Patient Information Leaflet: Information for the Patient

MOMENFLOGO 600 mg granules for oral solution in sachets

ibuprofen
Generic medicine
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 others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Momenflogo is and what it is used for

This medicinal product contains the active substance ibuprofen, which belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs) that work by relieving pain (analgesic effect) and reducing symptoms of inflammation (anti-inflammatory effect).
Momenflogo is indicated for the treatment of pain or inflammatory conditions in the following cases:

pains of various origin and nature such as headache, toothache, menstrual pain, neuralgia (pain along the nerves), osteoarticular (bone) and muscular pain, pain following episiotomy (surgical incision during childbirth) and postpartum pain, pain after dental extractions, postoperative pain, pain caused by minor injuries or trauma;
inflammatory conditions (inflammatory rheumatism): rheumatoid arthritis, ankylosing spondylitis, Still's disease (juvenile rheumatoid arthritis);
degenerative diseases (degenerative rheumatism) affecting the joints (osteoarthritis), of the spine (cervical, dorsal or lumbar spondylosis), of the knee (gonarthrosis), of the hip (coxarthrosis), or involving multiple joints (polyarthrosis), etc.;
extra-articular rheumatic conditions such as tendinitis (inflammation of tendons), fibrositis (of muscles and tissues), bursitis, myalgia (muscle pain), lumbago (back pain), scapulo-humeral periarthritis (inflammation of fibrous tissues surrounding the joint), sciatica (leg pain caused by irritation of the sciatic nerve), radiculoneuritis (inflammation of nerve roots and nerves).

2. What you should know before taking Momenflogo

Do not take Momenflogo

If you are allergic to ibuprofen, to other similar medicines, or to any of the other ingredients of this medicine (listed in section 6).
If you have previously experienced stomach or intestinal disorders associated with bleeding (gastrointestinal haemorrhage or perforation related to previous treatment with anti-inflammatory medicines (NSAIDs) or a history of recurrent peptic bleeding/ulceration, with two or more distinct episodes of proven ulceration or bleeding);
If you suffer from stomach or intestinal disorders associated with lesions and bleeding (active or recurrent peptic ulcer);
If you have bleeding in the stomach or intestine (gastrointestinal haemorrhage);
If you have other ongoing bleeding, such as cerebrovascular haemorrhage;
If you suffer from chronic inflammatory bowel diseases such as ulcerative colitis (inflammation of the colon with ulcers) or inflammation of the digestive tract (Crohn's disease);
If you have severe liver or kidney problems (severe hepatic or renal insufficiency);
If you have bleeding disorders (haemorrhagic diathesis);
If you suffer from severe heart problems (severe heart failure);
If in the past, after taking acetylsalicylic acid or other anti-inflammatory medicines (NSAIDs), you experienced swelling of the face due to fluid accumulation, especially around the mouth and eyes (angioedema), severe breathing difficulty (bronchospasm), breathing problems (asthma), skin irritation (urticaria), nasal inflammation (rhinitis), or nasal polyps;
If you suffer from systemic lupus erythematosus or other skin diseases (collagen diseases);
If you are in the third trimester of pregnancy (see section “Pregnancy, breastfeeding and fertility”);
If you have phenylketonuria, a condition in which blood and urine tests show abnormal levels of certain substances. In this case, do not take Momenflogo as it contains aspartame;
If you are already taking other anti-inflammatory medicines (including selective COX-2 inhibitors, see section “Other medicines and Momenflogo”).

Warnings and precautions – Be especially careful with Momenflogo
What you should know before taking Momenflogo
Allergic reactions to this medicine, including breathing difficulties, swelling of the face and neck (angioedema), and chest pain, have been reported with ibuprofen.
Stop taking Momenflogo immediately and contact your doctor or emergency medical services right away if you notice any of these signs.
Consult your doctor or pharmacist before taking Momenflogo and pay special attention in the following cases, keeping in mind that any risk is more likely at high doses and with prolonged treatment. The risk of adverse effects can be reduced by using the lowest effective dose for the shortest possible time. Do not exceed the recommended dose or duration of treatment.
Risk of stroke and heart attack: Anti-inflammatory/pain-relieving medicines containing ibuprofen, such as Momenflogo, may be associated with a small increase in the risk of heart attack ("myocardial infarction") 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 Momenflogo if you have:

Heart problems, including heart attack, angina (chest pain), 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, family history of heart disease or stroke, or if you are a smoker.

Gastrointestinal risks: If you are elderly, the risk of adverse effects is higher, especially bleeding and perforation of the stomach and intestine (gastrointestinal events), which can be fatal. At any time, with or without warning symptoms or previous history of serious gastrointestinal events, gastrointestinal bleeding (gastrointestinal haemorrhage), formation of severe lesions (ulceration and perforation), which may be fatal, have been reported.
If you have previously suffered from ulcers, the risk of gastrointestinal bleeding, ulceration, or perforation is higher with increased NSAID doses.
If you are elderly or have had ulcers, especially if ulcers were associated with bleeding or perforation (see section “Do not take Momenflogo”), because the risk of bleeding, ulcer, or perforation is higher, particularly with higher doses of anti-inflammatory medicines. In such cases, treatment should be started with the lowest available dose, and you may need to consult your doctor for a medicine that protects the stomach (misoprostol or proton pump inhibitors). This should also be considered if you are taking low-dose acetylsalicylic acid or other medicines that may increase the risk of stomach and/or intestinal diseases (see section “Other medicines and Momenflogo”). If you have a history of gastrointestinal toxicity, especially if you are elderly, inform your doctor of any unusual abdominal symptoms (particularly gastrointestinal bleeding), especially during the initial stages of treatment. At doses above 1000 mg per day, bleeding time may be prolonged.
Your doctor may recommend taking specific medicines to protect the stomach, such as misoprostol or proton pump inhibitors, especially if you are taking other medicines (e.g., aspirin or medicines that increase the risk of gastrointestinal problems).
If you experience gastrointestinal bleeding or ulceration, stop treatment with Momenflogo and consult your doctor or the nearest hospital immediately.
Take this medicine with caution and discuss treatment with your doctor or pharmacist before taking Momenflogo if:

You are already taking other anti-inflammatory medicines (including selective COX-2 inhibitors, see section “Other medicines and Momenflogo”);
You are taking other medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants like warfarin, selective serotonin reuptake inhibitors, or antiplatelet agents such as acetylsalicylic acid (see section “Other medicines and Momenflogo”);
You suffer or have suffered from high blood pressure (hypertension and/or heart failure), as fluid retention and swelling due to fluid accumulation (oedema) have occurred during NSAID therapy;
You have previously suffered from intestinal disorders (ulcerative colitis, Crohn's disease);
You suffer from heart disorders (mild to moderate congestive heart failure);
You have previously had breathing problems (bronchospasm), especially after using medicines (see section “Warnings and precautions”); bronchospasm may worsen in patients who suffer or have suffered from bronchial asthma or allergic diseases. In such cases, especially for prolonged treatments, your doctor may recommend periodic tests;
You suffer from coagulation disorders or reduced function of the heart, liver, or kidneys; in such cases, especially for prolonged treatments, periodic tests may be necessary; hypersensitivity to Momenflogo may cause liver problems (hepatotoxic reactions);
You suffer from systemic lupus erythematosus, an autoimmune skin disease causing facial lesions and pain, or other skin diseases (collagen diseases). In such cases, consult your doctor before taking Momenflogo;
You intend to become pregnant, as the use of Momenflogo may impair female fertility; use of Momenflogo should be discontinued in women who have fertility problems or who are undergoing fertility investigations.
If you have an infection – see section «Infections» below;

Infections
Momenflogo may mask symptoms of infections such as fever and pain. Therefore, Momenflogo could delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult your doctor immediately.
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 taking Momenflogo and consult your doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.
Vision problems
If you experience vision disturbances, stop treatment with this medicine and consult an ophthalmologist.
Use caution when starting ibuprofen treatment if you suffer from severe dehydration.
Risks associated with habitual and long-term use of analgesics include headache and analgesic nephropathy.
NSAIDs may cause an increase in liver function test results.
Other medicines and Momenflogo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, as they may affect or be affected by treatment with Momenflogo.
Taking Momenflogo, like other similar medicines (non-steroidal anti-inflammatory drugs, analgesics, antipyretics), may cause allergic-type reactions (hypersensitivity), even severe ones (see section “Possible side effects”). Do not use Momenflogo if you are taking other anti-inflammatory medicines (e.g., analgesics, antipyretics, and other NSAIDs such as acetylsalicylic acid/aspirin), as the risk of adverse effects may increase. If you are taking acetylsalicylic acid for heart problems, do not take Momenflogo simultaneously, as it may reduce the cardioprotective effect.
Use this medicine with caution and consult your doctor if you are taking the following medicines:

Medicines used to reduce inflammation and treat allergies (oral corticosteroids); Momenflogo may increase the risk of ulcers or bleeding in the stomach or intestine;
Medicines with anticoagulant effects (i.e., substances that thin the blood and prevent clot formation, e.g., aspirin/acetylsalicylic acid, warfarin, and ticlopidine). Momenflogo may enhance the anticoagulant effect of these medicines; your doctor may therefore require appropriate tests to assess whether your treatment needs adjustment. Momenflogo may also increase the risk of gastrointestinal bleeding when taken concomitantly with antiplatelet agents;
Medicines that lower high blood pressure (diuretics, ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II antagonists such as losartan). Momenflogo may alter the effect of these medicines if taken simultaneously. Additionally, if you have kidney problems, especially if you are elderly or dehydrated, Momenflogo may worsen your condition when taken with ACE inhibitors or angiotensin II antagonists; in such cases, adequate fluid intake is necessary, and your doctor may periodically monitor your kidney function after starting treatment;
Medicines used to treat depression and anxiety disorders (serotonin reuptake inhibitors); Momenflogo may increase the risk of gastrointestinal bleeding;
Medicines containing lithium or phenytoin used for mental disorders; Momenflogo may increase blood levels of these substances;
Medicines used to treat heart conditions such as digoxin; Momenflogo may increase blood levels of this substance.

Other medicines may also affect or be affected by treatment with Momenflogo. Therefore, consult your doctor or pharmacist before using Momenflogo with other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Before starting treatment, ensure you are not pregnant; discontinue treatment if you become pregnant.
Do not use Momenflogo during the last three months of pregnancy as it may harm the fetus or cause problems during childbirth. 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 more than expected.
You should not take Momenflogo 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 for the shortest possible time should be used.
From week 20 of pregnancy, MOMENFLOGO 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
Avoid taking Momenflogo while breastfeeding.
Fertility
Do not take Momenflogo if you have fertility problems.
Children The use of this medicine is limited to adult patients.
Driving and using machines
This medicine may cause drowsiness, dizziness, headache, and depression, which may impair your ability to drive or operate machinery. If these effects occur, avoid driving and using machinery.
Momenflogo contains sucrose, sorbitol, aspartame, sodium, and potassium

Sucrose: If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking this medicine;
Sorbitol: It is a source of fructose. If your doctor has told you (or your child) that you are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic condition where patients cannot properly metabolize fructose, speak with your doctor before you (or your child) take this medicine;
Aspartame: This medicine contains 20 mg of aspartame per sachet, equivalent to 5 mg/g. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it;
This medicine contains 67 mg of sodium (2.9 mmol) (main component of table salt) per sachet. This corresponds to 3.35% of the maximum recommended daily dietary intake for an adult;
This medicine contains 115 mg of potassium (2.9 mmol) per sachet: this should be considered in patients with reduced kidney function or those on a low-potassium diet.

3. How to take Momenflogo

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
This medicine is intended only for adults.
If you are taking this medicine to treat rheumatic pain, take the first dose in the morning upon waking, and subsequent doses with meals.
The recommended dose is 1–3 sachets daily, as directed by the physician. The maximum daily dose must not exceed 1800 mg (3 sachets).
Dissolve the contents of one sachet in a glass of water (50–100 ml) and take immediately after dissolving. This medicine should be taken with food.
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).

Use in the elderly
If you are elderly, consult your doctor, as a dose reduction may be necessary.

Use in patients with impaired renal, hepatic or cardiac function
If you have impaired renal, hepatic or cardiac function, always consult your doctor, as a dose reduction may be required. Momenflogo is contraindicated in cases of severe renal, hepatic or cardiac insufficiency (see section "Do not take Momenflogo").

If you take more Momenflogo than you should
If you have taken more Momenflogo than you should, or if your child has accidentally taken this medicine, contact a doctor or the nearest hospital immediately for advice on the risks and necessary actions.
If you take an excessive dose (overdose) of ibuprofen, you may commonly experience the following symptoms: nausea, vomiting, stomach pain, abdominal pain, deep sleep with reduced response to normal stimuli (lethargy), drowsiness, headache, dizziness, double vision, loss of muscle coordination (ataxia), severe muscle problems (rhabdomyolysis), epileptic seizures, ringing in the ears (tinnitus), uncontrolled body movements (convulsions), and loss of consciousness. Symptoms of overdose may appear within 4–6 hours after taking ibuprofen.
Rarely, you may experience: uncontrolled eye movements (nystagmus), lowered body temperature (hypothermia), kidney-related effects, gastrointestinal bleeding, profound loss of consciousness (coma), temporary interruption of breathing (apnea), diarrhoea, reduced activity of the nervous system (central nervous system depression) and reduced respiration (respiratory depression).
Additionally, you may also experience: disorientation, excited state, fainting, low blood pressure (hypotension), decreased, increased or irregular heart rate (bradycardia or tachycardia).
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 blood), headache, ringing in the ears, confusion, and uncontrolled eye movements. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (especially in children), weakness, dizziness, blood in the urine, low blood potassium levels, feeling cold, and breathing difficulties may occur.
Taking significantly excessive doses of ibuprofen may cause serious kidney damage (renal failure) and liver damage.
Exacerbation of asthma is possible in patients with asthma.
In case of accidental ingestion/overdose of Momenflogo, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about using Momenflogo, consult your doctor or pharmacist.

If you forget to take Momenflogo
Do not take a double dose to make up for the missed sachet.
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 Momenflogo 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 (erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis);
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 occur at the beginning of treatment (generalized acute exanthematous pustulosis);
Patients appear to be at higher risk in the early stages of therapy: reactions usually occur within the first month of treatment. Discontinue treatment with Momenflogo at the first sign of skin rash, mucosal lesions or any other sign of hypersensitivity/allergy. Hepatotoxic reactions may occur as part of generalized hypersensitivity reactions.
Since ocular disorders have been observed, although very rarely, during treatment with ibuprofen, it is recommended to discontinue treatment if visual disturbances occur.
In such cases, consult an ophthalmologist.
During treatment with all NSAIDs, gastrointestinal bleeding, ulceration and perforation, which may be fatal, have been reported at any time, with or without warning symptoms or previous history of serious gastrointestinal events. If gastrointestinal bleeding or ulceration/perforation occurs in patients taking Momenflogo, treatment must be discontinued.

The possible side effects are listed below according to frequency.
If you experience any side effects during treatment, stop the therapy immediately and consult your doctor.

Very common (may affect more than 1 in 10 people)

indigestion (dyspepsia);
diarrhoea.

Common (may affect up to 1 in 10 people)

stomach pain or discomfort, burning sensation in the stomach (pyrosis), nausea, flatulence;
headache (cephalalgia), dizziness;
skin rash; skin disease.

Uncommon (may affect up to 1 in 100 people)

formation of stomach or intestinal lesions (peptic ulcers or bleeding), sometimes fatal, particularly in elderly patients (see section “What you need to know before taking Momenflogo”);
vomiting;
presence of blood in stools (melena);
inflammation of the stomach (gastritis);
inflammation of the mouth (stomatitis);
confusion;
drowsiness;
itching, skin irritation (urticaria, exanthema), serious skin condition associated with bleeding (purpura);
swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in breathing and swallowing (angioedema);
allergic reactions;
breathing difficulties (asthma, worsening of asthma, bronchospasm, dyspnoea).

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

formation of stomach or intestinal lesions (gastrointestinal perforation);
constipation;
presence of blood in vomit (haematemesis);
inflammation of the mouth associated with lesions (ulcerative stomatitis);
worsening of certain intestinal disorders (colitis and Crohn’s disease);
hearing disorders, ringing in the ears (tinnitus);
visual disturbances (blurred vision and amblyopia);
changes in platelet, white blood cell and red blood cell levels (thrombocytopenia, agranulocytosis, aplastic anaemia, haemolytic anaemia, granulocytopenia);
presence of blood in urine (haematuria);
difficulty in passing urine (dysuria);
liver problems;
changes in liver function tests (elevated transaminases);
difficulty distinguishing colours;
severe allergic reaction (anaphylaxis).

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

impairment of sensory functions and orientation (mental confusion);
severe skin disorders (exfoliative dermatitis, reactions including Stevens-Johnson syndrome and erythema multiforme, toxic epidermal necrolysis, allergic vasculitis);
kidney problems (interstitial nephritis, papillary necrosis, renal failure, including acute form).

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

decreased appetite and body weight (anorexia);
swelling of a body part due to fluid accumulation (oedema);
fever;
heart problems (heart failure);
increase in high blood pressure (hypertension);
blood circulation problems (thrombosis);
decrease in blood pressure (hypotension);
depression and mental disorders (psychotic reaction);
infection of the membranes covering the brain without bacterial growth in culture (aseptic meningitis);
worsening of skin rashes;
unexpected and exaggerated skin reactions to sunlight exposure (photosensitivity reaction);
anaemia;
muscle stiffness;
increased levels of uric acid in the blood (uricaemia);
poor excretion of sodium and fluids, resulting in swelling (oedema);
menstrual cycle disorders;
inflammation of the liver (hepatitis), liver damage, jaundice;
changes in kidney function tests;
severe clinical reaction triggered in a sensitized individual upon contact with a specific allergen (anaphylactic shock);
burning and pain in the throat (throat irritation);
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 cells).
A widespread, red, scaly rash, with pustule formation under the skin and blisters, mainly localized in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (generalized acute exanthematous pustulosis). Stop using Momenflogo 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.

Medicines such as Momenflogo may be associated with a slight increase in the risk of heart attack ("myocardial infarction") or stroke.

Reporting of side effects
If you experience any side effects, 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 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 Momenflogo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP.
The expiry date refers to the last day of that month.
Do not store above 25°C.
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 Momenflogo contains

The active substance is sodium ibuprofen dihydrate 768 mg, equivalent to 600 mg of ibuprofen.
The other components are sucrose, potassium bicarbonate, sorbitol, aspartame (see section 2. Momenflogo contains sucrose, sorbitol, aspartame, sodium and potassium), orange flavour, acesulfame potassium, sucralose, mint-liquorice flavour, anhydrous colloidal silica.

Description of the appearance of Momenflogo and contents of the pack
Momenflogo is presented as an oral solution granulate in sachets.
It is available in packs of 30 sachets.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aziende Chimiche Riunite Angelini Francesco – A.C.R.A.F. S.p.A.
Viale Amelia, 70 – 00181 ROME
Manufacturer
E-Pharma Trento S.p.A. - Via Provina, 2 – 38123 Trento, Ravina fraction (TN)
ACRAF S.p.A. – Vecchia del Pinocchio 22 – 60131 Ancona (AN)