Dip hit

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT DIP HIT

Composition:

Active substances: eucalyptus oil, turpentine oil, menthol, methyl salicylate;

1 g of cream contains: eucalyptus oil 1.97%, turpentine oil 1.47%, menthol 5.91%, methyl salicylate 12.80%;

Excipients: propylene glycol, cetostearyl alcohol, sodium cetostearyl sulfate, lanolin, mineral oil, purified water.

Pharmaceutical form. Cream.

Main physicochemical properties: homogeneous white cream with a menthol and methyl salicylate odor.

Pharmacotherapeutic group.

Topically applied agents for joint and muscle pain. ATC code M02AX.

Pharmacological properties.

Pharmacodynamics.

Dip Heat is a combination medicinal product with the pharmacological properties of the active ingredients contained in its composition.

Methyl salicylate penetrates through the skin and has analgesic and anti-inflammatory effects.

Turpentine oil, when applied locally, causes reflexive increase in blood flow, which promotes faster absorption of active components.

Eucalyptus oil, when applied locally, has a similar effect.

Menthol has a mild local anesthetic action, accompanied by a sensation of relief from muscle, ligament, and joint pain.

Dip Heat has local irritant, anti-inflammatory, and analgesic effects, produces a warming sensation at the site of application, and stimulates local blood circulation in tissues.

Pharmacokinetics.

The medicinal product is intended for topical use; therefore, studies on absorption have not been conducted.

Clinical characteristics.

Indications.

Symptomatic treatment of muscle pain, stiffness (including low back pain), sciatica, lumbago, fibrositis, rheumatic pain, frostbite, pain from blows and ligament sprains, including those caused by minor sports injuries.

Contraindications.

Hypersensitivity to any component of the medicinal product.

Hypersensitivity to acetylsalicylic acid, ibuprofen, or to other nonsteroidal anti-inflammatory agents (including when administered orally), especially in patients with a history of bronchial asthma.

Interaction with other medicinal products and other forms of interaction.

Although adequate controlled interaction studies have not been conducted, excessive use of topically applied salicylates may potentially enhance the effect of coumarin anticoagulants and antiplatelet medicinal products. Therefore, caution should be exercised in patients receiving coumarin anticoagulants and antiplatelet medicinal products, including aspirin.

Special precautions for use.

Salicylates may enhance the effect of anticoagulant and antiplatelet medicinal agents (see section "Interaction with other medicinal products and other forms of interaction").

The medicinal product is intended for topical use only. Do not apply the cream to damaged or inflamed areas of skin. Prior to use, the product should first be applied to a small area of skin to help prevent the development of allergic reactions.

Some patients, especially those with sensitive skin, may experience discomfort when using the product in hot weather or after taking a bath.

Do not use under occlusive dressings.

After applying Dip Heat medicinal cream, hands should always be washed unless they are the area being treated.

Avoid contact with eyes and sensitive areas of skin. If the cream accidentally gets into the eyes, rinse thoroughly with water and seek medical advice immediately.

In case of accidental ingestion of the medicinal product, seek medical advice or go to the nearest emergency facility immediately.

The medicinal product contains propylene glycol, which may cause skin irritation.

Contains cetyl stearyl alcohol and lanolin, which may cause local skin reactions (e.g. contact dermatitis).

With prolonged use over large areas of skin, systemic effects of the medicinal product cannot be excluded.

Absorption of the medicinal product may be significantly increased during heating or physical activity (e.g. exercise).

Do not use under tight or warming bandages, or together with electric heating pads. The application site may only be lightly covered.

The use of salicylates has been associated with the development of Reye's syndrome.

During use of the medicinal product, safety precautions must be observed: do not smoke or go near open flames, as there is a risk of serious burns. Fabrics (clothing, bed linen, dressings, etc.) that have come into contact with the medicinal product Dip Heat are more flammable and pose a serious fire hazard. Laundering of clothing and bed linen may reduce accumulation of the medicinal product but will not completely remove it.

Use during pregnancy or breastfeeding.

There are insufficient data on the use of the medicinal product during pregnancy or breastfeeding. Use during pregnancy or breastfeeding should be avoided unless considered necessary. Consult a physician prior to use.

Ability to affect reaction speed when driving or operating machinery.

Not established.

Method of Administration and Dosage

For external use only.

For use in adults and children aged 5 years and older.

Apply a thin layer of the cream to the affected area of skin and gently rub in 2–3 times daily.

May be used before and after physical exertion.

The duration of treatment is determined individually by a physician.

Children

For use in children aged 5 years and older.

Overdose

Overdose is unlikely with recommended use. Excessive application may lead to salicylate toxicity: application over a large skin area or accidental ingestion of the medicinal product may cause systemic adverse reactions, depending on the amount applied.

Treatment: supportive and symptomatic therapy.

Side effects.

Allergic reactions to the components of the medicinal product are possible. Skin burns, blisters, and transient skin reactions including redness, burning sensation, irritation, pain, paraesthesia, and rash may occur.

Sensation of cold followed by warmth, tingling, itching, urticaria may occur.

Immune system: angioneurotic edema.

Respiratory, thoracic and mediastinal disorders: dyspnoea.

If any adverse effects occur, use of the medicinal product should be discontinued and medical advice must be sought immediately.

Shelf life.

3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C, in a place inaccessible to children.

Packaging.

15 g or 67 g of cream in a tube; 1 tube in a cardboard box.

Prescription status.

Over-the-counter (without prescription).

Manufacturer.

Mentholatum Company Limited.

Manufacturer's address and place of business.

1 Redwood Avenue, Peel Park Campus, East Kilbride, G74 5PE, United Kingdom.