VICKS MEDINAIT*SYRUP 90ML

Vicks MediNait 0.5 mg/ml + 0.25 mg/ml + 20 mg/ml syrup
Dextromethorphan hydrobromide, doxylamine succinate, paracetamol

What it is and what it is used for
Vicks MediNait is used in the treatment of cold and flu symptoms.
Vicks MediNait contains:
- dextromethorphan hydrobromide: a substance that calms cough symptoms;
- doxylamine succinate: an antihistamine substance that acts on some cold symptoms, such as a runny nose and sneezing;
- paracetamol: a substance with analgesic and antipyretic action, capable of lowering fever.
Consult your doctor if you do not feel better or if you feel worse after 3 days.

What you need to know before taking the medicine
Do not use Vicks MediNait
- if you are allergic to the active ingredients or any of the other ingredients of this medicine (listed in section 6);
- if the subject to be treated is a child or adolescent under 12 years of age;
- if you suffer or have suffered from asthma (a disease that causes narrowing and inflammation of the bronchi);
- if you have diabetes, a disease that causes an increase in blood sugar (amount of sugar in the blood);
- if you suffer or have suffered from epilepsy (a disease that causes loss of consciousness and violent involuntary muscle contractions);
- if you have severe liver or kidney problems;
- if you suffer from glaucoma (a disease that causes an increase in eye pressure and vision problems);
- if you have an enlarged prostate (prostatic hypertrophy);
- if you have difficulty urinating;
- if you suffer from narrowing of the stomach or intestine or urinary or genital tracts;
- if you have an obstruction that makes it difficult for stomach contents to pass into the intestine;
- if you have a deficiency of an enzyme called glucose-6-phosphate dehydrogenase;
- if you suffer from hemolytic anemia (a disease that causes the breakdown of red blood cells);
- if you have previously suffered from bleeding or perforation of the stomach or intestine due to treatment with anti-inflammatory, antipyretic and analgesic medicines or recurrent (two or more episodes of proven ulcer or bleeding);
- if you have severe heart failure (a condition in which the body cannot balance the reduction in the heart's contractile activity);
- if you are already taking medicines belonging to the class of monoamine oxidase inhibitors (MAOIs), used for the treatment of depression and anxiety in the treatment of Parkinson's disease (a disease that causes tremor, rigidity and slowness of movement), or if you have stopped taking them less than two weeks ago;
- if you are already taking medicines belonging to the class of serotonin reuptake inhibitors (SSRIs) - used for the treatment of depression and anxiety.

Warnings and precautions
Consult your doctor or pharmacist before taking Vicks MediNait.
This medicine should not be used for a long time.
This medicine can lead to abuse and dependence. Therefore, the treatment should be short-term.
Side effects can be minimized with the shortest possible treatment duration needed to control symptoms.
Elderly people have a greater susceptibility to the onset of side effects.
The concomitant use of Vicks MediNait with anti-inflammatory, antipyretic and analgesic medicines should be avoided. Other drugs can affect liver function and can increase liver toxicity.
Consult your doctor:
- if you have a chronic or persistent cough (due, for example, to smoking and certain respiratory diseases such as emphysema/asthma);
- if your cough is irritating with abundant mucus production;
- if you suffer from liver or kidney problems;
- if you abuse alcohol;
- if you suffer from a liver disease due to alcohol abuse;
- if you have an intestinal disease (ulcerative colitis, Crohn's disease);
- if you are taking antibiotics (medicines used to treat infections caused by bacteria), because Vicks MediNait can delay the perception of hearing damage caused by some antibiotics;
- if you have heart disease;
- if you suffer from high blood pressure;
- if you suffer from hyperthyroidism (a thyroid disease caused by increased activity);
- if you suffer from high blood pressure not sufficiently controlled with medicines;
- if you suffer from congestive heart failure (a disease in which the heart is unable to pump blood efficiently);
- if you have confirmed ischemic heart disease (heart suffering due to reduced oxygen supply);
- if you have peripheral arterial disease and/or cerebrovascular disease (disease of the arteries and blood vessels of the brain), as you should use Vicks MediNait only after careful medical evaluation;
- if you have a history of drug or substance abuse (psychoactive substances capable of altering the psychophysical state);
- if the subject to be treated is an adolescent or young adult.
The concomitant use of Vicks MediNait with sedative medicines such as benzodiazepines or similar medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma (state of deep unconsciousness) and can be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes Vicks MediNait together with sedative medicines, the dose and duration of concomitant treatment should be limited by your doctor.
Inform your doctor of all sedative medicines you are taking and carefully follow their recommendations on the dose. It may be helpful to inform friends or family so that they are aware of the signs and symptoms described above. If you experience these symptoms, contact your doctor.
Elderly people are more at risk of developing adverse reactions to anti-inflammatory, antipyretic and analgesic medicines, such as sedation (altered consciousness), dizziness (feeling of movement or rotation) and gastrointestinal bleeding and perforations, which can be fatal.
During treatment with all anti-inflammatory, antipyretic and analgesic medicines, such as Vicks MediNait, at any time, with or without warning symptoms or a previous history of serious gastrointestinal events, gastrointestinal bleeding, ulceration and perforation have been reported, which can be fatal.
Patients who have previously suffered from these conditions have a higher risk (see Do not take Vicks MediNait).
Report any abdominal signs or symptoms (including gastrointestinal bleeding) even at the start of treatment.
Immediately stop treatment with Vicks MediNait at the first signs of gastrointestinal bleeding or ulceration.
Inform your doctor if you are taking medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids (medicines used for the treatment of inflammatory conditions), anticoagulants (medicines that delay blood clotting), such as warfarin, or antiplatelet agents (medicines that prevent platelet aggregation) such as acetylsalicylic acid (see Other medicines and Vicks MediNait).
Inform your doctor if you are taking medicines to treat depression and anxiety (see Do not use Vicks MediNait and Other medicines and Vicks MediNait).
Severe skin reactions, some of which fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of anti-inflammatory, antipyretic and analgesic medicines (see Possible side effects). The reaction occurs in most cases in the initial stages of treatment. Stop using Vicks MediNait if a rash, mucosal lesions or any other sign of hypersensitivity (allergic reaction) appears.
If you are taking medicines such as some antidepressants or antipsychotics: Vicks MediNait can interact with these medicines and mental status changes (e.g., agitation, hallucinations, coma) and other effects such as body temperature above 38℃, increased heart rate, unstable blood pressure, exaggerated reflexes, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) may occur.
During treatment with Vicks MediNait, immediately inform your doctor:
If you suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage) or malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In patients in these situations, a serious condition called metabolic acidosis (an anomaly of the blood and fluids) has been reported when paracetamol is used at regular doses for 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.

Laboratory tests
Paracetamol, contained in Vicks MediNait, can interfere with the determination of uric acid or glucose levels in the blood (uricemia and glycemia).

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop treatment and immediately inform your doctor if you experience the following symptoms:
- skin rashes and itching;
- severe allergic reaction (anaphylaxis);
- constriction of the bronchi causing difficulty breathing (bronchospasm);
- swelling of the throat due to fluid accumulation (laryngeal edema), swelling of the face, lips, mouth, tongue and throat that can cause problems with breathing and swallowing (angioedema);
- these can be signs of severe allergic reactions (anaphylactic shock) whose signs may include difficulty breathing, chest pain or chest tightness and/or dizziness/fainting, skin itching or raised lumps on the skin, swelling of the face, lips, tongue and/or throat and which can be potentially life-threatening; skin irritation, hives;
- formation of red papules or widespread blisters and peeling, particularly on the legs, arms, hands and feet, which may extend to the face, lips and mucous membranes, occasionally accompanied by fever. These can be signs of severe skin diseases such as Erythema Multiforme, Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome;
- nosebleed (epistaxis);
- increased tendency to bruising or if you notice an increased tendency for wounds to bleed.

Other reported side effects are:
Common (may affect up to 1 in 10 people)
- drowsiness;
- dizziness (feeling of movement or rotation);
- headache;
- blurred vision;
- psychomotor impairment;
- dry mouth;
- constipation;
- gastric reflux (stomach acid rising causing heartburn).

Rare (may affect up to 1 in 1000 people)
- nausea;
- vomiting;
- abdominal pain;
- diarrhea;
- hypersensitivity (allergies);
- erythema (skin redness);
- hives;
- insomnia (alteration of sleep quantity and quality).

Very rare (may affect up to 1 in 10,000 people)
- thrombocytopenia (reduction in the number of platelets);
- pancytopenia (reduction in the number of all blood cells);
- agranulocytosis (reduction in the number of a type of white blood cells called granulocytes);
- neutropenia (reduction in the number of a type of white blood cells called neutrophils);
- leukopenia (reduction in the number of white blood cells);
- reduction of hemoglobin (substance that transports oxygen in the blood), caused by the destruction of red blood cells (hemolytic anemia);
- fixed drug eruption (skin redness with blisters and vesicles).

Not known (frequency cannot be estimated from the available data)
- flatulence (excessive gas production in the intestine);
- dyspepsia (difficult digestion);
- melena (presence of digested blood in the stool);
- hematemesis (vomiting blood);
- ulcerative stomatitis (inflammation of the mouth);
- worsening of (colitis, an intestinal inflammation characterized by episodes of diarrhea and abdominal bloating);
- worsening of Crohn's disease (a severe inflammation of the intestine), see Warnings and precautions;
- increase in GOT and GPT (proteins in the blood that increase in case of liver damage);
- jaundice (yellowing of the skin and the whites of the eyes);
- hepatitis (inflammation of the liver) up to liver necrosis (liver death);
- gastritis (inflammation of the stomach) and peptic ulcers (stomach lesions), sometimes fatal and especially in the elderly;
- gastrointestinal perforation or hemorrhage (bleeding of the stomach and/or intestine), see Warnings and precautions;
- urinary retention (inability to empty the bladder) and dysuria (difficulty urinating);
- anuria (lack of urine production);
- hematuria (presence of blood in the urine);
- acute kidney failure, interstitial nephritis (alterations of kidney function);
- asthenia (weakness);
- photosensitivity (sensitivity reaction to sunlight or UV lamps);
- convulsions (involuntary, sudden and uncontrolled muscle movements);
- breathing difficulties due to increased secretions in the bronchi;
- heart rhythm disturbances especially in the elderly [extrasystoles (irregular beats) and tachycardia (increased number of beats per minute)];
- low blood pressure especially in the elderly;
- edema (accumulation of fluid in the body);
- high blood pressure;
- fatigue;
- heart failure (altered pumping function of the heart);
- psychomotor hyperactivity especially in children;
- severe condition that can make the blood more acidic (called metabolic acidosis), in patients with a severe illness who use paracetamol (see paragraph 2).

Reporting of side effects
If you get any side effects, including those 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.