Herbapini

Package Leaflet: Information for the Patient

HERBAPINI, (424 mg + 64 mg +3 mg)/5 ml, syrup

Pine extract fluid + Fennel tincture + Codeine phosphate hemihydrate

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet for the patient or as advised by a doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 7 days or if the patient feels worse, they should contact their doctor.

Table of Contents of the Package Leaflet

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

1. What is Herbapini and what is it used for

Herbapini is a medicine that contains codeine phosphate, with an antitussive effect.

Indications for Use

For temporary use in dry, irritating cough in the course of upper respiratory tract infections. Herbapini is indicated for use in adults and adolescents over 12 years of age.

2. Important Information Before Taking Herbapini

When Not to Take Herbapini

• if the patient is allergic to the active substances or other opioids, or to plants of the Apiaceae/Umbelliferae family (such as anise, caraway, celery, coriander, and dill), or to anethole, or to any of the other ingredients of this medicine (listed in section 6);
• in patients with asthma or a tendency to bronchospasm, in acute respiratory failure;
• in patients with chronic constipation;
• in patients at risk of paralytic ileus (due to the presence of codeine);
• in respiratory diseases with thick secretions in the bronchial tree and difficulty in expectoration;
• in patients addicted to drugs and opioid substances, as well as those taking monoamine oxidase inhibitors (MAOIs) or morphine agonists/antagonists;
• if the patient knows they metabolize codeine to morphine very quickly;
• in patients in a coma;
• in patients with severe liver dysfunction;
• in children under 12 years of age;
• in breastfeeding women.

Avoid taking the medicine in patients with increased intracranial pressure or head injury (in addition to the risk of respiratory depression and increased intracranial pressure, it may affect pupils and other body reactions important for neurological assessment).

Children and Adolescents

Do not take Herbapini in children under 12 years of age due to the increased risk of developing severe and life-threatening side effects. Adolescents over 12 years of age should not be given Herbapini for symptomatic treatment of cough and/or cold if they have respiratory function disorders.

Warnings and Precautions

Before starting to take Herbapini, discuss it with your doctor or pharmacist. Patients with kidney failure, hyperthyroidism, abdominal pain, prostatic hypertrophy, bronchial asthma, chronic obstructive pulmonary disease, epilepsy, head injuries, and after surgical procedures in the gastrointestinal or genitourinary tract should consult their doctor before taking the medicine. There is a risk of central nervous system stimulation and depression during concurrent use of opioids with MAOIs, and such use is not recommended. Liver function disorders - in the case of severe liver function disorders, the medicine should not be taken. Codeine may cause coma. Inflammatory bowel disease - codeine reduces intestinal peristalsis, increases tension and segmentation in the intestines, and may increase colon pressure, so caution should be exercised when using it in acute colitis, diverticulitis, diarrhea associated with pseudomembranous colitis, or after colon surgery. Gallbladder and cholelithiasis - opioids may cause contraction of the bile ducts. The medicine should be avoided in bile duct disorders. Pheochromocytoma - opioids may stimulate the release of endogenous histamine through the induction of catecholamine release. Codeine phosphate should be used with caution in the following cases:

• hypothyroidism;
• adrenal cortex insufficiency, e.g., Addison's disease;
• hypotension and shock;
• myasthenia (muscle weakness).

In elderly patients, the metabolism and elimination of opioid analgesics are slower than in younger patients. 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 variant of this enzyme, which can cause different effects in them. In some people, morphine is not produced or is produced in very small quantities, and the medicine will not have an antitussive effect. In other people, it is more likely to experience severe side effects due to the large amounts of morphine produced. If the patient experiences any of the following side effects, they should stop taking the medicine and immediately consult a doctor: slow or shallow breathing, disorientation, drowsiness, miosis, nausea or vomiting, constipation, loss of appetite. Long-term use of the medicine, especially in high doses, may lead to dependence. Therefore, it is not recommended to take it for more than 7 days or to exceed the recommended doses.

Herbapini and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. Due to the presence of codeine phosphate, it is not recommended to take Herbapini concurrently with:

• MAOIs (e.g., linezolid, moclobemide, selegiline) and for up to 2 weeks after their discontinuation.

Herbapini, due to the presence of codeine phosphate, should be used with caution when taken concurrently with:

• alcohol;
• old-generation antihistamines (sedating);
• sleeping pills and anxiolytics;
• anticholinergic drugs (e.g., atropine);
• metoclopramide and domperidone;
• anti-diarrheal drugs (e.g., loperamide, kaolin);
• anesthetics;
• tricyclic antidepressants;
• antipsychotics;
• opioid receptor antagonists, e.g., buprenorphine, naltrexone, naloxone;
• quinidine;
• antihypertensive drugs;
• ciprofloxacin;
• ritonavir;
• mexiletine;
• cimetidine.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine. Do not take Herbapini during pregnancy. Herbapini is contraindicated during breastfeeding. Codeine and morphine pass into breast milk.

Driving and Using Machines

Due to the possibility of drowsiness, be cautious when driving vehicles and operating machines. It is best not to drive vehicles immediately after taking the medicine.

Herbapini Contains Sucrose and Ethanol

Sucrose The medicine contains 12 g of sucrose in 15 ml of syrup (36 g in 45 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, they should consult their doctor before taking the medicine. Ethanol This medicine contains 1.05 g of alcohol (ethanol) in each 15 ml of syrup (3.15 g of alcohol (ethanol) in each 45 ml of syrup). The amount of alcohol in this product is equivalent to 26 ml of beer or 11 ml of wine per 15 ml of syrup (78 ml of beer or 33 ml of wine per 45 ml of syrup). The alcohol in this medicine may alter the effects of other medicines. If you are taking other medicines, consult your doctor or pharmacist. If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking this medicine. If you are addicted to alcohol, consult your doctor or pharmacist before taking this medicine. The alcohol in this medicine may affect children. Symptoms may include drowsiness and changes in behavior; it may also affect concentration and physical activity. If you have epilepsy or liver problems, consult your doctor or pharmacist before taking the medicine.

3. How to Take Herbapini

This medicine should always be taken exactly as described in this package leaflet for the patient or as advised by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist. Oral administration: Adults and adolescents over 12 years of age: 3 times a day, 15 ml of syrup.

Use in Children and Adolescents

Children under 12 years of age: Herbapini is contraindicated in children under 12 years of age. Adolescents from 12 to 18 years of age: It is not recommended to take Herbapini in adolescents from 12 to 18 years of age with respiratory function disorders.

Overdose of Herbapini

There have been no reports of overdose to date. In the event of significant overdose of the syrup, respiratory depression, central nervous system depression, seizures, loss of consciousness may occur. In such a case, consult a doctor or pharmacist immediately. Symptoms of overdose may worsen when taken with alcohol and psychotropic drugs.

Missed Dose of Herbapini

Missing a dose of the medicine does not significantly affect the course of the therapy. Continue treatment, maintaining the previous dosage. Do not take a double dose to make up for a missed dose. If you have any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Codeine phosphate may cause:

• rash, urticaria, itching, difficulty breathing, increased sweating, flushing, or facial flushing; fever, splenomegaly, and lymphadenopathy;
• hyperglycemia (increased blood sugar levels);
• anorexia;
• confusion, drowsiness, malaise, fatigue, dizziness, mood changes, hallucinations, central nervous system stimulation (restlessness/agitation), seizures, depression, headaches, nightmares, increased intracranial pressure, tolerance or dependence, mood disorders, hypothermia;
• miosis, blurred or double vision;
• bradycardia, tachycardia, hypotension, orthostatic hypotension;
• respiratory depression at higher doses;
• constipation (including constipation resulting from long-term use), biliary colic, nausea, vomiting, dry mouth, abdominal pain, pancreatitis;
• muscle tremors or stiffness;
• ureteral spasm, antidiuretic effect, urinary retention;
• decreased libido and potency, sexual disorders, erectile dysfunction.

Regular long-term use of codeine may lead to dependence and tolerance. Withdrawal of the medicine may cause symptoms of anxiety and irritability. Fennel may cause allergic reactions of the skin or respiratory system. Frequency not known. If symptoms of hypersensitivity such as urticaria, itching, and skin rash occur, discontinue the syrup.

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 18 C, 02-222 Warsaw, Tel.: +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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Herbapini

Store in a tightly closed container, at a temperature not exceeding 25°C. Keep the medicine out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. Medicines should 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 Pack and Other Information

What Herbapini Contains

• The active substances of the medicine are pine extract, fennel tincture, and codeine phosphate. 100 g of syrup contains:

codeine phosphate (Codeini phosphas hemihydricus) - 0.05 g, fluid extract of Pinus sylvestris L., turiones (pine shoots, dry) (DER: 1:1.6) - 6.6 g, [extractant: ethanol 90% (v/v)], fennel tincture from Foeniculum vulgare Miller subsp. vulgare var. vulgare, fructus (bitter fennel fruit) (DER: 1:5) - 1 g, [extractant: ethanol 70% (v/v)].

• Other ingredients: sucrose, phosphoric acid 85%, calcium lactate pentahydrate, purified water.

Alcohol content not more than 7% (m/v) 15 ml of syrup contains 9 mg of codeine phosphate.

What Herbapini Looks Like and Contents of the Pack

Brown glass bottle with a polyethylene cap and a measuring cup in a cardboard box. 1 bottle of 116 ml

Marketing Authorization Holder

Polpharma S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. +48 22 364 61 01

Manufacturer

Herbapol-Lublin S.A., ul. Diamentowa 25, 20-471 Lublin

Date of Last Revision of the Package Leaflet: