Advanced pain and inflammation
relief gel.

Voltaren Emulgel

Diclofenac Diethylamine (1.16%) w/w gel

Voltaren Emulgel is now available without prescription and can be purchased from any pharmacy island wide and is a common feature in many household, first-aid kits and gym bags. What makes this gel so special is that it both relieves pain and inflammation.

Voltaren Emulgel is available in 20 g and 50 g tubes.

Gels

How &

When

How Voltaren Emulgel Can Help You Relieve Pain?

Voltaren Emulgel contains the non-steroidal anti-inflammatory drug (NSAID) diclofenac. Unlike cooling gels and heat patches that work by only cooling or heating the skin, diclofenac works to relieve pain and reduce inflammation at the source. Voltaren Emulgel is an emulsion gel, which allows the active ingredient (diclofenac) to penetrate the skin rapidly in order to relieve pain and inflammation.
How to use Voltaren Emulgel?

Adults and children over 12 years: rub the gel gently into the affected area. Apply three or four times each day. The amount you will need will depend on the size of the affected area. Usually an amount ranging in size from a cherry to a walnut will be enough. The emulsion gel is a combination of a gel and cream providing both a cooling and soothing effect when applied to the skin. Voltaren Emulgel has a cooling, moisturising effect without strong odours. Due to its good tolerability, Voltaren Emulgel can be used for up to 14-21 days depending on the indication. If the pain gets worse or does not ease after 7 days, a doctor or pharmacist should be consulted. Always read the label.

When to use it?

Voltaren Emulgel is used to relieve pain and inflammation in muscles, joints, tendons and ligaments, caused by sprains and strains, sports injuries (e.g. tennis elbow) and soft tissue rheumatism (e.g. bursitis; tendonitis), as well as for the relief of pain of non-serious arthritis of the knee or fingers.

How it works?

Voltaren Emulgel contains the non-steroidal anti-inflammatory drug (NSAID) diclofenac. Unlike cooling gels and heat patches that work by only cooling or heating the skin, diclofenac works to relieve pain and reduce inflammation at the source. Voltaren Emulgel is an emulsion gel, which allows the active ingredient (diclofenac) to penetrate the skin rapidly in order to relieve pain and inflammation.
How to use it?

Adults and children over 12 years: rub the gel gently into the affected area. Apply three or four times each day. The amount you will need will depend on the size of the affected area. Usually an amount ranging in size from a cherry to a walnut will be enough. The emulsion gel is a combination of a gel and cream providing both a cooling and soothing effect when applied to the skin. Voltaren Emulgel has a cooling, moisturising effect without strong odours. Due to its good tolerability, Voltaren Emulgel can be used for up to 14-21 days depending on the indication. If the pain gets worse or does not ease after 7 days, a doctor should be consulted. Always read the label.
When to use it?

Voltaren Emulgel is used to relieve pain and inflammation in muscles, joints, tendons and ligaments, caused by sprains and strains, sports injuries (e.g. tennis elbow) and soft tissue rheumatism (e.g. bursitis; tendonitis), as well as for the relief of pain of non-serious arthritis of the knee or fingers.

Voltaren Emulgel product information

Voltaren Emulgel is an anti-inflammatory and analgesic preparation for topical application.

Local symptomatic relief of:

Soft tissue rheumatism (eg: tendonitis, shoulder-hand syndrome, bursitis and periarthropathy)
Rheumatic disease (eg: osteo-arthritis of the spine and peripheral joints)
Post traumatic inflammation of the tendors, ligaments, muscle and joints. (Sprains, strains and muscle pain)

Dosage Form and Strength

Diclofenac Diethylamine (1.16%) w/w gel

Clinical Particulars

Indications:

Voltaren Emulgel is an anti-inflammatory and analgesic preparation for topical application.
Local symptomatic relief of:

Soft tissue rheumatism (eg: tendonitis, shoulder-hand syndrome, bursitis and periarthropathy),
Rheumatic disease (eg: osteo-arthritis of the spine and peripheral joints),
Post traumatic inflammation of the tendons, ligaments, muscle and joints. (sprains, strains and muscle pain).

Dosage regimen and method of administration

For use only on the skin. Adults and adolescents aged 12 years and over:

Voltaren Emulgel should be applied over the affected area 3 or 4 times daily and rubbed gently into the skin. The amount needed depends on the size of the painful area: 2 g to 4 g Voltaren Emulgel (a quantity ranging in size from a cherry to a walnut) is sufficient to treat an area of about 400-800 cm². After application, the hands should be washed, unless they are the site being treated.

Do not use for more than:

2 weeks for muscle and joint injuries (e.g. sprains, strains, bruises) or tendonitis.
3 weeks for arthritis pain without consulting a doctor or pharmacist.

Use no more than is required for shortest period of time needed. If the pain and swelling do not improve within 7 days, or if they get worsen, consult the doctor or pharmacist.

Contra-indications

Do not take if you:

are allergic to diclofenac or other non-steroidal anti- inflammatory medicines (ibuprofen or aspirin) used to treat pain, fever or inflammation or any of the other ingredients contained in this medicine. If you are not sure, ask your doctor or pharmacist. (Symptoms of an allergic reaction to these medicines may include: wheezing or shortness of breath (asthma); skin rash with blisters or hives; swelling of the face or tongue; runny nose.)
If you are in the last 3 months of pregnancy

Warnings and Precautions

Do not apply to skin with conditions such as cuts, open wounds, or on skin that has a rash or eczema. Discontinue the treatment if a skin rash develops after applying the product.

Do not use more product than directed or for a longer period of time than directed, unless told by your doctor or pharmacist.

Do not use in the mouth. Do not swallow. Wash your hands after use. Be careful not to get this medicine in your eyes. If this happens, rinse your eyes well with clean water. See your doctor or pharmacist if any discomfort persists.

A brace or wrap commonly used for injuries like sprains can be used but do not use under airtight (plastic) bandages.

Voltaren Emulgel contains propylene glycol esters, which may cause mild, localised skin irritation in some people.

Keep out of the sight and reach of children.

Patients should be instructed to be cautious when smoking or near naked flames due to risk of severe burns. Voltaren contains paraffin which is potentially flammable when it builds up on fabric (clothing, bedding, dressings etc.). Washing clothing and bedding may reduce product build up but not totally remove it.

Adverse effects

When using this product, you may experience:

Skin rash with or without blisters; hives; wheezing, shortness of breath or feeling of tightness in the chest (asthma); swelling of the face, lips, tongue or throat; itching or reddening of the skin.
The skin may be more sensitive to sunlight (sun or tanning both). Possible signs are sunburn with itching, swelling and blistering.

Drug interactions

Tell your doctor or pharmacist before use if you are taking, or have recently taken, any regular medication on prescription or over the counter products.

Fertility, Pregnancy and Lactation

Use only on advice of your doctor or pharmacist before use if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.
Do not use if you are in the last 3 months of pregnancy, as it could harm your unborn child or cause problems at delivery.

Overdose

If you swallow this medicine: Seek medical advice immediately.

The low systemic absorption of diclofenac when applied topically makes overdose more unlikely.

Treatment of overdose

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. Further management should be as clinically indicated or as recommended by the national poisons centres where available.

Pharmacological Properties

Pharmacological action

Voltaren Emulgel is a non-steroidal anti-inflammatory topical gel

Mechanism of action

Diclofenac is a potent non-steroidal anti-inflammatory drug (NSAID) with effective analgesic, anti-inflammatory and antipyretic properties. Diclofenac exerts its therapeutic effects primarily through inhibition of prostaglandin synthesis.

Relevant pharmacokinetic data

Absorption: The quantity of diclofenac absorbed through the skin is proportional to the size of the treated area, and depends on both the total dose applied and the degree of skin hydration. Absorption amounts to about 6% of the applied dose of diclofenac after topical application of 2.5 g Voltaren Emulgel on 500 cm² skin, determined by total renal elimination, compared with Voltaren tablets. A 10-hour occlusion leads to a three-fold increase in the amount of diclofenac absorbed.

Distribution: 99.7% of diclofenac is bound to serum proteins, mainly albumin (99.4%).
Diclofenac concentrations have been measured from plasma, synovial tissue and synovial fluid after topical administration of a diclofenac diethylamine gel to hand and knee joints. Maximum plasma concentrations are approximately 100 times lower than after oral administration of the same quantity of diclofenac. Diclofenac accumulates in the skin which acts as reservoir from where there is a sustained release of drug into underlying tissues. From the skin and underlying tissue, diclofenac preferentially distributes and persists in deep inflamed tissues (such as the joint), rather than in the bloodstream. Diclofenac is found in tissues at concentrations up to 20 times higher than in plasma.

Metabolism: The biotransformation of diclofenac involves single and multiple hydroxylation steps followed by glucuronidation, and glucuronidation of the intact molecule.

Elimination: Diclofenac and its metabolites are excreted mainly in the urine.
The total systemic clearance of diclofenac from plasma is 263±56 ml/min. The terminal plasma half-life is 1-2 hours. Four of the metabolites, including the two active ones, also have short plasma half-lives of 1-3 hours. One metabolite, 3'-hydroxy-4'-methoxy-diclofenac, has a longer half-life but is virtually inactive.

Special Patient Populations
Renal and hepatic impairment
No accumulation of diclofenac and its metabolites is to be expected in patients suffering from renal impairment. In patients with chronic hepatitis or non-decompensated cirrhosis, the kinetics and metabolism of diclofenac are the same as in patients without liver disease.

Pharmaceutical Particulars

Excipients

Isopropyl alcohol
Liquid paraffin
Macrogol cetostearyl ether

Incompatibilities
Not applicable

Shelf life:
36 months from the date of manufacture.

Storage condition:
Protect from heat. Do not store above 30°C.

Package size
Tubes of 20 and 50 g.

Product description
Voltaren Emulgel is a colourless fatty emulsion in an aqueous gel filled and sealed in a laminate tube

Manufacturer
Haleon CH SARL
Route de l'Etraz 2, CH-1260 Nyon,
Switzerland.

Marketed by:
SmithKline Beecham Pvt Ltd
Level 34, West Tower, World Trade Centre, Echelon Square,
Colombo 01, Sri Lanka.

Download leaflet

1 g Voltaren Emulgel contains 11.6 mg of the active ingredient diclofenac diethylamine (1.16%).

Do not exceed the stated dose. Always read the enclosed leaflet before use to check if this product is suitable for you.

Side effects may include skin irritation or redness. Should side effects appear, please contact a medical professional. Topical application reduces the risk of certain side effects, such as cardiovascular and gastrointestinal, compared with oral NSAIDs.

In case of accidental ingestion/ overdosage, contact your doctor or pharmacist immediately.

Download leaflet

Ingredients

1 g Voltaren Emulgel contains 11.6 mg of the active ingredient diclofenac diethylamine (1.16%).
Precautions

Do not exceed the stated dose. Always read the enclosed leaflet before use to check if this product is suitable for you.
Side effects

Side effects may include skin irritation or redness. Should side effects appear, please contact a medical professional. Topical application reduces the risk of certain side effects, such as cardiovascular and gastrointestinal, compared with oral NSAIDs.

In case of accidental ingestion/ overdosage, contact your doctor or pharmacist immediately.

Questions & Answers

What is Voltaren Emulgel?

Voltaren Emulgel is a medicated treatment containing a non-steroidal anti-inflammatory drug. The active ingredient (diclofenac) penetrates the skin to provide relief of pain and inflammation. It works differently from heat or cooling rubs, which contain ingredients that stimulate nerves in the skin, to provide a sensation of heating or cooling.
Voltaren Emulgel is non-greasy, with no strong odour.
What does Emulgel mean?

Emulgel is a technology designed for Voltaren Emulgel formulation. It helps the gel to penetrate deeply into the skin. In addition, the Emulgel technology uses a unique combination of a gel and cream to provide both a cooling and soothing effect when applied to the skin.
How do I apply Voltaren gel?

Gently rub or massage in a small amount of gel into the skin around painful or swollen area. An amount ranging in size from cherry to a walnut will usually be sufficient. However, the amount of gel needed will vary depending upon the size of the painful or swollen area. Check the label of the product you are using for correct dosage information.
When should I NOT use Voltaren Emulgel?

You are allergic to diclofenac, propylene glycol, isopropyl alcohol, butylhydroxy toluene or any of the other ingredients

You are in the last three months of pregnancy

You have ever had an asthma attack or allergic reaction after taking aspirin or other NSAIDs such as diclofenac or ibuprofen

If you have any other health conditions or you are taking any other medications, including those that do not require a prescription, always ask your pharmacist or doctor if Voltaren Emulgel is suitable for you. In addition, before you start using Voltaren Emulgel carefully read the product information leaflet included in the pack for instructions on how to use.

Voltaren Emulgel Gel should only be applied to healthy skin and not rubbed into open wounds, infections, open injuries or any other area where the skin is abnormal.

Voltaren Emulgel should not be used with air-tight or water-tight dressings, however, non-sealed breathable bandages can be used. For further details regarding precautions of using Voltaren products please consult your doctor or pharmacist.