SPECIAL WARNINGS

- If a significant increase in transaminase levels is observed, treatment will be suspended and possible hepatotoxicity will be monitored.

SENIORS

No specific problems have been described in the elderly that would require a dosage adjustment.

PATIENT ADVICE

- Continue treatment for the period recommended by the manufacturer. If further treatment is required, allow a few days' break. Avoid using it for more than 2 months per year.

- Consult your doctor and/or pharmacist if symptoms persist or a high fever develops during treatment.

CONTRAINDICATIONS

- Hypersensitivity to echinacea. Cases of cross-hypersensitivity have been described between different species of the Asteraceae family, so people allergic to other plants of this family (chamomile, artichoke) should avoid using echinacea.

- Diseases in which stimulation of the immune system could be dangerous, such as autoimmune diseases ([COLAGENOSIS], [MULTIPLE SCLEROSIS]), progressive systemic disorders ([TUBERCULOSIS], [SARCOIDOSIS]), [IMMUNODEFICIENCY] (including patients with [HIV INFECTION] or on immunosuppressant treatment) and pathologies affecting white blood cells ([NEUTROPENIA], [LEUKEMIA]).

EFFECTS ON DRIVING

Echinacea does not appear to significantly affect the ability to drive.

PREGNANCY

Animal safety : no data available.

Safety in humans : There are several hundred reported cases of pregnant women taking echinacea during pregnancy, with no adverse reactions reported in the child. Adequate and well-controlled studies in humans are not available. Its use is not recommended except under medical supervision.

Effects on fertility : no specific studies have been conducted on its effects on fertility.

INDICATIONS

- Complementary treatment of [COMMON COLD], [FLU] and irritation of the upper respiratory tract.

INTERACTIONS

No interactions have been described.

LACTATION

It is unknown whether its components are excreted in breast milk, and what consequences this might have for the infant. Its use is not recommended except under medical supervision.

CHILDREN

Echinacea can be used in children or adolescents from 6 years of age. See the Dosage section for more information.

GUIDELINES FOR PROPER ADMINISTRATION

- Tablets, capsules: swallow whole with a glass of water or other liquid.

POSOLOGY

"ECHINACEA ARKOPHARMA"

- Adults, the elderly, and adolescents over 12 years: 2 capsules, 3 times a day, with main meals. Start treatment at the first sign of symptoms.

Treatment duration : 10 days.

Missed dose : Do not double the next dose.

DOSAGE IN HEPATIC INSUFFICIENCY

Use with caution, although no specific dosage recommendations have been made.

DOSAGE IN RENAL INSUFFICIENCY

No specific dosage recommendations have been made.

PRECAUTIONS

- Hypersensitivity reactions. Echinacea has been linked to allergic reactions, sometimes severe, including anaphylaxis. The risk of these reactions is higher in atopic individuals, such as patients with asthma.

ADVERSE REACTIONS

Adverse reactions are described according to each frequency interval, being considered very common (>10%), common (1-10%), uncommon (0.1-1%), rare (0.01-0.1%), very rare (<0.01%) or of unknown frequency (cannot be estimated from the available data).

- Cardiovascular: very rare [HYPOTENSION].

- Respiratory: very rare [DYSPNEA].

- Allergic: very rare [HYPERSENSITIVITY REACTIONS], especially in predisposed patients, and which may present with symptoms such as [SKIN RASHES], [PRURITUS], [SKIN EDEMA], [BRONCHOSPASM], [ASTHMA], and in the most severe cases [STEVENS-JOHNSON SYNDROME] or [ANAPHYLAXIS].

- Optic: very rare [VERTIGO].

- Hematological: frequency unknown [LEUKOPENIA] in case of use for prolonged periods, exceeding 8 weeks.

OVERDOSE

Symptoms: There is no clinical experience with echinacea overdose.

Treatment: symptomatic.