Olfen ® Hydrogel gel is used for the local treatment of pain and inflammation of joints, muscles, ligaments and tendons of rheumatic or traumatic origin.
Composition
The active substance is diclofenac (1 g of gel contains diclofenac sodium 10 mg).
Excipients: lactic acid, diisopropyl adipate, isopropyl alcohol, sodium metabisulfite (E 223), hydroxyethylcellulose, hydroxypropylcellulose, purified water.
Contraindication
Hypersensitivity to diclofenac or any other component of the drug; history of attacks of bronchial asthma, urticaria or acute rhinitis caused by taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
Method of application
The gel is intended for external use only.
Adults and children over 14 years old
The amount of the drug used depends on the size of the affected area. Approximately, 2-4 g of gel (the volume corresponds to applying a strip of gel to the surface of 1-2 fingertips) is sufficient for application to an area of 400-800 cm2. The gel should be applied 3-4 times a day to the damaged area of the body, without rubbing. The daily dose should not exceed 15 g of gel.
After applying the drug, hands must be washed, except when this is the area to be treated.
"Olfen ® Hydrogel" can be used in combination therapy with other dosage forms of "Olfen ®".
The duration of therapy depends on the nature of the disease and the effectiveness of the treatment.
The drug should not be used for longer than 14 consecutive days.
If after 7 days of treatment the patient's condition has not improved or has worsened, the drug should be discontinued and a doctor should be consulted.
Elderly patients do not require dose adjustment.
Application features
Pregnant women
Systemic concentrations of diclofenac are lower after topical administration than after oral administration. Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo-fetal development. Epidemiological data indicate an increased risk of miscarriage, cardiac malformations and gastroschisis following the use of prostaglandin synthesis inhibitors in early pregnancy. This risk is believed to increase with increasing dose and duration of therapy.
Diclofenac sodium should not be used in the first and second trimesters of pregnancy unless absolutely necessary.
If diclofenac sodium is used in a woman attempting to conceive or in the first or second trimester of pregnancy, the dose should be kept as low and the duration of treatment as short as possible.
Diclofenac sodium is contraindicated in the third trimester of pregnancy due to the fact that all prostaglandin synthesis inhibitors can:
expose the fetus to the following risks: cardiopulmonary toxicity (with premature closure of the ductus arteriosus and the development of pulmonary hypertension), renal dysfunction, which progresses to renal failure with oligohydramnios; expose the mother and child to the following risks: possible prolonged bleeding - an effect associated with the inhibition of platelet aggregation, which can occur even against the background of taking very low doses of the drug; inhibition of uterine muscle contractions, which leads to a delay or prolongation of labor.
Like other non-steroidal anti-inflammatory drugs, diclofenac passes into breast milk in small amounts. However, when using diclofenac in therapeutic doses, no effects on the breast-fed child are expected. The decision to use the drug is made by the doctor if there are good reasons for its use during breastfeeding, when the expected benefit of treatment outweighs the potential risk. The drug should not be applied to the mammary glands or large areas of skin and should not be used for a long time.
Children
"Olfen ® Hydrogel" is not recommended for use in children under 14 years of age. When using the drug in children over 14 years of age for more than 7 days or if the symptoms of the disease worsen, it is necessary to consult a doctor.
Drivers
The drug does not affect the reaction speed when driving vehicles or other mechanisms.
Overdose
Due to the low absorption of diclofenac into the systemic bloodstream, cases of overdose with topical application are unlikely.
In the event of any symptomatic side effects due to improper use or possible overdose, general therapeutic measures for the treatment of intoxication with nonsteroidal anti-inflammatory substances should be applied.
In case of accidental ingestion, the possibility of systemic adverse reactions should be considered. In such cases, the stomach should be emptied immediately and an adsorbent should be taken. Symptomatic treatment is indicated, using therapeutic measures used for the treatment of poisoning with nonsteroidal anti-inflammatory drugs.
Side effects
"Olfen ® Hydrogel" is usually well tolerated. Adverse reactions include mild temporary skin reactions at the site of application. Allergic reactions may occur.
Infections and infestations: pustular eruptions.
Immune system disorders: hypersensitivity reactions (including urticaria), angioedema.
Skin and subcutaneous tissue disorders: rash, eczema, edema, erythema, dermatitis, including contact dermatitis, bullous dermatitis, photosensitivity, burning sensation of the skin, itching.
Storage conditions
Store at a temperature not exceeding 25 °C, out of the reach of children.
Shelf life - 3 years.
