Each hard capsule contains: De-oiled enriched soybean phospholipids 600 mg.
Excipients/Active Ingredients: Hard fat, refined soy oil (Ph. Eur.), hydrogenated castor oil, 3-ethoxy-4-hydroxybenzaldehyde, 1-(4-methoxyphenyl)ethanone, α-tocopherol, 96% ethanol, gelatin, titanium dioxide (E171), iron (III) oxide-hydroxide (E172), iron (III) oxide (E172), iron (II,III) oxide (E172).
Hepatoprotector.
Pharmacology: Pharmacodynamics: In many experimental models of acute liver damage, such as damage from ethanol, alkyl alcohol, tetra-chloromethane, paracetamol and galactosamine, liver protective effects have been reported among the pharmacodynamic properties of the substance. In addition, inhibition of steatosis and fibrosis has also been observed in chronic models (ethanol, thioacetamide, organic solvents). The mechanism of action is assumed to be accelerated regeneration and stabilization of membranes, and inhibition of lipid peroxidation and collagen synthesis. There are no specific studies available on pharmacodynamics in man.
Pharmacokinetics: Animal experiments on pharmacokinetics have shown that orally administered radiolabeled soybean phospholipids were over 90% absorbed in the small intestine. Most of the phospholipids were cleaved by phospholipase A into 1-acyl-lysophosphatidylcholine, approximately 50% of which was reacylated immediately into polyunsaturated phosphatidylcholine during the absorption process in the mucosa of the small intestine. The phosphatidylcholine reaches the blood through the lymph pathway and then passes into the liver in particular, mostly bound to HDL. Pharmacokinetic studies in man were conducted with 3H and 14C radiolabeled dilinoleoylphosphatidylcholine, among other substances. The choline residue was labeled with 3H and the linoleic acid with 14C.
Peak 3H concentrations were reached between 6 and 24 hours and accounted for 19.9% of the dose. The half-life of the choline component was 66 hours.
Peak 14C concentrations were reached between 4 and 12 hours and were 27.9% of the dose. The half-life of this component was 32 hours. 2% of the 3H and 4.5% of the 14C markers were recovered in the feces. 6% of the 3H and only trace amounts of the 14C markers were recovered in the urine. These results therefore show that more than 90% of both isotopes were absorbed in the intestine.
Toxicology: Preclinical Safety Data: No toxicological studies are available for soybean phospholipids. The no-effect dose following 48-week oral administration of phosphatidylcholine (a constituent of soybean phospholipids) in rats was more than 3750 mg/kg BW/day. This corresponds to 100 times the daily dose of Phospholipids (Essentiale Max) 600 mg hard capsules, i.e. 1800 mg. In studies in dams, embryos and offspring, involving administration of up to 3750 mg of soybean phospholipids/kg BW, no teratogenic effects were found. However, since the studies did not fulfil current requirements and were also not complete, no final evaluation of the finding can be made with regard to embryotoxicity. In rodents, phosphatidylcholine showed no teratogenic or embryotoxic effects at therapeutic doses. The lowest teratogenic-embryotoxic daily dose following oral administration was more than 1 g/kg BW in rats and more than 0.5 g/kg BW in rabbits. Fertility studies in rats showed no effects on male or female fertility up to 3750 mg/kg. There are no data available concerning fertility in humans.
In various in vitro test systems, no mutagenic potential was demonstrated. Carcinogenicity studies are not available.
Phospholipids (Essentiale Max) 600 mg hard capsules are used to improve subjective symptoms, such as loss of appetite or a feeling of pressure in the upper right abdomen, in patients with liver damage caused by the toxic effects of certain foods or hepatitis.
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Phospholipids (Essentiale Max) 600 mg hard capsules should be swallowed whole with sufficient liquid (preferably a [200 ml] glass of water) during meals.
In principle, there is no time limit for the duration of administration.
The patient is advised to take into account the information under "Take special care with Essentiale Max 600 mg hard capsules".
There are no known cases of overdose or intoxication with Phospholipids (Essentiale Max) 600 mg hard capsules. In the monograph, the patient is advised of the following: "It is possible that side effects listed as follows could occur with greater intensity. If this happens, please inform a doctor. He or she can decide whether any measures need to be taken."
Phospholipids (Essentiale Max) 600 mg hard capsules must not be used in patients with known allergy to soybean preparations, peanuts, or to any of the other ingredients of this medicinal product.
The patient is advised that "This medicine is not a substitute for avoiding substances that damage the liver (e.g. alcohol)".
If the patient has chronic liver inflammation (hepatitis), supportive treatment with this medicine is only justified if they notice an improvement in their symptoms. If symptoms worsen or if other unclear symptoms appear, the patient should consult a doctor.
Contains alcohol (less than 100 mg per single dose).
Effects on ability to drive and use machines: Phospholipids (Essentiale Max) 600 mg hard capsules have no influence on the ability to drive and use machines.
Use in Children: Children and adolescents up to 18 years of age: Sufficient studies are not available concerning use of Phospholipids (Essentiale Max) 600 mg hard capsules in children and adolescents.
In addition, given the therapeutic uses of this medicine, there is no relevant indication in this patient group. Phospholipids (Essentiale Max) 600 mg hard capsules should therefore not be used in children and adolescents under 18 years of age.
Limited data are available on the use of Phospholipids (Essentiale Max) 600 mg hard capsules in pregnant women. Animal studies concerning reproduction toxicity are insufficient (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Use of Phospholipids (Essentiale Max) 600 mg hard capsules in pregnant women is not recommended.
It is not known whether components of soybean phospholipids or their metabolites pass into breast milk. A risk for breast-fed infants cannot be ruled out. Phospholipids (Essentiale Max) 600 mg hard capsules should not be taken by breast-feeding women.
Preclinical studies in animals have not demonstrated an effect on male or female fertility.
Adverse effects are classified as follows in terms of incidence: Very common (≥1/10); Common (≥100 to ≥1/10); Uncommon (≥1/1,000 to ≥1/100); Rare (≥1/10,000 to ≥1/1,000); Very rare (<1/10,000); Unknown (incidence cannot be assessed based on available data).
Gastrointestinal disorders: Not known: Gastrointestinal disorders may occur during treatment with Phospholipids (Essentiale Max) 600 mg hard capsules, such as nausea, vomiting, soft stools and/or diarrhea.
Investigations: Not known: Increased blood pressure.
Cardiac disorders: Not known: Palpitations.
Nervous system disorders: Not known: Dizziness.
Skin and subcutaneous tissue disorders: Not known: Allergic reactions such as exanthema and urticaria, pruritus.
In rare cases, this medicinal product can cause severe allergic reactions, as it contains soy oil.
Side effects that are not mentioned in the monograph should be reported to a doctor or pharmacist. The patient is advised of the following in the monograph: "If you notice that you have any of the side effects listed previously, particularly allergic reactions, stop taking Phospholipids (Essentiale Max) 600 mg hard capsules and inform your doctor. He or she can determine the severity of the side effect and decide whether any measures need to be taken".
An interaction between Phospholipids (Essentiale Max) 600 mg hard capsules and anticoagulants cannot be ruled out. Therefore, it may be necessary to adjust the dose of this medicinal product.
The monograph indicates that patients who are taking Phospholipids (Essentiale Max) 600 mg hard capsules at the same time as this type of medicine should inform their doctor.
Incompatibilities: Not applicable.
Do not store above 30°C. Store in original package. Protect from moisture.
A05BA10 - phospholipids ; Belongs to the class of drugs used in liver therapy.
Essentiale Max cap 600 mg
30's
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