Package leaflet: Information for the patient

Acatar Acti Form
12.2 mg, hard capsules
Phenylephrini hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please contact your pharmacist. If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 7 days, or if you feel worse, you should consult your doctor.

Table of contents

What Acatar Acti Form is and what it is used for
Important information before taking Acatar Acti Form
How to take Acatar Acti Form
Possible side effects
How to store Acatar Acti Form
Contents of the pack and other information

1. What Acatar Acti Form is and what it is used for

Acatar Acti Form contains phenylephrine. It is an oral nasal decongestant. The phenylephrine contained in this medicine causes constriction of small blood vessels in the nasal mucosa, thereby reducing swelling and facilitating breathing, as well as decreasing nasal discharge.
Acatar Acti Form is intended for use in adults and children over 12 years of age.
Acatar Acti Form is indicated for the short-term relief of nasal mucosa swelling (nasal congestion) associated with the common cold, influenza, or allergic rhinitis (hay fever).

2. Important information before using Acatar Acti Form

When not to use Acatar Acti Form

if the patient is allergic (hypersensitive) to phenylephrine or other drugs with similar action, or to any of the other ingredients of this medicine (listed in section 6),
if any of the following conditions are present:
o cardiovascular disorders,
o cardiac arrhythmias,
o arterial hypertension,
o diabetes,
o pheochromocytoma,
o narrow-angle glaucoma,
o hyperthyroidism,
o benign prostatic hyperplasia,
during treatment with monoamine oxidase inhibitors (MAOIs) (used in the treatment of hypotension and depression) and within 14 days after discontinuation of such treatment,
during pregnancy or breastfeeding,
in children under 12 years of age.

Warnings and precautions
Before starting treatment with Acatar Acti Form, consult a doctor or pharmacist if any of the following apply:

Raynaud's syndrome (pallor followed by cyanosis of fingers, toes, earlobes, and nasal tip, often triggered by cold or emotional stress),
occlusive vascular disease,
stable coronary artery disease,
respiratory insufficiency,
bronchial asthma. Use with caution in patients taking beta-adrenergic receptor antagonists (medicines used, for example, in the treatment of arterial hypertension).

Contact a doctor even if the above warnings refer to conditions that occurred in the past.
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.

Children
This medicine must not be used in children under 12 years of age.

Acatar Acti Form and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines you plan to use.
Do not use this medicine simultaneously with other medicines containing:

phenylephrine or pseudoephedrine (medicines used for symptomatic treatment of rhinitis, i.e. nasal congestion);
other medicines with similar action to phenylephrine or MAO inhibitors (medicines used in hypotension and depression).

Seek medical advice before using Acatar Acti Form concomitantly with:

indomethacin (a pain-relieving and anti-inflammatory medicine used in rheumatic diseases);
β-adrenergic receptor antagonists (medicines used in arterial hypertension and circulatory disorders);
tricyclic antidepressants (medicines used in psychiatric disorders);
guanethidine, mecamylamine, or reserpine (medicines used in the treatment of hypertension).

Taking Acatar Acti Form with food and drink
Food does not reduce absorption of the medicine; it may be taken independently of meals.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Do not use during pregnancy.
Do not use during breastfeeding.

Driving and operating machinery
Exercise caution while driving and operating machinery during treatment with this medicine.

Acatar Acti Form contains sugar - lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.

3. How to use Acatar Acti Form

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults and adolescents over 12 years of age:
Orally, 1 capsule every 4 to 6 hours (maximum 4 capsules per day).
Use in children
Do not use in children under 12 years of age.
Elderly patients
There is no need to reduce the dose in elderly patients.
This medicine should not be used for longer than 7 days without medical advice.
Taking more Acatar Acti Form than recommended
In case of overdose, symptoms may include increased heart rate, elevated blood pressure, vasodilation leading to a significant drop in blood pressure, and difficulty breathing.
If less than 1 hour has passed since the overdose, induce vomiting and contact a doctor immediately, as specialized hospital treatment may be necessary.
Treatment includes gastric lavage and administration of beta-adrenolytic drugs. In cases of severe poisoning, monitoring of vital functions, respiratory and circulatory support in intensive care conditions are required.
If you have taken more than the recommended dose, seek medical advice immediately from your doctor or pharmacist.
Missed dose of Acatar Acti Form
Do not take a double dose to make up for a missed dose.
Stopping Acatar Acti Form
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
The frequency of adverse reactions has been classified as follows:
Common (may occur in no more than 1 in 10 people):

nausea, vomiting, digestive disturbances, loss of appetite.

Rare (may occur in fewer than 1 in 1,000 people):

itching, urticaria (hives),
allergic and hypersensitivity reactions up to symptoms of anaphylactic shock (confusion, pallor, drop in blood pressure, sweating, reduced urine output, rapid breathing, weakness and fainting) and bronchospasm,
increased blood pressure, tachycardia, cardiac arrhythmias, palpitations, pallor of the skin.

Very rare (may occur in fewer than 1 in 10,000 people):

anxiety, restlessness, tremors, nervousness, insomnia, irritability, dizziness and headache, hallucinations.

Frequency not known (cannot be estimated from available data):

urinary retention.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: +48 22 492-13-01
fax: +48 22 492-13-09
e-mail: [email protected] .
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Acatar Acti Form

Store below 25°C.
Keep the medicine in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the outer carton and immediate packaging (month/year). The expiry date refers to the last day of the specified month.
Blister labelling: EXP – expiry date, Lot – batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the pack and other information

What Acatar Acti Form contains
The active substance is phenylephrine hydrochloride 12.2 mg.
The other ingredients are: maize starch, monohydrate lactose, pregelatinized maize starch,
magnesium stearate.
Capsule shell: gelatin, titanium dioxide (E 171), quinoline yellow (E 104).

What Acatar Acti Form looks like and contents of the pack
Elongated, yellow capsules for oral administration.
Packed in PVC/Aluminum blisters in a cardboard box with a leaflet.
The medicine is available in the following pack sizes:
12 capsules in a blister.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Importer
US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50-507 Wrocław
For further information, please contact:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warszawa
tel. +48 (22) 543 60 00