ACTISINU*12 tablets 200mg+30mg

ACTISINU 200 mg/30 mg, film-coated tablets
Ibuprofen/Pseudoephedrine hydrochloride

What it is and what it is used for
ACTISINU contains two active ingredients: ibuprofen and pseudoephedrine hydrochloride.

Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by easing pain and lowering fever.
Pseudoephedrine hydrochloride belongs to a group of active ingredients called vasoconstrictors which act on the blood vessels in the nose to relieve nasal congestion.

ACTISINU is used for the symptomatic treatment of nasal congestion in colds associated with headache and/or fever in adults and adolescents aged 15 years and over.

You should only take this combination product if you have a blocked nose with headache or fever. If you only have one of these symptoms, speak to your pharmacist or doctor about using ibuprofen or pseudoephedrine alone.

Consult your doctor if symptoms worsen or if the medicine is needed for more than 4 days in adults or 3 days in adolescents.

What you need to know before taking the medicine
Do not take ACTISINU if:
• you are allergic to ibuprofen or pseudoephedrine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• you are under 15 years of age;
• you are in the third trimester of pregnancy (6 months or more);
• you are breastfeeding;
• you have a history of allergic reaction including breathing problems, swelling of the face and neck (angioedema) and chest pain during treatment with acetylsalicylic acid or other NSAIDs including ibuprofen. Stop ACTISINU immediately and contact your doctor or emergency medical service immediately if you notice any of these signs;
• you have active episodes or a history of recurrent stomach/duodenal ulcers (peptic ulcers) or bleeding (at least two distinct confirmed episodes of ulcers or bleeding);
• you have a history of gastrointestinal bleeding or perforation related to previous NSAID use;
• you have severe liver failure and/or suffer from severe acute (sudden) or chronic (long-term) kidney disease or kidney failure;
• you have severe heart failure;
• you have severe heart or circulation problems (heart disease, high blood pressure (hypertension), fast heartbeat), overactive thyroid gland, diabetes, phaeochromocytoma (a tumour of the adrenal gland);
• you have a history of heart attack (myocardial infarction);
• you have had a stroke or have been told you are at risk of stroke;
• you have a history of seizures (epileptic fits);
• you suffer from disorders of blood cell production of unknown origin;
• you have increased eye pressure (narrow-angle glaucoma);
• you have difficulty urinating due to prostate problems;
• you have been diagnosed with systemic lupus erythematosus (SLE), a disease that affects the immune system and causes joint pain, skin changes and other problems;
• you are taking:
- other oral or nasal decongestants (vasoconstrictor medicines) (e.g. phenylpropanolamine, phenylephrine, ephedrine, xylometazoline or oxymetazoline);
- methylphenidate, a medicine for attention deficit hyperactivity disorder (ADHD);
- medicines for depression such as non-selective monoamine oxidase inhibitors (known as MAOIs, e.g. iproniazid) or if you have taken them in the last 14 days

Warnings and precautions
Undesirable effects can be minimised by using the lowest effective dose for the shortest possible period. Elderly people are at higher risk of side effects.

Talk to your doctor or pharmacist before taking ACTISINU if:
• you suffer from asthma; the use of this medicine can cause an asthma attack;
• you have a history of gastrointestinal problems (such as hiatus hernia, gastrointestinal bleeding, peptic or duodenal ulcer, previous stomach ulcer or increased tendency to bleeding of another nature;
• you have or have had gastrointestinal disease (ulcerative colitis or Crohn's disease);
• you have high blood pressure, diabetes, high cholesterol levels, a family history of heart disease or stroke or if you are a smoker;
• you have had 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 narrowing or blockage of arteries), or any type of stroke (including mini-stroke or transient ischemic attack TIA);
• you have liver or kidney problems;
• you have diabetes due to potential diabetic nephropathy;
• you have an overactive thyroid gland (hyperthyroidism) or psychosis;
• you have a blood clotting disorder;
• you are pregnant or breastfeeding - See section Pregnancy, breastfeeding and fertility below;
• you have an infection - see section Infections below;
• you are dehydrated, as there is a risk of renal impairment, particularly in dehydrated adolescents and the elderly.

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 result in reduced blood supply to the brain.
Stop using Actisinu 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).

Lowest effective dose
Do not use this medicine for purposes other than its intended use and never take more than the recommended amount. Do not take for longer than the recommended treatment duration (4 days in adults or 3 days in adolescents).
Increased doses of pseudoephedrine can be toxic and continuous use can lead to taking more ACTISINU than the recommended dose to achieve the desired effect, increasing the risk of overdose. If you suddenly stop treatment, depression may occur.
Concomitant use of NSAIDs, including specific cyclooxygenase (COX)-2 inhibitors, increases the risk of adverse reactions (see section Other medicines and ACTISINU below) and should be avoided.

Prolonged use of any type of painkiller for headache can lead to worsening. If this situation occurs or is suspected, consult a doctor and discontinue treatment. The diagnosis of medication overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) regular use of headache medicines.

Gastrointestinal bleeding, ulcers and perforations
Sudden abdominal pain or rectal bleeding may occur with ACTISINU, due to colon inflammation (ischemic colitis). If you develop these gastrointestinal symptoms, stop taking ACTISINU and contact your doctor or seek immediate medical attention. See section 4.

Heart attack and stroke
Anti-inflammatory/painkilling medicines such as ibuprofen may be associated with a modest increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.

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

Skin reactions
Severe skin reactions have been reported in association with ACTISINU treatment. Stop taking ACTISINU and consult your doctor immediately if you develop a rash, mucosal lesions, blisters or other signs of allergy, as these may be the first signs of a very severe skin reaction. See section 4.

Severe skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalised exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Stop using ACTISINU 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 widespread feverish rash associated with pustules, stop taking ACTISINU and contact your doctor or seek immediate medical attention. See section 4.

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

Interference with blood test results
Pseudoephedrine may interfere with some diagnostic blood tests. Tell your doctor that you are taking this medicine if you need to have a blood test.

Children and adolescents
ACTISINU should not be given to children under 15 years of age.
There is a risk of kidney failure in dehydrated adolescents.

Athletes
For those engaged in sports: the use of the drug without therapeutic necessity constitutes doping and can in any case lead to positive anti-doping tests.

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

Stop ACTISINU and consult a doctor immediately if you notice:

• serious conditions affecting the cerebral blood vessels known as reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:
- severe headache with sudden onset;
- nausea;
- feeling unwell;
- vomiting;
- confusion;
- seizures;
- changes in vision;
• signs of intestinal bleeding such as: bright red stools, black tarry stools, vomit containing blood or dark particles like coffee grounds;
• signs of colitis (inflammation of the colon) such as: sudden stomach pain, blood in stools, rectal bleeding and diarrhoea;
• signs of a severe allergic reaction such as: raised, target-shaped or circular red patches on the torso, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis];
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome;
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome);
• Widespread, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis);
• Sudden onset of severe headache, nausea, vomiting or visual disturbances that may be symptoms of conditions known as Reversible Posterior Encephalopathy Syndrome (PRES) or Reversible Cerebral Vasoconstriction Syndrome (RCVS).

Contact your doctor if you experience any of the following side effects, notice worsening, or any other effects not listed.

Common (may affect up to 1 in 10 people)
• indigestion, stomach discomfort or pain, nausea, vomiting, flatulence, diarrhoea, constipation, mild gastrointestinal bleeding, which rarely leads to anaemia
• insomnia, dry mouth

Uncommon (may affect up to 1 in 100 people)
• hypersensitivity reactions with urticaria, itching and asthma attacks (with a drop in blood pressure)
• central nervous system disorders such as headache, dizziness, difficulty sleeping, agitation, irritability or tiredness
• visual disturbances
• gastrointestinal ulcers, sometimes with bleeding and perforation, gastritis, swelling of the mouth lining with ulceration (ulcerative 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)
• restlessness, tremor
• 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. necrotising 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 with blood cell production (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis), which could lead to easy bruising or increased susceptibility to infections
• severe allergic reactions
• psychotic reactions and depression
• high blood pressure, irregular heartbeat, heart failure, heart attack
• skin rash, itching (skin pruritus)
• inflammation of the oesophagus (oesophagitis) and pancreas (pancreatitis), diaphragm-like intestinal stenosis
• liver dysfunction, liver damage, especially with long-term therapy, liver failure, acute liver inflammation (hepatitis)
• severe skin reactions including rashes with redness and blisters (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell's syndrome), hair loss (alopecia), severe skin infections and soft tissue complications in case of chickenpox (varicella zoster virus infection)
• increased serum creatinine, oedema (particularly in patients with arterial hypertension or renal failure), nephrotic syndrome, interstitial nephritis, acute renal failure

Not known (frequency cannot be estimated from the available data)
• abnormal behaviour
• stroke, seizures, headache
• chest pain, rapid heartbeat, irregular heartbeat
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome. In this case, contact your doctor immediately
• thirst, nausea, vomiting
• hives, itching, excessive sweating, tingling sensation
• euphoric mood, hallucinations, nervousness, anxiety
• drowsiness
• skin redness, blisters or rash
• pain, discomfort or difficulty urinating, inability to urinate
• high blood pressure
• angioedema (difficulty breathing, rash, swelling of the face, hands or feet)
• reduced blood flow to the optic nerve (ischemic optic neuropathy)
• inflammation of the colon due to insufficient blood supply (ischemic colitis)
• a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cell)
• skin becomes sensitive to light
• a widespread, red and scaly rash, with pustules forming under the skin and blisters localised mainly on skin folds, trunk and upper limbs accompanied by fever (Acute Generalized Exanthematous Pustulosis - AGEP) may occur at the start or within the first 2 days of ACTISINU treatment

Stop using ACTISINU if you develop these symptoms and contact your doctor or seek immediate medical attention. See section 2.
Medicines similar to ACTISINU 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, including any 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/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.ù