11.6 mg / g gel
Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.
– Save this information, you may need to read it again.
– If you need further information or advice, ask your doctor or pharmacist.
– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.
– You must talk to a doctor if you do not feel better or if you feel worse after 7 days.
In this leaflet you will find information about:
1. What Diklofenak ABECE is and what it is used for
2. What you need to know before you use Diklofenak ABECE
3. How to use Diklofenak ABECE
4. Possible side effects
5. How to store Diklofenak ABECE 6. Contents of the pack
and other information
1. What Diclofenac ABECE is and what it is used for
Diclofenac, the active substance in Diclofenac Abece, belongs to a group of medicines called non-steroidal anti-inflammatory drugs ( NSAIDs ). Diclofenacrelieves pain and has an anti-inflammatory effect.
Diclofenac Abece is used for mild to moderate pain in connection with the muscle and joint injuries, such as. sports injuries.
Diclofenac Abece is for skin use only.
Diclofenac contained in Diclofenac Abece may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Diclofenac ABECE
Do not use Diclofenac ABECE
- if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6).
- if you have had an allergic reaction to acetylsalicylic acid or any other anti-inflammatory drug ( NSAID ). Symptoms of an allergic reaction may include wheezing or shortness of breath ( asthma ), difficulty breathing, swelling of the face or tongue, rash, or runny nose.
- during the last three months of pregnancy (see “Pregnancy, breast-feeding and fertility”).
Warnings and cautions
Talk to your doctor or pharmacist before using diclofenac Abece.
- Talk to your doctor before starting treatment with Diclofenac Abece if you have impaired kidney, heart, liver, or stomach ulcers.
- Do not use Diclofenac Abece with airtight bandages. When sprained, the joint can be wound, but not so hard that the blood circulation is restricted.
- Avoid contact with eyes and mucous membranes.
- Do not use on damaged or infected skin, e.g. eczema, acne, or open sores.
- Diclofenac Abece is for skin use only. Diclofenac Abece must never be swallowed.
- Avoid direct sunlight and solarium on the treated area during treatment and at least two weeks after completion of treatment. For example. by covering the treated area with clothing.
- Discontinue treatment if you get a rash.
- The risk of side effects increases over time. The recommended treatment time should therefore not be exceeded.
Children and young people
Diclofenac Abece should not be used in children and adolescents under 14 years of age.
Other medicines and Diclofenac ABECE
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Diclofenac ABECE with food, drink, and alcohol
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 taking this medicine.
Pregnant women should not use Diclofenac Abece during the last three months of pregnancy. The use of Diclofenac Abece should be avoided by women who are planning to become pregnant or are pregnant. Treatment during any part of the pregnancy should only be done after a doctor’s prescription.
The use of Diclofenac Abece during the latter part of pregnancy may cause problems during childbirth and affect the development and health of the unborn baby.
Small amounts of diclofenac pass into breast milk. Diclofenac Abece should only be used during breast-feeding if prescribed by a doctor.
Driving and using machines
Diclofenac Abece does not affect your ability to drive or use machines.
Diclofenac ABECE contains propylene glycol
Propylene glycol can cause skin irritation.
How to use Diclofenac ABECE
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is:
Adults and young people over 14 years
2 to 4 g (6 to 12 cm gel strand) is applied 3 to 4 times daily. Do not use more than 16 g per day. Gently massage the gel into the skin on the painful or inflamed area.
You may experience a slight cooling sensation when the gel is massaged in.
- Wash hands afterward to avoid accidental contact with mouth and eyes, provided, of course, that it is not the hands that are to be treated.
- Contact a doctor if symptoms worsen or do not improve within 7 days. The treatment should not last longer than 14 days other than on the advice of a doctor.
If you use more Diklofenak ABECE then you should
If you have used too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you forget to use Diclofenac ABECE
Use gel one as soon as you remember, but do not take a double dose to make up for a forgotten dose. Then continue dosing one as before.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects are usually mild and transient skin reactions at the treatment site. In rare cases, allergic reactions may occur.
Stop using Diclofenac ABECE doctor immediately if you experience swelling of among others face, tongue and/or throat or hives, shortness of breath, and difficulty swallowing occur.
Common (affects more than 1 user in 100): Rash, eczema, reddening of the skin and inflammation of the skin, and itching where the gel has been applied.
Rare (affects less than 1 in 1,000 people): Skin inflammation with blistering where the gel has been applied.
Very rare (affects less than 1 user in 10,000):
Photosensitivity reactions in the skin, asthma, rash with swollen bladders, hypersensitivity reactions (including hives ), and angioedema (swelling of the skin and mucous membranes, eg in the face and finger joints).
Has been reported (occurs in an unknown number of users): Burning sensation at the application site, dry skin.
5. How to store Diklofenak ABECE
Keep this medicine out of the sight and reach of children.
Do not store above 30 ° C.
Used before the expiration date specified after the Expiration Date. on the box and the tube. The expiration date is the last day of the specified month.
Once the tube has been opened, cream one should be used within 1 year.
The medicine 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. Contents of the packaging and other information
- The active substance is diclofenac diethylamine. 1 g of gel contains 11.6 mg (1.16%) of diclofenac diethylamine, equivalent to 10 mg of diclofenac sodium.
- The other ingredients are propylene glycol, isopropyl alcohol, diethylamine, liquid paraffin, macrogol acetostearyl ether, carbomer, cocoyl caprylocaprate, perfume, water.
What the medicine looks like and the contents of the pack
Diclofenac Abece is a white, viscous gel .
The product is available in tubes of 60 g and 100 g.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Evolan Pharma AB
182 12 Danderyd
Tel .: 08-544 960 30
Kern Pharma SL
Polygono Ind. Colon II
Venus, 72, 08228 Terrace Barcelona