Patient Information Leaflet

FLECTORGO 12.5 mg soft capsules, 25 mg soft capsules

Diclofenac epolamine
Generic medicine
Please read all of this leaflet carefully before you take this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, contact your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.

Contents of this leaflet:

What FLECTORGO is and what it is used for
What you need to know before taking FLECTORGO
How to take FLECTORGO
Possible side effects
How to store FLECTORGO
Contents of the pack and other information

1. What FLECTORGO is and what it is used for

FLECTORGO contains the active substance diclofenac epolamine.
FLECTORGO is a medicine that belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs). This medicine is a pain reliever that can also reduce inflammation and swelling.
FLECTORGO is used to provide short-term symptomatic relief in the following conditions:
mild to moderate pain (such as headache, toothache, menstrual pain, rheumatic pain, and muscle pain).

2. What you need to know before taking FLECTORGO

DO NOT take FLECTORGO:

if you are allergic to diclofenac epolamine or to any of the other ingredients of this medicine (listed in section 6), or to diclofenac, acetylsalicylic acid, or any other non-steroidal anti-inflammatory drug (NSAID). Signs of an allergic reaction include asthma, breathing difficulties, rash, swelling of the face and mouth, or runny nose
if you currently have a gastric (stomach) or duodenal (intestinal) ulcer, bleeding, or perforation
if you have blood cell production disorders of unknown origin
if you have a history of bleeding or perforation in the gastrointestinal tract related to previous NSAID therapy
if you have had two or more episodes of gastric (in the stomach) or duodenal (in the intestine) ulcer or gastrointestinal bleeding (including blood in vomit, bleeding during bowel movements, fresh blood in stools, or black, tarry stools)
if you have established heart disease and/or cerebrovascular disease, for example, if you have had a heart attack, stroke, mini-stroke (transient ischemic attack - TIA), or blockage of blood vessels supplying the heart or brain, or surgery to remove or prevent such blockages
if you suffer or have suffered from circulatory problems (peripheral arterial disease)
if you have severe kidney, liver, or heart failure
if you are more than six months pregnant (see also "Pregnancy, breastfeeding and fertility")
if you are under 14 years of age.

If any of the above situations apply to you, consult your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking FLECTORGO if:

you suffer or have suffered from any stomach or intestinal disorder, including ulcerative colitis or Crohn's disease
you are elderly
you have kidney or liver problems
you have a condition called porphyria
you suffer from any blood disorder or bleeding condition
you have ever had asthma
you are breastfeeding
you suffer from angina, blood clots, high blood pressure, high cholesterol or triglyceride levels
you have diabetes
you are a smoker
you have recently undergone surgery
you are at risk of dehydration (e.g. due to illness or diarrhea). In these cases, FLECTORGO may not be the right medicine for you.
As an anti-inflammatory medicine, the active ingredient in FLECTORGO may mask the signs and symptoms of infection. If you feel unwell and need to see a doctor, do not forget to tell them that you are taking FLECTORGO.

Cardiovascular disease
Medicines such as FLECTORGO may be associated with a slight increase in the risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely with higher doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
Ensure your doctor knows before FLECTORGO is prescribed to you:

if you smoke
if you have diabetes
if you suffer from angina, blood clots, high blood pressure, high cholesterol, or high triglycerides

Adverse effects can be minimized by using the lowest effective dose for the shortest necessary duration.
Children and adolescents
Children and adolescents under 14 years of age must not take FLECTORGO (see also "Do not take FLECTORGO").
Other medicines and FLECTORGO
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Ask your doctor for advice before taking FLECTORGO if you are using any of the following medicines:

Digoxin (a medicine to strengthen the heart), phenytoin (a medicine to treat epilepsy), or lithium (a medicine to treat mental disorders). FLECTORGO may increase blood levels of these substances.
Diuretics and medicines to lower blood pressure (diuretics and antihypertensives). FLECTORGO may reduce the effect of these medicines.
Potassium-sparing diuretics (a specific type of diuretic). FLECTORGO may increase potassium levels in the blood.
Medicines for heart failure and high blood pressure (ACE inhibitors and angiotensin II antagonists). FLECTORGO may reduce the effectiveness of these medicines and may also increase the risk of kidney dysfunction.
Anticoagulant medicines such as warfarin. Like other NSAIDs, FLECTORGO may enhance the effect of these medicines.
Oral antidiabetic medicines. In some cases, dosage adjustment of antidiabetic medicines may be necessary. As a precaution, blood glucose levels should be monitored.
Other NSAIDs (used for pain and inflammation, e.g. ibuprofen, COX-2 inhibitors, and aspirin) or medicines containing glucocorticoids. FLECTORGO increases the risk of gastrointestinal ulcers or bleeding.
Platelet aggregation inhibitors such as acetylsalicylic acid (aspirin) and certain antidepressants (selective serotonin reuptake inhibitors or SSRIs). These may increase the risk of gastrointestinal bleeding.
Cyclosporine and tacrolimus (medicines used to prevent transplant rejection, but also for treating rheumatic diseases or severe skin conditions). NSAIDs may increase kidney-related adverse effects caused by cyclosporine and tacrolimus.
Methotrexate. Using FLECTORGO within 24 hours before or after methotrexate may increase methotrexate blood levels and lead to increased adverse effects of this substance.
Medicines for gout containing sulfinpyrazone or voriconazole. These may delay the elimination of FLECTORGO, resulting in higher concentrations of DAHILO in the body and increased adverse effects.
Colestipol and cholestyramine. These may delay or reduce the absorption of FLECTORGO. It is recommended to take FLECTORGO at least one hour before or 4–6 hours after the other medicine.
Quinolones (a type of antibiotic). Isolated cases of seizures have been reported.
Cardiac glycosides: concomitant use with NSAIDs may worsen heart failure, reduce renal filtration, and increase plasma levels of cardiac glycosides.
Mifepristone: NSAIDs should not be used for 8–12 days after mifepristone administration, as they may reduce its effectiveness.

FLECTORGO and alcohol
While taking FLECTORGO, you must not drink alcohol. Alcohol may increase the possible adverse effects of FLECTORGO, particularly fatigue and dizziness, and gastrointestinal effects.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
If you become pregnant while using FLECTORGO, you must inform your doctor. During the first six months of pregnancy, you may use FLECTORGO only after discussing it with your doctor. During the last three months of pregnancy, FLECTORGO must not be used due to increased risk of complications for both mother and baby.
Breastfeeding
FLECTORGO must not be taken if you are breastfeeding, as it could be harmful to the newborn. Inform your doctor if you are breastfeeding.
Fertility
FLECTORGO belongs to a group of medicines (NSAIDs) that may affect female fertility. This effect is reversible when the medicine is discontinued.
Therefore, the use of FLECTORGO is not recommended for women attempting to conceive, experiencing difficulty conceiving, or undergoing infertility investigations.
Driving and using machines
When using FLECTORGO, adverse effects such as visual disturbances, dizziness, drowsiness, feeling sleepy, or other central nervous system disorders may occur. These effects are increased when combined with alcohol.
If you experience these effects, you must not drive or operate machinery.
FLECTORGO contains sorbitol (E420)
If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.

3. How to take FLECTORGO

Swallow the capsules whole with a glass of water.
To ensure the medicine works as effectively as possible, take the capsule on an empty stomach.
Adults and adolescents aged 14 years and older:
It is important that you use the lowest dose that controls your pain and that you do not take FLECTORGO for longer than necessary.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you. If you have any doubts, consult your doctor or pharmacist.
For FLECTORGO 12.5 mg
Initially take 1 or 2 soft capsules, and subsequently, if needed, 1 or 2 soft capsules every 4–6 hours.
In any case, do not take more than 6 soft capsules (75 mg) within 24 hours.
For FLECTORGO 25 mg
Initially take 1 soft capsule, and subsequently, if needed, 1 soft capsule every 4–6 hours.
In any case, do not take more than 3 soft capsules (75 mg) within 24 hours.
FLECTORGO must not be taken for more than 3 days. If symptoms persist or worsen, consult your doctor.
If you take more FLECTORGO than you should
If you accidentally take too much, inform your doctor immediately or go straight to the nearest emergency department, taking the medicine pack with you.
You may need medical treatment.
If you forget to take FLECTORGO
If you forget a dose, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose and take the next capsule at your usual time. Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some side effects may be serious.
Stop taking FLECTORGO and contact your doctor immediately if you experience:

severe pain in the upper abdomen, feeling unwell, general malaise
vomiting blood or black particles, black stools or blood in stools
allergic reactions such as skin rash, itching, bruising, painful red areas, skin 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 (jaundice)
persistent sore throat or high temperature, unusual bleeding or bruising
unexpected change in the amount or appearance of urine produced
mild abdominal cramps and tenderness, starting shortly after beginning treatment with FLECTORGO, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours after the onset of abdominal pain (frequency not known, frequency cannot be estimated from the available data).

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, indigestion (dyspepsia), abdominal pain, flatulence, loss of appetite
Skin rash and itching

Uncommon (may affect up to 1 in 100 people)

Increased liver enzyme levels in blood

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

Hypersensitivity, anaphylactic and anaphylactoid reactions (severe allergic reactions, including drop in blood pressure and shock)
Allergic swelling including facial oedema (angioedema)
Drowsiness
Feeling of tightness in the chest (asthma), including shortness of breath (dyspnoea)
Inflammation of the stomach (gastritis), gastric (stomach) or duodenal (intestinal) ulcer (with or without bleeding or perforation)
Hepatitis (inflammation of the liver), jaundice
Urticaria
Oedema (fluid retention in the body)

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

Disorders in the formation of red and white blood cells
Confusion, depression, insomnia, nightmares, irritability, psychotic reactions
Sensory disturbances (paraesthesia), memory impairment, seizures or spasms, anxiety, tremor, non-infectious meningitis, taste disturbances
Visual disturbances, blurred or double vision
Ringing in the ears (tinnitus), impaired hearing
Palpitations, chest pain, weakness of the heart muscle (heart failure)
High blood pressure (hypertension), inflammation of blood vessels (vasculitis)
Inflammation of the lungs (pneumonitis)
Inflammation of the colon (colitis), including bleeding and worsening of Crohn's disease or ulcerative colitis, constipation
Inflammation of the mouth lining (stomatitis), inflammation of the tongue, oesophageal lesions (damage to the oesophagus), formation of membrane-like constrictions in the intestine, inflammation of the pancreas (pancreatitis)
Liver failure
Skin rash (including eczema and blisters), light sensitivity, small areas of bleeding under 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 (kidney failure), blood in urine (haematuria), protein in urine (proteinuria), nephrotic syndrome (fluid retention in the body and high levels of protein in urine), kidney tissue damage (interstitial nephritis, papillary necrosis)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store FLECTORGO

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

6. Package contents and other information

What FLECTORGO contains
The active substance is diclofenac epolamine.
For FLECTORGO 12.5 mg
Each soft capsule contains diclofenac in the form of 15.38 mg of diclofenac epolamine, equivalent
to 12.5 mg of potassium diclofenac.
For FLECTORGO 25 mg
Each soft capsule contains diclofenac in the form of 30.76 mg of diclofenac epolamine, equivalent
to 25 mg of potassium diclofenac.
The other components are:
Capsule contents:
Macrogol 600, anhydrous glycerol, purified water
Capsule shell:
Gelatin, anhydrous glycerol, partially dehydrated liquid sorbitol (E420), hydroxypropylbetadex,
sodium hydroxide, purified water.

Description of the appearance of FLECTORGO and package contents
For FLECTORGO 12.5 mg
Oval-shaped, transparent, yellowish soft gelatin capsule approximately 0.8 cm in size, containing a slightly viscous solution.
For FLECTORGO 25 mg
Oval-shaped, transparent, yellowish soft gelatin capsule approximately 1 cm in size, containing a slightly viscous solution.
The soft capsules are packaged in blisters.
For FLECTORGO 12.5 mg
Pack sizes: 10, 20, 30 or 40 soft capsules.
For FLECTORGO 25 mg
Pack sizes: 10 or 20 soft capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
IBSA Farmaceutici Italia S.r.l., Via Martiri di Cefalonia, 2, 26900 Lodi