Pharmacotherapeutic group:
Topical products for joint and muscular pain, anti inflammatory preparations, non-steroids for topical use.

DICLOFEN® Cremogel is a non-steroidal anti-inflammatory (NSAID) and analgesic preparation designed for external application.
Due to an aqueous-alcoholic base the gel exerts a soothing and cooling effect.
Therapeutic indications:
For the local symptomatic relief of pain and inflammation in:
- Trauma of the tendons, ligaments, muscles and joints, e.g. due to sprains, strains and bruises
- Localised forms of soft tissue rheumatism
It is recommended that treatment be reviewed after 14 days in these indications.
For the treatment of osteoarthritis of superficial joints such as the knee.
In the treatment of osteoarthritis, therapy should be reviewed after 4 weeks.

a. Do not take DICLOFEN® Cremogel if one of the following applies to you:
• Patients with or without chronic asthma in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid (aspirin)
or other non-steroidal anti-inflammatory drugs (NSAIDs).
• Hypersensitivity to diclofenac or any of the excipients.
• Third trimester of pregnancy.
The use in children and adolescents aged less than 14 years is contraindicated.
b. Take special care with DICLOFEN® Cremogel
The posibility of systemic adverse events from application of DICLOFEN® Cremogel cannot be excluded if the preparation is used on large areas of skin and over a prolonged period.
DICLOFEN® Cremogel contains propylene glycol, which may cause mild, localised skin irritation in some people.
Concomitant use of oral NSAID’s should be cautioned as the incidence of untoward effects, particularly systemic side effects, may increase.
DICLOFEN® Cremogel should not be co-administered with other products containing diclofenac.
DICLOFEN® Cremogel should be applied only to intact, non-diseased
skin and not to skin wounds or open injuries. It should not be allowed to come into contact with the eyes or mucous membranes, and should not be ingested.
Discontinue the treatment if a skin rash develops after applying the product.
DICLOFEN® Cremogel can be used with non-occlusive bandages but should not be used with an airtight occlusive dressing.
Some possibility of gastro-intestinal bleeding in those with a significant history of this condition has been reported in isolated cases.
c. Taking other medicines, herbal or dietary supplements
Since systemic absorption of diclofenac from a topical application is very low such interactions are very unlikely. There are no known interactions with DICLOFEN® Cremogel but for a list of interactions
known with oral diclofenac the data sheet for oral dosage forms should be consulted.
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a prescription.
d. Pregnancy and breast-feeding
Pregnancy
Pregnancy Category C
The systemic concentration of diclofenac is lower after topical administration, compared to oral formulations. With reference to experience from treatment with NSAIDs with systemic uptake, the following is recommended:
Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/fetal development. 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 for cardiovascular malformation was increased from less than 1%, up to approximately 1.5 %. The risk is believed to increase with dose and duration of therapy. During the first and second trimester of pregnancy, diclofenac should not be given unless clearly necessary. If diclofenac is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to:
- cardiopulmonary toxicity (with premature closure of the ductus arteriosus
and pulmonary hypertension); renal dysfunction, which may progress to renal failure with oligo-hydroamniosis;
The mother and the neonate, at the end of pregnancy, to:
- Possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.
- Inhibition of uterine contractions resulting in delayed or prolonged labour.
Consequently, diclofenac is contraindicated during the third trimester of pregnancy.
Lactation
Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, at therapeutic doses of DICLOFEN® Cremogel
no effects on the suckling child are anticipated. Because of a lack of controlled studies in lactating women, the product should only be used during lactation under advice from a healthcare professional. Under this circumstance, DICLOFEN® Cremogel should not be applied on the breasts of nursing mothers, nor elsewhere on large areas of skin or for a prolonged period of time.
f. Driving and using machines
Cutaneous application of DICLOFEN® Cremogel has no influence on the ability to drive and use machines.
g. Important information about some of the ingredients of
DICLOFEN® Cremogel
DICLOFEN® Cremogel contains propylene glycol, which may cause mild, localised skin irritation in some people. Do not take DICLOFEN® Cremogel if you have hypersensitivity to diclofenac or any of the other excipients.
 

Always take DICLOFEN® Cremogel exactly as your doctor or health care provider has told you. You should check with your doctor, health care provider or pharmacist if you are not sure.
• Dosage and administration
Route of administration: Topical.
• Adults: DICLOFEN® Cremogel should be rubbed gently into the skin. Depending on the size of the affected site to be treated 2-4g (a circular shaped mass approximately 2.0-2.5cm in diameter) should be applied 3 - 4 times a daily. After application, the hands should be washed unless they are the site being treated.
• Use in the elderly: The usual adult dosage may be used.
• Children and adolescents: There are insufficient data on efficacy and safety available for the children and adolescents below 14 years of age. In children aged 14 years and over, if this product is required for more than 7 days for pain relief or if the symptoms worsen the patient/parents of the adolescent is/are advised to consult a doctor.
• DICLOFEN® Cremogel is suitable for the transmission of ultrasound
and may be used as a couplant in combination with ultrasound therapy. If large areas of the body are covered with gel, systemic absorption will be greater and the risk of side-effects increased, especially
if the therapy is used frequently.
a. If you take more DICLOFEN® Cremogel than you should
Signs and symptoms
The low systemic absorption of DICLOFEN® Cremogel renders overdose very unlikely. However, undesirable effects, similar to those observed following an overdose of diclofenac tablets, can be expected
if DICLOFEN® Cremogel is inadvertently ingested (1 tube of 100g contains the equivalent of 1000mg of diclofenac sodium). In the event of accidental ingestion, resulting in significant systemic adverse effects, general therapeutic measures normally adopted to treat poisoning with non-steroidal anti-inflammatory medicines should be used. Gastric decontamination and the use of activated charcoal should be considered, especially within a short time of ingestion.
Treatment
Management of overdosage with NSAIDs essentially consists of supportive and symptomatic measures. There is no typical clinical picture resulting from DICLOFEN® Cremogel overdosage. Supportive
and symptomatic treatment should be given for complications such as hypotension, renal failure, convulsions, gastro-intestinal irritation, and respiratory depression; specific therapies such as forced diuresis, dialysis or haemoperfusion are probably of no help in eliminating NSAIDs due to their high rate of protein binding and extensive metabolism.
b. If you forget to take DICLOFEN® Cremogel
Take DICLOFEN® Cremogel daily as prescribed. However if you miss a dose, just carry on with the next dose as normal. Do not take a double dose to make up for a forgotten one.
c. If you stop taking DICLOFEN® Cremogel
Talk to your doctor before stopping this treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist

Possible side effects
Like all medicines, DICLOFEN® Cremogel can cause side effects, although not everybody gets them.
Adverse reactions are ranked under heading of frequency, the most frequent first, using the following convention:

very common (> 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000), not known: cannot be estimated from the available data.

Although less likely with topical administration, some side effects normally associated with systemically administered diclofenac may also occur.
Immune system disorder; Very rare: Hypersensitivity (including urticaria), angioneurotic oedema.
Infections and infestations; Very rare: Rash pustular.
Respiratory, thoracic and mediastinal disorders; Very rare: Asthma.
Skin and subcutaneous tissue disorders; Common: Rash, eczema, erythema, dermatitis (including dermatitis contact), pruritus, Rare: Dermatitis bullous, Very rare: Photosensitivity reaction
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Serious side effects
WARNING: CARDIOVASCULAR
AND GASTROINTESTINAL RISK
Cardiovascular Risk:
• Non-steroidal anti-inflammatory drugs (NSAIDs) may cause an increased
risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
• DICLOFEN® Cremogel is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
Gastrointestinal Risk:
• Non-steroidal anti-inflammatory drugs (NSAIDs), including DICLOFEN
® Cremogel, cause an increased risk of serious gastrointestinal
adverse events including bleeding, ulceration, and perforation
of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.

- Keep out of the reach and sight of children.
- Store below 30°C.
- Discard the content after one month from first opening.
- Do not use DICLOFEN® Cremogel after the expiry date (Exp. Date) which is stated on the outer pack. The expiry date refers to the last day of that 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.