Dicloflam Dispersible Tablets 15s

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Dicloflam
ZA100240
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DICLOFLAM DISPERSIBLE Except when intended for the emergency treatment of acute gout attacks and when intended for the treatment of post traumatic conditions such as pain, swelling and inflammation, for a maximum period of 5 days. S2 COMPOSITIONEach DICLOFLAM DISPERSIBLE dispersible tablet contains 46,5 mg of diclofenac free acid, equivalent to 50,0 mg of diclofenac sodium. PHARMACOLOGICAL...
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DICLOFLAM DISPERSIBLE 


Except when intended for the emergency treatment of acute gout attacks and when intended for the treatment of post traumatic conditions such as pain, swelling and inflammation, for a maximum period of 5 days. S2 

COMPOSITION
Each DICLOFLAM DISPERSIBLE dispersible tablet contains 46,5 mg of diclofenac free acid, equivalent to 50,0 mg of 
diclofenac sodium. 

PHARMACOLOGICAL CLASSIFICATION 
A 3.1 Antirheumatics (anti-inflammatory agents) 

PHARMACOLOGICAL ACTION 
Diclofenac is a non-steroidal anti-inflammatory compound (NSAID) with analgesic, antipyretic and anti-inflammatory activities. It causes decreased formation of prostaglandins and thromboxanes through inhibition of the activity of the enzyme cyclo-oxygenase. Prostaglandins play a major role in the causation of inflammation, pain and fever and the inhibition of prostaglandin synthesis may have an important bearing on diclofenac’s mechanism of action. Diclofenac inhibits platelet aggregation in vitro. 
Pharmacokinetics: 
Diclofenac is well absorbed after oral administration. Peak plasma concentrations are reached within approximately 1 hour. Administration with food slows the rate but does not alter the extent of absorption. There is a substantial first-pass effect (only 50% of diclofenac is available systemically). 
Diclofenac is extensively bound to plasma proteins (99%) and its plasma half-life is 1 to 2 hours. 
Diclofenac is metabolised in the liver by a cytochrome P-450 isozyme of the CYP2C subfamily and excreted in the form of metabolites via the kidneys (approximately 60%) and faeces (approximately 30%). Less than 1% is excreted in unchanged form. 

INDICATIONS 
DICLOFLAM DISPERSIBLE is indicated as short-term treatment in the following acute conditions: 

Painful musculoskeletal conditions
Non-articular rheumatism
Acute attacks of gout
Painful post-operative and post-traumatic inflammation and swelling
Pain following dental surgery
Flare-up of osteoarthrosis
Symptomatic treatment of primary dysmenorrhoea
Classical migraine headaches


CONTRA-INDICATIONS 

Hypersensitivity to diclofenac or to any of the ingredients.
Hypersensitivity to other NSAIDs including aspirin.
Gastric or intestinal ulcer.
Asthmatic patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other medicines with prostaglandin-synthetase inhibiting activity.
Pregnancy (see PREGNANCY AND LACTATION)
Porphyria


WARNINGS 
Close medical surveillance and strict accuracy of diagnosis are imperative in patients with 

Symptoms indicative of gastrointestinal disease
Ulcerative colitis
Crohn’s disease
a case history suggestive of gastro-intestinal disease
impaired hepatic function
Pre-existing dyshaemopoiesis or disorders of blood coagulation.

DICLOFLAM DISPERSIBLE should be used with caution in patients with hepatic or renal failure.
Concomitant use of DICLOFLAM DISPERSIBLE and methotrexate could result in serious interactions. (See INTERACTIONS)
Acetylsalicylic acid/aspirin: The bioavailability of both DICLOFLAM DISPERSIBLE and acetylsalicylic acid may be reduced if used concurrently.

INTERACTIONS 
Methotrexate: Concurrent administration of methotrexate with DICLOFLAM DISPERSIBLE may result in increased methotrexate toxicity (see WARNINGS). 
Lithium or digoxin: Raised plasma concentrations of lithium or digoxin may occur if taken together with DICLOFLAM DISPERSIBLE. 
Glucocorticoids and other NSAIDs: Gastrointestinal adverse effects may be exacerbated by the concomitant administration of DICLOFLAM DISPERSIBLE. Concurrent treatment with two or more NSAIDs may increase the risk of adverse effects. 
Antidiabetic medicines: DICLOFLAM DISPERSIBLE may cause both hypo- or hyperglycaemia. Dosage of antidiabetic medicines may need to be changed. 
Anticoagulants: There is an increased risk of haemorrhage if DICLOFLAM DISPERSIBLE is used concurrently with any anticoagulants. Careful monitoring is necessary. 
Cyclosporin: Nephrotoxicity of cyclosporin may be increased by the effects of DICLOFLAM DISPERSIBLE on renal prostaglandins. 
Quinolone antibiotics: There have been isolated reports of convulsions which may have been due to concomitant use of quinolone antibiotics and NSAIDs. 

PREGNANCY AND LACTATION 
Safety and efficacy in pregnancy and lactation have not been established. 
Use of NSAIDs during the third trimester of pregnancy may result in premature closure of the ductus arteriosus in utero and possibly in persistent pulmonary hypertension in the newborn. The onset of labour may be delayed and its duration increased. (See CONTRA-INDICATIONS). 

DOSAGE AND DIRECTIONS FOR USE 
Adults: 
Initial daily dose: 100 to 150 mg in two to three divided doses, with a maximum daily dose of 150 mg in divided doses. 
Milder cases: 75 to 100 mg daily in divided doses. 
Primary dysmenorrhoea: 50 to 150 mg daily in divided doses. Dosage should be individually determined. Treatment should be initiated at onset of symptoms and continued for a few days, depending on intensity of pain. 
Classical migraine: 50 mg taken at first signs of an impending attack. If pain relief is not sufficient within 2 hours after the first dose, a second dose of 50 mg may be taken. A third dose may be taken after 4 to 6 hours if necessary but the total daily dose of 150 mg must not be exceeded. 
The use of DICLOFLAM DISPERSIBLE in migraine attacks has not been established in children. 

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Side-effects:
Frequently-occurring:
Nervous system disorders:

Headache
Dizziness
Vertigo
Nervousness

Gastrointestinal disorders: 

Epigastric pain
Nausea
Vomiting
Diarrhoea
Abdominal cramps
Dyspepsia
Flatulence
Eructation
Anorexia
Local irritation

Hepatobiliary disorders: 

Elevated transaminase levels (ALT, AST)

Skin and subcutaneous tissue disorders: 
•Rash and skin reactions 

Less frequently occurring:
Blood and lymphatic system disorders:

Leucopenia
Thrombocytopenia
Aplastic anaemia
Haemolytic anaemia
Agranulocytosis

Cardiac disorders: 

Palpitations
Chest pain
Hypertension

Congestive heart failure 

Oedema

Nervous system disorders: 

Tiredness
Disturbances of sensation ( including paraesthesia)
Memory disturbance
Disorientation
Insomnia
Irritability
Convulsions
Depression
Anxiety
Nightmares
Tremor
Psychotic reactions
Aseptic meningitis

Gastrointestinal disorders: 

Gastrointestinal bleeding
Haematemesis
Melaena
Bloody diarrhoea
Peptic ulcer with or without bleeding or perforation
Lower gut disorders such as non-specific haemorrhagic colitis
Exacerbation of ulcerative colitis of Crohn’s proctocolitis
Glossitis
Aphthous stomatitis
Oeasophageal lesions
Diaphragm-like intestinal strictures
Constipation
Pancreatitis
Alteration in taste

Genitourinary disorders: 

Acute renal failure
Urinary abnormalities such as haematuria, proteinuria, interstitial nephritis, nephritic syndrome, papillary necrosis

Hepatobiliary disorders: 

Hepatitis with or without jaundice
Fulminant hepatitis

Eye disorders: 

Disturbances of vision (diplopia, blurred vision)

Skin and subcutaneous tissue disorders: 

Urticaria
Bullous eruptions
Eczema
Erythema multiforme
Stevens Johnson syndrome
Lyell’s syndrome (acute toxic epidermolysis)
Erythroderma (exfoliative dermatitis)
Loss of hair
Photosensitivity reaction
Purpura, including allergic purpura

Other: 

Impaired hearing
Tinnitus
Hypersensitivity reactions (such as bronchospasm, anaphylactic systemic reactions including hypotension)
Vasculitis and pneumonitis may occur without prior exposure to DICLOFLAM DISPERSIBLE. Discontinue treatment immediately.

Special precautions: 
Patients who experience dizziness or other central nervous system disturbances while taking DICLOFLAM DISPERSIBLE should refrain from driving a vehicle or operating machinery.
DICLOFLAM DISPERSIBLE may mask signs and symptoms of infection due to its pharmacodynamic properties.
Gastric bleeding may occur at any time during treatment with DICLOFLAM DISPERSIBLE. Discontinue treatment immediately.
A reduction in dosage may be required in the elderly, especially the very frail or those with a low body mass.
Heart failure may be precipitated in some compromised patients, due to the inherent potential of DICLOFLAM DISPERSIBLE to cause fluid retention.
Patients suffering from renal, hepatic or cardiac impairment or those being treated with diuretics or who have extracellular volume depletion from any cause, should be carefully monitored because of the role of prostaglandins in maintaining renal blood flow.
During prolonged treatment with DICLOFLAM DISPERSIBLE, blood counts and monitoring of hepatic and renal function are indicated. If abnormal liver function tests persist and symptoms of hepatic disease develop, discontinue DICLOFLAM DISPERSIBLE.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
(See SIDE-EFFECTS AND SPECIAL PRECAUTIONS)
Treatment is symptomatic and supportive, especially for hypotension, renal failure, convulsions, gastro-intestinal irritation and respiratory depression.
Absorption should be prevented as soon as possible after an overdose by means of gastric lavage and activated charcoal.
Specific therapies such as forced diuresis, dialysis or haemoperfusion are of little value in eliminating DICLOFLAM DISPERSIBLE because of its high protein binding and extensive metabolism.

IDENTIFICATION 
A white, diamond-shaped biconvex tablet, bisected on one side, and embossed “P”on the other side 

PRESENTATION 
One strip of 15 tablets in clear plastic pockets containing one tablet in each pocket and sealed with printed aluminium foil. Blister packed into an outer carton of printed cardboard along with a printed package insert. 

STORAGE INSTRUCTIONS 
Store below 25ºC in tightly closed containers. 
Protect from light and moisture. 
KEEP OUT OF REACH OF CHILDREN. 

No more returns on international orders

Please note that due to new Covid-19 related rules, the South African Government no longer allows returns of medicines from abroad. If your parcel is refused entry into your country and marked "Return-to-Shipper", we will not be able to receive your returned parcel. Instead it will be destroyed by the S.A Customs Department upon arrival.

How to return an item from within South Africa

If you need to return an item, please follow these simple steps

28 day cooling off period

If you would like to return an item please notify us within 14 days of your order being delivered. You then have a further 14 days to return the item back to us. This gives you a maximum of 28 days in total to return an item.

You can contact us by completing the form on our contact us page, selecting 'returns' from the drop-down menu. Alternatively, you can notify a member of our Customer Care team on 011 568 3064.

Please note that we are unable to accept returns for the following unless they are damaged or faulty:

  • Perishable items.
  • Unsealed items with a protective seal due to health protection or hygiene reasons.
  • Medicinal products or services that are dispensed on prescription.

Please note, this does not affect your statutory rights.

Where do I send returns?

Once our Customer Care team have been notified, please arrange postage to:

F.A.O: Returns Department
25 Adderley St
Cape Town City Centre
Cape Town
8000
South Africa.

Unfortunately, we're unable to cover the costs of returning your items and cannot be liable for any damages incurred during transit. Please ensure they are properly secured and packaged and we'd recommend sending all returns via a recorded delivery service.

How long will it take to process my refund?

We aim to process your refund within 3-5 working days of receiving your item, however it can take up to 30 days to receive the refund via the original payment method.

Once you've cancelled the contract, you have a legal 'duty of care' to keep the items in a good condition and return them at your expense. We are entitled to deduct an amount from the refund to reflect any loss of revenue in the value of goods supplied which may be 100%, if the loss is the result of unnecessary handling of the goods by you.

In accordance with the Consumer Protection Act, Regulations 68 of 2008, we will refund you the full amount paid for the items returned within 14 days of receipt of the notice of cancellation.

To read out full terms and conditions, please click here.

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011 568 3064
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Dicloflam Dispersible Tablets 15s
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