MOMENDOL 220 MG SOFT CAPSULE 12 CAPSULES IN PVC/PCTFE/AL BLISTER

Name
MOMENDOL 220 mg soft capsules
Naproxen sodium


What it is and what it is used for
Momendol contains naproxen, a medicine that belongs to the class of analgesics-anti-inflammatory, i.e. drugs that fight pain and inflammation.
Momendol is used in adults and adolescents aged 16 years and over for the short-term treatment of:
- mild to moderate pain such as headache, joint and muscle pain (e.g. backache, stiff neck), toothache and menstrual pain;
- fever.

Talk to your doctor if you do not feel better or if you feel worse.
Do not prolong treatment with Momendol for:
- more than 7 days for pain;
- more than 3 days for fever.


What you need to know before taking the medicine
Do not take Momendol
- if you are allergic to naproxen or any of the other ingredients of this medicine (listed in section 6);
- if you are allergic to substances closely related to naproxen from a chemical point of view;
- if you suffer from allergic diseases, such as asthma, hives, runny nose (rhinitis), polyps in the nose, swelling of the skin and mucous membranes (angioedema);
- if you have had allergic reactions caused by acetylsalicylic acid, painkillers, anti-inflammatories or drugs used to treat rheumatism;
- if you have suffered from gastrointestinal or other bleeding, such as cerebrovascular;
- if you have had bleeding or perforation of the stomach or intestine in the past following the intake of medicines;
- if you have had two or more distinct episodes of stomach ulcers or bleeding in the past;
- if you have suffered from inflammation of the stomach lining (e.g. congestive gastropathy, atrophic gastritis);
- if you have an active stomach or duodenal ulcer;
- if you suffer from inflammatory bowel diseases (e.g. ulcerative colitis and Crohn's disease);
- if you are under 16 years of age;
- if you are pregnant or breast-feeding (see section "Pregnancy and breast-feeding");
- if you have serious heart disease;
- if you have severe liver or kidney disease;
- if you are taking diuretics (medicines to treat high blood pressure) in high doses (see section "Other medicines and Momendol");
- if you are currently bleeding or are taking anticoagulant medicines (medicines that thin the blood) and are at risk of bleeding.


Warnings and precautions
In general, adverse effects may be minimized by using the lowest effective dose, and for the shortest duration of treatment necessary to control symptoms, especially in elderly patients.

Talk to your doctor or pharmacist before taking Momendol:
- if you are taking other anti-inflammatory medicines (including selective COX-2 inhibitors and some NSAIDs) as they may cause a small increase in the risk of heart attack (myocardial infarction) or failure of blood flow to the brain (stroke) (see section "Other medicines and Momendol");
- if you suffer from high blood pressure and/or have non-serious heart disease, since fluid retention, increased blood pressure and swelling have been reported following treatment with NSAIDs;
- if you suspect you have an infection;
- if you are elderly, have known non-serious kidney, liver or heart problems or are taking an anti-inflammatory medicine for a long time; in these cases your doctor will advise you to start treatment with the lowest dose and possibly use concomitant medicines that protect the stomach;
- if you habitually drink high doses of alcohol;
- if you want to take Momendol because you have stomach pain;
- if you have suffered from non-serious stomach and/or intestinal problems in the past due to a medicine;
- if you are taking medicines against inflammation (oral corticosteroids), medicines that thin the blood (anticoagulants such as warfarin) or medicines against depression (selective serotonin reuptake inhibitors);
- if you are taking Aspirin/acetylsalicylic acid to prevent blood clots;
- serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with Momendol. If you notice any of the symptoms of these serious skin reactions, described in section 4, stop taking Momendol and contact your doctor immediately.

Stop taking Momendol and contact your doctor or pharmacist if while taking Momendol:
- vision problems appear;
- have an infection or notice a worsening of an infection;
- in the event of an injury you notice a prolongation of the time it takes for the bleeding to stop;
- a sudden, intense pain appears in your stomach;
- especially in the first few days of treatment, you experience any unusual symptoms in your stomach and/or intestines (especially bleeding);
- particularly in the first month of treatment, you experience changes in the skin or mucous membranes or any other sign of hypersensitivity which could be signs of serious allergic reactions (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis).

Your doctor will monitor your kidney function:
- if he is elderly;
- if you suffer from diseases that compromise kidney function and diuresis (the process that allows the formation of urine);
- if you are taking diuretics (medicines used to treat high blood pressure and which increase the amount of urine);
- if you have recently undergone surgery involving hypovolaemia (decrease in blood volume).

During treatment with Momendol, your doctor will monitor you carefully:
- if you have any diseases that alter blood clotting;
- if you are taking any medicines that may affect blood clotting.

Children and adolescents
Momendol can be used in adolescents aged 16 years and over.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

The use of Momendol can cause side effects that are generally mild or moderate (nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia (difficulty digesting), abdominal pain), or more serious, allergic-type reactions.

If you develop an ulcer, or if you experience bleeding in the stomach with melaena (passage of blackish stools), haematemesis (vomiting blood) and/or in the intestine or lesions of the skin and/or mucous membranes, you must stop treatment with Momendol and contact your doctor.
Furthermore, if you experience any of the following symptoms, STOP using Momendol immediately and contact your doctor or the nearest hospital where you will be given appropriate and specific treatment:
• skin rashes or lesions
• mucosal lesions
• signs of allergic reaction (erythema, itching, urticaria)
• flaking skin
• severe skin rash or peeling of the skin (toxic epidermal necrolysis, Stevens-Johnson syndrome)
• bleeding, ulceration and perforation of the stomach and intestines, which can be fatal, particularly in the elderly
• visual disturbances
• edema, hypertension and heart failure.

The risk of experiencing these symptoms is higher in the early stages of therapy. In most cases, the reaction occurs within the first month of treatment.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.

You may also experience other side effects, listed below according to frequency:

Common (may affect up to 1 in 10 people)
• nausea
• difficulty digesting (dyspepsia)
• vomit
• heartburn (pyrosis)
• stomach pain (gastralgia)
• emission of gas (flatulence)
• headache (cephalea)
• drowsiness
• dizziness
• dizziness

Uncommon (may affect up to 1 in 100 people)
• diarrhea
• constipation
• sleep disturbances, insomnia and drowsiness
• excitement
• vision disorders
• ringing in the ears (tinnitus)
• hearing disorders
• allergic reactions with swelling and angioedema
• chills
• skin rash
• itching
• swelling (edema)
• bruises (ecchymosis)
• reduced kidney function

Rare (may affect up to 1 in 1,000 people)
• stomach or intestinal ulcer
• stomach or intestinal bleeding
• perforation of the stomach or intestine
• blood in vomit (hematemesis)
• lesions inside the mouth (ulcerative stomatitis)
• worsening of colitis
• worsening of a chronic inflammatory bowel disease (Crohn's disease)
• kidney inflammation (glomerulonephritis)
• weakness and muscle pain (myalgia)
• fever
• increase and decrease in blood glucose

Very rare (may affect up to 1 in 10,000 people)
• inflammation inside the mouth (stomatitis), aphthous ulcers
• inflammatory disease of the colon and intestine (colitis), pancreas (pancreatitis) and esophagus (esophagitis)
• yellowish coloration of the skin (jaundice)
• inflammation of the liver (hepatitis)
• reduced liver function
• decrease in hemoglobin, the substance that carries oxygen in the blood (aplastic or hemolytic anemia)
• reduction in the number of platelets in the blood (thrombocytopenia)
• decreased number of white blood cells (granulocytopenia, leukopenia) up to complete absence (agranulocytosis)
• increase in blood cells called eosinophils (eosinophilia)
• difficulty breathing (dyspnea, asthma), eosinophilic pneumonia, alveolitis
• sensitivity to light (photosensitivity)
• reduction in the quantity of hair and fur (alopecia)
• skin rash with blisters (vesicular rash) or with nodules, pustules or reddish spots
• red rosette-shaped patches on the skin (erythema multiforme)
• redness and blisters (fixed erythema)
inflammatory reaction with formation of small purple papules (lichen planus) • sweating
• systemic lupus erythematosus (chronic autoimmune disease)
• rapid heartbeat (tachycardia)
• swelling (edema) and inflammation of the vessels (vasculitis)
• high blood pressure (hypertension)
• heart failure (serious heart disease)
• renal failure
• inflammation or damage to the kidneys with loss of proteins and blood in the urine
• increased potassium in the blood
• increased creatinine in the blood
• symptoms such as fever, drowsiness, headache, sensitivity to light in patients with immune system diseases (meningitis-like symptoms) and convulsions
• cognitive disorders
• thirst and malaise
• depression and difficulty concentrating and thinking
• inflammation of the anterior part of the optic nerve (papillitis)
• inflammation of the back of the optic nerve (retrobulbar optic neuritis)
• swelling of the papilla at the back of the eye (papilledema)
• hearing loss.

Not known: frequency cannot be estimated from the available data

Stop taking Momendol and contact your doctor immediately if you notice any of the following side effects:

-Extensive skin rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other organs (Drug Reaction with Eosinophilia and Systemic Symptoms, also known as DRESS). See also section 2.

-A distinctive allergic skin reaction known as a fixed drug eruption, which usually recurs at the same site or sites with new exposure to the medicine and may appear as round or oval patches of red, swollen skin, a rash with blisters (hives), or an itchy sensation.

• inflammation of the stomach (gastritis)

Other side effects that have been reported with other medicines similar to Momendol and which may therefore also be potential side effects of Momendol:
• allergic reactions, even serious ones.
The characteristic symptoms of a serious allergic reaction are: sudden severe low blood pressure, rapid or slow heartbeat, unusual tiredness or weakness, anxiety, agitation, loss of consciousness, difficulty breathing or swallowing, itching, hives with or without swelling of the skin, redness of the skin, nausea, vomiting, abdominal pain with cramps, diarrhoea.
Medicines similar to Momendol may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.