Vicks Medinait - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf life and Storage Composition and pharmaceutical form

Active ingredients: Dextromethorphan (Dextromethorphan hydrobromide), Doxylamine (Doxylamine succinate), Paracetamol

VICKS MEDINAIT “Syrup” bottle 90 ml
VICKS MEDINAIT “Syrup” bottle 180 ml

Why is Vicks Medinait used? What is it for?

WHAT IS IT

Vicks Medinait is a "combination of several components in liquid form to simultaneously reduce the most frequent and important symptoms of colds and flu."

WHY IT IS USED

Treatment of cold and flu symptoms.

Contraindications When Vicks Medinait should not be used

Hypersensitivity to the active substance or to any of the excipients.

From children under 12 years of age. Asthma, diabetes, glaucoma (high pressure in the eye), prostatic hypertrophy (swelling of the prostate), stenosis of the gastrointestinal and urogenital tract (narrowing of the gastrointestinal tract and / or of the urinary and genital tract), epilepsy, severe hepatocellular insufficiency ( liver disease) or renal impairment. Paracetamol products are contraindicated in patients with manifest insufficiency of glucose-6-phosphate dehydrogenase (particular genetic blood disorder) and in those with severe haemolytic anemia (blood disease). also contraindicated in patients with a history of gastrointestinal haemorrhage or perforation related to previous active treatments or a history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding). The product is contraindicated in patients with severe heart failure. of concomitant administration with monoamine inhibitors idase (drugs used to treat depression) or within two weeks of taking these.

Precautions for use What you need to know before taking Vicks Medinait

It is not recommended for use during pregnancy and breastfeeding. Do not administer to children under 12 years of age. The product contains sugar, this should be taken into account in case of low calorie diets.

Interactions Which drugs or foods can change the effect of Vicks Medinait

Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.

Do not use during or in the two weeks following treatment with antidepressant (anti-MAO) drugs. The use of the product is not recommended if the patient is being treated with anti-inflammatories. Additive effects may occur with alcohol, sleeping pills, sedatives or tranquilizers, which therefore should not be taken at the same time. Patients being treated with rifampicin (a drug used to treat tuberculosis and leprosy), cimetidine (anti-ulcer drug) or with antiepileptic drugs such as glutethymide, phenobarbital, carbamazepine and even alcohol should use paracetamol with extreme caution and only under strict medical supervision because these substances can increase the ability to induce a harmful effect on the liver by paracetamol. The administration of paracetamol can interfere with the determination of laboratory tests such as that of uric acid (by the method of phosphotungstic acid) and that of glycaemia (by the method of glucose-oxidase-peroxidase). The absorption rate of paracetamol can be increased by metoclopramide or domperidone (drugs used to increase the rate of gastric transit) and absorption can be reduced by cholestyramine (a drug used for high cholesterol).

There is a potential for interaction between the dextromethorphan contained in this medicinal product and medicinal products which inhibit the CYP2D6 isoenzyme such as selective serotonin reuptake inhibitors (eg fluoxetine, paroxetine, drugs used to treat depression). NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function) co-administration of an ACE inhibitor or angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, usually reversible. These interactions should be considered in patients taking Vicks Medinait concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy. NSAIDs may enhance the effects of anticoagulants, such as warfarin. The concomitant use of antiplatelet agents and selective reuptake inhibitors of serotonin (SSRIs) may increase the risk of gastrointestinal bleeding. The concomitant use of corticosteroids may increase the risk of gastrointestinal ulceration or bleeding.

WHEN IT CAN ONLY BE USED AFTER CONSULTING YOUR DOCTOR

Ask your doctor before use if you have cough that occurs with excessive phlegm (mucus) or persistent cough, such as that manifested by smoking, asthma, or emphysema. High or prolonged doses of paracetamol, present in the product, may cause changes high risk liver and kidney and blood alterations, even serious ones. Paracetamol should only be used by prescription in subjects with renal or liver insufficiency, including those with liver disease, non-cirrhotic, linked to the intake of alcohol. The dangers of excessive dosage are greater in people with liver disease related to alcohol intake. Do not use with any other product containing paracetamol. During treatment with paracetamol before taking any other drug check that it does not contain the same active ingredient, as if paracetamol is taken in high doses, serious adverse reactions may occur. In the course of therapy with oral anticoagulants, doses should be reduced. In the rare cases of occurrence of allergic reactions, administration should be suspended. Particular caution is required in determining the dose in elderly subjects in consideration of their greater sensitivity to antihistamines. The use of antihistamines at the same time as certain antibiotics harmful to the ear can mask the first signs of damage to the ear, which can only be revealed when the damage is irreversible. The use of Vicks Medinait should be avoided concomitantly with NSAIDs, including selective COX-2 inhibitors. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible treatment duration needed to control the symptoms. Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see "How to use this medicine"). Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported during treatment with all NSAIDs at any time, with or without warning symptoms or a previous history of serious gastrointestinal events. In the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see "When it should not be used"), the risk of gastrointestinal bleeding, ulceration or perforation is higher with increased doses of NSAIDs. These patients should start treatment with the lowest available dose. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low dose aspirin or other drugs that may increase the risk of gastrointestinal events. Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment. Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin , selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin (see "Which Medicines or Foods May Change the" Effect of the Medicine "). When gastrointestinal bleeding or ulceration occurs in patients taking Vicks Medinait, treatment should be discontinued. eso. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see "Undesirable effects"). Caution should be exercised in patients with a history of hypertension and / or heart failure as fluid retention and edema have been reported in association with NSAID therapy. The product should be administered under medical supervision in patients with cardiovascular disease, hypertension (high blood pressure), hyperthyroidism (dysfunction that involves increased thyroid activity). Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. In the early stages of therapy, patients appear to be at higher risk: the onset of the reaction occurs in most cases in the early stages of treatment. Vicks Medinait should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity.

Also, before combining any other drug, contact your doctor. See also "Which medicines or foods can change the" effect of the medicine ".

Warnings It is important to know that:

WHAT TO DO DURING PREGNANCY AND BREASTFEEDING

Ask your doctor or pharmacist for advice before taking any medicine. Vicks Medinait should not be used during pregnancy and / or breastfeeding. Use should also be avoided if you suspect pregnancy or plan to maternity leave.

Pregnancy

Inhibition of prostaglandin synthesis may adversely affect pregnancy and / or embryo / fetal development. Results from epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in early stages of pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk was considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased pre- and post-implantation loss and embryo-fetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to:

  • cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension);
  • renal dysfunction, which can progress to renal failure with oligo-hydroamnios; the mother and the newborn, at the end of pregnancy, to:
  • possible prolongation of bleeding time, and antiplatelet effect which may occur even at very low doses; inhibition of uterine contractions resulting in delayed or prolonged labor.

EFFECTS ON THE ABILITY TO DRIVE VEHICLES AND ON THE USE OF MACHINERY

The product can cause drowsiness (especially in conjunction with the intake of alcohol or other medicines that can reduce reaction times), this must be taken into account by those who may drive vehicles or attend to operations requiring integrity of the degree of vigilance, which will have to refrain from such duties after taking the product.

Dosage and method of use How to use Vicks Medinait: Dosage

HOW MUCH:

Use the measuring cup included in the package. Adults and children over 12 years: one level measuring cup (30 ml = 2 tablespoons), once a day, for no more than 3 days.

WHEN AND FOR HOW LONG:

The product should be taken only before going to bed for a night's rest and on a full stomach. Do not exceed the recommended doses: in particular elderly patients should strictly follow the dosages indicated above. After 3 days of continuous use, without noticeable results, consult your doctor.

Overdose What to do if you have taken too much Vicks Medinait

In case of accidental ingestion / intake of an excessive dose of Vicks Medinait, notify your doctor immediately or go to the nearest hospital. In case of accidental overdose, the most relevant symptom is persistent drowsiness. In this case it is necessary to consult the doctor. Paracetamol can cause severe liver dysfunction, which can lead to irreversible damage to its function (massive necrosis).

Symptoms

Paracetamol:

Symptoms of paracetamol overdose in the first 24 hours are paleness, nausea, vomiting, anorexia (lack of appetite) and abdominal pain. Liver damage can occur 12 to 48 hours after ingestion. Abnormalities in glucose metabolism (transformation of sugar in the body) and metabolic acidosis (increase in blood acids) may occur. In severe poisoning, liver failure can progress to encephalopathy (brain disease), coma and death. Acute renal failure with tubular necrosis (rapid suppression of kidney function associated with the destruction of certain cells) can also develop. in the absence of severe liver damage. Heart rhythm changes have been reported. Other symptoms may include central nervous system depression, effects on the heart, and kidney damage.

Dextromethorphan or Doxylamine:

Symptoms such as excitation, confusion, convulsions and respiratory depression may occur following overdose with dextromethorphan or doxylamine.

Treatment of overdose

Immediate treatment is essential for the management of acetaminophen overdose. Despite the lack of significant early symptoms, patients must urgently go to the hospital for immediate medical attention and any patient who has ingested approximately 7.5 g or more paracetamol within the previous 4 hours must undergo gastric lavage. Administration may be required. of oral methionine or intravenous N-acetylcysteine, which may have a beneficial effect up to at least 48 hours after overdose General supportive measures should be available.

If you have any questions about the use of Vicks Medinait, ask your doctor or pharmacist.

Side Effects What are the side effects of Vicks Medinait

Like all medicines, Vicks Medinait can cause side effects, although not everybody gets them.

Disorders of the blood and lymphatic system:

Serious changes and reductions in blood cells, such as thrombocytopenia, agranulocytosis, haemolytic anemia, neutropenia, leukopenia, pancytopenia, have been reported very rarely with the use of paracetamol or doxylamine, but these were not necessarily causally related.

Immune system disorders:

There are rare cases of allergy or hypersensitivity reactions with paracetamol and doxylamine, including rash, hives, anaphylaxis (severe allergic reaction) and bronchospasm (contraction of the muscles of the bronchi). Hypersensitivity reactions (allergic reactions) such as angioedema (widespread swelling), edema of the larynx (swelling of the larynx), anaphylactic shock (severe allergic reaction) have also been reported.

Nervous system disorders:

Somnolence is common with doxylamine and may rarely occur with dextromethorphan. Other side effects that are more common with antihistamines such as doxylamine are headache, blurred vision, and psychomotor impairment. Dextromethorphan is also rarely associated with dizziness.

Gastrointestinal disorders:

The most commonly observed adverse events are gastrointestinal in nature. Dry mouth, constipation (constipation) and increased gastric reflux can occur with antihistamines, such as doxylamine. Gastrointestinal disorders which may rarely occur with doxylamine or dextromethorphan, include nausea, vomiting, abdominal pain, diarrhea. Flatulence, dyspepsia, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported. Gastritis has been observed less frequently. Peptic ulcers, gastrointestinal perforation or bleeding, sometimes fatal, may occur, particularly in the elderly.

Hepatobiliary disorders:

Changes in liver function and hepatitis. In case of overdosing, paracetamol can cause cytolysis of the liver (cell injury), which can lead to irreversible damage to its function (massive necrosis).

Skin and subcutaneous tissue disorders:

Rarely, hypersensitivity (allergic reactions) including skin rash and urticaria may occur with the use of paracetamol. Serious skin reactions of various types and severities have been reported with the use of paracetamol (including cases of erythema multiforme), bullous reactions including Stevens - Johnson and Toxic Epidermal Necrolysis (very rarely). With the use of pseudoephedrine and also dextromethorphan, rashes have been reported rarely, with or without irritation.

Renal and urinary disorders:

Antihistamines, such as doxylamine, can cause urinary retention or difficulty urinating, kidney changes (acute renal failure, interstitial nephritis, hematuria, anuria).

Other adverse effects:

Antihistamines can also cause asthenia (a sense of tiredness), photosensitivity (sensitivity to light) and, at high doses, convulsions, breathing difficulties due to thickening of bronchial secretions and, especially in the elderly, extrasystoles (irregular heartbeat), tachycardia (acceleration of the heartbeat) and hypotension (low blood pressure). Edema (swelling), hypertension (high blood pressure) and heart failure have been reported in association with treatment with NSAIDs (Non-Steroidal Anti-Inflammatory Drugs).

Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects. These side effects are usually transient.

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. Side effects can also be reported directly via the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

Expiry and Retention

Expiry: see the expiry date printed on the package. The expiry date refers to the product in intact packaging, properly stored.

Warning: do not use the medicine after the expiry date indicated on the package.

Any variation in the color of the syrup does not alter the quality of the product. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment. Keep this medicine out of the sight and reach of children. It is important to always have the information on the medicine available, so keep both the box and the package leaflet.

Composition and pharmaceutical form

COMPOSITION:

100 ml of syrup contain:

ACTIVE INGREDIENTS: Dextromethorphan hydrobromide 0.05 g, Doxylamine succinate 0.025 g, Paracetamol 2 g.

EXCIPIENTS: Propylene glycol, Sodium citrate dihydrate, Citric acid monohydrate, Sodium benzoate, Polyethylene glycol 300, Sugar (sucrose), Glycerin, Anethole, Quinoline yellow (E 104), Brilliant blue FCF (E133), Demineralized water.

HOW IT LOOKS

Syrup in bottles of 90 ml and 180 ml, with 30 ml measuring cup.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Vicks Medinait can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction 04.6 Pregnancy and lactation 04.7 Effects on ability to drive and use machines 04.8 Undesirable effects 04.9 Overdose 05.0 PHARMACOLOGICAL PROPERTIES 05.1 Pharmacodynamic properties 05.2 Pharmacokinetic properties 05.3 Preclinical safety data 06.0 PHARMACEUTICAL PARTICULARS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER 08.0 MARKETING AUTHORIZATION NUMBER 09 .0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIO DRUGS, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS AND QUALITY CONTROLS

01.0 NAME OF THE MEDICINAL PRODUCT

VICKS MEDINAIT

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

100 ml of syrup contain:

Active principles

Dextromethorphan hydrobromide 0.0500 g;

doxylamine succinate 0.0250 g;

paracetamol 2.0000 g.

For the full list of excipients, see section 6.1.

03.0 PHARMACEUTICAL FORM

Syrup.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Treatment of cold and flu symptoms.


04.2 Posology and method of administration

Adults and children over 12 years: one level measuring cup (30 ml = 2 tablespoons), once a day, for no more than 3 days.


04.3 Contraindications

Known individual hypersensitivity to the components. Children under 12 years of age. Asthma, diabetes, glaucoma, prostatic hypertrophy, stenosis of the gastrointestinal and urogenital tract, epilepsy, severe liver disease or severe renal impairment. Paracetamol-based products are contraindicated in patients with manifest insufficiency of glucose-6-phosphate dehydrogenase and in those suffering from severe haemolytic anemia.

History of gastrointestinal bleeding or perforation related to previous active treatments or history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding). Severe heart failure. In case of concomitant administration with MAOIs (monoamine oxidase inhibitors) or within two weeks of taking MAOIs.


04.4 Special warnings and appropriate precautions for use

Seek medical advice before use if you have a cough that occurs with excessive phlegm (mucus) or a persistent cough, such as that occurs with smoking, asthma, or emphysema.

High or prolonged doses of paracetamol, present in the product, can cause a "high-risk liver disease and even severe changes in the kidney and blood. Paracetamol should be used with caution in subjects with renal or hepatic insufficiency, including those with non-renal liver disease. alcoholic cirrhosis The dangers of overdose are greater in those with alcoholic liver disease.

Do not use with any other product containing paracetamol. The use of the product is not recommended if the patient is being treated with anti-inflammatory drugs. In the course of therapy with oral anticoagulants, doses should be reduced. In the rare cases of the appearance of allergic reactions, administration should be suspended. the elderly, in consideration of their greater sensitivity to antihistamines. The use of antihistamines at the same time as certain ototoxic antibiotics can mask the first signs of ototoxicity, which can only reveal itself when the damage is irreversible. The product should be administered with caution in patients with cardiovascular diseases, hypertension, hyperthyroidism. Caution should be exercised in patients with a history of hypertension and / or heart failure as fluid retention and edema have been reported in association with NSAID therapy. Additive effects may occur with alcohol, hypnotics, sedatives or tranquilizers which therefore should not be taken at the same time.

The use of Vicks Medinait should be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors.

Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms.

Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see section 4.2).

Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported during treatment with all NSAIDs, at any time, with or without warning symptoms or a previous history of serious gastrointestinal events.

In the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), the risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing doses of NSAIDs. These patients should start treatment with the lowest available dose. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low dose aspirin or other drugs that may increase the risk of gastrointestinal events (see below and section 4.5). .

Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment.

Caution should be exercised in patients taking concomitant medications that could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin (see section 4.5). Gastrointestinal bleeding or ulceration occurs in patients taking Vicks Medinait treatment should be discontinued NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see par. - side effects).

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). In the early stages of therapy, patients appear to be be at higher risk: the onset of the reaction occurs in most cases in the early stages of treatment. Vicks Medinait should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity.

The product contains sucrose, this should be taken into account in case of low calorie diets. After 3 days of continuous use, without noticeable results, consult your doctor. Instruct the patient to contact the physician before associating any other medication

Use the measuring cup included in the package. The product should be taken only before going to bed for a night's rest and on a full stomach. Do not exceed the recommended doses: in particular elderly patients should strictly follow the minimum dosages indicated above.


04.5 Interactions with other medicinal products and other forms of interaction

Do not use during or in the two weeks following treatment with antidepressant (anti-MAO) drugs. Use with extreme caution and under strict control during chronic treatment with drugs that can determine the induction of hepatic monooxygenases or in case of exposure to substances that can have this effect (for example rifampicin, cimetidine, antiepileptics such as glutethimide, phenobarbital, carbamazepine and also alcohol). These substances can increase the hepatotoxicity of paracetamol.The administration of paracetamol can interfere with the determination of uricaemia (by the phosphotungstic acid method) and that of blood glucose (by the glucose-oxidase-peroxidase method). The absorption rate of paracetamol can be increased by metoclopramide or domperidone and absorption can be reduced by cholestyramine.

There is a potential for interaction between dextromethorphan and medicinal products that inhibit the CYP2D6 isoenzyme such as SSRIs (eg, fluoxetine, paroxetine).

Diuretics, ACE inhibitors and Angiotensin II antagonists:

NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (eg dehydrated patients or elderly patients with impaired renal function) co-administration of an ACE inhibitor or an angiotensin antagonist II and agents that inhibit the cyclo-oxygenase system can lead to further deterioration of renal function, including possible acute renal failure, usually reversible. These interactions should be considered in patients taking Vicks Medinait concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and considered. monitoring of renal function after initiation of concomitant therapy.

Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4).

Anticoagulants: NSAIDs may increase the effects of anticoagulants, such as warfarin (see section 4.4).

Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4).


04.6 Pregnancy and breastfeeding

Do not use during pregnancy or breastfeeding.

Pregnancy

Inhibition of prostaglandin synthesis can adversely affect pregnancy and / or embryo / fetal development.

Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% up to approximately 1.5%. The risk has been considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased loss of pre- and post-implantation and of embryo-fetal mortality.

In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to:

- cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension);

- renal dysfunction, which can progress to renal failure with oligo-hydroamnios;

the mother and the newborn, at the end of pregnancy, to:

- possible prolongation of bleeding time, and antiplatelet effect which may occur even at very low doses;

- inhibition of uterine contractions resulting in delayed or prolonged labor


04.7 Effects on ability to drive and use machines

The product can cause drowsiness (especially in conjunction with the intake of alcohol or other medicines that can reduce reaction times), this must be taken into account by those who may drive vehicles or attend to operations requiring integrity of the degree of vigilance, which will have to refrain from such duties after taking the product.


04.8 Undesirable effects

In general, no serious side effects are expected.

Disorders of the blood and lymphatic system:

Blood dyscrasias, such as thrombocytopenia, agranulocytosis, haemolytic anemia, neutropenia, leukopenia, pancytopenia, have been reported very rarely with the use of paracetamol or doxylamine, but these were not necessarily causally related.

Disorders of the immune system:

There are rare cases of allergy or hypersensitivity reactions with acetaminophen and doxylamine, including rash, hives, anaphylaxis and bronchospasm. Hypersensitivity reactions such as angioedema, larynx edema, anaphylactic shock have also been reported.

Nervous system disorders:

Somnolence is common with doxylamine and may rarely occur with dextromethorphan. Other side effects that are more common with antihistamines such as doxylamine are headache, blurred vision, and psychomotor impairment. Dextromethorphan is also rarely associated with dizziness.

Gastrointestinal disorders:

The most commonly observed adverse events are gastrointestinal in nature. Dry mouth, constipation, and increased gastric reflux can occur with antihistamines, such as doxylamine.

Gastrointestinal disorders which may rarely occur with doxylamine or dextromethorphan, include nausea, vomiting, abdominal pain, diarrhea. Flatulence, dyspepsia, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported (see section 4.4). Gastritis has been observed less frequently. Peptic ulcers, gastrointestinal perforation or haemorrhage, sometimes fatal, may occur, particularly in the elderly (see section 4.4).

Hepatobiliary disorders:

Changes in liver function and hepatitis. In case of overdose, paracetamol can cause hepatic cytolysis, which can evolve towards massive and irreversible necrosis (see section 4.9).

Skin and subcutaneous tissue disorders:

Rarely, hypersensitivity including skin rashes and urticaria may occur with the use of paracetamol. Skin reactions of various types and severity have been reported with the use of paracetamol including cases of erythema multiforme and bullous reactions including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis (very rarely). With the use of pseudoephedrine and also dextromethorphan, rashes have been reported rarely, with or without irritation.

Renal and urinary disorders:

Antihistamines, such as doxylamine, can cause urinary retention or difficulty in urination, alterations in the kidney (acute renal failure, interstitial nephritis, hematuria, anuria).

Other adverse effects:

Antihistamines can also cause asthenia, photosensitivity and, at high doses, convulsions, breathing difficulties due to thickening of bronchial secretions, and, especially in the elderly, extrasystoles, tachycardia and hypotension.

Edema, hypertension and heart failure have been reported in association with NSAID treatment.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. on the website: www.agenziafarmaco.gov.it/it/responsabili of the Italian Medicines Agency.


04.9 Overdose

In case of overdose, paracetamol can cause hepatic cytolysis, which can evolve towards massive and irreversible necrosis.

Symptoms

Paracetamol:

Symptoms of paracetamol overdose in the first 24 hours are paleness, nausea, vomiting, anorexia and abdominal pain. Liver damage may occur 12 to 48 hours after ingestion. Abnormalities in glucose metabolism and metabolic acidosis may occur. In severe poisoning, liver failure can progress to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis can develop even in the absence of severe liver damage. Cardiac arrhythmias have been reported.

Other symptoms may include CNS depression, cardiovascular effects, and kidney damage.

Dextromethorphan or Doxylamine:

Symptoms such as excitation, confusion, convulsions and respiratory depression may occur following overdose with dextromethorphan or doxylamine.

Treatment of overdose

Immediate treatment is essential for the management of acetaminophen overdose. Despite the lack of significant early symptoms, patients must urgently go to the hospital for immediate medical attention and any patient who has ingested approximately 7.5 g or more of paracetamol in the previous 4 hours must undergo gastric lavage.

Administration of oral methionine or intravenous N-acetylcysteine ​​may be required, which may have a beneficial effect for up to at least 48 hours after overdose. General supportive measures should be available.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Medicinal product category: cough suppressants, excluding associations with expectorants.

ATC code: R05DA20.

Vicks Medinait administered orally at doses of 2-4-8 ml / kg did not cause any significant changes in blood pressure or cardiac dynamics, bile flow, or duodenal motility in normal-pressure dogs. Vicks Medinait has shown to have a marked antitussive action in the guinea pig, by means of ammonia aerosol tests, acrolein inhalation, and electrical stimulation of the superior laryngeal nerve. Vicks Medinait has finally shown in the guinea pig a very relevant action in inhibiting the histamine bronchospasm.


05.2 "Pharmacokinetic properties

Maximum blood levels are reached by the active ingredients between 30 and 40 minutes after oral administration of Vicks Medinait. The active ingredients are widely distributed in tissues and organic liquids and their half-life is between 7 and a half and 10 hours. When Vicks Medinait is administered, the bioavailability of the active ingredients manifests itself according to curves that are completely superimposable to those obtained by administering the active ingredients separately and individually in aqueous solutions. The elimination of them occurs almost entirely by the kidney, in small part unchanged, but mainly in the form of metabolites


05.3 Preclinical safety data

The oral LD50 in the mouse is 33.7 ml / kg, in the rat 32.0 ml / kg and in the dog it is greater than 15 ml / kg. Chronic oral toxicity studies in two animal species, dog and rat, did not reveal any damage to the tested animals or their organs. Vicks Medinait was shown to be devoid of teratogenic effects in rats and rabbits, nor did it affect the fertility of the animals tested.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

Propylene glycol, sodium citrate dihydrate, citric acid monohydrate, sodium benzoate, polyethylene glycol 300, sugar (sucrose), glycerin, anethole, quinoline yellow (E 104), brilliant blue FCF (E133), demineralized water.


06.2 Incompatibility

Incompatibilities with other drugs have never been reported.


06.3 Period of validity

3 years.


06.4 Special precautions for storage

None. Any variation in the color of the syrup does not alter the quality of the product.


06.5 Nature of the immediate packaging and contents of the package

Glass bottle of 90 and 180 ml.


06.6 Instructions for use and handling

Unused medicine and wastes derived from this medicine must be disposed of in accordance with local regulations

07.0 MARKETING AUTHORIZATION HOLDER

PROCTER & GAMBLE S.r.l. - Viale Giorgio Ribotta, 11 - 00144 Rome.

08.0 MARKETING AUTHORIZATION NUMBER

VICKS MEDINAIT syrup - 90 ml bottle A.I.C. n. 024449050

VICKS MEDINAIT syrup - 180 ml bottle A.I.C. n. 024449062

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION

Date of first authorization: June 1981

Latest renewal date: January 2016

10.0 DATE OF REVISION OF THE TEXT

January 2016

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL

none:  onychomycosis Welfare nutrition-and-health