Thiocodin

Package Leaflet: Information for the User

Thiocodin

(15 mg + 300 mg)/10 ml, syrup
Codeine phosphate hemihydrate + Sulfogaiacol

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 directed 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 3 days or the patient feels worse, they should contact their doctor.

Table of Contents of the Package Leaflet

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

1. What is Thiocodin and what is it used for

Thiocodin syrup contains two active substances: codeine phosphate hemihydrate and sulfogaiacol.
Codeine phosphate hemihydrate has an antitussive effect, inhibiting the cough reflex and reducing the frequency of cough attacks.
Sulfogaiacol has an expectorant effect, facilitating the movement of liquefied secretions in the respiratory tract and their coughing up.
Thiocodin syrup should be taken orally only.

Indications for the use of Thiocodin:

Treatment of dry, persistent cough without expectoration of secretions.

2. Important information before taking Thiocodin

When not to take Thiocodin

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If the patient is allergic to codeine phosphate hemihydrate, sulfogaiacol, or any of the other ingredients of this medicine (listed in section 6),
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If the patient has asthma,
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If the patient has respiratory failure (difficulty breathing, e.g., shallow breathing, slower and/or irregular breathing, pulmonary emphysema),
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If the patient is in a coma,
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If the patient has cystic fibrosis (a genetic disease characterized by the production of excessively thick mucus),
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If the patient has bronchiectasis (chronic inflammation of the bronchi, characterized by coughing up large amounts of secretions),
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If the patient is addicted to alcohol,
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If the patient is addicted to opioids (morphine, heroin),
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If the patient is under 12 years old,
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If it is known that the patient's metabolism of codeine to morphine is very rapid,
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If the patient is pregnant,
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If the patient is breastfeeding,
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If the patient is coughing up secretions (because this medicine inhibits the cough reflex and may lead to excessive accumulation of secretions in the respiratory tract),
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If the patient is currently taking or has taken monoamine oxidase inhibitors within the last 14 days.

Warnings and precautions

Before starting to take Thiocodin, the patient should discuss it with their doctor or pharmacist:
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If the patient has respiratory function disorders (difficulty breathing, e.g., shallow breathing, slower and/or irregular breathing, chronic lung disease),
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If the patient has reduced blood volume,
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If the patient has increased intracranial pressure or head injuries, as codeine may increase intracranial pressure,
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If the patient has kidney failure,
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If the patient has liver function disorders,
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If the patient has hypertension,
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If the patient has diabetes,
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If the patient has peripheral vascular disease (e.g., thromboangiitis obliterans, peripheral venous disease),
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If the patient has hypothyroidism,
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If the patient has adrenal insufficiency,
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If the patient has glaucoma (nerve damage and retinal damage leading to impaired or lost vision due to increased pressure in the eyeball),
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If the patient has inflammatory or obstructive bowel disease (bloody diarrhea in the course of pseudomembranous colitis or bowel obstruction, characterized by acute constipation, bloating, nausea, stomach pain or cramps, vomiting),
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If the patient has biliary tract disease (e.g., cholelithiasis), as codeine may cause a biliary colic attack,
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If the patient has had surgery on the biliary tract (e.g., cholecystectomy),
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If the patient has prostatic hyperplasia and difficulty urinating (frequent urination, difficulty or pain while urinating, urinary retention),
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If the patient has kidney stones, as codeine may cause a renal colic attack,
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If the patient is elderly (over 65 years old), as the risk of side effects is increased in this population,
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If the patient is currently taking another codeine-containing medicine, as there is a risk of codeine overdose.
Do not take the medicine if any of the above warnings apply or have applied to the patient in the past. In case of doubt, consult a doctor or pharmacist before taking this medicine.
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 variant of this enzyme, which can cause different effects. 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 large amounts of morphine produced. If the patient experiences any of the following side effects, they should stop taking this medicine and seek medical attention immediately: slow or shallow breathing, disorientation, drowsiness, pupil constriction, nausea or vomiting, constipation, loss of appetite.

• If the cough does not subside after 3 days of taking the medicine or if a high body temperature, skin rash, or headache occurs, the patient should consult their doctor.
• Abuse of Thiocodin (i.e., taking it for longer than recommended and/or in higher doses than recommended) may lead to dependence.
• In the event of abuse of this medicine and sudden cessation of its use, withdrawal symptoms may occur (see section: Stopping Thiocodin).
• In athletes, Thiocodin may cause a positive result in doping tests.

Children

Do not use in children under 12 years old.

Adolescents over 12 years old

Do not recommend the use of Thiocodin in adolescents with respiratory function disorders for the treatment of cough.
Do not recommend the use of codeine in children whose respiratory function may be impaired, including those with neuromuscular disorders, severe heart or respiratory disease, upper respiratory tract infections or pneumonia, multiple organ injuries, or extensive surgical procedures.

Thiocodin and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Do nottake Thiocodin with the following medicines:

• anxiolytics (e.g., chlorpromazine, diazepam, temazepam),
• antidepressants (e.g., monoamine oxidase inhibitors, such as moclobemide, or tricyclic antidepressants, such as amitriptyline) and for 14 days after stopping these medicines,
• antihistamines (medicines used in allergic diseases),
• sedatives (e.g., diazepam, temazepam),
• cytostatics (medicines used in cancer),
• opioid analgesics (morphine, heroin),
• muscle relaxants (e.g., diazepam, tetrazepam, and temazepam - medicines used to reduce increased muscle tone),
• clonidine (a medicine used to treat hypertension),
• medicines used in Parkinson's disease (e.g., levodopa, selegiline),
• metoclopramide (a medicine with antiemetic and prokinetic effects),
• quinidine (a medicine used to treat arrhythmias),
• the antibiotic rifampicin,
• medicines containing alcohol (see section: Thiocodin with alcohol).

Thiocodin with alcohol

Do not drink alcohol while taking this medicine. Alcohol may enhance the effect of codeine.
Consider that alcohol may be an ingredient in some foods and medicines.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Do not use in pregnant women. Do not take Thiocodin during breastfeeding.
Codeine and morphine pass into breast milk.
Taking codeine-containing medicines by breastfeeding women is not safe due to the risk of life-threatening poisoning of the child with morphine, a codeine metabolite. Cases of breastfeeding problems, apathy (decreased sensitivity to stimuli), coma, apnea, stroke have been reported in children breastfed by mothers taking codeine-containing medicines.

Driving and operating machinery

Do notdrive vehicles, operate machinery, or use appliances in motion while taking this medicine. It may cause dizziness and drowsiness, which can impair the psychophysical abilities necessary to perform these activities.

Thiocodin contains sucrose, sodium benzoate (E 211), propyl hydroxybenzoate (E 216), propylene glycol (E 1520), ethanol, and sodium

The medicine contains sucrose (a type of sugar). If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains 6 g of sucrose in 10 ml of syrup. This should be taken into account in patients with diabetes.
The medicine contains 25.2 mg of sodium benzoate in 10 ml of syrup.
The medicine contains propyl hydroxybenzoate and may cause allergic reactions (possible late reactions).
The medicine contains 5.01 mg of propylene glycol in 10 ml of syrup.
This medicine contains less than 0.0006 mg of alcohol (ethanol) in 10 ml of the medicine. The amount of alcohol in 10 ml of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not have noticeable effects.
The medicine contains less than 1 mmol (23 mg) of sodium in 10 ml of syrup (1 dose), which means the medicine is considered "sodium-free".

3. How to take Thiocodin

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.

Recommended dosage

Adults and adolescents over 12 years old:
10 ml of syrup (i.e., 1 measuring cup) 3 times a day, not more often than every 4 to 6 hours.
Do not recommend the use of Thiocodin in adolescents between 12 and 18 years old with respiratory function disorders for the treatment of cough.
Do not use in children under 12 years old.

Method of administration

The medicine should be taken orally, during meals.
Drink at least 2 liters of fluids during the day. This will facilitate the coughing up of secretions.

• Do not take higher doses than recommended.
• Do not take the medicine for longer than 3 days without a doctor's recommendation. The doctor should decide on the extension of treatment.

Taking a higher dose of Thiocodin than recommended

In case of taking a higher dose of the medicine than recommended, consult a doctor or pharmacist immediately.
The following overdose symptoms may occur:

• nausea, vomiting,
• irritability,
• breathing disorders (slow and shallow breathing, irregular breathing, cyanosis),
• drowsiness progressing to coma,
• pupil constriction,
• muscle weakness,
• blood pressure drop, very slow heart rate,
• cold and sweaty skin. In severe cases of overdose, loss of consciousness, seizures, respiratory arrest, or cardiac arrest may occur.

Missing a dose of Thiocodin

In case of missing a dose of the medicine, take the missed dose as soon as possible.
If it is time for the next dose according to the dosing schedule, do not take the missed dose. Remember to maintain a 4-6 hour interval between doses.
Do not take a double dose to make up for the missed dose.

Stopping Thiocodin

Sudden cessation of this medicine after the recommended 3-day period does not cause withdrawal symptoms.
Abuse of Thiocodin is associated with a risk of dependence and the occurrence of withdrawal symptoms after sudden cessation of its use.
The following withdrawal symptoms may occur:

• anxiety, sudden mood changes (joy or sadness),
• insomnia, difficulty falling asleep,
• irritability, restlessness, difficulty concentrating,
• muscle tremors, muscle and joint pain,
• tearfulness, pupil dilation, yawning,
• sweating, pale skin and mucous membranes, rapid heartbeat, headaches,
• nausea, vomiting, diarrhea, loss of appetite. In case of any further doubts related to the use of 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.
Very common side effects(occurring in more than 1 in 10 patients):

• nausea and vomiting,
• constipation,
• dizziness,
• sedation.

Uncommon side effects(occurring in less than 1 in 100 patients):

• allergic reactions (itching, hives, rash, skin eruptions),
• sudden mood changes (excessive joy or sadness),
• breathing disorders (reduced breathing frequency and shallow, irregular breathing),
• bronchospasm,
• rapid heartbeat,
• blood pressure drop and fainting,
• drowsiness,
• pupil constriction,
• urinary retention,
• headaches,
• acute abdominal pain (mainly in patients after cholecystectomy),
• decreased appetite,
• excessive sweating,
• hallucinations,
• vision and hearing disorders,
• irritation of the mucous membrane of the gastrointestinal tract, which may cause symptoms such as stomach pain (after taking large doses of the medicine).

Reporting side effects

If side effects occur, including those not listed in this package leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Thiocodin

Store the medicine out of sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Thiocodin can be used for 6 months after the first opening of the packaging, without exceeding the expiry date stated on the packaging.
Medicines should not be disposed of via wastewater or household waste. Ask a 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 Thiocodin contains

• The active substances of the medicine are: codeine phosphate hemihydrate and sulfogaiacol. 10 ml of syrup contains 15 mg of codeine phosphate hemihydrate and 300 mg of sulfogaiacol.
• The other ingredients are: sucrose, glycerol (E 422), sodium benzoate (E 211), strawberry flavor 502301T (contains propylene glycol (E 1520) and ethanol), citric acid monohydrate (E 330), propyl hydroxybenzoate (E 216), purified water.

What Thiocodin looks like and what the package contains

Thiocodin syrup is a clear solution with a strawberry flavor.
The medicine is available in a 100 ml brown PET bottle with an HDPE cap and a PP measuring cup, in a cardboard box.
The bottle contains 100 ml of syrup.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne "UNIA" Spółdzielnia Pracy
ul. Chłodna 56/60, 00-872 Warsaw
tel.: 22 620 90 81 ext. 190, fax: 22 654 92 40
e-mail: [email protected]
The content of the Thiocodin package leaflet is available in the Ulotka Audio system at the national, free phone number: 800 706 848.

Date of the last update of the package leaflet: