Intellan

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT INTELLAN (INTELLAN)

Composition:

Active substances: 1 capsule contains: dry extract of ginkgo biloba leaves (Ginkgo biloba) (4:1) (extraction solvent – water) 50 mg, dry extract of centella asiatica herb (Centella asiatica) (4.17:1) (extraction solvent – water) 120 mg, dry extract of herpestis monniera herb (Herpestis monniera) (4.17:1) (extraction solvent – water) 30 mg, dry extract of coriander seed (Coriandrum sativum) (4:1) (extraction solvent – water) 50 mg, dry extract of amomum subulatum fruits (Amomum subulatum) (4:1) (extraction solvent – water) 50 mg, dry extract of emblica officinalis fruits (Emblica officinalis) (4:1) (extraction solvent – water) 100 mg;

Excipient: talc.

Pharmaceutical form. Capsules.

Main physicochemical characteristics: grey-colored capsules, size "0", containing brown-colored powder; "INTELLAN" is printed on the body and cap of the capsule.

Pharmacotherapeutic group.
Agents affecting the nervous system. ATC code N07XX.

Pharmacological Properties.

Pharmacodynamics. The drug contains 6 pharmacologically active herbs that include amino acids, microelements, biologically active alkaloids, and glycosides. Indirectly through glutamic and aspartic acids, biologically active alkaloids, and glycosides, the drug acts as a neurohumoral modulator of neurotransmission and exerts a stimulating effect on the metabolism of the cerebral cortex, thereby enhancing brain activity and improving memory. It also improves nourishment of nerve cells and promotes the elimination of toxic metabolic waste products (ammonia), thus optimizing brain structure function. It enhances cerebral circulation, resulting in reduced sensation of fatigue. The mild neurostimulatory effect alleviates feelings of anxiety and aids in the treatment of subacute depressive states.

Each herbal component of the drug possesses specific properties:

Ginkgo biloba improves capillary circulation in the extremities, internal organs, and brain, and prevents thrombosis.

Centella asiatica. The primary active constituent of centella is nitric oxide, which enhances memory, blood flow and microcirculation, and liver and kidney functions; in addition, centella has antioxidant properties.

Hydrocotyle asiatica. The components of hydrocotyle asiatica improve memory and attention, mediate the synthesis of GABA in brain neurons, thereby providing anticonvulsant effects; they also reduce arterial pressure and have sedative, analgesic, and antioxidant actions.

Coriandrum sativum exerts antihyperglycemic, antihyperlipidemic, antioxidant, antiproliferative, hypotensive, and anticonvulsant effects.

Amomum subulatum is used as a tonic, anti-inflammatory, and analgesic agent. It has the ability to neutralize toxins of both exogenous origin and those produced within the body.

Phyllanthus emblica – a source of vitamin C; by stimulating mucocytes, it produces an expectorant effect, has moderate antibacterial activity, and improves cardiovascular functions (adrenaline-like effect).

Clinical characteristics.

Indications.

Memory impairment, chronic stress situations, nervous tension and fatigue, impaired concentration and disorientation, functional cognitive insufficiency, dizziness, disturbances in balance sensation, anxiety states, depression – as part of complex therapy or as an adjunctive treatment.

Contraindications.

Hypersensitivity (allergy) to any component of the drug.

Interaction with other medicinal products and other forms of interactions.

Clinical studies on the interaction with Ginkgo biloba (Egb 761) have demonstrated potentiation or inhibition of cytochrome P450 isoenzymes. Changes in midazolam concentration levels were observed after concomitant administration of Ginkgo biloba (Egb 761), suggesting a possible interaction via CYP3A4. Therefore, medicinal products that are primarily metabolized through CYP3A4 and have a narrow therapeutic index should be used with caution. When Ginkgo products are used concurrently with drugs that inhibit blood coagulation (coumarin anticoagulants (phenprocoumon and warfarin), acetylsalicylic acid), the effect of the latter may be enhanced – increasing the risk of bleeding. The drug should not be taken during prolonged use of thiazide diuretics.

Ginkgo preparations accelerate the metabolism of antiepileptic drugs (valproate, phenytoin) that are metabolized via the CYP2C enzyme system. When used concomitantly with antiepileptic agents, the seizure threshold may be reduced, increasing the likelihood of epileptic seizures.

If simultaneous use with any other medicinal products is required, consult a physician.

Special precautions for use.

The first signs of improvement occur one month after the start of treatment. Close monitoring is recommended for patients taking drugs metabolized by cytochrome P450 3A4. There is no evidence of abuse potential with Ginkgo biloba (EGb 761). Based on its pharmacological profile, Ginkgo biloba (EGb 761) has no potential for abuse. Sleep disturbances may occur when taking Intelan before bedtime.

Before initiating treatment with this medicinal product, it should be confirmed that the pathological symptoms observed are not due to an underlying condition requiring specific treatment.

Patients with an increased tendency to bleeding (hemorrhagic diathesis), as well as those receiving anticoagulant drugs, antidiabetic agents, or antihypertensive medications, should consult a physician before starting treatment with Ginkgo.

If hypersensitivity to any component of the medicinal product occurs, treatment should be discontinued.

Prior to surgical procedures, patients should inform their physician about the use of Ginkgo preparations.

Ginkgo extract-containing preparations may provoke seizures in patients with epilepsy; however, a causal relationship between the use of the product and seizure occurrence has not been established.

Use during pregnancy or breastfeeding.

This medicinal product is primarily intended for elderly patients, among whom the risk of pregnancy is negligible. Due to the lack of adequate clinical data, the use of this product during pregnancy or breastfeeding is not recommended.

Ability to influence reaction speed when driving or operating machinery.

The use of this medicinal product may affect the ability to drive or operate precision machinery (possible reduction in attention); therefore, patients should avoid driving or operating potentially hazardous machinery.

Dosage and Administration.

Take the medication orally after meals. The adult dose is 1 capsule twice daily, in the morning and evening, after eating. In cases of sleep disturbances, it is recommended to take the medication at least 3 hours before bedtime. The treatment course is 3 months. For prolonged therapy, it is advisable to take a 3-week break after every 3 months of treatment.

If symptoms do not improve or worsen, consult a physician.

Children. Do not use in children.

Overdose.

Overdose is unlikely. No cases of accidental overdose have been reported.

In the event of overdose, gastrointestinal disturbances, impaired consciousness, and headache may occur. Treatment is symptomatic.

Side effects.

Taking the medication before bedtime may disturb sleep; therefore, it is recommended to take the medication at least 3 hours before going to sleep.

Rarely occurring reactions include:

• Gastrointestinal system: digestive disturbances; dyspepsia; diarrhea; abdominal pain;
  nausea, vomiting;

• Immune system: hypersensitivity reactions, including angioneurotic edema,
  urticaria, dyspnea;

• Cardiovascular system: arterial hypertension;

• Skin: skin inflammation, redness, swelling, rash, itching, eczema;

• Nervous system: headache, dizziness, syncope (including vasovagal).

Rare cases of bleeding (gastrointestinal, ocular, cerebral) have been reported with the use of products containing Ginkgo extract. The risk of these adverse effects may be increased when used concomitantly with anticoagulants and nonsteroidal anti-inflammatory drugs.

If any unusual reactions occur, discontinue use of the medication and consult a physician immediately.

Shelf life: 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.

Packaging.

20 or 60 capsules in a bottle №1, in a cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer.

Herbion Pakistan Private Limited, Pakistan.

Manufacturer's address.

Plot №30, Sector 28, Korangi Industrial Area, Karachi, Pakistan.