Active ingredients: Propiphenazone, Butalbital, Caffeine
OPTALIDON coated tablets
OPTALIDON suppositories
Why is Optalidon used? What is it for?
Pharmacotherapeutic group
Analgesic.
Therapeutic indications
Symptomatic treatment of painful states such as: headache, joint and muscle rheumatism; toothache; menstrual pain and pain in general.
Contraindications When Optalidon should not be used
- Hypersensitivity to the active ingredients or to other closely related substances from a chemical point of view and / or to any of the excipients.
- Overdose and intoxication by alcohol, hypnotics, analgesics and psychotropic drugs.
- Granulocytopenia.
- Porphyria.
- Deficiency of glucose -6 phosphate dehydrogenase.
- Pregnancy and breastfeeding.
- Age under 18.
Precautions for use What you need to know before taking Optalidon
It is advisable to reserve OPTALIDON for the treatment of painful episodes; it is not indicated for continuous therapies.
Barbiturates can be addictive.
Rarely, symptoms of caffeine hyperexcitability may occur in susceptible individuals.
Due to the reciprocal enhancement, alcoholic beverages are not recommended during treatment.
If fever, angina, skin or mucous membrane changes appear during treatment, discontinue therapy and consult your doctor.
High or prolonged doses of the product can cause damage to the blood.
Optalidon should be prescribed with caution in elderly or debilitated patients, or in patients with renal, hepatic or acute abdominal disease.
Interactions Which drugs or foods may change the effect of Optalidon
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
The association with other psychotropic drugs requires particular caution and vigilance on the part of the physician, to avoid unexpected undesirable effects from interaction.
The effect of alcohol and central nervous system depressants can be enhanced by Optalidon.
Barbiturates can cause changes in enzyme production with consequent changes in the metabolism of other drugs (eg anticoagulants). In particular, the concomitant administration of hormonal contraceptives should be avoided as barbiturates can decrease their contraceptive activity.
Pyrazolone derivatives can accentuate the effects of alcohol and can interact with phenytoin, with some oral hypoglycemic agents (tolbutamide, chlorpropamide, acetohexamide) and anticoagulants (warfarin).
Warnings It is important to know that:
Pregnancy and breastfeeding
The use of the product is contraindicated during pregnancy and breastfeeding.
Driving and using machines
Due to the possible onset of drowsiness, lightheadedness, dizziness and sedation, Optalidon impairs the mental and / or physical capacity required to perform activities such as driving a vehicle and / or operating machinery. Therefore, do not use Optalidon when driving vehicles or use of machinery.
Important information about some of the ingredients of Optalidon coated tablets
Contains sucrose: if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Dosage and method of use How to use Optalidon: Dosage
Adults (over 18 years): 1-2 coated tablets or 1 suppository several times a day.
Maximum daily dose: 6 coated tablets or 2-3 suppositories.
Elderly patients: in the treatment of elderly patients the posology must be carefully established by the doctor who will have to evaluate a possible reduction of the dosages indicated above.
Optalidon tablets should be swallowed without chewing.
The oral analgesic preparations must be taken on a full stomach.
Overdose What to do if you have taken an overdose of Optalidon
In case of accidental ingestion / intake of an excessive dose of Optalidon, notify your doctor immediately or go to the nearest hospital.
The effects of Optalidon overdose may be nausea, vomiting, headache, drowsiness, confusion, comatose accompanied by a characteristic autonomic syndrome (irregular bradypnea, tracheobronchial obstruction, arterial hypotension).
In such cases, the following measures should be taken:
- eliminate the drug by causing vomiting; gastric lavage; increase urinary excretion (cause polyuria, alkalinization of the urine), if necessary, dialysis;
- control of breathing and circulation
Due to the presence of caffeine, always for high doses, hyperstimulation with excitement, insomnia, muscle tremor, nausea, vomiting, increased diuresis, tachycardia, ectopic beats, scotoma may occur.
Contact your doctor or pharmacist for clarification on the use of the medicine
Side Effects What are the side effects of Optalidon
Like all medicines, Optalidon can cause side effects, although not everybody gets them.
Due to the presence of butalbital undesirable effects such as drowsiness, lightheadedness, dizziness and sedation are possible.
Due to the presence of propiphenazone, undesirable effects on the gastrointestinal tract (nausea, vomiting, abdominal pain), blood (leukopenia, agranulocytosis) and kidney (acute renal failure, interstitial nephritis, haematuria) are possible.
Due to the presence of caffeine, undesirable effects such as excitement, insomnia, irritability and tachycardia are possible.
In rare cases allergic reactions of different types and locations have been found, more frequently affecting the skin and mucous membranes with skin rashes, hives, itching as well as, in very rare cases, anaphylactic phenomena.
Sedation, ataxia, nystagmus and mental confusion may arise, especially in the elderly, following the administration of high doses.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Expiry and Retention
Warning: do not use the medicine after the expiry date shown on the package.
Optalidon suppositories should not be stored above 30 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Keep this medicine out of the reach and sight of children.
Composition
Coated tablets
One coated tablet contains - Active ingredients: propiphenazone 125 mg; butalbital 50 mg; caffeine mg 25 - Excipients: hydroxypropylcellulose; magnesium stearate; cornstarch; sucrose; talc; Arabic gum; erythrosine.
Suppositories
One suppository contains - Active ingredients: propiphenazone 375 mg; butalbital 150 mg; caffeine mg 75 - Excipients: yellow orange S; erythrosine; solid semisynthetic glycerides; purified water.
Pharmaceutical forms and packaging
OPTALIDON coated tablets: 25 coated tablets OPTALIDON suppositories: 6 suppositories
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
OPTALIDON
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Coated tablets
One coated tablet contains - Active ingredients: propiphenazone 125 mg; butalbital 50 mg; caffeine 25 mg.
Suppositories
One suppository contains - Active ingredients: propiphenazone 375 mg; butalbital 150 mg; caffeine 75 mg.
03.0 PHARMACEUTICAL FORM
Coated tablets
Suppositories
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Against all painful states: headache; joint and muscle rheumatism; toothache; menstrual pain and pain in general.
04.2 Posology and method of administration
Optalidon coated tablets are swallowed without chewing.
A faster effect is achieved by ingesting Optalidon with a hot drink.
Adults: 1-2 coated tablets or 1 suppository several times a day.
Maximum daily dose: 6 coated tablets or 2-3 suppositories.
In the "pain insomnia: 2-4 coated tablets or 1-2 suppositories half" hour before bedtime.
Children: 1 coated tablet 1-3 times a day according to age.
Elderly patients: in the treatment of elderly patients the posology must be carefully established by the doctor who will have to evaluate a possible reduction of the dosages indicated above.
04.3 Contraindications
Known hypersensitivity to one or more of the components.
Overdose and intoxication by alcohol, hypnotics, analgesics and psychotropic drugs.
Granulocytopenia. Porphyria.
04.4 Special warnings and appropriate precautions for use
It is advisable to reserve Optalidon for the treatment of painful episodes; it is not indicated for continuous therapies.
Barbiturates can be addictive.
Rarely, in predisposed individuals, symptoms of caffeine hyperexcitability may occur.
In hypersensitive subjects, high or prolonged doses of the product can cause damage to the blood.
04.5 Interactions with other medicinal products and other forms of interaction
The association with other psychotropic drugs requires particular caution and vigilance on the part of the physician, to avoid unexpected undesirable effects from interaction.
The effect of alcohol and central nervous system depressants can be enhanced by Optalidon.
Barbiturates can cause changes in enzymatic production with consequent changes in the metabolism of other drugs (eg anticoagulants). In particular, the concomitant administration of hormonal contraceptives should be avoided as barbiturates can decrease their contraceptive activity.
04.6 Pregnancy and lactation
As with all other drugs, caution is required during pregnancy for Optalidon.
04.7 Effects on ability to drive and use machines
Occasionally, sedation may occur and this may affect patients' reactions when driving vehicles or operating machines.
04.8 Undesirable effects
In rare cases, allergic reactions of different types have been found at the site, most frequently cutaneous with urticaria, itching.
04.9 Overdose
The toxic effects of Optalidon overdose appear only after taking a very large number of coated tablets. In such cases, the following measures should be taken:
eliminate the drug by causing vomiting; gastric lavage; increase urinary excretion (cause polyuria, alkalinization of the urine), if necessary, dialysis;
control of breathing and circulation.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Analgesic.
Pharmacodynamics: Optalidon displays a high anti-inflammatory, pain-relieving and antipyretic activity with positive synergism between the components.
Experiments carried out in rats and dogs, per os and rectally, have shown that Optalidon does not induce changes in cardiocirculatory and respiratory parameters.
05.2 Pharmacokinetic properties
Caffeine, a classic component of associations with analgesics, is easily absorbed, metabolized almost completely and then excreted through the renal emunctory. The plasma half-life is indicated in man in about 3.5 hours.
Butalbital, a drug with a known sedative action that enhances the effect of analgesics, is classified as a barbiturate with a medium duration of action. Protein binding and plasma half-life were estimated to be approximately 26% and 40 hours, respectively.
Propiphenazone, a known analgesic and antipyretic, is easily absorbed and has more prolonged plasma concentrations with the simultaneous administration of caffeine.
Rectally, the times of maximum concentration (in hours) and the maximum concentrations reached (in? G / ml) were, for the three components, respectively the following: butalbital: 8.0-2.4; caffeine: 1.8-0.72; propiphenazone: 2.2-1.3.
05.3 Preclinical safety data
The LD50 (mg / kg) calculated separately for males and females, resulted in the following in rats and mice:
Subacute and chronic toxicity tests did not modify the examined parameters and also the local tolerability, after repeated treatment, (gastrointestinal and rectal mucosa) is to be considered satisfactory.
Optalidon was not toxic to either pregnant animals or the product of conception.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Coated tablets
Hydroxypropylcellulose, magnesium stearate, corn starch, sucrose, talc, gum arabic, erythrosine.
Suppositories
Orange yellow S, erythrosine, semisynthetic glycerides, demineralized water.
06.2 Incompatibility
None.
06.3 Period of validity
Coated tablets: 5 years
Suppositories: 5 years
06.4 Special precautions for storage
None.
06.5 Nature of the immediate packaging and contents of the package
OPTALIDON coated tablets: Blister containing 25 coated tablets
OPTALIDON suppositories: PVC blisters containing 6 suppositories
06.6 Instructions for use and handling
None.
07.0 MARKETING AUTHORIZATION HOLDER
Novartis Consumer Health S.p.A., Origgio (VA)
08.0 MARKETING AUTHORIZATION NUMBER
Coated tablets: A.I.C. n 005125012
Suppositories: A.I.C. n 005125024
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
A.I.C renewal: 01.06.2005
10.0 DATE OF REVISION OF THE TEXT
March 2006
