Instructions for Olfen Forte hydrogel 2% tube 50 g
Composition
active ingredient: diclofenac diethylamine;
1 g of gel contains diclofenac diethylamine 23.2 mg, which is equivalent to diclofenac sodium 20 mg;
excipients: isopropyl alcohol, propylene glycol (E 1520), cocoyl caprylocaprate, mineral oil, carbomer 974P, polyethylene glycol cetostearyl ether 22, diethylamine, flavoring (camphor, eucalyptol, ambroxide, citronellol, benzyl alcohol, citral, coumarin, eugenol, farnesol, geraniol, limonene, linalool), oleic acid (E 570), butylhydroxytoluene (E 321), purified water.
Dosage form
Gel.
Main physicochemical properties: homogeneous creamy gel from white to almost white in color.
Pharmacotherapeutic group
Topical agents for joint and muscle pain. Nonsteroidal anti-inflammatory drugs for topical use. Diclofenac.
ATX code M02A A15.
Pharmacological properties
Pharmacodynamics.
Diclofenac is a nonsteroidal anti-inflammatory drug with pronounced antirheumatic, analgesic, anti-inflammatory and antipyretic effects. The main mechanism of action is the inhibition of prostaglandin biosynthesis by cyclooxygenase 2.
Diclofenac reduces pain, swelling and fever caused by inflammation, reversibly inhibits ADP and collagen-induced platelet aggregation. Clinical studies have shown a statistically significant and clinically significant reduction in pain on movement three days after the start of treatment, as well as a significant improvement in the function of the joints of the lower extremities within the first three days of use.
Pharmacokinetics.
Absorption
The amount of diclofenac absorbed through the skin is proportional to the area of application and depends on the total applied dose of the drug and the degree of skin hydration. After topical application twice a day to a skin surface area of 400 cm2, the degree of systemic absorption of the drug, defined as the concentration of the active substance in the blood plasma, is equivalent to applying 4 times a day a gel of diclofenac diethylamine with a concentration of 1.16%. The relative systemic bioavailability of diclofenac when using the drug on the 7th day is 4.5% compared to 50 mg tablets (at the same dose of diclofenac sodium). Absorption is independent of the use of a moisture-permeable and vapor-permeable dressing.
Distribution
99.7% of diclofenac is bound to serum proteins, mainly albumin (99.4%). After application of the drug to the skin of the joints of the hand and knee, diclofenac is found in the blood plasma (where its maximum concentration is approximately 100 times lower than after oral administration of the same amount of diclofenac), in the synovial membrane and synovial fluid.
Diclofenac accumulates in the skin, which serves as a reservoir from which the substance is gradually released into the surrounding tissues. From there, diclofenac mainly enters deeper inflamed tissues, such as joints and ligaments. There it continues to act and is detected in concentrations up to 20 times higher than in blood plasma.
Biotransformation
Diclofenac is metabolized partly by glucuronidation and mainly by hydroxylation to form several phenolic derivatives, two of which are pharmacologically active, but to a much lesser extent than diclofenac.
Breeding
Diclofenac and its metabolites are excreted mainly in the urine. Diclofenac is eliminated from plasma with a systemic clearance of 263 ± 56 ml/min. The terminal half-life of diclofenac from plasma is on average 1–2 hours. Four metabolites, including two active ones, also have short half-lives of 1–3 hours. One of the metabolites, 3´-hydroxy-4´-methoxydiclofenac, has a longer half-life but is pharmacologically inactive.
Special patient groups
In renal failure, accumulation of diclofenac and its metabolites in the body is not observed. In chronic hepatitis or compensated cirrhosis of the liver, the kinetics and metabolism of diclofenac do not change.
Indication
Treatment of pain, inflammation and swelling in:
soft tissue injuries: injuries to tendons, ligaments, muscles and joints (e.g. due to dislocation, sprain, contusion) and back pain (sports injuries);
localized forms of soft tissue rheumatism: tendinitis (including "tennis elbow"), bursitis, shoulder syndrome and periarthropathy.
Symptomatic treatment of osteoarthritis of small and medium-sized superficial joints, such as finger joints or knee joints.
Contraindication
Hypersensitivity to diclofenac or to other components of the drug.
History of attacks of bronchial asthma, bronchospasm, angioedema, urticaria or acute rhinitis caused by taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
Do not apply to mucous membranes, open wounds, or inflammatory and infectious skin diseases such as eczema.
Children and adolescents under 14 years of age.
The last trimester of pregnancy.
Interaction with other medicinal products and other types of interactions
Since the systemic absorption of diclofenac when applied topically is very low, interactions are unlikely. The concomitant use of Olfen Forte HYDROGEL with systemic NSAIDs and steroids may increase the incidence of side effects.
Application features
Use with caution with oral nonsteroidal anti-inflammatory drugs.
The possibility of developing systemic adverse reactions (which occur with the use of systemic forms of diclofenac) cannot be excluded when the drug is applied to large areas of skin or for a longer period than recommended.
The drug Olfen Forte HYDROGEL should be applied only to intact, undamaged areas of the skin, preventing contact with damaged (wounded or infected) skin. Contact with the drug with eyes and mucous membranes should be avoided. The drug should not be swallowed.
Patients with bronchial asthma, hay fever, mucosal edema (nasal polyps), chronic obstructive pulmonary disease or chronic respiratory infections (especially if associated with symptoms resembling allergic rhinitis) are more prone to attacks of bronchial asthma (so-called analgesic intolerance, aspirin asthma), angioedema and urticaria. For such patients, precautions are recommended (readiness for emergency medical care). This also applies to patients with allergies to other substances, manifested by skin reactions, itching or urticaria.
If any skin rash occurs, the drug should be discontinued. Patients should be advised to avoid excessive exposure to sunlight to reduce the likelihood of photosensitivity.
The drug Olfen Forte HYDROGEL should not be used under an airtight occlusive dressing, but it can be used under a non-occlusive dressing.
As a precautionary measure, it is necessary to ensure that children do not come into contact with areas of skin where the gel has been applied.
The drug Olfen Forte HYDROGEL contains propylene glycol (E 1520), which may cause mild localized skin irritation in some people, as well as butylhydroxytoluene (E 321), which may cause localized skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.
The medicinal product contains benzyl alcohol (0.15 mg/g), citral, citronellol, coumarin, eugenol, farnesol, geraniol, limonene, linalool, which may cause allergic reactions. Benzyl alcohol may cause mild local irritation.
Use during pregnancy or breastfeeding
Pregnancy. Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo-foetal development. Epidemiological studies have shown an increased risk of miscarriage and of cardiac malformations and gastroschisis following the use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiovascular malformations was increased from less than 1% to approximately 1.5%. It is assumed that the risk increases with dose and duration of treatment. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, an increased incidence of various malformations, particularly of the cardiovascular system, has been reported in animals treated with a prostaglandin synthesis inhibitor during organogenesis.
During the first and second trimesters of pregnancy, diclofenac should be used only if clearly needed. If diclofenac is used by a woman attempting to conceive, or during the first and second trimesters of pregnancy, the dose should be kept as low and the duration of treatment as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may affect the fetus in the following ways:
cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
renal dysfunction, which may progress to renal failure with oligohydramnios.
Effects on the mother and newborn, as well as at the end of pregnancy:
possible prolongation of bleeding time, antiplatelet effect, which can be observed even at very low doses;
inhibition of uterine contractions, leading to delayed or prolonged labor.
Therefore, the drug Olfen Forte HYDROGEL is contraindicated in the third trimester of pregnancy (see the section "Contraindications").
Breastfeeding. Like other NSAIDs, diclofenac passes into breast milk in small amounts. When using therapeutic doses of diclofenac, no negative effects on the infant are expected. No studies have been conducted in women during breastfeeding, so this drug should be used on the recommendation of a doctor. Therefore, if there are good reasons for using the gel during breastfeeding, it should not be applied to the mammary glands or large areas of skin and should not be used for a long time.
Ability to influence reaction speed when driving vehicles or other mechanisms
Topical application of diclofenac does not affect the ability to drive vehicles and other mechanisms.
Method of administration and doses
The medicine is intended for external use only.
Adults and children over 14 years of age should apply the medicine twice a day (morning and evening), lightly rubbing into the skin at the site of pain. The analgesic effect lasts up to 12 hours.
The amount of medicine used depends on the size of the affected area (for example, 2–4 g of gel, the size of a cherry or walnut, is enough to apply to an area of 400–800 cm2), the maximum daily dose of the medicine is 8 g (160 mg of diclofenac sodium, respectively).
After applying the product, it is necessary to wash your hands, except in cases where this is the area to be treated.
Before applying a bandage, you should let the gel dry for a few minutes.
The duration of therapy depends on the indication and effectiveness of the treatment. The drug should not be used for longer than 14 consecutive days for soft tissue injuries or rheumatism and for longer than 21 days for joint pain of arthritic origin, unless otherwise recommended by a doctor.
If after 7 days of treatment the patient's condition has not improved or worsens, it is necessary to consult a doctor.
Elderly patients do not require dose adjustment of the drug, however, due to possible adverse reactions, they require careful monitoring.
Patients with renal insufficiency and patients with hepatic insufficiency do not require dose adjustment of the drug.
Children. The drug Olfen Forte HYDROGEL is contraindicated for use in children under 14 years of age.
Overdose
Overdose is unlikely due to the low absorption of diclofenac into the systemic circulation when applied topically. If more gel than recommended is applied, the residue should be washed off with water.
In case of accidental ingestion of the drug, side effects characteristic of systemic adverse reactions of diclofenac may occur (the contents of one tube of the drug Olfen Forte HYDROGEL 100 g are equivalent to 2000 mg of diclofenac sodium).
In such a case, in case of development of significant systemic adverse reactions, it is necessary to apply therapeutic measures for treatment of poisonings with NSAIDs. After accidental ingestion of the drug, it is necessary to immediately wash out the stomach and take an adsorbent. There is no specific antidote.
Adverse reactions
The adverse reactions listed below are classified by system organ class and frequency. Frequency: very common (≥ 1/10); common (≥ 1/100, ≥ 1/1000, ≥ 1/10000, cannot be estimated from the available data).
Infections and infestations: Very rare: pustular eruptions.
Immune system disorders: Very rare: hypersensitivity reactions (including urticaria), angioedema.
Respiratory system: Very rare: bronchial asthma.
Gastrointestinal disorders: Very rare: gastrointestinal complaints.
Skin and connective tissue disorders: Common: dermatitis (including contact dermatitis), rash, erythema, eczema, pruritus. Uncommon: peeling, skin dehydration, oedema. Rare: bullous dermatitis. Very rare: photosensitivity. Frequency unknown: burning sensation at the application site, dry skin.
When applying the gel to large areas of skin and for a long time, the possibility of systemic adverse reactions to diclofenac (for example, from the kidneys, liver or gastrointestinal tract, systemic hypersensitivity reactions) cannot be ruled out.
Reporting of suspected adverse reactions.
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
Expiration date
2 years.
Do not use an open tube after the expiration date indicated on the package.
Storage conditions
The medicinal product does not require any special storage conditions. Store in the original packaging to protect from light. Keep out of the reach of children.
Packaging
30 g or 50 g or 100 g of gel in a tube; 1 tube in a cardboard box.
Vacation category
Without a prescription.
Producer
Merkle GmbH.
Location of the manufacturer and address of its place of business.
Graf-Arko Str. 3, 89079 Ulm, Germany.
