The information below refers to the medicinal preparation OKi 80 mg granules for oral solution ketoprofen lysine salt. The same indications, posology and doses, precautions can also be referred to the versions in oral liquid solution (drops), suppositories and injectable ampoules.
Read all of this leaflet carefully before taking this medicine as it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others.It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. What OKi is and what it is used
for OKi 80 mg granules for oral solution contains ketoprofen lysine salt as the active ingredient which belongs to a group of medicines used for pain and inflammation called ‘Non-Steroidal Anti-Inflammatory Drugs’ (NSAIDs). OKI is used for
Adults: symptomatic treatment of inflammatory states associated with pain including:
– rheumatoid arthritis (autoimmune disease that causes joint pain and stiffness),
– ankylosing spondylitis (chronic inflammatory disease that mainly affects the spine and joints),
– painful arthrosis (disease affecting the joints),
– extra-articular rheumatism (rheumatic diseases affecting structures outside the joints),
– post-traumatic inflammation (inflammatory state on a traumatic basis),
– painful inflammatory conditions in dentistry, otolaryngology, urology and pulmonology;
Children and adolescents: symptomatic and short-term treatment of inflammatory states associated with pain, also accompanied by pyrexia (fever), such as those affecting the osteoarticular system, post-operative pain and ear infections. What you need to know before you take OK I
Do not take OKi:
– if you are allergic to ketoprofen, other non-steroidal anti-inflammatory drugs (NSAIDs) or any of the other ingredients of this medicine (listed in section 6 ‘Contents of the pack and other information’);
– if you have a history of hypersensitivity (allergy) reactions such as bronchospasm, asthma attacks, acute rhinitis, hives, nasal polyps, angioneurotic edema (swelling of the deep dermis and subcutaneous tissue which can also affect the mucous membranes) or other allergic type to ketoprofen or to substances with a similar mechanism of action (for example acetylsalicylic acid or other NSAIDs). Severe, rarely fatal, anaphylactic reactions have been observed in these patients (see section 4 “Possible side effects”);
– if you suffer from previous bronchial asthma;
– if you have severe heart failure (inability of the heart to pump the adequate amount of blood necessary for the body’s needs);
– if you currently have a peptic (stomach) ulcer or bleeding, or have suffered in the past from recurrent peptic ulcer or bleeding (two or more distinct, proven episodes of bleeding or ulceration);
– if you have suffered in the past from gastrointestinal bleeding, ulceration or perforation or chronic dyspepsia;
– if you have a history of gastrointestinal bleeding or perforation following previous NSAID therapy;
– if you have leukopenia (reduction in the number of white blood cells) and thrombocytopenia (reduction in the number of platelets in the blood);
– if you suffer from Crohn’s disease or ulcerative colitis;
– if you suffer from gastritis;
– if you have severe liver failure (cirrhosis of the liver, severe hepatitis, impaired liver function) or kidney (impaired kidney function);
– if you suffer from bleeding diathesis (predisposition to the development of bleeding) and other bleeding disorders or if you have haemostatic disorders;
– if you are on intensive diuretic therapy;
– if and in the last three months of pregnancy;
Do not give this medicine to children under 6 years of age. Warnings and precautions before taking OKI
Undesirable effects can be minimized with the use of the shortest possible duration of treatment that is needed to control symptoms (see the subsection “How to take OKi and the sections below on gastrointestinal and cardiovascular risks”). The concomitant use of OKi with other NSAIDs should be avoided, including selective cyclooxygenase-2 inhibitors. Cases of gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported during treatment with all NSAIDs, such as OKi, at any time, with or without warning symptoms or a previous history of serious gastrointestinal events.
Your doctor may recommend the concomitant use of stomach protective medicines (for example misoprostol or proton pump inhibitors), especially if you are elderly, have ever had an ulcer or are taking low doses of acetylsalicylic acid or other medicines that may increase the risk of gastrointestinal events (see the sub-section “Other medicines and OKi”).
Report any unusual abdominal signs or symptoms (especially gastrointestinal bleeding) particularly in the early stages of treatment. Use caution if you are taking medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids (medicines used to treat inflammatory states), selective serotonin reuptake inhibitors (such as medicines used to treat depression), anticoagulants (blood-thinning medicines such as warfarin), or antiplatelet agents such as acetylsalicylic acid (see ‘Other medicines and OKi’ subsection).
Elderly patients are at increased risk of developing adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see section 3 “How to take OKi”). Elderly patients are more prone to reduced kidney, heart and liver function. Children:gastrointestinal haemorrhages, occasionally severe, and ulcer have been reported in some pediatric patients treated with ketoprofen lysine salt (see section 4 “Possible side effects”); therefore the product must be administered under strict supervision of the physician who will have to evaluate the necessary dosage schedule from time to time. You should be carefully monitored if you have or have had in the past a gastrointestinal disease, for the appearance of digestive disorders, especially gastrointestinal bleeding. Stop treatment with OKi immediately at the first signs of gastrointestinal bleeding or ulceration. Patients with active or previous peptic ulcer:be careful if you have a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease), as these conditions can recur with the use of NSAIDs (see section 4 ‘Possible side effects’). Ketoprofen, especially at high doses, may be associated with a higher risk of severe gastrointestinal toxicity than other NSAIDs. Skin reactions:severe cutaneous (skin) reactions, some of them fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4 ‘Possible side effects »). In the early stages of therapy, patients appear to be at higher risk: the reaction occurs in most cases within the first month of treatment. Stop using OKi at the first appearance of a skin rash, mucosal lesions or any other signs of hypersensitivity.
If you have celiac disease (gluten intolerance), you can take OKi as it does not contain gluten.
If you have phenylketonuria (a rare disease characterized by the inability to metabolise the amino acid phenylalanine), you can take OKi as it does not contain aspartame.
If you have diabetes, you can take OKi as it does not affect low-calorie or controlled diets. Talk to your doctor or pharmacist before taking OKi: If you have impaired kidney function, OKi should be administered with caution:
If you have heart failure (a condition in which the heart is weakened), if you have changes in liver function, such as cirrhosis (severe liver impairment), if you have changes in kidney function, such as nephrosis (degenerative kidney disease ), or if you have chronic kidney failure (impaired kidney function),
if you are being treated with diuretics (medicines used to increase urine production), or if you may have low blood volume (hypovolaemia), especially if you have elderly at the start of treatment, as kidney function should be closely monitored. As with all NSAIDs, the medicine may increase the value of some laboratory tests, such as plasma urea nitrogen and creatinine.
If you have liver disease or have abnormal liver function tests, as the levels of transaminases (liver enzymes) should be evaluated periodically, particularly in long-term therapy.
As with other NSAIDs, the medicine can cause transient small increases in some liver parameters and also significant increases in transaminases GPT / ALT and GOT / AST (liver enzymes) (see section 4 ‘Possible side effects’). In the event of a significant increase in these parameters, therapy must be discontinued. Rare cases of jaundice (yellowing of the skin and eyes) and hepatitis (liver disease) have been reported with the use of ketoprofen. Liver and kidney function tests and blood counts should be checked during long-term therapy.
If you have uncontrolled hypertension (high blood pressure), congestive heart failure (accumulation of fluid in the lungs, abdominal organs and peripheral tissues due to inadequate pumping function of the heart), known ischemic heart disease (heart disease which appears as a result of reduced blood flow due to narrowing of the coronary arteries), peripheral artery disease and / or cerebrovascular disease (of the blood vessels of the brain), as it must be treated with ketoprofen lysine salt, as well as with all NSAIDs, only after careful evaluation.
If you have heart problems, or a history of stroke (cerebrovascular accident) or think you may be at risk for these conditions (for example if you have high blood pressure, diabetes or high cholesterol or if you smoke).
If you have a history (including family history) of hypertension (high blood pressure) and / or congestive heart failure (accumulation of fluid in the lungs, abdominal organs and peripheral tissues due to inadequate pumping function of the heart) from mild moderate, as adequate monitoring and instructions are required. Fluid retention and edema (swelling) have been reported during treatment with NSAIDs.
Medicines such as OKi may be associated with a small increased risk of heart attack (myocardial infarction) or stroke (cerebrovascular accident). Any risk is more likely with high doses and prolonged treatments.
An increased risk of atrial fibrillation (heart rhythm disturbance) associated with the use of NSAIDs has been reported.
Hyperkalaemia may occur, especially if you have diabetes, renal insufficiency and / or are on therapy with agents that promote hyperkalaemia (see sub-section “Other medicines and OKi”). In these circumstances, potassium levels need to be monitored.
Like other NSAIDs, in the presence of an infectious disease, ketoprofen can mask common symptoms of the progression of the infection, such as fever.
If you have allergic manifestations or have suffered from allergy in the past, as the medicine should be administered with caution.
Like all non-steroidal drugs, the use of ketoprofen in patients with bronchial asthma or with allergic diathesis (predisposition to allergy) can cause an asthma crisis. If you have asthma associated with chronic rhinitis, chronic sinusitis and / or nasal polyposis, as you are more exposed to the risk of allergy to acetylsalicylic acid and / or NSAIDs than the rest of the population. Administration of this medicine can cause asthma attacks or bronchospasm, shock and other allergic phenomena especially in subjects allergic to acetylsalicylic acid and / or NSAIDs (see the sub-section “Do not take OKi”).
Talk to your doctor if you have visual disturbances, such as blurred vision, as treatment needs to be stopped.
If you have haematopoietic disorders (which change the formation and maturation of blood cells), systemic lupus erythematosus (immune system disease) or mixed connective tissue disorders, as OKi should be administered with caution. Other medicines and OKi
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is not recommended that you take OKi in combination with:
– Other NSAIDs (including selective cyclooxygenase 2 inhibitors) and high doses of salicylates (over 3 g per day) as they may increase the risk of gastrointestinal ulcers and bleeding . §
– Blood thinning medicines (Anticoagulants such as heparin and warfarin and Inhibitors platelet aggregation, such as ticlopidine and clopidogrel). NSAIDs may amplify the effects of these medicines (see the ‘Warnings and precautions’ subsection), thereby increasing the risk of bleeding. If co-administration cannot be avoided, you should be closely monitored.
– Lithium (medicine used to treat manic-depressive psychosis). NSAIDs may raise blood lithium levels to toxic levels.
– Methotrexate (medicine indicated in the treatment of some autoimmune diseases and some cancers), used at doses above 15 mg / week: there may be an increased risk of blood toxicity of methotrexate. Allow at least 12 hours between stopping or starting treatment with ketoprofen and administering methotrexate.
– Hydantoins (such as phenytoin) and sulphonamides (such as some antibiotics and other medicines): the toxic effects of these substances can be increased.
Caution is required if you take OKi in combination with:
– Drugs that may promote hyperkalaemia, such as potassium salts, potassium-sparing diuretics, enzyme converter inhibitors (ACE inhibitors), angiotensin II receptor blockers, NSAIDs, heparins (low molecular weight or unfractionated), cyclosporine, tacrolimus and trimethoprim.
– Tenofovir (medicine used to treat some infections caused by viruses): can increase the risk of kidney failure.
– Drugs used to treat high blood pressure, such as beta blockers, diuretics, ACE inhibitors and angiotensin II antagonists. You must be adequately hydrated prior to initiation of concomitant therapy and monitoring of renal function should be considered after initiation of concomitant therapy (see sub-section “Warnings and Precautions”). NSAIDs can reduce the effect of diuretics.
– Methotrexate (medicine indicated in the treatment of some autoimmune diseases and some cancers), used at doses below 15 mg / week: there may be an increase in the blood toxicity of methotrexate. During the first weeks of use of the combination, a weekly monitoring of the complete blood count should be performed. If you are an elderly patient or renal function is impaired, monitoring should be more frequent.
– Corticosteroids (medicines used to treat inflammatory conditions): there may be an increased risk of gastrointestinal ulceration or bleeding (see sub-section “Warnings and Precautions”).
– Pentoxifylline (medicine used to improve blood circulation in the limbs): there may be an increased risk of bleeding. More frequent clinical monitoring may be required.
– Zidovudine (medicine used to treat HIV): increased blood toxicity may occur with possible severe anemia. Blood tests are needed after starting NSAID treatment.
– Sulfonylureas (medicines against diabetes, such as glycazide): NSAIDs can increase the hypoglycemic effect of sulfonylureas.
– Cardiac glycosides: NSAIDs can exacerbate heart failure, reduce the rate of glomerural filtration and increase the levels of cardiac glycosides; however, the pharmacokinetic interaction between ketoprofen and active glycosides has not been demonstrated. OKI, Combinations with other medicines
– Antihypertensive medicines (Beta-blockers, ACE inhibitors, diuretics): NSAIDs can reduce the effect of antihypertensive medicines.
– Mifepristone (medicine used for voluntary termination of pregnancy): the effectiveness of the contraceptive method can theoretically be reduced due to the properties of NSAIDs.
– Intrauterine contraceptive devices: the effectiveness of the device may be reduced resulting in pregnancy.
– Ciclosporin, tacrolimus (medicines used after transplantation or to treat immune system disorders): risk of additional toxic effects on the kidneys, particularly in the elderly.
– Thrombolytics (medicines that help dissolve blood clots): increased risk of bleeding.
– Antiplatelet agents (ticlopidine and clopidogrel) and selective serotonin reuptake inhibitors (SSRIs, such as some antidepressants): increased risk of gastrointestinal bleeding.
– Probenecid (medicine used to treat gout): co-administration of probenecid can increase blood concentrations of ketoprofen.
– Quinolone antibiotics: possible increased risk of developing seizures.
– Diphenylhydantoin and sulfonamides: the dosage may need to be reduced.
– Gemeprost (medicine used in the operations of the female reproductive system): reduction in effectiveness.
– Avoid alcohol intake. OKI Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy and OKI
The use of ketoprofen during the first and second trimester of pregnancy should be avoided. Inhibition of prostaglandin synthesis can adversely affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis (defect of the fetal abdominal wall) after use of a prostaglandin synthesis inhibitor in early pregnancy. The risk was believed to increase with dose and duration of therapy.
During the first and second trimester of pregnancy, only take this medicine when clearly needed and on the advice of your doctor. If ketoprofen is used by a woman wishing to become pregnant, or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to:
– cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension, ie increased pressure in the pulmonary circulation);
– renal dysfunction, which can progress to renal failure with oligohydroamnios (less than normal amount of amniotic fluid);
the mother and the newborn, at the end of pregnancy, to:
– possible prolongation of the bleeding time, and antiplatelet effect which can occur even at very low doses;
– inhibition of uterine contractions resulting in delayed or prolonged labor.
The use of the drug in the vicinity of childbirth can cause haemodynamics alterations of the small circulation of the unborn child with serious consequences for breathing. Therefore, DO NOT use OKi during the third trimester of pregnancy (see the sub-section “Do not take OKi”). Lactation and OKI
There is no information available on the excretion of ketoprofen in human milk. Ketoprofen is not recommended while breastfeeding. Fertility
The use of NSAIDs, including OKi, can reduce female fertility and is not recommended for women intending to become pregnant. Administration of NSAIDs, including OKi, should be discontinued in women who have fertility problems or who are undergoing investigation of fertility. Driving and using machines
If you experience drowsiness, dizziness or convulsions following the administration of ketoprofen, avoid driving, using machines or carrying out activities that require special vigilance. 3. How to take OKi Always
take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist. The recommended doses are
Adults: one 80 mg sachet (full dose) three times a day with meals. The maximum daily dose is 320 mg of ketoprofen lysine salt. Higher doses are not recommended (see sub-section “Warnings and precautions”). Special populations Use in children aged between 6 and 14 years: half a 40 mg sachet (half dose), three times a day with meals. OKi 80 mg granules for oral solution is contraindicated in children under 6 years of age (see the sub-section “Do not take OKi”). Use in the elderly: the dose must be carefully established by the doctor who will have to evaluate a possible reduction of the dosages indicated above (see the sub-section “Warnings and precautions”).Use in patients with hepatic insufficiency: it is recommended to initiate therapy at the minimum daily dosage (see the sub-section “Warnings and precautions”). Use in patients with mild or moderate renal insufficiency: it is recommended to reduce the starting dose and practice maintenance therapy with the lowest effective dose. Individualized adjustments can be considered only after establishing good tolerability of the drug. Monitor urine volume and kidney function (see sub-section “Warnings and precautions”).
OKi 80 mg granules must not be used if you have severe liver and kidney dysfunction (see the sub-section “Do not take OKi”). Method of administration
Opening the sachet along the line marked «half dose» gives a dose of 40 mg.
Opening the sachet along the line marked «full dose» gives a dose of 80 mg.
Pour the contents of the sachet into half a glass of water and mix. If you take more OKi than you should
In case of accidental ingestion / intake of an overdose of OKi, notify your doctor immediately or go to the nearest hospital. Cases of overdose have been reported with doses up to 2.5 g of ketoprofen. In most cases, benign symptoms were observed and limited to lethargy, somnolence, nausea, vomiting, epigastric pain (in the upper abdomen) and abdominal pain, headache, dizziness and diarrhea. In cases of severe overdose, hypotension, respiratory depression and gastrointestinal bleeding have been observed. The patient must be immediately transferred to a specialist center to begin symptomatic treatment.
There is no specific antidote to ketoprofen overdose. In case of suspected massive overdose, gastric lavage is recommended and symptomatic and supportive treatment instituted. In case of kidney failure, hemodialysis can be helpful in removing the drug from the body. 4. Possible side effects of OKI
Like all medicines, this medicine can cause side effects, although not everybody gets them. The most commonly observed adverse events are gastrointestinal in nature.
The following adverse reactions have been observed with the use of ketoprofen in
adults:
Common (may affect up to 1 in 10 people):
– dyspepsia (indigestion), nausea, abdominal pain, vomiting.
Uncommon (may affect up to 1 in 100 people):
– headache, dizziness, vertigo, somnolence;
– constipation (constipation), diarrhea, flatulence (presence of gas in the intestine),
gastritis, abdominal discomfort;
– skin rash, itching;
– edema (fluid buildup causing swelling), fatigue, peripheral edema (swelling), chills.
Rare (may affect up to 1 in 1,000 people):
– haemorrhagic anemia (blood loss anemia);
– paraesthesia (abnormal sensation on the skin, tingling);
– blurred vision (see the sub-section “Warnings and precautions”);
– tinnitus (ringing in the ear);
– asthma;
– stomatitis (ulcer in the mouth), peptic ulcer (gastric or duodenal ulcer), colitis;
– hepatitis, increased transaminases (liver enzymes), increased blood bilirubin (elevated serum bilirubin levels due to liver disorders), jaundice;
– increased weight.
Very rare (may affect up to 1 in 10,000 people):
– dyskinesia (movement disorder), syncope;
– hypotension (lowering of blood pressure);
– edema (swelling) of the larynx;
– hematuria (blood in the urine);
– asthenia (physical weakness), edema of the face.
Not known (frequency cannot be estimated from the available data):
– thrombocytopenia (reduction in the number of platelets in the blood), agranulocytosis (severe reduction in the number of white blood cells in the blood), bone marrow failure (reduction in the production of blood cells), haemolytic anemia (anemia due to abnormal destruction of red blood cells) neutropenia ( decrease in the number of neutrophil-type white blood cells); aplastic anemia (anemia due to insufficient production of blood cells in the bone marrow); leukocytosis (increased number of leukocytes in the blood), thrombocytopenic purpura; leukopenia (reduction in the number of white blood cells);
– anaphylactic reactions (including shock); hypersensitivity;
– depression, hallucinations, confusion, mood swings, excitability, insomnia. Anxiety and behavioral disturbance also occurred in a pediatric patient who had taken twice the dose recommended in the CPR.
– convulsions;
– dysgeusia (altered taste);
– tremor, hyperkinesis;
– heart failure (weak heart), atrial fibrillation (altered heart rhythm), palpitations, tachycardia (increased heart rate);
– hypertension (increased blood pressure), vasodilation (dilation of blood vessels), vasculitis (inflammation of blood or lymphatic vessels) (including leukocytoplastic vasculitis);
– bronchospasm (mainly in patients with known hypersensitivity to acetylsalicylic acid and other NSAIDs), rhinitis, dyspnoea (difficulty breathing), laryngospasm, acute respiratory failure (a single case has been reported, with a fatal outcome, in an asthmatic and sensitive patient aspirin);
– gastralgia (stomach pain), exacerbation of colitis and Crohn’s disease, gastrointestinal bleeding, gastrointestinal perforation (sometimes fatal, particularly in the elderly), heartburn (heartburn), gastric ulcer, duodenal ulcer, edema (swelling) of the mouth, pancreatitis, erosive gastritis, haematemesis (vomiting of blood) or melaena (emission of digested blood in the stool), hyperchlorhydria (excess hydrochloric acid in the stomach juice), gastric pain (stomach pain), edema of the tongue;
– photosensitization (reaction from exposure to sunlight or UV lamps), alopecia (hair loss), hives, angioedema, bullous rashes including Stevens-Johnson syndrome, Lyell’s syndrome and toxic epidermal necrolysis (severe skin reactions), erythema ( redness of the skin), rash (rash), maculo-papular rash, purpura, acute generalized exanthematous pustulosis (pustular rash), dermatitis;
– acute renal failure, interstitial tubular nephritis, nephritis or nephritic syndrome, nephrotic syndrome, glomerular nephritis, water / sodium retention with possible edema, acute tubular necrosis (damage to the tubular cells of the kidneys), renal papillary necrosis (damage to the kidney papillae) , oliguria (decreased urine output), evidence of abnormal kidney function;
– periorbital edema (swelling around the eyes);
– aseptic meningitis (inflammation of the membranes lining the brain not caused by bacteria);
– lymphangitis (inflammation of the lymphatic vessels);
– hyperkalaemia (increase in the amount of potassium in the blood), hyponatremia (decrease in the amount of sodium in the blood).
Medicines such as OKi may be associated (especially at high doses and for long-term treatment) with an increased risk of arterial thrombotic events (formation of blood clots in blood vessels), such as heart attack (myocardial infarction) or stroke. (cerebro-vascular accident) (see section 2 ‘What you need to know before you take OKi’).
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects. Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazioneavversa. By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store OKi
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month. The expiry date indicated refers to the product in intact packaging, correctly stored.
This medicinal product does not require any special storage conditions.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment. 6. Contents of the pack and other information
What OKi contains
– The active substance is ketoprofen lysine salt. One bipartite sachet contains 80 mg of ketoprofen lysine salt corresponding to 50 mg of ketoprofen.
– The other ingredients are mannitol, sodium chloride, colloidal silica, ammonium glycyrrhizinate, povidone, sodium saccharin, extra mint flavor 125. What OKi looks like and contents of the pack
Granules for oral solution – pack of 30 bipartite sachets.
Marketing authorization holder: Dompe pharmaceutici SpA – Via San Martino, 12 – 20122 Milano. Manufacturer: Dompe pharmaceutici SpA – Via Campo di Pile – L’Aquila or Lamp San Prospero SpA – Via della Pace 25 / A – San Prospero (Mo).
