Flectorgo

Package Leaflet: Information for the User

Flectorgo, 12.5 mg, soft capsules

Flectorgo, 25 mg, soft capsules

Diclofenac epolamine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Flectorgo and what is it used for
• 2. Important information before taking Flectorgo
• 3. How to take Flectorgo
• 4. Possible side effects
• 5. How to store Flectorgo
• 6. Contents of the pack and other information

1. What is Flectorgo and what is it used for

Flectorgo contains the active substance diclofenac epolamine.
Flectorgo belongs to a group of non-steroidal anti-inflammatory drugs (NSAIDs). It is a pain reliever that can also reduce inflammation and swelling.
Flectorgo is used for the short-term relief of pain in the following situations:
mild to moderate pain (rheumatic pain, muscle pain, toothache, menstrual pain, and headache).

2. Important information before taking Flectorgo

When NOT to take Flectorgo:

• if you are allergic to: o diclofenac or any of the other ingredients of this medicine (listed in section 6); o diclofenac, acetylsalicylic acid or any other non-steroidal anti-inflammatory drug (NSAID).
• if you currently have stomach or duodenal ulcer (gastrointestinal)bleeding or perforation;
• if you have blood disorders of unknown cause;
• if you have had gastrointestinal bleeding or perforationin connection with previous NSAID treatment;
• if you have had two or more episodes of ulcerof the stomach or duodenum or gastrointestinal bleeding(including vomiting blood, bleeding during bowel movements, presence of fresh blood in stool or black, tarry stools);
• if you have been diagnosed with heart diseaseand (or) cerebrovascular disease, such as if you have had a heart attack, stroke, transient cerebral ischemia or vascular occlusion of the heart or brain, or have undergone surgery to open up a coronary artery or have had vascular prostheses implanted to bypass occlusions;

if you have circulatory disorders(peripheral arterial disease);

• if you have severe kidney, liver, or heart failure;
• if you are pregnant more than six months (see also "Pregnancy, breastfeeding, and fertility");
• if you are under 14 years of age.

If any of the above applies to you, tell your doctor or pharmacist.

Warnings and precautions

Before taking Flectorgo, discuss it with your doctor or pharmacist if:

• you think you may be allergic to diclofenac, acetylsalicylic acid, or any other NSAID, or any of the other ingredients of Flectorgo. Symptoms of hypersensitivity include swelling of the face and lips (angioedema), difficulty breathing, chest pain, runny nose, rash, or any other allergic reaction;
• you currently have or have had any stomach or intestinal disorders, including ulcerative colitis or Crohn's disease;
• you are elderly;
• you have kidney or liver disorders;
• you have porphyria;
• you have blood or coagulation disorders;
• you have had asthma;
• you are breastfeeding;
• you have angina, blood clots, high blood pressure, elevated cholesterol or triglycerides;
• you have diabetes;
• you smoke;
• you have recently undergone surgery;
• you are at risk of dehydration (e.g., due to vomiting or diarrhea);
• you have recently undergone or are scheduled to undergo stomach or intestinal surgery, as Flectorgo may sometimes cause weakening of the intestinal healing process after surgery. In such cases, Flectorgo may not be suitable for you.
• Because the medicine has anti-inflammatory effects, the active substance of Flectorgo may mask the symptoms of infection. If you feel unwell and need to seek medical attention, tell your doctor that you are taking Flectorgo.

Cardiovascular disease

Medicines like Flectorgo may cause a slight increase in the risk of heart attack ("myocardial infarction") or stroke. The risk is greater with higher doses and longer treatment duration. Do not exceed the recommended dose or treatment duration.
Before taking Flectorgo, tell your doctor:

• if you smoke,
• if you have diabetes,
• if you have angina, blood clots, high blood pressure, elevated cholesterol or triglycerides.

Side effects can be minimized by using the smallest effective dose for the shortest necessary time.

Children and adolescents

Children and adolescents under 14 years of age must not take Flectorgo (see also "When not to take Flectorgo").

Flectorgo and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

Before taking Flectorgo, consult your doctor if you are taking any of the following medicines:

• Digoxin (a heart-strengthening medicine), phenytoin (a medicine used to treat epilepsy) or lithium (a medicine used to treat mental disorders). Flectorgo may increase the levels of these substances in the blood.
• Diuretics and blood pressure-lowering medicines (diuretics and antihypertensives). Flectorgo may weaken the effect of these medicines.
• Potassium-sparing diuretics (certain diuretics). Flectorgo may increase potassium levels in the blood.
• Medicines used to treat heart failure and high blood pressure (ACE inhibitors and angiotensin II antagonists). Flectorgo may weaken the effect of these medicines and increase the risk of kidney problems.
• Anticoagulant medicines such as warfarin. Like other NSAIDs, Flectorgo may cause these medicines to work more strongly.
• Oral anti-diabetic medicines. In some cases, it may be necessary to adjust the dose of anti-diabetic medicines. Monitor blood glucose levels as a precaution.
• Other NSAIDs (used to treat pain and inflammation, e.g., ibuprofen, COX II inhibitors, and aspirin) or medicines containing corticosteroids. Flectorgo increases the risk of stomach ulcers and gastrointestinal bleeding.
• Platelet aggregation inhibitors, such as acetylsalicylic acid (aspirin) and certain antidepressants (selective serotonin reuptake inhibitors (SSRIs)). May increase the risk of gastrointestinal bleeding.
• Cyclosporin and tacrolimus (medicines used to prevent transplant rejection, but also used to treat rheumatic diseases or severe skin diseases). NSAIDs may enhance the harmful effects of cyclosporin and tacrolimus on the kidneys.
• Methotrexate. Taking Flectorgo within 24 hours before or after methotrexate may increase methotrexate levels in the blood and lead to increased side effects of this substance.
• Medicines used to treat gout containing sulfinpyrazone or voriconazole. May delay the elimination of Flectorgo, resulting in higher levels of Flectorgo in the body and increased side effects.
• Cholestyramine and colestipol. May cause delayed or reduced absorption of Flectorgo. It is recommended to take Flectorgo at least one hour before or 4 to 6 hours after administration of the other medicine.
• Quinolones (a type of antibiotic). There have been reports of single cases of seizures.
• Cardiac glycosides: Concomitant use with NSAIDs may worsen heart failure, reduce renal function, and increase serum glycoside levels.
• Mifepristone: Do not use NSAIDs for 8-12 days after mifepristone administration, as NSAIDs may reduce the effect of mifepristone.

Flectorgo with alcohol

Do not drink alcohol while taking Flectorgo. Alcohol may increase the possible side effects of Flectorgo, especially fatigue and dizziness, and affect the digestive tract.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a child, consult your doctor or pharmacist before taking this medicine.

Pregnancy

If you become pregnant while taking Flectorgo, tell your

doctor.Do not take Flectorgo during the last 3 months of pregnancy, as it may harm the unborn child or cause problems during delivery. Flectorgo may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in the mother and child and prolong labor. During the first 6 months of pregnancy, do not take Flectorgo unless your doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. From the 20th week of pregnancy, Flectorgo may cause kidney problems in the unborn child if taken for more than a few days. This may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for a longer period, your doctor may recommend additional monitoring.

Breastfeeding

Do not take Flectorgo while breastfeeding, as it may harm the baby. If you are breastfeeding, tell your doctor.

Fertility

Flectorgo belongs to a group of medicines (NSAIDs) that may affect female fertility. This effect is reversible after stopping the medicine.
Therefore, it is not recommended to take Flectorgo in women who are trying to conceive, have difficulty conceiving, or are undergoing investigations for infertility.

Driving and using machines

While taking Flectorgo, side effects such as vision disturbances, dizziness, dry mouth, excessive drowsiness, or other central nervous system disorders may occur. These effects are enhanced by alcohol.
Patients who experience these side effects should not drive or operate machinery.
This medicine contains a maximum of 8.02 mg and 10.07 mg of sorbitol, in each 12.5 mg and 25 mg capsule, respectively.
The medicine contains less than 1 mmol (23 mg) of sodium per dose unit, which means the medicine is considered "sodium-free".

3. How to take Flectorgo

Swallow the capsules whole with water.
To ensure the best possible effect of the medicine, take the capsules on an empty stomach.

Adults and children over 14 years:

It is important to use the smallest dose that controls the pain and not to take Flectorgo for longer than necessary.
Always take this medicine exactly as described in the patient information leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Flectorgo, 12.5 mg
Initially, take 1 or 2 soft capsules, and then, if necessary, take 1 or 2 soft capsules every 4 to 6 hours. Do not take more than 6 soft capsules (75 mg) in 24 hours.
Flectorgo, 25 mg
Initially, take 1 soft capsule, and then, if necessary, take 1 soft capsule every 4-6 hours. Do not take more than 3 soft capsules (75 mg) in 24 hours.
Do not take Flectorgo for more than 3 days. If symptoms persist or worsen, consult your doctor.

Taking a higher dose of Flectorgo than recommended

If you have taken more than the recommended dose of Flectorgo, tell your doctor or go to the nearest hospital emergency department immediately, taking the medicine packaging with you. You may need medical attention.

Missing a dose of Flectorgo

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next capsule at the usual time. Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Flectorgo 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 experience any of the following symptoms:

• severe stomach pain, nausea, vomiting;
• vomiting blood or black particles, black stools or blood in stool
• allergic reactions, such as skin rash, itching, swelling, appearance of red painful spots on the skin, skin peeling, or blisters;
• 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 fever, unusual bleeding or bruising;
• unusual changes in urine output or appearance;
• appearance of mild abdominal cramps and tenderness shortly after starting Flectorgo therapy, followed by rectal bleeding or bloody diarrhea usually within 24 hours of abdominal pain (frequency not known, cannot be estimated from available data).

Tell your doctor immediately if you experience any of the following symptoms:

• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome

Medicines like Flectorgo may cause an increased risk of heart attack ("myocardial infarction") or stroke.

The following side effects have also been reported:

Common (affects no more than 1 in 10 people)

• headache, dizziness
• nausea, vomiting, diarrhea, digestive disorders (indigestion), stomach pain, bloating, loss of appetite
• skin rash and itching

Uncommon (affects no more than 1 in 100 people)

• increased liver enzyme activity in the blood

Rare (affects no more than 1 in 1,000 people)

• hypersensitivity, anaphylactic, and pseudo-anaphylactic reactions (severe allergic reactions, including low blood pressure and shock)
• angioedema, including facial edema (angioedema)
• numbness
• bronchospasm (asthma), including shortness of breath (dyspnea)
• gastritis, stomach or duodenal ulcer (with or without bleeding or perforation)
• hepatitis, jaundice
• hives
• edema (fluid retention)

Very rare (affects no more than 1 in 10,000 people)

• disorders of red and white blood cell production
• disorientation, depression, insomnia, nightmares, irritability, psychotic disorders
• sensory disturbances (paresthesia), memory disorders, seizures or convulsions, anxiety, tremors, meningitis not related to infection, taste disorders
• vision disturbances, blurred or double vision
• tinnitus, hearing disorders
• palpitations, chest pain, heart failure (heart failure)
• high blood pressure (hypertension), vasculitis
• pneumonitis
• ulcerative colitis (colitis), including bleeding or worsening of Crohn's disease or ulcerative colitis, constipation
• stomatitis, glossitis, esophageal damage, formation of diaphragm-like strictures in the intestines, pancreatitis
• liver failure
• skin rash (including erythema and blisters), photosensitivity, small areas of bleeding on the skin, severe skin reactions such as blistering rash (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell's syndrome), hair loss
• acute kidney failure (renal failure), blood in urine (hematuria), protein in urine (proteinuria), nephrotic syndrome (fluid retention and high protein levels in urine), kidney tissue damage (interstitial nephritis, renal papillary necrosis)

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to:
Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Flectorgo

• Keep the medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month.
• Store in a temperature below 25°C.
• Store in the original packaging to protect from light and moisture.

6. Contents of the pack and other information

What Flectorgo contains

The active substance is diclofenac epolamine.
Flectorgo, 12.5 mg:
Each soft capsule contains 15.38 mg of diclofenac in the form of diclofenac epolamine, equivalent to 12.5 mg of diclofenac potassium.
Flectorgo, 25 mg:
Each soft capsule contains 30.76 mg of diclofenac in the form of diclofenac epolamine, equivalent to 25 mg of diclofenac potassium.
Other ingredients are:
Capsule contents:
Polyethylene glycol 600, anhydrous glycerol, purified water
Capsule shell:
Gelatin, anhydrous glycerol, sorbitol liquid partially dehydrated (E 420),
hydroxypropyl betadex, sodium hydroxide, purified water.

What Flectorgo looks like and contents of the pack

Flectorgo, 12.5 mg:
A transparent, yellowish, oval-shaped soft gelatin capsule, approximately 0.8 cm in size, containing a slightly sticky solution.
Flectorgo, 25 mg:
A transparent, yellowish, oval-shaped soft gelatin capsule, approximately 1 cm in size, containing a slightly sticky solution.
The soft capsules are packaged in blisters.
Pack sizes:
Flectorgo, 12.5 mg: 10, 20, 30, or 40 soft capsules.
Flectorgo, 25 mg: 10, 20, or 30 soft capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

IBSA Farmaceutici Italia S.r.l.
Via Martiri di Cefalonia 2,
26900 Lodi, Italy

Importer

IBSA Farmaceutici Italia srl
Via Martiri di Cefalonia, 2
26900 Lodi
Italy
Date of last revision of the leaflet:May 2023