Flectorflam

Package leaflet: Information for the patient

FLECTORFLAM 50 mg granules for oral solution

Diclofenac hydroxyethylpyrrolidine
Read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT FLECTORFLAM IS AND WHAT IT IS USED FOR

FLECTORFLAM contains the active substance diclofenac hydroxyethylpyrrolidine and belongs to the class
of medicines used against pain and inflammation (non-steroidal anti-inflammatory drugs, NSAIDs). Other NSAIDs
include aspirin and ibuprofen.
FLECTORFLAM is used for the symptomatic treatment of conditions such as:

• inflammations of the joints (such as rheumatoid arthritis, periarthritis) or of the muscles (fibromyositis);
• joint pain due to gout;
• pain due to osteoarthritis;
• back pain.

Consult your doctor if, while using FLECTORFLAM, you do not feel better or feel worse after
a short period of treatment.

2. What you need to know before taking FLECTORFLAM

Do not take FLECTORFLAM:

• if you are allergic to the active substance (diclofenac), to aspirin, ibuprofen, or other NSAIDs;
• if you are allergic to any of the other ingredients of this medicine (listed in section 6);
• if you have a stomach or intestinal (gastrointestinal) ulcer, bleeding, or perforation;
• if you have previously experienced stomach or intestinal bleeding or perforation caused by taking NSAIDs;
• if you have had two or more separate episodes of stomach or duodenal (peptic) ulcers or bleeding, or intestinal bleeding (including blood in vomit or stool, or black, tarry stools);

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• if you have previously experienced asthma, hives, or nasal inflammation (acute rhinitis) caused by taking NSAIDs or aspirin;
• if you have severe liver problems;
• if you have severe kidney problems;
• if you have heart disease (established cardiopathy) or cerebrovascular disease (e.g., if you have had a heart attack, stroke, mini-stroke (TIA), blockage of blood vessels to the heart or brain, or have undergone surgery to remove or prevent such blockages);
• if you suffer or have suffered from blood circulation problems (peripheral arterial disease);
• if you currently have bleeding, blood clotting disorders, or are taking medications that thin the blood (anticoagulants);
• if you are taking diuretic medications at high doses or in combination (intensive diuretic therapy);
• from the sixth month of pregnancy or while breastfeeding.

FLECTORFLAM must not be used in children and adolescents under 14 years of age.
Be careful with FLECTORFLAM
Talk to your doctor before taking FLECTORFLAM if:

• you think you may be allergic to diclofenac, aspirin, ibuprofen, or any other NSAID, or to any other component of FLECTORFLAM. (A list of ingredients is available at the end of this leaflet.) Signs of hypersensitivity reactions include swelling of the face and mouth (angioedema), breathing difficulties, chest pain, runny nose, skin rash, or any other allergic-type reaction.
• you have previously had ulcers or bleeding in the stomach or duodenum (peptic) or intestine, symptoms of which may include blood in vomit or stool, or black, tarry stools;
• you have intestinal diseases, including ulcerative colitis or Crohn's disease;
• you have or have had kidney problems;
• you have liver problems (e.g., hepatic porphyria);
• you have suffered or suffer from blood disorders;
• you suffer or have suffered from asthma, chronic obstructive bronchopneumopathy (COPD), nasal polyps, or allergic rhinitis;
• you are planning a pregnancy, as FLECTORFLAM may interfere with fertility.
• you have recently undergone or are about to undergo surgery on the stomach or intestinal tract before receiving/using/taking FLECTORFLAM, since FLECTORFLAM may sometimes impair wound healing in the intestine after surgery.

Warnings and precautions

• Medicines such as FLECTORFLAM may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk increases with higher doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment. Before taking FLECTORFLAM, make sure your doctor knows:
• if you smoke;
• if you have diabetes;
• if you suffer from chest pain (angina), blood clots (hematological), high blood pressure, high cholesterol, or high triglycerides.
• FLECTORFLAM is an anti-inflammatory medicine and may reduce symptoms of infection such as headache or fever. If you do not feel well and need to see a doctor, remember to inform them that you are taking FLECTORFLAM.
• Elderly patients are more likely to experience adverse effects associated with FLECTORFLAM: inform your doctor if you experience unusual symptoms.

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BE CAREFUL because:

• during treatment with all anti-inflammatory drugs (NSAIDs), at any time and with or without warning symptoms, even in patients without previous serious stomach or intestinal (gastrointestinal) problems, bleeding, ulceration, or perforation of the stomach or intestine may occur, which can be fatal;
• very rarely, severe skin reactions, some of which have been fatal, have been reported, manifesting as redness, blistering, and skin peeling (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis). During the initial phase of therapy, patients appear to be at higher risk: such reactions mostly occur within the first month of treatment.

Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary. Do not exceed the dose of FLECTORFLAM or take it for long periods; always follow your doctor's instructions carefully.
STOP treatment and contact your doctor if:

• you notice any stomach or intestinal (gastrointestinal) symptoms, especially if they involve bleeding;
• a skin rash, mucosal lesions, or any other sign of an allergic reaction appears (e.g., redness, itching, swelling of the face and throat, sudden drop in blood pressure).

Other medicines and FLECTORFLAM
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription (e.g., over-the-counter medicines or recreational substances). Some medicines may interfere with your treatment.
Inform your doctor if you are taking any of the following medicines:

• other NSAIDs or cyclooxygenase-2 (COX-2) inhibitors, such as aspirin or ibuprofen (painkillers);
• antidiabetic agents;
• anticoagulants (blood thinners such as warfarin or heparin);
• antiplatelet agents (to prevent blood clot formation);
• diuretics (medicines that increase urine flow);
• lithium (a medicine used to treat certain types of depression);
• phenytoin (a medicine used to treat epilepsy);
• cardiac glycosides (e.g., digoxin; medicines for heart problems);
• methotrexate (a medicine used for certain types of inflammation and cancer);
• cyclosporine (used for certain types of inflammation and as an immunosuppressant after organ transplants);
• quinolone antibiotics (medicines used to treat certain infections);
• steroids (medicines for inflammation and treatment of immune system disorders);
• colestipol (a medicine used to lower cholesterol);
• cholestyramine (a medicine used to lower cholesterol and treat liver problems and Crohn's disease);
• sulfinpyrazone (a medicine used to treat gout);
• voriconazole (a medicine used to treat fungal infections);
• medicines for heart failure or hypertension, such as beta-blockers or ACE inhibitors;
• anxiolytics or antidepressants known as selective serotonin reuptake inhibitors (SSRIs).

Pregnancy, breastfeeding, and fertility
Consult your doctor or pharmacist before taking any medicine.
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• FLECTORFLAM may make it difficult to conceive. Inform your doctor if you have difficulty conceiving.
• If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor, who will assess whether FLECTORFLAM should be used.
• Do not take FLECTORFLAM during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your and your baby's tendency to bleed and may delay or prolong labor more than expected. You should not take FLECTORFLAM during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is needed during this period or during attempts to conceive, the lowest possible dose for the shortest possible time should be used. From week 20 of pregnancy onwards, FLECTORFLAM may cause kidney problems in the fetus if taken for more than a few days, reducing the levels of amniotic fluid surrounding the baby (oligohydramnios), or cause narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for more than a few days is required, your doctor may recommend additional monitoring.
• Do not take FLECTORFLAM if you are breastfeeding, as it may cause adverse effects in the nursing infant.

Driving and using machines
FLECTORFLAM may cause dizziness, vertigo, drowsiness, visual disturbances, or nervous system disorders. Avoid driving or operating machinery if you experience any of these symptoms.
FLECTORFLAM contains:
sorbitol: this medicine contains 1.703 mg of sorbitol per sachet, equivalent to 3.406 mg for the recommended daily dose of 2 sachets. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic condition in which patients cannot properly metabolize fructose, consult your doctor before taking this medicine.
aspartame: this medicine contains 50 mg of aspartame per sachet, equivalent to 100 mg for the recommended daily dose of 2 sachets. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.

3. HOW TO TAKE FLECTORFLAM

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Adults and adolescents over 14 years of age: 1 sachet of FLECTORFLAM, twice daily (at
breakfast and dinner). Dissolve the granules in half a glass of water and take it with food.
Elderly patients: Your doctor may prescribe a lower dose than the recommended adult dose if you are elderly.
Children: Do not use in children under 14 years of age.
If you take more FLECTORFLAM than you should, you may experience the following symptoms: vomiting,
gastrointestinal bleeding, diarrhea, dizziness, tinnitus (ringing, buzzing, whistling, or other persistent
sounds in the ears), and seizures. In more severe cases, kidney or liver damage may occur (symptoms
include difficulty urinating or increased urination, muscle cramps, fatigue, swelling of the hands, feet and face, nausea or vomiting, yellowing of the skin (jaundice)).
In case of overdose, contact your doctor immediately or go to the nearest hospital, as appropriate measures
(e.g. activated charcoal, gastric lavage) may be necessary.
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If you forget to take FLECTORFLAM
Do not take a double dose to make up for the missed dose.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, FLECTORFLAM may cause adverse reactions, although not everyone experiences them.
Some adverse reactions can be serious.

Stop taking FLECTORFLAM and inform your doctor immediately if you notice:

• Mild abdominal cramps and tenderness occurring shortly after starting treatment with FLECTORFLAM, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of the onset of abdominal pain (frequency not known, cannot be estimated from available data).

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

• Severe allergic reactions, including: swelling (angioedema) of the face, throat or tongue, breathing difficulties, shortness of breath, and skin rash possibly accompanied by a sudden drop in blood pressure (anaphylactic and anaphylactoid reactions);
• Stomach or intestinal pain due to ulceration or perforation;
• Any signs of bleeding in the stomach or intestines (gastrointestinal haemorrhage), such as blood during bowel movements (haemorrhagic diarrhoea), blackish stools (melena), blood in vomit (haematemesis), or unusual fatigue with reduced urine output (due to non-visible bleeding);
• Severe skin rashes, redness and pain, blistering rash or skin peeling (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis);
• Liver problems, which may cause nausea, loss of appetite, general malaise, abdominal pain, yellowing of the skin or whites of the eyes (jaundice), and possible signs of liver failure or necrosis, or hepatitis (including fulminant hepatitis);
• Unusual changes in the amount and/or appearance of urine produced: presence of blood in the urine (haematuria), which may indicate serious kidney problems (papillary necrosis, nephrotic syndrome), kidney inflammation (interstitial nephritis), impaired kidney function (acute renal failure), or loss of protein in the urine (proteinuria);
• Heart attack (myocardial infarction) or stroke, high blood pressure (hypertension), reduced heart function (heart failure), palpitations, chest pain, inflammation of blood vessels (vasculitis);
• Inflammation of the meninges (aseptic meningitis), presenting with neck stiffness, headache, nausea, vomiting, fever or confusion, and extreme sensitivity to light.

Other adverse reactions
Common adverse reactions (may affect up to 1 in 10 people)

• Nausea, vomiting, diarrhoea, intestinal gas (flatulence), indigestion (dyspepsia), abdominal pain, loss or reduction of appetite (anorexia);
• Sudden or gradual appearance of skin lesions, such as discoloured spots or widespread rash;
• Headache, dizziness, vertigo;
• Increased transaminase levels.

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

• Urticaria;
• Asthma or dyspnoea;
• Inflammation of the stomach lining (gastritis) with pain, vomiting and loss of appetite;
• Somnolence;
• Swelling (oedema).

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

• Itching, skin lesions, even after sun exposure (photosensitivity reaction), such as blister formation (bullous eruption), redness (eczema, erythema, erythema multiforme), or red-purple spots (purpura, allergic purpura);
• Hair loss;
• Inflammation of the mouth mucosa, sometimes with ulcers (stomatitis), inflammation of the tongue (glossitis), oesophageal problems, difficulty passing stools (constipation), intestinal problems such as narrowing (diaphragm-like stenosis), colon disorders (including intestinal inflammation and worsening of ulcerative colitis or Crohn's disease);
• Inflammation of the pancreas, presenting with severe stomach pain that may extend to the back or shoulder;
• Blood disorders such as: reduced platelet count (thrombocytopenia), manifesting as increased tendency to bleed; reduced white blood cell count (leukopenia) and granulocyte count (agranulocytosis), manifesting as increased susceptibility to infections; reduced red blood cell count (anaemia), with symptoms including fatigue, headache, dizziness and pallor;
• Visual disturbances such as blurred vision or double vision (diplopia);
• Tinnitus (ringing, buzzing, whistling or other persistent sounds in the ears), worsening of hearing;
• Sensory disturbances (paraesthesia), memory disorders, seizures, anxiety, tremors, taste alterations;
• Disorientation, depression, sleep disorders (insomnia, nightmares), irritability, loss of contact with reality (psychotic reactions);
• Lung infection (pneumonia).

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report adverse reactions directly via the national reporting system at the following website: “https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse”.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE FLECTORFLAM

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month. This date applies to the product in its original packaging, stored correctly.
Store at a temperature not exceeding 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

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What FLECTORFLAM contains
The active substance is diclofenac hydroxyethylpyrrolidine.
Each sachet contains 65 mg of diclofenac hydroxyethylpyrrolidine (equivalent to 50 mg of sodium diclofenac).
The other components are: aspartame, acesulfame potassium, polyvinylpyrrolidone, peach flavour, mint flavour, sorbitol, and aerosil 200 (anhydrous colloidal silica).
Description of the appearance of FLECTORFLAM and contents of the pack
This medicinal product is available in a pack containing 30 double sachets.
Marketing Authorization Holder
IBSA Farmaceutici Italia, Via Martiri di Cefalonia, 2 26900 Lodi
Manufacturer
IBSA Farmaceutici Italia, Via Martiri di Cefalonia, 2 26900 Lodi
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