Sirop sosnovi zvozhoni Aflofarm

INFORMATION PLACED ON OUTER AND DIRECT PACKAGING

PACKAGING

Leaflet

1. NAME OF THE MEDICINAL PRODUCT

Complex Pine Syrup Aflofarm,

(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 extract (Pini extractum fluidum)DER
1:0.9-1.1 extractant: ethanol 96% (v/v), 194.4 mg of anise tincture (Anisi tinctura)DER 1:4.5-5.5
extractant: ethanol 70% (v/v) ,9.72 mg of codeine phosphate (Codeini phosphas hemihydricus)

3. LIST OF EXCIPIENTS

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 CONTENT OF THE PACKAGE

Syrup
125 g
Code: 5909990669714

5. METHOD AND ROUTE OF ADMINISTRATION

Oral administration.
Before using the medicinal product, you should read the contents of the leaflet, to do this, you should
peel off the label in the upper right corner at the point marked with an arrow.

6. WARNING ABOUT STORAGE OF THE MEDICINAL PRODUCT

IN A PLACE INVISIBLE AND INACCESSIBLE TO CHILDREN

The medicinal product should be stored in a place invisible and inaccessible to 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.
Store in the original packaging.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED

MEDICINAL PRODUCT OR WASTE DERIVED FROM IT, IF

APPLICABLE

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

Marketing authorisation number: R/6697

13. BATCH NUMBER

Batch number:

14. GENERAL CATEGORY OF AVAILABILITY

OTC – Medicinal product available without a prescription.

15. INSTRUCTIONS FOR USE

Indications for use:For temporary use in dry, irritating cough in the course of upper respiratory tract infections.
When not to use the medicinal product:If the patient is allergic to pine extract, anise tincture and codeine phosphate or any of the other ingredients of this medicinal product.
If the patient:

• has asthma or a tendency to bronchospasm;
• has acute respiratory failure (breathing difficulties, e.g. shallow breathing);
• takes benzodiazepines and barbiturate derivatives;
• is addicted to opioid drugs;
• has chronic constipation;
• is pregnant or breastfeeding;
• has a rapid metabolism of codeine to morphine;
• is under 12 years of age.

Warnings and precautions:Misuse of codeine-containing medicinal products (use for longer
than recommended and/or in higher doses than recommended) may lead to physical and psychological dependence. After sudden cessation of treatment, withdrawal symptoms may occur.

Caution should be exercised when using the medicinal product in patients:

• addicted to opioid drugs and those taking agonist or antagonist morphine drugs;
• with central nervous system depression (CNS);
• with respiratory depression and chronic pulmonary diseases;
• with increased intracranial pressure or head injuries;
• with biliary tract diseases, including cholelithiasis;
• with renal failure;
• with inflammatory or obstructive bowel diseases;
• elderly due to the risk of constipation.

Codeine suppresses the cough reflex and should not be used in patients who are expectorating secretions.
Codeine is converted to morphine in the liver with the participation of an enzyme. Morphine is the substance that determines the action 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 quantities and therefore will not have an antitussive effect. In others, it is more likely to cause severe adverse reactions due to the very large amounts of morphine produced. If the patient experiences any of the following adverse reactions
the use of this medicinal product should be discontinued and medical advice should be sought immediately:
slow or shallow breathing, disorientation, drowsiness, pupil constriction, nausea or vomiting, constipation,
loss of appetite.

The medicinal product contains ethanol and sucrose

This medicinal product contains 1329.6 mg of alcohol ( ethanol) in 15 ml of syrup. The amount of alcohol in 15 ml of this medicinal product is equivalent to 33 ml of beer and 13.2 ml of wine.
This medicinal product contains 886.4 mg of alcohol (ethanol) in 10 ml of syrup. The amount of alcohol in 10 ml of this medicinal product is equivalent to 22 ml of beer and 8.8 ml of wine.
The amount of alcohol in this medicinal product is unlikely to have an effect on adults and adolescents, and its effect on children is unlikely to be noticeable. It may cause some effect in younger children, such as drowsiness.
Alcohol in this medicinal product may alter the effect of other medicinal products. If the patient is taking other medicinal products, they should consult a doctor or pharmacist.
If the patient is pregnant or breastfeeding, they should consult a doctor or pharmacist before using this medicinal product.
If the patient is addicted to alcohol, they should consult a doctor or pharmacist before using this medicinal product.
The medicinal product contains 12.053 g of sucrosein 15 ml of syrup. This should be taken into account in patients with diabetes.
If the patient has previously been diagnosed with intolerance to some sugars,
the patient should consult a doctor before taking the medicinal product.
Complex Pine Syrup Aflofarm and other medicinal products:The medicinal product should not be used at the same time as the following medicinal products:

• benzodiazepines (medicinal products with anxiolytic, sedative action);
• barbiturates (medicinal products used in the treatment of insomnia and epilepsy);
• neuroleptics (medicinal products used in the treatment of mental disorders);
• clonidine (medicinal product used in the treatment of hypertension);
• opioid analgesics (strong painkillers, e.g. morphine);
• glutethimide (medicinal product with sedative action);
• MAO inhibitors (medicinal products used in the treatment of depression), and for 14 days after their discontinuation;
• antihistamine medicinal products (medicinal products used, among others, in the treatment of allergies);
• medicinal products that lower blood pressure;
• metoclopramide (medicinal product with antiemetic and prokinetic action);
• codeine may enhance the depressant effect on the respiratory center of other opioid analgesics and increase the effect of ethanol.

If the patient is unsure whether they are taking any of the above-mentioned medicinal products, they should consult a doctor or pharmacist.
Pregnancy and breastfeeding:The medicinal product should not be used during pregnancy and breastfeeding. Codeine and morphine pass into breast milk.
Driving and operating machinery:The medicinal product may cause impairment of psychophysical performance, ability to drive vehicles and operate machinery due to codeine phosphate.

Method of administration and route of administration:

Oral administration.
Adults (over 18 years): 3 times a day, 15 ml each time.
Adolescents (12-18 years): 3 times a day, 5-10 ml of syrup each time.
Children under 12 years of age:
The medicinal product should not be used in children under 12 years of age.
Adolescents (12-18 years):
The medicinal product is not recommended for adolescents with respiratory function disorders in the treatment of cough.
This medicinal product should always be taken exactly as described in this leaflet or as directed by a doctor or pharmacist. In case of doubts, a doctor or pharmacist should be consulted.
The medicinal product should not be used for more than 7 days without consulting a doctor.
Overdose:After taking a higher dose of the medicinal product than recommended, respiratory depression (cyanosis, respiratory depression, shallow breathing), central nervous system depression, convulsions, loss of consciousness may occur.
In case of overdose, a doctor should be consulted.
If a dose of the medicinal product is missed, the missed dose should be taken as soon as possible.
Adverse reactions:Like all medicinal products, this medicinal product can cause adverse reactions, although not everybody gets them.
Due to the content of codeine in the medicinal product, the following may occur: drowsiness, dizziness, blood pressure drops, reduced breathing frequency, bronchospasm, difficulty urinating, constipation, biliary colic, nausea, vomiting, dry mouth feeling. Anethole contained in anise tincture may cause allergic reactions.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, a doctor or pharmacist should be informed. Adverse reactions can be reported directly to: Department for Monitoring of Adverse Reactions to 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 reactions can also be reported to the marketing authorisation holder.
Reporting of adverse reactions allows for the collection of more information on the safety of the medicinal product.

Date of last revision of the text:

16. INFORMATION PROVIDED IN BRAILLE

Complex Pine Syrup Aflofarm

17. UNIQUE IDENTIFIER – 2D CODE

Not applicable.

18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA

Not applicable.