Package leaflet: Information for the user
Diclofenac Orifarm, 11.6 mg/g gel
diclofenac diethylamin
Read all of this leaflet carefully before you start using this medicine because it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told
you.Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet.
You must talk to a doctor if you do not feel better or if you feel worse within 7 days.
What is 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
1.
What Diclofenac Orifarm is and what it is used for
Diclofenac Orifarm is a gel that contains diclofenac, which is a non-steroidal anti-inflammatory drug
(NSAID). Diclofenac reduces pain and have an anti-inflammatory effect.
Diclofenac Orifarm is used for treatment of local pain of mild to moderate intensity in connection with
inflammation or muscle- og joint injury.
Diclofenac Orifarm is only intended for cutaneous use.
You must talk to a doctor if you do not feel better or if you feel worse.
2.
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 allergic (hypersensitive) to acetylsalicylic acid or other NSAID.
if you have a history of symptoms of asthma, urticaria (hives) or acute rhinitis (runny nose) after using
acetylsalicylic acid or other NSAID.
if you are more than 6 months pregnant.
if you have damaged skin e.g. eczema, acne, infected skin, open wounds or burns.
if you are younger than 14 years.
Warnings and precautions
Talk to your doctor or pharmacist before taking Diclofenac Orifarm
if you suffer from reduced kidney function, reduced heart function or reduced liver function.
if you have an active peptic ulcer.
if you are using other NSAID.
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if you are elderly, as the risk of side effects is higher.
if you are exposed to direct sunlight or artificial sun as there is a risk of skin reactions. You should
avoid sunlight or artificial sun during treatment and for two weeks after stopping treatment.
Contact with eyes and mucosa should be avoided. The gel must not be eaten.
The recommended treatment duration should not be exceeded because of the risk of side effects increases
over time.
If you develop a rash at any time during treatment you should stop using Diclofenac Orifarm.
Diclofenac Orifarm is not intended for use with occlusive bandages. Joint strains can be supported by
bandage, but the winding must not be so hard that the blood circulation is stopped.
Other medicines and Diclofenac Orifarm
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
Because Diclofenac Orifarm is used on the skin the absorption of diclofenac into the blood stream is low.
Therefore the risk of interactions with other medicinal producs is small.
Use of Diclofenac Orifarm while using acetylsalicylic acid or other NSAID may increase the risk of side
effects.
Pregnancy, breast-feeding 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.
Pregnancy
You must not use Diclofenac Orifarm if you are more than 6 months pregnant.
Lactation
Diclofenac passes into mother milk. However, effects on the baby seem unlikely with therapeutic doses for
the mother. Diclofenac Orifarm should not be applied to the breasts or to large areas of skin if you are breastfeeding.
Driving and using machines
Diclofenac Orifarm does not affect the ability to drive or operate machinery.
Diclofenac Orifarm contains propylenglycol
Diclofenac Orifarm contains propyleneglycol which may cause skin irritation.
3.
How to use Diclofenac Orifarm
Adults and adolescents above the age of 14 years
Apply Diclofenac Orifarm gel 3-4 times a day. Massage the gel gently into the skin where the pain or
inflammation is localised. The amount you need is dependent on the size of the area you are treating.
Normally 2-4 g (corresponding to 6-12 cm gel) is sufficient. The maximum dose is 16 g per day. You may
experience a slight cooling when the gel is rubbed in.
After use
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Wash your hands after you have rubbed in Diclofenac Orifarm unless you intend to treat your hands.
Children under 14 years of age:
Diclofenac Orifarm is not recommended for children under 14 years of age.
Contact your doctor if your symptoms have not improved within 7 days.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
Check with your doctor or pharmacist if you are not sure.
If you use more Diclofenac Orifarm than you should
An overdose is unlikely to happen if you use more Diclofenac Orifarm than you should, because the
absorption into the blood stream is low.
If you by accident swallow the gel you should contact 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 often mild and reversible skin reactions at the treatment site. In rare cases allergic
reactions can occur. If this happens you should stop using Diclofenac Orifarm and contact your doctor
immediately.
Stop using Diclofenac Orifarm immediately if you experience swelling of the face, mouth, tongue or throath,
which may also include breathing difficulties. Contact your doctor immediately if you experience these
symptoms.
Common (occurs in less than 1 out of 10 and more than 1 out 100 patients):
Rash, eczema, redness of the skin, dermatitis (including contact dermatitis), itching.
Uncommon (occurs in less than 1 out of 100 and more than 1 out of 1000):
Skin redness, point forned bleedings in the skin, allergic eczema, burning sensation at the treatment site.
Rare (occurs in less than 1 out of 1000 and more than 1 out of 10000 patients):
Blisters on the skin (bullous dermatitis).
Very rare (occurs in less than 1 out of 10000 patients)
Blistering rash (pustular rash), hypersensitivity including urticaria, swelling of face, throat, tongue and eyes
(angioedema) which may be serious and can include breathing difficulties, light sensitivity reactions,
urticaria, dry skin, asthma, bronchospasm.
Unknown frequency:
Severe allergic (anaphylactic) reactions which may be serious.
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this
leaflet.
5.
How to store Diclofenac Orifarm
Keep this medicine out of the sight and reach of children.
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Do not use this medicine after the expiry date which is stated on the package after EXP.The expiry date
refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.
6.
Content of the pack and other information
What Diclofenac Orifarm contains
- The active substance is: Diclofenac diethylamine 11.6 mg/g, which corresponds to 10 mg/g of diclofenac
sodium.
- The other ingredients are: carbomers, cocoyl caprylocaprate, diethylamine, isopropyl alcohol, magrogol
cetostearyl ether, liquid paraffin, propylene glycol and purified water.
What Diclofenac Orifarm looks like and contents of the pack
Diclofenac Orifarm is a white gel.
Pack sizes: Aluminium tubes of 50 g or 100 g.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Orifarm Generics A/S
Energivej 15, POB 69
DK-5260 Odense S
Denmark
Email: info@orifarm.com
This medicinal product is authorised in the Member States of the EEA under the following names:
Denmark and Sweden
Diclofenac Orifarm
This leaflet was last revised in
2012-09-28
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