FERENS 400 mg Effervescent Tablet

Зміст інструкції

1. FERENS 400 mg effervescent tablets
   1. What FERENS is and what it is used for
   2. What you need to know before taking FERENS
   3. How to take FERENS
   4. Possible side effects
   5. How to store FERENS
   6. Contents of the pack and other information

FERENS 400 mg effervescent tablets

ibuprofen
generic medicine

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What FERENS is and what it is used for

FERENS contains ibuprofen, which belongs to a class of medicines called NSAIDs (non-steroidal anti-inflammatory drugs). These medicines work by reducing pain and swelling caused by inflammation and fever.
FERENS is used as an antirheumatic in:

• osteoarthritis in all its locations (cervical, dorsal, lumbar osteoarthritis; osteoarthritis of the shoulder, hip, knee, widespread osteoarthritis, etc.), scapulo-humeral periarthritis, lumbago, sciatica, radiculo-neuritis; fibrositis, tenosynovitis, myositis, sports traumatology; rheumatoid arthritis, Still's disease. as an analgesic in painful conditions of various etiologies:
• in accidental and sports traumatology;
• in dentistry, for post-extraction pain and after odontostomatological interventions;
• in obstetrics: for post-episiotomy and post-partum pain;
• in gynecology: in the prevention and treatment of dysmenorrhea;
• in surgery: in the treatment of post-operative pain;
• in ophthalmology: for post-operative pain and painful conditions of various etiologies;
• in general medicine: in the treatment of migraine and headache.

2. What you need to know before taking FERENS

Do not take FERENS

• if you are allergic to the active ingredient, to similar substances or to any of the other ingredients of FERENS (listed in section 6)
• if you suffer from chronic swelling of the nasal mucosa (nasal polyps);
• if you suffer from or have suffered from allergic reactions such as swelling of the lips, face, tongue or throat (angioedema);
• if you have suffered from ulcers or bleeding of the stomach or intestines in relation to previous treatments with active substances;
• if you have suffered from ulcers or bleeding of the stomach or intestines (severe or active peptic ulcer) or if you have suffered from two or more distinct episodes of this type (recurrent peptic ulcer);
• if you suffer from severe problems with the liver, kidneys (severe hepatic or renal insufficiency) or heart (severe heart failure)
• if you are in the last three months of pregnancy
• if you are breastfeeding
• if you have significant dehydration (caused by vomiting, diarrhea or insufficient fluid intake)
• if the person who needs to take the medicine is a child under the age of 12.

Warnings and precautions
Consult your doctor or pharmacist before taking FERENS.
Take this medicine with cautionand after consulting your doctor in the following situations:

• if you suffer from chronic inflammatory diseases of the intestine such as inflammation of the colon with ulcers (ulcerative colitis), inflammation affecting the digestive tract (Crohn's disease).
• if you suffer from problems related to the normal blood clotting mechanism. FERENS may prolong bleeding time.
• if you have previously experienced difficulty breathing due to narrowing of the airways (bronchospasm) following the use of medicines used to treat inflammation (non-steroidal anti-inflammatory drugs)
• if you suffer from respiratory problems (asthma), chronic rhinitis or current or previous allergic diseases
• if you suffer from problems with the liver, kidneys, heart or high blood pressure
• if you are taking other anti-inflammatory medicines (including selective COX-2 inhibitors)
• if the patient is an adolescent and is dehydrated
• if you have an infection (see section “Infections” below)

Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck (angioedema) and chest pain, have been reported with ibuprofen.
Immediately stop treatment with Ferens and contact your doctor or emergency health service immediately if you notice any of these signs.

Tellyour doctor in the following cases:

• if you experience any unusual abdominal symptoms, especially if these symptoms occur early in treatment. In fact, the risk of bleedingor ulcerationof the

digestive tract is greater in this case, especially if you are elderly, if you take high doses
of this medicine and if you take other medicines (see section “Other medicines and
FERENS”). If bleeding or ulceration of the digestive tract occurs, treatment
must be stopped because it can be fatal. You should be particularly careful if
you have had a gastric or intestinal ulcer, especially if it has been complicated by perforation
or accompanied by bleeding

• if you suffer from heart problems, have had a strokeor think you may be at risk of developing these diseases (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker). This medicine may increase the risk of heart attack (myocardial infarction) or stroke, especially if you take high doses or for prolonged periods. Never exceed the recommended dose or duration of treatment. Be particularly careful if you take this medicine at high doses (2400 mg per day) and for prolonged treatments, as it may increase the risk of heart problems (stroke and heart attack)
• if you are undergoing prolonged treatment with this medicine or suffer from systemic lupus erythematosus your doctor will need to subject you to periodic kidney checks
• if you experience swelling of the legs (edema), heart problems (heart failure) or high blood pressure, which may be symptoms of kidney problems. FERENS can in fact cause kidney problems especially in elderly people or who already have kidney, heart, liver problems or who are taking diuretics or ACE inhibitors. Stop treatment if you experience kidney problems.

This medicine can cause:

• problems with the eyes. If you take this medicine for prolonged periods, undergo periodic checks
• aseptic meningitis in rare cases. This can occur especially in people who suffer from diseases such as systemic lupus erythematosus and connective tissue diseases related to it, but has also been observed in patients without concomitant chronic pathologies.
• permanent kidney damage, with a risk of kidney failure. This can happen if you regularly take this medicine
• allergic-type reactions (hypersensitivity reactions) even severe (anaphylactoid reactions). The risk increases if you have previously suffered from these problems following the use of an anti-inflammatory medicine (analgesics, antipyretics, NSAIDs) or if you suffer from asthma, hay fever, rhinitis or other disorders (nasal polyps, chronic obstructive respiratory diseases, angioedema, see section “Do not take FERENS”). Allergic-type reactions can be in the form of breathing crises (analgesic asthma) or can manifest as skin rashes (urticaria, Quincke's edema). Stop treatment at the first signs of manifestation.

Be particularly careful with Ferens
Severe skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (PEAG) have been reported in association with treatment with ibuprofen.
Stop using Ferens and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Infections
Ferens can mask the symptoms of infections such as fever and pain. Therefore, it is possible that Ferens
may delay adequate treatment of the infection, which could increase the risk of
complications. This has been observed in pneumonia caused by bacteria and in skin infections
related to varicella.
If you take this medicine while you have an infection and the symptoms of the infection persist or
worsen, consult your doctor immediately.

Children and adolescents
This medicine is not recommended for children under the age of 12.
Kidney damage can occur in children and adolescents who are dehydrated.

Elderly
If you are elderly you may be more prone to adverse effects, especially
bleeding and perforation of the digestive tract, which can be fatal.

Other medicines and FERENS
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those without a prescription.
The side effects of FERENS may be increased if it is taken at the same time
with certain medicines. FERENS can also increase or decrease the effects of other medicines or
increase their side effects if taken at the same time.
Tell your doctor or pharmacist if you are taking any of the following medicines:

• other NSAIDs(non-steroidal anti-inflammatory drugs - medicines for inflammation) such as acetylsalicylic acid, or COX-2 inhibitors
• anticoagulants(used against the formation of clots), such as warfarin or heparin
• antiplatelet agents(used against the formation of clots) including acetylsalicylic acid
• methotrexate(used in the treatment of cancer and autoimmune diseases).
• Cardiac glycosides(used for the treatment of various heart diseases)
• phenytoin(used in epilepsy)
• lithium(used to treat depression and mania)
• diuretics
• antihypertensives(for the treatment of high blood pressure) such as:
• ACE inhibitors
• angiotensin II antagonists
• cholestyramine(used in the treatment of high cholesterol)
• aminoglycosides(medicines against some types of bacteria)
• SSRIs(medicines against depression)
• moclobemide(RIMA - a medicine used for the treatment of depressive illness or social phobia)
• cyclosporine, tacrolimus(used for immunosuppression after organ transplantation)
• zidovudine and ritonavir(used for the treatment of HIV-positive patients)
• mifepristone(also used for medical abortion)
• probenecid(used for the treatment of gout)
• quinolone antibiotics
• sulfonylureas(used for the treatment of type 2 diabetes)
• corticosteroids(used against inflammation)
• bisphosphonates(used in osteoporosis, Paget's disease and to reduce high levels of calcium in the blood)
• oxpentifylline[(pentoxifylline) used in the treatment of circulatory disease of the legs or arms]
• baclofen(a muscle relaxant)
• CYP2C9 inhibitors(such as voriconazole and fluconazole) used in the treatment of fungal infections.
• Ginkgo biloba plant extracts.

FERENS with food, drinks and alcohol
Avoid drinking alcohol as it may increase the side effects of FERENS, especially
those affecting the stomach, intestines or brain.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take FERENS during the last three months of pregnancy as it can cause serious
disorders to the heart, lungs and kidneys of the fetus. If used at the end of pregnancy, it can cause
a tendency to bleeding in both mother and fetus and weaken the strength of uterine contractions, delaying
the onset of labor.
Breastfeeding
FERENS appears in breast milk in very small amounts and it is generally not necessary
to discontinue breastfeeding during short-term treatments. However, if a
prolonged treatment is prescribed, the doctor must assess the possibility of early weaning. NSAIDs
should be avoided during breastfeeding.
Fertility
FERENS may impair female fertility and is not recommended for women trying to
conceive. Tell your doctor if you are planning a pregnancy or have fertility problems.

Driving and using machines
FERENS generally has no adverse effects on the ability to drive vehicles or operate
machinery. However, drowsiness, dizziness or depression may occur. If these effects occur,
avoid driving and using machinery.

FERENS contains sorbitol, sucrose monopalmitate, sodium and potassium
This medicine contains:

• 376 mg of sorbitol per tablet. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) are intolerant to some sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients cannot transform fructose, talk to your doctor before you (or your child) take this medicine.
• sucrose. If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking this medicine.
• 2.2 mmol (or 50 mg) of sodium (the main component of table salt) per tablet. This is equivalent to 2.53% of the recommended daily intake with the diet of an adult.
• 22 mmol (or 866 mg) of potassium per tablet. To be taken into consideration in patients with reduced kidney function or in patients following a low-potassium diet.

3. How to take FERENS

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
Undesirable effects can be minimised by using the lowest effective dose, for the
shortest period of time necessary to control the symptoms.
If you have an infection, consult your doctor immediately if the symptoms (for example fever and
pain) persist or worsen (see section 2).

Use in adults and adolescents
The recommended dose ranges from two to four tablets per day. The maximum dose should not exceed
1800 mg per day.
Dissolve the tablet in a glass of water and drink the resulting solution immediately.

Rheumatic diseases
If you are taking this medicine for the treatment of rheumatic diseases, take the first dose of the
day in the morning immediately after waking up and the subsequent doses after meals.

Use in the elderly and in people with kidney or liver problems
The doctor will assess whether to reduce the doses of this medicine and will indicate the necessary dose. If you
are elderly you will be more prone to undesirable effects, particularly bleeding and
perforation of the digestive tract, which can be fatal. FERENS is contraindicated in patients with
severe hepatic or renal insufficiency.

If you take more FERENS than you should
The most common symptoms of overdose are nausea, vomiting, abdominal pain, drowsiness and severe
fatigue (lethargy). In addition, headache, ringing in the ears (or tinnitus),
dizziness, convulsions, loss of consciousness, eye problems (nystagmus), metabolic acidosis,
lowering of body temperature (hypothermia), kidney disorders, bleeding in the stomach or
intestine, coma, breathing problems (apnea), diarrhea, reduced function of the nervous system
(CNS depression) and breathing, feeling of disorientation, excited state,
fainting, effects on the heartbeat (bradycardia, tachycardia, hypotension). In the most severe
cases, kidney problems (renal failure) and liver damage (hepatic damage) may occur.
If you have ingested/taken an excessive dose of this medicine, consult
your doctor immediately or go to the nearest hospital.

If you forget to take FERENS
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking FERENS and contact your doctor immediately if you experience the following side effects:

• formation of lesions in the stomach or intestine (peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal), especially in elderly people;
• feeling of fullness in the stomach, nausea, vomiting, diarrhea, flatulence, constipation, digestive disorders (dyspepsia), abdominal pain, epigastric pain, heartburn, presence of blood in the stool (melena) and in vomit (hematemesis);
• infection of the mouth with the formation of lesions (ulcerative stomatitis);
• worsening of some intestinal disorders (colitis and Crohn's disease).
• increased risk of heart problems (stroke and heart attack), especially if you take this medicine at high doses and for prolonged treatments;
• exacerbation of infection-related inflammation has been described (e.g. development of necrotizing fasciitis).
• reduction of hemoglobin and hematocrit, renal failure in patients with impaired function.
• reddish, non-raised, target- or circular-shaped patches on the trunk, often with central blisters, skin exfoliation, ulcers of the mouth, throat, nose, genitals and eyes. These severe skin rashes 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 and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Common(may affect up to 1 in 10 people):
discomfort, dizziness, fatigue.

Uncommon(may affect up to 1 in 100 people):

• increased stomach acid (gastritis);
• reactions due to hypersensitivity, such as skin rashes, urticaria, itching, purpura, angioedema, exanthema, reactions affecting the respiratory tract such as asthma, bronchospasm or dyspnea (sometimes accompanied by low blood pressure)
• insomnia, drowsiness
• anxiety
• reduced sensitivity in the legs and arms (paresthesia)
• congestion of the airways, common cold (rhinitis)
• breathing difficulties (bronchospasm, dyspnea, apnea)
• vision disorders
• ringing in the ears, vertigo, impaired hearing
• liver disorders (hepatitis, jaundice, altered liver function)
• skin sensitivity to light (photosensitivity)
• kidney problems (kidney damage and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome, and renal failure).
• difficulty breathing (bronchospasm)

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

• eye problems (optic neuritis, eye alteration with resulting visual disturbances, toxic optic neuropathy)
• depression, confused state, hallucinations
• systemic lupus erythematosus
• reduction of platelets (thrombocytopenia), white blood cells (leukopenia, neutropenia, agranulocytosis), red blood cells (hemolytic anemia), reduction of all blood components (aplastic anemia).
• inflammation of the brain membrane in the absence of bacterial infection (aseptic meningitis), especially if you have suffered from immune system disorders in the past (such as systemic lupus erythematosus and mixed connective tissue disease); it may manifest with symptoms such as headache, stiff neck, nausea, vomiting, fever, disorientation;
• swelling due to fluid accumulation (edema).

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

• severe skin rash with blisters on the skin, especially on legs, arms, hands and feet, which may spread to the face and lips (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• The symptoms may include: facial edema, swelling of the tongue, internal larynx swelling with constriction of the airways, dyspnea, tachycardia, anaphylaxis
• noticeable awareness of heartbeat (palpitations), heart failure, heart attack or high blood pressure, acute pulmonary edema, edema.
• pancreatic disorders (pancreatitis).
• Liver failure

Not known(frequency cannot be estimated from the available data)

• a widespread, red and scaly rash, with the formation of pustules under the skin and blisters located mainly on the skin folds, on the trunk and on the upper limbs accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using Ferens if you develop these symptoms and contact your doctor immediately. See also paragraph 2.
• Kounis syndrome

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 FERENS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.” The
expiry date refers to the last day of the month.
Keep the blister pack tightly closed to protect it from moisture.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What FERENS contains
Each tablet contains sodium dihydrate ibuprofen 512.0 mg equivalent to ibuprofen 400 mg
The other components are: potassium carbonate, anhydrous citric acid, sorbitol, sodium saccharin, aroma
mint, sucrose monopalmitate.

Description of the appearance of FERENS and contents of the pack
Pack containing 30 effervescent tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Farmakopea S.p.A. - Via Aldo Moro, 11 - 20074 Carpiano (MI)

Manufacturer
E-Pharma Trento S.p.A. – Frazione Ravina, Via Provina, 2 - 38123 Trento (TN)