ZERINOACTIV 200MG/30MG FILM-COATED TABLETS 20 TABLETS IN PVC/PVDC/AL BLISTER

Name
ZERINOACTIV 200 mg/30 mg film-coated tablets
Ibuprofen/pseudoephedrine hydrochloride


What is it and what is it for?
ZERINOACTIV film-coated tablets contain two active ingredients: ibuprofen and pseudoephedrine.

Ibuprofen belongs to a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by reducing pain and lowering fever. Pseudoephedrine belongs to a class of drugs called vasoconstrictors, which act on the blood vessels in the nose to relieve nasal congestion.

ZERINOACTIV film-coated tablets are indicated for the symptomatic treatment of nasal congestion associated with headache and/or fever in adults and adolescents over 15 years of age suffering from the common cold.

You should only take this combination if you have a stuffy nose with pain or fever. If you experience any of these symptoms, you should consult your pharmacist or doctor about using ibuprofen or pseudoephedrine alone.

Contact your doctor if you do not feel better or if you feel worse after 5 days.


What you need to know before taking the medicine
Do not take ZERINOACTIV
• if you are allergic to ibuprofen or pseudoephedrine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if you have ever had a previous allergic reaction or asthma, rash, runny or itchy nose or facial swelling while taking this product, ibuprofen, acetylsalicylic acid or other similar medicines;
• if you have a history of recurrent gastric or duodenal ulcer or have had gastrointestinal bleeding related to previous NSAID therapy;
• if you suffer from severe liver disease;
• if you suffer from severe acute (sudden) or chronic (long-term) kidney disease or kidney failure;
• if you have heart problems (such as coronary heart disease);
• if you have very high blood pressure (severe hypertension) or hypertension not controlled by drugs;
• if you have a history of seizures (epileptic fits);
• if you suffer from disorders of blood component production of unknown origin;
• if you suffer from increased intraocular pressure (closed-angle glaucoma);
• if you suffer from difficulty urinating related to prostate problems;
• if 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;
• if you are taking:
- other nasal decongestants (vasoconstrictors) administered orally or nasally (e.g. phenylpropanolamine, phenylephrine, ephedrine, xylometazoline or oxymetazoline);
- 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;
• if you suffer from significant dehydration due to vomiting, diarrhoea or insufficient fluid intake;
• if it is between the ^28th and 40th ^week of pregnancy (third trimester of pregnancy).


Warnings and precautions
You should discuss your treatment with your doctor or pharmacist before taking ZERINOACTIV:
• if you suffer from asthma; using this medicine may cause an asthma attack;
• if you have a history of gastrointestinal disorders (such as hiatal hernia, gastrointestinal bleeding, peptic or duodenal ulcer) and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease);
• if you have heart problems including heart attack, angina (chest pain) or if you have had a heart attack, coronary artery bypass surgery, peripheral artery 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 'TIA', transient ischaemic attack);
• if you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker;
• if you suffer from hyperthyroidism (overactive thyroid);
• if you have systemic lupus erythematosus (connective tissue disease), and mixed connective tissue disease, or congenital disorder of porphyrin metabolism;
• if you take medicines that interact with ZERINOACTIV, see the list below;
• if you have an infection – see section “Infections” below;
• if you develop a rash or skin symptoms, you should stop taking ibuprofen immediately, seek medical advice immediately and tell your doctor that you are taking this medicine.

Anti-inflammatory/painkiller medications such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when taken in high doses. Do not exceed the recommended dose or duration of treatment.

Signs of an allergic reaction to ibuprofen have been reported, including breathing problems, swelling of the face and neck (angioedema), and chest pain. Stop taking ZERINOACTIV immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

Skin reactions
Serious skin reactions, 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), have been reported in association with ibuprofen treatment. Stop using ZERINOACTIV and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

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

In very rare cases, serious skin reactions have been reported when using an NSAID. Patients appear to be at greatest risk at the beginning of therapy; the onset of the reaction occurs in most cases within the first month of treatment. Stop taking ZERINOACTIV and contact your doctor or seek immediate medical attention if you develop a skin rash or mucosal lesions.

Infections
ZERINOACTIV may hide the symptoms of infections, such as fever and pain. Therefore, ZERINOACTIV may delay adequate 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 persist or worsen, contact your doctor immediately.

During a chickenpox infection it is advisable to avoid the use of this medicine.

In patients with systemic lupus erythematosus and mixed connective tissue diseases, there may be an increased risk of aseptic meningitis or hepatitis.

Prolonged use of any type of painkiller for headaches can worsen the condition. If you experience frequent or daily headaches despite (or because of) regular use of headache medications, consult your doctor before taking another painkiller. Treatment should be discontinued if medication-overuse headaches are diagnosed.

Contact your doctor if you are taking ibuprofen for a long time, as your liver and kidney function, as well as your blood count, should be monitored regularly.

Regular use of painkillers, especially the combination of several painkillers, can lead to permanent kidney damage with the risk of renal failure (analgesic nephropathy). This risk may be increased by physical exertion associated with salt loss and dehydration. Therefore, it should be avoided.

Cases of posterior reversible 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 flow to the brain. Stop using ZERINOACTIV 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).

With ZERINOACTIV, reduced blood flow to the optic nerve may occur. If you experience sudden vision loss, stop taking ZERINOACTIV and contact your doctor or healthcare provider immediately. See section 4.

Interference with blood tests
Pseudoephedrine can potentially interfere with some blood tests. You should tell your doctor that you are taking this medication if you are having a blood test.

Children and adolescents
ZERINOACTIV should not be administered to children under 15 years of age.
There is a risk of kidney damage in adolescents who are dehydrated.


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

Stop taking ZERINOACTIV immediately and consult your doctor immediately if any of the following conditions occur:
- signs of intestinal bleeding such as: bright red stools (faeces), black stools, vomit containing blood or dark particles resembling coffee grounds;
- signs of a serious allergic reaction such as: severe skin rash, peeling or flaking or blistering of the skin, facial swelling, wheezing of unknown origin, shortness of breath, easy bruising;
- flat, reddish, target-shaped or circular spots on the trunk, often with central blisters, peeling skin, and 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);
- widespread skin 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 appear at the start of treatment (acute generalized exanthematous pustulosis).

Frequency "unknown"
• serious conditions affecting the blood vessels in the brain known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).

Stop treatment with ZERINOACTIV immediately and contact your doctor urgently if you develop symptoms that could be signs of posterior reversible encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction syndrome (RCVS). These include:
• severe headache with sudden onset;
• nausea;
• vomit;
• confusion;
• convulsions;
• changes in vision;
• Inflammation of the colon due to insufficient blood supply (ischemic colitis);
• reduction of blood flow to the optic nerve (ischemic optic neuropathy).
Stop using ZERINOACTIV if you develop these symptoms and contact your doctor immediately .
See also paragraph 2 .

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

Common (affects 1 to 10 users in 100):
- indigestion, heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation.

Uncommon (affects 1 to 10 users in 1000):
- headache, dizziness, difficulty sleeping, agitation, irritability or tiredness;
- visual impairment;
- gastric or intestinal ulcers, sometimes with bleeding and perforation, worsening of colitis and Crohn's disease;
- skin rashes.

Rare (affects 1 to 10 users in 10,000):
- tinnitus (ringing in the ears);
- kidney damage.

Very rare (affects less than 1 in 10,000 users):
- problems in the production of blood cells that can make you more susceptible to bruising or infections;
- severe allergic reactions;
- psychotic reactions and depression;
- high blood pressure, palpitations, heart attack;
- inflammation of the blood vessels (vasculitis);
- liver damage;
- severe skin reactions;
- kidney damage or difficulty urinating.

Not known (frequency cannot be estimated from the available data):
• increased sensitivity of the skin to the sun;
• convulsions (seizures), drowsiness, tremors;
• thirst, chest pain, physical weakness or lack of energy;
• difficulty emptying the bladder completely;
• fixed drug eruption (such as round or oval patches of redness and swelling of the skin), itching;
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Reporting of side effects
If you experience 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.