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| - Perorální antikoagulancia: fenofibrát zvyšuje antikoagulační účinek a může zvýšit riziko krvácení. Doporučuje se snížení dávky antikoagulancií asi o třetinu na počátku léčby a potom v případě nutnosti její postupné upravování na základě monitorování INR (International Normalised Ratio). Proto se kombinovaná léčba s perorálními antikoagulancii nedoporučuje.
Cyklosporin: během současného podávání fenofibrátu a cyklosporinu byly zaznamenány závažné případy reverzibilního poškození ledvinových funkcí. Proto musí být funkce ledvin těchto pacientů pečlivě monitorovány a léčba fenofibrátem by měla být ukončena v případě vážné změny laboratorních parametrů.
Inhibitory HMG-CoA reduktázy a jiné fibráty: riziko závažné svalové toxicity je zvýšeno, pokud je fenofibrát podáván současně s inhibitory HMG-CoA reduktázy nebo jinými fibráty. Tato kombinační léčba má být používána s opatrností a pacienti mají být přísně monitorováni na příznaky svalové toxicity (viz bod 4.4).
Glitazony: během současného podávání fenofibrátu a glitazonů byly zaznamenány případy reversibilní paradoxní redukce HDL-cholesterolu. Je proto doporučováno monitorovat HDL-cholesterol v případě, kdy je jeden z těchto léků přidán k druhému. Pokud je hladina HDL-cholesterolu příliš nízká, doporučuje se zastavení léčby jedním z přípravků.
Enzymy cytochromu P450: studie in vitro používající lidské jaterní mikrozomy ukázaly, že fenofibrát a kyselina fenofibrová neinhibují izoformy cytochromu (CYP) P450 CYP3A4, CYP2D6, CYP2E1 nebo CYP1A2. V terapeutických koncentracích jsou slabými inhibitory CYP2C19 a CYP2A6 a mírnými až středně silnými inhibitory CYP2C9.
Pacienti užívající fenofibrát spolu s léky s úzkým terapeutickým indexem, které jsou metabolizovány CYP2C19, CYP2A6 a zvláště CYP2C9, by měli být pečlivě sledováni a pokud je to nezbytné, doporučuje se úprava dávky těchto léků.
Provide information on the potential for clinically relevant interactions based on the pharmacodynamic properties and in vivo pharmacokinetic studies of the medicinal product. A particular emphasis should be described for the interactions that result in a recommendation regarding the use of this medicinal product. This includes in vivo interaction results which are important for extrapolating an effect on a marker (‘probe’) substance to other medicinal products having the same pharmacokinetic property as the marker.
Interactions affecting the use of this medicinal product should be given first, followed by those interactions resulting in clinically relevant changes on the use of others.
Interactions referred to in other sections of the SPC should be outlined here and cross-referenced to the other sections.
The following information should be given for each clinically relevant interaction:
Possible recommendations
Contraindication of concomitant use (cross-refer to Section 4.3)
Concomitant use not recommended (cross-refer to Section 4.4)
Precautions, including dose adjustment (cross-refer to Sections 4.2, 4.4), mentioning specific situations where these may be required (For the actual dose recommendation, refer to Section 4.2.)
Any clinical manifestations and effects on plasma levels and AUC of parent compounds or active metabolites and/or on laboratory parameters
Mechanism if known
Interactions not studied in vivo but predicted from in vitro studies or deducible from other situations or studies should be described if they result in a change in the use of the medicinal product, cross-referring to Section 4.2 or 4.4.
This section should mention the duration of interaction when a medicinal product with clinically important interaction (eg, enzyme inhibitor or inducer) is discontinued. Adjustment of dosing may be required as a result. The implication for the need for a washout period when using medicines consecutively should also be mentioned.
Provide information on other relevant interactions such as with herbal medicinal products, food, or pharmacologically active substances not used for medical purposes. With regard to pharmacodynamic effects where there is a possibility of a clinically relevant potentiation or a harmful additive effect, this should be stated. Mention any implications for the need for a washout period when using medicines consecutively. Results demonstrating an absence of interaction should be mentioned here only if this is of likely major interest to the prescriber.
If applicable, include one of the following statements and delete the other statement:
Information specific to a special age group should be given here.
If interactions exist that are specific to children this information could be given under a subheading ‘paediatric patients’. General effects of a drug on enzymes are probably the same in adults and children. However, the resulting exposure and clinical consequences of a pharmacokinetic interaction can differ between adults and children. This is especially important if any specific dose recommendations are made.
The same also applies to pharmacodynamic drug interactions. In cases where there is an interaction with food leading to a recommendation on coadministration with a meal or specific food, it should, if possible, be noted whether this information is relevant for children (especially newborns and infants) whose diet may be totally different (100 % milk in newborns versus maybe 0% in adults) compared to the study setting leading to the recommendation.
If no interaction studies have been performed, this should be clearly stated.
Revise or delete the appropriate statements below:
General recommendations
Contraindication in pregnancy should be supported by human data (teratogenicity or fetotoxicity) or by strong nonclinical data. When a contraindication in pregnancy or lactation is made, this should be included in Section 4.3.
Efforts should be made by the MAH to provide the reasons for recommendations for use in pregnant or lactating women, and in women of childbearing potential. The following should be mentioned.
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