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Diclofenac Duo® 75mg
2 forms of diclofenac in 1 intelligent capsule 1. NAME OF THE MEDICINAL PRODUCT
Trade name: Diclofenac Duo
INN: Diclofenac sodium
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release capsule, hard, contains 75 mg diclofenac sodium.(25 mg diclofenac sodium
in gastroresistant form, 50 mg diclofenac sodium in prolonged-release form). 3. CLINICAL PARTICULARS
3.1 Therapeutic indications
Symptomatic treatment of pain and inflammation in
• Acute arthritis (including attacks of gout) • Chronic arthritis, including rheumatoid arthritis (chronic polyarthritis) • Ankylosing spondylitis (Bechterew’s Disease) and other inflammatory rheumatic diseases of
• Painful conditions associated with arthritis and spondylarthropathy
• Inflammatory rheumatic diseases of soft tissue
• Painful swelling or inflammation after injury.
Because the release of active substance from Diclofenac Duo 75 mg is delayed, this preparation is
not suitable for starting treatment in conditions where rapid onset of action is needed. 3.2 Posology and method of administration
The dose of diclofenac depends on the severity of the condition. The recommended dose range for
adults lies between 50 and 100 mg diclofenac sodium per day.
(equivalent to 75 mg diclofenac sodium) (equivalent to 150 mg diclofenac sodium)
Method and duration of administration:
Those with sensitive stomachs are recommended to take Diclofenac Duo 75 mg during meals. 3.3 Contraindications
• Hypersensitivity to the active substance diclofenac, soya, peanut or to any of the excipients; • Known past reactions of bronchospasm, asthma, rhinitis or urticaria after taking acetylsalicylic
acid or other non-steroidal antirheumatic/anti-inflammatory agents (NSAIDs);
• Unexplained haematopoietic disorders; • Existing or past history of repeated peptic ulceration or haemorrhage (at least 2 different
episodes of proven ulceration or bleeding);
• History of gastrointestinal bleeding or perforation associated with previous NSAID treatment;
• Cerebrovascular or other active bleeding;
• Severe hepatic dysfunction or renal impairment;
• Severe cardiac impairment;
• Last trimester of pregnancy
Diclofenac Duo 75 mg is not suitable for children and adolescents under 15 years because the
content of active substance is too high. 3.4 Undesirable effects
Are dose-dependent. The most common undesirable effects are:
Blood and lymphatic system disorders:
Fever, sore throat, superficial lesions in the mouth, ‘flu-like symptoms, severe exhaustion,
nosebleeds and bleeding into the skin.
Nervous system disorders:
Common: central nervous system disorders such as headaches, dizziness, drowsiness, agitation,
irritability or fatigue.
Very common: gastrointestinal problems such as nausea, vomiting and diarrhoea, also slight
gastrointestinal blood loss, which in exceptional cases can cause anaemia.
Common: dyspepsia, flatulence, abdominal cramps, loss of appetite and gastrointestinal ulcers (in
some circumstances with bleeding and perforation).
Immune system disorders:
Common: hypersensitivity reactions such as skin rash and itching of the skin.
Common: elevation of serum transaminases. 4. PHARMACOLOGICAL PROPERTIES
4.1 Pharmacodynamic properties
Non-steroidal anti-inflammatory and anti-rheumatic agents;
Acetic acid derivatives and related substances
ATC code: M01AB05
Diclofenac is a non-steroidal anti-inflammatory/anti-rheumatic agent, which has proved effective by
inhibiting prostaglandin synthesis in the usual inflammation models in animal studies. In human
beings diclofenac reduces pain, swelling and fever which are caused by inflammation. Diclofenac
also inhibits platelet aggregation caused by ADP and collagen. 4.2 Pharmacokinetic properties
After oral administration of the usual gastroresistant pharmaceutical forms diclofenac is fully
absorbed distal to the stomach. Maximum plasma levels are attained, depending on the duration of
the passage through the stomach, after 1 - 16 hours, the mean being after 2 - 3 hours. After IM
administration, maximum plasma levels are attained after 10 - 20 minutes; after rectal
administration after about 30 minutes. Orally administered diclofenac is subject to a marked
first-pass effect; only 35 - 70% of the active substance absorbed reaches the post-hepatic circulation
unchanged. About 30% of the active substance is eliminated in metabolised form with the faeces.
About 70% is excreted by the kidneys after hepatic metabolic conversion (hydroxylation and conjugation) as pharmacologically inactive metabolites. The elimination half-life, which is largely independent of liver and renal function, is about 2 hours. Plasma protein binding is about 99%. The mean plasma level curves of Diclofenac-Dvido 75 mg (Diclo-Divido)* compared with reference preparations in a time/concentration diagram:
Key: Konzentration = Concentration
*Composition identical to that of Diclofenac Duo 75 mg
5. NATURE AND CONTENTS OF CONTANINER
Blister packs of PVC/PVDC foil and aluminium foil
Original pack of 10, 20, 50, 100 prolonged-release capsules, hard. Avaiable in Albania: blister pack of 30 prolonged-release capsules, hard.
6. ADDITIONAL INFORMATION
Marketing authorization Holder: PharmaSwiss
d.o.o., Vojvode Stepe 18, Beograd
Representative in Albania: PharmaSwiss
, Rruga Vaso Pasha, Pallati i Ri, Nr.20, Kati III, Tirane
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