Diclosafe Forte

Diclosafe Forte

diclofenac

Manufacturer:

Kusum Healthcare

Distributor:

Kusum Healthcare
Full Prescribing Info
Contents
Diclofenac diethylamine.
Description
Diclosafe Forte contains the active substance diclofenac, which is a non-steroidal anti-inflammatory drug (NSAID). It is specially formulated for rubbing into the skin.
Indications/Uses
It can be used to treat: muscle and joints injuries (e.g. sprains, strains, bruises, backache, sports injuries); tendonitis (e.g. tennis elbow), swelling around elbow or knee; mild arthritis of the knee or fingers.
Diclosafe Forte is intended for use in adults and adolescents aged 12 years and older.
Dosage/Direction for Use
Apply Diclosafe Forte 2 times a day (morning and evening) on the painful area.
The amount needed will vary depending upon the size of the painful or swollen area; an amount ranging in size from a cherry to a walnut will usually be sufficient.
Do not use Diclosafe Forte for more than 2 weeks. Use no more than is required for shortest period of time needed. If the pain and swelling does not improve within 7 days, or if they get worse, tell the doctor. Longer treatment may be recommended by a doctor.
Missed dose: If the patient misses an application of Diclosafe Forte at the correct time, apply it when patient remembers and then carry on as normal. Do not apply a double quantity to make up for the forgotten application.
Overdosage
Signs and Symptoms of Overdose: Over dosage can cause symptoms such as headache, nausea, vomiting, epigastric pain, gastrointestinal haemorrhage, diarrhoea, dizziness, disorientation, excitation, coma, drowsiness, tinnitus, fainting or convulsions. In the case of significant poisoning acute renal failure and liver damage are possible.
What to do when the patient has taken more than the recommended dosage: If the gel was used more than it should be, wipe off the surplus gel with a tissue. If a patient or a child accidentally swallows the gel, seek medical advice immediately.
Contraindications
Do not use Diclosafe Forte if: the patient is allergic (hypersensitive) to diclofenac or other non-steroidal anti-inflammatory medicines used to treat pain, fever or inflammation, such as ibuprofen or aspirin (a substance also used to prevent blood clotting), or any of the other ingredients of this medicine. If not sure, ask the doctor or pharmacist. Symptoms of an allergic reaction may include: wheezing or shortness of breath (asthma); skin rash with blisters or hives; swelling of the face or tongue; runny nose.
Patient is in the last 3 months of pregnancy.
Important information about some of the ingredients of Diclosafe Forte: The gel formulation contains propylene glycol, which may cause mild localized skin irritation in some people, and butylhydroxytoluene, which may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.
Use in Children: Do not use Diclosafe Forte in children under 12 years of age.
Special Precautions
Things patient must do: If the patient has any further questions on the use of this product, ask a doctor or pharmacist.
Things patient must not do: 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 the doctor.
Diclosafe Forte is for topical use only. Do not use it in the mouth. Do not swallow it. Be careful not to get Diclosafe Forte in the eyes. If this happens, rinse eyes well with clean water. See a 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.
Consult a doctor: If the pain and swelling does not improve within 7 days, or if they get worse. If the patient experiences any first sign of any adverse drug reaction.
Use In Pregnancy & Lactation
Use only on advice of a doctor if the patient is pregnant or breast-feeding, may be pregnant or is planning to have a baby. Do not use Diclosafe Forte if the patient is in the last 3 months of pregnancy, as it could harm the unborn child or cause problems at delivery.
Adverse Reactions
When using this product, the patient 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 booth). Possible signs are sunburn with itching, swelling and blistering.
Patient may report any side effects or adverse drug reactions directly to the regulatory authority.
Drug Interactions
Please tell the doctor or pharmacist if the patient is taking, or has recently taken, any regular medication on prescription or over the counter products.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M02AA15 - diclofenac ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.
Presentation/Packing
Form
Diclosafe Forte topical emulsion gel 2.32% w/w
Packing/Price
30 g x 1's (P437.5/box)
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