ZERINOACTIV*20 TABS 200MG+30MG

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

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

Ibuprofen belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by reducing pain and lowering fever. Pseudoephedrine belongs to a class of medicines called vasoconstrictors, which act on the blood vessels inside 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 who suffer from the common cold.

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

Consult 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, itchy runny 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 or kidney disease.
• If you have heart problems (e.g. coronary artery disease).
• If you suffer from uncontrolled high blood pressure.
• If you have a history of seizures (epileptic fits).
• If you suffer from disorders of unknown origin of blood component production.
• 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 you are between the 28^th and 40^th week of pregnancy (third trimester of pregnancy).

Warnings and precautions
You should discuss the therapy with your doctor or pharmacist before taking ZERINOACTIV:
• if you suffer from asthma; the use of this medicine can cause an asthma attack;
• if you have a history of gastrointestinal diseases (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 a history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation to the legs or feet due to narrowing or obstruction of the arteries) or any type of stroke (including mini-stroke or TIA, transient ischemic 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 are taking medicines that interact with ZERINOACTIV, see the list below;
• if you have an infection - see section Infections below.

Anti-inflammatory/pain relief medicines such as ibuprofen may be associated with a modest increased risk of heart attack or stroke, especially if administered in high doses. Do not exceed the recommended dose or duration of treatment.

Skin reactions

Serious 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 ZERINOACTIV 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.

If you develop signs of a severe allergic reaction such as: severe skin rashes, skin exfoliation, flaking or blistering of the skin, facial swelling, unexplained wheezing, shortness of breath, easy bruising, stop taking ZERINOACTIV and contact your doctor or seek immediate medical attention. See section 4.

In very rare cases, severe 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 in the first month of treatment. Stop taking ZERINOACTIV and contact your doctor or seek immediate medical attention if you develop a rash or mucosal lesions.

Infections
ZERINOACTIV can mask 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 of the infection persist or worsen, contact your doctor immediately.

During a chickenpox infection, it is advisable to avoid using 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 headache can worsen this condition. If you experience frequent or daily headaches despite (or because of) regular use of headache medication, consult your doctor before taking another painkiller. Treatment should be stopped if medication overuse headache is diagnosed.

Contact your doctor in case of prolonged treatment with ibuprofen, as liver and kidney function, as well as blood count, should be checked regularly.

Habitual use of painkillers, especially the combination of different painkiller medicines, can lead to permanent kidney damage with the risk of kidney failure (analgesic nephropathy). This risk can be increased during physical exertion associated with salt loss and dehydration. Therefore, it should be avoided.

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

Interference with blood tests
Pseudoephedrine can potentially interfere with certain diagnostic blood tests. You should tell your doctor that you are taking this medicine if you are undergoing a blood test.

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

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 occur:
- Signs of intestinal bleeding such as: bright red stools (faeces), black stools, vomiting containing blood or dark particles resembling coffee grounds.
- Signs of severe allergic reaction such as: severe skin rashes, peeling or flaking or blistering of the skin, facial swelling, unexplained shortness of breath, difficulty breathing, easy bruising.
- Reddish, non-raised, target-shaped or circular patches on the trunk, often with central blisters, skin exfoliation, ulcers of 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).
- Extensive rash, high body temperature and enlarged lymph nodes (DRESS syndrome).
- Extensive, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Frequency not known
• Inflammation of the colon due to insufficient blood supply (ischemic colitis).
• Reduced blood flow to the optic nerve (ischemic optic neuropathy)

Stop using ZERINOACTIV if you develop these symptoms and contact your doctor immediately.
See also section 2.

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

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

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

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

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

Not known (frequency cannot be estimated from the available data)
• increased skin sensitivity to sunlight
• Seizures, drowsiness, tremors
• Thirst, chest pain, physical weakness or lack of energy
• Difficulty emptying the bladder completely

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.