ACTIFED (1.25 mg + 30 mg + 10 mg)/5 ml Syrup

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Actifed, (1.25 mg + 30 mg + 10 mg)/5 ml, syrup
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Actifed and what is it used for
4. Important information before taking Actifed
   1. When not to take Actifed:
   2. Warnings and precautions
   3. The use of this medicine may lead to dependence. Therefore, treatment should be short-term.
   4. Actifed and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. The medicine contains methyl hydroxybenzoate and carmoisine
5. How to take Actifed
   1. Dosage for adults and children over 12 years old
   2. Dosage for children between 7 and 12 years old
   3. Use in children and adolescents
   4. Dosage for elderly patients
   5. Dosage in patients with liver failure
   6. Dosage in patients with kidney failure
   7. Use of a higher than recommended dose of Actifed
   8. Missing a dose of Actifed
6. Possible side effects
   1. Frequency not known (frequency cannot be estimated from the available data)
   2. Reporting side effects
7. How to store Actifed
8. Contents of the packaging and other information
   1. What Actifed contains
   2. What Actifed looks like and what the packaging contains
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer

Leaflet accompanying the packaging: patient information

Actifed, (1.25 mg + 30 mg + 10 mg)/5 ml, syrup

Triprolidine hydrochloride + Pseudoephedrine hydrochloride + Dextromethorphan hydrobromide

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Actifed and what is it used for
• 2. Important information before taking Actifed
• 3. How to take Actifed
• 4. Possible side effects
• 5. How to store Actifed
• 6. Contents of the packaging and other information

1. What is Actifed and what is it used for

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.

2. Important information before taking Actifed

When not to take Actifed:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe coronary artery disease;
• if the patient has very high blood pressure (severe hypertension) or uncontrolled hypertension;
• if the patient has severe acute (sudden) or chronic (long-term) kidney disease or kidney failure;
• if the patient has severe liver failure;
• if the patient is taking or has taken monoamine oxidase inhibitors (MAOIs) (medicines used for depression) in the last two weeks;
• if the patient is taking furazolidone (an antibacterial medicine).

Warnings and precautions

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.

The use of this medicine may lead to dependence. Therefore, treatment should be short-term.

Before taking Actifed, the patient should discuss it with their doctor or pharmacist:

• if the patient has heart disease, hypertension;
• if the patient has thyroid disease, diabetes, increased intraocular pressure, glaucoma, or prostatic hyperplasia;
• if the patient has liver or kidney function disorders;
• if the patient has chronic obstructive pulmonary disease, chronic bronchitis, acute or chronic asthma,
• if the patient has persistent or chronic cough, such as in asthma or cough with excessive mucus;
• if the patient has poor metabolism of the CYP2D6 enzyme;
• if the patient is taking certain antidepressants or antipsychotics, as Actifed may interact with them, causing changes in mental status (e.g., agitation, hallucinations, coma) and other symptoms, such as body temperature above 38°C, increased heart rate, unstable blood pressure, and exaggerated reflexes, muscle stiffness, lack of coordination, and gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

The patient should stop taking Actifed and immediately contact their doctor or seek medical attention if they experience:

• sudden abdominal pain, rectal bleeding, or other symptoms of developing colitis;
• fever with generalized skin rash and pustular eruption;
• sudden loss of vision. During treatment with Actifed, a decrease in blood flow to the optic nerve may occur. See section 4.

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.

Actifed and other medicines

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:

• monoamine oxidase inhibitors (MAOIs) (medicines used for depression),
• furazolidone (an antibacterial medicine).

Before taking Actifed, the patient should consult their doctor if they are taking:

• tricyclic antidepressants,
• decongestants,
• appetite suppressants,
• psychotropic medicines with amphetamine-like effects,
• blood pressure-lowering medicines, such as bretylium, betanidine, guanethidine, debryzochine, methyldopa, and alpha- and beta-adrenergic receptor blockers,
• sedatives and hypnotics,
• CYP2D6 enzyme inhibitors, such as fluoxetine, paroxetine, sertraline, bupropion (antidepressants), quinidine, amiodarone, flecainide, propafenone (antiarrhythmics), terbinafine (antifungal), methadone (analgesic), cinacalcet (calcimimetic), haloperidol, perphenazine, and thioridazine (antipsychotics),
• metoprolol (a medicine used for hypertension),
• isavuconazole (an antifungal medicine),
• selective serotonin reuptake inhibitors (medicines used for depression).

Pregnancy and breastfeeding

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.

Driving and using machines

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 contains methyl hydroxybenzoate and carmoisine

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".

3. How to take Actifed

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.

Dosage for adults and children over 12 years old

10 ml of syrup three or four times a day.
The maximum daily dose is 40 ml.

Dosage for children between 7 and 12 years old

5 ml of syrup three or four times a day.
The maximum daily dose is 20 ml.

Use in children and adolescents

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.

Dosage for elderly patients

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").

Dosage in patients with liver 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.

Dosage in patients with kidney failure

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.

Use of a higher than recommended dose of Actifed

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:

• conversion disorders (psychiatric disorders), various hallucinations, insomnia, anxiety, psychosis, confusion,
• clumsiness, decreased level of consciousness, speech disorders, lethargy, oculogyric crisis, serotonin syndrome (altered consciousness, tremors, and muscle contractions, impaired motor coordination, shivering, sweating, increased body temperature, diarrhea, seizures), tremors, sympathomimetic symptoms, including stimulation or inhibition of central nervous system activity, symptoms of cholinolytic syndrome (pupil dilation, flushing, fever, dry mouth, urinary retention, decreased bowel sounds),
• pupil constriction or dilation,
• decreased respiratory rate,
• urinary retention, kidney failure,
• intestinal infarction, ischemic colitis,
• palpitations, bradycardia, arrhythmias, myocardial infarction, hypertension, hypertensive crisis, intracranial hemorrhage, hypotension,
• muscle damage,
• low potassium levels in the blood,
• increased body temperature.

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.

Missing a dose of Actifed

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.

4. Possible side effects

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:

• agitation, anxiety, euphoria, hallucinations, visual hallucinations, irritability, restlessness, insomnia,
• stroke, headache, dizziness, paresthesia (unpleasant sensation, usually of tingling, numbness, or change in skin temperature), excessive psychomotor activity, drowsiness, tremors,
• arrhythmias, myocardial infarction, palpitations, tachycardia,
• nasal bleeding,
• abdominal discomfort, abdominal pain, ischemic colitis (see section Warnings and precautions), diarrhea, vomiting, nausea,
• sudden onset of limited skin and/or mucous membrane swelling, rash, erythematous rash, itching, urticaria, pustular changes accompanied by swelling and redness, and fever,
• painful urination, urinary retention,
• fatigue,
• drug hypersensitivity, hypersensitivity,
• decreased appetite,
• increased blood pressure.

Frequency not known (frequency cannot be estimated from the available data)

• Severe conditions affecting the blood vessels in the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). The patient should immediately stop taking Actifed and seek medical attention if they experience symptoms that may indicate PRES or RCVS, including:
• sudden severe headache,
• nausea,
• vomiting,
• confusion,
• seizures,
• changes in vision.
• Decreased blood flow to the optic nerve (ischemic optic neuropathy).
• Sudden fever, skin redness, or numerous small pustules (possible symptoms of acute generalized exanthematous pustulosis - AGEP) may occur within the first 2 days of taking Actifed. See section 2.

If such symptoms occur, the patient should stop taking Actifed and contact their doctor or seek medical attention immediately.

Reporting side effects

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.

5. How to store Actifed

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.

6. Contents of the packaging and other information

What Actifed contains

• The active substances of the medicine are: triprolidine hydrochloride, pseudoephedrine hydrochloride, dextromethorphan hydrobromide. 5 ml of syrup contains: 1.25 mg of triprolidine hydrochloride, 30 mg of pseudoephedrine hydrochloride, 10 mg of dextromethorphan hydrobromide.
• The other ingredients are: sorbitol 70% solution, sucrose, sodium benzoate, methyl hydroxybenzoate, carmoisine, ethanol 96%, blackcurrant flavor (contains ethanol 96%, cinnamaldehyde, d-limonene), levomenthol, vanillin, purified water.

What Actifed looks like and what the packaging contains

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.

Marketing authorization holder and manufacturer

Marketing authorization holder

McNeil Healthcare (Ireland) Limited
Office 5, 6 & 7, Block 5
High Street, Tallaght
Dublin 24, D24 YK8N
Ireland

Manufacturer

Delpharm Orléans
5, avenue de Concyr
45071 Orléans Cedex 2
France
To obtain more detailed information, please contact:
email: [email protected]
Date of last revision of the leaflet:March 2024