Package leaflet: Information for the patient

Caution! Keep this leaflet. Information on the immediate packaging in a foreign language.
Efferalgan Codeine (Cod-Efferalgan)
500 mg + 30 mg, effervescent tablets
Paracetamolum + Codeini phosphas hemihydricus
Efferalgan Codeine and Cod-Efferalgan are different brand names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

1. What Efferalgan Codeine is and what it is used for

Efferalgan Codeine is an analgesic medicine containing two active substances with analgesic properties: paracetamol, which also has antipyretic activity, and codeine phosphate hemihydrate (an opioid analgesic).
Paracetamol irritates the gastric mucosa less than salicylates.
Codeine belongs to a group of medicines called opioid analgesics, which relieve pain.
It may be used in monotherapy or in combination with other analgesics such as paracetamol.
The combination of paracetamol and codeine provides stronger and longer-lasting analgesic effect than either component alone.
Indications: moderate to severe pain unrelieved by peripherally-acting analgesics.
In adolescents aged 12 years and older, due to the presence of codeine, Efferalgan Codeine may be used for short-term relief of moderate pain not relieved by other analgesics such as paracetamol or ibuprofen used in monotherapy.

2. Important information before using Efferalgan Codeine

When not to use Efferalgan Codeine

if the patient is allergic to paracetamol or propacetamol hydrochloride (a prodrug of paracetamol), codeine, or any of the other ingredients of this medicine (listed in section 6),
in children under 12 years of age due to the risk associated with opioid toxicity resulting from variable and unpredictable metabolism of codeine into morphine,
in children weighing less than 33 kg (under 12 years of age),
in children and adolescents (aged 0 to 18 years) undergoing tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome due to increased risk of severe and life-threatening adverse reactions,
if the patient has severe liver dysfunction or active, untreated liver disease,
if the patient has severe renal failure,
if the patient has alcoholic liver disease,
if the patient is being treated with MAO inhibitors (medicines used, among others, in depression) and within 14 days after stopping such treatment,
when used concomitantly with mixed agonist-antagonist analgesics: buprenorphine, butorphanol, nalbuphine, nalorphine, pentazocine,
if the patient has bronchial asthma or respiratory insufficiency,
if the patient metabolises codeine to morphine too rapidly,
in women during the first trimester of pregnancy,
in breastfeeding women.

Warnings and precautions
Before starting treatment with Efferalgan Codeine, discuss this with your doctor, pharmacist, or
nurse:

if the patient is or has been addicted to opioids, alcohol, prescription medicines, or illicit substances,
if the patient has psychiatric disorders (e.g. severe depression). Regular or long-term use of codeine (one of the active substances in this medicine) may lead to dependence and abuse, potentially resulting in overdose and/or death. This medicine should not be taken longer than necessary.

Do not give this medicine to other people. Do not use without medical advice.
Efferalgan Codeine contains paracetamol and codeine – an opioid analgesic; therefore, it should be used with caution when considering concomitant use of other medicines containing paracetamol or codeine (including those available by prescription or over-the-counter) to avoid exceeding the recommended daily dose (see section 3. How to use Efferalgan Codeine).
Long-term use of high doses of codeine may lead to dependence. Prolonged use of this medicine is not recommended. Exercise caution when using this medicine in patients with a history of abuse and/or dependence (including drugs or alcohol) or with psychiatric disorders (e.g. severe depression). Abuse or misuse may lead to overdose and/or death (see section 3. How to use Efferalgan Codeine. Use of a higher than recommended dose of Efferalgan Codeine).
Neuropathic pain does not respond to codeine and paracetamol.
Codeine may be administered to children for pain relief only on a doctor's prescription.
Special attention should be paid to the child's level of consciousness (awareness of surroundings): before administration, check whether the child shows excessive or abnormal drowsiness.
Do not exceed the recommended doses. Doses of paracetamol higher than recommended carry a risk of severe liver damage. Symptoms of liver damage usually appear one to two days after paracetamol overdose, with maximum severity typically occurring around days 3–4.
Paracetamol may cause serious skin reactions (see section 4), such as acute generalised exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which may be fatal. Inform your doctor if any skin reactions occur and discontinue use of the medicine if a skin rash or any other sign of allergy appears.
Opioids may depress the central nervous system, leading to severe, life-threatening respiratory depression (inhibition of respiratory function). The risk of respiratory depression may be increased when other medicines are used concomitantly or due to the patient's genetic predisposition.
Codeine use may increase existing intracranial pressure. Use with caution in patients with head injuries and other intracranial lesions.
Use with caution in patients with epilepsy.
Long-term use of analgesics, including opioids, increases the risk of medication-overuse headache.
In some individuals, opioid treatment, particularly with chronic use, may increase sensitivity to pain.
Opioid administration may mask symptoms of serious abdominal conditions.
Codeine is converted to morphine by liver enzymes. Morphine is the substance that relieves pain. Some individuals have altered enzyme activity, which may affect them differently. In some people, morphine is not produced or is produced in very small amounts, resulting in inadequate pain relief. Others are at higher risk of severe adverse effects due to excessive morphine production. If the patient experiences any of the following adverse effects, stop taking this medicine and contact a doctor immediately: slow or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, loss of appetite.
In patients after cholecystectomy, codeine may cause acute abdominal pain related to the biliary tract or pancreas, often accompanied by laboratory abnormalities indicating spasm of the sphincter of Oddi.
Use with caution in patients with biliary tract diseases (e.g. gallstones), benign prostatic hyperplasia, or urinary retention, hypothyroidism, or adrenal insufficiency. Opioids may cause urinary retention by reducing the tone of the smooth muscles of the bladder and distending the bladder, as well as by inhibiting the micturition reflex.
Codeine may suppress the cough reflex and therefore should not be used in patients who are expectorating mucus.
Use with caution in patients with hormonal disorders.
During treatment, muscle stiffness and/or alternating muscle contractions and relaxations (clonic seizures) may occur.
With long-term use of opioid medicines, tolerance to the drug or reduced analgesic efficacy may develop.
Some opioids, including morphine, may have immunosuppressive effects.
In patients with reduced circulating blood volume and low blood pressure who are treated with opioids, cardiovascular function should be continuously monitored.
Codeine may cause: constipation, which may be resistant to laxative treatment and require regular monitoring of bowel function; nausea and vomiting; itching.
Exercise caution when using paracetamol if the patient has any of the following conditions:

mild to moderate liver dysfunction, including Gilbert's syndrome (familial hyperbilirubinaemia),
moderate to severe renal dysfunction,
glucose-6-phosphate dehydrogenase deficiency,
chronic alcoholism,
chronic malnutrition (low hepatic glutathione reserves), anorexia, cachexia, bulimia,
dehydration,
oligemia (reduced circulating blood volume).

Alcohol consumption is not recommended during treatment.
Long-term (over 3 months) use of analgesics in patients with chronic headache, taken two or more times per week, may lead to the development or worsening of headache. Medication-overuse headache (MOH) should not be treated by increasing the dose. In such cases, in consultation with a doctor, analgesic use should be discontinued.
Use in elderly patients
Elderly patients may have an increased risk of adverse effects associated with opioid treatment, such as respiratory depression and constipation. In these patients, treatment should be initiated with lower starting doses than usually used in adults (see section 3). Elderly patients are also more likely to be taking other medicines, which may increase the risk of adverse effects.
Children and adolescents
Do not use in children (under 12 years of age), adolescents weighing less than 33 kg, or adolescents (up to 18 years) undergoing tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome (see "When not to use Efferalgan Codeine" and section 3).
Codeine is not recommended in children with breathing disorders, as symptoms of morphine toxicity may worsen.
Children and adolescents should be closely monitored for progressive signs of central nervous system depression caused by codeine, such as excessive drowsiness and reduced respiratory rate. Individual variability in codeine metabolism may increase the risk of adverse effects or reduce treatment response in some patients.
Efferalgan Codeine and other medicines
Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Efferalgan Codeine and other medicines may interact and affect each other when used simultaneously:

MAO inhibitors – do not use simultaneously with MAO inhibitors or within 2 weeks after stopping treatment with these medicines due to the risk of agitation and high fever.
medicines containing salicylamide (analgesic, also used in fever)
concomitant use prolongs the elimination of paracetamol.
medicines increasing hepatic metabolism – concomitant use of paracetamol with drugs such as St. John's wort, antiepileptics, barbiturates (medicines mainly used in epilepsy), rifampicin (used in tuberculosis and other infectious diseases) may lead to liver damage, even at recommended paracetamol doses (see "Use of a higher than recommended dose of Efferalgan Codeine" in section 3).
isoniazid (used in tuberculosis) and zidovudine (an antiviral used in HIV infection) – exercise caution when used concomitantly with these medicines.
non-steroidal anti-inflammatory drugs (NSAIDs) – concomitant use increases the risk of renal dysfunction.
oral anticoagulants – concomitant use of paracetamol with coumarin anticoagulants such as warfarin may slightly alter INR values. INR monitoring should be increased during concomitant use and for one week after stopping paracetamol.
phenytoin (used in epilepsy) – concomitant use may reduce paracetamol efficacy and increase the risk of hepatotoxicity. Patients treated with phenytoin should avoid high and/or chronic doses of paracetamol. These patients should be continuously monitored for signs of liver damage.
probenecid (used in gout) – reduces paracetamol excretion. Consider reducing the paracetamol dose.
flucloxacillin – exercise caution when using flucloxacillin concomitantly with paracetamol due to increased risk of developing a blood and body fluid disorder (metabolic acidosis with high anion gap), especially in patients with risk factors for glutathione deficiency such as severe renal dysfunction, sepsis, malnutrition, and chronic alcoholism. Metabolic acidosis with high anion gap is a serious condition requiring urgent treatment.
enzyme-inducing substances – exercise caution when used concomitantly.
other medicines with central nervous system depressant effects, such as barbiturates, anxiolytics (anti-anxiety medicines), and antidepressants, including tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), benzodiazepines, and hypnotics, may enhance the CNS depressant effects of codeine.
other medicines metabolised by or inhibiting the hepatic enzyme CYP2D6, such as SSRIs (paroxetine, fluoxetine, bupropion, sertraline), neuroleptics (chlorpromazine, haloperidol, levomepromazine, thioridazine), tricyclic antidepressants (imipramine, clomipramine, amitriptyline, nortriptyline), celecoxib, quinidine, dexamethasone, and rifampicin, may reduce the analgesic effect of codeine.
morphine agonists and antagonists (buprenorphine, butorphanol, nalbuphine, nalorphine, pentazocine – opioid analgesics) – concomitant use may limit analgesic effect and increase the risk of withdrawal syndrome.
nalmefene and naltrexone (opioid receptor antagonists) – concomitant use may reduce analgesic effect. Doses of morphine derivatives may need to be increased if necessary.
other morphine derivatives with analgesic effects (alfentanil, dextromoramide, dextropropoxyphene, dihydrocodeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine, phenoperidine, remifentanil, sufentanil, tramadol), morphine derivatives with antitussive effects (dextromethorphan, noscapine, pholcodine), morphine derivatives suppressing the cough reflex (codeine, ethylmorphine), and benzodiazepines (medicines with anxiolytic, sedative, hypnotic, anticonvulsant effects), barbiturates (medicines with sedative effects, among others), methadone (an opioid analgesic)
concomitant use increases the risk of respiratory centre depression in the brain, which in case of overdose may lead to death.
other sedative medicines: morphine derivatives (analgesics, antitussives, and medicines used in substitution therapy), neuroleptics, barbiturates, benzodiazepines, non-benzodiazepine anxiolytics (meprobamate), hypnotics, sedative antidepressants causing drowsiness (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), H1-receptor blocking antihistamines with sedative effects, centrally-acting antihypertensives, baclofen, and thalidomide
concomitant use increases the risk of central nervous system depression, leading to disturbances in consciousness that may pose a danger when driving or operating machinery.
concomitant use of codeine with anticholinergic medicines may increase inhibition of intestinal function and lead to paralytic ileus.

Inform your doctor about using this medicine if your doctor orders tests for uric acid or blood glucose.
In athletes, this medicine may cause a positive result in doping tests.
Use of Efferalgan Codeine with alcohol
Do not drink alcohol or take medicines containing alcohol while taking this medicine.
Alcohol enhances the sedative effect of opioid analgesics. The intensity of codeine's effect, causing disturbances in consciousness, may pose a danger when driving or operating machinery. Additionally, there is a risk of hepatotoxic damage, particularly in individuals who are chronically malnourished and regularly consume alcohol.
Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor before using this medicine.
Pregnancy
This medicine is contraindicated in the first trimester of pregnancy. In the second and third trimesters, single doses may be used only if absolutely necessary.
Efferalgan Codeine may be given to pregnant women if necessary. The lowest effective dose should be used to relieve pain or reduce fever, and the medicine should be taken for the shortest possible duration. If pain is not relieved or fever does not subside, or if increased dosing frequency is required, consult a doctor.
Breastfeeding
Codeine should not be taken during breastfeeding. Codeine and morphine pass into breast milk. This medicine is contraindicated if the patient is breastfeeding.
Fertility
There is no conclusive evidence of fertility disorders related to codeine use. There are insufficient data to determine whether paracetamol affects fertility.
Driving and operating machinery
This medicine may impair psychomotor performance and therefore patients should not drive or operate machinery while taking it.
Warnings regarding excipients with known effects
Each effervescent tablet contains glucose and sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking the medicine.
The medicine contains 5 mg of fructose in each effervescent tablet.
The medicine contains 0.5 mg of alcohol (ethanol) in each effervescent tablet. The amount of alcohol in one tablet is equivalent to a small amount of beer or wine (trace amounts). The small amount of alcohol in this medicine will not cause noticeable effects.
Each effervescent tablet contains 385 mg of sodium (a main component of table salt). This corresponds to 19% of the maximum recommended daily sodium intake in the diet of adults. Patients, especially those monitoring sodium intake, who take one or more effervescent tablets per day over a long period, should consult a doctor or pharmacist.
Each effervescent tablet contains 300 mg of sorbitol. Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance (a rare genetic disorder in which the body cannot break down fructose), they should consult a doctor before taking the medicine or giving it to a child.
Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
Each effervescent tablet contains 30 mg of aspartame. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria (a rare genetic disorder in which phenylalanine accumulates in the body due to improper excretion). Patients with phenylketonuria should not use this medicine.
Sodium benzoate contained in the medicine may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age) whose mothers used this medicine during pregnancy.
The product contains trace amounts of sulphites. The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to use Efferalgan Codeine

This medicine should always be used according to the instructions provided by your doctor or pharmacist. If you have any doubts,
please consult your doctor or pharmacist.
This medicine is intended for use in adults and adolescents with a body weight of 33 kg and above (aged 12 years and older).
Warning!
Do not exceed the recommended doses. To avoid overdose, check whether other medicines you are taking concurrently (including those prescribed or available without a prescription) contain paracetamol or codeine.
Codeine should be used at the lowest effective dose for the shortest possible duration.
Recommended dose:
Adults: one effervescent tablet at a time. The dose may be repeated if necessary, but not more frequently than every 6 hours. In case of severe pain, two effervescent tablets may be taken at once.
Usually, a daily dose exceeding 6 effervescent tablets is not necessary. However, in cases of very intense pain, the daily dose may be increased up to a maximum of 8 effervescent tablets. The maximum daily dose of paracetamol, considering all medicines containing paracetamol, is 4 g, and of codeine is 240 mg.

Children and adolescents
Children under 12 years of age: codeine should not be used due to the risk of opioid toxicity associated with variable and unpredictable metabolism of codeine to morphine (see section 2, "When not to use Efferalgan Codeine").
Adolescents with body weight between 33 kg and 50 kg (aged 12 years and older): the dose should be calculated based on body weight.
The recommended dose of paracetamol is 10 to 15 mg/kg body weight (b.w.) every 4 to 6 hours, up to a maximum daily dose of 60 mg/kg b.w./day (up to 3 g paracetamol for a patient weighing 50 kg).
The recommended dose of codeine is 0.5 mg/kg b.w. to 1 mg/kg b.w. every 6 hours, up to a maximum daily dose of codeine of 240 mg.
The usual recommended dose is one effervescent tablet (500 mg paracetamol and 30 mg codeine) at a time. The dose may be repeated if necessary, but not more frequently than every 6 hours. Do not take more than 4 effervescent tablets per day (equivalent to 2 g paracetamol and 120 mg codeine).
Adolescents with body weight above 50 kg (aged 12 years and older): one effervescent tablet at a time. The dose may be repeated if necessary, but not more frequently than every 6 hours.
In case of severe pain, two effervescent tablets may be taken at once. Usually, a daily dose exceeding 6 effervescent tablets is not necessary; however, in cases of very intense pain, the daily dose may be increased up to a maximum of 8 effervescent tablets (equivalent to 4 g paracetamol and 240 mg codeine).

Elderly patients: may show increased sensitivity to the effects of opioid analgesics. The initial dose should be halved compared to the usual recommended dose for adults. The dose may then be increased depending on tolerance and need.

Patients with renal impairment: there is a risk of accumulation of codeine and paracetamol. In patients with moderate to severe renal impairment, the recommended dose is one effervescent tablet (500 mg paracetamol and 30 mg codeine), and the minimum interval between doses should follow the scheme below:
Creatinine clearance Interval between doses
CrCl 10–50 ml/min 6 hours
CrCl < 10 ml/min 8 hours

Renal failure in adolescents
Adolescents with renal failure should be under close medical supervision due to the risk of accumulation of codeine and paracetamol in the body.
Therefore, the interval between doses should be at least 8 hours.
Dose reduction should also be considered, and the child's condition should be carefully monitored.

Patients with hepatic impairment: the dose of the medicine should be reduced or the intervals between doses extended. In the following situations, the maximum daily dose of paracetamol should not exceed 60 mg/kg b.w./day (should not exceed 2 g/day):

in adults with body weight below 50 kg,
chronic or compensated active liver disease, especially mild to moderate hepatic insufficiency,
Gilbert's syndrome (familial non-hemolytic hyperbilirubinemia),
chronic alcohol-related disease,
prolonged malnutrition (low glutathione reserves in the liver),
dehydration.
In patients with hepatic impairment, reduction of the codeine dose should also be considered.

Administration method
Oral administration. The tablet must be dissolved in water before ingestion. Do not swallow or chew the tablets.

Frequency of administration
Regular use of the medicine helps prevent periodic exacerbations of pain or fever.
The interval between doses must not be less than 6 hours.

Duration of treatment
The duration of treatment should be limited to 3 days. If effective pain relief has not been achieved, patients (or caregivers) should consult a doctor.

Use of a higher than recommended dose of Efferalgan Codeine
If an excessive dose is taken or if Efferalgan Codeine is taken by mistake, contact a doctor immediately for appropriate advice.

Paracetamol
Overdose is particularly dangerous in elderly individuals, young children, chronically malnourished patients, patients with alcohol-related disease, liver diseases, and patients taking medicines that induce liver enzymes, as these individuals are at increased risk of liver damage.
Symptoms: overdose may cause symptoms within several to a dozen or so hours, such as nausea, vomiting, anorexia, pallor, excessive sweating, drowsiness, and general weakness.
These symptoms may subside the next day, even though liver damage may already be developing, manifesting as abdominal discomfort, recurrence of nausea, and jaundice.
Management in case of overdose: in any case where a single dose of paracetamol of 5 g or more has been ingested, induce vomiting if less than one hour has passed since ingestion, and contact a doctor immediately. Administration of 60–100 g of activated charcoal orally is recommended, preferably mixed with water. Immediate medical advice should be sought.

Codeine
Symptoms in adults: acute respiratory depression (cyanosis, respiratory depression, shallow breathing), excessive sedation, and constricted pupils are the main symptoms of codeine and other opioid overdoses. Other central nervous system-related symptoms may also occur, such as headache, vomiting, urinary retention, slowed intestinal motility, bradycardia, and low blood pressure. Additionally, slowed heart function may occur, along with drowsiness, rash, vomiting, itching of the skin, ataxia, pulmonary edema (rarely), apnea, seizures, and histamine release symptoms: facial flushing and swelling, urticaria, collapse, urinary retention.

Symptoms in children (toxic threshold dose: 2 mg/kg b.w. taken at once): reduced respiratory rate, apnea, constricted pupils, seizures, and histamine release symptoms: facial flushing and swelling, urticaria, collapse, urinary retention.

Management in case of overdose: the patient should be immediately transported to hospital, respiratory function should be monitored, and if necessary, respiratory support, oxygen therapy, and other symptomatic treatments should be administered, along with the antidote naloxone.

Rare cases of acute pancreatitis have been observed.

Missed dose of Efferalgan Codeine
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The frequency of occurrence of the adverse effects listed below is defined as follows:
Rare: in less than 1 in 1,000 but more than 1 in 10,000 treated patients
Very rare: in less than 1 in 10,000 treated patients
Not known: cannot be estimated from the available data.
Frequency not known: increased hepatic aminotransferase activity, anaphylactic reaction (including hypotension), anaphylactic shock, angioedema (swelling of deep skin layers and subcutaneous tissue), hypersensitivity reactions, diarrhoea, abdominal pain, nausea, vomiting, thrombocytopenia (reduced platelet count), leukopenia (reduced white blood cell count), neutropenia (reduced neutrophil count – a type of white blood cell), urticaria, erythema, rash, purpura, acute generalized exanthematous pustulosis, toxic epidermal necrolysis, Stevens-Johnson syndrome.
Rare: hypotension.
Very rare: tachycardia, renal colic, renal papillary necrosis, acute renal failure.
Very rare cases of hypersensitivity reactions requiring discontinuation of treatment have been reported:
dyspnoea, bronchospasm, excessive sweating.
Codeine, when used at therapeutic doses, may cause adverse effects similar to those observed with other opioids, although less frequently and with milder severity.
The following may occur: sedation, euphoria, mood disturbances, miosis (constriction of pupils), urinary retention, hypersensitivity reactions (itching, urticaria and rash), constipation, nausea, vomiting, somnolence, dizziness, bronchospasm, respiratory depression (see section 2. When not to use Efferalgan Codeine), acute abdominal pain with features characteristic of biliary or pancreatic disorders, indicating spasm of the sphincter of Oddi; this mainly concerns patients after cholecystectomy.
Use of codeine in doses higher than therapeutic carries a risk of abuse, dependence with long-term use, and withdrawal symptoms upon abrupt discontinuation of the drug. Withdrawal symptoms may occur in treated individuals or in newborns born to mothers dependent on codeine.
Other adverse effects associated with the use of Efferalgan Codeine: pancreatitis, weakness, malaise, biliary colic, hepatitis, anaphylactic reactions (rapid-onset allergic reactions), increased alkaline phosphatase levels in blood, increased gamma-glutamyl transferase levels, rhabdomyolysis (a syndrome associated with damage to striated muscles), alternating muscle contractions and relaxations, paresthesia (tingling, numbness), fainting, tremor, confusion, drug abuse (see section 2. Important information before taking Efferalgan Codeine, Warnings and precautions), drug dependence (see section 2. Important information before taking Efferalgan Codeine, Warnings and precautions), withdrawal syndrome, hallucinations (there is a risk of withdrawal syndrome occurring after abrupt discontinuation of treatment, which may be observed in patients and newborns of mothers addicted to codeine during pregnancy (see section 2. Important information before taking Efferalgan Codeine. Pregnancy, breastfeeding and effect on fertility), erythema, hypotension.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Efferalgan Codeine

Keep this medicine out of the reach and sight of children.
Store in the original packaging to protect from heat and moisture.
Do not use Efferalgan Codeine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Efferalgan Codeine contains
The active substances are paracetamol and codeine phosphate hemihydrate. Each effervescent tablet contains 500 mg of paracetamol and 30 mg of codeine phosphate hemihydrate.
The other ingredients are: sodium hydrogen carbonate, sodium carbonate, citric acid, sorbitol (E 420), sodium lauryl sulfate, sodium benzoate (E 211), povidone, aspartame (E 951), natural grapefruit flavour.

What Efferalgan Codeine looks like and contents of the pack
Aluminium blisters containing 16 effervescent tablets in a cardboard box.
For further information, contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Spain, country of export:
UPSA SAS
3 rue Joseph Monier
92500 Rueil-Malmaison
France

Manufacturer
UPSA
979, Avenue des Pyrénées, 47520 - Le Passage
France
UPSA
304, Avenue du Dr Jean Bru, 47000 – Agen
France

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Relabelled and/or repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Spanish Marketing Authorisation Number (country of export): 669549.4
Parallel Import Licence Number: 103/24

Efferalgan codeine