Optalidon 500/75 Mg 6 Suppositories

Optalidon 500/75 Mg 6 Suppositories

Propiphenazone, caffeine anhydrous

ACTION AND MECHANISM

Propiphenazone is an analgesic and antipyretic, a pyrazolonic derivative, which acts by inhibiting cyclooxygenase, thereby decreasing the synthesis of prostaglandins. The mechanism of antipyretic action is central, producing increased thermolysis, cutaneous vasodilation, and sweating.
Caffeine is a stimulant of the central nervous system.

INDICATIONS

- [PAIN] mild or moderate.

POSOLOGY

Orally:
Adults and children over 12 years: 1 to 2 tablets / dose. This dose can be repeated 3 times a day up to a maximum of 6 tablets a day.
Rectally:
Adults and children over 12 years of age: The usual dose will be 1 suppository / day. The maximum dose will be 2 suppositories / day.

RULES FOR CORRECT ADMINISTRATION

Oral forms: Take with a glass of water after taking some food.

CONTRAINDICATIONS

- Contraindicated in [ALLERGY TO PYRAZOLONES] or [ALLERGY TO XANTHINES].
- [ALLERGY TO NSAIDs]: Due to the possibility of cross-hypersensitivity with acetylsalicylic acid and other non-steroidal anti-inflammatory drugs, do not administer to patients with a previous history of hypersensitivity to said components who, when taking them, have presented pictures of rhinitis, asthma, angiodema or hives.
- History of [AGRANULOCITOSIS] by drugs, [APLASICA ANEMIA].
- [ANXIETY].
- [PEPTIC ULCER].
- [GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY].
- [PORFIRIA].
- Patients with severe liver, kidney or heart disorders.

PRECAUTIONS

- A special clinical control should be carried out in patients with [ARTERIAL HYPERTENSION], [HEART FAILURE], [CORONARY FAILURE].
- [KIDNEY FAILURE] or [HEPATIC FAILURE].
- [INSOMNIA], [ANXIETY].
- [ASTHMA] or [CHRONIC OBSTRUCTIVE PULMONARY DISEASE] (risk of acute attacks).
- Patients with a history of blood disorders.
- Before the appearance of fever or mucosal ulcerations, abandon the treatment and carry out a hematogram.
- Be careful not to simultaneously drink large amounts of coffee, tea or cola or use other medications that contain caffeine.

ADVICE TO THE PATIENT

- It should not be used for more than 10 days in a row except medical criteria.
- Notify your doctor or pharmacist if you experience an episode of unexplained fever or mouth ulcer as these may be the initial symptoms of a serious blood disorder.
- Due to its caffeine content, be careful not to simultaneously drink large amounts of coffee, tea or cola or use other medications that contain caffeine.

SPECIAL WARNINGS

- In the event of fever, mouth ulceration or any other premonitory symptom of agranulocytosis, treatment should be immediately suspended and a blood count performed.
- When used uninterruptedly and for a long time (more than 10 days), periodic blood tests should be carried out.
- It should not be used for more than 10 days except medical criteria, since cases of adverse effects on hematopoiesis have been described. In cases of longer treatment, periodic blood tests should be carried out.

INTERACTIONS

- Oral anticoagulants: Propiphenazone can enhance the action of oral anticoagulants.
- It can interact with beverages that contain caffeine (coffee, tea, soft drinks), medicines that contain caffeine, medicines that stimulate the CNS or with monoamine oxidase inhibitors (MAOIs).
Caffeine can also antagonize the effects of barbiturates and antihistamines, increases the urinary excretion of lithium, decreasing its therapeutic effect.
With results of diagnostic tests:
Caffeine: Negates the effects of dipyridamole on myocardial blood flow. Patients should be advised to avoid ingesting it 8 to 12 hours prior to testing.
- Produces false positive elevations of serum urate (when measured by Bittner's method).
- Increases blood glucose levels.
- Raises urinary concentrations of vanillylmandelic acid (VMA), catecholamines and 5-hydroxyindoleacetic acid, so you should avoid caffeine intake before testing.

PREGNANCY

Should not be administered during pregnancy. In the last 6 weeks it can inhibit uterine contractions and increase the tendency to bleed.
Caffeine crosses the placenta and reaches tissue concentrations similar to maternal concentrations, and can cause fetal arrhythmias due to excessive use.

LACTATION

Since propiphenazone and caffeine pass into breast milk, it should not be administered during breastfeeding.

CHILDREN

It should not be given to children under 12 years of age.

EFFECTS ON DRIVING

They have not been described.,

ADVERSE REACTIONS

The adverse effects of metamizole are, in general, rare but moderately important. The most characteristic adverse effects are:
-Occasionally (1-9%): allergic reactions ([EXANTEMATIC ERUPTIONS] with blistering (in individual cases, Steven-Johnson syndrome or Lyell's syndrome), [ITCHING], [BLUSHING] ), [NAUSEAS], [DIZZINESS], [NERVOSISM], [GASTRITIS], [TACHYCARDIA], [PALPITATIONS].
-Exceptionally (<< 1%): [AGRANULOCYTOSIS], [APLASIC ANEMIA], [LEUCOPENIA], [THROMBOPENIA]; [ANAPHILAXIA] and [DYSNEA].

OVERDOSE

- Symptoms: abdominal pain, nausea, vomiting, drowsiness or insomnia, excitement, irregular heartbeat, respiratory depression, seizures, coma with hypotension, shock and oliguria.
- Treatment: Treatment is symptomatic. The drug should be removed from the body as soon as possible by gastric lavage, forced diuresis or dialysis. 

Datasheet Optalidon 500/75 Mg 6 Suppositories