Acatar Acti Form

Leaflet attached to the packaging: patient information

Acatar Acti Form

12.2 mg, hard capsules

Phenylephrine hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist. If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days or if you feel worse, consult a doctor.

Table of contents of the leaflet

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

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

Acatar Acti Form contains phenylephrine. It is an oral decongestant. The phenylephrine in the medicine causes the constriction of small blood vessels in the nasal mucosa, which reduces its swelling, making it easier to breathe and reducing the amount of nasal discharge. Acatar Acti Form is intended for use in adults and children over 12 years of age. The indication for use of Acatar Acti Form is the temporary relief of symptoms of nasal mucosa swelling (cold) occurring in a cold, flu, or allergic rhinitis (hay fever).

2. Important information before taking Acatar Acti Form

When not to take Acatar Acti Form

• if you are allergic (hypersensitive) to phenylephrine or other medicines with similar action, or any of the other ingredients of this medicine (listed in section 6),
• if you have the following diseases: cardiovascular disorders, heart rhythm disorders, hypertension, diabetes, pheochromocytoma, glaucoma with closed-angle glaucoma, hyperthyroidism, prostate enlargement,
• while taking monoamine oxidase inhibitors (MAOIs) (used to treat low blood pressure and depression) and for 14 days after stopping their use,
• during pregnancy or breastfeeding,
• in children under 12 years of age.

Warnings and precautions

Before taking Acatar Acti Form, consult a doctor or pharmacist if you have:

• Raynaud's syndrome (pallor, followed by cyanosis of the fingers, toes, earlobes, and nose tip, often occurring under the influence of cold or emotions),
• arteriosclerosis,
• stable coronary artery disease,
• respiratory failure,
• asthma. Use with caution in patients taking beta-adrenergic receptor antagonists (medicines used, for example, in the treatment of hypertension).

Consult a doctor even if the above warnings apply to past situations. If you have previously been diagnosed with intolerance to some sugars, you should consult a doctor before taking the medicine.

Children

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

Acatar Acti Form and other medicines

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. Do not take the medicine at the same time as other medicines containing:

• phenylephrine or pseudoephedrine (medicines used in the symptomatic treatment of rhinitis, i.e., cold);
• other medicines with similar action to phenylephrine or MAO inhibitors (medicines used in low blood pressure and depression).

Consult a doctor before taking the medicine with:

• indomethacin (a pain reliever and anti-inflammatory used in rheumatic diseases);
• beta-adrenergic receptor antagonists (medicines used in hypertension and cardiovascular diseases);
• tricyclic antidepressants (medicines used in mental disorders);
• guanethidine, mecamylamine, or reserpine (medicines used in the treatment of hypertension).

Taking Acatar Acti Form with food and drink

Food does not reduce the absorption of the medicine, it can be taken independently of meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before taking this medicine. Do not use during pregnancy. Do not use during breastfeeding.

Driving and using machines

While taking the medicine, be careful when driving vehicles and operating machines.

Acatar Acti Form contains sugar - lactose

If you have previously been diagnosed with intolerance to some sugars, consult a doctor before taking the medicine.

3. How to take Acatar Acti Form

Always take this medicine exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If you have any doubts, consult a 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

No dose reduction is needed in elderly patients. Do not use the medicine for more than 7 days without consulting a doctor.

Overdose of Acatar Acti Form

In case of overdose, rapid heart rate, high blood pressure, vasodilation leading to a significant drop in blood pressure, and difficulty breathing may occur. If the overdose occurred no more than 1 hour ago, induce vomiting and consult a doctor, as specialized treatment in a hospital may be necessary. Treatment involves gastric lavage and administration of beta-adrenergic blockers. In case of severe poisoning, monitoring of vital functions, respiratory support, and circulation in intensive care is necessary. In case of taking a higher dose of the medicine than recommended, consult a doctor or pharmacist immediately.

Missed dose of Acatar Acti Form

Do not take a double dose to make up for a missed dose.

Stopping treatment with Acatar Acti Form

If you have any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Acatar Acti Form can cause side effects, although not everybody gets them. The frequency of side effects is classified as follows:

Frequent(may occur in up to 1 in 10 people):

• nausea, vomiting, digestive disorders, loss of appetite.

Rare(may occur in less than 1 in 1000 people):

• itching, hives,
• allergic reactions and hypersensitivity up to anaphylactic shock symptoms (confusion, pallor, blood pressure drop, sweating, oliguria, rapid breathing, weakness, and fainting) and bronchospasm,
• high blood pressure, tachycardia, heart rhythm disorders, palpitations, pallor. Very rare(may occur in less than 1 in 10,000 people):
• anxiety, restlessness, tremors, nervousness, insomnia, irritability, dizziness, and headaches, hallucinations. Frequency not known(cannot be estimated from available data):
• urinary retention.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, consult a doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of 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]. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Acatar Acti Form

Store at a temperature below 25°C. Keep the medicine out of sight and reach of children. Do not use the medicine after the expiry date stated on the carton and blister pack (month/year). The expiry date refers to the last day of the month. The applied labeling for the blister is: EXP - expiry date, Lot - batch number. Medicines should not be disposed of via wastewater or household waste. 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 Acatar Acti Form contains

The active substance of the medicine is phenylephrine hydrochloride 12.2 mg. The other ingredients are: cornstarch, lactose monohydrate, cornstarch, magnesium stearate. Capsule: gelatin, titanium dioxide (E 171), quinoline yellow (E 104).

What Acatar Acti Form looks like and what the package contains

Yellow, elongated capsules for oral use. Packaged in a PVC/Aluminum blister pack in a carton with a leaflet. The medicine is available in packages: 12 capsules in a blister pack. Not all pack sizes may be marketed.

Marketing authorization holder and importer

US Pharmacia Sp. z o.o., ul. Ziębicka 40, 50-507 Wrocław. For more detailed information, please contact: USP Zdrowie Sp. z o.o., ul. Poleczki 35, 02-822 Warsaw, tel.: +48 (22) 543 60 00.

Date of last revision of the leaflet: November 2022