Acatar Acti-tabs

Leaflet attached to the packaging: patient information

AcatarActi-Tabs,60 mg + 2.5 mg, tablets,

Please read carefully 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 as directed by
the doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform the doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact the doctor.

Table of contents of the leaflet

• 1. What is Acatar Acti-Tabs and what is it used for
• 2. Important information before using Acatar Acti-Tabs
• 3. How to use Acatar Acti-Tabs
• 4. Possible side effects
• 5. How to store Acatar Acti-Tabs
• 6. Contents of the packaging and other information

1. What is Acatar Acti-Tabs and what is it used for

Acatar Acti-Tabs contains two active substances: pseudoephedrine and triprolidine. Pseudoephedrine
reduces swelling and congestion of the nasal mucosa and paranasal sinuses, reduces the feeling of
a blocked nose (unblocks the nose). It reduces the amount of discharge from the nose. Triprolidine reduces
sneezing and nasal itching.
The indication for the use of Acatar Acti-Tabs is to relieve symptoms of rhinitis, such as: swelling of the nasal mucosa and paranasal sinuses, runny nose (cold), feeling of a blocked nose and sneezing, occurring in colds and flu. The medicine can also be used occasionally in case of allergic rhinitis and vasomotor rhinitis.
The action of Acatar Acti-Tabs starts after about 15-30 minutes of administration and lasts for at least 4 hours.
Acatar Acti-Tabs is intended for the treatment of adults and children over 12 years of age.

2. Important information before using Acatar Acti-Tabs

When not to use Acatar Acti-Tabs:

• if the patient is hypersensitive to the active substances or to any of the other ingredients of this medicine (listed in section 6) or to sympathomimetic amines such as ephedrine or phenylephrine used, among others, to shrink the nasal mucosa,
• if the patient is taking or has taken in the last 14 days monoamine oxidase inhibitors used sometimes in the treatment of depression,
• 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,
• in patients with unstable coronary artery disease,
• in patients with severe liver failure,
• during pregnancy and breastfeeding,
• if the patient is taking furazolidone (an antibiotic) or other medicines containing pseudoephedrine or antihistamines,
• in children under 12 years of age.

Warnings and precautions

Before starting to use Acatar Acti-Tabs, the patient should discuss it with their doctor or pharmacist.
The medicine should not be taken without consulting a doctor in the following cases:

• in patients with diabetes, heart rhythm disorders, hyperthyroidism, heart disease, with hypertension, with increased intraocular pressure, with urinary outflow disorders, e.g. due to prostate enlargement or urethral stricture, due to the content of pseudoephedrine;
• in patients with pyloric stenosis, asthma, acute angle-closure glaucoma, epilepsy, kidney failure, liver failure, chronic obstructive pulmonary disease, due to the content of triprolidine; elderly patients may be more sensitive to the sedative effect of triprolidine;
• in patients taking antihypertensive drugs, tricyclic antidepressants, drugs stimulating the sympathetic nervous system, such as: drugs constricting blood vessels of the mucous membranes, appetite suppressants and psychotropic drugs with an effect similar to amphetamine (see section "Acatar Acti-Tabs and other medicines"). In such cases, the doctor will assess the effect of a single dose of the medicine on blood pressure.

During the use of Acatar Acti-Tabs, sudden abdominal pain or rectal bleeding may occur due to inflammation of the large intestine (ischemic colitis). If such gastrointestinal symptoms occur, the use of Acatar Acti-Tabs should be discontinued and medical advice should be sought immediately. See section 4.
During the use of Acatar Acti-Tabs, a decrease in blood flow in the optic nerve may occur. In case of sudden vision loss, the use of Acatar Acti-Tabs should be discontinued and medical advice should be sought immediately. See section 4.
If the symptoms persist, worsen or do not improve after 3 days, or if new symptoms occur, the patient should consult a doctor.
If the patient experiences fever with generalized skin redness and pustular rash, they should discontinue the use of Acatar Acti-Tabs and consult a doctor or seek medical attention immediately. See section 4.
After the use of 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.
In case of symptoms that may be symptoms of PRES or RCVS, the use of Acatar Acti-Tabs should be discontinued immediately and medical attention should be sought immediately (symptoms, see section 4 "Possible side effects").

Children and adolescents

The medicine should not be used in children under 12 years of age.

Acatar Acti-Tabs and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as about medicines they plan to take.
During the use of Acatar Acti-Tabs, the patient should avoid taking sedative medicines.
Concomitant use of Acatar Acti-Tabs with medicines that constrict blood vessels of the mucous membranes (phenylephrine, oxymetazoline), tricyclic antidepressants (amitriptyline, imipramine, opipramol), appetite suppressants (sibutramine), psychotropic medicines with an effect similar to amphetamine (bupropion, phentermine) or monoamine oxidase inhibitors (moclobemide) may sometimes cause an increase in blood pressure (see section "Important information before using Acatar Acti-Tabs").
Tripolidine may enhance the effect of ethanol.
Pseudoephedrine may partially weaken the effect of blood pressure-lowering medicines that disrupt the function of the sympathetic nervous system, such as: bretylium, betanidine, guanethidine, debryzochine, methyldopa, alpha- and beta-adrenergic receptor blockers.

Acatar Acti-Tabs with food, drink, or alcohol

During the use of Acatar Acti-Tabs, the patient should avoid consuming alcohol.

Pregnancy, breastfeeding, and fertility

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 using this medicine.
Acatar Acti-Tabs should not be used in pregnant or breastfeeding women.

Driving and using machines

Patients using Acatar Acti-Tabs should not drive vehicles or operate machines, as the medicine may cause drowsiness.

Acatar Acti-Tabs contains lactose

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

3. How to use Acatar Acti-Tabs

This medicine should always be used exactly as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Take orally.
Recommended dose: adults and children over 12 years of age 1 tablet every 6 to 8 hours. Do not take more than 4 tablets per day.

Use in children and adolescents

The medicine should not be given to children under 12 years of age.

Using a higher dose of Acatar Acti-Tabs than recommended

In case of using a higher dose of the medicine than recommended, the following symptoms may occur: drowsiness, lethargy, dizziness, clumsiness, weakness, decreased muscle tone, respiratory failure, dryness of the skin and mucous membranes, increased heart rate, hypertension, high fever, excitement, irritability, seizures, difficulty urinating.
In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Acatar Acti-Tabs

A double dose should not be taken to make up for a missed dose.

4. Possible side effects

Like all medicines, Acatar Acti-Tabs can cause side effects, although not everybody gets them.
The use of Acatar Acti-Tabs should be discontinued immediately and medical attention should be sought immediately if symptoms occur that may indicate posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• severe headache with sudden onset,
• nausea,
• vomiting,
• confusion,
• seizures, changes in vision

The following side effects may occur:
Side effects with unknown frequency (cannot be estimated from available data):

• severe vascular disorders affecting the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS),
• hallucinations,
• drowsiness, sleep disorders,
• increased heart rate (tachycardia),
• hypertension,
• dryness of the mouth, nose, and throat,
• rash, sometimes with itching,
• urinary retention in men who received pseudoephedrine (in such cases, an important predisposing factor may be prostate enlargement),
• ischemic colitis (reduced blood flow to the large intestine),
• decreased blood flow in 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 using Acatar Acti-Tabs. See section 2.
If such symptoms occur, the use of Acatar Acti-Tabs should be discontinued and the patient should consult their doctor or seek medical attention immediately.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance 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 to gather more information on the safety of the medicine.

5. How to store Acatar Acti-Tabs

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Do not use after the expiry date stated on the carton and blister packaging (month/year). The applied labeling for the blister is: EXP - expiry date, Lot - batch number.
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 Acatar Acti-Tabs contains

• The active substances of the medicine are pseudoephedrine hydrochloride and triprolidine hydrochloride. 1 tablet contains: 60 mg of pseudoephedrine hydrochloride and 2.5 mg of triprolidine hydrochloride.
• The other ingredients are: microcrystalline cellulose, pregelatinized starch, lactose, stearic acid (50), anhydrous colloidal silica, magnesium stearate.

What Acatar Acti-Tabs looks like and contents of the packaging

White, round, biconvex tablet with a line and the inscription 160 on one part.
The packaging contains: 2 tablets (1 blister of 2 tablets); 4 tablets (1 blister of 4 tablets); 6 tablets (1 blister of 6 tablets) or 12 tablets (1 blister of 12 tablets).

Marketing authorization holder and manufacturer

US Pharmacia Sp. z o.o.
Ziębicka 40 Street,
50-507 Wrocław
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder:
USP Zdrowie Sp. z o.o.
Poleczki 35 Street
02-822 Warsaw
phone: +48 (22) 543 60 00

Date of the last update of the leaflet: April 2024