Triprolidine hydrochloride + Pseudoephedrine hydrochloride + Dextromethorphan hydrobromide
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.
Actifed is a clear red syrup with a blackcurrant flavor.
Actifed contains triprolidine, pseudoephedrine, and dextromethorphan. Triprolidine is an antihistamine, which reduces nasal congestion, runny nose, itching, and sneezing.
Pseudoephedrine is a decongestant that reduces swelling of the nasal mucosa and the upper respiratory tract.
Dextromethorphan acts as a cough suppressant by inhibiting the cough center in the brainstem. As a result of the action of the three active substances, the medicine alleviates symptoms of the common cold, such as a runny nose and cough.
Actifed is indicated for the relief of symptoms associated with upper respiratory tract inflammatory conditions, where the administration of a decongestant, antihistamine, and cough suppressant is beneficial. The medicine is indicated for use in adults and children over 7 years old.
There is a possibility of dependence on the medicine
There have been reports of dextromethorphan abuse and dependence. Particular caution is recommended when administering this medicine to adolescents and young adults, as well as to patients with a history of drug or psychoactive substance abuse.
Before taking Actifed, the patient should discuss it with their doctor or pharmacist:
The patient should stop taking Actifed and immediately contact their doctor or seek medical attention if they experience:
After taking pseudoephedrine-containing medicines, cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported. PRES and RCVS are rare conditions that may be associated with reduced blood flow to the brain.
If symptoms occur that may be indicative of PRES or RCVS, the patient should immediately stop taking Actifed and seek medical attention (symptoms, see section 4 "Possible side effects").
The patient should not consume alcohol while taking Actifed.
The medicine may cause drowsiness.
If symptoms do not improve, worsen, or new symptoms appear, the patient should stop taking Actifed and consult their doctor.
The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Actifed should not be taken with the following medicines:
Before taking Actifed, the patient should consult their doctor if they are taking:
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Actifed may be used during pregnancy and breastfeeding only if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus or breastfed child.
The patient should not drive or operate machinery while taking Actifed.
The medicine contains 207.8 mg of alcohol (ethanol)in 5 ml of syrup. The amount of alcohol in 5 ml of this medicine is equivalent to less than 6 ml of beer or 3 ml of wine. The small amount of alcohol in this medicine will not have noticeable effects.
The medicine contains 2.835 g of sucrosein 5 ml of syrup. This should be taken into account in patients with diabetes.
If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
The medicine contains 1000 mg of sorbitol (70% solution)in 5 ml of syrup, which corresponds to 200 mg/ml. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or hereditary fructose intolerance, a rare genetic disorder in which the patient's body does not break down fructose, they should contact their doctor before taking the medicine or giving it to their child.
Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
The medicine contains 5 mg of sodium benzoatein 5 ml of syrup.
The medicine may cause allergic reactions (possible late reactions).
The medicine contains less than 1 mmol (23 mg) of sodiumin 5 ml of syrup, which means the medicine is considered "sodium-free".
This medicine should always be taken exactly as described in this patient leaflet or as directed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The medicine is taken orally.
10 ml of syrup three or four times a day.
The maximum daily dose is 40 ml.
5 ml of syrup three or four times a day.
The maximum daily dose is 20 ml.
In case of overdose in children, severe side effects may occur, including neurological disorders. Caregivers should not give a dose larger than recommended.
The use of Actifed syrup is contraindicated in children under 7 years old.
No specific studies have been conducted on the use of Actifed in elderly patients, but experience suggests that the recommended adult dosage is also suitable for these patients. Particular attention should be paid to renal and hepatic function (see below "Dosage in patients with liver failure" and "Dosage in patients with kidney failure").
Experience suggests that the recommended adult dosage is also suitable for patients with mild liver failure. Caution is recommended when administering the medicine to patients with mild or moderate liver failure. In case of severe liver failure, Actifed should not be used.
Care should be taken when administering the medicine to patients with moderate kidney failure, especially those with concomitant cardiovascular disease. In case of severe kidney function disorders, Actifed should not be used.
If the patient takes a higher dose of Actifed than recommended, the following symptoms may occur:
nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, impaired consciousness, involuntary rapid eye movements, cardiac disorders (rapid heartbeat), coordination disorders, psychosis with visual hallucinations, and increased excitability.
Other symptoms of a large overdose may include: coma, severe respiratory disorders, and seizures.
Other overdose symptoms may be:
In case of any of the above symptoms, the patient should immediately contact their doctor or go to the hospital. The doctor will take appropriate measures, such as supporting breathing and administering anticonvulsant medicines if necessary. In justified cases, gastric lavage and catheterization of the bladder may be necessary. If the doctor deems it necessary, the elimination of pseudoephedrine can be accelerated by administering acidifying medicines or dialysis.
In case of dextromethorphan overdose, patients without symptoms who have taken an excessive dose of dextromethorphan in the last hour can be given activated charcoal.
In patients who have taken dextromethorphan and experienced sedation or coma, the doctor may consider using naloxone. If seizures occur, the doctor may use benzodiazepines, and in case of hyperthermia, benzodiazepines and external cooling.
The patient should not take a double dose to make up for a missed dose.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.
Like all medicines, Actifed can cause side effects, although not everybody gets them.
Very rare (less than 1 in 10,000 patients)side effects reported after the medicine was placed on the market include:
If such symptoms occur, the patient should stop taking Actifed and contact their doctor or seek medical attention immediately.
If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.
Store in a temperature below 25°C. Protect from light.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
Actifed is a red syrup with a blackcurrant flavor.
The packaging is a brown glass bottle containing 100 ml of syrup, placed in a cardboard box with a double-sided measuring spoon with a capacity of 2.5 ml and 5 ml.
McNeil Healthcare (Ireland) Limited
Office 5, 6 & 7, Block 5
High Street, Tallaght
Dublin 24, D24 YK8N
Ireland
Delpharm Orléans
5, avenue de Concyr
45071 Orléans Cedex 2
France
To obtain more detailed information, please contact:
email: consumer-pl@kenvue.com
Date of last revision of the leaflet:March 2024
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