Acti-trin

Leaflet attached to the packaging: patient information

ACTI-trin

(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 the patient leaflet or according to the doctor's or pharmacist's instructions.

• 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 the leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is ACTI-trin and what is it used for
• 2. Important information before taking ACTI-trin
• 3. How to take ACTI-trin
• 4. Possible side effects
• 5. How to store ACTI-trin
• 6. Package contents and other information

1. What is ACTI-trin and what is it used for

ACTI-trin contains three active substances: triprolidine, pseudoephedrine, and dextromethorphan.
Tripolidine in combination with pseudoephedrine inhibits the cough reflex, reduces the amount of nasal discharge and other symptoms of a cold.
Pseudoephedrine also reduces swelling and congestion of the nasal mucosa, thereby increasing its patency.
Dextromethorphan has an antitussive effect.
ACTI-trin is used for symptomatic treatment of inflammatory conditions of the upper respiratory tract (flu, colds, and other upper respiratory tract infections) accompanied by cough, nasal congestion, and runny nose.

2. Important information before taking ACTI-trin

When not to take ACTI-trin:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• while being treated with monoamine oxidase inhibitors (MAOIs) (such as iproniazid, phenelzine, isocarboxazid, tranylcypromine, clorgyline, selegiline, toloxatone, amiflamine, moclobemide, lazabemide) and for 2 weeks after discontinuing MAOIs;
• in asthma;
• in severe liver failure;
• if the patient has severe acute (sudden) or chronic (long-term) kidney disease or kidney failure;

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• in respiratory failure;
• in cough with a large amount of discharge and cough associated with asthma;
• if the patient has very high blood pressure (severe hypertension) or uncontrolled hypertension;
• in severe coronary heart disease;
• in cystic fibrosis;
• in pregnant and breastfeeding women;
• in children under 7 years of age.

Warnings and precautions

Taking this medicine may lead to dependence. Therefore, treatment should be short-term.
Before taking ACTI-trin, you should talk to your doctor or pharmacist:

• if you are taking certain antidepressants or antipsychotics - ACTI-trin may interact with them, causing changes in mental state (e.g., excitement, hallucinations, coma) and other symptoms, such as body temperature above 38°C, increased heart rate, unstable blood pressure, as well as exaggerated reflexes, muscle stiffness, lack of coordination, and (or) gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

You should be particularly careful when taking ACTI-trin syrup:

• you should not take the medicine before 14 days have passed since stopping treatment with monoamine oxidase inhibitors (such as iproniazid, phenelzine, isocarboxazid, tranylcypromine, clorgyline, selegiline, toloxatone, amiflamine, moclobemide, lazabemide);
• while taking ACTI-trin, you should not take medicines that act on the central nervous system (sedatives and tranquilizers) or drink alcohol or take medicines containing alcohol;
• in patients with hyperthyroidism, prostatic hypertrophy, glaucoma, heart disease, increased intraocular pressure, diabetes, hypertension.

After taking medicines containing pseudoephedrine, 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 symptoms of PRES or RCVS, you should immediately stop taking ACTI-trin and seek medical help immediately (symptoms, see section 4 "Possible side effects").
You should talk to your doctor, even if the above warnings refer to situations that have occurred in the past.

Children

The medicine is contraindicated in children under 7 years of age.

Using ACTI-trin in patients with liver function disorders

The medicine should be used with caution in patients with liver disease.

ACTI-trin and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
ACTI-trin syrup taken together with monoamine oxidase inhibitors enhances their effect and may cause fainting, coma, high fever, and increased blood pressure (see sections: "When not to take ACTI-trin" and "Warnings and precautions").
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Taking ACTI-trin syrup and medicines that act on the central nervous system (sedatives and tranquilizers) as well as anticholinergic or anticholinergic-like medicines (muscle relaxants used in functional bowel disorders, obstructive bronchitis, asthma, bradycardia, Parkinson's disease) may enhance their effect.
The effect of blood pressure-lowering medicines such as bretylium, betanidine, guanethidine, debrisoquine, methyldopa, and alpha- and beta-adrenergic blockers may be weakened by the pseudoephedrine contained in ACTI-trin.
Concomitant administration of ACTI-trin syrup and quinidine may inhibit the hepatic metabolism of dextromethorphan contained in the medicine, increasing its concentration in the blood serum and thus enhancing side effects.
Taking ACTI-trin syrup with other medicines that stimulate the sympathetic nervous system, such as vasoconstrictors, tricyclic antidepressants, anorectic agents, psychotropic drugs with amphetamine-like effects, may sometimes cause increased blood pressure (see section: "When not to take ACTI-trin" and "Warnings and precautions").
While taking ACTI-trin, you should not take other medicines containing alcohol or drink alcoholic beverages.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
No studies have been conducted to determine the combined effect of the active substances on the course of pregnancy.
Therefore, ACTI-trin should not be taken by pregnant women.
The active substances of the medicine pass into breast milk, so it should not be taken by breastfeeding women.

ACTI-trin contains ethanol

The medicine contains 4.58% v/v ethanol (alcohol), i.e., up to 181 mg per dose (5 ml syrup), which is equivalent to 4.58 ml of beer or 1.91 ml of wine per dose. It is harmful to people with alcoholism.
The presence of alcohol should be taken into account when administering to children and to people at high risk, such as patients with liver disease or epilepsy.

ACTI-trin contains sodium benzoate

The medicine contains 3.02 mg of sodium benzoate in 5 ml of syrup.

ACTI-trin contains methyl parahydroxybenzoate

The medicine may cause allergic reactions (possible late reactions).

ACTI-trin contains liquid maltitol

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

Driving and operating machinery

The medicine may impair the ability to drive vehicles due to the possibility of drowsiness and dizziness. While taking ACTI-trin, you should not drive vehicles or operate machinery.

3. How to take ACTI-trin

This medicine should always be taken exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions.
In case of doubt, you should consult your doctor or pharmacist.
The medicine is taken orally.
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Adults and children over 12 years: 10 ml of syrup 3 to 4 times a day, not more often than every 6 hours.
Children from 7 to 12 years: 5 ml of syrup 3 to 4 times a day, not more often than every 6 hours.
A spoon or cup for administering medicines is attached to the packaging.
Children
In case of overdose in children, severe side effects may occur, including neurological disorders. Caregivers should not give a dose larger than recommended.

Taking a larger dose of ACTI-trin than recommended

If you take a larger dose of ACTI-trin than you should, the following symptoms may occur:
nausea and vomiting, involuntary muscle contractions, excitement, 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 convulsions.
Other overdose symptoms: dizziness, irritability, disorientation, auditory hallucinations, sleep disorders, restlessness, weakness, decreased muscle tone, dryness of the skin and mucous membranes, hypertension, increased body temperature, difficulty urinating.
If any of the above symptoms occur, you should immediately contact your doctor or go to the hospital.

Missing a dose of ACTI-trin

You should take the missed dose as soon as possible. You should not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should immediately stop taking ACTI-trin and seek medical help if you experience symptoms indicating posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• severe headache with a sudden onset,
• nausea,
• vomiting,
• confusion,
• convulsions,
• vision changes.

Very rare (less than 1 in 10,000 patients taking the medicine): depression, fatigue, excitement, dizziness, sleep disorders, drowsiness, restlessness, hallucinations, cardiac rhythm disorders (tachycardia), nausea, vomiting, constipation or diarrhea, dryness of the mucous membranes of the mouth and throat, urinary retention, and painful urination (especially in men with symptoms of prostatic hypertrophy), rash with or without itching, urticaria.
Frequency not known (frequency cannot be estimated from the available data): severe vascular disorders affecting the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw
phone: +48 22 49 21 301, fax: +48 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 ACTI-trin

Store in a temperature below 25°C. Store in the original packaging to 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 given month.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What ACTI-trin contains

• The active substances of the medicine are triprolidine, pseudoephedrine, and dextromethorphan. 5 ml of syrup contains: 1.25 mg of triprolidine hydrochloride, 30 mg of pseudoephedrine hydrochloride, and 10 mg of dextromethorphan hydrobromide.
• The other ingredients (excipients) are: liquid maltitol, sodium benzoate, methyl parahydroxybenzoate, sodium saccharin, levomenthol, vanillin, flavor and aroma enhancer "cola" (natural flavorings, triacetin, ethanol), 96% ethanol (v/v), purified water.

What ACTI-trin looks like and what the package contains

The medicine is a syrup, packaged in a brown glass bottle with an aluminum or polyethylene cap in a cardboard box with a spoon or cup for administering medicines.
1 bottle contains 100 ml of syrup.

Marketing authorization holder and manufacturer

"HASCO-LEK" Pharmaceutical Company S.A.
51-131 Wrocław, Żmigrodzka 242 E

Medicine information

phone: (22) 742 00 22
e-mail: [email protected]
Date of last update of the leaflet:04/2024
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