Package leaflet: Information for the patient

MOMENTFENE 600 mg film-coated tablets

Ibuprofen
Equivalent medicine
Please 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Momentfene is and what it is used for

Momentfene contains ibuprofen, which belongs to a class of medicines called non-steroidal anti-inflammatory and anti-rheumatic drugs, i.e. medicines that relieve pain and inflammation.
Momentfene is indicated in adults and adolescents over 12 years of age (weighing more than 40 kg) for the treatment of:

rheumatic inflammation causing pain in bones, muscles and joints (e.g. rheumatoid arthritis, Still's disease);
inflammatory and painful conditions due to bone and joint deformities (osteoarthritis, e.g. cervical, dorsal, lumbar osteoarthritis, shoulder, hip or knee osteoarthritis, generalized osteoarthritis, etc.);
inflammatory and painful conditions affecting muscles, tendons and nerves (e.g. tendinitis, myositis, fibrositis, myalgia, lumbago, shoulder periarthritis, sciatica, radiculoneuritis);
pain caused by accidental or sports-related injuries or trauma;
toothache and pain following dental extractions;
menstrual pain and pain associated with childbirth (including episiotomy);
post-operative pain;
painful eye conditions;
headache.

Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Momentfene

Do not take Momentfene

If you are allergic to ibuprofen, or to other substances similar to ibuprofen, or to any of the other ingredients of this medicine (listed in section 6).
If the person taking the medicine is a child under 12 years of age or weighing less than 40 kg.
If you suffer from an allergy to acetylsalicylic acid or to other medicines used to treat pain and inflammation (non-steroidal anti-inflammatory drugs, NSAIDs), meaning if these medicines cause you breathing difficulties (asthma), skin reactions (urticaria), nasal congestion and runny nose (rhinitis), nasal polyps, or swelling of the face, lips, and throat (angioedema).
If you suffer from severe impairment of liver and/or kidney function.
If you suffer from severe impairment of heart function (severe heart failure).
If you have severe or active gastric ulcer.
If you have previously experienced bleeding or perforation of the stomach and/or intestine following treatment with medicines, or if you have repeatedly suffered from gastrointestinal bleeding/ulcers (two or more distinct episodes of confirmed ulceration or bleeding).
If you have medical conditions that increase the tendency to bleed.
If you have significant dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake).
If you are in the third trimester of pregnancy (from the 7th to the 9th month, inclusive).

Warnings and precautions
What you need to know before taking Momentfene
Consult your doctor or pharmacist before taking Momentfene if:

You are taking other non-steroidal anti-inflammatory drugs (medicines used to treat pain and inflammation), including selective COX-2 inhibitors (see section "Other medicines and Momentfene").
You have previously suffered from stomach or intestinal disorders, particularly if you are elderly. In such cases, especially if you have had ulcers with bleeding or perforation, your doctor may advise starting treatment with the lowest available dose and possibly using concomitant medicines that protect the stomach. This also applies to patients taking low-dose aspirin or other medicines that may increase the risk of stomach and intestinal disorders (see section "Other medicines and Momentfene").
You are taking medicines that could increase the risk of ulcer or bleeding, such as oral corticosteroids (medicines for treating inflammation), anticoagulants, or antiplatelet agents (medicines that make the blood thinner), such as warfarin or aspirin, or selective serotonin reuptake inhibitors (medicines for treating depression) (see section "Other medicines and Momentfene").
You have suffered from inflammatory bowel disease (ulcerative colitis, Crohn's disease), as these conditions may worsen (see section 4. Possible side effects).
You have coagulation disorders.
You have suffered from high blood pressure and/or heart disease, as fluid retention and swelling may occur.
You have had a heart attack or stroke (cerebral ischemia), or if you think you may be at risk for these conditions (e.g., if you have high blood pressure, elevated blood sugar or lipid levels, or if you smoke). Anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a modest increase in the risk of heart attack or stroke, especially when administered at high doses. Do not exceed the recommended dose or duration of treatment.
You suffer from a disease of the immune system (systemic lupus erythematosus), as you may develop aseptic meningitis (a central nervous system disorder of non-bacterial origin).
You are dehydrated (reduced fluid volume in the body), as you may be more prone to kidney-related side effects, especially if you are elderly or an adolescent, or if you are taking other medicines that increase fluid/electrolyte elimination (diuretics, ACE inhibitors).
You have reduced kidney function.
You suffer or have suffered from breathing difficulties due to bronchial constriction (asthma, bronchospasm), particularly if this occurred following the use of other medicines.
You have or have had allergies (e.g., hay fever).
You have nasal inflammation (chronic rhinitis) or nasal polyps.
You have previously experienced swelling of the hands, feet, ankles, face, lips, tongue, and/or throat (angioedema).
You have kidney and/or liver or heart disease. Your doctor will perform periodic examinations, especially during prolonged treatment.
You have chickenpox, as pain and anti-inflammatory medicines (NSAIDs) may worsen the severity of skin lesions caused by it. In such cases, your doctor may advise against using this medicine.
You have an infection – see section "Infections" below.

Heart attack and stroke
Anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a modest increase in the 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 BRUFEN 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.

Signs of an allergic reaction to ibuprofen have been reported, including breathing difficulties, facial and neck swelling (angioedema), and chest pain. Stop taking MOMENTFENE immediately and contact your doctor or emergency medical services if you notice any of these signs.
Skin reactions
Serious skin reactions have been reported with ibuprofen 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 Momentfene and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Report to your doctor any unusual stomach or intestinal symptoms (especially gastrointestinal bleeding), particularly during the initial stages of treatment. If an ulcer or bleeding occurs, treatment must be discontinued.
If you are undergoing prolonged treatment with Momentfene, have periodic eye examinations.

Infections
Momentfene may mask symptoms of infections such as fever and pain. Therefore, Momentfene 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 persist or worsen, consult your doctor immediately.
BE CAREFUL, because during treatment with all non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain and inflammation:

At any time, with or without warning symptoms, even in patients without prior serious gastrointestinal problems, bleeding, ulceration, or perforation of the stomach or intestine may occur, which can be life-threatening (see section "Do not take BRUFEN"). If you are elderly or have previously experienced such problems, the risk of these events increases with higher doses. In this case, your doctor may advise starting treatment with the lowest available dose and may prescribe a gastroprotective medicine (such as misoprostol or proton pump inhibitors) to be taken together with BRUFEN.
Very rarely, severe skin reactions, some of which have been fatal, have been reported, characterized by redness, blistering, and skin peeling (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis). The risk of such reactions is higher during the initial stages of treatment, particularly within the first month.
Severe allergic reactions (anaphylactoid reactions, up to anaphylactic shock) may occur.
Eye disorders may occur with BRUFEN use. Periodic eye examinations are necessary during treatment, especially for prolonged therapy.
Headache may occur, especially if used for prolonged periods and at high doses; in such cases, do not increase the BRUFEN dose to relieve pain.

If you have impaired heart, liver, or kidney function (particularly if you have systemic lupus erythematosus), your doctor will prescribe periodic specific tests, especially during prolonged treatment, and will prescribe the lowest effective dose for the shortest possible duration needed to control symptoms.
The risk of side effects may be reduced by using the lowest effective dose for the shortest possible duration needed to control symptoms. Do not exceed the recommended dose of BRUFEN or take it for long periods; always follow your doctor's instructions carefully.
STOP treatment and contact your doctor if:

You notice any gastrointestinal symptoms, especially bleeding, particularly if this occurs early in treatment, if you are elderly, or if you have previously had gastrointestinal problems.
A skin rash, mucosal lesions, or any other sign of an allergic reaction appears (e.g., redness, itching, facial or throat swelling, sudden drop in blood pressure).
You experience vision problems.
You experience liver problems.

Children and adolescents
Do not give Momentfene to children aged 0 to 12 years (see section "Do not take Momentfene"). There is a risk of kidney damage in dehydrated children and adolescents.
Other medicines and MOMENTFENE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Momentfene may interact with or be affected by other medicines and should therefore be used with caution with:

Medicines for treating inflammation (e.g., corticosteroids) or other NSAIDs, as this combination may increase the risk of stomach or intestinal ulcer or bleeding (see section "Warnings and precautions").
Medicines with anticoagulant and/or antiplatelet effects (i.e., substances that thin the blood and prevent clotting, e.g., aspirin/acetylsalicylic acid, warfarin, ticlopidine).
Acetylsalicylic acid, as Momentfene may reduce its effect.
Medicines for treating depression (selective serotonin reuptake inhibitors), as this combination may increase the risk of gastrointestinal bleeding (see section "Warnings and precautions").
Medicines that lower high blood pressure (diuretics, ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan): Momentfene may reduce the effectiveness of these medicines. If you have kidney disease, especially if you are elderly, this combination may worsen kidney function. Therefore, your doctor will perform tests and monitoring during treatment with Momentfene.
Medicines for treating certain mental disorders (phenytoin, lithium).
Medicine used to treat certain cancers and immune disorders (methotrexate), as methotrexate may become toxic to the kidneys when taken with Momentfene.
Aminoglycosides (a class of antibiotics), as their elimination may be reduced when taken with Momentfene.
Medicines for treating heart rhythm disorders (digoxin).
Medicine used to lower blood cholesterol (cholestyramine), as it may reduce the effect of ibuprofen.
Medicines that reduce immune system activity, e.g., after organ transplantation (cyclosporine, tacrolimus), as they may increase kidney-related side effects.
Ginkgo Biloba (a herbal extract).
Medicine used for abortion (mifepristone), as it may reduce the effect of mifepristone.
Quinolones (a class of antibiotics), as using Momentfene with these antibiotics may cause seizures.
Medicines used to treat diabetes (sulfonylureas), as their effect may be increased.
Medicine used to treat HIV (zidovudine), as blood-related side effects may increase.
Ritonavir (an HIV treatment medicine) and probenecid (a medicine used to treat gout), as they may increase the effect of Momentfene.
Medicines used to treat fungal infections (voriconazole and fluconazole). Ibuprofen increases its effect when taken with these medicines; therefore, your doctor will reduce the dose of Momentfene.
Bisphosphonates, medicines used to treat bone diseases, as they may increase gastrointestinal side effects.
Oxpentifylline (pentoxifylline), a medicine used to treat leg ulcers, as it may increase gastrointestinal side effects.
Baclofen, a medicine used to relax muscles.
Moclobemide, a medicine used to treat depression.

Other medicines may also affect or be affected by treatment with Momentfene. Therefore, consult your doctor or pharmacist before using Momentfene with other medicines.
Momentfene with food, drinks, and alcohol
Avoid drinking alcohol, as it may increase the side effects of Momentfene, particularly those affecting the stomach, intestine, or brain.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not use Momentfene during the last three months of pregnancy, as it may harm the fetus or cause delivery complications. 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 labour beyond normal.
You should not take Momentfene during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or during attempts to conceive, the lowest possible dose should be used for the shortest possible time.
From the 20th week of pregnancy, Momentfene 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.
Breastfeeding
The use of Momentfene is not recommended during breastfeeding, as it passes into breast milk in very small amounts. If prolonged treatment with this medicine is prescribed, your doctor should consider the possibility of early weaning.
Fertility
If you have fertility problems or are planning to become pregnant, discontinue the use of Momentfene.
Driving and using machines
Momentfene may cause side effects that could impair your reaction to stimuli, such as headache, dizziness, vertigo, drowsiness, fatigue, and visual disturbances. Make sure you do not experience any of these side effects before driving, operating machinery, or performing any activity requiring alertness. This is particularly important if you consume alcohol during treatment with Momentfene.
Momentfene contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
Momentfene contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".

3. How to take Momentfene

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults and adolescents aged 12 years and older (weight > 40 kg)
The recommended dose is 1 to 3 tablets daily, as determined by the doctor.
The maximum daily dose must not exceed 1800 mg (3 tablets).
If you suffer from rheumatism, take the first daily dose upon waking and subsequent doses with meals.
Patients with impaired liver or kidney function
If you have liver or kidney problems, your doctor may reduce your dose and will monitor your liver and kidney function periodically, especially if treatment is prolonged.
If you have severe hepatic or renal insufficiency, do not take Momentfene (see section 2).
Elderly patients
If you are elderly, your doctor may reduce your dose.
The lowest effective dose for the shortest necessary duration should be used to relieve symptoms. If you have an infection, contact your doctor immediately if symptoms (e.g., fever and pain) persist or worsen (see section 2).
Do not exceed the recommended dose or duration of treatment.
Method of administration
Taking Momentfene during meals is recommended for patients with gastric sensitivity. Momentfene tablets should be swallowed whole with plenty of water. The tablets must not be chewed, broken, crushed, or sucked.
If you take more Momentfene than you should
If you have taken more Momentfene than prescribed, or if your child has accidentally ingested this medicine, contact a doctor or the nearest hospital immediately for advice on potential risks and necessary actions.
In cases of severe poisoning, metabolic acidosis (increased acid levels in the blood) may occur. Symptoms of overdose may include nausea, stomach ache, vomiting (possibly with traces of blood), headache, tinnitus, 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, low blood potassium levels, feeling cold, and breathing difficulties may occur.
Additionally, the following symptoms may appear: deep sleep with reduced response to normal stimuli (lethargy), lowered body temperature (hypothermia), kidney effects, gastrointestinal bleeding, profound loss of consciousness (coma), temporary cessation of breathing (apnea), diarrhea, reduced activity of the central nervous system and respiratory function, disorientation, agitation, fainting, low blood pressure (hypotension), and decreased or increased heart rate (bradycardia or tachycardia).
If significantly high doses of ibuprofen are taken, severe kidney (renal failure) and liver damage may occur.
Symptoms of overdose may appear within 4–6 hours after ibuprofen ingestion.
If you have any doubts about using Momentfene, consult your doctor or pharmacist.
If you forget to take Momentfene
Do not take a double dose to make up for a missed tablet.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following symptoms, stop using Momentfene immediately and
contact your doctor or go to the nearest hospital, where you will be given appropriate and
specific treatment:

Flat, reddish spots, 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 (including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported very rarely in association with NSAID use. Patients appear to be at higher risk during the initial stages of therapy: the reaction usually occurs within the first month of treatment. Discontinue treatment with Momentfene at the first sign of skin rash, mucosal lesions or any other sign of hypersensitivity/allergy.
Signs of allergic reaction which may include: itching, urticaria, purpura (reddish skin discoloration due to blood accumulation under the skin), angioedema (swelling of hands, feet, ankles, face, lips, tongue and/or throat), unspecified allergic reactions, anaphylactic reactions (severe allergic reactions). Hepatotoxic reactions may occur as part of generalized hypersensitivity reactions.
During treatment with all NSAIDs, at any time, with or without warning symptoms or previous history of serious gastrointestinal events, gastrointestinal bleeding, ulceration and perforation have been reported, which may be fatal. If gastrointestinal bleeding or ulceration/perforation occurs in patients taking Momentfene, treatment must be discontinued.
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 (acute generalized exanthematous pustulosis).

If you experience any side effects during treatment, stop the therapy immediately and consult your doctor.
Additionally, you may experience other side effects.
Common (may affect up to 1 in 10 people):

Headache, dizziness
Indigestion, diarrhoea, nausea, vomiting, stomach pain, flatulence, constipation, blood in stools, blood in vomit, gastrointestinal bleeding, stomach discomfort, heartburn
Skin rash
Fatigue

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

Nasal congestion (rhinitis)
Hypersensitivity
Insomnia, anxiety
Numbness of limbs or other body parts (paraesthesia), drowsiness
Visual disturbances
Impaired hearing, ringing in the ears (tinnitus), vertigo
Breathing problems (asthma)
Difficulty breathing (bronchospasm, dyspnoea)
Temporary cessation of breathing (apnoea)
Inflammation of the stomach (gastritis), mouth sores, intestinal or stomach ulcer (duodenal ulcer, gastric ulcer), perforation of the stomach or intestine
Inflammation of the liver (hepatitis), yellowing of the skin and whites of the eyes (jaundice), reduced liver function
Urticaria, itching, red spots on the skin (purpura), swelling of the skin and mucous membranes (angioedema), increased sensitivity to sunlight (photosensitivity)
Kidney disorders leading to reduced kidney function, including interstitial nephritis, nephrotic syndrome and renal failure
Reduced blood flow to the kidneys (especially if you already have renal perfusion problems).

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

Aseptic meningitis (especially if you suffer from autoimmune diseases such as systemic lupus erythematosus or mixed connective tissue disease). Aseptic meningitis is a central nervous system disease of non-bacterial origin, with symptoms including neck stiffness, headache, nausea, vomiting, fever or confusion.
Decreased number of white blood cells in the blood (leucopenia/neutropenia/agranulocytosis)
Decreased number of platelets in the blood (thrombocytopenia), resulting in reduced platelet aggregation and increased risk of bleeding
Decreased number of all types of blood cells (aplastic anaemia)
Decreased haemoglobin in the blood (haemolytic anaemia)
Severe, rapidly occurring, life-threatening allergic reaction (anaphylactic reaction)
Depression, confusion, perception of non-existent things (hallucinations)
Vision disturbances, for example due to inflammation of the optic nerve (optic neuritis) or toxic optic neuropathy
Swelling due to fluid accumulation in tissues (oedema)
Malaise

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

Inflammation of the pancreas (pancreatitis)
Liver disease (hepatic failure)
Severe skin reactions presenting as skin rash (e.g. exfoliative and bullous dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme), disease that may affect various organs and tissues of the body (lupus erythematosus)
Severe heart diseases (heart failure), increased risk of heart attack (myocardial infarction) or reduced or blocked blood flow to the brain (stroke), awareness of your own heartbeat (palpitations), accumulation of fluid around the lungs (acute pulmonary oedema)
High blood pressure (hypertension)

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

Worsening of inflammatory bowel diseases (colitis and Crohn's disease)
A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cell).
A widespread, red, scaly rash, with pustules under the skin and blisters, mainly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using Momentfene if you develop these symptoms and contact your doctor immediately. See also section 2.
Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Other side effects

Inflammation of the mouth mucosa with ulcers (ulcerative stomatitis);
Worsening of skin infections caused by chickenpox.
Side effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet,
please contact your doctor or pharmacist. You may 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 Momentfene

This medicine does not require any special storage conditions.
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 carton 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. Contents of the pack and other information

What Momentfene contains

The active substance is ibuprofen 600 mg.
The other ingredients are: tablet core: pregelatinized starch, croscarmellose sodium, sodium carboxymethyl starch (see section “Momentfene contains sodium”), sodium lauryl sulfate, microcrystalline cellulose, povidone, talc, hydrated colloidal silica. Film coating: lactose monohydrate (see section “Momentfene contains lactose”), hypromellose, titanium dioxide, macrogol 4000.

Description of the appearance of Momentfene and pack sizes
Momentfene is available as film-coated tablets for oral use, packed in blisters.
Pack sizes of 10, 12, 20, 24 and 30 film-coated tablets are available.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Aziende Chimiche Riunite Angelini Francesco – A.C.R.A.F. S.p.A.
Viale Amelia, 70 – 00181 ROMA
Manufacturer
ACRAF S.p.A. – Via Vecchia del Pinocchio 22 - 60131 Ancona (AN)