PENNSAID SOL CUT 30ML 16MG/ML

PENNSAID 16 MG/ML CUTANATION

active ingredients

1 ml of skin solution contains 16 mg of sodium diclofenac. Excipient with known effects: Dimethylsulphur dioxide For the full list of excipients, see paragraph 6.1.

Excellent

Dimethyl sulfoxide, ethanol, glycerin, propylene glycol, distilled water.

Therapeutic indications

PENNSAID (16 mg/ml of sodium diclofenac) is a skin solution indicated in the symptomatic relief of pain associated with osteoarthritis of superficial joints, including the knee. No data on the use of PENNSAID in large and deep joints, covered by muscle layers or other soft tissues, such as hip or spine.

Contraindications

PENNSAID (16 mg/ml of sodium diclofenac) is contraindicated: - in patients with hypersensitivity to the active ingredient, dimethylsolfoxide (DMSO) or any of the excipients listed in paragraph 6.1; - during pregnancy and nursing; - in those subjects in which they have occurred, after intake of acetylsalicylic acid (ASA) by mouth or other non-steroidal anti-inflammatory drugs (FANS), asthmatic access, hives, acute rites or other allergic manifestations, since there is a potential for cross-sensitivity with other NSAIDs, also of different groups.

Population

Posology and method of administration: PENNSAID applies locally to the sore joint. After washing with soap and water the part to be treated and expected to be dry, apply about 20 or 40 drops (about 0.5 or 1 ml) of PENNSAID (16 mg/ml of sodium diclofenac) respectively for an average joint (e.g. wrist) or large (e.g. knee). Patients must use up to a maximum of 40 drops four times a day per joint as recommended by the attending physician. So that the product does not take away from the area to be treated, apply the solution by subdividing it into portions of 5 or 10 drops for an average or large joint. Distribute PENNSAID evenly on the part to be treated with the hand or fingers. Repeat the procedure until you have applied the entire recommended dose PENNSAID. Run the application 4 times a day. Renal and hepatic comprogation. Patients with kidney and liver impairment: For use of PENNSAID in patients with liver or kidney impairment see paragraph 4.4 Pediatric population: Security and effectiveness of PENNSAID in children were not established. Since no experience has been acquired with PENNSAID in pediatric use, it is not recommended to use in this group of patients. Way of administration: Skin use.

Conservation

Do not store at temperature above 25°C. Don't refrigerate. For storage conditions after first opening see paragraph 6.3.

Warnings

The appearance of side effects can be reduced by using the minimum effective dose for the shortest time necessary for the control of symptoms. Seniors: there is an increased frequency of adverse reactions to NSAIDs for oral use, especially hemorrhages and gastrointestinal perforations, which can be fatal. Patients with history of gastrointestinal toxicity, especially if elderly, must report any abnormal symptoms at the abdominal level (especially gastrointestinal hemorrhage) especially in the early stages of therapy. They were reported very rarely, in association with the use of NSAIDs, severe skin reactions, some of which fatal, including exfoliatory dermatitis, Stevens-Johnson syndrome, and epidermal toxic necrolysis (see paragraph 4.8). In patients the maximum risk of such reactions occurs in the early stages of therapy: the onset of reactions occurs in fact within the first month of therapy in most cases. Therapy with PENNSAID must be interrupted to the first appearance of skin rash, mucosa lesions or any other sign of hypersensitivity. Patients should be recommended to wash their hands after application to avoid contact with eyes, mucosa and skin not interested in treatment. No other medicinal product shall be applied to the area concerned at the same time as PENNSAID. The possibility that side effects may occur as a result of the topical application of PENNSAID is very low when compared with the frequency of occurrence of unwanted effects following administration of diclofenac by mouth, due to low systemic absorption of PENNSAID. This medicine must be used with caution in patients with impaired kidney function as isolated cases of systemic reactions have been observed with deterioration of kidney function following oral or topical administration of NSAIDs. Must be taken into account the lowest dosage of PENNSAID for joint. Hepathetic system: You can experience a slight increase in values in liver function tests following treatment with PENNSAID. If such abnormal values persist or worsen, or if signs or clinical symptoms indicate a liver disease, or other manifestations (e.g. eosinophilia, rash) should arise PENNSAID must be interrupted. If the need to administer this medicine should occur in the presence of a serious compromise of liver function, this must be done under careful medical observation. Use caution in using sodium diclofenac in patients with liver porphyria, as sodium diclofenac can trigger a crisis. Gastrointestinal system: Peptic ulcers, perforations and gastrointestinal hemorrhages, sometimes serious and rarely fatal, in the presence or absence of preliminary symptoms, were reported during oral or rectal therapies with non-steroidal anti-inflammatory drugs (NSAIDs). However, the maximum level of diclofenac in serum, after the topical application of PENNSAID, is low (50 times lower than that achieved after oral administration of 25 mg diclofenac). So, PENNSAID (diclofenac sodium) can be reasonably administered under strict medical control to patients prone to gastrointestinal irritations, including those with history of peptic ulcer induced by other nonsteroidal anti-inflammatory drugs or affected by other inflammatory diseases of the gastrointestinal tract (such as ulcerative colitis or Crohn's disease). In such cases, the doctor must assess the benefits of treatment in relation to possible risks (See paragraphs 4.3 and 4.8). The patient must be instructed to immediately contact his doctor with the first signs or symptoms of gastric ulcer or gastrointestinal hemorrhage. Such reactions may occur at any time during treatment, without symptoms or preliminary signs. Dermatology: The part treated with PENNSAID should not be covered by occlusive bandages. PENNSAID should be applied on the skin without injury or infections. Do not use PENNSAID in joint surfaces with previous skin diseases (e.g. psoriasis) if not after advice of your doctor. The application of PENNSAID on the mucosa. Hypersensitivity: Dimethylsolfoxide (DMSO) contained in PENNSAID can induce the release of istamine and occasionally reactions from hypersensitivity after topical administration have been reported. In the presence of any anaphylactoid reactions it is necessary to establish adequate therapy and to stop the application of PENNSAID. . Ophthalmology: In animal studies, high doses, especially by mouth, of DMSO caused abnormal changes in the eye crystalline. In studies on primates and in man, such modifications were not observed after ocular and oral administration of dimethylsolfoxide. Infections: Anti-inflammatory and analgesic effects of sodium diclofenac can mask the usual signs of infection. Then the doctor should pay particular attention to the possible development of localized skin infections in the area on which the patient applied the drug. It was found that the maximum concentration of diclofenac in the blood, after the application of the maximum dose of PENNSAID (1ml), is less than 10 ng/ml. This value is 50 times lower than the maximum concentration of diclofenac in the blood after oral administration of 25 mg diclofenac. Excipients: PENNSAID contains dimethylsolfoxide (DMSO) which can cause drowsiness and headache and can be irritating to the skin.

Interactions

The interactions reported in this paragraph were observed after systemic administration of sodium diclofenac. The risk associated with topical use PENNSAID it is not known, but it is probably of low entity. Acetylsalicylic acid (ASA): Levels in diclofenac serum can decrease when taking it simultaneously to acetylsalicylic acid. The bioavailability of acetylsalicylic acid is reduced by the presence of diclofenac. Although such pharmacokinetic interactions do not seem to be clinically relevant, there is no benefit established in the concomitant use of these two drugs. Digoxin: Diclofenac can increase the concentration of digoxin in plasma. Posological changes may therefore be necessary. Litio: Plasma lithium concentrations can increase when administered simultaneously to diclofenac (which alters renal clearance of lithium). You may need to adjust the lithium dosage. Oral hypoglycemic drugs: Studies of pharmacodynamics have not shown any strengthening of the effects due to contemporary administration with diclofenac; however, isolated cases of hypoglycemic and hyperglycemic effects have been reported on the dosage of hypoglycemic drugs. Antiagulants: NSAIDs can increase the effects of anticoagulants, such as warfarin (see paragraph 4.4) Diuretics: It is known that non-steroidal anti-inflammatory drugs inhibit diuretic activity. The contemporary intake of anti-inflammatory and diuretic potassium savers can cause an increase in serum potassium, and thus make it necessary to periodic control of blood/plasm levels. Glucocorticoids: Contemporary administration can aggravate the unwanted gastrointestinal effects. Non-steroidal anti-inflammatory drugs (FANS): Contemporary oral administration of two or more non-steroidal anti-inflammatory drugs can promote the appearance of unwanted effects (see Special Warnings and Precautions of Use). Methotrex: The administration of non-steroidal anti-inflammatory drugs less than 24 hours before or after treatment with metotrexate should be done with caution, since such drugs may elevate its blood concentration and increase its toxicity. Ciclosporin: Neurotoxicity of cyclosporin can be increased due to the effects of non-steroidal anti-inflammatory drugs on renal prostaglandin. Antibacterial kinolonic: Isolated convulsions have been reported, which may have been due to the concomitant use of kinolonics and non-steroidal anti-inflammatory drugs. Antihypertensive drugs: As well as other non-steroidal anti-inflammatory drugs, diclofenac can reduce the antihypertensive effects of propranolol, other beta blockers and other antihypertensive drugs. Other medicines: Diclofenac salt sodium should not be used along with diclofenac salt potassium, as both are present in the underform plasma of the same organic active ion. Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see paragraph 4.4). Anti-aggregating agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see paragraph 4.4).

Effects

Undesirable effects are divided into those manifested on the application site and those manifested as a systemic effect. Topical application: Six double-cyeco controlled clinical trials highlighted the following side effects with a significant increase in incidence in the group treated with PENNSAID compared to the comparison group treated with placebo. In the application site, the cases of skin dryness (35.80% versus 6.86% of the group treated with placebo) and rash (10.44% versus 2.86% of the group treated with placebo) were statistically significant. Other side effects PENNSAID, which are statistically significant results compared to placebo, are constipation (3,83% versus 0.57%), dispepsia (8,98% versus 4%) and flatulence (4,49% versus 0.57%). Photoallergic reactions and contact dermatitis were reported after the topical application of diclofenac. Systemic absorption of sodium diclofenac after topical application of PENNSAID is very low compared to that related to taking diclofenac sodium tablets, however, when PENNSAID is applied to a relatively extended skin area for a prolonged period of time, the possibility of systemic side effects similar to systemic effects caused by diclofenac (see below) orally cannot be completely excluded. Possible systemic side effects are described later. Oral administration: Oral administration of diclofenac causes adverse events due to gastrointestinal reactions both on a systemic and local level. The most serious gastrointestinal adverse events are ulcerations and hemorrhages, while the most serious dermatological reactions, although rare, are represented by multiform erythema (sindromi by Stevens-Johnson and Lyell). Occasional deaths were reported, especially in the elderly. Bollose reactions included Stevens Johnson Syndrome and Epidermal Toxic Necrolysis (very rare). Edema, hypertension and heart failure were reported in association with NSAIDs. Adverse events are classified according to the frequency as follows: very common (≥1/10), common (≥1/100, gastrointestinal pathologies. Not common: epigastric pain, gastric or abdominal pain, abdominal cramps, nausea, dyspepsia, anorexia, diarrhea, vomiting and flatulence; Rare: gastrointestinal bleeding (blood diarrhea, melena, ematemesis) gastric and intestinal ulcerations with or without bleeding or perforation; Notable: cranial bowel affections (e.g. hemorrhagic colitis not specific and aggravation of ulcerative colitis or Crohn's disease), diaphragmtic intestinal stroking, hyperacidity, stomatitis, glossitis, kneaded tongue, esophagus lesions, constipation and pancreatis, disorders of the alteration of taste. Diseases of the nervous system. . Not common: dizziness, cephales and dizziness; Rare: drowsiness, malaise, concentration disorders and fatigue; Notable: sensory disorders including paresthesia, memory disorders, disorientation, insomnia, irritability, convulsions, depression, anxiety, nightmares, tremors, psychotic reactions and aseptic meningitis. Pathologies of the eye. . Notable: vision disorder (black vision, diplopia). Ear and labyrinth pathologies. Notable: hearing impairment, tinnitus. Heart disease. . Rare: palpitations, angina and arrhythmia; Not yeta: aggravation of heart failure and hypertension. Vascular diseases. . Notable: vasculite. Pathologies of skin and subcutaneous tissue. . Not common: rashes and itching; Rare: hives; Notable: bollous dermatosis, erythema, eczema, multiform erythema, Stevens- Johnson syndrome, Lyell syndrome (toxic epidermal necrolysis), erythroderma (exfoliating dermatitis), hair loss, photosensitivity and purple reactions, which include allergic purple, burning sensation in place of application, dry skin. Kidney and urinary pathologies. . Rare: edema (to the face, generalized, peripheral); Notable: acute kidney failure, nephrotic syndrome, urinary abnormalities (e.g. hematuria and proteinuria), interstitial nephritis and papillary necrosis. Emolinfopoietic system pathologies. . Notable: thrombocytopenia, leucopenia, agranulocytosis, hemolytic anemia, aplastic anemia and anemia due to gastrointestinal bleeding. Hepatobiliary pathologies. . Not common: increases (≥ 3 times above the normal limit) of AST, ALT; Rare: changes in liver function including hepatitis with or without jaundice; Notable: lightning hepatitis. Respiratory, chest and mediastinic pathologies. . Rare: hypersensitivity reactions such as asthma in patients sensitive to acetylsalicylic acid, e.g.bronchospasm;systemic anaphylactic/anaphylactoid reactions, including hypotension; NotablePneumonia. Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

PENNSAID must be administered exclusively for external use. Low systemic absorption of diclofenac from PENNSAID suggests that cases of overdose toxicity by topical means are extremely unlikely. In case of accidental ingestion the amount of sodium diclofenac (900 mg) contained in a 60 ml bottle PENNSAID may cause gastric disorders and/or transient kidney dysfunction. Absorption must be reduced to a minimum as soon as possible by the administration of activated carbon. Renal and gastrointestinal features must be checked for irritation or bleeding. Complications such as hypotension, gastrointestinal hemorrhage and kidney failure should be treated with symptomatic treatments and support. Forced diuresis can be of limited utility. The amount of DMSO (36 g) would be much lower than the minimum levels of danger in man (based on DL50 in monkeys > 11 g/kg). Acute exposure to DMSO from inhalation of high concentrations of steam with the use or abuse of PENNSAID is extremely unlikely. If this happens, it can cause irritation of the mucous membranes of the upper respiratory tract, respiratory sibilus, nausea or vomiting. The therapy involves the administration of oxygen or other symptomatic measures considered necessary.

Pregnancy: PENNSAID is contraindicated during pregnancy. (see paragraphs 4.3 and 5.3). Nursing: PENNSAID is contraindicated during nursing (see paragraphs 4.3 and 5.3)

Source: Farmadati