Porciola (Capsules) Instructions for Use

Marketing Authorization Holder

Wellosophy Corporation (USA)

Manufactured By

SupraNaturals LLS (USA)

Contact Information

ALIUM JSC (Russia)

Dosage Form

Porciola

Capsules: 10 or 60 pcs.

Dosage Form, Packaging, and Product Composition

* substance purity > 99.995%

Excipients food-grade L-leucine binder 5%, gelatin.

10 capsules in a blister pack made of polyvinyl chloride film and aluminum foil together with the instructions for use are placed in a cardboard box.
60 capsules in a plastic bottle with a screw cap made of the same material and a foil safety valve together with the instructions for use are placed in a cardboard box.

Properties

Medical device.

Porciola are transparent gelatin capsules without odor or taste. Each capsule contains ultra-pure Carbomer polyacrylic acid manufactured using SWELL^® technology, which has high absorptive (absorbing and retaining) capacity in an aqueous environment.

Purpose and main characteristics

Porciola is intended for weight loss and providing a prolonged (up to 4 hours) feeling of satiety, which helps reduce the amount of food consumed and body weight correction. Reducing portion sizes does not require changing the usual diet, ensures gradual but targeted weight loss, and excludes the development of complications arising from rapid weight loss. Porciola can be used in combination with medications and food supplements that promote weight loss, as well as while following a specialized diet and physical activity.

Calorie expenditure for different types of physical activity

Mechanism of action and product operation procedure

2 Porciola capsules are taken orally with 350 ml of clean, non-mineral drinking water at room temperature.

The capsule shells dissolve in the stomach and release SWELL^® carbomer particles. The particles, interacting with water, swell within 20 minutes and retain an amount of fluid 1000 times greater than the dry mass of the carbomer.

This forms a soft structural hydrogel that fills part of the stomach volume. The contents of two capsules and 350 ml of water form 350 ml of hydrogel.

SWELL^® technology – formation of an inert, safe gel that swells in the stomach, providing a 1000-fold volume increase!

The formed hydrogel remains in the stomach for 4 hours (the average time food stays in the stomach) and acts as a temporary stomach filler.

In the body, the feeling of satiety is provided by two main mechanisms.

Primary (sensory) satiety is a fast way to suppress hunger: due to the mechanical effect of food intake, a feeling of fullness occurs within 5 minutes.

Secondary (metabolic) satiety is a delayed process. It is realized through hormonal excitation of the satiety center by the first portion of nutrients entering the blood 20-30 minutes after eating.

Porciola, thanks to the inert filling of the stomach, helps suppress hunger through the natural primary, physiological mechanism of satiety, thereby allowing to reduce the amount of food consumed. Thus, weight loss occurs without hunger, stress, or harm to the body.

Reducing calorie intake from food initiates their consumption from the body’s own adipose tissue. This is how the process of natural weight loss occurs.

From the first day of intake, Porciola reduces the amount of food consumed without hunger. Regular intake of Porciola capsules ensures constant weight loss. Using Porciola capsules for several months develops the habit of consuming reduced food portions. The habit of satiety with smaller portions remains for another 2 months after discontinuation of Porciola capsules.

For best results, Porciola capsules should be used in combination with appropriate physical activity and healthy eating. Reducing the amount of food consumed decreases calorie intake into the body.

Regular intake – guarantee of result

Safety

The formation of hydrogel in the stomach is a safe process and does not cause any sensations.

Acting exclusively in the gastrointestinal tract lumen, Porciola is not absorbed and does not have a systemic effect on the body. After 4 hours, the hydrogel passes from the stomach into the duodenum, then moves through the intestines and is excreted in the stool unchanged without adverse events.

During passage through the gastrointestinal tract, the hydrogel does not interact with the mucous membrane.

Polyacrylic acid hydrogel

• Has no nutritional value for the body (0 calories).
• Absolutely biologically inert for the body, does not interact with the gastrointestinal mucosa.
• Is not absorbed and does not cause active biological processes in the human body.
• Remains in the gastrointestinal tract for a short time (food transit time).
• Is physiologically excreted from the body unchanged without causing any sensations.
• As a result of numerous studies, it has been established that ultra-pure polyacrylic acid hydrogel is a non-toxic compound, does not have mutagenic, teratogenic, or carcinogenic effects, and also has no chemical, pharmacological, immunological, or metabolic effects on the human body.

Rationale for using Porciola capsules

One of the main causes of excess weight and obesity is excessive food consumption.

The energy obtained from food, with insufficient physical activity, becomes excessive for the body’s normal functioning and inevitably transforms into adipose tissue storage and, accordingly, leads to increased body weight and obesity. That is why one of the most effective and natural ways to lose weight is to reduce the amount of food consumed (portion control system).

Efficacy

Clinical trials demonstrated a weight loss of 3-5 kg/month when taking 2 capsules once a day before the main meal. Experience of use was obtained with continuous courses lasting 3 months. For stable weight maintenance, regular intake of Porciola capsules is recommended, which ensures a constant reduction in calorie intake.

Scope of Application

Of the Porciola product

• Weight loss;
• Support of stable body weight;
• Prevention of excess weight gain;
• Reduction of food intake in the presence of excess body weight and obesity.

ICD codes

Dosage Regimen

The likelihood of successful use of Porciola capsules for weight loss is significantly increased in patients motivated to lose weight. Porciola capsules must be swallowed whole, without opening or chewing, with 350 ml of clean, non-mineral drinking water at room temperature, based on 180 ml per 1 capsule or 350 ml for 2 capsules for hydrogel formation. The capsules are taken 20 minutes before the start of a meal (usually dinner).

Unless otherwise prescribed by a doctor, the following application scheme should be followed

BMI* 25-30 kg/m² • Purpose of taking Porciola capsules – weight loss to BMI< 24.99 kg/m²

BMI* 31-50 kg/m² • Purpose of taking Porciola capsules – weight loss to BMI< 25-30 kg/m²

BMI* up to 24.99 kg/m² • Purpose of taking Porciola capsules – support of stable body weight.

* – Body Mass Index.

The maximum single dose should not exceed 4 capsules.

The maximum daily dose should not exceed 12 capsules.

Contraindications

• Individual intolerance to the components included in the composition;
• Age under 18 years (studies have not been conducted);
• Exacerbation of gastric ulcer and significant gastroesophageal reflux.

Consult a specialist before use in the following cases

• With grade III-IV obesity;
• In the presence of significantly pronounced gastroesophageal reflux;
• After gastrointestinal surgery;
• In the presence of diabetes mellitus or severe somatic diseases.

Use during pregnancy and lactation

Clinical studies to evaluate efficacy and safety in pregnant women and during lactation have not been conducted. Consult a doctor before use during pregnancy and breastfeeding.

Special instructions

Intake of medications or food supplements should be carried out 30 minutes before or no earlier than 30 minutes after taking Porciola capsules.

To replenish the necessary balance of vitamins and microelements against the background of reduced food intake, it is recommended to include specialized vitamin-mineral complexes used for weight loss in the daily diet.

Porciola does not affect the ability to drive vehicles, operate machinery, or perform work requiring increased attention and speed of motor reactions.

Storage Conditions

Keep out of reach of children, in a dry, light-protected place at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 5 years.

Do not use after the expiration date. The manufacturing date is indicated on the bottle and cardboard packaging.

Dispensing Status

Over-the-Counter

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.