Relieve Pain Gel Cream Ointment / Diclofenac Diethylammonium Gel NSAIDs

Relieve Pain Gel Cream Ointment / Diclofenac Diethylammonium Gel NSAIDs

Product : Diclofenac Diethylammonium Gel

Specification : 1%: 30g, tube

Standard : BP, USP

Packing : one tube/box

1. WHAT DICLOFENAC DIETHYLAMMONIUM EMULGEL IS AND WHAT IT IS USED FOR

Diclofenac Diethylammonium Emulgel contains the active substance diclofenac which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

It is specially formulated for rubbing into the skin and used to relieve pain and reduce inflammation and swelling in painful conditions affecting the joints and muscles.

Diclofenac Diethylammonium Emulgel can be used to treat:

• muscle and joint injuries (e.g. sprains, strains, bruises, backache, sports injuries)

• tendonitis (e.g. tennis elbow)

• osteoarthritis.

2. BEFORE YOU USE DICLOFENAC DIETHYLAMMONIUM EMULGEL

DO NOT use Diclofenac Diethylammonium Emulgel if you:

• are in the last 3 months of your pregnancy (see also pregnancy and lactation section)

• have an allergy (hypersensitivity) to any of the ingredients in the product (see Section 6 ‘What Diclofenac Diethylammonium Emulgel contains’).

• have ever had an allergic reaction to diclofenac or other medicines used to treat pain, fever or inflammation, such as aspirin (acetylsalicylic acid) or ibuprofen. Symptoms of an allergic reaction to these medicines may include: asthma, wheezing or shortness of breath; skin rash or hives; swelling of the face or tongue; runny nose.

This medicine is not recommended for use in children under 14 years of age.

Take special care with Diclofenac Diethylammonium Emulgel

• Do not apply the gel to skin that has (i) a rash or eczema (ii) cuts or open wounds. Stop the treatment if a skin rash develops after applying the product.

• Avoid applying on large areas of skin and over a prolonged period of time, unless under medical advice.

• Be careful when sunbathing or using sun lamps as your skin may be more sensitive to sunlight.

• If you have a stomach or duodenal ulcer (or a history of), tell your doctor or pharmacist before using the gel.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription.

Do not use Diclofenac Diethylammonium Emulgel if you are already taking diclofenac tablets or other NSAID pain/inflammation tablets (e.g. aspirin or ibuprofen).

Pregnancy and Breast-feeding

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.

Diclofenac Diethylammonium Emulgel must not be used during the last 3 months of pregnancy, as it could harm your unborn child or cause problems at delivery. Diclofenac Diethylammonium Emulgel 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.

Diclofenac Diethylammonium Emulgel should only be used under medical advice during breast-feeding as diclofenac passes into breast milk in small amounts. However, Diclofenac Diethylammonium Emulgel should not be applied on the breasts of nursing mothers nor elsewhere on large areas of skin or for a prolonged period of time.

Consult your doctor or pharmacist for further information if you are pregnant or breastfeeding.

Driving and using machines

Diclofenac Diethylammonium Emulgel, when used as directed, is not expected to have any effect on your ability to drive or use machines.

Important information about some of the ingredients of Diclofenac Diethylammonium Emulgel

The gel formulation contains propylene glycol and benzyl benzoate, which may cause mild localised skin irritation in some people.

3. HOW TO USE DICLOFENAC DIETHYLAMMONIUM EMULGEL

• Always use Diclofenac Diethylammonium Emulgel exactly as your doctor has told you.

• The gel is for external use only. Do not use it in your mouth. Inform your doctor immediately in case of accidental swallowing.

• Do not put Diclofenac Diethylammonium Emulgel in your eyes. If this happens, rinse your eyes well with clean water. See your doctor or pharmacist if any discomfort persists.

Adults

1. Take the tube out of the carton: Unscrew and remove cap. When using for the first time, reverse the cap, engage with the nozzle, twist and remove the seal from the tube. Do not use if seal is broken.

2. Gently squeeze out a small amount of gel from the tube and apply to the painful or swollen area 3 to 4 times a day, slowly rubbing into the skin. The amount needed will vary depending on the size of the painful or swollen area; an amount ranging in size from a 1 penny to a 2 pence piece will usually be sufficient. You may notice a slight cooling effect when you rub the gel in.

3. Do not rub the gel into cuts, open wounds or any other area where the skin is abnormal. After rubbing the gel into the skin, do not cover with bandages or sticking plaster.

4. Be careful not to get the gel in your eyes. If this happens, rinse your eyes with clean water and tell your doctor.

5. Wash your hands after rubbing in Diclofenac Diethylammonium Emulgel, unless your hands are the site being treated. Replace the cap.

6. Allow at least four hours between applications of the gel. Do not apply more than 4 times in any 24 hour period.

This medicine is not recommended for use in children under 14 years of age.

Do not use Diclofenac Diethylammonium Emulgel for more than:

• 2 weeks for muscle and joints injuries (e.g. sprains, strains, bruises) or tendonitis.

• If you are using the gel for arthritis, your doctor may wish to review your treatment regularly.

If symptoms do not improve within this time, or they get worse, consult your doctor. 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.

If you use more Diclofenac Diethylammonium Emulgel than you should

If you or a child accidentally swallows Diclofenac Diethylammonium Emulgel, contact your doctor or accident and emergency department immediately.

If you forget to use Diclofenac Diethylammonium Emulgel

If you miss your application of Diclofenac Diethylammonium Emulgel at the correct time, apply it as soon as you remember then carry on as normal. Do not apply a double quantity to make up for a forgotten application.

If you have any further questions on the use of this product, ask your pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Diclofenac Diethylammonium Emulgel can cause side effects, although not everybody gets them.

Some rare and very rare side effects might be serious

If you experience any of the following signs of allergy, STOP using Diclofenac Diethylammonium Emulgel and tell a doctor or pharmacist immediately:

Skin rash with blisters; hives (may affect between 1 and 10 in every 10,000 people).

Wheezing, shortness of breath or feeling of tightness in the chest (asthma) (may affect less than 1 in every 10,000 people).

Swelling of the face, lips, tongue or throat (may affect less than 1 in every 10,000 people).

Other side effects which may occur are usually mild, passing and harmless (if you are concerned, tell a doctor or pharmacist).

Common side effects (may affect between 1 and 10 in every 100 people) Skin rash, itching, reddening or smarting of the skin

Very rare side effects (may affect less than 1 in every 10,000 people) The skin may be more sensitive to the sun. Possible signs are sunburn with itching, swelling and blistering.