Microsoft word - pl18800201 amended with track changes.doc

Diclofenac Sodium 75mg/3ml
Solution for Injection
1. DESCRIPTION OF THE MEDICINAL PRODUCT
1.1 Name: Urigon
1.2 Composition: Active Ingredient: Diclofenac Sodium
Excipients: Sodium Metabisulfite, Mannitol, Benzyl Alcohol 360mg/3ml, Sodium Hydroxide 1N, Propylene Glycol, Water for injections 1.3 Pharmacotechnical form: Solution for injection
1.4 Strength in active ingredient: Each 3ml ampoule contains 75mg of Diclofenac sodium.
1.5 Description-Package: URIGON is a clear, colourless to pale yellowish solution, packed in
caramel-coloured glass ampoules and in carton boxes of 5 ampoules.
1.6 Pharmacotherapeutic class: Anti-inflammatory, antirheumatic drug.
1.7 Marketing Authorization Holder-Manufacturer: DEMO S.A., 21st km National Road Athens-
Lamia, 145 68 Kryoneri, Athens, Tel: +30 210 8161802, Fax: +30 210 8161587.
2. WHAT SHOULD YOU KNOW FOR THE MEDICINE YOUR DOCTOR PRESCRIBED
2.1 General Information: URIGON relieves from the symptoms of inflammation, such as swelling
and pain. It has no effect on the cause of the inflammation.
2.2 Indications: Ampoules for im use
- Chronic inflammatory arthropathies (rheumatoid arthritis, ankylotic spondyloarthritis, psoriatic arthritis etc.) - Degenerative arthropathies of the peripheral joints and spinal cord. - Arthritis from depositions of crystals (uric monosodium, pyrophosphate calcium, phosphate calcium, oxalic calcium). - Painful extra-arthric musculosceletal syndromes (periarthritis, tendonitis, traumatic lesions etc.) - Migraine crisis. - Colic of the ureters - Post-operative pain 2.3 Contraindications: You should not take URIGON in the following cases:
- If you have a stomach or bowel ulcer.
- If you have ever had an allergic reaction (e.g. rash or stridor) to drugs containing diclofenac or
similar substances such as acetylsalicylic acid (aspirin) or ibuprofen in the past. - If you have ever had an allergic reaction to any other ingredient of the drug.
- If you had blood in your faeces or black faeces.
- If you suffer from hepatic porphyria.
- If you are pregnant, intend to get pregnant or if you are breast-feeding.
Urigon should not be administered to children below 14 years.
Notify your physician in case of any of the above because URIGON is probably not suitable for you in
these cases.
2.4 Special warnings and precautions for use:
URIGON is a potentially dangerous drug and its administration requires close monitoring of the patient. Adverse effects might appear suddenly and be serious; therefore the patient should be informed. Administration of URIGON can cause ulcer, hemorrhage and perforation of the gastrointestinal canal. In case of appearance of symptoms which are indicative of such conditions the drug must be stopped immediately and the symptoms must be treated immediately. These adverse effects might appear in all kinds of patients, nevertheless they are more likely to appear in patients who receive the drug for a long period or in high doses, as well as in elderly patients, who may have especially intense reactions. URIGON administration might cause increase in the values of one or more hepatic function tests. These increases can be temporary, steady or aggravate during treatment. The increase is more often observed in SGPT. Cases of serious hepatic reaction with jaundice and fulminant hepatitis have been reported. Prostaglandins play an important role in maintaining the renal hematic flow in some categories of patients. The inhibition of their synthesis from diclofenac can lead to reduced renal function in patients with cardiac insufficiency, in patients who take diuretics, in patients with renal vessel conditions and elderly patients. In rare cases hypersensitivity reactions might appear, from urticaria and vessel edema to fatal anaphylaxis. The appearance of such symptoms requires stopping of URIGON administration and immediate treatment. URIGON can inhibit the appearance of the symptoms of an infection. Special caution is necessary in elderly people and in patients with cardiac insufficiency, arterial hypertension, hepatic or renal function disorders. In order to reduce the risk of adverse effects from the gastrointestinal system, the drug can be administered after the meal or in combination with antacids, H2 inhibitors, inhibitors of the proton pump, sucralfate or prostaglandin analogues. Patients who take URIGON chronically should receive regular clinical and laboratory monitoring. Regular monitoring of blood, transaminase, uria, creatinine, electrolyte and urine is also necessary. 2.5 Interaction with other medicinal products and other forms of interaction: Inform your
physician if you take other drugs because it might be necessary to change dosage or stop taking one
of the drugs. This applies to drugs given both with and without medical prescription. The effects of the
following drugs in particular may be affected by diclofenac:
- Lithium, digoxin, methotrexate and cyclosporin
- Drugs used for the treatment of diabetes
- Drugs used for the increase of urine production (diuretics)
- Drugs used for preventing the creation of blood clots (anti-coagulants) such as warfarin
- Other NSAIDs such as acetylsalicylic acid (aspirin) or ibuprofen
- Some drugs used for the treatment of infections (antibacterial of quinolone)
- Corticoids, anti-hypertensives, cholestyramine, colestipol and misoprostol
2.6 Posology and method of administration:
Dosage is individualized and depends on the disease, condition and response of the patient. The dosage is generally one 75mg ampoule daily, given by deep intragluteal injection into the upper outer
quadrant. In severe cases (e.g. colic) the daily dose can exceptionally be increased to two injections
of 75mg, separated by an internal of a few hours (one into each buttock). The duration of
maintenance treatment is determined by the attending physician according to the response of the
patient. For management of acute conditions that require short-term therapy, pharmaceutical forms of
rapid absorption are preferred.
For severe migraine crisis 1 ampoule of URIGON (75mg) is administered intramuscularly, followed if
necessary by the administration of suppositories of Diclofenac Sodium within the same day. The
maximum total daily dose of 150mg should not be exceeded.
For colic of the ureter, the use of injectable forms in doses up to 150mg is recommended. The use of injections should not continue for more than 2 days. In the elderly and patients with nephropathies, heart conditions and hepatic conditions, therapy should start with the lowest dosages and continue with the lowest effective dose are recommended. Use of URIGON is not recommended in children. 2.7 Overdose: There is no specific clinical picture due to diclofenac overdosage. Emesis,
somnolence, dizziness, unconsciousness, increased intracranial pressure and aspiration pneumonia
have been reported, which led to death.
Specific measures such as forced diuresis are unlikely to be helpful in eliminating NSAIDs because of their high protein-binding rate and extansive metabolism. Haemodialysis and peritoneal dialysis may be of little value. Supportive and symptomatic treatment can be performed. 2.8 What you should know in case you have missed a dose: If you have to take the drug on a
regular basis, you should take the dose you have missed the soonest possible. If however it is almost
time for your next dose, do not take the dose that you missed, but continue your regular therapy.
2.9 Undesirable effects: The most common adverse effects are from the gastrointestinal and
central nervous system. The following adverse effects have been reported:
Gastrointestinal: Diarrhoea, indigestion, nausea, emesis, constipation, flatulence, ulcer, hemorrhage, increase of the hepatic enzymes. More rarely aphthous stomatitis, oesophagitis, dryness of the mucosa, hepatitis, hepatic necrosis, pancreatitis, colitis, rectitis- proctitis from the use of suppositories. Nervous system: Dizziness and vertigo. More rarely insomnia, depression, diplopia, anxiety, emotivity, aseptic meningitis and rarely hallucinations, memory disorders, nightmares, tremor, muscular dyssynergia, spasms, disorientation, psychosic reactions. Skin: Eruption and itching. More rarely alopecia, urticaria, eczema, redness of the face, dermatitis, blisters, allergic peliosis, pleomorphic erythema, vessel edema, Stevens-Johnson’s syndrome, necrotic epidermolysis and rarely ephidrosis and exfoliative dermatitis. Cardiovascular: Rarely hypertension, cardiac insufficiency, pulse feeling, tachycardia, supraabdominal extrasystole, cardiac muscle infarction. Blood: Rarely decrease of the haemoglobin value, leucopenia, thrombopenia, hemolytic anemia, refractory anemia, agranulocytosis, peliosis. Sense organs: Rarely vision blurring, taste disorders, reversible deafness. Genitourinary: Rarely nephrosic syndrome, proteinuria, oliguria, interstitial nephritis, renal papilla necrosis, azotemia, acute renal insufficiency, thamuria, nycturia, hematuria, impotence, vaginal hemorrhage. Respiratory: Rarely epistaxis, asthma, pharynx or larynx edema, anhelation, hyperpnea. Body: Abdominal pain or colic, headache, fluid retention, abdomen dilatation and more rarely malaise, tongue and lips edema, photosensitivity, anaphylactic reactions, anaphylaxis, chest pain. 2.10 Expiry date: It is recorded on both inside and outside package. In case this date has passed, do
not take the drug.
2.11 Special precautions for storage of the product: Store at a temperature not exceeding 25°C,
protected from light.
3. GENERAL INFORMATION FOR THE RATIONAL USE OF DRUGS
- This drug has been prescribed to you by your physician for a specific medical condition. You should
not give it to other people, nor use it for any other condition without having consulted your physician first. - Should any problem with the drug arise during treatment, inform your physician or pharmacist - If you have any questions regarding the information on your drug, or if you need to know more details for your medical condition, do not hesitate to request this information from your physician or pharmacist. - In order for your drug to be effective and safe, you should take it according to the prescribed - For your safety and health it is important that you read carefully all the information about the drug - Do not keep your medicines in bath closets because heat and humidity can deteriorate the drug - Do not keep drugs that you no longer need or that have already expired. - For more safety keep all drugs in a safe place out of the reach of children. This medicine is subjected to medical prescription only.
Reg. No.: 21824/05/06 GR
DEMO S.A. Pharmaceutical Industry
21st km National Road Athens-Lamia,
145 68 Kryoneri, Athens, GREECE
Tel.: + 30 210 8161802, Fax: + 30 210 8161587

Source: http://old.medicinesauthority.gov.mt/products/PIL_MA188%2000201_Urigon_Solution%20for%20injection_Diclofenac%20Sodium%2075%20mg%20per%203ml_Demo%20SA%20Pharmaceutical%20Industry_Greece_PoM_M01AB05_21.12.07.pdf