Prohistam (Tablets) Instructions for Use

Marketing Authorization Holder

Materia Medica Holding NPF, LLC (Russia)

Dosage Form

Prohistam

Lozenges 3 mg: 20, 40, 50, 75, or 100 pcs.

Dosage Form, Packaging, and Composition

50 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
75 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – contour cell packs (1) – cardboard packs.
20 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – contour cell packs (5) – cardboard packs.

Clinical-Pharmacological Group

Drug with antiallergic action

Pharmacotherapeutic Group

Homeopathic agent

Indications

• For use as part of complex therapy for allergic conditions of various origins to alleviate symptoms.
• Allergic rhinitis (both seasonal, such as hay fever, and perennial) to reduce sneezing, nasal congestion, rhinorrhea, and itching in the nose.
• Allergic conjunctivitis for the relief of ocular symptoms, including redness, itching, tearing, and swelling of the eyes.
• Chronic idiopathic urticaria and other allergic skin reactions to reduce the intensity and frequency of hives (wheals) and associated pruritus (itching).
• As an adjunct in the management of atopic dermatitis and angioedema to help control itching and swelling.
• For the relief of symptoms associated with food and drug allergies, such as cutaneous manifestations and mild upper respiratory tract symptoms, as part of a comprehensive treatment plan under medical supervision.

Contraindications

• Hypersensitivity to the active substance (affinity purified antibodies to histamine) or to any of the excipients of the drug.
• Congenital galactosemia, glucose-galactose malabsorption, or lactase deficiency, as the lozenges contain lactose monohydrate.
• Children under 18 years of age, due to the lack of sufficient clinical data on the safety and efficacy of the drug in this patient population.
• Pregnancy and breastfeeding. The use of Prohistam during pregnancy and lactation is contraindicated because clinical studies to establish safety for the fetus, the pregnant woman, and the infant have not been conducted.

Dosage Regimen

The dosage of Prohistam is individualized and should be determined by a physician. The following is a general recommended dosing guideline for adults and elderly patients.

Method of administration: The tablet should be held in the mouth until completely dissolved. Do not swallow whole or chew. It is recommended to take the drug between meals, ideally 30 minutes before or after eating and drinking.

Standard Adult Dosage (18 years and older): A single dose is 1 tablet (3 mg). The tablet should be taken orally, allowing it to dissolve completely in the mouth.

Dosing Frequency: Depending on the severity of the allergic condition and the physician’s recommendation, the dosing frequency may vary. In the acute phase of allergic conditions, the drug may be taken up to 4 times per day with intervals between doses not less than 2 hours. For long-term therapy and prevention, the frequency of administration may be reduced to 1-2 times per day.

Duration of Treatment: The course of treatment is determined by the doctor based on the clinical picture and the patient’s response to therapy. The drug can be used both in short courses for the relief of acute symptoms and in longer courses for the management of chronic allergic conditions.

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not double the dose to make up for a missed one.

Adverse Reactions

Prohistam is generally well-tolerated. Adverse reactions are rare and usually mild and transient.

The most commonly reported adverse reactions are allergic reactions, which may include skin rash, urticaria, itching, and redness of the skin. In very rare cases, more severe hypersensitivity reactions, including angioedema, may occur.

During the initial days of treatment, a temporary initial worsening of existing symptoms may be observed, which is a known phenomenon in homeopathic practice and typically subsides without intervention. If the worsening is severe or persists, the patient should discontinue the drug and consult a physician.

Other rarely reported adverse effects may include gastrointestinal discomfort, such as nausea or epigastric pain, and headache. Due to the lactose content in the formulation, individuals with severe lactose intolerance might experience gastrointestinal symptoms (e.g., bloating, diarrhea).

If any adverse reactions not described in these instructions occur, or if known reactions worsen, the patient should inform their doctor. Reporting of suspected adverse reactions is important for continuous safety monitoring of the medicinal product.

Drug Interactions

To date, no specific pharmacokinetic or pharmacodynamic interactions between Prohistam and other medicinal products have been identified in formal studies.

However, due to the pharmacological action of the drug, it may potentially modify the effects of other antiallergic medications. When used concomitantly with other antihistamines, mast cell stabilizers, or corticosteroids, an additive therapeutic effect is theoretically possible, which may be either desirable or require dose adjustment.

There is no evidence that Prohistam affects the ability to drive and operate machinery. Nevertheless, patients who experience drowsiness or other central nervous system-related adverse reactions with other antiallergic medications should exercise caution until their individual response to Prohistam is fully known.

It is highly recommended to inform your healthcare provider about all the medications you are currently taking, including prescription, over-the-counter, and herbal products, to allow for a comprehensive assessment of potential interactions.

Overdose

Cases of overdose with Prohistam have not been reported to date. Given the nature of the active substance and its homeopathic preparation, the risk of acute toxic effects from an overdose is considered to be very low.

In the event of accidental ingestion of a significantly larger than prescribed number of tablets, gastrointestinal discomfort due to the excipient load (primarily lactose) is the most likely consequence. Symptoms may include nausea, abdominal pain, diarrhea, or bloating.

There is no specific antidote for Prohistam overdose. Management should be symptomatic and supportive. It is advisable to consult a doctor or contact a poison control center for advice. Gastric lavage or administration of activated charcoal is not expected to be necessary due to the composition of the drug.

Patients or caregivers should be advised to store the medication properly to prevent accidental ingestion by children or unintentional overuse.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

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.