Phospholipids

Phospholipids

300mg Hard Gel Capsule

Category: Hepatoprotector

Composition:

Phospholipids as active ingredient. is from soya-bean 300mg

Indications:

Nutritional support in the management of damaged liver (due to chronic liver disease, liver cirrhosis, fatty liver and intoxication by hepatotoxic substances).

Dosage and Administrations:

Age and/or Body Weight : Children from 12 years (approx. 43 kg), Adolescents and adults

Single dose: 2 hard capsules (600mg of soya-bean phospholipids)

Total daily dose: 3 times daily 2 hard capsules (1800mg of soya-bean phospholipids)

Phospholipids 300mg hard gel capsule is taken unchewed with meals with plenty of liquid (e.g. with a glass of water).

Basically, the duration of the application is not limited.

Contraindications:

Known hypersensitivity to soya-bean preparations or to any of the excipients.

Special warnings and precautions for use:

This drug therapy is not a substitute for the avoidance of the noxious agent causing liver damage (e.g. alcohol). In chronic hepatitis the adjuvant therapy with soya-bean phospholipids is justified only when improved subjective well-being becomes manifest during therapy.

Consult your doctor when complaints aggravate or when other unclear complaints occur.

Children:

As information about the administration in children is insufficient, Phospholipids 300mg hard gel capsule should not be given to children under 12 years of age.

Due to the content in soya-bean oil the medicinal product may provoke severe allergic reactions.

Interaction with other medicinal products and other forms of interaction:

An interaction of Phospholipids 300mg hard gel capsule with anti-coagulants cannot be excluded. For this reason, dose adjustment of the anti-coagulants might be necessary.

Consult a doctor in the case of simultaneous application.

Pregnancy and lactation:

Preparation from soya-bean are largely used in human food and so for no clue has appeared that would suggest any risk during pregnancy. Results from investigation are insufficient. For this reason, the use of Phospholipids 300mg hard gel capsule is not recommended during pregnancy and lactation.

Effects on ability to drive and use machines:

Phospholipids 300mg hard gel capsule has no effect on the ability to drive and to use machines.

Side Effects:

For the evaluation of any adverse effects the following incidences are considered:

very frequent (≥1/10)

frequent (≥1/100 to ≥1/10)

occasional (≥1/1,000 to ≥1/1,00)

rare (≥1/10,000 to ≥1/1,000)

very rare (<1/10,000)

Occasionally the administration of Phospholipids 300mg hard gel capsule may provoke gastrointestinal disorders, such as stomach complaints, soft stools and diarrhea. On very rare occasions allergic reactions may occur, such as exanthema and urticaria. The doctor or pharmacist should be informed about any undesirable effect not listed.

The administration of Phospholipids 300mg hard gel capsule should be discontinued in the event of one of the above mentioned undesirable effects, especially in hypersensitivity reactions. The patient should consult who may decide the severity and any measures that might be necessary.

Overdose:

No overdose reaction nor symptom of intoxication has been reported to date with Phospholipids 300mg hard gel capsule.

The listed undesirable effects may be reinforced.

The patient should consult the doctor who may decide about the severity and any measures that might be necessary.

Clinical Pharmacology

Pharmacodynamic:

Among the pharmacodynamic properties reported were hepatoprotective effects found in numerous experimental models in acute liver damage (induced by ethanol, alcyl alcohol, carbon tetrachloride, paracetamol and galactosamine). Furthermore, it was also seen to inhibit steatosis and fibrosis in chronic liver damage models (induced by ethanol, thioacetamide, and organic solvents). Its suggested principal actions have been through accelerated membrane regeneration and stabilization, inhibited lipid peroxidation and inhibited collagen synthesis.

Pharmacokinetic:

Animal experiments into the pharmacokinetics showed that more than 90% of the orally applied soya-bean phospholipids are absorbed in the small intestines. Most of it is split by phospholipase A to 1-acyl-lysophosphatidylcholine, 50% of which reacylated immediately into polyunsaturated phosphotidylcholine still during the process of absorption in the intestinal mucosa. This polyunsaturated phosphatidylcholine reaches the blood via the lymph pathway and from there – mainly bound to HDL – it passes in particular to the liver.

Tests into human pharmacokinetics were performed with radioactively labeled dilinoleoyl-phosphatidlcholine (³H and ¹⁴C). The choline moiety was ³H-labeled and the linoleic acid had the ¹⁴C-label. The maximum ¹⁴C concentration was achieved after 4 to 12 hours and amounted to 27.9% of the dose. The half-life for this component was 32 hours.

In the feces were found 2% of the ³H and 4.5% of the ¹⁴C label,in the urine 6% of the ³H and only minor amounts of the ¹⁴C label.

These results show that both isotopes are absorbed to over 90% in the intestines.

Storage Conditions:

Store in the original container, not above 25^oC

Store in the original container in order to protect from humidity.

Do not use after the expiry date.

Shelf life: 2 years