Ilmodol joint and muscle pains - 10 medicated plasters

Product Description

Anti-inflammatory patches for muscle and joint pain.

Indications

Ilmodol Joint and Muscle Pain are patches for the local symptomatic treatment of rheumatic or traumatic pain and inflammation of joints, muscles, tendons and ligaments.

Composition

Active ingredients
Each medicated plaster measuring 10 cm x 14 cm contains a total of 180 mg of Diclofenac Epolamina equivalent to 140 mg of Diclofenac Sodium.

Excipients
Backing layer: non-woven polyester backing.
Adhesive layer (active gel): gelatin, povidone (K90), liquid sorbitol (non-crystallizable), heavy kaolin, titanium dioxide (E171), glycol Propylene glycol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), disodium edetate, tartaric acid, aluminum glycinate, sodium carmellose, sodium polyacrylate, 1,3-butylene glycol, polysorbate 80, purified water.
Protective layer: polypropylene film.

Directions for use and Dosage

For cutaneous use only.
Dosage: One patch in the most painful area once or twice a day.
Duration of administration: Ilmodol joint and muscle pain should be used for as long as possible. short time possible.
The maximum duration of treatment is 14 consecutive days.

Elderly: This medicine should be used with caution in elderly patients as they are more susceptible to side effects.
Children and adolescents under 16 years: There are insufficient data on the safety and efficacy of the medicine in children and adolescents under 16 years of age.
In adolescents aged 16 years and over, if the product is needed for a treatment period longer than 7 days for pain relief or if the symptoms worsen, the patient/parents of the adolescent are advised to consult a doctor.

Method of administration: Cut the sachet containing the medicated plaster as indicated.
Extract a medicated plaster, remove the plastic film used to protect the adhesive surface and apply the plaster to the painful joint or surface.
If necessary, the plaster can be removed. be held in place with an elastic mesh bandage. Carefully close the pouch with the sliding closure.
The patch must be used whole.

Warnings

The medicated plaster should be applied only to intact, healthy skin and should not be applied to broken skin or open wounds, and should not be applied while bathing or showering.
The medicated plaster should not come into contact with or be applied to mucous membranes or eyes.
Do not use with an occlusive dressing.
Treatment should be discontinued immediately if a rash develops after applying the medicated plaster.
Do not administer another medicinal product containing Diclofenac or other NSAIDs topically or systemically at the same time.
The possibility of systemic adverse events produced by the application of topical Diclofenac cannot be ruled out. be excluded if the preparation is used for a prolonged period.
Although systemic effects may be minimal, the patch should be used with caution in patients with impaired renal, cardiac or hepatic function, with a history of peptic ulcer, intestinal inflammation or haemorrhagic diathesis.
Nonsteroidal anti-inflammatory drugs should be used with particular caution in elderly patients, as they are more susceptible to the onset of adverse effects.
This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.
They may cause allergic reactions (possibly delayed).
It also contains propylene glycol, which may cause skin irritation.
Patients should be advised not to expose themselves to direct sunlight or sunlamps in order to reduce the risk of photosensitivity.
Bronchospasm may occur. be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease or allergy to acetylsalicylic acid or other NSAIDs.
The medicated plaster should be used with caution in patients with or without chronic asthma in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or other nonsteroidal anti-inflammatory agents.
In order to minimize the occurrence of adverse effects, it is recommended to use the lowest effective dose for the longest duration. short as necessary to control symptoms, without exceeding the approved maximum of 14 days.

Contraindications

This medicine is contraindicated in the following cases:

• Hypersensitivity to Diclofenac, acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs).
  Patients who have had asthma attacks, urticaria or acute rhinitis triggered by acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs).
• Damaged skin, regardless of the type of lesion: exudative dermatitis, eczema, infected lesion, burns or wounds.
• From the beginning of the sixth month of pregnancy (Pregnancy and breastfeeding).
• Patients with active peptic ulcer.
• Children and adolescents under 16 years of age years.

Interactions

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.

Undesirable effects

Adverse reactions (Table 1) are listed by frequency, the most common first. frequent, using the following convention:

• very common (>1/10);
• common (>1/100, <1/10);
• uncommon (>1/1,000, <1/100);
• rare (>1/10,000, <1/1,000);
• very rare (<1/10,000);
• not known: frequency cannot be estimated from the available data.

The systemic absorption of Diclofenac is very low when compared to the plasma levels measured after oral intake of Diclofenac and the probability of systemic side effects (such as gastric, hepatic and renal disorders) is very low compared to the frequency of side effects associated with oral use of Diclofenac.
However, if Ilmodol joint and muscle pain is used on large areas of skin and for long periods of time, systemic side effects may occur.

Pregnancy and Breastfeeding

Pregnancy:
The systemic concentration of Diclofenac, compared to oral formulations, is lower after topical administration.
With reference 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%, up to approximately 1.5%.
The risk was considered to increase with dose and duration of therapy.
In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss and embryo-fetal mortality.
Furthermore, 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 trimesters of pregnancy, Diclofenac should not be administered unless clearly necessary. necessary.
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 may expose the fetus to:

• cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
• renal dysfunction, which may progress to renal failure with oligohydramnios;

the mother and the neonate, at the end of pregnancy, to:

• possible prolongation of bleeding time, and antiaggregant effect which may increase the risk of serious complications. 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, at therapeutic doses of Diclofenac medicated plaster, no effects on the infant are expected.
Due to the lack of controlled studies in breastfeeding women, the product should be used during breastfeeding only under the advice of a healthcare professional.
In this circumstance, Ilmodol joint and muscle pain should not be applied to the breasts of nursing mothers, nor elsewhere on large areas of skin or for a prolonged period of time.

Format

10 medicated plasters