PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

SIRUPUS PINI COMPOSITUS
Pini extractum fluidum + Foeniculi tinctura + Codeini phosphas hemihydricus
420.0 mg + 64.0 mg + 3.2 mg/5 ml
syrup
Please read carefully all the information in this leaflet 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
your doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any side effects, including any 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, consult your doctor.

Table of contents of the leaflet

What Sirupus Pini compositus is and what it is used for
Important information before taking Sirupus Pini compositus
How to take Sirupus Pini compositus
Possible side effects
How to store Sirupus Pini compositus
Contents of the pack and other information

1. WHAT SIRUPUS PINI COMPOSITUS IS AND WHAT IT IS USED FOR
Sirupus Pini compositus is a combination medicine containing codeine phosphate with antitussive action, and plant-derived ingredients: fluid pine extract and fennel tincture.
The codeine phosphate contained in this product suppresses central cough reflexes, thereby reducing cough intensity.

Indications
The syrup is used for temporary relief of dry, exhausting cough associated with upper respiratory tract infections.

2. IMPORTANT INFORMATION BEFORE TAKING SIRUPUS PINI COMPOSITUS

When not to use Sirupus Pini compositus
Do not use this medicine if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).
Children under 12 years of age.
If it is known that you metabolize codeine to morphine very rapidly.
If you are breastfeeding.
Do not use the syrup during acute asthma attack, acute respiratory failure, emphysema, or chronic constipation.
The medicine is not recommended in respiratory diseases associated with accumulation of thick mucus in the bronchial tree and difficulty in expectoration.
Prolonged use of this medicine, especially in high doses, may lead to dependence. Therefore, use for longer than 7 days or exceeding the recommended doses is not advised.

Warnings and precautions
Codeine is converted into morphine in the liver by an enzyme. Morphine is the substance responsible for codeine’s effect. Some individuals have a genetic variation in 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 reactions. If you experience any of the following side effects, discontinue use immediately and consult your doctor:
slow or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, loss of appetite.

Children
Sirupus Pini compositus is contraindicated in children under 12 years of age.

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

Sirupus Pini compositus with other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Codeine phosphate may enhance the central nervous system depressant effects of certain antidepressants (e.g. benzodiazepines), hypnotics (barbituric acid derivatives), and neuroleptics. It may increase respiratory depression caused by other opioid medicines and enhance the effects of ethanol. Concurrent use of codeine with glutethimide may cause euphoria.
Codeine may also interact with MAO inhibitors (monoamine oxidase inhibitors), antihistamines, and antihypertensive medicines.

Pregnancy, breastfeeding, and fertility
Do not take Sirupus Pini compositus 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 psycho-motor performance. Therefore, patients should not drive or operate machinery during treatment.

Sirupus Pini compositus contains sucrose and alcohol
The product contains approximately 12 g of sucrose in 15 ml. This should be taken into account in patients with diabetes.
If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before using this medicine.
The medicinal product contains up to 5.0% (m/m) ethanol (alcohol), i.e., up to 975 mg of alcohol in a single 15 ml dose, equivalent to 20 ml of beer and 8 ml of wine. Due to its ethanol content, the syrup should not be used in patients with alcoholism, liver disease, or epilepsy.

3. HOW TO USE THE MEDICINAL PRODUCT SIRUPUS PINI COMPOSITUS

This medicinal product should always be used exactly as described in the patient information leaflet or as directed by a physician or pharmacist. If in doubt, consult a physician or pharmacist.
Dosage
Adults and adolescents over 12 years of age: 15 ml three times daily.
Adolescents over 12 years of age:
Sirupus Pini compositus is not recommended for use in adolescents aged 12 to 18 years with respiratory system function disorders.
Children
Children under 12 years of age:
Sirupus Pini compositus is contraindicated in children under 12 years of age.
Method of administration
For oral use. Dose the medicinal product using the measuring device supplied with the package.
Duration of treatment
Prolonged use beyond 7 days is not recommended without consulting a physician.
Use of a higher than recommended dose of Sirupus Pini compositus
Symptoms of overdose have not been observed to date during use of the syrup.
However, in extreme cases, following ingestion of doses many times higher than recommended, nausea, vomiting, abdominal pain, headache, depression, respiratory disturbances, agitation, profuse sweating, and seizures may occur. In such cases, seek immediate medical advice from a physician.
In case of ingestion of a higher than recommended dose, consult a physician or pharmacist.
Missed dose of Sirupus Pini compositus
Do not take a double dose to make up for a missed dose.
Discontinuation of Sirupus Pini compositus
If you have any further doubts regarding the use of this medicinal product, consult a physician or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Possible adverse reactions of the medicine are listed below by system organ class according to
MedDRA and frequency: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); frequency not known (cannot be estimated from the available data).
The following adverse reactions may occur during use of the syrup:
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. skin rashes) – frequency not known.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone number: +48 22 49-21-301, fax number: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl.
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 SIRUPUS PINI COMPOSITUS
The medicine should be stored at a temperature not exceeding 25 °C, in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label/carton.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What the medicinal product Sirupus Pini compositus contains
The active substances are (in 100 g):
6.6 g Pini extractum fluidum (Liquid pine extract) (1:1), extraction solvent: ethanol 90% (v/v)
1.0 g Foeniculi tinctura (Tincture of fennel fruit) (1:4.5–5.0), extraction solvent: ethanol 70% (v/v)
0.05 g Codeini phosphas hemihydricus (Codeine phosphate hemihydrate)

Excipients: sucrose, purified water, calcium lactate pentahydrate, phosphoric acid.
The syrup contains no more than 5% (m/m) ethanol.
One dose of syrup (15 ml) contains 9.6 mg of codeine phosphate.

What Sirupus Pini compositus looks like and contents of the pack
The syrup is straw-yellow, clear, with permissible opalescence.
The immediate packaging consists of an amber glass bottle closed with an HDPE screw cap, with a 30 ml measuring cup, packed in a cardboard box.
The pack contains 125 g of syrup.

Marketing Authorisation Holder and Manufacturer
Wrocławskie Zakłady Zielarskie „Herbapol” S.A.
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