THIOCODIN 15 mg/300 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Thiocodin
3. 15 mg + 300 mg, tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
4. What is Thiocodin and what is it used for
   1. Indications for the use of Thiocodin:
5. Important information before taking Thiocodin
   1. When not to take Thiocodin
   2. Warnings and precautions
   3. Children
   4. Adolescents over 12 years old
   5. Thiocodin and other medicines
   6. Thiocodin with alcohol
   7. Pregnancy and breastfeeding
   8. Driving and operating machinery
6. How to take Thiocodin
   1. Recommended dosage
   2. Method of administration
   3. Taking a higher dose of Thiocodin than recommended
   4. Missing a dose of Thiocodin
   5. Stopping Thiocodin
7. Possible side effects
   1. Reporting side effects
8. How to store Thiocodin
9. Package contents and other information
   1. What Thiocodin contains
   2. What Thiocodin looks like and what the package contains
   3. Marketing authorization holder and manufacturer

Leaflet attached to the packaging: information for the user

Thiocodin

15 mg + 300 mg, tablets

Codeine phosphate hemihydrate + Sulfogaiacol

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

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• 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 possible side effects not listed in the 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 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. Package contents and other information

1. What is Thiocodin and what is it used for

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

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

Warnings and precautions

Before starting to take Thiocodin, the patient should discuss it with their doctor or pharmacist:
 if the patient has respiratory function disorders (breathing difficulties, e.g., shallow breathing, slower and/or irregular breathing, chronic lung disease),
 if the patient has reduced blood volume,
 if the patient has increased intracranial pressure or head injuries, as codeine may increase intracranial pressure,
 if the patient has kidney failure,
 if the patient has liver function disorders,
 if the patient has hypertension,
 if the patient has diabetes,
 if the patient has peripheral vascular disease (e.g., thromboembolic obliteration of arteries, peripheral venous disease),
 if the patient has hypothyroidism,
 if the patient has adrenal insufficiency,
 if the patient has glaucoma (nerve damage and retinal damage leading to impaired or lost vision due to excessive growth of intraocular pressure),
 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),
 if the patient has biliary tract disease (e.g., cholelithiasis), as codeine may cause a biliary colic attack,
 if the patient has undergone surgical procedures in the biliary tract (e.g., cholecystectomy),
 if the patient has prostatic hyperplasia and difficulty urinating (frequent urination, difficulty or pain while urinating, urinary retention),
 if the patient has kidney stones, as codeine may cause a renal colic attack,
 if the patient is elderly (over 65 years old), as the risk of side effects is increased in such individuals,
 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 individuals, a variant of this enzyme occurs, which may cause different effects. In some individuals, morphine is not produced or is produced in very small amounts, and therefore, it will not have an antitussive effect. In other individuals, it is more likely that severe side effects will occur due to the large amounts of morphine produced. If the patient experiences any of the following side effects, they should stop taking this medicine and immediately consult a doctor:
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 a 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

Thiocodin is not recommended for adolescents over 12 years old with respiratory function disorders in the treatment of cough.

Thiocodin 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.
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, i.e., affecting gut motility),
• 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 a 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 morphine toxicity in the infant. Cases of feeding 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, and equipment in motion while taking this medicine. It may cause dizziness and drowsiness, which impairs the psychophysical abilities necessary to perform these activities.

3. How to take Thiocodin

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Recommended dosage

Adults and adolescents over 12 years old:
1 tablet 3 times a day, not more often than every 4 to 6 hours.
Thiocodin is not recommended for adolescents over 12 years old with respiratory function disorders in the treatment of cough.
Do not use in children under 12 years old.

Method of administration

The medicine should be taken orally, during meals. The tablet should be swallowed whole, washed down with a glass of water.
Drink at least 2 liters of fluids per day. This will facilitate the expectoration 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 leading 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

If a dose of the medicine is missed, 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 (elation 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, palpitations, headaches,
• nausea, vomiting, diarrhea, loss of appetite.

In case of any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Thiocodin 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 elation or sadness),
• breathing disorders (reduced breathing frequency and shallow, irregular breathing),
• bronchospasm,
• palpitations,
• blood pressure drop and fainting,
• drowsiness,
• pupil constriction,
• urinary retention,
• headaches,
• acute abdominal pain (mainly in patients after cholecystectomy),
• decreased appetite,
• excessive sweating,
• hallucinations (perception of non-existent objects),
• vision and hearing disorders,
• irritation of the mucous membrane of the digestive tract, which may manifest as stomach pain (after taking large doses of the medicine).

Reporting side effects

If side effects occur, including any side effects not listed in the 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 gather more information on the safety of the medicine.

5. How to store Thiocodin

The medicine should be stored 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 given month.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Thiocodin contains

• The active substances of the medicine are: codeine phosphate hemihydrate and sulfogaiacol.
  1 tablet contains 15 mg of codeine phosphate hemihydrate and 300 mg of sulfogaiacol.
• Other ingredients are: talc, potato starch, magnesium stearate.

What Thiocodin looks like and what the package contains

The medicine is in the form of almost white tablets.
The tablets are packaged in PCW/Aluminum blisters. The package contains 10 tablets (1 blister), 16 tablets (2 blisters), or 20 tablets (2 blisters) along with the patient information leaflet in a cardboard box. Not all pack sizes may be marketed.

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 leaflet is available in the Ulotka Audio system at the national, toll-free phone number: 800 706 848.
Date of last update of the leaflet:May 2021