Doppelherz^® Vitamine E forte (Capsules) Instructions for Use

Marketing Authorization Holder

Queisser Pharma, GmbH & Co. KG (Germany)

Manufactured By

Swiss Caps SCA Contract Manufacturing, AG (Germany)

ATC Code

A11HA03 (Tocopherol (Vitamin E))

Dosage Form

Doppelherz^® Vitamin E forte

Capsules 200 IU: 60 or 100 pcs.

Dosage Form, Packaging, and Composition

Capsules are soft gelatin, oval in shape; the capsule contents are an oily yellow liquid, odorless.

	1 caps.
Concentrate of RRR-alpha-tocopheryl acetate	182 mg,
Including RRR-alpha-tocopheryl Acetate	147 mg (200 IU)
Soybean oil	35 mg

Excipients : Soybean oil (88 mg).

Capsule shell composition gelatin, glycerol, sorbitol 70% solution (non-crystallizing), purified water.

20 pcs. – blisters (3) – cardboard packs.
20 pcs. – blisters (5) – cardboard packs.

Clinical-Pharmacological Group

Vitamin preparation

Pharmacotherapeutic Group

Vitamin

Pharmacological Action

Plant-derived vitamin E. It has an antioxidant effect. It protects the cell membranes of the body’s tissues from oxidative changes. It stimulates the synthesis of heme and heme-containing enzymes – hemoglobin, myoglobin, cytochromes, catalase, peroxidase. It inhibits the oxidation of unsaturated fatty acids. It inhibits cholesterol synthesis, helps normalize plasma lipid levels, and prevents increased capillary permeability. It reduces blood clotting, participates in tissue respiration and other processes of tissue metabolism.

Vitamin E is necessary for the normal development and functioning of the gonads. It participates in the biosynthesis of collagen, heme, and proteins, and activates cell proliferation.

Pharmacokinetics

Data on the pharmacokinetics of Doppelherz Vitamin E forte are not provided.

Indications

Vitamin E deficiency;
Increased physical and mental stress;
As part of complex therapy for peri- and postmenopausal disorders;
Degenerative and proliferative changes in joints, spinal ligaments, muscles;
Asthenic conditions (including in the elderly).

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
E56.0	Vitamin E deficiency
F48.0	Neurasthenia
M15	Polyosteoarthritis
M47	Spondylosis
N95.1	Menopausal and other perimenopausal disorders
N95.3	States associated with artificial menopause
Z73.0	Burn-out
Z73.3	Stress, not elsewhere classified (physical and mental strain)

ICD-11 code	Indication
5B58	Vitamin E deficiency
6A8Z	Affective disorders, unspecified
8D40.1	Neuropathy due to nutritional deficiency
FA05	Polyosteoarthritis
FA8Z	Degenerative disease of spine, unspecified
GA30.00	Menopausal or climacteric states in women
GA30.3	States associated with artificial menopause
QD85	Burn-out
QE01	Stress, not elsewhere classified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Adults are prescribed 1 capsule/day, after a meal. The capsule is taken orally, without chewing, with a small amount of liquid.

For degenerative and proliferative changes in joints, spinal ligaments, muscles – 1 capsule/day.

For vitamin E deficiency – 1 capsule/day, maximum dose – 2 capsules/day. The duration of the treatment course is determined by the attending physician.

Adverse Reactions

Allergic reactions: itching, skin hyperemia.

Contraindications

Acute myocardial infarction;
Children under 18 years of age;
Hypersensitivity to the drug components.

With caution, the drug should be prescribed for severe cardiosclerosis (after a previous myocardial infarction), with an increased risk of thromboembolism, hypoprothrombinemia caused by vitamin K deficiency.

Use in Pregnancy and Lactation

During pregnancy and breastfeeding, the drug is prescribed in the average daily dose for adults under medical supervision.

Special Precautions

It is necessary to strictly adhere to the dosing regimen.

With long-term use of the drug and/or the need to prescribe repeated courses of therapy, it is recommended to periodically monitor blood clotting parameters, as well as blood cholesterol levels.

Overdose

Symptoms: when taking vitamin E for a long period in doses of 400-800 IU/day, blurred vision, dizziness, headache, nausea, severe fatigue, diarrhea, gastralgia, asthenia are noted.

When taking a dose of more than 800 IU/day for a long period – an increased risk of bleeding in patients with vitamin K deficiency, impaired metabolism of thyroid hormones, sexual dysfunction, thrombophlebitis, thromboembolism, necrotizing colitis, sepsis, renal failure, retinal hemorrhage, hemorrhagic stroke, ascites.

Treatment: drug withdrawal. Symptomatic therapy is carried out, corticosteroids are prescribed.

Drug Interactions

Iron preparations are recommended to be used 8-12 hours before or after taking Doppelherz Vitamin E forte (because possible impairment of iron absorption).

Taking vitamin E in high doses may enhance the effect of indirect anticoagulants. When taking indirect anticoagulants and vitamin E simultaneously, it is necessary to regularly monitor blood clotting parameters.

It enhances the effect of corticosteroids, NSAIDs, antioxidants.

Vitamin E in high doses can cause vitamin A deficiency in the body.

It increases the effectiveness of antiepileptic drugs in patients with epilepsy (who have elevated levels of lipid peroxidation products in the blood).

Cholestyramine, colestipol, mineral oils reduce the absorption of vitamin E.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 4 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer