Bainvail ointment intensiv

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BAINVEL CREAM INTENSIVE

Composition:

Active ingredients: natural camphor, turpentine, eucalyptus oil, racemic menthol, pine needle oil;

1 g of cream contains 0.06 g of natural camphor, 0.06 g of turpentine, 0.04 g of eucalyptus oil, 0.02 g of racemic menthol, 0.014 g of pine needle oil;

Excipients: non-ionic emulsifying wax, mineral oil, polyethylene glycol (macrogol) cetylstearyl ether and stearyl alcohol, pine needle flavoring, methylparahydroxybenzoate (E 218), propylparahydroxybenzoate (E 216), potassium dihydrogen phosphate, disodium phosphate, purified water.

Pharmaceutical form. Cream.

Main physicochemical properties: homogeneous soft white cream with the odor of essential oils.

Pharmacotherapeutic group. Products used locally in joint and muscular pain. ATC code M02AX10.

Pharmacological properties.

Pharmacodynamics. "Bainvel Ointment Intensive" is a combined medicinal product for topical use. The therapeutic effect of the ointment is due to the pharmacological properties of its active ingredients. The ointment exerts counterirritant, anti-inflammatory, local irritant, and mild antiseptic actions.

When rubbed into the skin, it stimulates sensory nerve endings of the skin and subcutaneous tissues, dilates superficial blood vessels, causes a sensation of warmth, and improves blood supply to the skin and subcutaneous tissues.

Pharmacokinetics. Pharmacokinetic studies of camphor, turpentine oil, eucalyptus oil, and pine needle oil show that these substances are absorbed both through the skin and via the respiratory tract (by inhalation), and are eliminated through the lungs or with urine and feces.

Clinical characteristics.

Indications.

For symptomatic treatment of rheumatic arthritis, lumbago, sciatica, back pain, myalgia, arthralgia, neuralgia; myositis, bruises and sprains; for therapeutic and sports massage.

Contraindications.

Hypersensitivity to the active substances, 1,8-cineole, or any excipients. Skin integrity impairment, skin lesions such as burns, eczema, dermatitis. Bronchial asthma, pertussis, pseudocroup, and other respiratory tract diseases associated with increased airway sensitivity – since inhalation of the product may cause bronchial muscle spasms. Predisposition to seizures, history of epileptic seizures. Contraindicated in children under 4 years of age, as products containing 1,8-cineole, like other essential oils, may cause laryngospasm; children with a history of seizures (febrile or otherwise).

Interaction with other medicinal products and other forms of interaction.

Eucalyptus oil enhances liver enzyme activity and may reduce the effect or shorten the duration of action of other drugs. This cannot be excluded with prolonged use of the product.

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

Special precautions for use.

Do not allow the drug "Bainvel cream intensive" to come into direct contact with mucous membranes of the eyes, mouth, or nose. If the cream gets onto mucous membranes or into the eyes, rinse immediately with plenty of water.

After application, hands should be thoroughly washed to prevent contact with the face, especially the eyes. Care should be taken to ensure that children do not touch areas of skin where the product has been applied. Accidental exposure of the drug to the nose or face of children may cause apnea due to laryngospasm (spasm of the vocal cords) — a condition requiring immediate medical attention.

Methylparahydroxybenzoate and propylparahydroxybenzoate may cause allergic reactions (possibly delayed).

Cetostearyl polyglycol ether (macrogol cetostearyl ether) and stearyl alcohol may cause local skin reactions (e.g., contact dermatitis).

If redness or swelling develops at the application sites, consult a physician.

Use during pregnancy or breastfeeding.

The safety of using this medicinal product during pregnancy or breastfeeding has not been established.

Due to insufficient data, the cream should not be used during pregnancy or breastfeeding.

Ability to influence reaction speed when driving or operating machinery.

No effect on the ability to drive or operate machinery has been observed. However, if adverse reactions affecting the nervous system (dizziness, excitation) occur, caution should be exercised.

Method of Administration and Dosage

Apply "Bainvel Intensive Ointment" gently 2–3 times daily to the affected painful areas of the body.

An amount of ointment approximately 0.5–1 cm in length is sufficient for an area of skin about the size of the palm. The ointment should be rubbed in gently until completely absorbed into the skin.

The product should be used until symptoms of the condition have resolved. If there is no improvement after 5 days of treatment, consult a physician without fail.

Children.

Do not use in children under 4 years of age. Avoid application to facial and neck areas in children under 6 years of age.

Overdose.

Overdose may cause skin irritation.

The product usually does not exhibit systemic toxic effects when the recommended dose is exceeded; however, excessive topical application over large skin areas may lead to toxic symptoms such as nephrotoxicity and disturbances of the central nervous system (shortly after application of camphor).

Incorrect Use.

Accidental ingestion of the ointment may cause gastrointestinal disturbances such as vomiting and diarrhea. Treatment is symptomatic.

In case of symptoms of acute poisoning (after accidental ingestion of a significant amount of the product), such as nausea, vomiting, abdominal pain, headache, dizziness, sensation of warmth/flushing, excitement, hallucinations, seizures, respiratory depression, or coma, hospitalization and medical supervision are indicated. In cases of respiratory depression, intubation is required and assisted mechanical ventilation and intensive care measures may be necessary. Patients with severe gastrointestinal or neurological symptoms of poisoning should be monitored and treated symptomatically. Induction of vomiting is not recommended.

Side effects.

Allergic reactions, including skin redness, rash, itching, urticaria, contact dermatitis; headache, dizziness, excitement, possible occurrence of seizures caused by camphor. In isolated cases, symptoms of mucous membrane irritation, bronchospasm may occur.

Skin irritation or allergic reactions are usually mild and occur very rarely. Inhalation during rubbing may cause reflex-induced symptoms such as wheezing, cough, dyspnea, and breathing difficulties due to narrowing of the airways. This may lead to an asthmatic condition and respiratory arrest.

With prolonged application over large areas of the body, kidney damage is possible.

Possible burns at the site of ointment application. Frequency unknown.

If adverse reactions occur, the use of the medicinal product must be discontinued immediately, residual product removed with a tissue, and medical advice sought.

Shelf life. 3 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

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

Packaging.

50 g or 100 g in a tube. 1 tube per cardboard box.

Supply classification. Over-the-counter.

Manufacturer/Marketing Authorisation Holder.

Dr. Theiss Naturwaren GmbH.

Manufacturer's address and place of business.

Michelinstrasse 10, 66424 Homburg, Germany.