11.6 mg / g gel Diclofenac
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.
1. What Diclofenac Apofri is and what it is used for
Diclofenac, the active substance in Diclofenac Apofri, belongs to a group of medicines called non-steroidal anti-inflammatory drugs ( NSAIDs ). Diclofenacrelieves pain and has an anti-inflammatory effect.
Diclofenac Apofri is used for mild to moderate pain associated with muscle and joint injuries, such as sports injuries.
Diclofenac Apofri is for skin use only.
Diclofenac contained in Diclofenac Apofri may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Diclofenac Apofri
Do not use Diclofenac Apofri
– 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 Diklofenak Apofri.
– Consult a doctor before starting treatment with Diklofenak Apofri if you have impaired kidney, heart, liver, or stomach ulcers.
– Do not use Diclofenac Apofri 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 Apofri is for skin use only. Diclofenac Apofri must never be swallowed.
– Avoid direct sunlight and tanning beds on the treated area during treatment and at least two weeks after the end of treatment. For example. by covering the treated area with clothing.
– Discontinue treatment if you get a rash.
– The risk of side effects increases with time. The recommended treatment time should therefore not be exceeded.
Children and young people
Diclofenac Apofri should not be used in children and adolescents under 14 years of age.
Other medicines and Diclofenac Apofri
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding, and fertility
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 Apofri during the last three months of pregnancy. The use of Diclofenac Apofri 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 Apofri during the latter part of pregnancy can cause problems during childbirth and affect the development and health of the unborn baby.
Small amounts of diclofenac pass into breast milk. Diclofenac Apofri should only be used during breast-feeding if prescribed by a doctor.
Driving and using machines
Diclofenac Apofri does not affect your ability to drive or use machines.
Diclofenac Apofri contains propylene glycol
Propylene glycol can cause skin irritation.
How to use Diclofenac Apofri
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 your hands afterward to avoid accidental contact with the 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 Diclofenac Apofri 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 Apofri
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 Diklofenak Apofri and contact a doctor immediately if swelling of e.g. 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 in 10,000 people): photosensitivity reactions in the skin, asthma, rash with hot blisters, 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 Diclofenac Apofri
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
Content declaration
– 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 Apofri 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
Apofri AB
Box 120
182 12 Danderyd
Tel .: 08-544 960 30
Manufacturer
Kern Pharma SL
Polygono Ind. Colon II
Venus, 72, 08228 Terrace Barcelona
Spain