Instructions for Olfen medical patch 140 mg/12 hours package No. 10
Composition
active ingredient: diclofenac sodium;
1 patch contains diclofenac sodium 140 mg/12 hours per 140 cm2;
excipients: macrogol lauryl ether, diisopropyl adipate, glycerol (E 422), propylene glycol, sorbitol crystallizing solution (E 420), sodium polyacrylate, carmellose sodium (E 466), basic butyl methacrylate copolymer, colloidal anhydrous silicon dioxide, light natural kaolin, anhydrous sodium sulfite (E 221), disodium edetate, dibutylhydroxytoluene (E 321), dry aluminum potassium sulfate, tartaric acid (E 334), L-menthol, purified water;
base: non-woven fabric (EL-8100S), polypropylene film.
Dosage form
Medical plaster.
Main physical and chemical properties: white to light brown paste, applied to non-woven fabric. The surface of the paste is covered with a transparent polymer film.
Pharmacotherapeutic group
Nonsteroidal anti-inflammatory drugs for topical use. ATC code M02A A15.
Pharmacological properties
Pharmacodynamics.
Olfen®, a therapeutic patch, is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic properties, intended for topical use. The therapeutic effect is due to the inhibitory effect of diclofenac sodium on prostaglandin synthesis.
When using Olfen®, a medical patch, topically, the active substance penetrates the skin, reaching the subcutaneous tissues, and has an analgesic, anti-inflammatory effect, reducing tissue swelling. When using Olfen®, a medical patch, in patients with significant sports injuries, the drug demonstrated an effective analgesic effect compared to placebo.
Pharmacokinetics.
The concentration of diclofenac in the tissues is maintained by constant penetration from the patch and does not depend on the time of day. The average concentration of the substance in the blood plasma is approximately 3 ng/ml.
The mechanism of metabolism and elimination of diclofenac after topical application corresponds to that after oral administration of diclofenac sodium preparations. The half-life is 1-2 hours.
Indication
Local short-term treatment:
inflammation of tendons, ligaments, muscles and joints of traumatic etiology, for example, with sprains of ligaments and tendons, dislocations, bruises;
localized forms of rheumatism of soft tissues and joints.
Contraindication
Hypersensitivity to diclofenac, acetylsalicylic acid, other nonsteroidal anti-inflammatory drugs, analgesics or to any component of the drug. History of attacks of bronchial asthma, urticaria or acute rhinitis caused by taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs. Exacerbation of gastric and duodenal ulcers, open skin lesions, burns, skin infections or eczema, III trimester of pregnancy.
Interaction with other medicinal products and other types of interactions
Systemic absorption of diclofenac when used correctly with Olfen®, a medical patch, is very low compared to oral administration, so interactions with other drugs are unlikely.
Application features
Olfen®, a medical plaster, should not be applied to open wounds (e.g. scratches, cuts) or eczematous areas of the skin. Avoid contact with eyes and mucous membranes.
If after 3 days of treatment the patient's condition has not improved or worsens, a doctor should be consulted.
To reduce the risk of side effects, the minimum effective dose of diclofenac sodium should be used for the shortest possible period of treatment.
In patients with a history of allergy or bronchial asthma, bronchospasm may occur when using NSAIDs.
If any skin rashes appear after using Olfen®, a medical patch, treatment with the drug should be discontinued.
Direct sunlight or solarium radiation should be avoided at the site of application for approximately 1 day to reduce the risk of photosensitivity.
Although the risk of systemic adverse reactions is minimal, Olfen®, a medical patch, should be used with caution in patients with impaired renal, cardiac or hepatic function, with a history of gastric and duodenal ulcer, intestinal phlegmon or hemorrhagic diathesis.
Elderly patients should use NSAIDs with caution due to a greater susceptibility to side effects.
Olfen®, a medical plaster, contains propylene glycol and dibutylhydroxytoluene. Propylene glycol may cause skin irritation. Dibutylhydroxytoluene may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.
It is not recommended to use any other NSAIDs or medicines containing diclofenac while using Olfen®, a medicated patch.
Use during pregnancy or breastfeeding.
There are no adequate clinical data on the use of diclofenac topically during pregnancy. Even though systemic exposure after topical application is lower than after oral administration, it is not known whether the systemic exposure achieved after topical application could be harmful to the embryo/foetus.
Animal studies have shown reproductive toxicity after systemic administration of the drug.
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 after use of prostaglandin synthesis inhibitors in early pregnancy. This risk is believed to increase with increasing dose and duration of therapy.
During the first and second trimesters of pregnancy, this medicine should not be used unless clearly necessary. If used during the first and second trimesters of pregnancy, the dose should be kept as low as possible and the duration of treatment as short as possible.
3rd trimester
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors, including diclofenac, may:
cause in the fetus:
cardiopulmonary toxicity (with premature closure of the ductus arteriosus and development of pulmonary hypertension);
renal dysfunction, progressing to renal failure with oligohydramnios, renal toxicity;
cause in the mother at the end of pregnancy and the newborn:
prolonged bleeding – an effect associated with inhibition of platelet aggregation, which can occur even when taking very low doses of the drug;
Inhibition of uterine muscle contractions, which leads to delayed or prolonged labor.
Therefore, the drug Olfen®, a medical patch, is contraindicated in the third trimester of pregnancy.
Breast-feeding
A small amount of diclofenac and its metabolites pass into breast milk. The decision on the use of the drug during breastfeeding is made by the doctor if there are good reasons for its use, when the expected benefit of treatment outweighs the potential risk. Olfen®, a medical patch, should not be applied to the mammary glands or large areas of skin and should not be used for a long time.
The ability to influence the reaction speed when driving vehicles or other mechanisms.
A negative effect is unlikely.
Interaction with other medicinal products and other types of interactions
Systemic absorption of diclofenac when used correctly with Olfen®, a medical patch, is very low compared to oral administration, so interactions with other drugs are unlikely.
Application features
Olfen®, a medical plaster, should not be applied to open wounds (e.g. scratches, cuts) or eczematous areas of the skin. Avoid contact with eyes and mucous membranes.
If after 3 days of treatment the patient's condition has not improved or worsens, a doctor should be consulted.
To reduce the risk of side effects, the minimum effective dose of diclofenac sodium should be used for the shortest possible period of treatment.
In patients with a history of allergy or bronchial asthma, bronchospasm may occur when using NSAIDs.
If any skin rashes appear after using Olfen®, a medical patch, treatment with the drug should be discontinued.
Direct sunlight or solarium radiation should be avoided at the site of application for approximately 1 day to reduce the risk of photosensitivity.
Although the risk of systemic adverse reactions is minimal, Olfen®, a medical patch, should be used with caution in patients with impaired renal, cardiac or hepatic function, with a history of gastric and duodenal ulcer, intestinal phlegmon or hemorrhagic diathesis.
Elderly patients should use NSAIDs with caution due to a greater susceptibility to side effects.
Olfen®, a medical plaster, contains propylene glycol and dibutylhydroxytoluene. Propylene glycol may cause skin irritation. Dibutylhydroxytoluene may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.
It is not recommended to use any other NSAIDs or medicines containing diclofenac while using Olfen®, a medicated patch.
Use during pregnancy or breastfeeding
I and II trimesters
There are no adequate clinical data on the use of diclofenac topically during pregnancy. Even though systemic exposure after topical application is lower than after oral administration, it is not known whether the systemic exposure achieved after topical application could be harmful to the embryo/foetus.
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 after use of prostaglandin synthesis inhibitors in early pregnancy. This risk is believed to increase with increasing dose and duration of therapy.
During the first and second trimesters of pregnancy, this medicine should not be used unless clearly necessary. If used during the first and second trimesters of pregnancy, the dose should be kept as low as possible and the duration of treatment as short as possible.
3rd trimester
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors, including diclofenac, may:
cause in the fetus:
cardiopulmonary toxicity (with premature closure of the ductus arteriosus and development of pulmonary hypertension);
renal dysfunction, progressing to renal failure with oligohydramnios, renal toxicity;
cause in the mother at the end of pregnancy and the newborn:
prolonged bleeding – an effect associated with inhibition of platelet aggregation, which can occur even when taking very low doses of the drug;
Inhibition of uterine muscle contractions, which leads to delayed or prolonged labor.
Therefore, the drug Olfen®, a medical patch, is contraindicated in the third trimester of pregnancy.
Breast-feeding
A small amount of diclofenac and its metabolites pass into breast milk. The decision on the use of the drug during breastfeeding is made by the doctor if there are good reasons for its use, when the expected benefit of treatment outweighs the potential risk. Olfen®, a medical patch, 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
A negative effect is unlikely.
Method of administration and doses
The patch is applied to the affected area of the body. Apply 1 patch 2 times a day, morning and evening. Before use, remove the transparent film that protects the surface of the patch. The patch cannot be separated. Do not use the patch with an occlusive dressing.
If necessary, the patch is fixed with an elastic bandage. One medical patch is designed for continuous use for 12 hours.
Only 1 patch should be applied to one affected area at a time. The maximum daily dose is 2 patches, even if it is necessary to apply the patch to more than one area.
The patch should be used for the shortest possible period.
The duration of treatment should not exceed 7 days.
Children
The efficacy and safety of Olfen®, a medicated patch, in children under 18 years of age have not been studied.
Overdose
No cases of overdose have been recorded.
If systemic side effects occur due to incorrect use or accidental overdose of Olfen®, a medical patch, appropriate measures should be taken, as in the case of intoxication with oral nonsteroidal anti-inflammatory drugs.
Side effects
Skin and subcutaneous fat
Common: redness, itching, burning sensation, erythema, skin rash, sometimes with pustules or blisters.
Uncommon: hypersensitivity reactions, local allergic reactions including contact dermatitis.
Frequency unknown: Generalized skin rashes, hypersensitivity reactions including angioedema, anaphylactic reactions, photosensitivity reactions have been observed in patients receiving topical NSAIDs.
When using Olfen®, a medical patch, on large areas for a long period, the appearance of systemic side effects (such as kidney or gastrointestinal diseases, bronchospasm) cannot be ruled out, but the risk of their occurrence is very low compared to those with oral use of drugs containing diclofenac sodium.
Expiration date
30 months.
Shelf life after first opening the package is 4 months at a temperature not exceeding 25 °C; 6 months at a temperature of 2-8 °C (in a refrigerator).
Storage conditions
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
No. 2: 2 patches per package, 1 package per box.
No. 5: 5 patches per package, 1 package per box.
No. 10: 5 patches per package, 2 packages per box.
Vacation category
Without a prescription.
Producer
Merkle GmbH.
Address
Ludwig-Merkle-Strasse 3, 89143 Blaubeuren, Germany.
