VICKS 1,33 mg/ml Syrop
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Jak stosować VIKKS TOSSE SEDATIVO
Treść ulotki
Vicks Tosse Sedativo
1.33 mg/ml syrup
dextromethorphan hydrobromide
Read this leaflet carefully before taking this medicine as it contains important information for you.
Always use 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 of the side effects become serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
- Talk to your doctor if you do not feel better or if your symptoms worsen after 5 - 7 days.
Contents of this leaflet:
- 1. What Vicks Tosse Sedativo is and what it is used for
- 2. What you need to know before you take Vicks Tosse Sedativo
- 3. How to take Vicks Tosse Sedativo
- 4. Possible side effects
- 5. How to store Vicks Tosse Sedativo
- 6. Contents of the pack and other information
1. What is Vicks Tosse Sedativo and what is it used for?
Vicks Tosse Sedativo contains dextromethorphanhydrobromide, a substance that helps to calm the
dry cough.
See your doctor if you do not feel better or if you feel worse after 5 - 7 days.
2. What you need to know before taking Vicks Tosse Sedativo
This medicine can lead to dependence. Therefore, treatment should be of short
duration.
Do not take Vicks TosseSedativo
- if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
- during and for the two weeks following therapy with drugs used to treat depression, called monoamine oxidase inhibitors (MAOIs);
- if you suffer from asthma, chronic obstructive pulmonary disease (COPD - chronic lung disease), pneumonia, breathing difficulties or respiratory depression;
- if you have cardiovascular diseases or suffer from high blood pressure;
- if you suffer from hyperthyroidism (increased thyroid function);
- if you have diabetes;
- if you suffer from increased pressure inside the eye (glaucoma);
- if you suffer from urinary disorders caused by enlargement of the prostate or other obstructions of the genitals or urinary tract;
- if you have obstructions of the esophagus, stomach or intestines;
- if you suffer from severe liver disease;
- if you suffer from epilepsy;
- if you are pregnant, especially in the first trimester (see section “Pregnancy, breastfeeding and fertility”);
- if you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”). Do not give Vicks TosseSedativoto children under 12 years of age.
Talk to your doctor or pharmacist before taking Vicks Tosse Sedativo:
If you are taking medicines such as some antidepressants or antipsychotics: Vicks Tosse Sedativo
may interact with these medicines and 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, exaggeration of reflexes, muscle rigidity,
lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) may occur.
Warnings and precautions
Talk to your doctor or pharmacist before taking Vicks Tosse Sedativo.
Pay particular attention and ask your doctor for advice before taking Vicks Tosse Sedativo if:
- your kidney and liver function is impaired (especially if severely compromised);
- you have persistent, irritating cough with significant mucus production (sputum) or accompanied by fever, rash, headache, nausea and vomiting; you have a reduced ability to metabolize certain drugs, with an increase in toxicity. Pay particular attention to prolonged use of the medicine as habituation, tolerance and mental and physical dependence on the medicine may occur (see “Possible side effects”). See your doctor if you do not obtain appreciable results after a short period of treatment (5 - 7 days), if the disorder recurs or if you have noticed any recent change in its characteristics.
Other medicines and Vicks Tosse Sedativo
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Do not take this medicine during and for the two weeks following therapy with some drugs
used to treat depression called monoamine oxidase inhibitors (MAOIs).See also section
“Do not take Vicks Tosse Sedativo”.
In particular, tell your doctor if you are taking or have recently taken:
- medicines to treat depression such as fluoxetine, paroxetine, sertraline and bupropion (see section 2 “Do not take Vicks Tosse Sedativo”);
- medicine to treat severe pain or to reduce withdrawal symptoms in cases of dependence (methadone);
- medicines to treat mental illnesses (haloperidol, thioridazine, perphenazine);
- medicines to treat heart rhythm disorders (amiodarone, quinidine, propafenone);
- medicines to treat heart rhythm abnormalities (flecainide);
- medicines to reduce calcium levels in the blood and treat a dysfunction of the body due to reduced secretion of the hormone that regulates these levels in the blood (hyperparathyroidism) such as cinacalcet;
- medicines used to prevent the development of fungi (terbinafine);
- antibacterial medicines such as linezolid;
- medicines against obesity such as sibutramine;
- hypnotics, sedatives or anxiolytics*;
- expectorants. *The concomitant use of Vicks Tosse Sedativo and sedatives such as benzodiazepines or related drugs increases the risk of drowsiness, difficulty breathing (respiratory depression) and coma, potentially endangering the patient's life. For this reason, concomitant use should only be considered when no alternative treatment options are available. However, if your doctor prescribes Vicks Tosse Sedativo together with sedatives, the dose and duration of concomitant treatment must be limited by the doctor. Inform your doctor about all the sedatives you are taking, and carefully follow the doctor's recommendations. It may be helpful to inform friends or relatives to pay attention to the signs and symptoms listed above. Contact your doctor if you have these symptoms.
Vicks Tosse Sedativo with drinks and alcohol
Avoid drinking alcohol if you are taking Vicks Tosse Sedativo.
Pay attention to grapefruit juice as it may increase the absorption of the medicine, with
consequent increase in its toxicity and decrease in its effect.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist before taking this medicine.
Pregnancy
Do not use Vicks Tosse Sedativo in the first trimester of pregnancy. In subsequent months, take this
medicine only if absolutely necessary and under the control of your doctor.
Breastfeeding
Do not use Vicks Tosse Sedativo during breastfeeding as it is not known whether the drug passes into
breast milk.
Driving and operating machinery
Vicks Tosse Sedativo may impair your ability to drive or operate machinery due to
drowsiness that may occur during treatment, especially in conjunction with
alcohol consumption or other medicines that may slow down reaction times.
Vicks Tosse Sedativo contains
- sucrose and inverted sugar (honey):if your doctor has diagnosed you with intolerance to some sugars, contact him before taking this medicine. This medicine contains about 5.55 g of sucrose (sugar) and 0.570 g of inverted sugar (honey) per 15 ml dose of syrup. To be taken into consideration in people affected by diabetes mellitus or who are following low-calorie diets.
- ethanol (alcohol):this medicine contains 5 vol % of ethanol (alcohol), e.g. up to 592 mg per 15 ml dose, equivalent to less than 15 ml of beer, 6 ml of wine per 15 ml dose of syrup. The small amount of alcohol in this medicine will not produce significant effects. .
- sodium:this medicine contains 28.2 mg of sodium (the main component of table salt) per 15 ml dose. This is equivalent to 1.40% of the recommended maximum daily intake with the diet of an adult;
- propylene glycol:this medicine contains 850.50 mg of propylene glycol per 15 ml of syrup. If you are pregnant or breastfeeding, do not take this medicine unless otherwise recommended by your doctor. The doctor may perform further checks during therapy. 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.
- sodium benzoate:this medicine contains 15 mg of sodium benzoate per 15 ml dose of syrup.
- honey: honey is a source of phenylalanine. It may be harmful if you suffer from Phenylketonuria, a rare genetic disease that causes the accumulation of phenylalanine because the body is unable to eliminate it.
3. How to take Vicks Tosse Sedativo
Use this medicine following exactly the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Adults and adolescents over 12 years
the recommended dose is 15 ml of syrup.
The dose can be repeated every 6 hours, up to 4 times a day.
Do not exceed the recommended dose.
Use the graduated measuring cup provided with the package.
Do not take Vicks Tosse for more than 5-7 days.
If you do not experience appreciable results after a short period of treatment, consult your doctor.
Children up to 12 years
Dextromethorphan must not be used.
If you take more Vicks Tosse Sedativo than you should
In case of accidental ingestion/intake or misuse of the medicine, contact your doctor or
the nearest hospital.
If you take more Vicks Tosse Sedativo than you should, the following symptoms may occur: nausea and
vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, cognitive impairment,
involuntary and rapid eye movements, cardiac disorders (accelerated heartbeat), coordination disorders,
psychosis with visual hallucinations and hyperexcitability.
Other symptoms in case of massive overdose may be: coma, severe respiratory problems and
convulsions.
In extreme cases, difficulty urinating and breathing may occur.
Contact your doctor or hospital immediately if you experience any of the above symptoms.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects may include:
Common (may affect up to 1 in 10 people)
- dizziness
- nausea;
- vomiting;
- gastrointestinal disorders of the stomach and intestines;
- loss of appetite;
- fatigue. Rare (may affect up to 1 in 1,000 people)
- skin rashes;
- drowsiness. Very rare (may affect up to 1 in 10,000 people)
- Hallucinations. Not known (frequency cannot be estimated from available data)
- hypersensitivity reactions, including anaphylactic reaction;
- swelling of the face, hands and feet, eyes, lips, larynx and/or tongue (angioedema);
- urticaria;
- itching;
- rash;
- erythema;
- diabetes mellitus;
- psychosis;
- very high fever (hyperpyrexia).
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the
national reporting system at: 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 Tosse Sedativo
Keep this medicine out of sight and reach of children.
Store at a temperature below 25°C.
Do not use this medicine after the expiry date which is stated on the packaging after “Scad.”. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 Tosse Sedativo contains
- The active ingredient isdextromethorphan hydrobromide. 1 ml of product contains 1.33 mg (0.133% w/v) of dextromethorphan hydrobromide.
- the other ingredients are: sucrose, sodium saccharin, propylene glycol, 96 percent ethanol, sodium croscarmellose, sodium citrate, citric acid, honey flavour (containing honey), verbena flavour, sodium benzoate, macrogol, menthoxypropanediol, macrogol stearate type I, purified water.
Description of the appearance of Vicks Tosse Sedativo and contents of the pack
Vicks Tosse Sedativo is available in opaque glass bottles of 120 ml and 180 ml with a child-resistant safety cap and a graduated polypropylene measuring cup.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Procter & Gamble S.r.l. - Viale Giorgio Ribotta, 11 - 00144 Rome
Manufacturer
Procter & Gamble Manufacturing GmbH, Procter-&-Gamble Strasse 1, 64521 Gross-Gerau, Germany.
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- Kraj rejestracji
- Postać farmaceutycznaSyrup, 1.33 mg/ml
- Kod ATCR05DA09
- Substancja czynna
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki VIKKS TOSSE SEDATIVOPostać farmaceutyczna: Oral drops, solution, 15 MG/MLSubstancja czynna: dextromethorphanWymaga receptyPostać farmaceutyczna: Syrup, 3 mg/mlSubstancja czynna: dextromethorphanProducent: MONTEFARMACO OTC S.P.A.Bez receptyPostać farmaceutyczna: Syrup, 2 MG/MLSubstancja czynna: dextromethorphanProducent: OPELLA HEALTHCARE ITALY S.R.L.Wymaga recepty
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VIKKS TOSSE SEDATIVO nie wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w VIKKS TOSSE SEDATIVO jest dextromethorphan. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
VIKKS TOSSE SEDATIVO jest produkowany przez PROCTER & GAMBLE S.R.L.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie VIKKS TOSSE SEDATIVO jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić VIKKS TOSSE SEDATIVO w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (dextromethorphan) to m.in. ARIKODILTOSSE, BEKILAR, BISOLVON TOSSE SEDATIVO. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
