Package leaflet: Information for the user

Thiocodin
(15 mg + 300 mg)/10 ml, syrup
Codeini phosphas hemihydricus + Sulfogaiacolum
Please read all of this leaflet carefully before taking this medicine, as it contains important information for you.
You must always take this medicine exactly as described in this patient leaflet or as your doctor or pharmacist has advised.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please contact your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Contents of the leaflet

What Thiocodin is and what it is used for
Important information before taking Thiocodin
How to take Thiocodin
Possible side effects
How to store Thiocodin
Contents of the pack and other information

1. What Thiocodin is and what it is used for

Thiocodin syrup contains two active substances: codeine phosphate hemihydrate and sulfoguaiacol.
Codeine phosphate hemihydrate acts as a cough suppressant by inhibiting the cough reflex, thereby reducing the frequency of coughing episodes.
Sulfoguaiacol acts as an expectorant, facilitating the movement of liquefied secretions in the respiratory tract and aiding their expulsion.
Thiocodin syrup is for oral use only.
Indications for Thiocodin:
treatment of dry, persistent cough without sputum production.

2. Important information before taking Thiocodin

When not to take Thiocodin
 if the patient is allergic to codeine phosphate hemihydrate, sulfoguaiacol, or any of the other
ingredients of this medicine (listed in section 6),
 if the patient has bronchial asthma,
 if the patient has respiratory insufficiency (breathing difficulties, e.g.: shallow breathing,
slower and/or irregular breathing, pulmonary emphysema),
 if the patient is in a state of coma,
 if the patient has cystic fibrosis (a genetic disorder causing excessive production of thick mucus),
 if the patient has bronchiectasis (chronic bronchial inflammation characterized by cough with
large amounts of sputum),
 if the patient is alcohol-dependent,
 if the patient is opioid-dependent (e.g. morphine, heroin),
 if the patient is under 12 years of age,
 if it is known that the patient metabolizes codeine to morphine very rapidly,
 if the patient is pregnant,
 if the patient is breastfeeding,
 if the patient is expectorating phlegm (because this medicine suppresses the cough reflex and may
lead to excessive accumulation of secretions in the airways),
 if the patient is currently taking monoamine oxidase inhibitors (MAOIs) or has taken such
medicines within the last 14 days.

Warnings and precautions
Before starting to take Thiocodin, discuss this with your doctor or pharmacist:
 if the patient has impaired respiratory function (difficulty breathing, e.g.: shallow, slower,
irregular breathing, chronic lung disease),
 if the patient has reduced blood volume,
 if the patient has increased intracranial pressure or head injuries, because codeine may
increase intracranial pressure,
 if the patient has renal insufficiency,
 if the patient has impaired liver function,
 if the patient has hypertension,
 if the patient has diabetes,
 if the patient has peripheral vascular diseases (e.g.: peripheral arterial disease, peripheral
venous disorders),
 if the patient has hypothyroidism,
 if the patient has adrenal insufficiency,
 if the patient has glaucoma (optic nerve and retinal damage leading to worsening or loss of
vision due to elevated intraocular pressure),
 if the patient has inflammatory or obstructive intestinal diseases (e.g.: bloody diarrhea in
pseudomembranous colitis or intestinal obstruction, presenting as acute constipation, bloating,
nausea, stomach pain or cramps, vomiting),
 if the patient has biliary tract diseases (e.g. gallstones), because codeine may trigger an attack
of biliary colic,
 if the patient has recently undergone surgery on the biliary tract (e.g. cholecystectomy),
 if the patient has benign prostatic hyperplasia and difficulty urinating (frequent urge to urinate,
difficulty or pain during urination, urinary retention),
 if the patient has kidney stones, because codeine may trigger an attack of renal colic,
 if the patient is elderly (over 65 years of age), as the risk of adverse effects is increased in this
age group,
 if the patient is currently taking another medicine containing codeine, due to the risk of
codeine overdose.
Do not take this medicine if any of the above warnings apply or have applied in the past. If in doubt,
consult your doctor or pharmacist before taking this medicine.
Codeine is metabolized to morphine in the liver by an enzyme. Morphine is the substance responsible
for the effect of codeine. Some individuals have a genetic variation of this enzyme, which may lead to
different 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 effects. If the patient experiences any of the following adverse
effects, discontinue use and seek immediate medical advice: slow or shallow breathing, confusion,
drowsiness, pinpoint pupils, nausea or vomiting, constipation, or loss of appetite.

If cough persists beyond 3 days of treatment or if high fever, skin rash, or headache occurs, consult a doctor.
Misuse of Thiocodin (i.e. use longer than recommended and/or in higher doses than recommended) may lead to dependence.
If this medicine is misused and then abruptly discontinued, withdrawal symptoms may occur (see section: Discontinuing Thiocodin).
In athletes, Thiocodin may cause a positive result in anti-doping tests.

Children
Do not use in children under 12 years of age.
Adolescents over 12 years of age
Use of Thiocodin is not recommended in adolescents with respiratory disorders for the treatment of
cough.
Codeine is not recommended in children whose respiratory function may be impaired, including
children with neuromuscular disorders, severe heart or respiratory disorders, upper respiratory or
lung infections, multi-organ trauma, or extensive surgical procedures.

Thiocodin with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any
medicines planned for future use.
Do not use 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 within 14 days after discontinuation of these medicines,
antihistamines (medicines used, among others, in allergic conditions),
hypnotics (e.g. diazepam, temazepam),
cytostatics (medicines used in cancer treatment),
opioid analgesics (e.g. morphine, heroin),
skeletal muscle relaxants (e.g. diazepam, tetrazepam, 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. stimulating intestinal motility),
quinidine (a medicine used in cardiac 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 effects of codeine.
Note that alcohol may be present in certain foods and medicines.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become
pregnant, she should consult a doctor or pharmacist before using this medicine.
Do not use in pregnant women. Do not take Thiocodin during breastfeeding.
Codeine and morphine pass into breast milk.
Use of codeine-containing medicines by breastfeeding women is not safe due to the risk of life-threatening poisoning in infants from codeine’s metabolite – morphine. Cases have been reported of feeding difficulties, apathy (reduced responsiveness to stimuli), lethargy, respiratory depression, apnea, stroke, and even death in breastfed infants whose mothers were taking codeine-containing medicines.

Driving and operating machinery
Do not drive or operate machinery or moving equipment while taking this medicine. It may cause
dizziness and drowsiness, impairing psycho-physical performance required for these activities.
Thiocodin contains sucrose, sodium benzoate (E 211), propyl parahydroxybenzoate (E 216),
propylene glycol (E 1520), ethanol, and sodium
This medicine contains sucrose (a type of sugar). If the patient has previously been diagnosed with
intolerance to certain sugars, consult a doctor before taking this medicine.
This medicine contains 6 g of sucrose in 10 ml of syrup. This should be taken into account in diabetic
patients.
This medicine contains 25.2 mg of sodium benzoate in 10 ml of syrup.
This medicine contains propyl parahydroxybenzoate and may cause allergic reactions (including delayed-type reactions).
This 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 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 cause noticeable effects.
This medicine contains less than 1 mmol (23 mg) of sodium in 10 ml of syrup (1 dose), meaning it is considered "sodium-free".

3. How to take Thiocodin

This medicine should always be taken exactly as described in this patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a physician or pharmacist.
Recommended dosage
Adults and adolescents over 12 years of age:
10 ml of syrup (i.e. 1 measuring spoon) three times daily, no more frequently than every 4 to 6 hours.
The use of Thiocodin is not recommended in adolescents aged 12 to 18 years with respiratory
function disorders for the treatment of cough.
Do not use in children under 12 years of age.
Method of administration
The medicine should be taken orally, during meals.
Drink at least 2 litres of fluids per day. This will help loosen and expel mucus more easily.

Do not exceed the recommended doses.
Do not use the medicine for longer than 3 days without medical advice. Any extension of treatment should be decided by a physician.

Overdose of Thiocodin
If an overdose is taken, seek immediate medical advice from a physician or pharmacist.
Symptoms of overdose may include:

nausea, vomiting,
irritability,
breathing difficulties (slowed and shallow breathing, irregular breathing, bluish skin and mucous membranes),
drowsiness progressing to coma,
constricted pupils,
muscle weakness,
low blood pressure, very slow heart rate,
cold and clammy skin. In severe cases of overdose, loss of consciousness, seizures, respiratory arrest, or cardiac arrest may occur.

Missed dose of Thiocodin
If a dose is missed, take it as soon as possible.
If it is almost time for the next scheduled dose, 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 a missed dose.
Discontinuation of Thiocodin
Abrupt discontinuation of this medicine after the recommended 3-day period does not cause withdrawal symptoms.
However, misuse of Thiocodin carries a risk of dependence and withdrawal symptoms following sudden discontinuation.
Withdrawal symptoms may include:

anxiety, sudden mood changes (euphoria or sadness),
insomnia, difficulty falling asleep,
irritability, restlessness, difficulty concentrating,
muscle tremors, muscle and joint pain,
tearing, dilated pupils, yawning,
sweating, pallor of skin and mucous membranes, palpitations, headache,
nausea, vomiting, diarrhoea, loss of appetite. If you have any further doubts regarding the use of this medicine, consult a physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everyone experiences them.
Very common adverse reactions (occurring in more than 1 in 10 patients):

nausea and vomiting,
constipation,
dizziness,
sedation.

Uncommon adverse reactions (occurring in less than 1 in 100 patients):

allergic reactions (itching, urticaria, rash, skin eruptions),
sudden mood changes (excessive happiness or sadness),
breathing disorders (reduced breathing rate and shallow, irregular respiration),
bronchospasm,
palpitations,
drop in blood pressure and fainting,
drowsiness,
miosis (pupil constriction),
urinary retention,
headache,
acute abdominal pain (mainly in patients after cholecystectomy),
decreased appetite,
excessive sweating,
hallucinations (perceiving non-existent objects),
visual and auditory disturbances,
irritation of the gastrointestinal mucosa, which may manifest as, among others, stomach pain (after taking high doses of the medicine).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Thiocodin

Keep this medicine out of sight and reach of children.
Store 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 stated month.
Thiocodin medicine may be used within 6 months after the date of first opening the container, without exceeding the expiry date stated on the packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices will help protect the environment.

6. Contents of the pack and other information

What Thiocodin contains

The active substances are:
o Codeine phosphate hemihydrate
o Guaiacolsulfonate
10 ml of syrup contains 15 mg of codeine phosphate hemihydrate and 300 mg of guaiacolsulfonate.
Other ingredients include:
sucrose, glycerol (E 422), sodium benzoate (E 211), strawberry flavour 502301T (containing propylene glycol (E 1520) and ethanol), citric acid monohydrate (E 330), propyl parahydroxybenzoate (E 216), purified water.

What Thiocodin looks like and contents of the pack
Thiocodin syrup is a clear solution with a strawberry flavour.
The medicine is supplied in a 100 ml brown PET bottle with an HDPE screw cap with tamper-evident ring, accompanied by a measuring cup made of PP, packed in a cardboard box.
The bottle contains 100 ml of syrup.

Marketing Authorisation 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 package leaflet of Thiocodin is available in the Audio Leaflet system via a nationwide free telephone number: 800 706 848.