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1. NAME OF THE MEDICINAL
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Propyphenazone (DCI) 175 mg
Anhydrous caffeine 25 mg
Propyphenazone (DCI) 500 mg
Anhydrous caffeine 75 mg
3. PHARMACEUTICAL FORM
Optalidón coated tablets: round tablets, lenticular pink
Optalidón suppositories: suppositories
Relief of mild to moderate pain
b) DOSAGE AND ADMINISTRATION
Adults and children over 12 years: The recommended dose is 1 to 2 tablets / outlet. This dose may be repeated 3 times a day up to six tablets a day.
Adults and children over 12 years: The usual dose is 1 suppository / day. The maximum dose is 2 suppositories / day.
Optalidón not be given under the following conditions:
- Hypersensitivity to propyphenazone, dipyrone, phenylbutazone or other pyrazolone.
- Sensitivity to caffeine or other xanthines (aminophylline, diprophylline, oxtriphylline, theobromine,
- If blood disorders (granulocytopenia, agranulocytosis).
- Metabolic diseases such as porphyria and congenital deficiency of glucose-6-phosphate dehydrogenase-.
- Due to the possibility of cross hypersensitivity to aspirin and other
Nonsteroidal anti-inflammatory drugs, not given to patients with prior history of
hypersensitivity to those components that have been submitted taking pictures
rhinitis, asthma, urticaria or angioedema.
- Patients with severe heart liver abnormalities, renal or.
- Anxiety Disorders
- Patients with peptic ulcer.
d) WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Do not use more than 10 days unless medically, since there have been reports of adverse effects on hematopoiesis. In cases of longer treatments should be performed hematologic regular checks.
Treatment should be discontinued immediately if the patient experiences an episode of fever or cold sore as they may be the initial symptoms of granulocytopenia.
Caution should be taken in case of hypertension, peptic ulcer, insomnia or anxiety.
In asthma or chronic obstructive airway diseases patients, carries the risk of acute crisis.
Take care not to simultaneously drinking large amounts of coffee, tea or colas or use other drugs that contain caffeine.
It should not be given to children under 12 years.
You must inform athletes this drug contains a component that can
establish an analytical result of doping control as positive.
Caffeine can raise blood glucose levels. In addition Optalidón contains dragees
89.87 mg of sucrose per tablet, which should be taken into account by diabetic patients.
e) DRUG INTERACTIONS AND OTHER FORMS OF
The propyphenazone may potentiate the action of oral anticoagulants.
You can interact with drinks containing caffeine (coffee, tea, soft drinks), caffeine-containing medications, medications that cause CNS stimulation or monoamine oxidase (MAO) inhibitors.
Caffeine can also antagonize the effects of barbiturates and antihistamines, it increases urinary excretion of lithium, reducing its therapeutic effect.
With diagnostic test results:
- Cancels the effects of dipyridamole on myocardial blood flow. It must warn
patients to avoid intake of 8 to 12 hours before testing.
- Produces false positive serum urate elevations (when measured by the method of Bittner).
- Increases blood glucose levels.
- Raise the urinary concentrations VMA acid (VMA), catecholamines and acid
5-hydroxyindole, so you should avoid caffeine intake before testing.
f) PREGNANCY AND BREASTFEEDING
Optalidón not be administered during pregnancy. In the last 6 weeks may inhibit uterine contractions and increase the tendency to bleed.
Caffeine crosses the placenta and reaches similar to maternal concentrations, can cause fetal arrhythmias overuse tissue concentrations.
Since propyphenazone and caffeine can pass into breast milk, it should not be administered during lactation.
g) EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
They not described, but if dizziness or drowsiness are present should not drive or operate machinery.
h) ADVERSE REACTIONS
Not usually observed at recommended doses. In hypersensitive subjects have been observed very rarely allergic skin reactions type: redness or itching, skin changes with blistering (in individual cases, Steven-Johnson syndrome or Lyell's syndrome), urticaria or shock.
Occasionally dizziness, nausea, nervousness, rapid heartbeat or may appear
Exceptionally (<< 1%), agranulocytosis, aplastic anemia, leukopenia, thrombocytopenia,
anaphylactic reactions and dyspnea.
Symptoms of overdose are: abdominal pain, nausea, vomiting, drowsiness or insomnia,
excitement, heart and irregular heartbeat, respiratory depression, convulsions, coma with
hypotension, shock and oliguria. Treatment is symptomatic. It should be removed as soon as possible
body medicine by gastric lavage, forced diuresis or dialysis.
5. PHARMACOLOGICAL PROPERTIES
a) PROPERTIES Pharmacodynamic
The propyphenazone has analgesic and antipyretic effects. The mechanism of analgesic action is inhibition of prostaglandin synthesis by inhibiting cyclooxygenase. The propyphenazone is able to relieve somatic pain, exerting little influence on visceral pain. The mechanism of action is central antipyretic, producing increased thermolysis, cutaneous vasodilation and sweating.
Caffeine is a stimulant of the central nervous system.
The propyphenazone 90% orally absorbed. The maximum plasma concentration is reached within 1-3 hours. The plasma protein binding is 10% to 20%, the volume of distribution of 1.3 L / kg. The elimination half-life is 1 to 1.5 hours. approximately
0.6% of the drug is excreted unchanged in the urine.
Caffeine is absorbed rapidly and almost completely after oral administration and is metabolized by the liver in large area (approx. 94%). The metabolites are excreted primarily in the urine. The elimination half-life is approximately 3.5 hours. The plasma protein binding is 35%.
c) Preclinical safety data
Animal studies to evaluate mutagenicity and teratogenicity of propyphenazone have not shown that the drug is teratogenic or mutagenic, nor have appeared signs of embryolethality under the conditions of these studies.
Also, propyphenazone is not related to the formation of malignant tumors according to studies of carcinogenesis.
a) LIST OF EXCIPIENTS
Optalidón dragees: 89.87 mg sucrose, stearic acid, colloidal silica, corn starch, carnauba wax, erythrosine, acacia, hydroxypropylcellulose, talc, cetyl palmitate.
Optalidón suppositories: yellow iron oxide, red iron oxide, fatty excipient for
b) INCOMPATILIDADES PHARMACEUTICAL
There have been described
c) SHELF LIFE
Optalidón dragees: 5 years
Optalidón suppositories: 5 years
d) SPECIAL STORAGE
No special storage conditions are required.
e) NATURE AND CONTENTS
Optalidón dragees: Pack containing 20 tablets in blister Al / PVC
Optalidón suppositories: Package with 6 suppositories in strips of PVC / PE
f) DIRECTIONS FOR USE / HANDLING
Optalidón dragees: Ingesting the tablets with a glass of water after taking some food.
Optalidón suppositories: If the suppository is too soft to insert, cool it in the
refrigerator for 30 minutes or put it under running cold water before removing the wrapper
plastic or later if necessary to prevent softening.
g) NAME AND ADDRESS PERMANENT AUTHROISATION
Omega Pharma Spain, S.A.
Office Park Sant Cugat Nord - Pza Xavier Cugat, 2 - Edif. D, 1st Floor.
08174- San Cugat del Valles (Barcelona)
7. DATE OF APPROVAL OF THE DATA CARD