Active ingredients: Diclofenac (Diclofenac sodium)
DOLAUT Gel for skin use at 4%
Why is Dolaut used? What is it for?
THERAPEUTIC DRUG CATEGORY
Anti-inflammatory - non-steroidal antirheumatic - Topical use
THERAPEUTIC INDICATIONS
Local treatment of painful and inflammatory conditions of a rheumatic or traumatic nature of the joints, muscles, tendons and ligaments.
Contraindications When Dolaut should not be used
Hypersensitivity to diclofenac or to any of the excipients.
Children and adolescents: Use in children and adolescents under the age of 14 is contraindicated. Patients who have experienced asthma attacks, urticaria or acute rhinitis after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs). ).
Third trimester of pregnancy.
Precautions for use What you need to know before taking Dolaut
The possibility of systemic adverse events with the application of topical diclofenac cannot be excluded if the preparation is used on large skin areas and for a prolonged period.
Therefore, particularly in patients with previous gastrointestinal diseases, the occurrence of systemic side effects such as nausea, dyspepsia, heartburn, excitation, taste alteration, conjunctivitis cannot be excluded for DOLAUT.
Topical diclofenac should only be applied to intact, non-diseased skin, and not to skin wounds or open lesions. It should not be allowed to come into contact with the eyes or mucous membranes and should not be ingested.
Discontinue treatment if skin rash develops after application of the product.
DOLAUT contains propylene glycol which may cause mild localized skin irritation in some people.
Topical diclofenac can be used with non-occlusive dressings, but should not be used with an occlusive dressing that does not allow air to pass.
External use.
Interactions Which drugs or foods can change the effect of Dolaut
Since the systemic absorption of diclofenac following topical application is very low, such interactions are very unlikely.
Warnings It is important to know that:
Pregnancy
The systemic concentration of diclofenac, compared with oral formulations, is lower after topical administration. Referring to experience with NSAID treatment for systemic administration, the following is recommended:
Inhibition of prostaglandin synthesis may adversely affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in early stages of pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk has been considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased pre- and post-implantation loss and embryo-fetal mortality.
In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, diclofenac should not be administered except in strictly necessary cases. If diclofenac is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low as possible and the duration of treatment as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to:
- cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension);
- renal dysfunction, which can progress to renal failure with oligo-hydroamnios;
the mother and the newborn, at the end of pregnancy, to:
- possible prolongation of bleeding time, and antiplatelet effect which may occur even at very low doses;
- inhibition of uterine contractions resulting in delayed or prolonged labor.
Consequently, diclofenac is contraindicated during the third trimester of pregnancy.
Breastfeeding
Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, no effects on the suckling child are anticipated at therapeutic doses of DOLAUT. Due to the lack of controlled studies in breastfeeding women, the product should only be used during breastfeeding under the advice of a healthcare professional. In this circumstance, DOLAUT should not be applied to the breast of nursing mothers, nor elsewhere on large areas. of skin or for an extended period of time.
KEEP OUT OF REACH OF CHILDREN.
After a short period of treatment, if symptoms persist, stop applying and consult your doctor.
The use, especially if prolonged, of products for topical use, can give rise to sensitization phenomena: in this case it is necessary to interrupt the treatment and consult the doctor to institute suitable therapy.
Dosage and method of use How to use Dolaut: Dosage
Adults over 18 years:
Apply Dolaut 3 or 4 times a day on the area to be treated, rubbing lightly. The amount to be applied depends on the size of the affected part. For example 3-5 sprays of Dolaut are sufficient to treat an area of 400-800 cm2. After application, wash your hands, otherwise they will also be treated with the gel.
Attention use only for short periods of treatment.
Wash and dry the painful area thoroughly
Three to five sprays, depending on the size of the area to be treated, three to four times a day.
Gently massage to promote absorption
Teenagers aged 14 to 18:
Apply Dolaut 3 or 4 times a day on the area to be treated, rubbing lightly. The amount to be applied depends on the size of the affected part. For example 3-5 sprays of Dolaut are sufficient to treat an area of 400-800 cm2. After application, wash your hands, otherwise they will also be treated with the gel.
If this product is needed for more than 7 days to relieve pain or if symptoms worsen, consult your doctor.
Senior citizens:
The usual adult dosage can be used.
Children under 14:
Insufficient data on efficacy and safety in children and adolescents under 14 years are available (see also section 4.3 Contraindications). Therefore the use of Dolaut is contraindicated in children below 14 years of age.
Overdose What to do if you have taken too much Dolaut
The low systemic absorption of topical diclofenac makes an overdose very unlikely. However, undesirable effects similar to those seen after an overdose of diclofenac tablets may be expected if topical diclofenac is inadvertently ingested (1 bottle of 25 g contains the equivalent of 1000 mg diclofenac sodium). In case of accidental ingestion resulting in significant systemic side effects, general therapeutic measures normally taken to treat poisoning with non-steroidal anti-inflammatory drugs should be undertaken. Gastric decontamination and the use of activated charcoal must be considered, especially within a short time of ingestion.
Side Effects What are the side effects of Dolaut
DOLAUT is generally well tolerated. Adverse reactions are listed by frequency, most frequent first, using the following convention: common (≥ 1/100 to <1/10); uncommon (≥ 1 / 1,000 to <1/100); rare (≥ 1 / 10,000, <1 / 1,000); very rare (<1 / 10,000); Not known: cannot be estimated from the available data.
Compliance with the instructions contained in this leaflet reduces the risk of undesirable effects.
Notify your doctor or pharmacist of any particular symptoms not described in this package leaflet.
Expiry and Retention
See the expiration date indicated on the package.
The validity period is intended for the product in intact packaging, correctly stored. Warning: do not use the drug beyond the expiration date shown on the package.
QUALI-QUANTITATIVE COMPOSITION
Each 100 g. of gels contain:
Active principle: Diclofenac sodium 4 g
Excipients : Propylene glycol, Isopropyl alcohol, Ethyl alcohol, Soy lecithin, Sodium phosphate dihydrate, Disodium phosphate dodecahydrate, Disodium edetate, Ascorbyl palmitate, Mint essence, Purified water.
PHARMACEUTICAL FORM AND PACKAGING
4% skin gel:
4% Gel bottle with dispenser of 25 g.
4% Gel bottle with 15 g dispenser.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
DOLAUT MONO 14 MG MEDICATED PATCH
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One patch measuring 100 x 70 mm (70 cm2) contains 14 mg of piroxicam.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Medicated plaster.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
DOLAUT MONO is indicated for the treatment of painful and inflammatory conditions of a rheumatic and traumatic nature of the joints, muscles, tendons and ligaments.
04.2 Posology and method of administration
It is recommended to use only one medicated plaster at a time and replace it every 24 hours for a period not exceeding 8 days. Do not apply two patches in the same day.
DOLAUT MONO is to be used exclusively on intact skin. After having thoroughly washed and dried the painful area, rub one of the corners of DOLAUT MONO between your fingers to remove the protective film and apply the adhesive part directly on the skin.
In the event that DOLAUT MONO has to be applied to joints with greater mobility, such as the elbow or knee, it is advisable to use a retention bandage to be applied to the flexed joint, in order to keep the patch in place.
Do not exceed the recommended doses.
04.3 Contraindications
Hypersensitivity to the active substance (piroxicam) or to any of the excipients.
Patients in whom substances with a similar mechanism of action (NSAIDs) have caused hypersensitivity reactions (see section 4.4)
DOLAUT MONO is contraindicated in patients with active peptic ulcer, patients with bronchial asthma, a history of gastrointestinal haemorrhage from NSAIDs.
Patients on anticoagulant therapy.
Pregnancy and lactation (see section 4.6).
Children under the age of 12
DOLAUT MONO 14 mg medicated plaster should not be used on open wounds or lesions, but only on intact skin. Avoid contact with eyes and mucous membranes.
04.4 Special warnings and appropriate precautions for use
The serum levels achieved with DOLAUT MONO were significantly lower than those obtained by oral administration but with a strong individual variability so the onset of systemic undesirable effects, especially at the gastrointestinal level, cannot be excluded.
Analgesics, antipyretics, non-steroidal anti-inflammatory drugs, including piroxicam, can cause hypersensitivity reactions, potentially serious even in subjects not previously exposed to this type of drug. These include asthma attacks, skin rashes, allergic rhinitis and anaphylactic-type reactions.
DOLAUT MONO should be used with caution in subjects with chronic obstructive diseases of the bronchi, allergic rhinitis or inflammation of the nasal mucosa (nasal polyps) in which asthma attacks or localized inflammatory reactions of the skin and mucosa (Quincke's edema) are more frequent. .
Use caution in patients with a history of peptic ulcer, in patients with a history of gastrointestinal bleeding not secondary to NSAID administration or with other bleeding disorders, in patients with Crohn's disease or ulcerative colitis, with severe liver or kidney dysfunction or heart failure.
Prolonged or repeated use of products for cutaneous use can give rise to sensitization phenomena. In the presence of hypersensitivity reactions, it is necessary to interrupt the therapy.
Caution should be exercised when treating elderly patients who are generally more predisposed to adverse events.
After a short therapy without results, consult your doctor.
To avoid any hypersensitivity or photosensitization phenomena, avoid exposure to direct sunlight.
Keep this medicine out of the reach and sight of children.
04.5 Interactions with other medicinal products and other forms of interaction
The use of piroxicam-based patches is unlikely to have interactions with other medicinal products. However, the possibility of competition between absorbed piroxicam and other drugs with high plasma protein binding cannot be excluded.
Do not use the product together with other drugs for oral or local use, containing piroxicam or other NSAIDs.
04.6 Pregnancy and lactation
DOLAUT MONO is contraindicated during pregnancy and breastfeeding and is not recommended in women intending to become pregnant. Administration should be suspended in women with fertility problems or who are undergoing fertility investigations.
04.7 Effects on ability to drive and use machines
DOLAUT MONO does not affect the ability to drive and use machines.
04.8 Undesirable effects
The use of the product may cause local irritative or allergic skin reactions such as erythema, itching, burning, contact dermatitis, numbness and tingling at the application site; cases of extensive and severe dermatological lesions have been reported with this type of medicines. urticaria, Quincke's edema, erythema multiforme More extensive and more severe photosensitivity reactions and skin and mucosal reactions are possible, including asthma attacks.
Undesirable systemic reactions following the topical use of piroxicam are unlikely; since the plasma levels obtained are lower than those measured after systemic administration but highly variable from individual to individual, it is not possible to exclude, especially in the case of prolonged therapies beyond recommended term and non-compliance with contraindications and warnings, the appearance of systemic undesirable effects, especially at the gastrointestinal level (see sections 4.4 and 5.2).
Any appearance of general or application site side effects requires discontinuation of therapy.
04.9 Overdose
There are no known cases of overdose.
In case of overdose with evident clinical manifestations, immediately institute symptomatic therapy and apply the necessary common emergency measures.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Topical drugs for joint and muscle pain.
ATC code: M02AA07.
DOLAUT MONO is a medicated plaster based on piroxicam, a non-steroidal anti-inflammatory drug with a strong anti-inflammatory and analgesic action. The pharmacological effects are mainly due to the inhibition of prostaglandinsynthetase.
The activity of the active principle administered topically in the various models of acute and chronic inflammation occurs even in the presence of reduced plasma levels.
05.2 "Pharmacokinetic properties
The application of DOLAUT MONO to healthy volunteers for 8 consecutive days confirmed that the systemic absorption is, on average, significantly lower than oral administration but with a strong individual variability; the levels of piroxicam in plasma can only be determined after the second-third application and reach a plateau value around the sixth day. As with other forms of piroxicam for topical use, with the use of DOLAUT MONO the mean systemic bioavailability of piroxicam was not greater than 1/10 of that of oral piroxicam.
05.3 Preclinical safety data
Toxicological tests performed on various animal species have shown that topical piroxicam is well tolerated and lacks teratogenic and mutagenic activity.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Acrylic copolymer, Eudragit E 100; non-woven fabric, silicone-coated polyester.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
Carton containing 8 laminated pouches, each pouch contains 1 medicated plaster of 14 mg.
Carton containing 4 laminated pouches, each pouch contains 1 medicated plaster of 14 mg.
06.6 Instructions for use and handling
Any unused product or waste material must be disposed of in accordance with local regulations in force.
07.0 MARKETING AUTHORIZATION HOLDER
Therabel GiEnne Pharma S.p.A. - Via Robert Koch, 1/2 - 20152 Milan
08.0 MARKETING AUTHORIZATION NUMBER
Box containing 8 patches - A.I.C. 038353025
Box containing 4 patches - A.I.C. 038353013
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
First authorization: 13/05/2009
Last renewal: 13/05/2014
10.0 DATE OF REVISION OF THE TEXT
December 5, 2014
