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INTRODUCTION
DFO 4X GEL(TOPICAL) contains Diclofenac which belongs to the group of medicines called Nonsteroidal Anti-Inflammatory Drugs (NSAIDs). It is used to treat pain and inflammation related to muscle and joint injuries (Ex. sprains, strains, bruises, sports injuries, backache), tendonitis (Ex. tennis elbow), osteoarthritis (flexible tissue at the ends of bones wears down), swelling around elbow or knee or post-trauma.
If you are using DFO 4X GEL(TOPICAL) for arthritis, your doctor may want to review your treatment regularly. If the pain and swelling do not improve within 7 days or if they worsen, inform your doctor. Avoid smoking or going near naked flames as there might be a risk of severe burns.
DFO 4X GEL(TOPICAL) is not recommended for use in patients having kidney failure, severe joint pain of recent onset (unrelated to an injury or period of overuse), illness, fever or any other symptoms along with the pain. Before using DFO 4X GEL(TOPICAL) inform your doctor if you have any stomach or bowel ulcer, asthma, liver, kidney or bleeding problems.
DFO 4X GEL(TOPICAL) is not recommended for use in pregnancy (especially in last 3 months) and should be used in breastfeeding women only under medical advice. DFO 4X GEL(TOPICAL) is not recommended for use in children and adolescents (below 14 years of age).
Be cautious when sunbathing or using sun lamps as your skin may be more sensitive to sunlight. The most common side effects of using DFO 4X GEL(TOPICAL) are skin rash, itching, reddening of the skin, etc. Call your doctor if any of the symptoms worsen.
USES OF DFO 4X GEL(TOPICAL)
Treats pain and inflammation related to:
- muscle and joint injuries (Ex. sprains, strains, bruises, sports injuries, backache)
- tendonitis (Ex. tennis elbow)
- osteoarthritis
- swelling around elbow or knee
- post-trauma
HOW DFO 4X GEL(TOPICAL) WORKS
DFO 4X GEL(TOPICAL) relieves pain and inflammation by inhibiting certain enzymes (COX-1 and COX-2) involved in synthesis of prostaglandins (chemicals responsible for inducing pain and inflammation).
DIRECTIONS FOR USE
Apply DFO 4X GEL(TOPICAL) as advised by your physician. It is for external use only. Apply on healthy skin only. Wash your hands before and after application. Do not cover the applied area with occlusive bandages or plasters. Do not apply DFO 4X GEL(TOPICAL) on injured or infected skin.
In case of accidental contact with eyes, mucous membranes or injured skin, wash the affected area with running water. If the irritation persists, call your doctor. Your doctor will decide a proper dose and duration for you depending upon your age, body weight and severity of your condition.
SIDE EFFECTS OF DFO 4X GEL(TOPICAL)
COMMON
- skin rash, itching, reddening, burning sensation or scaling of the skin
- skin disorder (eczema)
- skin inflammation in the applied area (rash, swelling or papules)
RARE
- bullous dermatitis (extensive skin changes with the appearance of redness, scaling and large bubbles)
- increased sun sensitivity (itching, swelling, blistering)
Stop using DFO 4X GEL(TOPICAL) and contact your doctor immediately if you experience any of the following side effects:
- allergic reaction (skin rash with blisters, hives, wheezing, breathlessness, chest tightness, swollen face, lips, tongue or throat)
- serious skin reactions (Ex. exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis)
HOW TO MANAGE SIDE EFFECTS
Skin rash:
Avoid hot showers as it can further irritate your skin. Do not scratch the affected area. Use protective clothing when going outdoors. Regularly moisturize your skin. If symptom persists, contact your doctor.
WARNING & PRECAUTIONS
PREGNANCY
DFO 4X GEL(TOPICAL) is not recommended for use in pregnancy (during last 3 months). DFO 4X GEL(TOPICAL) should be used only under medical advice during first 6 months of pregnancy. Consult your doctor for advice.
BREASTFEEDING
DFO 4X GEL(TOPICAL) should only be used under medical advice during breast-feeding as it passes into breast milk in small amounts. However, prolonged application on the breasts of nursing mothers or elsewhere on large areas of skin should be avoided. Consult your doctor for advice.
DRIVING AND USING MACHINES
DFO 4X GEL(TOPICAL) generally does not affect your ability to drive or use machines.
KIDNEY
DFO 4X GEL(TOPICAL) is not recommended for use in patients with kidney failure. DFO 4X GEL(TOPICAL) should be used with caution in patients having other kidney problems. Consult your doctor for advice.
LIVER
DFO 4X GEL(TOPICAL) should be used with caution in patients having liver problems. Consult your doctor for advice.
ALLERGY
DFO 4X GEL(TOPICAL) is not recommended for use if you are allergic to Diclofenac, aspirin, ibuprofen, other NSAIDs, peanut, soya or any of the other ingredients of this medicine.
LUNGS
DFO 4X GEL(TOPICAL) should be used with caution in patients having asthma. Consult your doctor for advice.
OTHERS
DFO 4X GEL(TOPICAL) is not recommended for use if you:
- have severe joint pain of recent onset (unrelated to an injury or period of overuse)
- feel ill, have fever or any other symptoms along with the pain
Before using DFO 4X GEL(TOPICAL), inform your doctor if you:
- have or had stomach or bowel ulcers
- have a tendency for bleeding
- have inflammatory bowel disease
- are dehydrated
Use in Paediatrics:
DFO 4X GEL(TOPICAL) is not recommended for use in children (under 14 years of age). Consult your child’s doctor for advice.
Use in Geriatrics:
DFO 4X GEL(TOPICAL) should be used with caution in elderly patients. Consult your doctor for advice.
INTERACTIONS
A. Drug-Drug Interactions:
Before using DFO 4X GEL(TOPICAL), inform your doctor if you are taking any of the following medicines:
- medicines used to remove excess water from body (Ex. spironolactone, furosemide)
- medicines used to treat high blood pressure and other heart problems (Ex. captopril, atenolol, metoprolol, digoxin)
- other medicines used for pain relief (Ex. aspirin, ibuprofen)
Overdosage:
If you or anyone else accidentally use too much of DFO 4X GEL(TOPICAL), consult your doctor immediately or visit the nearby hospital.
SYNOPSIS
| Drug | : | Diclofenac |
| Pharmacological Category | : | Cyclooxygenase Inhibitors |
| Therapeutic Indication | : | Pain and inflammation |
| Dosage Forms | : | Tablet, Capsule, Dispersible tablet, Injection, Infusion, PFS, Eye drops, Gel, Nano gel, Spray, Solution, Topical Solution, Liniment, Sachet, Patch, Suppository, Ointment |
MORE INFORMATION
- Keep DFO 4X GEL(TOPICAL) out of reach of children
- Store DFO 4X GEL(TOPICAL) below 30°C
FAQs ABOUT DFO 4X GEL(TOPICAL)
Can I use DFO 4X GEL(TOPICAL) if I am taking paracetamol?
It is safe to use DFO 4X GEL(TOPICAL) with paracetamol, but this does not necessarily mean no interactions exist. Consult your doctor before taking any other medicine with DFO 4X GEL(TOPICAL), especially other similar painkillers (NSAIDs).
What if I forget to apply a dose of DFO 4X GEL(TOPICAL)?
If you forget to apply a dose of DFO 4X GEL(TOPICAL), do it as soon as you remember. However, omit that dose if it's almost time for the next one. Do not apply a double quantity of DFO 4X GEL(TOPICAL) to make up for the missed dose.
Can I stop using DFO 4X GEL(TOPICAL) on my own?
DFO 4X GEL(TOPICAL) treatment can be stopped at any time, without requiring special care. However, you may feel pain or swelling in the affected area again. If you have any further queries on the use of this medicine, ask your doctor.
Is DFO 4X GEL(TOPICAL) safe to use in asthmatic patients?
DFO 4X GEL(TOPICAL) should be used with caution if you have or ever had asthma. Consult your doctor for advice. Your doctor will determine a proper dose of DFO 4X GEL(TOPICAL) or select a suitable alternative treatment for you according to your condition.
Can DFO 4X GEL(TOPICAL) be used during pregnancy?
DFO 4X GEL(TOPICAL) must not be used during the last 3 months of pregnancy, as it could harm your unborn baby or cause problems at delivery. It should only be used under medical advice during the first 6 months of pregnancy and the dose and duration should be kept as small as possible. If you are pregnant, think you may be pregnant or are planning for a baby, consult your doctor before using it.
What if I accidentally swallow DFO 4X GEL(TOPICAL)?
If you or anyone else accidentally swallow DFO 4X GEL(TOPICAL), see your doctor immediately or go to your nearest hospital. Take your medicine with you for the doctor to know what you’ve ingested.
REFERENCES
1. KD. Tripathi. Nonsteroidal Anti-inflammatory Drugs and Antipyretic-Analgesics. Essentials of Medical Pharmacology. Eighth edition. 2019. Page – 221.
2. Sharma Y, Philip VM, Sharma S. Prospective, open-label, randomized, parallel group, comparative clinical study of two topical formulations of diclofenac diethylamine in the treatment of acute painful musculoskeletal conditions. Journal of Marine Medical Society. March 2020. [Accessed on 8th November 2022] https://www.marinemedicalsociety.in/article.asp?issn=0975-3605;year=2020;volume=22;issue=1;spage=35;epage=39;aulast=Sharma
3. Bariguian Revel, F., Fayet, M., & Hagen, M. Topical Diclofenac, an Efficacious Treatment for Osteoarthritis: A Narrative Review. NIH National Library of Medicine, National center for biotechnology information. Pubmed Central. June 2020. [Accessed on 8th November 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7211216/
4. GlaxoSmithKline Consumer Healthcare GmbH & Co. KG. Electronic Medicines Compendium (EMC). [Revised in October 2021] [Accessed on 8th November 2022] https://www.medicines.org.uk/emc/files/pil.8775.pdf
5. Laboratórios Basi – Indústria Farmacêutica, S.A. Electronic Medicines Compendium (EMC). [Revised in July 2021] [Accessed on 8th November 2022] https://www.medicines.org.uk/emc/files/pil.12073.pdf
6. GlaxoSmithKline Consumer Healthcare (UK). Electronic Medicines Compendium (EMC). [Revised in March 2020] [Accessed on 8th November 2022] https://www.medicines.org.uk/emc/files/pil.366.pdf
7. Pharbil Waltrop GmbH. Electronic Medicines Compendium (EMC). [Revised in February 2020] [Accessed on 8th November 2022] https://www.hpra.ie/img/uploaded/swedocuments/a870f2f5-07e1-4e3b-86ac-388c5c7de2e1.pdf
AUTHOR DETAILS
Written By Dr. Jeenal Rajani, Pharm.D.
Last updated on 16 Nov 2022 | 04:26 PM(IST)
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