Fenextra

Package leaflet: Information for the patient

FENEXTRA 200 mg, granules for oral suspension

dexibuprofen
Please read all of this leaflet carefully before taking this medicine as it contains important information for you.

• Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to do.
• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any of the side effects occur, 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 you notice worsening of symptoms after a short period of treatment.

Contents of this leaflet:

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

1. What FENEXTRA is and what it is used for

This medicinal product contains the active substance dexibuprofen and belongs to a class of medicines called NSAIDs (non-steroidal anti-inflammatory drugs) which act against pain and inflammation.
FENEXTRA is used to reduce:

• pain and inflammation due to osteoarthritis (degeneration of the joints);
• pain of various origin and nature, for example, toothache, menstrual pain (primary dysmenorrhoea), or pain in bones or muscles (musculoskeletal).

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

2. What you need to know before taking FENEXTRA

Do not take FENEXTRA:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other pain-relieving medicines (analgesics) or anti-inflammatory medicines (non-steroidal anti-inflammatory drugs, NSAIDs);
• if taking non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin (acetylsalicylic acid) has previously caused you to develop asthma, breathing difficulties (bronchospasm), itching, urticaria, swelling of the face or throat (angioedema), nasal inflammation (acute rhinitis), or nasal polyps;
• if you currently have or have previously had gastrointestinal bleeding caused by taking medicines;
• if you have experienced two or more separate episodes of stomach or intestinal ulcer or bleeding (including blood in vomit or during bowel movements, or black, tarry stools);
• if you suffer from intestinal diseases such as Crohn’s disease or ulcerative colitis;
• if you have severe liver, kidney, or heart problems;
• if you are prone to bleeding episodes (haemorrhagic diathesis) or have other coagulation disorders, or are taking blood-thinning medicines (anticoagulants);
• if you are severely dehydrated, which may be caused by vomiting, diarrhoea, or insufficient fluid intake;
• after the sixth month of pregnancy;
• if you are under 18 years of age.

Warnings and precautions
Talk to your doctor before taking FENEXTRA if:

• you are taking other medicines that relieve pain (analgesics) and inflammation (NSAIDs);
• you are taking blood-thinning medicines (anticoagulants);
• you have had stomach or intestinal disorders, such as ulcers or bleeding, or Crohn’s disease;
• you are elderly, as you are at higher risk of developing adverse effects from this medicine, especially bleeding and perforation of the stomach or intestines, which may be fatal;
• you have alcohol-related problems (alcoholism);
• you have kidney problems or are taking medicines that increase urine production (diuretics);
• you currently have or have previously suffered from asthma;
• you currently have or have previously suffered from high blood pressure or severe liver problems;
• you have connective tissue diseases causing joint or muscle pain, skin disorders such as exfoliative dermatitis, Stevens-Johnson syndrome, or toxic epidermal necrolysis, and problems affecting other organs (autoimmune diseases), for example systemic lupus erythematosus (SLE, also known as lupus);
• you have heart or blood vessel problems, a history of stroke or heart attack, or believe you may be at risk for these conditions (for example, if you have high blood pressure, diabetes, high cholesterol, or smoke), as medicines like FENEXTRA may be associated with a small increased risk of heart attack (myocardial infarction) or stroke;
• you have an infection – see section “Infections” below.

Inform your doctor if:

• you do not feel better or feel worse after a short period of treatment, as treatment with anti-inflammatory medicines (NSAIDs) may mask signs of infection;
• you experience any unusual gastrointestinal symptoms (especially gastrointestinal bleeding);
• you have problems with your liver, kidneys, or heart.

IN ALL THESE CASES, YOUR DOCTOR WILL ASSESS WHETHER CONTROL EXAMINATIONS ARE NECESSARY.
Anti-inflammatory/pain-relieving medicines such as dexibuprofen may be associated with a small increased
risk of heart attack or stroke, especially when administered at high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss treatment with your doctor or pharmacist before taking FENEXTRA if you have:

• heart problems including heart attack, angina (chest pain), or a history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries), or any type of stroke (including “mini-stroke” or “TIA”, transient ischaemic attack);
• high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

BE CAREFUL because:

• during treatment with all anti-inflammatory medicines (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 have been reported, which may be fatal;
• prolonged and high-dose use of pain-relieving medicines such as FENEXTRA may cause headaches; in such cases, do not increase the dose of FENEXTRA to relieve pain; with dexibuprofen, signs of an allergic reaction to this medicine have been reported, including breathing difficulties, swelling of the face and neck (angioedema), and chest pain. Stop taking FENEXTRA immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

Serious skin reactions have been reported in association with treatment, including exfoliative dermatitis,
erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP).
Stop using FENEXTRA and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
You can reduce the risk of unwanted effects by using the lowest effective dose for the shortest possible duration needed to control your symptoms.
STOP TREATMENT AND CONTACT YOUR DOCTOR IF:

• you notice any symptoms affecting the stomach or intestine (gastrointestinal), especially 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).

This medicine may affect the results of certain laboratory tests, increasing blood levels of urea nitrogen, creatinine, transaminases, and other liver parameters. If you notice any abnormal test results, contact your doctor.
Children and adolescents
FENEXTRA is not suitable for patients under 18 years of age.
Other medicines and FENEXTRA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, as some medicines may interact with FENEXTRA or increase the risk of adverse events, even serious ones.
FENEXTRA may affect or be affected by other medicines. For example:

• medicines containing cortisone (corticosteroids);
• medicines with anticoagulant effects (i.e. substances that thin the blood and prevent clot formation, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine, or heparin);
• medicines that increase urine flow (diuretics) such as: thiazides, thiazide-related substances, loop diuretics, and potassium-sparing diuretics;
• medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan);
• medicines called ‘selective serotonin reuptake inhibitors’ (SSRIs), used as antidepressants;
• other medicines that reduce inflammation (NSAIDs and salicylates);
• lithium and moclobemide, used in depression;
• methotrexate, used for certain conditions (immune diseases) and cancer;
• cyclosporine and tacrolimus, medicines that suppress the immune system;
• cardiac glycosides (digoxin), medicines used for heart problems;
• phenytoin, used for epilepsy;
• antibiotic medicines (trimethoprim, aminoglycosides, quinolone antibiotics);
• medicines used to lower cholesterol levels in the blood (cholestyramine);
• herbal extracts (Ginkgo biloba);
• antiprogestogenic medicines used to terminate pregnancy (mifepristone);
• medicines that reduce blood glucose levels (sulfonylureas);
• medicines used against viral infections (antivirals zidovudine, ritonavir);
• medicines used in the treatment of gout (probenecid);
• medicines called ‘cytochrome CYP2C9 inhibitors’;
• medicines used to inhibit bone resorption (bisphosphonates);
• medicines used in the treatment of venous ulcers (oxpentifylline);
• medicines used against muscle spasms (baclofen);
• medicines that increase blood potassium levels;
• alcohol.

Other medicines may also affect or be affected by treatment with FENEXTRA.
Therefore, always consult your doctor or pharmacist before taking FENEXTRA with other medicines.
Fertility, pregnancy, and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take FENEXTRA during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause heart, lung, or kidney problems in the fetus. It may also affect your tendency and your baby's tendency to bleed, and delay or prolong labour more than expected.
You should not take FENEXTRA during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or while trying to conceive, the lowest possible dose for the shortest possible duration should be used. From week 20 of pregnancy, FENEXTRA 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 causing narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.
Be cautious with FENEXTRA:

• if you are planning a pregnancy or have fertility problems, as this medicine may impair fertility. This effect is reversible upon discontinuation of the medicine;
• during the first months of pregnancy (up to the sixth month), as this medicine should only be used when strictly necessary and under direct medical supervision;
• if you are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
FENEXTRA may cause dizziness and fatigue. Exercise particular caution before driving vehicles or operating machinery.
FENEXTRA Granules contain yellow (E110): may cause allergic reactions.
Infections
FENEXTRA may mask symptoms of infections such as fever and pain. Therefore, FENEXTRA may delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox.
If you take this medicine while having an infection and the symptoms of infection persist or worsen, consult your doctor immediately.

3. How to take FENEXTRA

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended daily dose is 600 mg, divided into up to 3 doses.
For mild or moderate pain, take an initial dose of 200 mg, up to a maximum of 600 mg per day. Do not take more than 400 mg at one time.
If you have severe pain or if symptoms recur, contact your doctor, who will assess whether higher doses of this medicine may be needed.
For menstrual pain (dysmenorrhea), do not exceed a single dose of 200 mg or a daily dose of 600 mg.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
If you have an infection, contact your doctor immediately if symptoms (for example, fever and pain) persist or worsen (see section 2).

Elderly patients or those with liver or kidney problems
It is advisable to follow the lowest dosages indicated above, unless otherwise directed by your doctor.

Children and adolescents
FENEXTRA is not suitable for patients under 18 years of age.

Method of administration
Take FENEXTRA by mouth (oral use), preferably with food, as follows:

• Oral suspension granules: take the granules by dissolving them in water.

If you take more FENEXTRA than you should
You may experience abdominal pain, nausea, vomiting, deep sleep (lethargy), drowsiness, headache, rhythmic, oscillating, involuntary eye movements (nystagmus), ringing in the ears (tinnitus), and lack of muscle coordination (ataxia). These symptoms usually occur within the first 4 hours after ingestion.
Rarely, more serious symptoms or signs may occur, such as gastrointestinal bleeding, low blood pressure (hypotension) or low body temperature (hypothermia), epileptic seizures, reduced kidney function, coma, severe breathing problems (respiratory distress syndrome), especially in adults, episodes of breathing cessation (apnea), particularly in younger children, and diarrhea, following ingestion of high doses.
Additionally, a decrease in blood pH (metabolic acidosis) may occur. Symptoms may include nausea, stomach ache, vomiting (possibly with traces of blood), headache, ringing in the ears, confusion, and uncontrolled eye movements. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in the urine, feeling cold, and breathing difficulties may also occur.
If you have taken more FENEXTRA than you should, or if your child has accidentally taken this medicine, contact a doctor or the nearest hospital immediately to obtain advice on the risk and actions to take (e.g. activated charcoal, stomach emptying, gastric lavage).

If you forget to take FENEXTRA
Do not take a double dose to make up for a forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop using FENEXTRA and consult your doctor immediately if you notice any of the following symptoms:

• severe stomach problems, burning or abdominal pain due to gastric or duodenal (peptic) ulcer;
• sudden, severe pain in the upper abdomen (perforation of the ulcer);
• vomiting blood (haematemesis) or black stools (melena), associated with bleeding in the stomach or intestine (gastrointestinal), or unusual fatigue with reduced urine output (due to non-visible bleeding);
• severe allergic reactions, presenting as swelling of the face, eyes, lips, swelling of the throat (angioedema), possibly causing difficulty in breathing; these side effects are uncommon. In rare cases, increased heart rate (tachycardia) and a drop, sometimes sudden, in blood pressure (anaphylaxis and shock) may also occur;
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome;
• flat, non-elevated red spots, target-shaped or circular rashes on the trunk, often with central blisters and skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin reactions may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis];
• widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome);
• widespread, red, scaly rash, with subcutaneous bumps and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized pustular eruption);
• difficulty breathing (asthma, bronchospasm or dyspnoea), breathing pauses (apnoea);
• worsening of infections, such as the onset of necrotizing fasciitis, presenting with fever, chills, weakness, sweating, diarrhoea, vomiting, redness, pain, swelling, bruising in one body area due to tissue necrosis (death of tissue cells);
• inflammation of the meninges (aseptic meningitis), presenting with: high fever, sudden headache, inability to bend the neck, nausea, vomiting, confusion, drowsiness, and sensitivity to light.

Inform your doctor if you notice:
Common side effects (may affect up to 1 in 10 people)

• more or less sudden appearance of skin lesions, for example, discoloured patches or widespread changes (rash);
• tiredness, drowsiness, headache, dizziness, vertigo;
• fatigue, malaise.

Uncommon side effects (may affect up to 1 in 100 people)

• urticaria, itching, red spots on the skin (purpura), inflammation of the nose (rhinitis), swelling of the throat (angioedema), difficulty breathing (asthma, bronchospasm or dyspnoea), breathing pauses (apnoea);
• gastritis;
• difficulty falling asleep (insomnia), anxiety, nervousness (restlessness);
• vision disturbances, ringing in the ears (tinnitus), hearing impairment;
• appearance of skin spots after sun exposure (photosensitivity);
• liver inflammation (hepatitis), increase in a substance called bilirubin causing yellowing of the eyes and/or skin (jaundice), changes in liver function;
• kidney problems such as changes in kidney function (renal failure), which may cause swelling (oedema), protein loss in urine, decreased blood protein levels (nephrotic syndrome), kidney inflammation (interstitial nephritis), toxic nephropathy.

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

• pain or burning (heartburn) in the upper abdomen, perforation or bleeding of the stomach or duodenum;
• loss of contact with reality (psychotic reactions), agitation, mood instability (irritability), depression, confusion or disorientation;
• vision disturbances, for example due to inflammation of the optic nerve (optic neuritis) or toxic optic neuropathy, weakening of vision in one eye (amblyopia, also known as lazy eye), optic neuritis;
• decrease in platelets (thrombocytopenia), decrease in white blood cells (leucopenia), severe reduction in granulocytes (granulocytopenia, agranulocytosis), decrease or destruction of red blood cells (aplastic anaemia, haemolytic anaemia), decrease in all blood cells (pancytopenia);
• systemic lupus erythematosus, presenting as butterfly-shaped facial redness or other skin changes, joint or muscle pain, and problems affecting other organs;
• swelling (oedema);
• inflammation of the meninges (aseptic meningitis).

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

• liver failure, inflammation of the pancreas (pancreatitis);
• sensation of the heart pounding in the throat (palpitations), heart attack, reduced heart function (heart failure), high blood pressure (hypertension);
• breathing problems due to lung oedema;
• inflammation of blood vessels (vasculitis);

Other side effects

• fever (possible sign of allergy);
• nausea, vomiting, diarrhoea, intestinal gas (flatulence), difficulty evacuating (constipation), indigestion (dyspepsia), abdominal pain, vomiting blood (haematemesis) or black stools (melena), inflammation of the mouth mucosa with ulcers (ulcerative stomatitis), worsening of colon inflammation (colitis) and Crohn's disease;
• worsening of skin infections caused by chickenpox;
• prolonged bleeding time;
• stroke;

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

5. How to store FENEXTRA

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What FENEXTRA contains
The active substance is: dexibuprofen.
Each FENEXTRA 200 mg sachet contains: 200 mg of dexibuprofen.
The other components are:
FENEXTRA Granules: sodium lauryl sulfate, sodium saccharin, methylcellulose, mannitol, yellow (E110), citric acid, orange flavour.
Description of the appearance of FENEXTRA and package contents
FENEXTRA 200 mg Granules are available in packs of 12 single-dose sachets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Bruno Farmaceutici S.p.A., Via delle Ande n. 15 – 00144 Rome (RM)
Manufacturer
Special Product’s Line S.p.A., Via Fratta Rotonda Vado Largo 1 – 03012 Anagni (FR)

Patient information leaflet

FENEXTRA 400 mg, film-coated tablets, 300 mg granules for oral suspension, 400 mg granules for oral suspension

dexibuprofen
Please 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What FENEXTRA is and what it is used for

This medicinal product contains the active substance dexibuprofen and belongs to a class of medicines called NSAIDs (non-steroidal anti-inflammatory drugs) which act against pain and inflammation.
FENEXTRA is used to reduce:

• pain and inflammation due to osteoarthritis (degeneration of the joints);
• pain of various origin and nature, for example, toothache, menstrual pain (primary dysmenorrhea), and pain in bones or muscles (musculoskeletal).

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

2. What you should know before taking FENEXTRA

Do not take FENEXTRA:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other pain-relieving medicines (analgesics) or anti-inflammatory medicines (non-steroidal anti-inflammatory drugs, NSAIDs);
• if the use of non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin (acetylsalicylic acid) has previously caused you asthma, breathing difficulties (bronchospasm), itching, hives, facial or throat swelling (angioedema), nasal inflammation (acute rhinitis), or nasal polyps;
• if you suffer or have suffered from stomach or intestinal bleeding caused by taking medicines;
• if you have experienced two or more separate episodes of stomach or intestinal ulcer or bleeding (including blood in vomit or stools, or black, tarry stools);
• if you suffer from bowel diseases such as Crohn’s disease or ulcerative colitis;
• if you have severe liver, kidney, or heart problems;
• if you are prone to bleeding episodes (hemorrhagic diathesis) or have other coagulation disorders, or are taking medicines that thin the blood (anticoagulants);
• if you have severe dehydration, which may result from vomiting, diarrhoea, or insufficient fluid intake;
• after the sixth month of pregnancy;
• if you are under 18 years of age.

Warnings and precautions
Talk to your doctor before taking FENEXTRA if:

• you are taking other medicines that relieve pain (analgesics) or reduce inflammation (NSAIDs);
• you are taking medicines that thin the blood (anticoagulants);
• you have had stomach or intestinal disorders, such as ulcers or bleeding, or Crohn’s disease;
• you are elderly, as you have a higher risk of developing adverse effects from this medicine, especially stomach or intestinal bleeding or perforation, which can be fatal;
• you have alcohol-related problems (alcoholism);
• you have kidney problems or are taking medicines that increase urine production (diuretics);
• you suffer or have suffered from asthma;
• you suffer or have suffered from high blood pressure or severe liver problems;
• you have connective tissue diseases causing joint or muscle pain, skin disorders such as exfoliative dermatitis, Stevens-Johnson syndrome, or toxic epidermal necrolysis, and problems affecting other organs (autoimmune diseases), for example systemic lupus erythematosus (SLE, commonly known as lupus);
• you have an infection – see section “Infections” below.

Inform your doctor if:

• you do not feel better or feel worse after a short period of treatment, as treatment with anti-inflammatory medicines (NSAIDs) may mask signs of infection;
• you experience any unusual gastrointestinal symptoms (especially gastrointestinal bleeding);
• you have liver, kidney, or heart problems.

IN ALL THESE CASES, YOUR DOCTOR WILL ASSESS WHETHER MONITORING TESTS ARE NECESSARY.
Anti-inflammatory/pain-relieving medicines such as dexibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss treatment with your doctor or pharmacist before taking FENEXTRA if you have:

• heart problems, including heart attack, angina (chest pain), or a history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries), or any type of stroke (including “mini-stroke” or “TIA”, transient ischemic attack);
• high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

BE CAREFUL because:

• during treatment with all anti-inflammatory medicines (NSAIDs), at any time and with or without warning symptoms, even in patients without previous serious stomach or intestinal (gastrointestinal) problems, cases of gastrointestinal bleeding, ulceration, or perforation of the stomach or intestine have been reported, which may be fatal;
• prolonged and high-dose use of pain-relieving medicines such as FENEXTRA may cause headaches; in such cases, do not increase the dose of FENEXTRA to relieve the pain;
• signs of an allergic reaction to this medicine, including breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported with dexibuprofen. Stop taking FENEXTRA immediately and contact your doctor or emergency medical services right away if you notice any of these signs.
• Serious skin reactions have been reported during treatment, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP).
• Stop using FENEXTRA and contact your doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.

You can reduce the risk of unwanted side effects by using the lowest effective dose for the shortest possible duration needed to control your symptoms.
STOP TREATMENT AND CONTACT YOUR DOCTOR IF:

• you notice any symptoms affecting the stomach or intestine (gastrointestinal), especially bleeding;
• a skin rash, mucosal lesions, or any other sign of an allergic reaction appear (e.g., redness, itching, facial or throat swelling, sudden drop in blood pressure).

This medicine may affect the results of certain laboratory tests, increasing blood levels of urea nitrogen, creatinine, transaminases, and other liver parameters. If abnormal test results occur, contact your doctor.
Children and adolescents
FENEXTRA is not suitable for patients under 18 years of age.
Other medicines and FENEXTRA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, as some medicines may interact with FENEXTRA or increase the risk of adverse effects, even serious ones.
FENEXTRA may affect or be affected by other medicines. For example:

• medicines containing cortisone (corticosteroids);
• medicines with anticoagulant effects (i.e., substances that thin the blood and prevent clotting, e.g., aspirin/acetylsalicylic acid, warfarin, ticlopidine, or heparin);
• medicines that increase urine flow (diuretics) such as: thiazides, thiazide-related substances, loop diuretics, and potassium-sparing diuretics;
• medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan);
• medicines called selective serotonin reuptake inhibitors (SSRIs), used as antidepressants;
• other medicines that reduce inflammation (NSAIDs and salicylates);
• lithium and moclobemide, used in depression;
• methotrexate, used for certain conditions (immune diseases) and cancer;
• cyclosporine and tacrolimus, medicines that suppress the immune system;
• cardiac glycosides (digoxin), medicines used for heart problems;
• phenytoin, used for epilepsy;
• antibiotic medicines (trimethoprim, aminoglycosides, quinolone antibiotics);
• medicines used to lower cholesterol levels in the blood (cholestyramine);
• herbal extracts (Ginkgo biloba);
• antiprogestogenic medicines used to terminate pregnancy (mifepristone);
• medicines that lower blood glucose levels (sulfonylureas);
• medicines used against viral infections (antivirals) (zidovudine, ritonavir);
• medicines used in the treatment of gout (probenecid);
• medicines called ‘cytochrome CYP2C9 inhibitors’;
• medicines used to inhibit bone resorption (bisphosphonates);
• medicines used in the treatment of venous ulcers (oxpentifylline);
• medicines used for muscle spasms (baclofen);
• medicines that increase blood potassium levels;
• alcohol.

Other medicines may also affect or be affected by treatment with FENEXTRA. Therefore, always consult your doctor or pharmacist before taking FENEXTRA with other medicines.
Fertility, pregnancy, and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Do not take FENEXTRA during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause heart, lung, or kidney problems in the fetus. It may affect your tendency or your baby’s tendency to bleed, or delay or prolong labour beyond normal duration.
You should not take FENEXTRA during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or while trying to conceive, the lowest possible dose for the shortest possible time should be used. From week 20 of pregnancy, FENEXTRA may cause kidney problems in the fetus if taken for more than a few days, thereby 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 is needed for more than a few days, your doctor may recommend additional monitoring.
Be cautious with FENEXTRA:

• if you are planning a pregnancy or have fertility problems, as this medicine may impair fertility. This effect is reversible upon discontinuation of the medicine;
• during the first months of pregnancy (up to the sixth month), as this medicine should only be used when strictly necessary and under direct medical supervision;
• if you are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
FENEXTRA may cause dizziness and fatigue. Exercise particular caution before driving or operating machinery.
FENEXTRA Granules contain tartrazine (E110): may cause allergic reactions.
Infections
FENEXTRA may mask symptoms of infections such as fever and pain. Therefore, FENEXTRA may delay appropriate treatment of an infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, seek medical advice immediately.

3. How to take FENEXTRA

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended daily dose is 600–900 mg, divided into up to 3 doses.
For mild or moderate pain, take up to a maximum of 600 mg per day. Do not take more than 400 mg at a time.
If you have severe pain or if symptoms recur, the maximum daily dose may be temporarily increased up to 1200 mg per day. Do not exceed this dose.
For menstrual pain (dysmenorrhoea), do not exceed a single dose of 300 mg or a daily dose of 900 mg.

The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
If you have an infection, contact your doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).

Elderly patients or patients with liver or kidney problems
It is advisable to follow the lowest recommended doses mentioned above, unless otherwise directed by your doctor.

Children and adolescents
FENEXTRA is not suitable for patients under 18 years of age.

Method of administration
Take FENEXTRA by mouth (oral use), preferably with food, as follows:

• Tablets: take the tablets with plenty of water;
• Oral suspension granules: dissolve the granules in water before taking.

If you take more FENEXTRA than you should
You may experience abdominal pain, nausea, vomiting, deep sleep (lethargy), drowsiness, headache, rhythmic, oscillating and involuntary eye movements (nystagmus), ringing in the ears (tinnitus), and lack of muscle coordination (ataxia). These symptoms usually occur within the first 4 hours after ingestion.
Rarely, more serious symptoms or signs may occur, such as gastrointestinal bleeding, low blood pressure (hypotension) or low body temperature (hypothermia), epileptic seizures, reduced kidney function, coma, severe breathing problems (respiratory distress syndrome), especially in adults, episodes of breathing cessation (apnea), especially in younger children, and diarrhoea, following ingestion of high doses.
Additionally, you may develop a decrease in blood pH (metabolic acidosis). Symptoms may include nausea, stomach ache, vomiting (possibly with traces of blood), headache, ringing in the ears, confusion, and uncontrolled eye movements. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in the urine, feeling cold, and breathing difficulties have been reported.

If you have taken more FENEXTRA than you should, or if your child has accidentally taken this medicine, contact a doctor or the nearest hospital immediately for advice on the risk and actions to take (e.g. activated charcoal, stomach emptying, gastric lavage).

If you forget to take FENEXTRA
Do not take a double dose to make up for the missed dose.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Stop using FENEXTRA and consult your doctor immediately if you notice any of the following symptoms:

• severe stomach problems, burning or abdominal pain due to gastric or duodenal (peptic) ulcer;
• sudden, severe pain in the upper abdomen (perforation of the ulcer);
• vomiting blood (haematemesis) or black stools (melena), associated with bleeding in the stomach or intestine (gastrointestinal); or unusual tiredness with reduced urine output (due to non-visible bleeding);
• severe allergic reactions, presenting as swelling of the face, eyes, lips, throat oedema (angioedema), possibly causing breathing difficulties; these side effects are uncommon. In rare cases, increased heart rate (tachycardia) and a drop in blood pressure, even sudden (anaphylaxis and shock), may also occur;
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome;
• flat, red, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin reactions may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis];
• widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome);
• widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized pustular eruption);
• difficulty breathing (asthma, bronchospasm or dyspnoea), breathing pauses (apnoea);
• worsening of infections, such as the onset of necrotizing fasciitis, presenting with fever, chills, weakness, sweating, diarrhoea, vomiting, redness, pain, swelling, bruising in one area of the body due to tissue necrosis (death of tissue cells);
• inflammation of the meninges (aseptic meningitis), presenting with: high fever, sudden headache, inability to bend the neck, nausea, vomiting, confusion, drowsiness, and sensitivity to light.

Tell your doctor if you notice:
Common side effects (may affect up to 1 in 10 people)

• sudden or gradual appearance of skin lesions, for example, discoloured spots or widespread changes (skin rashes);
• fatigue, drowsiness, headache, dizziness, vertigo;
• tiredness, malaise.

Uncommon side effects (may affect up to 1 in 100 people)

• urticaria, itching, red spots on the skin (purpura), nasal inflammation (rhinitis), throat swelling (angioedema), breathing difficulties (asthma, bronchospasm or dyspnoea), breathing pauses (apnoea);
• gastritis;
• difficulty falling asleep (insomnia), anxiety, nervousness (restlessness);
• vision disturbances, ringing in the ears (tinnitus), hearing impairment;
• appearance of skin spots after sun exposure (photosensitivity);
• liver inflammation (hepatitis), increase in a substance called bilirubin causing yellowing of the eyes and/or skin (jaundice), changes in liver function;
• kidney problems such as changes in kidney function (renal failure), which may cause swelling (oedema), loss of protein in the urine, decreased blood protein levels (nephrotic syndrome), kidney inflammation (interstitial nephritis), toxic nephropathy.

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

• pain or burning (pyrosis) in the upper abdomen, perforation or bleeding of the stomach or duodenum;
• loss of touch with reality (psychotic reactions), agitation, mood instability (irritability), depression, confusion or disorientation;
• vision changes, for example due to inflammation of the optic nerve (optic neuritis) or toxic optic neuropathy, reduced vision in one eye (amblyopia, also known as lazy eye), optic neuritis;
• decreased platelets (thrombocytopenia), decreased white blood cells (leucopenia), severe reduction in granulocytes (granulocytopenia, agranulocytosis), decreased or destruction of red blood cells (aplastic anaemia, haemolytic anaemia), reduction in all blood cells (pancytopenia);
• systemic lupus erythematosus, presenting as a butterfly-shaped facial redness or other skin changes, joint or muscle pain, and problems affecting other organs;
• swelling (oedema);
• inflammation of the meninges (aseptic meningitis).

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

• liver failure, inflammation of the pancreas (pancreatitis);
• sensation of the heart pounding (palpitations), heart attack, reduced heart function (heart failure), high blood pressure (hypertension);
• breathing problems due to lung oedema;
• inflammation of blood vessels (vasculitis);

Other side effects

• fever (possible sign of allergy);
• nausea, vomiting, diarrhoea, intestinal gas (flatulence), difficulty passing stools (constipation), indigestion (dyspepsia), abdominal pain, vomiting blood (haematemesis) or black stools (melena), inflammation of the mouth mucosa with ulcers (ulcerative stomatitis), worsening of colon inflammation (colitis) and Crohn's disease;
• worsening of skin infections caused by chickenpox;
• prolonged bleeding time;
• stroke.

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 website: “https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse”. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store FENEXTRA

Keep this medicine out of the sight and reach of children.
This medicine requires no special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What FENEXTRA contains
The active substance is: dexibuprofen.
Each FENEXTRA 400 mg tablet contains 400 mg of dexibuprofen.
Each FENEXTRA 300 mg and 400 mg sachet contains 300 mg and 400 mg of dexibuprofen, respectively.
The other components are:

• FENEXTRA Tablets: microcrystalline cellulose, sodium starch glycolate, anhydrous colloidal silica, talc, macrogol 4000, macrogol 6000, hydroxypropylcellulose, titanium dioxide (E171);
• FENEXTRA Granules: sodium lauryl sulfate, sodium saccharin, methylcellulose, mannitol, yellow (E110), citric acid, orange flavour.

Description of the appearance of FENEXTRA and contents of the pack
FENEXTRA Tablets are available in packs of 30 tablets of 400 mg.
FENEXTRA Granules 300 mg and 400 mg are available in packs of 30 single-dose sachets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bruno Farmaceutici S.p.A., Via delle Ande n. 15 – 00144 Rome (RM)
Manufacturer
Special Product’s Line S.p.A., Via Fratta Rotonda Vado Largo 1 – 03012 Anagni (FR)