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

Moment contains ibuprofen, a medicine which belongs to the class of anti-inflammatory analgesics, that is the group of medicines used to relieve pain and inflammation.

Moment is used in adults and in adolescents aged 12 years or over to:

-  treat pain of various types and origins (headache, toothache, neuralgia, joint and muscle pain, menstrual pain);

-  reduce the symptoms of fever and flu.

You must talk to a doctor if you do not feel better or if you feel worse after 3 days of treatment.

Do not take Moment

-             If you are allergic to ibuprofen and/or any of the other ingredients of this medicine (listed in section 6).

-             If you are allergic to other antirheumatic drugs (e.g. acetylsalicylic acid, etc.), medicines used to treat joint or muscle pain (see section “Other medicines and Moment”).

-             If the patient is a child under 12 years of age.

-             If you are in the last trimester of pregnancy or are breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

-             If you have a stomach or intestinal disease (for example, active or severe gastroduodenal ulcer).

-             If you have a history of stomach or intestinal bleeding or perforation after taking any medications.

-             If you have had two or more distinct episodes of stomach ulcer or bleeding.

-             If you have a serious heart disease (serious heart failure).

-             If you have a serious liver or kidney disease.

-             If you have lost a lot of water from your body (severe dehydration) due to vomiting, diarrhoea or insufficient intake of liquids.

Talk to your doctor or pharmacist before taking Moment:

-             If you have had episodes of difficulty breathing (bronchospasm) after using acetylsalicylic acid (aspirin) or other anti-inflammatory drugs.

-             If you have asthma, runny nose (chronic rhinitis), polyps in the nose (nasal polyposis) or inflammation of the sinus mucosa (sinusitis), or if you have had/have allergies, because you may experience difficulty breathing (bronchospasm), reddening of the skin with itching (urticaria) or swelling of the skin and throat (angioedema), especially if you have already had allergic reactions after using other medicines used to treat joint or muscle pain, fever or to treat inflammation (NSAIDs).

-             If you are taking other anti-inflammatory drugs, including selective COX-2 inhibitors (an enzyme involved in inflammatory processes), as in these cases the risk of ulcers and bleeding may increase (see section “Other medicines and Moment”).

-             If you are elderly or if you have had an ulcer, especially if the ulcer has occurred with bleeding or perforation (see section “Do not take Moment”), as the risk of bleeding, ulceration or perforation is higher, especially with higher doses of anti-inflammatory drugs. In these cases, you should start treatment with the lowest available dose and, if necessary, ask your doctor to prescribe you a medicine to protect the stomach (such as misoprostol or proton pump inhibitors). This option should also be taken into consideration if you are taking low doses of acetylsalicylic acid or medications that may increase the risk of stomach and/or intestinal diseases (see section “Other medicines and Moment”).

-             If you have or have had a chronic intestinal disease (ulcerative colitis, Crohn's disease), as they may worsen (see section 4 “Possible side effects”).

-             If you have had a stomach or intestinal disease related to medication use, and particularly if you are elderly, you should report any unusual intestinal symptoms (especially bleeding) to your doctor, especially in the initial stages of treatment.

-             If you notice a skin rash, mucosal lesions or any other sign of hypersensitivity, vision disturbances or persistent signs of liver malfunction. In such cases, treatment with Moment must be discontinued. The greatest risk occurs at the beginning of your treatment. In the majority of cases, the reaction occurs within the first month of treatment. Severe skin reactions, some of which were fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section “Possible side effects”).

-             If you are taking other medicines that increase the risk of stomach and/or intestinal ulcers or bleeding, such as oral corticosteroids (e.g. cortisone), anticoagulants (e.g. warfarin), antidepressants (selective serotonin reuptake inhibitors) or antiplatelet agents (e.g. acetylsalicylic acid). See also the section “Other medicines and Moment”. If gastrointestinal bleeding or ulceration occurs in patients receiving Moment, discontinue treatment.

-             If you have high blood pressure and the medicines you are taking fail to lower it and/or you have heart disease or a circulatory disease of the brain or other body regions, or think you may be at risk for these diseases (for instance, if you have high blood pressure, diabetes or high cholesterol or if you smoke).

-             If you have high blood pressure and/or heart disease, since fluid retention, increased blood pressure and swelling have been found following treatment with NSAIDs. NSAIDs may reduce the action of medicines to lower blood pressure (see section “Other medicines and Moment”).-             If you have lost a considerable amount of fluid or if swelling, heart disease or high blood pressure arise.

-             If you have reduced kidney function, heart or liver malfunction, if you are elderly or are being treated with medications for high blood pressure, since you may be more predisposed to the onset of kidney problems. In addition, habitual concomitant use of various painkillers can further increase this risk.

-             If you suffer from a blood coagulation disease or you are taking medicines to slow down clotting (anticoagulants) (see section “Other medicines and Moment”).

-             If you have a disease that can affect various organs and tissues of the body (widespread or systemic lupus erythematosus) or from a connective tissue disease, present in many parts of the body, e.g. bones and cartilage, because on rare occasions symptoms of “aseptic meningitis” have been observed in patients being treated with ibuprofen. Although it is more likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has also been observed in patients who did not show chronic concomitant diseases.-             If you are taking medicines to treat pain, heart disease or high blood pressure (see section “Other medicines and Moment”).-             If you are planning to become pregnant (see section “Pregnancy, breastfeeding and fertility”).-             If you are having difficulties becoming pregnant or if you are undergoing fertility tests (see section “Pregnancy, breastfeeding and fertility”).

Anti-inflammatory/pain medicines, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, particularly when administered at high doses. Do not exceed the recommended dose or duration of treatment.

You should discuss your treatment with your doctor or pharmacist before taking Moment if you have:

-        heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries) or any kind of stroke (including “mini-stroke” or “TIA - transient ischaemic attack);

-        high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.

Medicines like Moment may:

-        be associated with the onset of potentially severe kidney diseases (such as renal papillary necrosis, analgesic nephropathy and renal failure). Your doctor will therefore monitor your kidney function;

-        mask the signs and symptoms of current infection (fever, pain and swelling);

-        give rise to eye disorders. It is therefore recommended to carry out regular eye tests in cases of prolonged treatment. If you experience visual disturbances, discontinue treatment with Moment.

Dehydrated adolescents are at risk of developing kidney disease.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Moment may influence or be influenced by other medicines. For example:

Do not take Moment in combination with acetylsalicylic acid (for example aspirin) or other anti-inflammatory drugs (such as COX-2 inhibitors or other NSAIDs).

Seek medical advice before using Moment with other medicines, in particular:

-     corticosteroids (medicines used to treat inflammation, such as cortisone);

-     medicines that are anti-coagulants (namely substances which slow down clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine);

-     medicines that reduce high blood pressure (diuretics, ACE-inhibitors such as captopril, beta-blockers such as atenolol, angiotensin-II receptor antagonists such as losartan). Moment may reduce the effect of these medicines. If you are being treated with any of these medicines, are elderly or have kidney disease, your doctor will ask you to drink plenty of liquids to prevent dehydration and may ask you to take blood tests;

-     selective serotonin reuptake inhibitors (medicines used to treat depression), as they may increase the risk of lesions or bleeding. Your doctor could therefore prescribe you a medicine to protect the stomach;

-     lithium (a medicine used to treat mental illnesses) or phenytoin (a medicine used to treat epilepsy). During treatment with these medicines, your doctor may ask you to undergo blood tests;

-     methotrexate, a medicine used to treat cancer or rheumatoid arthritis;

-     moclobemide, a medicine used to treat depression;

-     aminoglycosides (antibiotics);

-     cardiac glycosides (medicines used to treat certain heart diseases). Medicines like Moment may aggravate heart diseases;

-     cholestyramine (a medicine used to reduce blood lipids);

-     ciclosporin (a medicine used if you have had an organ transplant), as medicines like Moment may increase the risk of kidney damage;

-     herbal extracts such as Ginkgo Biloba because, if they are taken together with medicines like Moment, they may increase the risk of gastrointestinal bleeding;

-     mifepristone (a medicine used in women to induce an abortion);

-     quinolone antibiotics (medicines used to treat infections) because, if they are taken together with medicines like Moment, there may be a greater risk of developing seizures;

-     sulphonylureas, medicines used to treat diabetes. Should you need concomitant treatment with these medications, your doctor may have you undergo blood tests;

-     tacrolimus, a medicine used to prevent and treat organ transplant rejection. Co-administration with Moment may increase the risk of kidney damage;

-     zidovudine and ritonavir, medicines used to treat AIDS. If concomitant treatment is necessary, your doctor may have you undergo blood tests;

-     probenecid, a medicine used to treat gout;

-     CYP2C9 inhibitors, such as voriconazole and fluconazole (medicines used to treat fungal infections);

-     bisphosphonates, medicines to treat bone diseases, as they may increase stomach and intestinal side effects;

-     oxpentifylline (pentoxifylline), a medicine used to treat leg ulcers, as it may increase stomach and intestinal side effects;

-     baclofen, a medicine used to relax muscles.

Some other medicines may also affect or be affected by treatment with Moment. Therefore, always consult your doctor or pharmacist before using Moment with other medicines.

Do not drink alcohol during treatment with Moment, as it may increase possible side effects.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Breastfeeding

Fertility

Moment does not usually affect the ability to drive or use machines. Nevertheless, when performing activities that require alertness, be careful if you notice the onset of drowsiness, vertigo or depression during treatment with Moment.

• Sucrose: if you have been told by your doctor that you have an intolerance to some sugars (such as sucrose), contact your doctor before taking this medicine.
• Sodium: this medicinal product contains less than 1 mmol sodium (23 mg) per dose, meaning it is essentially ‘sodium- free’.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Consult your doctor if you notice any recent change in the characteristics of your disorder.

Adults and adolescents aged over 12 years:the recommended dose is 1-2 tablets, two-three times daily.

Swallow the tablet with a glass of water.

Moment can be taken on an empty stomach. Patients with gastric tolerability problems should take this medicine on a full stomach.

If there are no clear signs of improvement after three days of treatment, consult your doctor.

Do not exceed the dose of 6 tablets per day. If you are elderly, you should follow the minimum dosages indicated above.

If you have kidney and/or liver or heart disease, consult your doctor, who will determine the right dose for you.

If you have severe liver disease, do not take Moment.

Consult your doctor, who will determine the correct dose for you by lowering the recommended dose, especially if you have kidney and/or liver disorders.

Consult your doctor if use of the medicine is necessary in adolescents for more than 3 days or in case of worsening symptoms.

If you have taken more Moment than you should or if your child has taken this medicine by accident, always contact a doctor or the nearest hospital to receive advice regarding the risks and what action to take.

Taking too much (overdose) of ibuprofen commonly presents the following side effects: nausea, vomiting, stomach ache, state of deep sleep with reduced response to normal stimuli (lethargy), drowsiness, headache, vertigo, ringing in the ears (tinnitus), involuntary body movements (seizures) and loss of consciousness. Symptoms of overdose may appear within 4-6 hours after ingestion of ibuprofen.

The following symptoms may rarely be experienced: involuntary eye movement (nystagmus), increased acids in the blood (metabolic acidosis), lowered body temperature (hypothermia), effects on the kidneys, stomach or intestinal bleeding, deep loss of consciousness (coma), momentary interruption of breathing (apnoea), diarrhoea, reduced activity of the nervous system (central nervous system depression) and breathing activity (respiratory system depression).

Furthermore, the following may occur: disorientation, state of excitation, fainting, lowered blood pressure (hypotension), decrease or increase of number of heart beats (bradycardia or tachycardia).

In the event of severe poisoning, there may be an accumulation of acids in the body (metabolic acidosis). Symptoms may include nausea, stomach ache, vomiting (possibly with traces of blood), headache, ringing in the ears, confusion and involuntary eye movement. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (above all in children), weakness and vertigo, blood in the urine, feeling cold and breathing problems have all been reported.

The use of a significantly higher dose of ibuprofen may cause severe kidney and liver damage.

If you have any further questions on the use of Moment, ask your doctor or pharmacist.

Do not take a double dose to make up for a forgotten tablet.

Like all medicines, Moment can cause undesirable effects, although not everybody gets them. The side effects of the medicine can be minimised if you use the lowest recommended dose or if you only use the medicine for the period of time necessary to control your symptoms.

If you get an ulcer or if stomach and/or intestinal bleeding or lesions of the skin and/or mucosa occur, discontinue treatment with Moment and contact your doctor. Usually these side effects are more common in the elderly.

Use of Moment can cause side effects that are generally minor or moderate and, rarely, more severe allergic reactions.

If any of the following symptoms arise, immediately DISCONTINUE use of Moment and contact a doctor or go to the nearest hospital where they can administer appropriate, specific treatment:

rashes or skin lesions,

mucosal lesions,

signs of allergic reaction, including severe symptoms (erythema, itching, urticaria, asthma, swelling of the skin and mucosa, anaphylactic shock),

flaking skin,

severe rash or peeling of the skin (toxic epidermal necrolysis, Stevens-Johnson syndrome),

visual disturbances,

liver disease (liver dysfunction),

bleeding, ulcer and perforation of the stomach or intestine, which could prove fatal, particularly in the elderly.

In the event of an allergic reaction as listed above, go to a hospital, as you need to have immediate access to equipment, medication and staff qualified to treat emergencies. In rare cases, severe side effects have been reported following the use of ibuprofen, sometimes with a fatal outcome, even in the absence of a known allergy.

The risk of developing such symptoms is higher in the initial stages of treatment. In most cases, the reaction occurs within the first month of treatment.

Furthermore, additional side effects may occur which have also been reported with other medicines similar to Moment and which are listed below by frequency:

common (may affect up to 1 in 10 people)

dizziness

malaise

fatigue

uncommon (may affect up to 1 in 100 people)

inflammation of the stomach (gastritis)

insomnia, anxiety

numbness in the limbs or in other parts of the body (paraesthesia), drowsiness

inflammation of the nasal mucosa (rhinitis)

difficulty breathing (bronchospasm, dyspnoea)

momentary interruption of breathing (apnoea)

visual disturbances

hearing impairment

ringing in the ears (tinnitus)

vertigo

liver disorders (impaired liver function)

liver inflammation (hepatitis)

yellowing of the skin and eyes (jaundice)

kidney disease (damage to kidney function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and kidney failure)

allergic reactions, such as skin rash, urticaria, itching, formation of red spots on the skin (purpura), swelling of the skin and mucosa (angioedema), asthma, difficulty breathing (bronchospasm or dyspnoea) and asthmatic attacks with possible lowered blood pressure

skin reactions to light (photosensitivity)

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

reduced number of blood cells: reduction in white blood cells (leukopenia, neutropaenia and agranulocytosis), in red blood cells (haemolytic anaemia and aplastic anaemia) and in blood platelets (thrombocytopenia)

reduced clotting capacity

depression, confusional state, hallucinations

inflammation of the optic nerve (optic neuritis)

inflammation of the meninges, the membranes covering the brain (aseptic meningitis, especially in patients with pre-existing autoimmune disorders, see section “Warnings and precautions”), with symptoms of nuchal rigidity, headache, nausea, vomiting, fever or disorientation

eye disorders with visual disturbances and optic nerve disorder (toxic optic neuropathy)

swelling due to the accumulation of fluid in tissues

lupus erythematosus syndrome (a disease which can affect various organs and tissues of the body)

worsening of inflammation caused by an already present infection (for example development of necrotising fasciitis)

high levels of nitrogen in the blood

altered liver function tests (elevated transaminases, elevated alkaline phosphatase)

abnormal blood tests (low haemoglobin, low haematocrit, prolonged bleeding time, low blood calcium, elevated uric acid in blood)

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

inflammation of the pancreas, a gland involved in digestive processes (pancreatitis)

sensation of feeling one's own heartbeat (palpitations)

heart disease (heart failure)

heart attack (myocardial infarction)

fluid in the lungs (acute pulmonary oedema)

liver disease (liver failure)

hypertension

severe allergic reactions, which may include symptoms such as swelling of the face, tongue and throat, making breathing difficult, fast heartbeat, severe allergic reaction with rapid onset, which can cause death (anaphylaxis), severe rash or peeling of the skin (toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme).

not known (cannot be estimated from the available data)

feeling of indigestion

nausea

vomiting

diarrhoea

flatulence

constipation

difficult digestion

abdominal pain

heartburn

blood in stool

blood in vomit

lesions inside the mouth

worsening of inflammatory diseases of the colon and intestine (colitis, Crohn's disease)

greater risk of sudden reduction of blood circulation in the brain (stroke)

allergic reactions

drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). There is a possibility of a serious skin reaction known as DRESS syndrome. The symptoms of DRESS include skin rash, fever, swelling of lymph nodes and increased eosinophil count (a type of white blood cell).

If you experience any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system on the website 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.

This medicine does not require any special temperature storage conditions.

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 throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Moment contains

-        The active ingredient is 200 mg ibuprofen.

-        The other ingredients are corn starch, sodium starch glycolate, povidone, colloidal anhydrous silica, talc, hydroxypropyl cellulose, gum arabic, sucrose, Macrogol 6000, light magnesium carbonate, titanium dioxide.

Moment comes in the form of oral, film-coated tablets.

Each pack contains 6, 10, 12, 20, 24, 30, 32 or 36 tablets.

The pack of 6 film-coated tablets includes a blister pack protection.

Not all pack sizes may be marketed.

Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.

Viale Amelia, 70 - 00181 Rome, Italy

A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, 22 - 60131 Ancona, Italy

Famar Italia S.p.A., Via Zambelletti, 25 - 20021 Baranzate di Bollate (MI), Italy

October 2019

Anyone may experience various types of pain, of varying origin, frequency and intensity, in particular, headache, toothache, muscle and joint pain and menstrual pain.

Headaches are certainly one of the most common pains. If you suffer from headaches, it is important that factors which may trigger them (irregular eating habits, particular foods, smoking, alcohol, stress, excessive physical strain, excessive exposure to sunlight, loud noises, heavy scents, etc.) be identified and prevented.

Menstrual pain, at times quite intense, can be fought by using painkillers that act by reducing the amount of prostaglandins, substances produced in the uterus and considered largely responsible for this complaint.

Use the QR Code on the box or go to http://leaflet.angelini.it/L01 to read the updated package leaflet and read the package leaflet in other languages.