Iodex UltraGel+ Pain Relief Gel

Iodex UltraGel+ penetrates deep into your muscles or joints and targets the root cause of pain, providing all-day pain relief¹.

Do you have pain, tenderness or swelling associated with inflammation or injury? Apply Iodex UltraGel+ at the site of the pain to help treat pain at its root. That way you can get back to being to your smiling, joyful self.

Learn How Iodex UltraGel+ Can Help You Relieve Pain

Don’t let aches and pains stop you from enjoying life to the fullest. Find out how Iodex UltraGel+ targets a frequent cause of pain and inflammation, to get you moving freely again. It is a 2% diclofenac formulation² that relieves pain, reduces inflammation and speeds your body’s natural healing process. What’s more? Thanks to its special Emulgel formulation which not only helps in easy application at the site of pain but also increases the absorption of the active ingredient through the skin, tissues and muscles. Iodex UltraGel+’s formulation allows it to permeate the skin 3 times deeper² thus treating pain at its root and providing relief. That’s all clinically proven!

Product information

How does it work

What is it used for

How to use it

F.A.Qs

Iodex UltraGel+ product information

Iodex UltraGel+ is a medicated treatment containing a non-steroidal anti-inflammatory drug, or NSAID^4,5, known as diclofenac diethylamine in the form of an emulsion gel. The active ingredient (diclofenac) penetrates the skin to provide relief for pain, inflammation and swelling⁶.

Unlike other products in the market which contain ingredients that stimulate nerves in the skin to provide a sensation of heating or cooling, Iodex UltraGel+ has a 2% formulation of diclofenac which penetrates deep into the skin in order to relieve pain and reduce inflammation where you need it.

Are you ready for the best part? Iodex UltraGel+ is non-greasy and has a pleasant odour. This way, you can relieve your pain without much hassle. No one needs to see, or smell, how you are managing your pain, letting you be in the moment with whatever activity it is you love doing.

Download the product leaflet

PRODUCT INFORMATION

1. Product Name

Brand Name: Iodex* UltraGel+

Generic Name: Diclofenac Diethylamine Gel I.P. 2.32%w/w
2. Qualitative & Quantitative Composition

Contains:

Diclofenac Diethylamine I.P. 2.32% w/w equivalent to Diclofenac Sodium I.P. 2% w/w
3. Dosage Form

Topical Gel
4. Clinical Particulars
4.1. Uses/ Indications

For the relief of pain, inflammation and swelling in:

Soft-tissue injuries: trauma of the tendons, ligaments, muscles and joints, e.g. due to sprains, strains, bruises and backache (sports injuries);

Localised forms of soft tissue rheumatism: tendonitis (e.g. tennis elbow), bursitis, shoulder-hand syndrome and periarthropathy;

For the relief of pain of non-serious arthritis of the knee or fingers.

4.2. Posology and method of administration

For topical use on the skin only.

For use by adults and children aged 12 years and above.

Elderly patients (over 65 years of age): the usual adult dosage may be used.

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.

Apply over the affected area 2 times a day and to be rubbed gently into the skin. The amount needed will vary depending upon the size of the painful or swollen area: 2 g to 4 g. Iodex UltraGel+ (a quantity ranging in size from a cherry to a walnut) is sufficient to treat an area of about 400-800 cm^².

After application:

the hands should be wiped with e.g., an absorbent paper, and then washed, unless they are the site being treated. The e.g., absorbent paper should be thrown in the trash after use.

Wait until Iodex UltraGel+ dries before showering, bathing.

Do not throw away any medicines via wastewater (e.g. toilet or sink). Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

If the pain and/or swelling do not improve within 7 days of staring the treatment, or if they get worse, tell your doctor.

4.3. Contra-indications

Do not use Iodex UltraGel+ if you:

are allergic to diclofenac or other non-steroidal anti-inflammatory medicines used to treat pain, fever or inflammation, such as ibuprofen or aspirin, or any of the other ingredients contained in this medicine. If you are not sure, ask your doctor or pharmacist.

are suffering from asthma, angioedema, urticaria, or acute rhinitis and it gets flared- up/precipitated by acetylsalicylic acid use or with other non-steroidal anti-inflammatory drugs (NSAIDs). If you are not sure, consult your doctor or pharmacist in case suffering from any of these conditions.

are in the last 3 months of pregnancy.

4.4. Special Warnings and Special Precautions for use

Do not apply on 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.

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.

Keep out of the sight and reach of children.

Be cautious when smoking or near naked flames due to risk of severe burns. Iodex UltraGel+ contains paraffin which is potentially flammable when it builds up on fabrics (clothing, bedding, dressing etc.) and may not be totally removed by laundering.

4.5. Interaction with other medicaments and other forms of interaction

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.

4.6. Pregnancy and Lactation

Seek medical advice before you use Iodex UltraGel+ if you are pregnant or breast-feeding or are planning to have a baby.

Not to be used in the last 3 months of pregnancy, as it could harm your unborn child or cause delivery related complications.

4.7. Effects on ability to drive and use machines

Topical application of diclofenac has no influence on the ability to drive and use machines.

4.8. Undesirable effects / side effects

Skin reddening, rash with or without blisters, itching, dermatitis; hives; wheezing, shortness of breath or feeling of tightness in the chest (asthma); Hypersensitivity in form of swelling of the face, lips, tongue or throat.

The skin may become more sensitive to sunlight (sun or tanning booth). Possible signs are sunburn with itching, swelling and blistering.

4.9. Overdosing

In case of overdosage, seek medical advice from a doctor immediately.

In case of overdosage, you may also contact the National Poisons Information Centre of India (24*7).

Details of the same are as below:
Department of Pharmacology
All India Institute of Medical Sciences
New Delhi-110029
Toll Free No. - 1800 116 117
Tel No.- 26589391, 26593677
E-mail: npicaiims2010@gmail.com
5. Pharmacological Properties

5.1. Pharmacodynamic Properties & mechanism of action

Pharmacotherapeutic group: Topical non-steroidal anti-inflammatory drug (NSAID)

ATC Code: M02AA15 (Anti-inflammatory preparations, non-steroids for topical use).

Pharmacodynamics effects & 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 by cyclo-oxygenase 2 (COX-2).

5.2. Pharmacokinetics

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 diclofenac diethylamine on 500 cm^² skin, determined by total renal elimination, compared with diclofenac tablets.

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 terminal plasma half-life is 1-2 hours.
6. Pharmaceutical Particulars

6.1. Chemical Structure

Diclofenac diethylamine:

6.2. List of Excipients

Carbomer 980NF
Macrogol Cetostearyl Ether
Cocyl Caprylocaprate- Cetiol LC
Diethylamine
Isopropyl Alcohol
Liquid paraffin
Propylene Glycol
Oleyl Alcohol
Eucalyptus Perfume
Butylhydroxytoluene
Purified Water

6.3. Incompatibilities

Not applicable

6.4. Shelf life

24 months from the date of manufacturing.

6.5. Special precautions for storage

Store in a cool, dry place, at a temperature not exceeding 25°C. Keep out of reach and sight of children.

6.6. Nature and specification of the container

For the aluminium laminated tube:
Aluminium laminated tube fitted with HDPE shoulder, foil seal on top of the nozzle & white PP standup screw cap. Remove foil seal on top of the nozzle before first use.

For the dispenser:
Pressurised aluminium container containing a multilayer pouch (low density polyethylene layer in contact with the product) with a high density polyethylene/titanium oxide valve and polyoxymethylene actuator with protective cap.

6.7. Instructions for Use and Handling

Refer section 4. Clinical Particulars and subsections there-under.

6.8. Manufacturing License Holder

Refer Pack for details on manufacturing license holder

6.9. Marketed By

GlaxoSmithKline Asia Private Limited,
Patiala Road, Nabha-147201
Punjab, India

* Trademarks are owned by or licensed to the GSK Group of companies

What is Emulgel anyway?

Emulgel is a technology developed for Iodex UltraGel+. It is an emulsion of a gel and cream that provides a cooling and soothing effect when applied to the skin.

Iodex UltraGel+ uses the same formulation as its global counterparts like Voltaren and Voltarol. It is available in 15g, 30g and 50g tubes.

How does Iodex UltraGel+ work?

Unlike products such as heat patches and cooling gels that work by only cooling or heating the skin, Iodex UltraGel+ contains a non-steroidal anti-inflammatory drug (NSAID)^4,5 called diclofenac which targets pain at its source and relieves pain as well as inflammation.⁶

Iodex UltraGel+’s special Emulgel technology helps the gel to permeate 3 times deeper² into the skin to enhance delivery of diclofenac to the point of pain. Applying the gel lets the active ingredient, diclofenac, penetrate the skin and accumulate in reservoirs that then target the source of inflammation⁷ and pain over time. Diclofenac works by blocking the body’s production of some of the chemicals that cause you to feel pain. Thus, it penetrates deep, reduces internal swelling and relieves pain at its root.

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What is Iodex UltraGel+ used for?

Iodex UltraGel+ brings targeted and localised relief from pain, swelling, and inflammation⁶ in muscles, for example the ones in the back or the neck. It relieves pain to help you get moving again. Iodex UltraGel+ can also be used for relief of mild arthritis in the knee and fingers. It provides relief from different types of musculoskeletal pains including but not limited to:

Low back pain
Joint pain
Knee pain
Shoulder pain
Neck pain
Sprains and strains

Iodex UltraGel+ can also be used for the relief of body pain, inflammation⁶ and swelling in:

Soft-tissue injuries: trauma of the tendons, ligaments, muscles and joints, due to sprains, strains, bruises and backache (e.g. in sports injuries);
Localised forms of soft tissue rheumatism: tendonitis (e.g. tennis elbow), bursitis, shoulder-hand syndrome and periarthropathy;
For the relief of pain of osteoarthritis of the knee or fingers

Read More

How to use Iodex UltraGel+?

We believe that pain relief should be simple and easy to use. That’s why using Iodex UltraGel+ couldn’t be easier.

Take the tube and open the cap.
Squeeze out the amount of gel you need. The amount of gel needed will vary depending upon the size of the painful or swollen area. An amount ranging in size from a cherry to a walnut (2g-4g) will usually be sufficient.
Gently rub the gel into your skin where you have pain or swelling.
Apply Iodex UltraGel+ twice daily, morning and evening.
Wash your hands thoroughly after use.
Experience pain relief and get back to doing the things you love.

Consult your doctor if pain and swelling do not improve within 7 days. The gel is not recommended for use in children under 12 years of age. Always read the label.

Iodex UltraGel+ Pain Relief 2.32% Gel contains 23.2mg/g of the non-steroidal anti-inflammatory (NSAID), diclofenac diethylamine ; this concentration means you can apply only twice per day (morning and evening) for all-day pain relief. Our Iodex UltraGel+ Pain Relief 2.32% Gel ingredients are what make it so effective. It contains a permeation enhancer which allows up to 3x more diclofenac to get through the skin.

Side effects: Always read the indications on the label before use. Side effects may include 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; and the skin may be more sensitive to the sunlight.

As with any drug, never exceed the recommended dose. We want to make sure that you are getting the best from Iodex. Read through the precautions to make sure that Iodex UltraGel+ is right for you before use.

Overdose

Consult your doctor immediately if you apply the medicine more than you should or if you swallow this product.

FOR MORE INFORMATION INCLUDING SAFETY, PLEASE REFER PATIENT INFORMATION LEAFLET

Frequently asked questions

Can I use Iodex UltraGel+ when pregnant?

The use of Iodex UltraGel+ containing the non-steroidal inflammatory drug (NSAID) diclofenac, has not been studied in pregnant women. Iodex UltraGel+ should only be used under medical advice during the first 6 months of pregnancy and the dose should be kept as low and duration of treatment as short as possible.

Do not use if you are in the last 3 months of pregnancy.
Can you take Iodex UltraGel+ when breastfeeding?

Iodex UltraGel+ should only be used under medical advice during breastfeeding as diclofenac passes into breast milk in small amounts.
Does the pain relief from Iodex UltraGel+ last all day?

Iodex UltraGel+ requires only two applications per day, approximately 12 hours apart (morning and evening). Diclofenac accumulates in the skin which acts as a reservoir from where there is a sustained release of drug into underlying tissue.
What is special about Iodex UltraGel+?

The added permeation enhancer in Iodex UltraGel+'s Emulgel technology allows for increased permeation of diclofenac through the skin², providing effective pain relief.

¹ With two 12 hourly applications. Refer pack for dosage instructions.
³ 2x Diclofenac vs Iodex UltraGel+, translating into 3x better permeation for longer duration of action
⁴ Rao P, Knaus EE. J Pharm Sci 2008;11:81s–110s.
⁵ Brune, 2007 A study in patients receiving endoprosthetic knee joint replacement (n=23) showed that after application of Voltaren Emulgel (80 mg) on the knee receiving surgery
⁶ Topical diclofenac improves joint function with regular use in osteoarthritis (Deng, et al. 2016)
⁷ Zhang Q, Flach CR, Mendelson R, Page L, Whitson S, Boncheva Bettex M.

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Health and wellness and your pain

Pain is rarely just physical nor is it always solved by taking medicine alone. Iodex is your ally in helping you take more control of your pain management, from the best sleeping position, to what you eat, mental wellbeing and complementary pain relief therapies.