Anti-inflammatory Dicloreum 10 Medical Patches 180mg

Local anti-inflammatory dicloreum is a non-steroidal anti-inflammatory drug for cutaneous use, it is used for the local treatment of painful and inflammatory conditions of a rheumatic or traumatic nature of joints, muscles, tendons and ligaments.

Contraindications

- Hypersensitivity to the active substance or to any of the excipients.
- Hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), as well as to isopropanol;
- Patients who have experienced asthma attacks, urticaria or acute rhinitis after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
- Damaged skin, regardless of the type of lesion: exudative dermatitis, eczema, infected lesion, burns or wounds.

Third trimester of pregnancy and breastfeeding (see "What to do during pregnancy and breastfeeding");

- Patients with active peptic ulcer. Children and adolescents :
Use in children and adolescents under the age of 16 is contraindicated.

Precautions for use

If diclofenac medicated plasters are used on large skin surfaces and for a prolonged period of time, the possibility of systemic adverse events cannot be excluded. The medicated plaster should only be applied to intact, healthy skin and should not be applied to broken skin or open wounds. The patches should not come into contact with the eyes or mucous membranes. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. Do not use with an occlusive dressing that does not allow air to pass. Treatment should be stopped immediately if a skin rash develops after applying the medicated plaster. Do not administer topically or systemically another diclofenac medicinal product or other NSAIDs at the same time. Although systemic effects are expected to be limited, the medicated plaster should be used with caution in patients with renal, cardiac or hepatic impairment, history of peptic ulcer or inflammatory bowel disease or bleeding diathesis. Non-steroidal anti-inflammatory drugs should be used with particular care in elderly patients who are more prone to side effects. This medicinal product contains methyl parahydroxybenzoate and propyl parahydroxybenzoate. It can cause allergic reactions (even delayed). It also contains propylene glycol, which can cause skin irritation. Patients should be advised not to expose themselves to direct sunlight or sunlamps for approximately one day after removal of the medicated plaster to reduce the risk of photosensitivity.

Which medicines or foods can change the effect of the medicine

Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
Since the systemic absorption of diclofenac following the use of medicated plasters is very low, the risk of developing clinically significant interactions with other medicinal products is negligible.

It is important to know that

The product should only be applied to intact and healthy skin and should not be applied when bathing or showering. The diclofenac medicated plaster should be used for the shortest possible time in relation to the indication for use.
When it can be used only after consulting your doctor
- Patients who have experienced asthma attacks, urticaria or acute rhinitis after taking acetylsalicylic acid or other non-steroidal inflammatory drugs (NSAIDs).
- Damaged skin, regardless of the type of lesion: exudative dermatitis, eczema, infected lesion, burns or wounds.
- Patients with peptic ulcer

It is advisable to consult the doctor even in cases in which these disorders have occurred in the past.

What to do during pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
The systemic concentration of diclofenac, compared with oral formulations, is lower after topical administration. Referring to the experience of treatment with NSAIDs for systemic administration, the following is recommended: Inhibition of prostaglandin synthesis may have adverse effects on pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk was believed 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 given 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.
Feeding time
Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, at therapeutic doses of diclofenac medicated plasters no effects on the suckling child are anticipated. 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, diclofenac medicated patches should not be applied to the breasts of nursing mothers, or elsewhere on large areas of skin or for an extended period of time (see "Precautions for use").

How to use this medicine

For cutaneous use only.
How many
-Apply one patch at a time
-Attention: do not exceed the indicated doses
When and for how long
Adults
The usual dosage regimen is 1 or 2 patches per day (one application every 12 or 24 hours) for up to 14 days. If no improvement is seen following the recommended treatment period, a doctor should be consulted.
Children and adolescents under the age of 16
The use of this medicated plaster is not recommended in children and adolescents under 16 years of age because there are insufficient data to evaluate the safety and efficacy of the medicine (see "When it should not be used").
In adolescents aged 16 years and over, if the product is required for a treatment period exceeding 7 days for pain relief or if symptoms worsen, the patient or the adolescent's relatives are advised to consult a physician. .
Senior citizens
This medicine should be used with caution in elderly patients as they are more prone to side effects (see "Precautions for use").
Patients with hepatic or renal insufficiency
For the use of diclofenac medicated plasters in patients with hepatic or renal insufficiency see the section "Precautions for use".
The diclofenac medicated plaster should be used for the shortest possible time in relation to the indication for use.
Such as
The product should only be applied to intact and healthy skin and should not be applied when bathing or showering. Cut the pouch containing the medicated plaster as indicated. Take out a medicated plaster, remove the plastic film used to protect the adhesive surface and apply the plaster on the joint or on the painful surface. If necessary, the patch can be held in place using an elastic band. Close the envelope carefully by pressing the edge where the drawstring is located. The patch must be used whole.

Side effects

Like all medicines, LOCAL ANTI-INFLAMMATORY CLOREUM can cause side effects, although not everybody gets them.
Stop taking LOCAL ANTI-INFLAMMATORY CLOREUM and tell your doctor or pharmacist immediately if you notice any of the following side effects:
Common (may affect up to 1 in 10 people)
- Rash, skin irritation (erythema), skin inflammation (eczema, dermatitis, including allergic dermatitis and contact dermatitis), itching
- Administration site reactions
Rare (may affect up to 1 in 1,000 people)
- Bullous dermatitis (eg bullous erythema), dry skin
Very rare (may affect up to 1 in 10,000 people)
- Hypersensitivity (including urticaria), anaphylactoid reaction (agitation, hypotension, nausea, etc.), generalized skin swelling
- Rash with raised skin (papules)
- Shortness or difficulty in breathing (asthma)
- Sensitivity reactions of the skin to exposure to sunlight (photosensitivity)

Expiry and retention

Expiry: see the expiry date shown on the package The expiry date refers to the product in intact packaging, correctly stored. Warning: do not use the medicine after the expiry date indicated on the package.
Store at a temperature not exceeding 30 ° C.
After the first opening, the product is valid for 3 months if the envelope containing the medicated plasters is properly resealed.
Keep this medicine out of the sight and reach of children.
It is important to always have the information on the medicine available, therefore keep both the box and the package leaflet.