TRICEF Film-coated tablet
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Περιεχόμενα
1. Name of the medicinal product
Tricef 400 mg film-coated tablets.
2. Qualitative and quantitative composition
Each film-coated tablet contains 400 mg of cefixime. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablets. White oblong film-coated tablets, engraved Bial and TF/400 on opposite sides.
4.1. Therapeutic indications
Tricef is indicated for the treatment of the following infections caused by susceptible agents (see section 4.4 and 5.1): Acute otitis media Upper respiratory tract infections (pharyngitis, tonsillitis, ...
4.2. Posology and method of administration
The usual recommended posology is as follows: <u>Adults and children older than 12 years (or weighing more than 30 kg):</u> 400 mg in a single daily dose. For the uncomplicated urinary tract infections ...
4.3. Contraindications
Hypersensitivity to the active substance and, in general, to beta-lactam antibiotics or to any of the excipients mentioned in section 6.1.
4.4. Special warnings and precautions for use
Tricef should be used with caution during pregnancy and lactation, the contraindications related to hypersensitivity to cefixime or its excipients should be respected, and also the dose reduction in renal ...
4.5. Interaction with other medicinal products and other forms of interaction
Antacids do not interfere with the absorption of cefixime. The tubular reabsorption inhibitors such as probenecid may hinder the urinary excretion of cefixime by increasing the values of C<sub>max</sub> ...
4.6. Pregnancy and lactation
In preclinical trials no differences were detected between the group of animals of control and the group that received the drug, with respect to fertility parameters, namely mating behavior, pregnancy ...
4.7. Effects on ability to drive and use machines
No effects were observed on the ability to drive and use machines.
4.8. Undesirable effects
The undesirable effects (according to the results of clinical trials) are listed in order of decreasing seriousness within each frequency class. The frequency, type and severity of adverse reactions in ...
4.9. Overdose
There is no information about cases of overdose. Doses of 2 g in healthy adults caused moderate gastrointestinal effects as those seen with therapeutic doses. In case of acute poisoning it is likely to ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> 1.1.2.3 Anti-infectious drugs. Antibacterials. Cephalosporins. 3rd generation cephalosporins <b>ATC code:</b> J01D D08 cefixime Mechanism of action Cefixime, the only ...
5.2. Pharmacokinetic properties
Absorption The presence of a vinyl radical in position 3 gives cefixime a satisfactory ability to be orally absorbed. In fact, the oral bioavailability of this antibiotic is about 48-50%. The presence ...
5.3. Preclinical safety data
The studies conducted in rodents and dogs have shown that cefixime is devoid of toxic effects at single or repeated administrations. There were not detected mutagenic or clastogenic properties. The capacity ...
6.1. List of excipients
Microcrystalline cellulose Starch pregelatinized Calcium hydrogen phosphate dihydrate Magnesium stearate Liquid paraffin Hidroxypropylmethylcellulose Sodium lauryl sulphate Titanium dioxide (E171)
6.2. Incompatibilities
None known.
6.3. Shelf life
2 years.
6.4. Special precautions for storage
Store at temperature below 30ºC.
6.5. Nature and contents of container
Tricef tablets are conditioned in Alu/Alu blisters and inserted in cardboard box. Packs of 2, 6 or 8 tablets. Not all packs sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
BIAL – Portela & Cª, S.A., À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal
8. Marketing authorization number(s)
19144
9. Date of first authorization / renewal of the authorization
Date of first authorization: 29<sup>th</sup> January 2001 Date of first renewal: 28<sup>th</sup> January 2006
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