FLECTORGO 25 MG SOFT CAPSULES 20 CAPSULES IN PVC/PE/PVDC/AL BLISTER

Name
FLECTORGO 12.5 mg soft capsules
FLECTORGO 25 mg soft capsules
Diclofenac epolamine
Equivalent medicine



What is it and what is it for?
FLECTORGO contains the active substance diclofenac epolamine .

FLECTORGO is a medicine that belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs). This medicine is a pain reliever that can also reduce inflammation and swelling.

FLECTORGO is used for the short-term symptomatic treatment of mild to moderate pain (such as headache, toothache, menstrual pain, rheumatic pain and muscle pain) in adults and adolescents aged 14 years and over.


What you need to know before taking the medicine
DO NOT take FLECTORGO:
• if you are allergic to diclofenac epolamine or any of the other ingredients of this medicine (listed in section 6)
• if you have suffered from allergic reactions including swelling of the face and mouth (angioedema), breathing problems, chest pain, runny nose, skin rash or any other allergic-type reaction following the use of acetylsalicylic acid or any other non-steroidal anti-inflammatory drug (NSAID)
• if you currently have a gastric (stomach) or duodenal (intestine) ulcer , bleeding or perforation
• if you have alterations of unknown origin in the production of blood cells
• if you have a history of bleeding or perforation in the digestive tract , related to previous NSAID therapy
• if you have had two or more episodes of gastric (stomach) or duodenal (intestine) ulcers or bleeding in the digestive tract (including blood in vomiting, bleeding during bowel movements, fresh blood in stools or black, tarry stools)
• if you suffer from a known heart disease and/or cerebrovascular disease , for example if you have had a heart attack, a stroke, a mini-stroke (transient ischemic attack - TIA) or a blockage of the blood vessels leading to the heart or brain or if you have had surgery to remove or avoid such blockages
• if you suffer or have suffered from blood circulation problems (peripheral arterial disease)
• if you have severe kidney or liver failure
• if you are in the last three months of pregnancy (see also "Pregnancy, breastfeeding and fertility")


Warnings and precautions
Talk to your doctor or pharmacist before taking FLECTORGO if:
• suffer or have suffered from any stomach or intestinal disorder, including ulcerative colitis or Crohn's disease
• he is old
• have kidney or liver problems
• has a condition called porphyria
• suffer from any blood or bleeding disorder
• has ever had asthma
• is breastfeeding
• suffer from angina pectoris, blood clots, high blood pressure, high cholesterol or triglyceride levels
• has diabetes
• is a smoker
• has recently undergone surgery
• is at risk of dehydration (e.g. from illness or diarrhea)
• have had or are about to have surgery on your stomach or intestinal tract before taking Flectorgo, as Flectorgo can sometimes worsen wound healing in your intestine following surgery.

• Since FLECTORGO is an anti-inflammatory medicine, the active substance may mask the signs and symptoms of an infection. If you feel unwell and need to see a doctor, don't forget to tell your doctor that you are taking FLECTORGO.

Cardiovascular disease
Medicines like FLECTORGO may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.

Make sure your doctor knows before you are given FLECTORGO:
• if she smokes
• if you suffer from diabetes
• if you suffer from angina pectoris, blood clots, high blood pressure, increased cholesterol or increased triglycerides

Undesirable effects can be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.

Children and adolescents
FLECTORGO is not recommended for children and adolescents under 14 years of age.


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

Some side effects can be serious.

Stop taking FLECTORGO and tell your doctor immediately if you notice any of the following side effects:
• sharp pain in the upper abdomen, feeling sick, feeling unwell
• vomiting blood or black particles, black stools or blood in the stool
• allergic reactions such as rash, itching, bruising, painful red areas, peeling or blistering
• wheezing or shortness of breath (bronchospasm), difficulty swallowing, collapse
• swelling of the face, lips, hands or fingers
• yellowing of the skin or eyes
• persistent sore throat or high temperature, unusual bleeding or bruising
• unexpected change in the amount of urine produced and/or its appearance
• mild cramps and tenderness in the abdomen, which begin shortly after starting treatment with FLECTORGO and are followed by bleeding from the rectum or bloody diarrhoea, usually within 24 hours of the onset of abdominal pain (frequency not known, frequency cannot be estimated from the available data).

Tell your doctor immediately if you notice any of the following reactions:
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome

Medicines such as FLECTORGO may be associated with an increased risk of heart attack ("myocardial infarction") or stroke.

The following side effects have also been reported:

Common (may affect up to 1 in 10 people)
• Headache, dizziness, vertigo
• Nausea, vomiting, diarrhoea, digestive disorders (dyspepsia), abdominal pain, flatulence, loss of appetite
• Rash and itching

Uncommon (may affect up to 1 in 100 people)
• Increased liver enzyme values ​​in the blood

Rare (may affect up to 1 in 1,000 people)
• Hypersensitivity, anaphylactic and anaphylactoid reactions (serious allergic reactions, including drop in blood pressure and shock)
• Allergic swelling including facial edema (angioedema)
• Drowsiness
• Feeling of constriction of the airways (asthma) including shortness of breath (dyspnea)
• Inflammation of the stomach (gastritis), gastric (stomach) or duodenal (intestine) ulcer (with or without bleeding or perforation)
• Hepatitis (inflammation of the liver), jaundice
• Hives
• Edema (fluid retention in the body)

Very rare (may affect up to 1 in 10,000 people)
• Disorders of red and white blood cell formation
• Disorientation, depression, insomnia, nightmares, irritability, psychotic reactions
• Sensitivity disturbances (paraesthesia), memory impairment, seizures or spasms, anxiety, tremor, meningitis not associated with an infection, taste disturbance
• Visual disturbance, blurred or double vision
• Noises in the ear (tinnitus), impaired hearing
• Palpitations, chest pain, weakness of the heart muscle (heart failure)
• High blood pressure (hypertension), inflammation of the blood vessels (vasculitis)
• Inflammation of the lungs (pneumonia)
• Inflammation of the colon (colitis), including bleeding and worsening of Crohn's disease or ulcerative colitis, constipation
• Inflammation of the oral mucosa (stomatitis), inflammation of the tongue, esophageal lesions (damage to the esophagus), formation of membranous strictures in the intestine, inflammation of the pancreas (pancreatitis)
• Liver failure
• Skin rash (including eczema and blisters), sensitivity to light, small areas of bleeding in the skin, severe skin reactions such as rash with blistering (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell's syndrome), hair loss
• Acute kidney dysfunction (renal failure), blood in the urine (hematuria), protein in the urine (proteinuria), nephrotic syndrome (fluid retention in the body and high levels of protein passing into the urine), kidney tissue damage (interstitial nephritis, papillary necrosis)

Reporting of side effects
If you experience 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-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.