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


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

Fluimucil Influenza and Cold is indicated to treat the symptoms of colds and flu.

Talk to your doctor if you do not feel better or if you feel worse after a short time of treatment.


What you need to know before taking the medicine
Do not take Fluimucil Influenza 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 breast-feeding (see section "Pregnancy and breast-feeding");
- if you are under 12 years of age (see the "Children" section);
- if you have a hereditary problem characterized by a lack of the enzyme glucose-6-phosphate dehydrogenase (glucose-6-phosphate dehydrogenase insufficiency);
- if you are taking medicines for depression belonging to the class of tricyclic antidepressants;
- if you are taking medicines for your heart or high blood pressure belonging to the class of beta-blockers;
- if you are taking sympathomimetic medicines used to treat low blood pressure or a blocked nose (see the section "other medicines and Fluimucil Influenza and Cold");
- if you are taking medicines used to treat depression and Parkinson's disease (monoamine oxidase inhibitors) or have stopped treatment with these medicines less than two weeks ago (see the section "Other medicines and Fluimucil Influenza and Cold");
- if you have very high blood pressure (severe hypertension) or hypertension not controlled by drugs;
- if you suffer from 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);
• heartbeat disturbances (arrhythmias);
• liver problems (liver failure);
• thyroid gland problems (hyperthyroidism);
• asthma;
• diabetes;
• difficulty urinating caused by a prostate problem (prostatic hypertrophy) or other diseases;
• eye disease in which there is an increase in pressure in the eye (closed-angle glaucoma);
• low levels of red blood cells in the blood (hemolytic anemia);
• adrenal tumor known as pheochromocytoma.



Warnings and precautions
Talk to your doctor or pharmacist before taking Fluimucil Influenza and Cold.

Talk to your doctor before taking this medicine if you are elderly or suffer from any of the following conditions:
- coronary artery disease (angina);
- high blood pressure (hypertension);
- palpitations or changes in heartbeat (arrhythmias), rapid heartbeat (tachycardia);
- liver problems (liver failure, acute hepatitis);
- kidney problems;
- thyroid gland problems (hyperthyroidism);
- asthma;
- diabetes mellitus;
- mental problems (psychosis);
- chronic malnutrition and dehydration;
- if you have a deficiency of an enzyme known as glucose-6-phosphate dehydrogenase (favism);
- difficulty urinating caused by a prostate problem (prostatic hypertrophy) or other diseases;
- eye disease in which there is an increase in pressure in the eye (glaucoma);
- low levels of red blood cells in the blood (hemolytic anemia);
- alcohol dependence (alcoholism).

Do not take Fluimucil Cold and Flu with other medicines containing paracetamol, as high doses of paracetamol can cause serious side effects. The risk of serious side effects is also increased when Fluimucil Cold and Flu is taken with other medicines used to relieve pain (analgesics) or reduce fever (antipyretics), so avoid using these medicines at the same time.

If you develop a generalized feverish rash associated with pustules, stop taking Fluimucil Influenza and Cold and contact your doctor or seek medical assistance immediately (see section 4 "Possible side effects").

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

Fluimucil Cold and Flu may cause reduced blood flow to the optic nerve. If you experience sudden vision loss, stop taking Fluimucil Cold and Flu 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 medicines containing pseudoephedrine. PRES and RCVS are rare conditions that can lead to reduced blood flow to the brain. Stop using Fluimucil Cold and Flu 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 in Fluimucil Cold and Flu, pseudoephedrine, can be abused, and high doses of pseudoephedrine can be toxic. Continued use may result in taking more Fluimucil Cold and Flu than the recommended dose 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).

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

If you are planning surgery, stop treatment with Fluimucil Influenza and Cold a few days beforehand.

During treatment with Fluimucil Influenza and Cold, tell your doctor immediately if:
If you have serious illnesses, including severe kidney failure 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.

For those who do sports
The use of the drug without therapeutic need constitutes doping and may still result in a positive result in anti-doping tests.

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


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop treatment with Fluimucil Cold and Flu 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.

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, 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, especially in patients with an 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 blood vessels in the brain 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 even 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);
- 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).

The sudden onset of fever, redness of the skin or numerous small pustules (possible symptoms of acute generalized exanthematous pustulosis - AGEP) may occur within the first 2 days of treatment with Fluimucil Influenza and Cold (frequency not known) (see section 2 "What you need to know before you take Fluimucil Influenza and Cold").
Stop using Fluimucil Cold and Flu if you develop these symptoms and contact your doctor or seek medical help immediately.

Other side effects that may occur after taking Fluimucil Influenza and Cold:
- sweating;
- thirst;
- chest pain over the heart (precordial pain);
- difficulty urinating;
- muscle weakness;
- dilation of the pupils;
- stomach and intestinal problems (gastrointestinal problems);
- serious alteration of the 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 which can be fatal (anaphylactic shock);
- anemia;
- alteration of liver function, inflammation of the liver (hepatitis);
- alteration of kidney function:
• severe kidney failure (acute renal failure);
• severe inflammation of the kidney (interstitial nephritis);
• presence of blood in the urine (hematuria);
• failure to pass urine (anuria).

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