NEOAZARINA

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

NEOAZARINA
Codeini phosphas hemihydricus + Thymi herba pulveratum
10 mg + 316 mg, coated tablets
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

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

Table of contents:

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

1. WHAT NEOAZARINA IS AND WHAT IT IS USED FOR
Neoazarina is a medicine with antitussive (cough-suppressant) action.
Indications:
For severe paroxysmal (especially nocturnal) coughing attacks. For upper respiratory tract infections.

2. IMPORTANT INFORMATION BEFORE TAKING NEOAZARINA

When not to take Neoazarina
Do not take this medicine if:

• You are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).
• You are under 12 years of age.
• It is known that you metabolize codeine to morphine very rapidly.
• You are breastfeeding.
  Neoazarina must not be used in acute respiratory failure, acute asthma attacks, breathing disorders, or chronic constipation.
  Prolonged use beyond 7 days and exceeding the recommended doses are not recommended due to the risk of dependence.

Warnings and precautions
This medicine contains lactose. If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
Codeine is converted to morphine in the liver by an enzyme. Morphine is the substance responsible for codeine's effect. Some individuals have a genetic variation of this enzyme, leading to different responses. In some people, morphine is not formed or is formed in very small amounts, resulting in lack of antitussive effect. In others, large amounts of morphine may be produced, increasing the risk of severe adverse effects. If you experience any of the following symptoms, discontinue use immediately and consult your doctor without delay:
slow or shallow breathing, disorientation, drowsiness, pinpoint pupils, nausea or vomiting, constipation, loss of appetite.

Adolescents over 12 years of age
Use of Neoazarina is not recommended in adolescents with respiratory function disorders for the treatment of cough or cold symptoms.

Interaction of Neoazarina with other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Neoazarina may enhance the central nervous system depressant effects of certain antidepressants (e.g., benzodiazepines), hypnotics (barbiturates), and neuroleptics. It increases respiratory depression caused by other opioid medicines and enhances the effects of ethanol (alcohol). It may interact with MAO inhibitors, antihistamines, and antihypertensive medicines.

Pregnancy, breastfeeding, and effects on fertility
Do not use Neoazarina during pregnancy or while breastfeeding. Codeine and morphine pass into breast milk.
If you suspect you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery
This medicine may impair psychomotor performance. Therefore, patients should not drive or operate machinery during treatment.

3. HOW TO USE NEOAZARINA

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 a doctor or pharmacist.
Administer Neoazarina orally.
Adults and adolescents over 12 years: 1 to 2 tablets three times daily.
Children under 12 years:
Neoazarina is contraindicated in children under 12 years of age.
Adolescents aged 12 to 18 years:
Neoazarina is not recommended for use in adolescents aged 12 to 18 years with respiratory system function disorders.
Taking more Neoazarina than recommended
No cases of overdose have been reported. In extreme cases, taking an excessive dose may cause nausea, vomiting, abdominal pain, headache, depression, respiratory disturbances, stimulation, profuse sweating, convulsions, and even loss of consciousness. If a significantly higher than recommended dose is taken, contact a doctor immediately.
Long-term use of high doses may lead to dependence.
Missing a dose of Neoazarina
Do not take a double dose to make up for a missed dose.
Stopping Neoazarina
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Possible adverse reactions of the medicine are presented according to MedDRA system organ class and frequency of occurrence: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000), not known (cannot be estimated from available data).
During the use of Neoazarina, the following may occur:
Gastrointestinal disorders (dryness of the mouth, nausea, vomiting, constipation) – frequency not known
Psychiatric disorders (sleep disturbances) – frequency not known
Immune system disorders
(allergic reactions, e.g. in the form of skin changes) – frequency not known

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform 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 181 C,
02-222 Warsaw,
Tel.: (22) 49 21 301,
Fax: (22) 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows the collection of additional information on the safety of the medicine.

5. HOW TO STORE NEOAZARINA
Store below 25°C, in a place inaccessible and not visible to children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask a pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Neoazarina contains
The active substances in this medicinal product are:
Codeine phosphate hemihydrate ( Codeini phosphas hemihydricus ) 10 mg
Powdered thyme herb ( Thymi herba pulveratum ) 316 mg
The excipients are: monohydrate lactose, potato starch, povidone K-30, macrogol 6000, talc.

What Neoazarina looks like and contents of the pack
Coated tablets ranging in colour from grey-green to green-brown.
The packaging consists of a cardboard box containing 1 or 2 blisters of 10 tablets each and a patient leaflet.

Marketing Authorisation Holder and Manufacturer
Wrocławskie Zakłady Zielarskie „Herbapol” SA
50-951 Wrocław, ul. św. Mikołaja 65/68
tel.: +48 71 335 72 25
fax: +48 71 372 47 40
e-mail: [email protected]

For further information, please contact the Marketing Authorisation Holder: tel. 71 321 86 04 ext. 123