Normotus expectorante 200 ml

What Normotus Expectorant is and what it is used for
It is a medicine that contains dextromethorphan hydrobromide, which is an antitussive, and guaifenesin, which is an expectorant.
It is indicated for the relief of cough and to facilitate the expulsion of excess mucus and phlegm in colds and flu for adults and children from 6 years of age.
You should consult a doctor if you get worse or if you do not improve after 7 days of treatment.

What you need to know before you start taking Normotus Expectorant
This medication can cause dependence. Therefore, treatment should be short-term.

Do not take Normotus Expectorant if:
If you are allergic to guaifenesin or dextromethorphan hydrobromide or any of the other ingredients of this medicine.
. If you have asthma.
. If you have a cough with a large amount of mucus and phlegm.
. If you have a serious lung disease.
. If you are being treated or have been treated for the previous 2 weeks with any monoamine oxidase inhibitor (MAOI) medicine used to treat depression or Parkinson's disease or other diseases.
 
Warnings and precautions
Talk to your doctor or pharmacist before taking Normotus Expectorant if you are a patient:
. With liver disease.
. With atopic dermatitis (inflammatory skin disease characterized by erythema, itching, exudation, crusting and peeling, which begins in childhood in individuals with a hereditary allergic predisposition).
If you are taking other medications such as antidepressants or antipsychotics, Normotus Expectorant may interact with these medications and you may experience changes in your mental status (e.g. agitation, hallucinations, coma) and other effects such as body temperature above 38°C. , increased heart rate, high blood pressure and exaggerated reflexes, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (e.g., nausea, vomiting and diarrhea).
Patients with a persistent or chronic cough, such as that due to tobacco, or who are sedated, weakened, or bedridden should not take this medication.
There have been cases of abuse of medications containing dextromethorphan by adolescents. This can cause serious adverse effects.

Interferences with analytical tests
If you are having any diagnostic tests performed (including blood tests, urine tests, skin tests that use allergens, etc.), tell your doctor that you are taking this medication, as it may alter the results.

Children and adolescents
This medication is contraindicated in children under 2 years of age. Children 2-6 years old should not take this medicine.

Other medications and Normotus Expectorant
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Please note that these instructions may also apply to medications that have been used before or may be used later.
Do not take this medicine during treatment, or within 2 weeks after treatment with the following medicines, as it may cause excitement, high blood pressure and a fever higher than 40ºC (hyperpyrexia):
. Medicines used to treat depression such as monoamine oxidase inhibitor (MAOI) antidepressants (moclobemide, tranylcypromine) and serotonin reuptake inhibitor antidepressants (paroxetine, fluoxetine).
. Bupropion (used to stop smoking).
. Linezolid (used as an antibacterial).
. Procarbazine (used to treat cancer).
. Selegiline (used to treat Parkinson's).
If you are using any of the following medications, it may be necessary to modify the dose of one of them or stop treatment:
. Amiodarone and quinidine (to treat heart arrhythmias).
. Anti-inflammatories (celecoxib, parecoxib or valdecoxib).
. Central nervous system depressants (some of them used to treat: mental illnesses, allergies, Parkinson's disease, etc.).
. Expectorants and mucolytics (used to eliminate phlegm and mucus).
. Haloperidol (antipsychotic).

Taking Normotus Expectorant with food, drinks and alcohol
Alcoholic beverages should not be consumed during treatment with this medication because it may cause adverse reactions.
Do not take together with grapefruit or bitter orange juice because they may increase the adverse effects of this medication.

Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines
On rare occasions, mild drowsiness and dizziness may occur during treatment with this medicine, so if you notice these symptoms you should not drive or operate dangerous machines.

Normotus Expectorant contains sodium, sodium benzoate, sorbitol, aspartame and ethanol
This medicine contains less than 1 mmol sodium (23 mg) per milliliter; that is, essentially “sodium-free.”
This medicine contains 3.50 mg of sodium benzoate in each milliliter.
Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).
This medicine contains 400 mg of sorbitol in each ml. Sorbitol may cause gastrointestinal upset and a slight laxative effect.
This medicine contains 4 mg of aspartame in each ml. Aspartame contains a source of phenylalanine which can be harmful if you have phenylketonuria (FCN), a rare genetic disease in which phenylalanine accumulates because the body is not able to eliminate it properly.
This medicine contains 0.99 mg of alcohol (ethanol) in each milliliter, which is equivalent to 0.1% w/v. The amount in ml of this medicine is equivalent to less than 0.025 ml of beer or 0.010 ml of wine.
The small amount of alcohol contained in this medicine has no noticeable effect.

How to take Normotus Expectorant
Exactly follow the instructions for administering this medicine contained in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose is:
Adults and adolescents from 12 years of age: 5 ml or 10 ml, every 4-6 hours as needed. Maximum 60 ml / 24 hours.

Use in children
Children from 6 to 12 years: 2.5 ml or 5 ml every 4-6 hours as needed. Maximum 30 ml / 24 hours.
Serious adverse effects may occur in children in case of overdose, including neurological disorders. Caregivers should not exceed the recommended dosage.
Children from 2 to 6 years: there are other presentations more suitable for this population. Administer only under medical supervision, due to the risk of paradoxical CNS stimulation effects.
Children under 2 years: contraindicated.

Patients with liver disease: the dose should be reduced to half that recommended for each population, never exceeding 4 daily doses.

This medication is taken orally.

How to drink:
Measure the amount of medication to take with the measuring cup that accompanies the bottle. After use, wash the measuring cup.
It is recommended to drink a glass of water after each meal and plenty of fluids during the day. It can be taken with or without food.
Do not take with grapefruit or bitter orange juice or alcoholic beverages.
You should consult a doctor if it worsens, or if you also have a high fever, skin rash, persistent headache, or if you do not improve after 7 days of treatment.


LEAFLET