VICKS MEDINAIT 0.5 MG/ML + 0.25 MG/ML + 20 MG/ML SYRUP 90 ML GLASS BOTTLE WITH DISPENSING GLASS

Name
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 to treat cold and flu symptoms.
Vicks MediNait contains:
- dextromethorphan hydrobromide : a substance that calms cough symptoms;
- doxylamine succinate : an antihistamine substance that works on some cold symptoms, such as a runny nose and sneezing;
- paracetamol : a substance with analgesic and antipyretic action, capable of lowering fever.
Contact 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 substances or any of the other ingredients of this medicine (listed in section 6);
- if the subject to be treated is a child or an 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 contractions of the muscles);
- if you have severe liver or kidney problems;
- if you suffer from glaucoma (a disease that causes increased pressure in the eye and problems with vision);
- if you have an enlarged prostate (prostatic hypertrophy);
- if you have difficulty urinating;
- if you suffer from narrowing of the stomach or intestines or urinary or genital tract;
- if you have a blockage that makes it difficult for stomach contents to pass into your intestine;
- if you have a deficiency of an enzyme called glucose-6-phosphate dehydrogenase;
- if you suffer from haemolytic anaemia (a disease that causes red blood cells to break down);
- if you have suffered in the past from bleeding or perforation of the stomach or intestine due to treatments with medicines with anti-inflammatory, antipyretic and analgesic activity or recurrent (two or more episodes of proven ulcer or bleeding);
- if you have severe heart failure (a condition in which the body is unable to 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 to treat depression and anxiety in the treatment of Parkinson's disease (a disease that causes shaking, stiffness 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 selective serotonin reuptake inhibitors (SSRIs) - used to treat depression and anxiety.


Warnings and precautions
Talk to 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, treatment should be short-term.
Undesirable effects may be minimised by using the shortest duration of treatment necessary to control symptoms.
Older people are more susceptible to the onset of adverse effects.
Concomitant use of Vicks MediNait with anti-inflammatory, antipyretic and analgesic drugs should be avoided. Other drugs may affect liver function and may increase liver toxicity.
Contact your doctor:
- if you have a chronic or persistent cough (for example due to smoking and some respiratory diseases such as emphysema / asthma);
- if your cough is irritating with abundant mucus production;
- if you suffer from liver or kidney problems;
- if he abuses alcohol;
- if you suffer from liver disease due to alcohol abuse;
- if you have a disease of the intestine (ulcerative colitis, Crohn's disease);
- if you are taking antibiotics (medicines used to treat infections caused by bacteria), because Vicks MediNait may 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 disease of the thyroid caused by its increased activity);
- if you suffer from high blood pressure that is 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 known ischemic heart disease (heart disease due to reduced oxygen supply);
- if you have peripheral arterial disease and/or cerebrovascular disease (disease of the arteries and vessels of the brain), as you should use Vicks MediNait only after careful consideration by your doctor;
- if you have a history of drug or narcotic abuse (psychoactive substances capable of altering the psycho-physical state);
- if the subject to be treated is an adolescent or a young adult.
Concomitant use of Vicks MediNait with sedative medicines such as benzodiazepines or similar medicines increases the risk of drowsiness, difficulty breathing (respiratory depression), coma (deep unconsciousness) and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are 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.
Tell your doctor about all the sedative medicines you are taking and follow his or her dose recommendations carefully. It may be helpful to tell friends or family members so they are aware of the signs and symptoms described above. If you experience these symptoms, contact your doctor.
Elderly people are at greater risk of developing adverse reactions to anti-inflammatory, antipyretic and analgesic drugs, such as sedation (alteration of consciousness), dizziness (sensation of movement or rotation) and gastrointestinal haemorrhages (bleeding) and perforations, which can be fatal.
Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported with all medicinal products with anti-inflammatory, antipyretic and analgesic activity, such as Vicks MediNait, at anytime during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events.
Patients who have suffered from these conditions in the past are at increased risk (see "Do not take Vicks MediNait").
Report any abdominal signs or symptoms (including gastrointestinal bleeding) even at the beginning of treatment.
Discontinue treatment with Vicks MediNait immediately at the first signs of gastrointestinal bleeding or ulceration.
Tell your doctor if you are taking medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids (medicines used to treat inflammatory conditions), anticoagulants (medicines that delay blood clotting) such as warfarin, or anti-platelet agents (medicines that prevent platelets from clumping together) such as acetylsalicylic acid (see "Other medicines and Vicks MediNait").
Tell your doctor if you are taking medicines to treat depression and anxiety (see "Do not use Vicks MediNait" and "Other medicines and Vicks MediNait").
Serious skin reactions, some of them fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of medicinal products with anti-inflammatory, antipyretic and analgesic activity (see "Possible side effects"). The reaction occurs in most cases in the early stages of treatment. Stop using Vicks MediNait if you experience a skin rash, mucosal lesions or any other sign of hypersensitivity (allergic reaction).
If you are taking medicines such as some antidepressants or antipsychotics: Vicks MediNait may interact with these medicines and changes in mental status (e.g. agitation, hallucinations, coma) and other effects such as body temperature above 38℃, increased heart rate, unstable blood pressure, exaggerated reflexes, muscle stiffness, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) may occur.
While taking Vicks MediNait, tell your doctor immediately:
If you have serious illnesses, including severe kidney failure 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). A serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses over a long 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 everybody gets them.
Stop treatment and inform your doctor immediately 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 (larynx edema), swelling of the face, lips, mouth, tongue and throat which may cause problems with breathing and swallowing (angioedema);
- these may be signs of serious allergic reactions (anaphylactic shock) the signs of which may include difficulty breathing, chest pain or tightness and/or dizziness/fainting, itching of the skin or raised lumps on the skin, swelling of the face, lips, tongue and/or throat and which may be potentially life-threatening; skin irritation, hives;
- widespread red bumps or blisters and scaling, especially on the legs, arms, hands and feet, which may extend to the face, lips and mucous membranes, occasionally accompanied by fever. These may be signs of serious skin diseases such as Erythema Multiforme, Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome;
- nosebleeds (epistaxis);
- increased tendency to bruise 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 (sensation of movement or rotation);
- headache (headache);
- blurred vision;
- psychomotor impairment;
- dry mouth;
- constipation;
- gastric reflux (backflow of stomach acid causing heartburn).

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

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

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 inflammation of the intestines characterized by episodes of diarrhea and abdominal swelling);
- worsening of Crohn's disease (a serious inflammation of the intestine), see Warnings and precautions;
- increased GOT and GPT (proteins in the blood that increase in case of liver damage);
- jaundice (yellowing of the skin and whites of the eyes);
- hepatitis (inflammation of the liver) up to hepatic necrosis (death of the liver);
- gastritis (inflammation of the stomach) and peptic ulcers (stomach lesions), sometimes fatal and especially in the elderly;
- gastrointestinal perforation or haemorrhage (bleeding from 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 renal failure, interstitial nephritis (alterations in renal function);
- asthenia (weakness);
- photosensitivity (sensitivity reaction to sunlight or UV lamps);
- convulsions (involuntary, sudden, uncontrolled muscle movements);
- breathing difficulties due to increased secretions in the bronchi;
- heartbeat alterations, especially in the elderly [extrasystoles (irregular heartbeats) 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;
- tiredness;
- heart failure (impairment of the heart's pumping function);
- psychomotor hyperactivity especially in children;
- a serious condition which can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see section 2).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.