1.
NAME OF THE MEDICINAL PRODUCT
Diclofenac Orifarm, 11.6 mg/g gel.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 gram Diclofenac Orifarm gel contains 11.6 mg (1.16%) diclofenac diethylamine, which corresponds to 10
mg of diclofenac sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gel.
A white gel.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
For symptomatic treatment of local pain of mild to moderate intensity in connection with inflammation or
muscle or joint injury.
4.2
Posology and method of administration
Adults and adolescents above the age of 14 years
Diclofenac Orifarm gel is applied to the affected area 3 to 4 times a day and is gently rubbed into the skin.
The amount of gel is dependent on the area of the affected area. 2 to 4 g of Diclofenac Orifarm
(corresponding to 6-12 cm gel) is sufficient to treatment of an area of 400 – 800 cm2. The maximal daily
dose is 16 g gel. Wash your hands after application unless the affected area is on the hands.
Treatment of acute, minor muscle or join injuries should only continue longer than 7 days after agreement
with a doctor.
Children below the age of 14 years
Diclofenac Orifarm is not recommended for children below the age of 14 years due to lack of data regarding
safety and efficacy. (See section 4.3 Contraindications.)
Elderly
No dosage adjustment is necessary.
4.3
Contraindications

Hypersensitivity to diclofenac or to any of the excipients listed in section 6.1.
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


Hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
Patients with a history of symptoms of asthma, urticaria or acute rhinitis after using acetylsalicylic
acid or other non-steroidal anti-inflammatory drugs.
Third trimester of pregnancy (see section 4.6)
The gel should not be used on pathologically changed skin, e.g. eczema, acne, infected skin or open
wounds or burns.
Should not be used for children and adolescents under the age of 14 years.
4.4
Special warnings and precautions for use


Contact with eyes and mucosa must be avoided and the medicinal product must not be taken orally.
Direct sunlight or artificial sun should be avoided during treatment and two weeks after treatment to avoid
the risk of photosensibility.
The recommended treatment duration should not be exceeded because the risk of developing contact
dermatitis increases over time.
If a rash develops at any time during treatment the treatment should be stopped.
The risk of systemic side effects caused by treatment with Diclofenac Orifarm cannot be excluded if the
medicinal product is used on a large area of skin and for a longer duration. The gel should therefore be used
with caution by patients with reduced renal function, reduced heart function or reduced liver function as well
as patients with active peptic ulcers in the stomach or duodenum.
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.
Concomitant use of Diclofenac Orifarm and NSAID may increased the systemic adverse reactions and
therefore the combination must be used with caution.
Special attention should be given to the use of NSAID in elderly patients, as this group has a higher risk of
developing adverse reactions.
Diclofenac Orifarm contains propyleneglycol which may lead cause skin irritation.
4.5
Interaction with other medicinal products and other forms of interaction
The systemic absorption of diclofenac from cutaenous gel treatment is very low. Therefore the risk of
interactions with other medicinal products is small.
Concomitant use of acetylsalicylic acid or other NSAID may lead to an increased risk of side effects.
4.6
Fertility, pregnancy and lactation
Systemic concentrations of diclofenac are lower after use of Diclofenac Orifarm gel compared with
oral preparations. The following recommendations apply to drug forms that result in systemic
uptake:
Pregnancy
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Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo-foetal
development when an NSAID is used. Data from epidemiological studies suggest an increased risk
of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis
inhibitor in early pregnancy. The absolute risk of cardiovascular malformation was increased from
less than 1% to approximately 1.5 %. The risk is believed to increase with a higher dose and
duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been
shown to result in increased pre- and post implantation loss and embryo-foetal lethality. In addition,
increased incidence of various malformations, including cardiovascular malformations, has been
reported in animals exposed to a prostaglandin synthesis inhibitor during the organogenetic period.
Topical use of Diclofenac Orifarm gel produces very low systemic blood levels. Nevertheless,
Diclofenac Orifarm gel should only be used if absolutely necessary during the first and second
trimester of pregnancy. The dose and the duration of therapy should be as low and as short as
possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus
to:
Cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary
hypertension)
Renal dysfunction, which may progress to renal failure with oligo-hydroamniosis.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the
mother and foetus, at the end of pregnancy, to:
Prolongation of bleeding time, due to an anti-aggregating effect on thrombocytes, which may
occur even at very low doses.
Inhibition of uterine contractions, which may result in delayed or prolonged labour.
In light of the above, Diclofenac Orifarm is contraindicated during the third trimester of pregnancy.
Breast-feeding
Diclofenac is secreted into human milk, but risk of affecting the child appears unlikely when
therapeutic doses are administered to the mother.
Diclofenac Orifarm must not be applied to the breasts of lactating women.
4.7
Effects on ability to drive and use machines
Diclofenac Orifarm has no influence on the ability to drive and use machines.
4.8
Undesirable effects
Like all medicines Diclofenac Orifarm can lead to side effects, although not everybody gets them.
The side effects are listed below according to system organ class and frequency. The frequencies are defined
as: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100),
Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000) and Not known (cannot be estimated from the available
data.
System organ class
Infections and infestations
Immune system disorders
Frequency
Very rare
Very rare
Reaction
Pustular rash
Hypersensitivity (including
urticaria), angioedema
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Skin and subcutaneous tissue
disorder
Unknown frequency
Common
Uncommon
Rare
Very rare
Respiratory, thoracic and
mediastinal disorders
General disorders and
administration side conditions
Very rare
Uncommon
Anaphylactic reactions
Rash, eczema, erythema,
dermatitis (including contact
dermatitis), pruritus
Redness, petechia, allergic
dermatitis
Bullous dermatitis
Light sensitivity reactions,
urticaria, dry skin
Asthma, bronchospasm
Burning sensation at the
application site
There is a risk of systemic reactions in long-term treatment (> 3 weeks) or when large areas of skin is treated
(e.g. more than 600 cm2 of surface). Reactions such as stomach pain, dyspepsia, gastric or renal disturbances
may occur.
4.9
Overdose
The low systemic absorption of topical diclofenac makes overdose very unlikely to happen.
It diclofenac gel is swallowed the same adverse reactions as with systemic diclofenac can occur. If
significant systemic reactions occur the same precautions as in overdose with NSAID should be taken and
the use of active charcoal can be considered.
5.
PHARMACOLOGICAL PROPERTIES
5.1
Pharmacodynamic properties
Pharmacotherapeutic group: anti-inflammatory preparations, non-steroids for topical use, ATC code:
M02AA15.
Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) with analgesic, anti-inflammatory and antipyretic properties. Inhibition of the prostaglandin synthesis is the primary action mechanism of diclofenac.
Diclofenac Orifarm is only recommended for cutaneous use.
5.2
Pharmacokinetic properties
Absorption
The amount of diclofenac that is absorbed systemically from diclofenac gel is proportionl to the
area of skin that is being treated and is dependent on both the applied total dose and the degree of
moisture of the skin. The absorption is approximately 6 percent of the diclofenac dose following
cutaneous application of 2.5 g of diclofenac gel on 500 cm2 skin as measured by total renal
elimination compared with diclofenac tablets. Ten hours of occlusion leads to a three-fold increase
in absorption of diclofenac.
Distribution
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The concentration of diclofenac has been measured in plasma; synovial tissue and synovial fluid
after cutaneous administration of diclofenac gel on hand and knee joints. The maximal
plasmaconcentration is approximately 100 times less than for oral administration of the
corresponding amount of diclofenac. Diclofenac is 99.7 % bound to serum proteins, predominantly
albumin (99.4 %).
Metabolism
The biotransformation of diclofenac occurs partly by glucuronidation of the intact molecule but the
main route is simple and multiple hydroxylations. This results in several phenol-metabolites, of
which the majority is converted to glucuronide conjugates. Two of these phenol-metabolites are
biologically active but in much less degree than diclofenac.
Elimination
The total clearance of diclofenac from plasma is 263 ± 56 ml/min. The terminal half-life in plasma
is 1-2 hours. Four of the metabolites, including the two active metabolites, also have a short plasma
half-life of 1-3 hours. One metabolite, 3'-hydroxy-4'-methoxy-diclofenac, has a longer half-life but
is practically inactive. Approximately 60 % of the administered dose is excreted in urine in the form
of metabolites. Less than 1 % is excreted as unchanged diclofenac. The rest of the dose is excreted
as metabolites in bile and faeces.
Reduced renal function
No accumulation of diclofenac or its metabolites is expected in patients with reduced renal function.
Reduced hepatic function
The pharmacokinetic and metabolism of diclofenac is the same in patients with chronic hepatitis or
uncompensated cirrhosis as for patients without liver disease.
5.3
Preclinical safety data
There are no preclinical safety data that are deemed to have a significant impact on clinical safety in
addition to the information provided in other parts of the summary of product characteristics.
6.
PHARMACEUTICAL PARTICULARS
6.1
List of excipients
Carbomer
Cocoyl caprylocaprate
Diethylamine
Isopropyl alcohol
Macrogol cetostearyl ether
Paraffin, liquid
Propylene glycol
Water, purified
6.2
Incompatibilities
Not applicable.
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6.3
Shelf life
3 years.
6.4
Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5
Nature and contents of container
Tube:
Aluminium tube with a PP screw cap closure.
Pack size:
50 g or 100 g.
Not all pack sizes may be marketed.
6.6
Special precautions for disposal
No special requirements.
7.
MARKETING AUTHORISATION HOLDER
Orifarm Generics A/S
Energivej 15, POB 69
DK-5260 Odense S
Denmark
8.
MARKETING AUTHORISATION NUMBER(S)
[To be completed nationally]
9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
[To be completed nationally]
10.
DATE OF REVISION OF THE TEXT
2012-09-28
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