DICLOFENAC TE*5CER MED 140MG

Diclofenac Teva 140 mg medicated plasters
Diclofenac sodium

What it is and what it is used for
Diclofenac Teva is a pain-relieving medicine. It belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs).

Diclofenac Teva is used for short-term treatment, for symptomatic local relief of acute pain associated with muscle strains, sprains, or bruises of the arms and legs resulting from non-penetrating trauma.
For cutaneous use only.

What you need to know before taking the medicine
Do not use Diclofenac Teva
- If you are allergic to diclofenac, propylene glycol, butylhydroxytoluene, or any of the excipients of this medicine (listed in section 6).
- If you are allergic to any other non-steroidal anti-inflammatory drug (NSAID, e.g., acetylsalicylic acid, ibuprofen).
- If you have experienced asthma, skin swelling, or swelling and irritation inside the nose after taking acetylsalicylic acid or other NSAIDs.
- If you suffer from active peptic ulcer.
- On broken skin (e.g., skin abrasions, cuts, burns), infected skin, or skin with eczema.
- During the last three months of pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before taking Diclofenac Teva
- If you suffer or have suffered in the past from bronchial asthma or allergies, you may experience a cramp in the bronchi (bronchospasm), which manifests as difficulty breathing.
- If a skin rash appears; immediately remove the medicated plaster and stop the treatment.
- If you suffer from kidney, heart, or liver dysfunction, or if you suffer or have suffered in the past from gastrointestinal ulcer, intestinal inflammation, or a tendency to bleeding.

Side effects can be minimized by using the lowest effective dose for the shortest possible treatment duration.

IMPORTANT precautions:
- If symptoms persist for more than 3 days, you should contact your doctor.
- Do not use the medicated plaster on the eyes or mucous membranes and avoid contact with these parts.
- The product should only be applied to intact and healthy skin and should not be kept on when bathing or showering.

Avoid exposing the treated area to direct sunlight or sunlamps for about one day after removing Diclofenac Teva, in order to reduce the risk of photosensitivity.

Do not use other diclofenac or other NSAID-based medicines simultaneously, either topically or systemically.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience the following symptoms, tell your doctor immediately and stop using the plaster:
sudden itchy skin rash (urticaria); swelling of the hands, feet, ankles, face, lips, mouth, or throat; difficulty breathing; low blood pressure or weakness.

The following side effects may occur:

Common (may affect up to 1 in 100 people): application site reactions, rash, eczema, skin redness, dermatitis (including allergic dermatitis and contact dermatitis), skin swelling, itching, and burning sensations.

Uncommon (may affect up to 1 in 1,000 people): generalized rash, hypersensitivity reactions (including urticaria), swelling of mucous membranes, generalized excessive allergic reaction.

Rare (may affect up to 1 in 10,000 people): bullous dermatitis, dry skin.

Very rare (may affect less than 1 in 10,000 people): asthma attack, severe eczema, pustular exanthema, ulcerative skin rash, photosensitivity reaction.

Frequency unknown (cannot be estimated from the available data): hematoma at the application site.

The absorption of diclofenac into the body through the skin is very low, and the concentration of diclofenac in the blood is also very low compared to the concentration of the active substance in the blood after oral intake. Therefore, the likelihood of systemic side effects (such as gastrointestinal, liver, or kidney disorders, bronchospasm) is very low after topical application compared to the frequency of side effects associated with the oral use of diclofenac. However, if diclofenac is used on large skin surfaces and for long periods of time, systemic side effects may occur.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-averse.
By reporting side effects, you can help provide more information on the safety of this medicine.