Class: Musculoskeletal System
Dosage Form: Tablets
Description: Non-steroidal antiphlogisitic/analgesic
Diclofenac sodium………………..75, 150 mg
Calcium hydrogen phosphate, cellulose, hydroxypropyl methvlcellulose, lactose, magnesium stearate, maize starch, poly(6-carboxymethyl) starch sodium, silicon dioxide, coloring agent ferric oxide red
Diclac is indicated in:
- Symptomatic treatment of pain and inflammation in-acute inflammations of a joint (arthritis) including attacks of gout
- Chronic inflammation of a pint (arthritis), especially in rheumatoid arthritis (chronic polyarthritis)
- Aankylosing spondylitis (Bechterew’s disease) and other inflammatory-rheumatic spinal diseases
- Irritative conditions in degenerative diseases of the joints and spine (arthrosis and spondylarthrosis)
- Inflammatory soft tissue-rheumatic diseases
- Painful swelling or inflammation after injuries or operations
The following interactions have been noted:
- Concurrent administration of Diclac 150 ID and digoxin (agent to strengthen cardiac power), phenytoin (agent to treat convulsive fits) or lithium (agent to treat mental-psychological disorders) can increase the concentrations of these medications in the blood
- Diclac 150 ID can weaken the efficacy of diuretics (dehydrating agents) and anti-hypertensives (blood pressure-lowering agents)
- Diclac 150 ID may reduce the effects of ACE inhibitors (agent to treat a weak heart and to lower blood pressure), Furthermore, co-administration involves the risk of the occurrence of renal function disturbances
- Concurrent administration of Diclac 150 ID and potassium-sparing diuretics (certain agents for dehydration) can lead to an increase in the potassium concentration in blood
- Concomitant administration of Diclac 150 ID with other anti-inflammatory or pain-relieving agents of the group of non-steroidal antiphlogistics or with glucocorticoids increases the risk of side effects in the gastrointestinal tract (see “Side effects”)
- Administration of Diclac 150 ID within 24 hours before or after administration of methotrexote can lead to an increased concentration of methotrexate and an increase in its undesired effects
- Medications containing probenecide or sulfinpyrazone (agent to treat gout) may delay the excretion of diclofenac. This may result in accumulation of Diclac 150 ID in the body associated with an increase in its undesired effects
- So far clinical studies have not shown any interactions between diclofenac and agents inhibiting blood coagulation, Nevertheless, appropriate monitoring of the coagulation status is recommended as a precaution In case of concomitant therapy
In connection with the following undesired drug effects it must be considered that they predominantly change and are individually variable. In particular, the risk for the occurrence of gastrointestinal bleeding (ulcers, mucosal defects, inflammations of the gastric mucosa) depends on the dose range and the duration of administration.
1. Blood/blood vessels:
In rare cases, disorders of blood formation may occur (agranulocytosis, anemia, leucopenia, thrombopenia), Initial signs may be: strong exhaustion, liver, flu-like complaints, throat pain, skin bleeding, nosebleeds and superficial mouth sores.
anemiIn these cases, the medication must be discontinued immediately and the doctor consulted (see “Precautionary measures”). You should not treat yourself with pain-relieving and fever-reducing medicinal products. In long-term therapy, blood counts should be monitored at regular intervals. in isolated cases, anemia may result from accelerated degradation of red blood cells (hemolytica), In isolated cases, inflammations of vessels caused by allergies (vasculitis) have been observed.
Hypersensitivity reactions, such as skin rashes and itching, have occasionally, neltio rash and hair loss have largely been observed, Skin rashes with reddening and vesiculation (erythema, eczema), hypersensitivity to light, small-dotted skin bleeding (purpura) and severe courses of skin reactions (Stevens-Johnson syndrome, Lyell’s syndrome) occur in isolated cases.
2. Cardiovascular system:
Isolated cases of palpitations, chest pain and high blood pressure hove been reported.
Heart muscle weakness (cardiac insufficiency) may occur in isolated cases.
Occasionally, an increase in liver enzyme values in blood (serum transaminases) may occur. Liver damage is rarely to be expected (inflammation of the liver with or without jaundice taking a very severe (fulminant) course in isolated cases, even without any early symptoms). Therefore, liver values should be monitored at regular Intervals
In isolated cases allergy-related inflammations of tine lung (pneumonitis) have been observed.
5. Nervous system:
Central nervous disorders such as drowsiness, excitation, headaches, fatigue, irritability and dizziness are occasionally to be expected.
In isolated cases nightmares, anxiety, depression, disorientation, memory defects, buzzing in the ears and temporary hearing disorders, visual disturbances (blurred or double vision), sensitivity disorders, changes in the sense of taste, tremor and other psychotic reactions hove been reported.
In isolated cases damage to renal tissue (interstitial nephritis, papillary necrosis) occurs, which may be accompanied by acute renal function disorders (renal insufficiency), protein in urine ; proteinuria) and/or blood in urine (hematuria).
In isolated cases the development of a nephrotic syndrome is possible (accumulation of liquid in tissue edema and high protein excretion in urine).
Reduced excretion of urine, accumulation of liquid in tissue (edema) as well as general malaise may be symptoms of a kidney disease up to kidney failure. If these symptoms occur or deteriorate, you must discontinue the intake of Diclac 150 ID and contact your doctor immediately.
Severe hypersensitivity reactions are possible. They can manifest themselves as swelling of face, tongue and inner larynx with constriction of the respiratory passages, shortness of breath up to asthmatic attack, racing heartbeat, drop in blood pressure up to shock. If one of these symptoms occurs, which is possible even with first administration, immediate medical attention is necessary.
8. Digestive tract:
The occurrence of gastrointestinal complaints such as diarrhea, vomiting and nausea and minor gastrointestinal blood loss, which may cause anemia in exceptional cases, is frequently to be expected.
Occasionally loss of appetite, abdominal cramps, flatulence, digestive disorders as well as gastric or intestinal ulcers (possibly in association with bleeding and rupture), and in rare cases vomiting of blood, blood in the stool, 01 bloody diarrhea may occur. If more intense pain in the epigastrium and/or black discoloring of the stools occur, you must discontinue Diclac 150 ID and inform your doctor immediately. Isolated cases of an inflammation of pancreas, oral mucosa and tongue, damage to esophagus (esophageal lesions), constipation, complaints in the hypogostium (e.g. bleeding inflammations of the large intestine, increase in Crohn’s disease/ulcerative colitis: certain inflammations of the large intestine associated with ulcers) as well as of enterostenosis have been reported.
9. Other side effects:
Rarely, accumulation of liquid in tissue (edemas, e.g. peripheral edemas) may occur, especially in patients with high blood pressure or impaired renal functional. In isolated cases deterioration in -related inflammations (e.g. development of a necrotising fascites; has been described in temporal connection with the administration of certain anti-inflammatory medicinal products (non-steroidal antiphlogistics such as Diclac 150 ID). If signs of an infection (e.g. reddening, swelling, hyperthermia, pain, fever) recur or deteriorate during administration of Diclac 150 ID, a doctor should thus be consulted without delay.
If you observe side effects not listed in this package insert, please inform your doctor or pharmacist.
Dosage and Administration:
- 75-150 mg per day given in 2 or 3 divided doses
- The maximum daily dose is 200 mg
2. Children older than 6 months:
- For relief of pain: 1-2 mg/kg/per day given in 2 or 3 divided doses
- For juvenile chronic arthritis: 1-3 mg/kg per day given in 2 or 3 divided doses
Store at room temperature, below 25°C.