Flector 180 mg - 5 medicated patches for joint and muscle pain

Product Description

Self-adhesive medicated plaster with analgesic and anti-inflammatory action, with a constant release of the active ingredient for up to 12 hours. With Hydrogel Technology, it acts rapidly and in a targeted manner to combat back pain.

Indications

Flector 180 mg medicated plaster from Ibsa Farmaceutici is based on Diclofenac, a nonsteroidal anti-inflammatory active ingredient for cutaneous use. The combination of Diclofenac with epolamine salt facilitates the absorption and concentration of the active ingredient in the area affected by pain and inflammation, promoting a rapid but prolonged anti-inflammatory and analgesic pharmacological action. When applied to the painful area, it provides rapid and targeted relief from pain and inflammation, thanks to the gradual and constant release of the active ingredient for up to 12 hours. The Flector medicated plaster is composed of three layers: a transparent protective film that is removed before application, a self-adhesive hydrogel layer containing the active ingredient, and a fabric layer that provides flexibility to the medicated plaster, providing the necessary comfort for the skin. Thanks to its reticular structure, the hydrogel retains a high amount of water (approximately 45%), which, upon evaporation, creates a cryogenic effect on the skin, allowing the active ingredient to permeate through the skin through osmosis. It is also useful when applied to delicate or sensitive skin because it is free of irritating solvents. If necessary, it can be easily removed and repositioned (the pharmacological action will last up to 12 hours from the first application).

Details

• Solvent-free self-adhesive: Flector is a self-adhesive medicated plaster: thanks to Hydrogel technology, the use of organic solvents (such as toluene, hexane, isopropanol) to make the plaster adhesive is avoided. Furthermore, thanks to the high water content of the Hydrogel, the medicated plaster provides a cooling effect upon application and continuous hydration of the skin.
• It works where it's needed: Flector acts locally, directly on the area affected by inflammation.
• Constant release: Flector continuously and consistently releases the active ingredient throughout the day (up to 12 hours).

Composition

Active ingredients

The active ingredient is diclofenac hydroxyethylpyrrolidine. One medicated plaster contains: 180 mg of diclofenac hydroxyethylpyrrolidine (equivalent to 140 mg of diclofenac sodium).

Excipients

The other ingredients are: gelatin, polyvinylpyrrolidone, sorbitol 70% solution, kaolin, titanium dioxide, propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, disodium edetate, tartaric acid, dihydroxyaluminium aminoacetate, sodium carboxymethylcellulose, sodium polyacrylate, 1-3 butylene glycol, polysorbate 80, perfume, purified water, synthetic felt, plastic film.

Directions for use and dosage

Flector plaster is applied to the skin (cutaneous use).

• Cut the sachet containing the medicated plasters and take one plaster;
• Remove the protective film protecting the adhesive side of the plaster;
• Apply the entire plaster to the affected area. If necessary, the plaster can be secured with the elastic mesh bandage provided in the package. Do not cover the treated area with plastic or airtight (occlusive) dressings.
• Carefully reseal the pouch.

Apply Flector only to healthy skin without lesions or open wounds.
Avoid contact with eyes or mucous membranes.
The medicated plaster should not be wet: bathing or showering between applications is recommended.

Adults over 18 years of age: The usual dose is 1 or 2 patches per day, every 12 or 24 hours, for a maximum of 14 days. The entire patch should be used. Consult your doctor if you do not feel better or if you feel worse after 14 days of treatment.

Adolescents over 16 years of age: Consult your doctor if you do not feel better or if you feel worse after 7 days of treatment.

Children and adolescents under 16 years of age: Do not use Flector on children or adolescents under 16 years of age.

Elderly people: Use this medicine with caution as elderly people are more susceptible to side effects.

Patients with hepatic or renal impairment: For the use of diclofenac medicated plasters in patients with hepatic or renal impairment, see the section "Warnings and precautions".

Warnings

Talk to your doctor or pharmacist before using Flector if:

• you have breathing problems such as asthma, allergic nasal inflammation (allergic rhinitis),
  nasal polyps, or bronchial disease;
• you have heart, liver, or kidney problems;
• you have had a stomach or duodenal (peptic) ulcer;
• you have suffered from inflammatory bowel disease;
• you are prone to bleeding (haemorrhagic diathesis);
• you are elderly, as you are more likely to experience side effects.

Do not expose yourself to direct sunlight or sunlamps (tanning lamps) for at least one day after removing the patch; This will reduce the risk of experiencing an adverse reaction to light (photosensitivity).

Like other topical medicines, especially with prolonged use, Flector may cause redness and itching (sensitivity reactions). Stop treatment and contact your doctor or pharmacist if you experience skin reactions at the application site while using this patch.

Side effects can be minimized by using the lowest effective dose for the shortest duration necessary. Do not exceed the recommended dose of Flector, do not apply it to large areas of skin, and do not take it for long periods.

Interactions with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, tell your doctor if you are taking other medicines containing diclofenac or other NSAIDs.

Contraindications

Do not use Flector:

• if you are allergic to diclofenac hydroxyethylpyrrolidine, acetylsalicylic acid, or other NSAIDs;
• if you are allergic to any of the other ingredients of this medicine (listed in section 6);
• during the last three months of pregnancy (see “Pregnancy, breastfeeding, and fertility”);
• if you have a stomach or duodenal (peptic) ulcer;
• if the skin where you want to apply the patch is damaged or has lesions (exudative dermatitis,
  eczema, infections, burns, or wounds);
• if you have had asthma, hives, or inflammation of the nose (acute rhinitis) after using medicines containing acetylsalicylic acid or other NSAIDs.

Do not use Flector in children and adolescents under 16 years of age.

Side effects

Like all medicines, Flector can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people)

• Skin rash and redness (eczema, erythema), inflammation of the skin (dermatitis, including allergic and contact dermatitis), itching at the site of the patch application.

Rare side effects (may affect up to 1 in 10 people) 1,000)

• Inflammation of the skin with blistering (bullous dermatitis).
• Dryness of the skin.

Very rare side effects (may affect up to 1 in 10,000 people)

• Symptoms due to allergic reactions: hives, swelling (angioedema) of the face, eyes, lips, and throat with difficulty breathing.
• Skin lesions after exposure to the sun (photosensitivity reaction).
• Asthma.
• Inflammation of the skin with the presence of pus (rash with pustules).

Since Flector patch is applied directly to the affected area, the risk of side effects affecting the whole body (systemic), such as stomach or intestinal problems, is low. is lower than taking diclofenac by mouth.

If medicated plasters are used incorrectly, on large areas of skin, or for a very long period of time, these effects may still occur. If medicated plasters are used in combination with other medicines containing diclofenac, the likelihood of skin reactions, including after sun exposure, such as blistering, erythema, and eczema, increases. In rare cases, even serious reactions may occur, such as rashes with redness, blistering, and peeling (e.g., Stevens-Johnson syndrome, Lyell syndrome).

Overdose

Do not exceed the dose of Flector and do not apply it to large areas of skin. Use Flector for as short a time as possible. Talk to your doctor if you notice no improvement or if your symptoms worsen after a short period of treatment.

If you use more Flector than you should, you may experience systemic side effects, such as stomach or intestinal problems. If this happens, tell your doctor immediately or go to the nearest hospital, as appropriate measures may be necessary.

If you forget to use Flector
Do not apply an extra patch to make up for a forgotten patch.

Pregnancy, breastfeeding, and fertility

• Pregnancy: If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice. He or she will decide whether you should use Flector. Do not use Flector during the last three months of pregnancy, as it may damage the fetus's circulation or kidneys and delay or prolong labor.
• Breastfeeding: There are insufficient data available in breastfeeding women. If you are breastfeeding, ask your doctor for advice, who will decide whether to use Flector. While breastfeeding, do not apply the patch to the breasts, large areas of skin, or for prolonged periods.
• Fertility: If you have problems conceiving and are using Flector, tell your doctor, as it may be appropriate to stop treatment.