Dualid-S (Amfepramone 75mg) – 1181/13

Batch No: 1181/13

 

 

Adjuvant medication for low calorie diets during obesity treatment. NOTE: The use of this class of drugs should be limited to 4 weeks, only to aid adherence to the low calorie diet. The limited benefit that substances of this class may offer should be compared with the potential risks.

 

 

DUALID S should not be used in cases of s e v e r e h y p e r t e n si o n , a d v a n c e d a t h e r o s c l e r o s i s , a r r h y t h m i a s , hyperthyroidism, pheochromocytoma, glaucoma, prostate adenoma, renal and / or

liver failure, patients with a history of psychiatric disorders, epilepsy and chronic alcoholism. It is also contraindicated in patients with a propensity to abuse drugs, alcohol or smoking, children under 12 years and the elderly. Do not use in patients hypersensitive to the active substance orother sympathomimetic amines. Do not use

concomitantly with MAO inhibitors for more than 15 days after stopping MAOI

administration before starting treatment with

 

 

during pregnancy and lactation. Warnings Anorectics have a structural similarity to amphetamine and may have the same drawbacks. The effectiveness of anorectic decreases after a few weeks (tolerance). Therefore it is recommended: – to inform the patient, especially not to increase the doses; – prescribe dualid s on a discontinued basis for periods of 4 weeks. Prolonged treatment may lead to drug dependence and severe psychotic disorders. For sports practitioners, note that amfepramone may induce a positive reaction in anti-doping tests. Dualids should not be used during breastfeeding because amfepramone and its metabolites are eliminated in breast milk. In some patients, amfepramone may cause behavioral changes. Driving or operating machines may be affected and activities that require attention when using dualids should be restricted

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MAO inhibitors may potentiate the sympathomimetic effect of DUALIDS.

Thyroid or CNS-acting drugs can reinforce the CNS stimulus. The effect of some antihypertensive agents (guanethidine, clonidine, methyldopa) may be attenuated.

Concomitant use of DUALIDS and volatile anesthetics may cause arrhythmias and

preoperative hypertensive crisis, and d i s c o n t i n u a t i o n o f D U A L I D S administration is recommended a few days prior to surgery. Diabetic patients should be adequa t e ly controll ed when using amf e p r amo n e c o n c omit a n tl y wit h hypocal ric diets.

 

 

Due to timed release, side effects may be mitigated. Still, the side effects reported during treatment with DUALID S are as follows: Vertigo, headache, insomnia, nervousness, irritability, depressive manifestations. Change in taste, dry mouth, nausea, vomiting, diarrhea or constipation. Hypertension, tachycardia, arrhythmias, precordial pain and hypotension. Disorders of sexual functions, urination disorders and gynecomastia. Urticaria, rash. Even using

the drug as recommended, the speed of reflexes may be altered, hindering the ability

to drive vehicles or operate machinery. This occurs particularly in cases of simultaneous

use of alcohol. In cases of prolonged use, drug dependence and serious changes may occur such as decreased concentration, weakness, personality changes. The most severe manifestation of chronic intoxication is p s y c h o ti c d is o r d e rs simil a r t o schizophrenia. (Note. Although nominal agreement was wrong the final rte remained

that way)

 

 

The dose for each patient is at the physician’s discretion. The following dosage is recommended: DUALID S 25 mg: On average, two capsules daily, preferably two hours before lunch and dinner, for a

maximum of four weeks. DUALID S 50 and 75 mg: 1 capsule daily, preferably two hours before lunch, for a maximum of four weeks. in cases where a repeat treatment is required, a break of at least 4 weeks should be

observed. If a tolerance phenomenon occurs, treatment should be discontinued. An

increase in dose is not advised in an attempt to reinforce the anorectic effect. ABUSE OF

T H I S M E D I C I N E M AY C A U S E DEPENDENCE

 

 

Acute overdose: CNS stimulation (agitation, tremors, diminished reflexes, tachycardia, confusion, aggression, hallucinations, anxiety state followed by fatigue and depression). Cardiovascular symptoms consist of arrhythmia, hyper or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting,

diarrhea and abdominal spasms. Treatment: It is essentially symptomatic, consisting of gastric lavage and sedation with barbiturates. Hemodialysis or peritoneal dialysis is not recommended. Chronic intoxication: May

manifest as severe acne, insomnia, instability, hyperactivity, or personality changes. The most severe manifestation is a psychosis that often is not distinguished from schizophrenia.