VIVINDUO FEVER CONG NAS 500 MG/60 MG GRANULES FOR ORAL SOLUTION 10 SACHETS PAPER/PE/AL/SURLYN

Name
VIVINDUO FEVER AND NASAL CONGESTION 500 mg/60 mg granules for oral solution
Paracetamol and pseudoephedrine hydrochloride
Equivalent medicine


What is it and what is it for?
VIVINDUO FEVER AND NASAL CONGESTION contains paracetamol, an analgesic, which works by relieving pain and lowering fever, and pseudoephedrine, a decongestant, which acts on the nasal mucosa to clear a stuffy nose.
VIVINDUO FEVER AND NASAL CONGESTION is a pain reliever, antipyretic and nasal decongestant medicine, and is used in the treatment of cold and flu symptoms.
Talk to your doctor if you do not feel better or if you feel worse after the maximum recommended treatment period, if the disorder occurs repeatedly, or if you have noticed any recent changes in its characteristics.


What you need to know before taking the medicine
Do not take VIVINDUO FEVER AND NASAL CONGESTION:
- if you are allergic to paracetamol, pseudoephedrine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
- during pregnancy and breastfeeding (see section "Pregnancy and breastfeeding");
- in the case of children under 12 years of age;
- if you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase (which can lead to the destruction of red blood cells in the blood);
- if you suffer from a severe form of the following diseases:
• coronary artery disease [chest pain (angina), previous heart attack];
• severe hypertension (if you have very high blood pressure) or hypertension not controlled by medications;
• arrhythmias (disturbance of heart rhythm or heart rate);
• liver failure (alterations in liver function);
• kidney failure (changes in kidney function) or if you suffer from severe acute (sudden) or chronic (long-term) kidney disease;
• asthma;
• diabetes;
• urinary problems caused by an increase in the size of the prostate (prostatic hypertrophy) or other diseases;
• hemolytic anemia (reduction in the number of red blood cells in the blood due to their destruction);
- hyperthyroidism (overactive thyroid);
- glaucoma and angle-closure glaucoma (increased pressure inside the eye);
- if you have a tumor of the adrenal gland known as pheochromocytoma;
- if you are using the following medicines:
• medicines against depression belonging to the class of tricyclic antidepressants;
• heart or blood pressure medicines belonging to the beta-blocker class;
• sympathomimetic medicines, used to treat low blood pressure or a blocked nose (see section "Other medicines and VIVINDUO FEVER AND NASAL CONGESTION");
- if you are using or have used in the last 14 days medicines for the treatment of depression and Parkinson's disease belonging to the class of monoamine oxidase inhibitors (see section "Other medicines and VIVINDUO FEVER AND NASAL CONGESTION").


Warnings and precautions
Talk to your doctor or pharmacist before taking VIVINDUO FEVER AND NASAL CONGESTION.

Talk to your doctor before taking VIVINDUO FEVER AND NASAL CONGESTION:
• if he is elderly;
• if you have kidney problems;
• if you have liver problems, including liver failure and acute hepatitis;
• if you have a deficiency of an enzyme known as glucose-6-phosphate dehydrogenase (see section "Do not take VIVINDUO FEVER AND NASAL CONGESTION");
• if you have a reduction in the number of red blood cells in your blood due to their destruction (haemolytic anaemia);
• if you suffer from a chronic form of malnutrition and dehydration;
• if you have heart and/or blood vessel problems such as chest pain (angina), palpitations or other heart rhythm disturbances;
• if you have diabetes mellitus;
• if you have an enlarged prostate (prostatic hypertrophy) which causes problems when urinating;
• if you have mental problems (psychosis);
• if your thyroid gland is overactive (hyperthyroidism);
• if you have asthma;
• if you have a disease characterized by high pressure inside the eye (glaucoma);
• if you have high blood pressure (hypertension);
• if you have an alcohol addiction (alcoholism) (see also paragraph "VIVINDUO FEVER AND NASAL CONGESTION and alcohol");
• if you are using any other medicines (see section "Other medicines and VIVINDUO FEVER AND NASAL CONGESTION"), in particular:
• other medicines that affect the liver (talk to your doctor if you are not sure if this applies to you);
• if you are using medicines that reduce blood clotting (anticoagulants) taken by mouth, because your doctor will assess whether to reduce the dose of the medicine.

Talk to your doctor if during treatment with VIVINDUO FEVER AND NASAL CONGESTION:
• pain or stuffy nose gets worse or lasts more than 5 days or if symptoms do not improve within 5 days;
• fever worsens or lasts more than 3 days;
• has redness or swelling;
• shows new symptoms.
While taking VIVINDUO FEVER AND NASAL CONGESTION, tell your doctor immediately if you have any serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported in patients with these conditions when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken in combination with flucloxacillin. Symptoms of metabolic acidosis may include severe breathing difficulties with rapid, deep breathing, drowsiness, nausea, and vomiting.

Pay particular attention:
• VIVINDUO FEVER AND NASAL CONGESTION contains paracetamol; before using any other medicine, check that it does not contain paracetamol as the use of high doses of paracetamol could cause serious side effects, such as liver damage;
• do not take VIVINDUO FEVER AND NASAL CONGESTION with other medicines used to treat pain and fever because serious side effects may occur;
• if you need to undergo surgery, tell your doctor that you are taking VIVINDUO FEVER AND NASAL CONGESTION, because treatment with VIVINDUO FEVER AND NASAL CONGESTION should be stopped a few days before the operation.

If you develop a generalized feverish rash associated with pustules, stop taking VIVINDUO FEVER AND NASAL CONGESTION and contact your doctor or seek medical assistance immediately.
See paragraph 4.

Sudden abdominal pain or rectal bleeding may occur with VIVINDUO FEVER AND NASAL CONGESTION due to inflammation of the colon (ischaemic colitis). If you experience these gastrointestinal symptoms, stop using VIVINDUO FEVER AND NASAL CONGESTION and contact your doctor or seek immediate medical attention. See section 4.
With VIVINDUO FEVER AND NASAL CONGESTION, reduced blood flow to the optic nerve may occur. If you experience sudden vision loss, stop taking VIVINDUO FEVER AND NASAL CONGESTION and contact your doctor or healthcare provider immediately. See section 4.
Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported following the use of medicinal products containing pseudoephedrine.
PRES and RCVS are rare conditions that can lead to reduced blood flow to the brain. Stop using VIVINDUO FEVER AND NASAL CONGESTION 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).

Caution is also advised in patients with a history of sensitivity to aspirin and/or nonsteroidal anti-inflammatory drugs (NSAIDs).

One of the active ingredients in VIVINDUO FEVER AND NASAL CONGESTION, pseudoephedrine, can be abused, and high doses of pseudoephedrine can be toxic. Continued use may result in taking more VIVINDUO FEVER AND NASAL CONGESTION than recommended to achieve the desired effect, thus increasing the risk of overdose. The maximum recommended dose and duration of treatment should not be exceeded (see section 3).

Children
VIVINDUO FEVER AND NASAL CONGESTION is contraindicated in children under 12 years of age.


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

Rare side effects (may affect up to 1 in 1,000 people):
• allergic reactions (hypersensitivity), including swelling of the skin or mucous membranes (angioedema);
• nervousness, insomnia, anxiety, agitation, hallucinations; especially in children;
• dizziness;
• heachache;
• tremors;
• alterations in heart rhythm (tachycardia, palpitations);
• increased blood pressure;
• vomiting, nausea, dry mouth;
• increased levels of some liver enzymes, visible through laboratory tests;
• skin rash, erythema, urticaria, itching;
• difficulty urinating, particularly in patients with an increased prostate volume (prostatic hypertrophy)

Very rare side effects (may affect up to 1 in 10,000 people):
• reduction in the number of platelets in the blood (thrombocytopenia);
• reduction in the number of white blood cells (leukopenia, agranulocytosis);
• reduction in the number of all blood cells (pancytopenia);
• severe skin reactions.

Side effects with unknown frequency (frequency cannot be estimated from the available data)
• 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 VIVINDUO FEVER AND NASAL CONGESTION immediately and contact your doctor urgently if you develop symptoms that could be signs of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).
These include:
- severe headache with sudden onset;
- nausea;
- vomit;
- confusion;
- convulsions;
- changes in vision;
• reduction in the number of neutrophils, a type of white blood cell (neutropenia);
• decrease in red blood cells (hemolytic anemia in patients with glucose-6-phosphate dehydrogenase deficiency);
• severe and sudden allergic reaction (anaphylactic shock);
• severe skin reaction which can even be fatal (Stevens-Johnson syndrome);
• severe allergic reaction involving the skin and mucous membranes, which can even be fatal (toxic epidermal necrolysis);
• swelling of the vocal cords, which prevents air from entering the lungs (larynx edema);
• confusion;
• irritability;
• movement disorder characterized by a substantial loss of motor coordination (ataxia);
• convulsions;
• insomnia;
• reduction of blood flow to the optic nerve (ischemic optic neuropathy);
• dilation of the pupils (mydriasis);
• a set of coronary symptoms that occur following a hypersensitivity reaction, an allergy or anaphylaxis (Kounis Syndrome);
• partial or total occlusion of a coronary artery (myocardial infarction);
• alteration of the heart rhythm (atrial fibrillation);
• hypertension;
• hypotension;
• premature heartbeats, that is, beats before the correct contraction, originating from the ventricle (ventricular extrasystoles);
• chest pain over the heart (precordial pain);
• inflammation of the colon due to insufficient blood supply (ischemic colitis);
• loss of blood from the stomach and intestines (gastrointestinal bleeding);
• reactions from the stomach and intestines (gastrointestinal reactions);
• taste alterations;
• sudden onset of fever and redness of the skin associated with the appearance of numerous small pustules (possible symptoms of acute generalized exanthematous pustulosis - AGEP) which may occur within the first 2 days of treatment with VIVINDUO FEVER AND NASAL CONGESTION. See section 2;
• skin disease similar to the symptoms of scarlet fever (pseudo-scarlet fever eczema);
• skin reaction that occurs after the administration of a drug (fixed drug eruption);
• allergic reaction involving the skin and mucous membranes (erythema multiforme);
• kidney damage (nephrotoxicity);
• alterations in kidney function (acute renal failure, interstitial nephritis (severe inflammation of the kidneys), hematuria (presence of blood in the urine), anuria (absence or extreme reduction in the amount of urine produced in 24 hours);
• abnormal contraction of the smooth muscles of the bronchi which causes them to narrow (bronchospasm);
• lung infection (pneumonia);
• a serious condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see section 2).

Stop using VIVINDUO FEVER AND NASAL CONGESTION if you develop these symptoms and contact your doctor or seek medical help immediately.

Other side effects that may occur after taking VIVINDUO FEVER AND NASAL CONGESTION:
• sweating;
• thirst;
• muscle weakness;
• severe alteration of the heart rhythm (ventricular arrhythmia);
• anemia;
• alteration of liver function, inflammation of the liver (hepatitis).
Following the instructions in the package leaflet reduces the risk of side effects. These side effects are generally temporary.
However, if they occur, it is advisable to consult your doctor or pharmacist.

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.