHER INFORMATION What SPRAYMIK contains
- The active substance is diclofenac sodium. 1 g of SPRAYMIK 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 SPRAYMIK looks like and contents of the pack
SPRAYMIK 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
MIKA Pharma GmbH AuestraBe 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: SPRAYMIK 4% w/w cutaneous spray
Germany: SPRAYMIK 40 mg/g Spray zur Anwendung auf der Haut, Losung
This leaflet was last approved in August 2014
m1-3-1-leaflet-UK DCP.docx 4