Sirupus Pini compositus

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE PATIENT

SIRUPUS PINI COMPOSITUS

Pine extract fluid + Fennel tincture + Codeine phosphate hemihydrate
420.0 mg + 64.0 mg + 3.2 mg/5 ml
syrup

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 tell their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. WHAT IS SIRUPUS PINI COMPOSITUS AND WHAT IS IT USED FOR

Sirupus Pini compositus is a complex product containing codeine phosphate with an antitussive effect and plant-derived substances: pine fluid extract and fennel tincture.
The codeine phosphate contained in the product inhibits central cough reflexes, reducing the intensity of coughing.

Indications for use

The syrup is used temporarily for dry, irritating cough in the course of upper respiratory tract infections.

2. IMPORTANT INFORMATION BEFORE USING SIRUPUS PINI COMPOSITUS

When not to use Sirupus Pini compositus

If the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6).
Children under 12 years of age.
If it is known that the patient's codeine metabolism to morphine is very rapid.
If the patient is breastfeeding.
The syrup should not be used during an acute asthma attack, in acute respiratory failure, in pulmonary edema, or in chronic constipation.
It is not recommended to use the medicine in respiratory diseases with thick secretions in the bronchial tree and difficulty expectorating.
Prolonged use of the medicine, especially in high doses, may lead to dependence. Therefore, it is not recommended to use it for more than 7 days and to exceed the recommended doses.

Warnings and precautions

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 variation of this enzyme, which may cause different effects in them. In some people, morphine is not produced or is produced in very small amounts, and therefore will not have an antitussive effect. In others, it is more likely to experience severe side effects due to very high amounts of morphine produced. If the patient experiences any of the following side effects, they should stop using this medicine and immediately consult a doctor:
slow or shallow breathing, disorientation, drowsiness, pupil constriction, 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

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

Sirupus Pini compositus and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Codeine phosphate may enhance the depressant effect on the central nervous system of some antidepressants (benzodiazepines), sedatives (barbituric acid derivatives), and neuroleptics. It may increase the depressant effect on the respiratory center of other opioid medicines and enhance the effect of ethanol. When used concurrently with codeine, glutethimide may cause a state of euphoria.
Codeine may also interact with MAO inhibitors (monoamine oxidase), antihistamines, and blood pressure-lowering medicines.

Pregnancy, breastfeeding, and fertility

Sirupus Pini compositus should not be taken 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 impair psychophysical fitness, so patients should not drive vehicles or operate machines during treatment.

Sirupus Pini compositus contains sucrose and alcohol

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

3. HOW TO USE SIRUPUS PINI COMPOSITUS

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
Dosage
Adults and adolescents over 12 years of age: 3 times a day, 15 ml each time.
Adolescents over 12 years of age:
Sirupus Pini compositus is not recommended for use in adolescents from 12 to 18 years of age with respiratory function disorders.
Children
Children under 12 years of age:
Sirupus Pini compositus is contraindicated in children under 12 years of age.
Method of administration
Oral administration. The medicine should be dosed using the measuring cup included in the package.
Duration of use
It is not recommended to use the medicine for more than 7 days without consulting a doctor.

Using a higher than recommended dose of Sirupus Pini compositus

No symptoms of overdose have been observed during the use of the syrup.
In extreme cases, as a result of taking doses many times higher than recommended, nausea, vomiting, abdominal pain, headache, depression, respiratory disorders, excitement, excessive sweating, and seizures may occur. In such a case, the patient should immediately consult a doctor.
In the event of taking a higher than recommended dose of the medicine, the patient should consult their doctor or pharmacist.

Missing a dose of Sirupus Pini compositus

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

Stopping the use of Sirupus Pini compositus

In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Sirupus Pini compositus 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 the syrup, the following may occur:
Gastrointestinal disorders (dry mouth, nausea, vomiting, constipation) - frequency not known.
Psychiatric disorders (sleep disorders) - frequency not known.
Immune system disorders (allergic reactions, e.g., skin changes) - frequency not known.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist.
Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49-21-301, fax: +48 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 allow for more information to be collected 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, out of sight and reach of children.
The medicine should not be used after the expiry date stated on the label/carton.
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 PACKAGE AND OTHER INFORMATION

What Sirupus Pini compositus contains

The active substances of the medicine are (per 100 g):
6.6 g Pine fluid extract (1:1), extractant: ethanol 90% (v/v)
1.0 g Fennel tincture (1:4.5-5.0), extractant: ethanol 70% (v/v)
0.05 g Codeine phosphate hemihydrate
The excipients are: sucrose, purified water, calcium pentahydrate lactate, phosphoric acid.
The syrup contains no more than 5% (m/m) ethanol.
The syrup contains 9.6 mg of codeine phosphate per dose (15 ml).

What Sirupus Pini compositus looks like and what the package contains

The syrup is straw-yellow, transparent with permissible opalescence.
The immediate packaging is a brown glass bottle closed with an HDPE cap with a 30 ml measuring cup in a cardboard box.
The package contains 125 g of syrup.

Marketing authorization holder and manufacturer

Wrocławskie Zakłady Zielarskie "Herbapol" S.A.

• 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 last revision of the leaflet:08.01.2025