MOMENXSIN 200 mg/30 mg Film-Coated Tablets

Зміст інструкції

1. Momenxsin 200 mg/30 mg film-coated tablets
   1. What is Momenxsin and what is it used for
   2. What you need to know before taking Momenxsin
   3. How to take Momenxsin
   4. Possible side effects
   5. How to store Momenxsin
   6. Contents of the pack and other information

Momenxsin 200 mg/30 mg film-coated tablets

Ibuprofen/Pseudoephedrine hydrochloride
For adults and adolescents aged 15 years and over

Read this leaflet carefully before taking this medicine as it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist
has told you to.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if your symptoms worsen or if you need to take this medicine for more than 4 days (adults) or 3 days (adolescents).

Contents of this leaflet:

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

1. What is Momenxsin and what is it used for

Momenxsin contains two active ingredients: ibuprofen and pseudoephedrine hydrochloride.
Ibuprofen belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs
provide relief by alleviating pain and reducing fever.
Pseudoephedrine hydrochloride belongs to a class of active ingredients called vasoconstrictors, which act on the
blood vessels in the nose to relieve nasal congestion.
Momenxsin is indicated for the symptomatic treatment of nasal congestion in case of a cold associated with
headache and/or fever, in adults and adolescents aged 15 years and over.
You should only take this combination of active ingredients if you have both a stuffy nose and a headache or
fever. If you experience only one of these symptoms, talk to your pharmacist or doctor about using ibuprofen
or pseudoephedrine alone.
Consult your doctor if your symptoms worsen or if you need to take this medicine for more than
4 days (adults) or 3 days (adolescents).

2. What you need to know before taking Momenxsin

Do not take Momenxsin if:

• you are allergic to ibuprofen or pseudoephedrine hydrochloride or to any of the other ingredients of this

medicinal product (listed in section 6)

• you are under 15 years of age
• you are in the third trimester of pregnancy (at least 7 months pregnant)
• you are breastfeeding
• you have previously had an allergic reaction or shortness of breath, asthma, rash, runny or itchy nose or swelling of the face after taking acetylsalicylic acid or other NSAIDs
• you have previously suffered from or currently suffer from recurrent gastric/duodenal bleeding or ulcers (peptic ulcers) (at least two distinct episodes of ulcers or confirmed bleeding)
• you have a history of gastrointestinal bleeding or perforation related to a previous treatment with NSAIDs
• if you have very high blood pressure (severe hypertension) or uncontrolled hypertension
• if you suffer from severe acute (sudden) or chronic (long-term) kidney disease or renal failure
• you suffer from severe hepatic or renal failure
• you suffer from severe heart failure
• you suffer from severe heart or circulatory problems (cardiopathy, high blood pressure, angina, increased heart rate), hyperthyroidism, diabetes, pheochromocytoma (a tumor of the adrenal gland)
• you have a history of heart attack (myocardial infarction)
• you have previously had a stroke or have been told you are at risk of stroke
• you have a history of seizures (convulsions)
• you suffer from disorders of blood cell production of unknown origin
• you experience an increase in eye pressure (closed-angle glaucoma)
• you have difficulty urinating related to prostate problems
• you have been diagnosed with systemic lupus erythematosus (SLE), a condition that affects the immune system and causes joint pain, skin changes and other problems
• you are taking:
• other nasal decongestants (vasoconstrictor drugs) orally or nasally (e.g. phenylpropanolamine, phenylephrine, ephedrine, xylometazoline or oxymetazoline)
• methylphenidate, a medicine for the treatment of attention deficit/hyperactivity disorder (ADHD)
• medicines for the treatment of depression, such as non-selective monoamine oxidase inhibitors (known as MAOIs, e.g. iproniazide) or have taken them in the last 14 days.

Warnings and precautions – Pay particular attention with Momenxsin
What you need to know before taking Momenxsin
Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck (angioedema) and chest pain, have been reported with ibuprofen. Stop
Momenxsin immediately and contact your doctor or emergency health service immediately if you notice
any of these signs.
Talk to your doctor or pharmacist before taking Momenxsin if:

• you suffer from asthma; the use of this medicine may cause an asthma attack
• you have a history of gastrointestinal disorders (such as hiatal hernia, gastrointestinal bleeding, peptic or duodenal ulcer)
• you suffer from or have previously suffered from gastrointestinal diseases (ulcerative colitis or Crohn's disease)
• you suffer from high blood pressure
• you have liver or kidney problems
• you suffer from diabetes, due to the potential development of diabetic nephropathy
• you suffer from hyperthyroidism or psychosis
• you suffer from a blood coagulation disorder
• you have an infection - see section “Infections” below.

Adverse effects can be minimized by using the lowest effective dose for the shortest possible period. Elderly patients are exposed to a greater risk of adverse effects.
The concomitant use of NSAIDs, including selective cyclo-oxygenase (COX-2) inhibitors, increases the risk of
adverse reactions (see section “Other medicines and Momenxsin” below) and should be avoided.
Anti-inflammatory/pain relievers such as ibuprofen may be associated with a slight increase in the risk of
heart attack or stroke, especially if taken in high doses. Do not exceed the duration of treatment or the dose
recommended.
Talk to your doctor or pharmacist before taking Momenxsin if:

• you suffer from heart problems, including heart failure and angina (chest pain), or have previously had a heart attack, a bypass operation, peripheral arterial disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries) or any type of stroke (including “mini-stroke” or transient ischemic attack “TIA”);
• you suffer from high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke or smoke. The following conditions are contraindicated due to the presence of pseudoephedrine (see section“Do not take Momenxsin if”): severe heart or circulatory problems (cardiopathy, high blood pressure, angina, increased heart rate), hyperthyroidism, diabetes, pheochromocytoma (atumor of the adrenal gland), history of heart attack (myocardial infarction), history of stroke or presence ofrisk factors for stroke.

Prolonged use of any type of pain reliever for headache can worsen it.
If this occurs or is suspected, medical advice should be sought and treatment discontinued.
The diagnosis of medication-overuse headache (MOH) should be suspected in patients
who experience frequent or daily headaches despite (or because of) regular use of headache medications.
Cases of reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported following the use of medicines containing pseudoephedrine. PRES and
RCVS are rare conditions that can lead to reduced blood supply to the brain. Stop
using Momenxsin immediately and seek immediate medical attention if you develop symptoms that could
be signs of PRES or RCVS (see section 4 “Possible side effects” for symptoms).
Sudden abdominal pain or rectal bleeding may occur with Momenxsin, due to
inflammation of the colon (ischemic colitis). If you develop these gastrointestinal symptoms, stop
taking Momenxsin and contact your doctor or seek immediate medical attention. See section

• 4.

With Momenxsin, a reduction in blood flow to the optic nerve may occur. If you experience
sudden loss of vision, stop taking Momenxsin and consult your
doctor or a healthcare facility immediately. See section 4.

Skin reactions
Severe skin reactions, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction
with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with treatment with Momenxin. Stop using
Momenxsin and contact your doctor immediately if you notice any of the symptoms related to these
severe skin reactions described in section 4.
If you develop a generalized feverish rash associated with pustules, stop taking Momenxsin and
contact your doctor or seek immediate medical attention. See section 4.

Interference with blood test results
Pseudoephedrine may interfere with some diagnostic blood tests. If you are to undergo blood tests, tell your doctor that you are taking this medicine.

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

Children and adolescents
Momenxsinshould not be given to children and adolescents under 15 years of age.
Dehydrated adolescents are at risk of kidney failure.

Athletes
For those who engage in sports: the use of the drug without therapeutic necessity constitutes doping and may
still result in positive doping tests.

Other medicines and Momenxsin

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

other medicines.
Momenxsin can affect or be affected by several other medicines. For example:

• anticoagulants (medicines that thin the blood and prevent clots, such as acetylsalicylic acid, warfarin, ticlopidine)
• medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II antagonists such as losartan).

Other medicines can also affect or be affected by treatment with Momenxsin. Always consult a doctor before using Momenxsin with other medicines.
Momenxsin should not be taken in combination with:

• other nasal vasoconstrictors used as nasal decongestants, administered orally or nasally (e.g. phenylpropanolamine, phenylephrine and ephedrine)
• a medicine for the treatment of attention deficit/hyperactivity disorder (ADHD) called methylphenidate
• medicines for the treatment of depression, such as non-selective monoamine oxidase inhibitors (MAOIs, such as iproniazide). Do not use this medicine even if you have taken these drugs in the

last 14 days.
In particular, tell your doctor or pharmacist if you are taking:

• other non-steroidal anti-inflammatory drugs (NSAIDs), including high-dose acetylsalicylic acid and selective COX-2 inhibitors
• medicines for the treatment of heart arrhythmias (cardiac glycosides, e.g. digoxin)
• medicines for the treatment of epilepsy (e.g. phenytoin)
• glucocorticoids, used for many conditions such as pain, swelling, allergies, asthma, rheumatism and skin problems
• injectable heparin
• some medicines for the treatment of depression (e.g. lithium, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (IMAOs))
• medicines for the suppression of the immune system, for example methotrexate (for the treatment of arthritis, psoriasis and some cancers), cyclosporine or tacrolimus (administered after transplants)
• antidiabetic medicines (sulfonylureas)
• medicines used to treat infections (e.g. quinolone antibiotics, trimethoprim)
• medicines that promote urination (diuretics, e.g. potassium-sparing diuretics)
• medicines for the treatment of gout (e.g. probenecid and sulfinpyrazone)
• any anti-migraine medicine (including ergot alkaloid derivatives)
• a medicine for the treatment of HIV/AIDS (zidovudine)
• preparations containing ginkgo biloba.

during a surgical intervention. If you are to undergo surgery, stop taking
Momenxsin several days in advance and inform the anesthesiologist.

Momenxsin and alcohol
You should avoid drinking alcohol during treatment.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Do not take Momenxsin in the last 3 months of pregnancy, as it may harm the fetus or cause problems
during childbirth. This can cause problems with the kidneys or heart of the fetus. It may affect your and
your baby's tendency to bleed and cause a delayed or prolonged labor. Do not
take Momenxsin in the first 6 months of pregnancy unless absolutely necessary and under the advice of
your doctor.
If treatment is needed during this period or while trying to become pregnant, the lowest dose should be used for the shortest possible time. If taken for more than a few days from
the twentieth week of pregnancy onwards, Momenxsin may cause kidney problems in the fetus that may
lead to low levels of amniotic fluid surrounding the baby (oligo-hydramnios) or narrowing of a
blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for more than a few
days, your doctor may recommend additional monitoring.

Breastfeeding
Do not take this medicine if you are breastfeeding, as it may harm the baby.

Fertility
Ibuprofen belongs to a class of medicines (NSAIDs) that can impair fertility in women.
This effect is reversible upon discontinuation of treatment.

Driving and using machines
Momenxsin may cause dizziness, hallucinations, unusual headache and disturbances of vision or hearing,
thus temporarily impairing the ability to drive and operate machinery. If you experience
any of these symptoms, you should avoid driving or operating machinery.

Momenxsin contains:

• Sodium:this medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially ‘sodium-free’.

3. How to take Momenxsin

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Duration of treatment
This medicine should only be used for short periods of treatment. You should take it for the shortest possible time at the minimum dose that relieves your symptoms.
Consult your doctor if your symptoms worsen or if you need to take this medicine for more than 4 days (adults) or 3 days (adolescents).

Dosage
The recommended dose for adults and adolescents aged 15 years or over is:
1 tablet every 6 hours, as needed. In case of more severe symptoms, take 2 tablets every 6 hours, as needed.
The lowest effective dose should be used for the shortest period necessary to relieve symptoms. If you have an infection, consult your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
Never exceed the maximum daily dose of 6 tablets per day (equivalent to 1200 mg of ibuprofen and 180 mg of pseudoephedrine hydrochloride).

Method of administration
The tablets are for oral use. They should be swallowed whole and not chewed, with a glass of water, preferably during meals.

Use in children and adolescents
Momenxsin should not be administered to children and adolescents under the age of 15 years.

If you take more Momenxsin than you should
If you have taken more Momenxsin than you should or if your child has accidentally taken this medicine, always contact a doctor or the nearest hospital to obtain advice on the risk and recommendations on what actions to take.
Stop treatment and consult your doctor immediately, even if you feel well.
In cases of severe poisoning, metabolic acidosis may occur.
Symptoms may include nausea, stomach pain, vomiting (possibly with traces of 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 and dizziness, blood in the urine, feeling cold to the body, and breathing problems have been reported.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Stop taking Momenxsin and consult a doctor immediately if you experience:

• signs of intestinal bleedingsuch as bright red stools (faeces), black tarry stools, vomiting blood or dark particles resembling coffee grounds
• signs of a severe allergic reactionsuch as severe skin rash, peeling, blistering or flaking of the skin, facial swelling, wheezing, shortness of breath, easy bruising
• reddish-purple, flat, target-like or circular spots on the trunk, often with a central blister, skin peeling, sores in the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)
• widespread rash, high temperature and swollen lymph nodes (DRESS syndrome)
• widespread, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear early in the treatment (acute generalized exanthematous pustulosis). Stop treatment with Momenxsin immediately and seek urgent medical attention if you develop symptoms that may be signs of reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:
• severe sudden onset headache
• nausea
• vomiting
• confusion
• seizures
• changes in vision.

Tell your doctor if you experience any of the following side effects, if they worsen
or if you experience any side effect not listed.

Common (may affect up to 1 in 10 people)

• indigestion, discomfort or abdominal pain, nausea, vomiting, flatulence, diarrhoea, constipation, mild gastrointestinal bleeding which in rare cases leads to anaemia

Uncommon (may affect up to 1 in 100 people)

• hypersensitivity reactions with urticaria, itching and asthma attacks (with low blood pressure)
• central nervous system disorders, such as headache, dizziness, difficulty sleeping, agitation, irritability or fatigue
• visual disturbances
• gastric or intestinal ulcers, sometimes associated with bleeding or perforation, gastritis, inflammation of the mouth lining with ulceration (ulcerous stomatitis), worsening of colitis and Crohn's disease
• various skin rashes

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

• tinnitus (ringing in the ears)
• insomnia, nervousness, anxiety, restlessness, tremors, hallucinations
• worsening of asthma or hypersensitivity reaction with shortness of breath
• kidney tissue damage (papillary necrosis), increased uric acid concentrations in the blood

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

• worsening of infectious inflammations (e.g. necrotizing fasciitis), aseptic meningitis (stiff neck, headache, nausea, vomiting, fever or disorientation) in patients with pre-existing autoimmune diseases (systemic lupus erythematosus (SLE), mixed connective tissue disease)
• problems in the production of blood cells (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis) which may cause a greater tendency to bruise or make you more vulnerable to infections
• severe allergic reactions
• psychotic reactions and depression
• high blood pressure, palpitations, heart failure, heart attack
• inflammation of the esophagus (esophagitis) and the pancreas (pancreatitis), diaphragm-like intestinal narrowing
• liver dysfunction, liver damage, particularly with prolonged therapy, liver failure, acute liver inflammation (hepatitis)
• severe skin reactions, including rashes with redness and blistering (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell's syndrome), hair loss (alopecia), severe skin infections and complications involving soft tissues in a varicella infection (varicella-zoster virus infection) increased serum creatinine, edema (particularly in patients with arterial hypertension or renal insufficiency), nephritic syndrome, interstitial nephritis, acute renal failure

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

• reduced blood flow to the optic nerve (ischaemic optic neuropathy)
• behavioural abnormalities
• stroke, seizures, headache
• palpitations, tachycardia, chest pain, arrhythmia
• high blood pressure
• dry mouth, thirst, nausea, vomiting
• rash, urticaria, itching, excessive sweating
• difficulty in urination
• it is possible to develop a serious skin reaction known as DRESS syndrome. Symptoms of DRESS include: rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cell).
• A widespread, red and scaly rash, with pustules under the skin and blisters
• mainly located on the skin folds, trunk and upper limbs accompanied by fever
  at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using Momenxsin if
  you develop these symptoms and contact your doctor immediately. See also paragraph 2.
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.
• Inflammation of the colon due to insufficient blood supply (ischaemic colitis).
• serious conditions affecting the blood vessels in the brain known as reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).

Stop using Momenxsin if you develop these symptoms and contact your doctor or seek immediate
medical assistance
Medicines like Momenxsin may be associated with a slight increase in the risk of heart attack
(“myocardial infarction”) or stroke.

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

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 package or blister after EXP. The
expiry date refers to the last day of the month.
Do not store at a temperature above 30°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Momenxsin contains

• The active ingredients are ibuprofen and pseudoephedrine hydrochloride. Each film-coated tablet contains 200 mg of ibuprofen and 30 mg of pseudoephedrine hydrochloride.
• The other ingredients are: Tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, croscarmellose sodium, corn starch, anhydrous colloidal silica, magnesium stearate. Tablet coating: hypromellose, macrogol 400, talc, titanium dioxide (E171), yellow iron oxide (E172).

Description of the appearance of Momenxsin and contents of the pack
Momenxsin are film-coated tablets, yellow in colour and round in shape.
Packs: 10, 12, 20 or 24 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Angelini Pharma S.p.A.
Viale Amelia, 70 - 00181 Rome.

Manufacturer
Dragenopharm Apotheker Püschl GmbH
Gӧllstraβe 1, 84529 Tittmoning-Germany

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Italy: Momenxsin 200 mg/30 mg film-coated tablets
By scanning the QR Code on the package or visiting the address http://leaflet.angelini.it/L13 you can read the updated and multilingual package leaflet