Neoazarina

LEAFLET ATTACHED TO THE PACKAGING: INFORMATION FOR THE PATIENT

NEOAZARINA

Codeini phosphashemihydricus + Thymi herba pulveratum
10 mg + 316 mg, coated tablets

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 as directed by a 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 side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If after a few days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

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

1. WHAT IS NEOAZARINA AND WHAT IS IT USED FOR

Neoazarina is a medicine with an anti-cough effect.

Indications for use:

In severe, paroxysmal (especially nocturnal) cough attacks. In upper respiratory tract infections.

2. IMPORTANT INFORMATION BEFORE USING NEOAZARINA

When not to use Neoazarina

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 is under 12 years old.
If it is known that the patient's metabolism of codeine to morphine is very rapid.
If the patient is breastfeeding.
Neoazarina should not be used in acute respiratory failure, acute asthma attacks, respiratory disorders, and chronic constipation.
It is not recommended to use the medicine for more than 7 days or to exceed the recommended doses due to the risk of addiction.

Warnings and precautions

The medicine contains lactose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
Codeine is converted to morphine in the liver with the participation of an enzyme. Morphine is the substance that determines the effect of codeine. In some people, there is a variant of this enzyme, which can cause different effects. In some people, morphine is not produced or is produced in very small amounts, and therefore will not have an anti-cough effect. In other people, it is more likely that serious side effects will occur due to the very large amounts of morphine produced. If the patient experiences any of the following side effects, they should stop using the medicine and immediately consult their doctor:
slow or shallow breathing, disorientation, drowsiness, pupil constriction, nausea or vomiting, constipation, loss of appetite.

Adolescents over 12 years old

It is not recommended to use Neoazarina in adolescents with respiratory function disorders for the treatment of cough or cold.

Neoazarina 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 any medicines they plan to take.
Neoazarina may enhance the depressive effect on the central nervous system of some antidepressant medicines (from the benzodiazepine group), sedatives (barbiturate derivatives), and neuroleptics. It increases the depressive effect on the respiratory center of other opioid medicines and enhances the effect of ethanol. It may interact with MAO inhibitors, antihistamines, and blood pressure-lowering medicines.

Pregnancy, breastfeeding, and fertility.

The medicine should not be used during pregnancy or breastfeeding. Codeine and morphine pass into breast milk.
If the patient suspects they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before using the medicine.

Driving and using machines

The medicine may cause impairment of physical and mental abilities, so patients should not drive or operate machinery during treatment.

3. HOW TO USE NEOAZARINA

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The medicine should be taken orally.
Adults and adolescents over 12 years old: 3 times a day, 1 to 2 tablets.
Children under 12 years old:
Neoazarina is contraindicated in children under 12 years old.
Adolescents from 12 to 18 years old:
Neoazarina is not recommended for use in adolescents from 12 to 18 years old with respiratory function disorders.

Using a higher dose of Neoazarina than recommended

No cases of overdose have been reported. In extreme cases, taking the medicine in too high a dose may cause nausea, vomiting, abdominal pain, headache, depression, respiratory disorders, excitement, excessive sweating, convulsions, and even loss of consciousness. If a significantly higher dose than recommended is taken, the patient should contact their doctor.
Long-term use of high doses may lead to addiction.

Missing a dose of Neoazarina

The patient should not take a double dose to make up for a missed dose.

Stopping the use of Neoazarina

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, this medicine can cause side effects, although not everybody gets them.
Possible side effects of the medicine are presented according to the MedDRA system organ classification and frequency of occurrence: very common (≥ 1/10); common (≥ 1/100 to <1>During the use of Neoazarina, the following side effects may occur:
Gastrointestinal disorders (dry mouth, nausea, vomiting, constipation) - unknown frequency
Psychiatric disorders (sleep disorders) - unknown frequency
Immune system disorders (allergic reactions, e.g., skin changes) - unknown frequency

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181 C,
02-222 Warsaw,
Phone: (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 NEOAZARINA

Store in a temperature below 25°C, out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified 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 Neoazarina contains

The active substances of the medicine are:
Codeine phosphate hemihydrate (Codeini phosphas hemihydricus) 10 mg
Dried thyme herb (Thymi herba pulveratum) 316 mg
The excipients are: lactose monohydrate, potato starch, povidone K-30, macrogol 6000, talc, anise essential oil.

What Neoazarina looks like and what the packaging contains

Coated tablets with a color from gray-green to green-brown.
The packaging consists of a cardboard box containing 1 or 2 blisters of 10 tablets and a patient leaflet.

Marketing authorization holder and manufacturer

Wrocławskie Zakłady Zielarskie „Herbapol” SA
50-951 Wrocław, ul. św. Mikołaja 65/68
phone: +48 71 335 72 25
fax: +48 71 372 47 40
e-mail: [email protected]
To obtain more detailed information, the patient should contact the marketing authorization holder: phone 71 321 86 04 ext. 123

Date of the last update of the leaflet: