11.6 mg / g gel 
diclofenac diethylamine

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, pharmacist, or nurse. 

  • Save this information, you may need to read it again.
  • Contact the pharmacy staff if you need more information or advice.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse.
  • You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

In this leaflet: 
1. What Diclofenac Orifarm is and what it is used for 
2. What you need to know before you use Diclofenac Orifarm 
3. How to use Diclofenac Orifarm 
4. Possible side effects 
5. How to store Diclofenac Orifarm 
6. Contents of the pack and other information 

What Diclofenac Orifarm is and what it is used for

Diclofenac, the active substance in Diclofenac Orifarm gel, belongs to the group of non-steroidal anti-inflammatory drugs ( NSAIDs ). Diclofenac relieves pain and has an anti-inflammatory effect.

Diclofenac Orifarm is used for mild to moderate pain in connection with the muscle and joint injuries, such as sports injuries.

Diclofenac Orifarm gel is for external use only.

You need to talk to a doctor if you do not feel better or if you feel worse.

Diclofenac contained in Diclofenac Orifarm 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.

You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

What you need to know before you use Diclofenac Orifarm

Do not use Diclofenac Orifarm

  • if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6).
  • if you are hypersensitive (allergic) to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs ( NSAIDs ). If you are not sure, ask your doctor or pharmacist.
  • if you have previously had symptoms of swelling of the face or tongue ( angioedema ), wheezing or shortness of breath ( asthma ), hives or rash ( urticaria), or runny nose ( acute rhinitis ) after using acetylsalicylic acid or another NSAID.
  • after 6 months of pregnancy.
  • if you are younger than 14 years.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Diclofenac Orifarm.

  • if you suffer from renal impairment, impaired heart function, or impaired liver function.
  • if you have an active stomach ulcer.
  • if you are using another NSAID.
  • if you are older, as the risk of side effects is higher then.
  • if you are exposed to direct sunlight or artificial sunlight as there is a risk of skin reactions. Avoid direct sunlight and tanning beds on the treated area during the treatment and at least two weeks after the end of the treatment.

Diclofenac Orifarm must not be used on damaged skin, e.g. eczema, acne, infected skin, open sores, or burns.

Avoid contact with eyes and mucous membranes. Gel one must never be swallowed.

Do not use more gel than recommended or for a long time as it may increase the risk of side effects.

Discontinue treatment with Diclofenac Orifarm if rash occurs after application.

Do not use Diclofenac Orifarm gel with airtight bandages. When sprained, the joint can be wound, but not so hard that the blood circulation is restricted.

Other medicines and Diclofenac Orifarm

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Because Diclofenac Orifarm is used on the skin, absorption of diclofenac into the blood is low. Therefore, the risk of interaction with other drugs is small.

Pregnancy and breastfeeding

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.

Pregnancy

The use of Diclofenac Orifarm 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. Pregnant women should not use Diclofenac Orifarm during the last three months of pregnancy.

Breast-feeding 

Small amounts of diclofenac pass into breast milk. Diclofenac Orifarm should only be used during breast-feeding if prescribed by a doctor. Diclofenac Orifarm should not be applied to the breasts of nursing mothers or elsewhere on large skin surfaces or for a long time.

Driving and using machines

Diclofenac Orifarm does not affect your ability to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Diclofenac Orifarm contains propylene glycol

Diclofenac Orifarm contains 50 mg of propylene glycol per gram of gel, which may cause skin irritation.

3. How to use Diclofenac Orifarm

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.

Recommended dose:

Adults and adolescents 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 grams per day. Gently massage the gel into the skin on the painful or inflamed area. When a gel is massaged in, you can feel a slight cooling feeling. Contact a doctor if symptoms worsen or do not improve within 7 days.

After use

Wash your hands after massaging Diclofenac Orifarm unless your hands are being treated. Diclofenac Orifarm should only be used on the skin.

Use for children

Diclofenac Orifarm should not be used in children and adolescents under 14 years of age.

If you use more Diclofenac Orifarm then you should 

An overdose is unlikely to occur if you use too much Diclofenac Orifarm because absorption is low in the blood.

If you happen to swallow a gel, contact your doctor or pharmacist.

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects are often mild skin reactions at the treatment site that go back. In rare cases, allergic reactions may occur. If this happens, stop using Diclofenac Orifarm and contact your doctor immediately.

Stop using Diclofenac Orifarm immediately if you experience swelling of the face, mouth, tongue, or throat, which may also make it difficult to breathe. Contact a doctor immediately if you experience these symptoms. 

Common (may affect up to 1 in 10 people):

Skin rash, eczema, skin redness, dermatitis (including contact dermatitis ), and itching.

Uncommon (may affect up to 1 in 100 people):

Skin redness, spotty bleeding in the skin, allergic eczema, and burning sensation at the treatment area.

Rare (may affect up to 1 in 1,000 people):

Skin inflammation with blistering (bullous dermatitis )

Very rare (may affect up to 1 in 10,000 people):

Rash with blisters (pustular rash), hypersensitivity including hives, swelling of the face, throat, tongue, and eyes ( angioedema ) which can be severe and include difficulty breathing, photosensitivity reactions, dry skin, asthma, and bronchospasm.

Has been reported (occurs in an unknown number of users):

Severe allergic (anaphylactic) reactions can be serious.

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

5. How to store Diclofenac Orifarm

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. dat / EXP. The expiration date is the last day of the specified month.

Medicines 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 11.6 mg, which is equivalent to 10 mg of diclofenac sodium.
  • The other ingredients are carbomer, cocoyl caprylocaprate, diethylamine, isopropyl alcohol, macrogol acetostearyl ether, liquid paraffin, propylene glycol, and purified water.

What the medicine looks like and the contents of the pack

Diclofenac Orifarm is a white gel .

Pack sizes: Aluminum tubes with 50, 100 g, or 2×100 g.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Orifarm Generics A / S

Energivej 15

5260 Odense S

Denmark

Local representative:

Orifarm Generics AB,

Box 56048,

102 17 Stockholm

info@orifarm.com

Muhammad Nadeem

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