FLUIMUCIL INFLUENZA RAFFR*8BPL

FLUIMUCIL FLU AND COLD 500 mg/60 mg granules for oral solution
Paracetamol and Pseudoephedrine hydrochloride

What it is and what it is used for
Fluimucil Flu and Cold contains two active ingredients: paracetamol and pseudoephedrine.
- Paracetamol belongs to a group of medicines known as analgesics and antipyretics that act by relieving pain (analgesic action) and lowering body temperature in case of fever (antipyretic action);
- Pseudoephedrine belongs to a group of medicines called sympathomimetics that act by clearing the nasal passages and facilitating breathing (decongestant action).

Fluimucil Flu and Cold is indicated for the treatment of cold and flu symptoms.

Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

What you need to know before taking the medicine
Do not take Fluimucil Flu and Cold:
- if you are allergic to paracetamol, pseudoephedrine, or any of the other ingredients of this medicine (listed in section 6);
- if you are pregnant or breastfeeding (see section Pregnancy and breastfeeding);
- if you are under 12 years of age (see section Children);
- if you have a hereditary problem characterized by a deficiency of the enzyme glucose-6-phosphate dehydrogenase (glucose-6-phosphate dehydrogenase insufficiency);
- if you are taking antidepressant medicines belonging to the class of tricyclic antidepressants;
- if you are taking heart or high blood pressure medicines belonging to the class of beta-blockers;
- if you are taking sympathomimetic medicines used for the treatment of low blood pressure or nasal congestion (see section Other medicines and Fluimucil Flu and Cold);
- if you are taking medicines used for the treatment of depression and Parkinson's disease (monoamine oxidase inhibitors) or have stopped treatment with these medicines for less than two weeks (see section Other medicines and Fluimucil Flu and Cold);
- if you have very high blood pressure (severe hypertension) or hypertension not controlled by medicines;
- if you suffer from a severe acute (sudden) or chronic (long-term) kidney disease or kidney failure;
- if you suffer from a severe form of the following diseases:
• coronary heart disease (angina, previous heart attack);
• heart rhythm disorders (arrhythmias);
• liver problems (hepatic insufficiency);
• thyroid gland problems (hyperthyroidism);
• asthma;
• diabetes;
• difficulty urinating caused by a prostate problem (prostatic hypertrophy) or other diseases;
• eye disease with increased eye pressure (angle-closure glaucoma);
• low red blood cell levels (hemolytic anemia);
• adrenal gland tumor known as pheochromocytoma.

Warnings and precautions
Consult your doctor or pharmacist before taking Fluimucil Flu and Cold.

Consult your doctor before taking this medicine if you are elderly or suffer from any of the following diseases:
- coronary heart disease (angina);
- high blood pressure (hypertension);
- palpitations or altered heart rhythm (arrhythmias), accelerated heartbeat (tachycardia);
- liver problems (hepatic insufficiency, acute hepatitis);
- kidney problems;
- thyroid gland problems (hyperthyroidism);
- asthma;
- diabetes mellitus;
- mental problems (psychosis);
- chronic malnutrition and dehydration;
- if you have an insufficiency of an enzyme known as glucose-6-phosphate dehydrogenase (favism);
- difficulty urinating caused by a prostate problem (prostatic hypertrophy) or other diseases;
- eye disease with increased eye pressure (glaucoma);
- low red blood cell levels (hemolytic anemia);
- alcohol dependence (alcoholism).

Do not take Fluimucil Flu and Cold together with other medicines containing paracetamol, as severe side effects can occur if paracetamol is taken in high doses. The risk of severe side effects is also increased when Fluimucil Flu and Cold is taken with other medicines used to relieve pain (analgesics) or lower fever (antipyretics), so avoid concomitant use of these medicines.

If you develop a widespread feverish rash associated with pustules, stop taking Fluimucil Flu and Cold and contact your doctor or seek immediate medical attention (see section 4 Possible side effects).

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

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

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 supply to the brain. Stop using Fluimucil Flu and Cold 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).

One of the active ingredients of Fluimucil Flu and Cold, pseudoephedrine, can cause abuse, and high doses of pseudoephedrine can be toxic. Continued use can lead to taking more Fluimucil Flu and Cold than the recommended dose to achieve the desired effect, with a consequent increased risk of overdose. The maximum recommended dose and duration of treatment must not be exceeded (see section 3).

Tell your doctor if:
- you are using other medicines, especially if you are taking blood thinners or medicines that may affect the liver;
- the pain or nasal congestion worsens or lasts more than 5 days (or if symptoms do not improve within 5 days);
- the fever worsens or lasts more than 3 days;
- redness or swelling is present or new symptoms occur.

If you have planned surgery, stop treatment with Fluimucil Flu and Cold a few days before.

For athletes
The use of the medicine without therapeutic necessity constitutes doping and can still lead to positive anti-doping tests.

Children
Fluimucil Flu and Cold is contraindicated in children under 12 years of age (see section Do not take Fluimucil Flu and Cold).

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop treatment with Fluimucil Flu and Cold 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;
• vomiting;
• confusion;
• seizures;
• changes in vision.

Rare side effects (may affect up to 1 in 1,000 people)
- allergic reactions, including swelling of the skin or mucous membranes (angioedema)
- nervousness, insomnia, anxiety, agitation, hallucinations, particularly in children
- dizziness
- headache
- tremors
- heart rhythm disturbances (tachycardia, palpitations)
- increased blood pressure
- vomiting, nausea, dry mouth
- increased levels of certain liver enzymes, visible through laboratory tests
- skin rash, erythema, hives, itching
- difficulty urinating, particularly in patients with enlarged prostate (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)

Side effects with unknown frequency (frequency cannot be estimated from the available data)
- serious conditions affecting the cerebral blood vessels known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)
- severe and sudden allergic reaction (anaphylactic shock)
- severe skin reaction (Stevens-Johnson syndrome)
- severe allergic reaction involving the skin and mucous membranes, which can also be fatal (toxic epidermal necrolysis)
- reduced blood flow to the optic nerve (ischemic optic neuropathy)
- inflammation of the colon due to insufficient blood supply (ischemic colitis)

The sudden onset of fever, skin redness or numerous small pustules (possible symptoms of acute generalized exanthematous pustulosis - AGEP) may occur within the first 2 days of treatment with Fluimucil Flu and Cold (frequency unknown) (see section 2 What you need to know before taking Fluimucil Flu and Cold).
Stop using Fluimucil Flu and Cold if you develop these symptoms and contact your doctor or seek immediate medical attention.

Other side effects that may occur after taking Fluimucil Flu and Cold:
- sweating
- thirst
- chest pain in the area of the heart (precordial pain)
- difficulty urinating
- muscle weakness
- pupil dilation
- stomach and intestinal problems (gastrointestinal problems)
- severe alteration of heart rhythm (ventricular arrhythmia)
- allergic reaction involving the skin and mucous membranes (erythema multiforme)
- swelling of the throat (laryngeal edema)
- severe and sudden allergic reaction causing collapse and potentially fatal (anaphylactic shock)
- anemia
- impaired liver function, liver inflammation (hepatitis) - impaired kidney function:
• severe kidney failure (acute renal failure)
• severe kidney inflammation (interstitial nephritis)
• presence of blood in the urine (hematuria)
• absence of urine output (anuria)

In very rare cases, severe skin reactions have been reported.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell 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.