Pine syrup compound aflofarm

INFORMATION ON OUTER PACKAGING AND
PRIMARY PACKAGING
Label-leaflet

1. NAME OF THE MEDICINAL PRODUCT

Aflofarm Pine Syrup Complex,
(1283.1 mg + 194.4 mg + 9.72 mg)/15 ml, syrup
Pini extractum fluidum + Anisi tinctura + Codeini phosphas hemihydricus

2. CONTENT OF ACTIVE SUBSTANCES

Composition: 15 mL of syrup contains 1283.1 mg of pine tar extract (Pini extractum fluidum) DER
1:0.9-1.1, extraction solvent: ethanol 96% (v/v), 194.4 mg of anise tincture (Anisi tinctura) DER 1:4.5-5.5,
extraction solvent: ethanol 70% (v/v), 9.72 mg of codeine phosphate (Codeini phosphas hemihydricus)

3. LIST OF EXCIPENTS

and excipients: calcium lactate pentahydrate, diluted phosphoric acid, sucrose,
purified water.
15 ml of syrup contains 9.72 mg of codeine phosphate, 1329.6 mg of ethanol, and 12.053 g of sucrose.

4. PHARMACEUTICAL FORM AND PACKAGE CONTENTS

Syrup
125 g Code: 5909990669714

5. METHOD AND ROUTE OF ADMINISTRATION

Oral use.
Read the contents of the label-leaflet before using the medicine. To do so, peel off the label in the upper right corner at the place marked with an arrow.

6. WARNINGS ON STORAGE OF THE MEDICINAL PRODUCT

KEEP OUT OF SIGHT AND REACH OF CHILDREN
Keep the medicine in a place out of sight and reach of children.
7. OTHER SPECIAL WARNINGS, IF NECESSARY
8. EXPIRY DATE
Expiry date:
Do not use after the expiry date.

9. SPECIAL STORAGE CONDITIONS

Store below 25°C. Do not store in the refrigerator. Do not freeze.
Keep in the original packaging.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED

MEDICINAL PRODUCT OR WASTE MATERIAL DERIVING FROM SUCH MEDICINAL
PRODUCT, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Marketing Authorisation Holder:
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel: (42) 22 53 100
{logo of the marketing authorisation holder}

12. MARKETING AUTHORISATION NUMBER

Authorisation number: R/6697

13. BATCH NUMBER

Batch number:

14. GENERAL AVAILABILITY CATEGORY

OTC – Medicinal product supplied without a prescription.

15. INSTRUCTIONS FOR USE

Indications: For temporary relief of dry, irritating cough associated with upper respiratory tract infections.
When not to use the medicine: If the patient is allergic to pine tar extract, anise tincture, codeine phosphate, or any of the other ingredients of this medicine.
Do not use if the patient:

• has bronchial asthma or a tendency to bronchospasm;
• has acute respiratory failure (breathing difficulties, e.g. shallow breathing);
• is taking medicines from the benzodiazepine group or barbituric acid derivatives;
• is addicted to opioid drugs;
• has chronic constipation;
• is pregnant or breastfeeding;
• has a very rapid metabolism of codeine to morphine;
• children under 12 years of age.

Warnings and precautions: Misuse of medicines containing codeine (use longer than recommended and/or in higher doses than recommended) may lead to physical and psychological dependence. Withdrawal symptoms may occur after abrupt discontinuation of treatment.
Exercise caution when using this medicine in patients:

• who are addicted to drugs or opioids, or who are taking medicines from the group of morphine agonists or antagonists;
• with central nervous system (CNS) depression;
• with respiratory depression and chronic lung diseases;
• with increased intracranial pressure or head injuries;
• with biliary tract diseases, including gallstones;
• with renal impairment;
• with inflammatory or obstructive intestinal disorders;
• elderly patients, due to the risk of constipation.

Codeine suppresses the cough reflex and therefore should not be used in patients who are expectorating mucus.
Codeine is metabolized into morphine in the liver by an enzyme. Morphine is the substance responsible for codeine's effects. Some individuals have a variant of this enzyme, leading to variable 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 the patient experiences any of the following adverse symptoms, discontinue use of this medicine immediately and seek medical advice:
slow or shallow breathing, disorientation, drowsiness, pinpoint pupils, nausea or vomiting, constipation, loss of appetite.
This medicine contains ethanol and sucrose
This medicine contains 1329.6 mg of alcohol (ethanol) in 15 ml of syrup. The amount of alcohol in 15 ml of this medicine is equivalent to 33 ml of beer and 13.2 ml of wine.
This medicine contains 886.4 mg of alcohol (ethanol) in 10 ml of syrup. The amount of alcohol in 10 ml of this medicine is equivalent to 22 ml of beer and 8.8 ml of wine.
The amount of alcohol in this medicine is unlikely to affect adults and adolescents, and its effect in children is likely to be unnoticeable. However, it may cause some effects in younger children, such as drowsiness.
Alcohol in this medicine may alter the effects of other medicines. If the patient is taking other medicines, they should consult a doctor or pharmacist.
If the patient is pregnant or breastfeeding, they should consult a doctor or pharmacist before using this medicine.
If the patient is alcohol-dependent, they should consult a doctor or pharmacist before using this medicine.
The medicine contains 12.053 g of sucrose in 15 ml of syrup. This should be taken into account in patients with diabetes.
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.
Syrop sosnowy złożony Aflofarm and other medicines: This medicine should not be used simultaneously with the following medicines:

• benzodiazepines (medicines with anxiolytic, hypnotic effects);
• barbiturates (medicines used to treat insomnia and epilepsy);
• neuroleptics (medicines used to treat psychiatric disorders);
• clonidine (a medicine used to treat hypertension);
• opioid analgesics (strong painkillers, e.g. morphine);
• glutethimide (a hypnotic medicine);
• MAO inhibitors (medicines used to treat depression), and within 14 days after discontinuation;
• antihistamines (medicines used, among others, for allergy treatment);
• medicines that lower blood pressure;
• metoclopramide (a medicine with antiemetic and prokinetic effects);
• codeine may enhance the respiratory depressant effect of other opioid medicines and intensify the effects of ethanol.

If the patient is unsure whether they are taking any of the above medicines, they should contact their doctor or pharmacist.
Pregnancy and breastfeeding: This medicine should not be used during pregnancy or breastfeeding. Codeine and morphine pass into breast milk.
Driving and operating machinery: This medicine, when used at recommended doses, may impair psycho-physical performance, ability to drive and operate machinery due to codeine phosphate.
Method of administration and route:
Oral administration.
Adults (over 18 years): 15 ml three times daily.
Adolescents aged 12 to 18 years: 5 to 10 ml of syrup three times daily.
Children under 12 years:
Do not use this medicine in children under 12 years of age.
Adolescents aged 12 to 18 years:
Use of this medicine for cough in adolescents with respiratory function disorders is not recommended.
This medicine should always be taken exactly as described in this package leaflet or as advised by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
Do not use this medicine for longer than 7 days without consulting a doctor.
Overdose: After taking a dose higher than recommended, respiratory center depression (cyanosis, respiratory depression, shallow breathing), central nervous system depression, seizures, and loss of consciousness may occur.
In case of overdose, contact a doctor immediately.
If a dose is missed, take it as soon as possible.
Adverse effects: Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Due to the presence of codeine, the following may occur: drowsiness, dizziness, hypotension, reduced respiratory rate, bronchospasm, difficulty in urination, constipation, biliary colic, nausea, vomiting, dry mouth. Anethole present in anise tincture may cause allergic reactions.
Reporting adverse effects
If any adverse effects occur, including those not listed in this package leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to:
Department of Monitoring of Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to gather more information on the safety of the medicine.
Date of last text revision:

16. INFORMATION PROVIDED IN BRAILLE SYSTEM

Syrop sosnowy złożony Aflofarm

17. UNIQUE IDENTIFIER – 2D CODE

Not applicable.

18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA

Not applicable.