Propalcof 15mg/5ml jarabe 200ml

What Propalcof is and what it is used for
Dextromethorphan, the active ingredient in this medicine, is an antitussive that inhibits the cough reflex.

It is indicated for the symptomatic treatment of cough that is not accompanied by expectoration (irritative cough, nervous cough) in adults and children from 6 years of age.

You should see a doctor if you get worse or if you do not get better after 7 days of treatment

2. What you need to know before you take Propalcof
Do not take Propalcof if:
- If you are allergic (hypersensitive) to dextromethorphan hydrobromide or any of the other ingredients of this medicine (listed in section 6 of the leaflet).
- If you have a serious lung disease.
- If you have asthma.
- If you have a cough accompanied by abundant secretions.
- If you are being treated or have been treated during the previous 2 weeks with any monoamine oxidase inhibitor (MAOI) drug used to treat depression, Parkinson's disease or other diseases, as well as other monoamine oxidase inhibitor drugs serotonin used to treat depression such as fluoxetine and paroxetine; or also with bupropion, which is a medicine used to stop smoking, or with linezolid, which is an antibacterial medicine. (See section on Use of Propalcof with other medicines).
Children under 6 years of age cannot take this medicine.
 
Warnings and precautions
Talk to your doctor, pharmacist or sick person before taking Propalcof if you are a patient.
This medicine can cause dependency. Therefore the treatment should be of short duration.

Patients with a persistent or chronic cough, such as that due to tobacco, should especially consult their doctor before using this medicine. in children chronic cough could be an early symptom of asthma, with liver or kidney disease, with atopic dermatitis (inflammatory skin disease characterized by erythema, itching, exudation Especially, crusting and scaling, which begins in childhood in individuals with hereditary allergic predisposition), who are sedated, debilitated or bedridden,
with CYP2D6 polymorphism (genetic alteration that affects the activity of this liver enzyme), concomitant use with alcohol should be avoided, if you are taking other medications such as antidepressants or antipsychotics, Propalcof may interact with these medications and you may experience changes in your mental status (e.g. anxiety, hallucinations, coma) and other effects such as body temperature above 38º C, increased heart rate, high blood pressure and exaggerated reflexes, muscle stiffness, lack of coordination and/or or gastrointestinal symptoms (eg, nausea, vomiting, and diarrhea).
 
Cases of abuse of medicines containing dextromethorphan in adolescents have been described, therefore this possibility should be taken into account, since serious adverse effects can be caused (see section "If you take more Propalcof than you should"). This product can also be addictive, so its high dose or prolonged use can cause tolerance and mental and physical dependence. In patients with a tendency to or abuse dependency, it will only be administered under strict medical control and in short periods of time.

children and adolescents
Do not use in children under 6 years of age.

Other medicines and Propalcof
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 for 2 weeks after treatment with the following medicines, as excitement, high blood pressure and fever higher than 40°C (hyperpyrexia) may occur:
- Monoamine oxidase inhibitor antidepressants (MAOIs) (moclobemide, tranylcypromine, clorgyline, iproniazid and isocarboxazid)
- Serotonin reuptake inhibitor antidepressants (fluoxetine, sibutramine, sertraline or paroxetine)
- Bupropion (used to stop smoking)
- Linezolid (used as an antibacterial)
- Procarbazine (used to treat cancer)
- Selegiline (used to treat Parkinson's)

Before you start taking this medicine you should talk to your doctor if you are taking any of the following medicines because it may be necessary to modify the dose of any 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 illness, allergy, Parkinson's disease, etc.)
- Expectorants and mucolytics (used to eliminate phlegm and mucus).
- CYP2D6 inhibitors such as Haloperidol (used to treat mental illness).
 
Taking Propalcof with food and drink
Alcoholic beverages should not be consumed during treatment, because they can cause adverse reactions.
Do not take together with grapefruit or orange juice during treatment, because they can increase the side effects of this medicine.

Fertility, pregnancy and lactation
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist before using this medicine.
Pregnant or lactating women should not take this medicine without consulting a doctor.

Driving and using machines
Mild drowsiness and dizziness, fatigue (tiredness), dystonia (involuntary muscle contractions) and visual hallucinations may occur during treatment with this medicine, which should be taken into account when driving or using dangerous machines.

Propalcof contains sucrose, sorbitol, ethanol, sodium benzoate (E-211) and glucose.
This medicine contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains 650 mg of sorbitol solution in 5 ml of syrup. Sorbitol is a source of fructose. If you (or your child) have been told by your doctor that you (or your child) have an intolerance to some sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease, in which the patient cannot break down fructose, consult you (or your child) with your doctor before taking this medicine.
This medicine contains 0.925 mg of alcohol (ethanol) in each dose (5 ml). The amount of alcohol in one dose of this medicine is equivalent to less than 24 ml of beer or 10 ml of wine.
The small amount of alcohol in this medicine has no significant effect. This medicine contains 12.5 mg of sodium benzoate in 5 ml of syrup. 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 glucose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How to take Propalcof
Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your doctor, pharmacist or nurse. If in doubt ask your doctor, pharmacist or nurse.
The recommended dose is:
- Adults and adolescents from 12 years of age: 5 ml (1 measuring spoon) (15 mg of dextromethorphan hydrobromide) every 4 hours, or 10 ml (2 measuring spoons) (30 mg) every 6-8 hours depending on the cough intensity. Do not exceed the dose of 120 mg/day (8 measuring spoons).
- Children from 6 to 12 years old: 2.5 ml (half a teaspoon) (7.5 mg) every 4 hours or 5 ml (1 teaspoon) (15 mg) every 6-8 hours depending on the intensity of cough. Do not exceed the dose of 60 mg/day (4 measuring spoons).
Do not exceed 6 daily intakes.

Pediatric population
Serious side effects may occur in children in case of overdose, including neurological disturbances. Caregivers should not exceed the recommended dose.

Administration method
Orally.
It cannot be dissolved or taken with grapefruit or orange juice or alcoholic beverages, see Taking Propalcof with food and drinks.

If the cough worsens or persists for more than 7 days, or if it is accompanied by a high fever, skin rash or persistent headache, you should see a doctor.

Use in children and adolescents
Do not administer to children under 6 years of age.

LEAFLET