Skip to Content

SPRAYMIK 4% CUTANEOUS SPRAY

Active substance(s): DICLOFENAC SODIUM

View full screen / Print PDF » Download PDF ⇩
Transcript
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
x 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.
x 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).
x If you are in the last 3 months of pregnancy (see section on ‘Pregnancy and breast-feeding’).
x Do not apply to the breast area if you are breast-feeding.
x If you are below 14 years of age.
Take special care with SPRAYMIK
x If you have or have had stomach ulcers, liver or kidney problems, a tendency for bleeding or
inflammatory bowel disease.
x If you have ever suffered from bronchial asthma or any other allergies.
x Avoid applying on large areas of skin and over a prolonged period of time, unless under medical
advice.
x 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.
x Never swallow SPRAYMIK.
x Do not sunbathe or use sunlamps whilst using this medicine.
x Discontinue use of SPRAYMIK if any skin rash develops.
x Do not cover the treated area with occlusive (waterproof or non breathable) bandages or plasters.
Children and adolescents
m1-3-1-leaflet-UK_DCP.docx

1

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.
m1-3-1-leaflet-UK_DCP.docx

2

-

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
estimated from available data):
Application site reaction, dry skin, burning sensation
m1-3-1-leaflet-UK_DCP.docx

3

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
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: SPRAYMIK 4% w/w cutaneous spray
Germany: SPRAYMIK 40 mg/g Spray zur Anwendung auf der Haut, Lösung
This leaflet was last approved in August 2014

m1-3-1-leaflet-UK_DCP.docx

4

Expand view ⇕

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.

Hide