VICKS 0.5 mg/ml + 0.25 mg/ml + 20 mg/ml Сироп

Содержание инструкции

1. Vicks MediNait 0.5 mg/ml + 0.25 mg/ml + 20 mg/ml syrup
   1. What is Vicks MediNait and what is it used for
   2. What you need to know before using Vicks MediNait
   3. How to take Vicks MediNait
   4. Possible side effects
   5. How to store Vicks MediNait
   6. Contents of the pack and other information

Vicks MediNait 0.5 mg/ml + 0.25 mg/ml + 20 mg/ml syrup

dextromethorphan hydrobromide, doxylamine succinate, paracetamol

Read this leaflet carefully before taking this medicine as it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 3 days.

Contents of this leaflet:

• 1. What Vicks MediNait is and what it is used for
• 2. What you need to know before you use Vicks MediNait
• 3. How to use Vicks MediNait
• 4. Possible side effects
• 5. How to store Vicks MediNait
• 6. Contents of the pack and other information

1. What is Vicks MediNait and what is it used for

Vicks MediNait is used in the treatment of cold and flu symptoms.
Vicks MediNait contains:

• dextromethorphan hydrobromide: a substance that soothes 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 reducing fever. Consult a doctor if you do not feel better or if you feel worse after 3 days.

2. What you need to know before using Vicks MediNait

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 the age of 12;
• if you suffer from 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 from 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 increased pressure in the eye and vision problems);
• if you have an enlarged prostate (prostatic hypertrophy);
• if you have difficulty urinating;
• if you suffer from a narrowing of the stomach or intestine or the urinary or genital tract;
• if you have an obstruction that makes it difficult for the contents of the stomach 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 rupture of red blood cells);
• if you have previously suffered 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 fails 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 for the treatment of depression and anxiety in the treatment of Parkinson's disease (a disease that causes tremor, rigidity and slowness of movements), 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 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, treatment should be short-term.
Undesirable effects can be minimized with the shortest possible duration of treatment
needed to control the symptoms.
The elderly are more susceptible to the onset of adverse effects.
Concomitant use of Vicks MediNait with medicines with anti-inflammatory, antipyretic and
analgesic activity should be avoided. Other drugs can affect liver function
and can increase hepatic toxicity.
Consult your doctor:

• if you have a chronic or persistent cough (due for example 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 you abuse alcohol;
• if you suffer from a 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 a heart condition;
• if you suffer from high blood pressure;
• if you suffer from hyperthyroidism (a thyroid disease caused by its increased activity);
• if you suffer from high blood pressure that is not sufficiently controlled with medication;
• 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 must use Vicks MediNait only after careful evaluation by the doctor;
• if you have a history of drug or substance abuse (psychoactive substances capable of altering the psycho-physical state);
• if the subject to be treated is an adolescent or young adult. Concomitant use of Vicks MediNait with sedatives such as benzodiazepines or similar medicines increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma (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 the doctor prescribes Vicks MediNait together with sedatives, the dose and duration of concomitant treatment must be limited by the doctor. Tell your doctor about all the sedatives you are taking and carefully follow their recommendations on dosage. 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. The elderly are more exposed to the risk of developing adverse reactions to medicines with anti-inflammatory, antipyretic and analgesic activity, such as sedation (altered consciousness), dizziness (sensation of movement or rotation) and gastrointestinal bleeding and perforations, which can be fatal. During treatment with all medicines with anti-inflammatory, antipyretic and analgesic activity, such as Vicks MediNait, at any time, with or without warning signs or a previous history of severe gastrointestinal events, gastrointestinal bleeding, ulceration and perforation have been reported, which can be fatal. Patients who have previously suffered from these conditions are at greater risk (see “Do not take Vicks MediNait”). Report any abdominal signs or symptoms (including gastrointestinal bleeding) even at the beginning of treatment. Stop treatment with Vicks MediNait immediately at the first signs of bleeding or gastrointestinal 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 states), 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”). 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”). Severe skin reactions (of the skin), some of which are fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of medicines with anti-inflammatory, antipyretic and analgesic activity (see “Possible side effects”). The reaction occurs most often in the early stages of treatment. Stop using Vicks MediNait if a rash appears,
  lesions of the mucous membranes or any other sign of hypersensitivity (allergic reaction).
  If you are taking medicines such as some antidepressants or antipsychotics: Vicks MediNait can
  interact with these medicines and alterations in mental status (e.g.
  agitation, hallucinations, coma) and other effects such as body temperature above 38° C,
  increased heart rate, unstable blood pressure, exaggeration of reflexes, muscle rigidity,
  lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting,
  diarrhea).
  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 abnormality 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 association with flucloxacillin. Symptoms of metabolic acidosis may include: severe
  difficulty breathing 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).

  Other medicines and Vicks MediNait
  Inform your doctor or pharmacist if you are taking, have recently taken or may take
  any other medicine.
  The use of Vicks MediNait is not recommended together with medicines with anti-inflammatory,
  antipyretic and analgesic activity.
  It is important to inform your doctor if you are using any of the following medicines:

  • isoniazid and rifampicin (antibiotics used to treat infections caused by bacteria);
  • cimetidine (a medicine used to treat ulcers and heartburn);
  • charcoal (used to eliminate excess intestinal gas);
  • lamotrigine, glutethimide, phenobarbital and carbamazepine (medicines used to treat epilepsy, (a disease that causes loss of consciousness and violent involuntary muscle contractions);
  • probenecid (a medicine used for the treatment of gout, a disease that causes pain, swelling and redness of the joints);
  • metoclopramide or domperidone (medicines used to treat nausea and vomiting);
  • cholestyramine (a medicine used to lower cholesterol levels);
  • warfarin and other anticoagulants (medicines that delay blood clotting);
  • fluoxetine, paroxetine, sertraline and bupropion (medicines used to treat depression);
  • hypnotics (medicines that induce sleep), sedatives (calming), anxiolytics (which reduce anxiety);
  • terbinafine (used for the treatment of fungal infections);
  • amiodarone, flecainide, propafenone, quinidine (medicines used for heart rhythm disorders);
  • antiplatelet agents (medicines that prevent platelet aggregation) such as acetylsalicylic acid);
  • methadone (used to treat severe pain or to reduce withdrawal symptoms in cases of substance dependence);
  • cinacalcet (used to reduce the amount of calcium in the blood);
  • haloperidol, perphenazine and thioridazine (medicines used to treat mental disorders);
  • diuretics, ACE inhibitors, angiotensin II receptor blockers (medicines used to lower blood pressure);
  • corticosteroids (medicines used to treat inflammatory states);
  • flucloxacillin (antibiotic), due to a serious risk of alterations of the blood and fluids (metabolic acidosis with high anion gap) that must be treated urgently (see paragraph 2)

  Vicks MediNait with alcohol
  Do not drink alcoholic beverages while being treated with this medicine because they can
  increase the toxicity of paracetamol to the liver. In addition, drinking alcohol can
  increase drowsiness and reduce reaction times (see “Driving and operating machinery”).

  Pregnancy and breastfeeding
  If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
  breast milk, ask your doctor or pharmacist for advice before taking this medicine.
  Data on the safety of use of Vicks MediNait during pregnancy and breastfeeding are limited.
  Vicks MediNait during pregnancy and breastfeeding is not recommended.
  Use should only be considered if the expected benefit to the mother outweighs the risk
  to the fetus or infant and it is appropriate to use for the shortest possible time.

  Driving and operating machinery
  This medicine can cause drowsiness and impair your ability to drive vehicles or operate
  machinery.
  Do not drive and do not operate machinery.

  Vicks MediNait contains:
  Sucrose:if you have been diagnosed with an intolerance to certain sugars, contact your doctor before
  taking this medicine. This medicine contains 8.25 g of sucrose per dose (30 ml). To be considered in people affected by diabetes mellitus and in case of hypocaloric diets.
  Sodium:this medicine contains about 75 mg of sodium per dose (30 ml). This is equivalent to about
  3.8% of the recommended daily intake with the diet of an adult.
  Sodium benzoate:this medicine contains 30 mg of sodium benzoate per dose (30 ml).
  Propylene glycol:this medicine contains 3 g of propylene glycol per dose (30 ml). If you are
  pregnant, breastfeeding or if you suffer from liver or kidney disease, do not take this
  medicine unless otherwise recommended by your doctor. The doctor may perform further checks
  during therapy.

  3. How to take Vicks MediNait

  Take this medicine following exactly as indicated in this leaflet or the instructions of your doctor or pharmacist. If you have doubts, consult your doctor or pharmacist.
  Adults and adolescents over 12 years of age
  The recommended dose is 30 ml (one measuring cup), 1 time a day, for no more than 3 days.
  Consult a doctor if after 3 days of continuous use you do not improve or if you notice a worsening
  of symptoms.
  30 ml contains 0.015 g of dextromethorphan hydrobromide, 0.0075 g of doxylamine succinate and 0.6
  g of paracetamol
  Do not exceed the recommended doses.
  Take on a full stomach, in the evening before bedtime to promote restful sleep.
  Use the measuring cup included in the package, filling it up to the indicated level.
  Shake well before use.
  Rinse with water after use.

  If you take more Vicks MediNait than you should
  If you take a dose of Vicks MediNait higher than the recommended one, immediately inform your
  doctor or go to the nearest hospital, even if you feel well, due to the risk of delayed liver damage. Symptoms of an overdose may include:
  pallor, nausea, vomiting, abdominal pain, anorexia (loss or lack of appetite),
  involuntary muscle contractions, agitation, excitement, seizures (involuntary, sudden and uncontrolled muscle movements), confusion, drowsiness, cognitive disorders, involuntary and rapid eye movements, altered state of consciousness, rapid and involuntary eye movements,
  cardiac disorders (rapid and irregular heartbeat, high blood pressure), hyperthermia (increased
  body temperature), disorders of motor coordination, psychosis (thought disorders) with
  visual hallucinations (seeing things that do not exist) and hyperexcitability, alteration of the function of the
  kidneys and serious respiratory problems. An alteration of glucose metabolism and a decrease in blood pH (metabolic acidosis) can also occur. In case of severe poisoning,
  liver failure (alteration of liver functions) can progress to brain alterations
  (hepatic encephalopathy), up to coma (deep unconsciousness) and death.

  If you forget to takeVicks MediNait
  Do not take a double dose to make up for a missed dose.
  If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

  4. Possible side effects

  Like all medicines, this medicine can cause side effects, although not everyone will experience them.

  Stop treatment and inform your doctor immediatelyif 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 may be signs of severe allergic reactions (anaphylactic shock) whose signs may include difficulty breathing, chest pain or chest tightness and/or dizziness/fainting, itchy skin or raised bumps on the skin, swelling of the face, lips, tongue and/or throat and which can be potentially life-threatening; skin irritation, urticaria;
  • formation of red papules or widespread blisters and scaling, particularly on 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 Necrolysisand 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 spinning);
  • headache;
  • blurred vision;
  • psychomotor impairment;
  • dry mouth;
  • constipation;
  • gastroesophageal reflux (rising of stomach acid causing heartburn). Rare (may affect up to 1 in 1000)
  • nausea;
  • vomiting;
  • abdominal pain;
  • diarrhea;
  • hypersensitivity (allergies);
  • erythema (redness of the skin);
  • urticaria;
  • insomnia (alteration of the amount and quality of sleep). Very rare (may affect up to 1 in 10,000)
  • 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 in hemoglobin (substance that carries oxygen in the blood), caused by the destruction of red blood cells (hemolytic anemia);
  • fixed drug eruption (redness of the skin with blisters and vesicles). Not known (frequency cannot be estimated from available data)
  • flatulence (excessive production of gas in the intestine);
  • dyspepsia (difficult digestion);
  • melena (presence of digested blood in the stool);
  • hematemesis (vomiting of 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;
  • increased 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 hepatic necrosis (death of the liver);
  • gastritis (inflammation of the stomach) and peptic ulcers (lesions of the stomach), sometimes fatal and especially in the elderly;
  • perforation or gastrointestinal bleeding (bleeding of the stomach and/or intestine), see Warnings and precautions;
  • urinary retention (inability to empty the bladder) and dysuria (difficulty urinating);
  • anuria (failure to produce urine);
  • hematuria (presence of blood in the urine);
  • acute renal failure, interstitial nephritis (alterations of renal function);
  • asthenia (weakness);
  • photosensitivity (sensitivity reaction to sunlight or UV lamps);
  • convulsions (involuntary, sudden and uncontrolled movements of the muscles);
  • difficulty breathing due to increased secretions in the bronchi;
  • alterations of the heartbeat, especially in the elderly [extrasystoles (irregular beats) and tachycardia (increase in the number of beats per minute)];
  • low blood pressure, especially in the elderly;
  • edema (accumulation of fluids in the body);
  • high blood pressure;
  • fatigue;
  • heart failure (alteration of the heart's pumping function);
  • psychomotor hyperactivity, especially in children;
  • severe condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who are using paracetamol (see paragraph 2).

  Reporting of side effects
  If you experience any side effects, including those not listed in this leaflet, please
  tell your doctor or pharmacist. You can also report side effects directly through
  the national reporting system at the address: https://www.aifa.gov.it/content/segnalazioni-
  reazioni-avverse.
  By reporting side effects you can help provide more information on the safety of
  this medicine.

  5. How to store Vicks MediNait

  Keep this medicine out of the sight and reach of children.
  Keep the bottle in the outer packaging to protect the medicine from light.
  Do not use this medicine after the expiry date that is stated on the pack after “Exp.”. The
  expiry date refers to the last day of that month.
  Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
  dispose of medicines you no longer use. This will help protect the environment.

  6. Contents of the pack and other information

  What Vicks MediNait contains

  • The active ingredients are: dextromethorphan hydrobromide, doxylamine succinate and paracetamol. 100 ml of syrup contains 0.05 g of dextromethorphan hydrobromide, 0.025 g of doxylamine succinate and 2 g of paracetamol.
  • The other ingredients are: propylene glycol, sodium citrate, citric acid monohydrate, potassium sorbate, sodium benzoate, macrogol, sucrose, glycerol, anethole, quinoline yellow (E 104), brilliant blue FCF (E 133) and purified water.

  Description of the appearance of Vicks MediNait and contents of the pack
  90 ml or 180 ml glass bottle with measuring cup.

  Marketing Authorisation Holder and Manufacturer

  Marketing Authorisation Holder
  Procter & Gamble S.r.l. - Viale Giorgio Ribotta, 11 - 00144 Roma

  Manufacturer
  Procter & Gamble Manufacturing GmbH Procter & Gamble Strasse 1, 64521 - Gross Gerau,
  Germany.