Vicks Medinait

Package leaflet: Information for the patient

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

dextromethorphan hydrobromide, doxylamine succinate, paracetamol
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, please consult your pharmacist.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement 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 taking 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

1. What Vicks MediNait 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 relieves cough symptoms;
• doxylamine succinate: an antihistamine substance that acts on certain cold symptoms such as runny nose and sneezing;
• paracetamol: a substance with analgesic and antipyretic action, capable of reducing fever. Consult your 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 substances or to any of the other ingredients of this medicine (listed in section 6);
• if the person to be treated is a child or adolescent under 12 years of age;
• if you suffer or have suffered from asthma (a condition causing narrowing and inflammation of the bronchi);
• if you have diabetes, a disease causing increased blood glucose (amount of sugar in the blood);
• if you suffer or have suffered from epilepsy (a disease causing loss of consciousness and violent involuntary muscle contractions);
• if you have severe liver or kidney problems;
• if you suffer from glaucoma (a disease causing 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 narrowing of the stomach, intestine, or urinary or genital tracts;
• if you have an obstruction making it difficult for stomach contents to pass into the intestine;
• if you lack an enzyme called glucose-6-phosphate dehydrogenase;
• if you suffer from haemolytic anaemia (a disease causing destruction of red blood cells);
• if you have previously experienced gastrointestinal bleeding or perforation due to treatment with anti-inflammatory, antipyretic and analgesic medicines, or recurrent episodes (two or more episodes of confirmed ulcer or bleeding);
• if you have severe heart failure (a condition in which the body cannot compensate for reduced contractile function of the heart);
• if you are currently taking medicines belonging to the class of monoamine oxidase inhibitors (MAOIs), used to treat depression and anxiety or Parkinson’s disease (a disease causing tremors, stiffness and slowness of movement), or if you have discontinued them less than two weeks ago;
• if you are currently taking medicines belonging to the class of 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 long periods.
This medicine may lead to abuse and dependence. Therefore, treatment should be short-term.
Adverse effects can be minimized by using the shortest duration of treatment necessary to control symptoms.
Elderly patients are more susceptible to the occurrence of adverse effects.
Concomitant use of Vicks MediNait with anti-inflammatory, antipyretic and analgesic medicines should be avoided. Other medicines may affect liver function and increase the risk of liver toxicity.

Talk to your doctor:

• if you have chronic or persistent cough (for example, due to smoking or respiratory diseases such as emphysema/asthma);
• if your cough is irritating and produces abundant mucus;
• if you have liver or kidney problems;
• if you abuse alcohol;
• if you have liver disease due to alcohol abuse;
• if you have intestinal disease (ulcerative colitis, Crohn’s disease);
• if you are taking antibiotics (medicines used to treat bacterial infections), because Vicks MediNait may delay the recognition of hearing damage caused by certain antibiotics;
• if you have heart disease;
• if you suffer from high blood pressure;
• if you have hyperthyroidism (a thyroid disease caused by increased thyroid activity);
• if you have high blood pressure not adequately controlled by medication;
• if you suffer from congestive heart failure (a disease in which the heart cannot pump blood efficiently);
• if you have confirmed ischemic heart disease (heart condition due to reduced oxygen supply);
• if you have peripheral arterial disease and/or cerebrovascular disease (disease of arteries and blood vessels in 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 mental and physical state);
• if the person to be treated is an adolescent or young adult. Concomitant use of Vicks MediNait with sedative medicines such as benzodiazepines or similar medicines increases the risk of drowsiness, breathing difficulties (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 available. However, if your doctor prescribes Vicks MediNait together with sedative medicines, the dose and duration of concomitant treatment must be limited by the doctor. Inform your doctor about all sedative medicines you are taking and follow their dosage recommendations carefully. It may be helpful to inform friends or family members so they are aware of the signs and symptoms described above. If you experience these symptoms, contact your doctor. Elderly patients are at higher risk of developing adverse reactions to anti-inflammatory, antipyretic and analgesic medicines, such as sedation (altered consciousness), dizziness (sensation of movement or spinning), gastrointestinal bleeding and gastrointestinal perforation, which can be fatal. During treatment with all anti-inflammatory, antipyretic and analgesic medicines, including Vicks MediNait, gastrointestinal bleeding, ulceration and perforation have been reported at any time, with or without warning symptoms or previous history of serious gastrointestinal events, and may be fatal. Patients who have previously suffered from these conditions are at higher risk (see "Do not take Vicks MediNait"). Report any abdominal signs or symptoms (including gastrointestinal bleeding) even at the beginning of treatment. Immediately discontinue 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 to treat 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 (of the skin), some of which have been fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been very rarely reported in association with the use of anti-inflammatory, antipyretic and analgesic medicines (see "Possible side effects"). These reactions occur mostly during the early stages of treatment. Discontinue use of Vicks MediNait if a skin rash, mucosal lesions or any other sign of hypersensitivity (allergic reaction) occurs.

If you are taking medicines such as certain antidepressants or antipsychotics: Vicks MediNait may interact with these medicines and cause changes in mental status (e.g. agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, unstable blood pressure, exaggerated reflexes, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea).
During treatment with Vicks MediNait, inform your doctor immediately:
If you suffer from serious illnesses, including severe renal impairment 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). In patients with these conditions, a serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported when paracetamol is used regularly for prolonged periods or when paracetamol is taken concomitantly with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep, rapid breathing, drowsiness, nausea and vomiting.

Laboratory tests
Paracetamol, contained in Vicks MediNait, may interfere with the measurement of uric acid or glucose levels in the blood (uricemia and glycaemia).

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

• isoniazid and rifampicin (antibiotics used to treat bacterial infections);
• 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 causing loss of consciousness and violent involuntary muscle contractions);
• probenecid (a medicine used to treat gout, a disease causing pain, swelling and redness of joints);
• metoclopramide or domperidone (medicines used to treat nausea and vomiting);
• colestyramine (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, anxiolytics (medicines that reduce anxiety);
• terbinafine (used to treat fungal infections, mycoses);
• amiodarone, flecainide, propafenone, quinidine (medicines used to treat 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 drug dependence);
• cinacalcet (used to reduce calcium levels 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 conditions);
• flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (metabolic acidosis with high anion gap) requiring urgent treatment (see section 2).

Vicks MediNait and alcohol
Do not consume alcoholic beverages while taking this medicine, as they may increase the liver toxicity of paracetamol. In addition, alcohol consumption may increase drowsiness and reduce reaction times (see "Driving and use of machines").

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

Driving and use of machines
This medicine may cause drowsiness and impair your ability to drive or operate machinery.
Do not drive or operate machinery.

Vicks MediNait contains:
Sucrose: If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine. This medicine contains 8.25 g of sucrose per dose (30 ml). This should be taken into account in people with diabetes mellitus or on low-calorie diets.
Sodium: This medicine contains approximately 75 mg of sodium per dose (30 ml). This corresponds to about 3.8% of the maximum daily dietary intake recommended for 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 suffer from liver or kidney disease, do not take this medicine unless otherwise recommended by your doctor. Your doctor may perform additional monitoring during treatment.

3. How to take Vicks MediNait

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults and adolescents over 12 years
The recommended dose is 30 ml (one dosing cup), once daily, for no more than 3 days.
Consult a doctor if you do not feel better after 3 days of continuous use or if you notice worsening of symptoms.
30 ml contain 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 with food, in the evening before going to bed, to aid restful sleep.
Use the dosing cup provided in the package, filling it 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 more Vicks MediNait than the recommended dose, contact your doctor immediately or go to the nearest hospital, even if you feel well, due to the risk of delayed liver damage. Symptoms of overdose may include:
pallor, nausea, vomiting, abdominal pain, anorexia (reduced or lack of appetite), involuntary muscle contractions, restlessness, excitement, convulsions (involuntary, sudden, uncontrolled muscle movements), confusion, drowsiness, cognitive disturbances, involuntary and rapid eye movements, altered consciousness, rapid and involuntary eye movements, cardiac disorders (fast and irregular heartbeat, high blood pressure), hyperthermia (increased body temperature), motor coordination disturbances, psychosis (thought disturbances) with visual hallucinations (seeing things that are not there) and hyperexcitability, kidney function impairment and severe respiratory problems.
In addition, disturbances in glucose metabolism and a decrease in blood pH (metabolic acidosis) may occur. In cases of severe poisoning, liver failure (impaired liver function) may progress to brain abnormalities (hepatic encephalopathy), leading to coma (a state of deep unconsciousness) and death.

If you forget to take Vicks MediNait
Do not take a double dose to make up for a forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking the medicine and contact your doctor immediately if you experience any of the
following symptoms:
skin rashes and itching;

• severe allergic reaction (anaphylaxis);
• bronchial constriction causing breathing difficulties (bronchospasm);
• swelling of the throat due to fluid accumulation (laryngeal edema), swelling of the face, lips, mouth, tongue and throat which may cause problems with breathing and swallowing (angioedema);
• these may be signs of severe allergic reactions (anaphylactic shock), whose symptoms may include difficulty breathing, chest pain or tightness in the chest and/or dizziness/fainting, skin itching or raised skin rashes (hives), swelling of the face, lips, tongue and/or throat, and which may potentially be life-threatening;
• red papules or widespread blisters and peeling skin, 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 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 spinning);
• headache;
• blurred vision;
• psychomotor impairment;
• dry mouth;
• constipation;
• gastric reflux (acid from the stomach rising up, causing heartburn).

Rare (may affect up to 1 in 1,000 people)

• nausea;
• vomiting;
• abdominal pain;
• diarrhoea;
• hypersensitivity (allergies);
• erythema (redness of the skin);
• urticaria (hives);
• insomnia (altered quantity and quality of sleep).

Very rare (may affect up to 1 in 10,000 people)

• thrombocytopenia (reduced platelet count);
• pancytopenia (reduced number of all blood cells);
• agranulocytosis (reduced number of a type of white blood cells called granulocytes);
• neutropenia (reduced number of a type of white blood cells called neutrophils);
• leucopenia (reduced number of white blood cells);
• reduced haemoglobin (the substance that carries oxygen in the blood), caused by destruction of red blood cells (haemolytic anaemia);
• fixed drug eruption (skin redness with blisters and vesicles).

Not known (frequency cannot be estimated from the available data)

• flatulence (excessive intestinal gas production);
• dyspepsia (indigestion);
• melaena (presence of digested blood in faeces);
• haematemesis (vomiting blood);
• ulcerative stomatitis (mouth inflammation);
• worsening of (colitis, an intestinal inflammation characterised by episodes of diarrhoea and abdominal bloating);
• worsening of Crohn’s Disease (a severe intestinal inflammation), see Warnings and precautions;
• increased GOT and GPT (blood proteins that rise in case of liver damage);
• jaundice (yellowing of the skin and whites of the eyes);
• hepatitis (liver inflammation), up to hepatic necrosis (liver death);
• gastritis (stomach inflammation) and peptic ulcers (stomach lesions), sometimes fatal, especially in the elderly;
• gastrointestinal perforation or bleeding (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);
• haematuria (presence of blood in urine);
• acute renal failure, interstitial nephritis (changes in kidney function);
• asthenia (weakness);
• photosensitivity (sensitivity reaction to sunlight or UV lamps);
• seizures (sudden, involuntary, uncontrolled movements of muscles);
• breathing difficulties due to increased bronchial secretions;
• changes in heart rhythm, especially in the elderly [extrasystoles (irregular beats) and tachycardia (increased heart rate)];
• low blood pressure, especially in the elderly;
• oedema (fluid accumulation in the body);
• high blood pressure;
• fatigue;
• heart failure (impaired pumping function of the heart);
• psychomotor hyperactivity, especially in children;
• severe condition that may make the blood more acidic (called metabolic acidosis), in patients with a serious illness who are using paracetamol (see section 2).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: 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 stated on the box after "Exp.".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Vicks MediNait contains

• The active substances are: dextromethorphan hydrobromide, doxylamine succinate and paracetamol. 100 ml of syrup contain 0.05 g of dextromethorphan hydrobromide, 0.025 g of doxylamine succinate and 2 g of paracetamol.
• The other components 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 dosing cup.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Procter & Gamble S.r.l. - Viale Giorgio Ribotta, 11 - 00144 Rome, Italy
Manufacturer
Procter & Gamble Manufacturing GmbH, Procter & Gamble Strasse 1, 64521 - Gross Gerau, Germany