Pantovigar (Capsules) Instructions for Use

Marketing Authorization Holder

Merz Pharma, GmbH & Co. KGaA (Germany)

Manufactured By

Acino Pharma, AG (Switzerland)

Contact Information

Merz Pharma LLC (Russia)

ATC Code

A11JC (Vitamins in combination with other drugs)

Dosage Form

Pantovigar

Capsules: 90, 150, or 300 pcs.

Dosage Form, Packaging, and Composition

Capsules are hard gelatin capsules, the capsule cap is dark green, the body is from white to yellowish-brown; the capsule contents are a powder from light yellow to light brown in color, with a characteristic odor.

Excipients: microcrystalline cellulose, talc, magnesium stearate, povidone, colloidal silicon dioxide; capsule shell: gelatin, purified water, titanium dioxide, yellow iron oxide dye, indigo carmine.

15 pcs. – blisters (6) – cardboard packs.
15 pcs. – blisters (10) – cardboard packs.
15 pcs. – blisters (2) – cardboard packs (10) – cardboard packs.

Cardboard packs may have a first-opening control.

Clinical-Pharmacological Group

Complex of vitamins with components of natural origin promoting the improvement of hair and nail growth and structure

Pharmacotherapeutic Group

Vitamins; other combined vitamin preparations; vitamins, other combinations

Pharmacological Action

The Pantovigar preparation contains elements necessary for hair and nails. The action of the preparation is due to the properties of its constituent components.

Pharmacokinetics

Pharmacokinetic studies of the preparation have not been conducted. The vitamins of the preparation are absorbed in the upper parts of the gastrointestinal tract. The amino acid components obtained from the hydrolysis of keratin (cystine and para-aminobenzoic acid) are absorbed by passive diffusion and/or with the participation of certain transport systems.

Indications

• Diffuse hair loss of non-hormonal etiology;
• Degenerative changes in hair structure (due to chemical exposure, damage to hair from solar and ultraviolet radiation);
• Impaired nail structure.

ICD codes

Dosage Regimen

Take orally, one capsule three times daily.

Administer with meals to improve tolerability and absorption.

Swallow the capsule whole; do not chew or crush.

Follow each dose with a small amount of liquid.

The average treatment duration is three to six months.

Continue therapy for the full prescribed duration for optimal effect, as hair formation is a slow process.

Treatment can be continued or repeated if medically indicated and deemed necessary by a physician.

For diffuse hair loss, use only after confirming a non-hormonal etiology.

Discontinue use and consult a physician if the condition worsens or progresses unfavorably.

Adverse Reactions

Adverse reactions are classified by frequency of occurrence as follows: very common (≥1/10), common (from ≥1/100 to <1/10), uncommon (from ≥1/1000 to <1/100), rare (from ≥1/10000 to <1/1000), very rare (<1/10000), frequency unknown (cannot be estimated from the available data).

Nervous system disorders frequency unknown – headache and dizziness.

Cardiac disorders rare – tachycardia, increased heart rate; frequency unknown – palpitations.

Gastrointestinal system disorders: frequency unknown – diarrhea, vomiting, abdominal pain, flatulence, heartburn, nausea.

Skin and subcutaneous tissue disorders rare – urticaria, rash, itching; frequency unknown – redness.

General disorders and administration site conditions rare – increased sweating.

Reporting of Suspected Adverse Reactions

It is important to report suspected adverse reactions after drug registration to ensure continuous monitoring of the benefit-risk balance of the drug. Healthcare professionals are recommended to report any suspected adverse drug reactions through the national adverse reaction reporting system of the member states of the Eurasian Economic Union.

Contraindications

• Hypersensitivity to the components of the preparation;
• Childhood.

Use in Pregnancy and Lactation

Pregnancy

The prescription of Pantovigar to pregnant women is permissible only in cases where the benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding period

The prescription of Pantovigar during breastfeeding is permissible only in cases where the benefit to the mother outweighs the potential risk to the child.

Pediatric Use

The preparation is contraindicated in children.

Special Precautions

Infectious nail diseases and androgenic alopecia are not indications for the use of the preparation. For these pathologies, the preparation can be used as part of combination therapy.

Since hair formation is a long process, it is important to take the preparation in the indicated dosages regularly for 3-6 months.

If hair or nail diseases take an unfavorable, strongly progressive course, it is necessary to consult a doctor, as these diseases can be signs of general diseases.

Influence on the ability to drive vehicles and mechanisms

The preparation has no or negligible influence on the ability to drive vehicles and work with mechanisms.

Overdose

No symptoms of overdose have been observed.

Drug Interactions

Interaction studies have not been conducted. With simultaneous use, Para-aminobenzoic acid may reduce the effect of sulfonamides.

Storage Conditions

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

Shelf Life

The shelf life is 3 years. Do not use after the expiration date.

Dispensing Status

The preparation is available without a prescription.

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.