Propalcof 15 mg/5 ml syrup
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROPALCOF 15 mg/5 ml syrup
Dextromethorphan hydrobromide
Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.
Follow exactly the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor, pharmacist, or nurse.
- Keep this leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
- You should consult your doctor if you worsen or do not improve after 7 days of treatment, or if the cough is accompanied by high fever, skin rash, or persistent headache.
Leaflet contents:
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What Propalcof is and what it is used for
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What you need to know before taking Propalcof
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How to take Propalcof
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Possible adverse effects
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Storage of Propalcof
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Contents of the container and additional information
1. What Propalcof is and what it is used for
Dextromethorphan, the active ingredient in this medicine, is an antitussive that suppresses the cough reflex.
It is indicated for the symptomatic treatment of dry cough (irritant cough, nervous cough) not accompanied by expectoration in adults and children aged 6 years and older.
You should consult a doctor if symptoms worsen or do not improve after 7 days of treatment.
2. What you need to know before taking Propalcof
Do not take Propalcof:
- If you are allergic (hypersensitive) to dextromethorphan hydrobromide or to any of the other ingredients of this medicine (listed in section 6).
- If you have a severe lung disease.
- If you have asthmatic cough.
- If you have a cough accompanied by abundant secretions.
- If you are currently being treated or have been treated within the previous 2 weeks with any monoamine oxidase inhibitor (MAOI) medicine used to treat depression, Parkinson's disease, or other conditions, as well as other serotonin reuptake inhibitors used for depression such as fluoxetine and paroxetine; or also with bupropion, a medicine used to stop smoking, or with linezolid, an antibacterial medicine. (See section "Taking Propalcof with other medicines").
- Children under 6 years of age must not take this medicine.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Propalcof if you are a patient.
This medicine may cause dependence. Therefore, treatment should be short-term only.
Patients should especially consult their doctor before using this medicine if they:
- Have persistent or chronic cough, such as that caused by smoking. Particularly in children, chronic cough may be an early sign of asthma.
- Have liver or kidney disease.
- Have atopic dermatitis (an inflammatory skin disease characterized by erythema, itching, exudation, crusts, and scaling, beginning in childhood in individuals with hereditary predisposition to allergy).
- Are sedated, weakened, or bedridden.
- Have CYP2D6 polymorphism (a genetic alteration affecting the activity of this liver enzyme).
- Should avoid concomitant use with alcohol.
- Are taking other medicines such as antidepressants or antipsychotics. Propalcof may interact with these medicines and you may experience changes in your mental state (e.g., agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, high blood pressure, exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).
Cases of abuse of medicines containing dextromethorphan have been reported in adolescents; therefore, this possibility should be considered, as it may lead to serious adverse effects (see section "If you take more Propalcof than you should"). This product may also be addictive, so prolonged or high-dose use may lead to mental and physical tolerance and dependence. In patients with a tendency to abuse or dependence, this medicine should only be administered under strict medical supervision and for short periods.
Children and adolescents
Do not use in children under 6 years of age.
Taking Propalcof with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Please note that these instructions may also apply to medicines that have been used previously or may be used in the future.
Do not take this medicine during treatment with, or within 2 weeks after treatment with, the following medicines, as it may cause excitation, high blood pressure, and fever above 40°C (hyperpyrexia):
- Monoamine oxidase inhibitor (MAOI) antidepressants (moclobemide, tranylcypromine, phenelzine, 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 disease)
Before starting this medicine, consult your doctor if you are taking any of the following medicines, as it may be necessary to adjust the dose or discontinue treatment:
- Amiodarone and quinidine (used to treat heart arrhythmias)
- Anti-inflammatory medicines (celecoxib, parecoxib, or valdecoxib)
- Central nervous system depressants (some used to treat: mental disorders, allergies, Parkinson's disease, etc.)
- Expectorants and mucolytics (used to help eliminate phlegm and mucus)
- CYP2D6 inhibitors such as haloperidol (used to treat mental disorders)
Taking Propalcof with food and drinks
Do not consume alcoholic beverages during treatment, as they may cause adverse reactions.
Do not take together with grapefruit or orange juice during treatment, as they may increase the adverse effects of this medicine.
Fertility, pregnancy, and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnant or breastfeeding women should not take this medicine without first consulting their doctor.
Driving and using machines
During treatment with this medicine, mild drowsiness, dizziness, fatigue (tiredness), dystonia (involuntary muscle contractions), and visual hallucinations may occur. These effects should be taken into account when driving or operating dangerous machinery.
Propalcof contains sucrose, sorbitol, ethanol, sodium benzoate (E-211), and glucose
This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.
This medicine contains 650 mg of sorbitol solution in 5 ml of syrup. Sorbitol is a source of fructose. If your doctor has told you (or your child) that you have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic condition in which the patient cannot break down fructose, consult your doctor before taking this medicine.
This medicine contains 0.925 mg of alcohol (ethanol) per 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 your doctor has told you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.
3. How to take Propalcof
Follow exactly the dosing instructions for this medicine provided in this leaflet or those given by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.
The recommended dose is:
? Adults and adolescents aged 12 years and over: 5 ml (1 measuring spoon) (15 mg dextromethorphan hydrobromide) every 4 hours, or 10 ml (2 measuring spoons) (30 mg) every 6–8 hours, depending on the intensity of the cough. Do not exceed a dose of 120 mg/day (8 measuring spoons).
? Children aged 6 to 12 years: 2.5 ml (half a measuring spoon) (7.5 mg) every 4 hours, or 5 ml (1 measuring spoon) (15 mg) every 6–8 hours, depending on the intensity of the cough. Do not exceed a dose of 60 mg/day (4 measuring spoons).
Do not exceed 6 doses per day.
Paediatric population
Serious adverse effects may occur in children in case of overdose, including neurological disturbances. Caregivers must not exceed the recommended dose.
Method of administration:
Oral use.
Do not dissolve or take with grapefruit or orange juice or with alcoholic beverages; see Taking Propalcof with food and drink.
If the cough worsens or persists for more than 7 days, or if it is accompanied by high fever, skin rash, or persistent headache, consult your doctor.
Use in children and adolescents
Do not administer to children under 6 years of age.
If you take more Propalcof than you should
If you take more Propalcof than indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, disturbances of consciousness, involuntary and rapid eye movements, cardiac disorders (increased heart rate), coordination disorders, psychosis with visual hallucinations, and hyperexcitability.
Other symptoms in cases of massive overdose may include: coma, severe breathing problems, and seizures.
Contact your doctor or hospital immediately if you experience any of the symptoms listed above.
Cases of abuse of medicines containing dextromethorphan have been reported in adolescents, which may lead to serious adverse effects such as tachycardia (rapid heartbeat), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, dizziness, gastrointestinal discomfort, hallucinations, slurred speech, nystagmus (involuntary, uncontrolled eye movements), fever, tachypnea (shallow and rapid breathing), brain damage, ataxia (uncoordinated movements), seizures, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeat), and death.
In case of poisoning, appropriate treatments for the symptoms will be administered, which may include intravenous naloxone injection and gastric lavage.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to a medical centre, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Propalcof
Do not take a double dose to make up for forgotten doses. If you have missed a dose, take it as soon as possible and then continue with your usual schedule, as indicated in section 3. How to take Propalcof.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, Propalcof may have adverse effects, although not everyone experiences them.
The following adverse effects have been observed during the period of use of dextromethorphan, although their frequency cannot be accurately determined:
- Nervous system disorders: drowsiness, dizziness, fatigue, involuntary muscle contractions, and more rarely mental confusion and headache.
- Gastrointestinal disorders: nausea, vomiting, gastrointestinal discomfort such as stomach pain, constipation.
- Ear and labyrinth disorders: vertigo.
- Immune system disorders: hypersensitivity and anaphylactic reaction including symptoms such as: skin rash, urticaria, edema, pruritus, and cardio-respiratory difficulty.
- Psychiatric disorders: visual hallucinations and confusion. These effects are much more pronounced in cases of overdose (See section "If you take more Propalcof than you should").
- Skin and subcutaneous tissue disorders: skin rash, urticaria, pruritus, erythema, allergic dermatitis.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish System for Pharmacovigilance of Human Medicines: https://notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Propalcof
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not freeze.
Do not use this medicine after the expiry date stated on the container, following EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Propalcof:
Each 5 ml of syrup (1 measuring spoonful) contains:
-The active substance is Dextromethorphan hydrobromide, 15 mg.
-The other components (excipients) are: Sucrose, sodium benzoate (E-211), sorbitol 70% solution, sweet orange oil, lemon tetraflavour, coriander oil, citric acid monohydrate, caramel colour (E-150 c), anhydrous ethanol, purified water.
Appearance of the medicine and contents of the pack
This medicine is presented in a plastic bottle.
The pack contains 200 ml. It includes a plastic measuring spoon with a capacity of 5 ml and markings at 2.5 ml.
Marketing Authorization Holder:
BAYER HISPANIA, S.L.
Av. Baix Llobregat, 3-5
08970 Sant Joan Despí (Barcelona), Spain
Manufacturer:
Delpharm Bladel B.V.
Industrieweg 1, 5531 AD
Bladel, The Netherlands
Date of the most recent revision of this leaflet: October 2019
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es