Efferalgan codeine: detailed information

Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is 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 questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are identical.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

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 effects, 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 as monotherapy or in combination with other analgesics, such as paracetamol.
The combination of paracetamol and codeine provides stronger and longer-lasting analgesic effects than either component alone.

Indications:
Moderate to severe pain that does not respond to 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 as 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 treatment of obstructive sleep apnoea syndrome due to increased risk of severe and life-threatening adverse reactions,
if the patient has severe liver dysfunction or active, uncompensated liver disease,
if the patient has severe renal insufficiency,
if the patient has alcoholic liver disease,
if the patient is being treated with monoamine oxidase inhibitors (MAOIs) (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 metabolizes 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 dependent on 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 pass this medicine on to other people.
Do not use without a doctor's prescription.
Efferalgan Codeine contains paracetamol and codeine – an opioid analgesic – therefore it should be used with caution when taking 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 take Efferalgan Codeine).
Long-term use of high doses of codeine may lead to dependence. Prolonged use of this medicine is not recommended. Caution should be exercised 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 inappropriate use may lead to overdose and/or death (see section 3. How to take Efferalgan Codeine. Taking more than the recommended dose of Efferalgan Codeine).
Neuropathic pain does not respond to codeine and paracetamol.
For pain relief in children, codeine should only be administered under a doctor's prescription.
The child's level of consciousness (awareness of surroundings) should be closely monitored: before administering the medicine, check whether the child shows excessive or abnormal drowsiness.
Do not exceed the recommended doses. Taking paracetamol doses higher than recommended may result in severe liver damage. Symptoms of liver damage usually appear one to two days after paracetamol overdose, with maximum severity typically occurring three to four days later.
Paracetamol may cause severe skin reactions (see section 4), such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which may be fatal. Inform your doctor if skin reactions occur and discontinue use of the medicine if a skin rash or any other sign of hypersensitivity appears.
Opioids' action on the central nervous system may cause severe, life-threatening respiratory depression (suppression 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 exacerbate existing intracranial hypertension. 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 opioid analgesics, increases the risk of medication-overuse headache.
In some individuals, opioid treatment, particularly with chronic use, may increase sensitivity to pain.
Administration of opioids may mask symptoms of serious abdominal conditions.
Codeine is metabolized into 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. Other individuals are at higher risk of severe adverse effects due to excessive morphine production. If the patient experiences any of the following adverse effects, discontinue use of 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, usually accompanied by laboratory abnormalities indicating Oddi sphincter spasm.
Use with caution in patients with biliary tract diseases (gallstones), prostatic hyperplasia or obstructed urinary flow, hypothyroidism, adrenal insufficiency. Opioids may cause urinary retention by reducing bladder smooth muscle tone and bladder distension, as well as by suppressing the micturition reflex.
Codeine may suppress the cough reflex and therefore should not be used in patients expectorating secretions.
Use with caution in patients with hormonal disorders.
During treatment, muscle stiffness and/or alternating muscle contractions and relaxations (clonic seizures) may occur.
With prolonged 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/or low arterial blood pressure treated with opioids, circulatory function should be continuously monitored.
Codeine may cause: constipation, which may be resistant to laxative treatment and require ongoing monitoring of bowel function; nausea and vomiting, itching.
Caution should be exercised 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 impairment,
glucose-6-phosphate dehydrogenase deficiency,
chronic alcoholism, excessive alcohol consumption (ingestion of 3 or more alcoholic drinks daily),
anorexia, bulimia, cachexia,
chronic malnutrition,
low glutathione reserves in the liver, e.g. eating disorders, cystic fibrosis, HIV infection, starvation or cachexia, sepsis,
dehydration,
oligemia (reduced circulating blood volume).

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 those 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 treatment of obstructive sleep apnoea syndrome (see "When not to use Efferalgan Codeine" and section 3).
Codeine use is not recommended in children with respiratory disorders, as symptoms of morphine toxicity may worsen in these children.
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. In some patients, individual variability in codeine metabolism may increase the risk of adverse effects or reduce response to treatment.
Efferalgan Codeine and Other Medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Efferalgan Codeine and other medicines may interact and affect each other's actions when used simultaneously:

MAO inhibitors – do not use concurrently with MAO inhibitors or within 2 weeks after stopping treatment with these medicines due to the risk of excitation and high fever.
Medicines containing salicylamide (an analgesic also used in feverish conditions) – concurrent use prolongs paracetamol elimination time.
Medicines increasing hepatic metabolism – concurrent use of paracetamol and medicines such as St. John's wort, antiepileptic drugs, barbiturates (medicines mainly used in epilepsy), rifampicin (used in tuberculosis and other infectious diseases) may lead to liver damage, even when recommended doses of paracetamol are used (see "Taking more than the 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) – concurrent use increases the risk of renal dysfunction.
Oral anticoagulants – concurrent use of paracetamol with coumarin anticoagulants, including warfarin, may slightly alter INR values. INR monitoring frequency should be increased during concomitant use and for one week after stopping paracetamol.
Phenytoin (used in epilepsy) – concurrent use may reduce paracetamol efficacy and increase the risk of hepatotoxicity. Patients treated with phenytoin should avoid high and/or chronically used paracetamol doses. These patients should be continuously monitored for signs of liver damage.
Probenecid (used in gout) – reduces paracetamol excretion. When Efferalgan Codeine is used concomitantly with probenecid, consider reducing the paracetamol dose.
Flucloxacillin – exercise caution when using flucloxacillin simultaneously with paracetamol due to increased risk of developing blood and body fluid disorders (metabolic acidosis with high anion gap), especially in patients with risk factors for glutathione deficiency such as severe renal impairment, sepsis, malnutrition, and chronic alcoholism. Metabolic acidosis with high anion gap is a serious condition requiring urgent treatment.
Enzyme-inducing substances – exercise caution during concomitant use.
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 central nervous system depressant effects of codeine.
Other medicines metabolized by or inhibiting the hepatic enzyme CYP2D6 activity, 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) – concurrent use leads to reduced analgesic effect and increased risk of withdrawal syndrome.
Naltrexone (opioid receptor antagonist/blocker) – concurrent 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 cough reflex (codeine, ethylmorphine), as well as benzodiazepines (medicines with anxiolytic, sedative, hypnotic, anticonvulsant effects), barbiturates (medicines with sedative effects, among others), methadone (opioid analgesic) – concurrent use increases the risk of respiratory centre depression in the brain, which in case of overdose may lead to death.
Other medicines with sedative effects: morphine derivatives (analgesics, antitussives, and medicines used in substitution therapy), neuroleptics, barbiturates, benzodiazepines, anxiolytics other than benzodiazepines (meprobamate), hypnotics, sedative antidepressants causing drowsiness (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), sedative antihistamines blocking H receptors, centrally-acting antihypertensives,

baclofen and thalidomide – concurrent use increases the risk of central nervous system depression causing disturbances in consciousness that may pose a danger when driving or operating machinery.

Concurrent administration 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 blood tests for uric acid
or glucose.
In athletes, this medicine may cause a positive result in anti-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 action, causing disturbances in consciousness, may pose a danger when driving or operating machinery. Additionally, there is a risk of hepatotoxicity, especially 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 is planning to have a
child, she should consult a doctor before using this medicine.
Pregnancy
This medicine is contraindicated during the first trimester of pregnancy. In the second and third trimesters, single doses may be used only if clearly necessary.
Efferalgan Codeine may be administered to pregnant women if necessary. The lowest possible dose that effectively relieves pain or reduces fever should be used, 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 becomes necessary, consult a doctor.
Breastfeeding
Do not take codeine 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 associated with codeine use. There are insufficient data to determine whether paracetamol affects fertility.
Driving and Operating Machinery
This medicine may impair psychomotor performance and therefore, during treatment, patients should not drive or operate machinery.
Efferalgan Codeine contains sodium, sorbitol, sodium benzoate and aspartame
Each effervescent tablet contains 385 mg of sodium (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 in their diet, who are taking one or more effervescent tablets daily over a long period, should consult their doctor or pharmacist.
Each effervescent tablet contains 300 mg of sorbitol. Sorbitol is a source of fructose. If fructose intolerance has previously been diagnosed in the patient (or their child), or hereditary fructose intolerance (a rare genetic disorder in which the patient's body does not break down fructose), the patient 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.

3. How to use Efferalgan Codeine

This medicine should always be used according to the instructions provided by your doctor or pharmacist. If in doubt,
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 use doses higher than those recommended. To avoid overdose, check whether other medicines being taken simultaneously (including those prescribed or available without 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, it is not necessary to use a daily dose exceeding 6 effervescent tablets. However, in cases of very severe 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 must not be used in children under 12 years of age 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 weighing between 33 kg and 50 kg (aged 12 years and above)
The dose is determined 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 of the medicine 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 use more than 4 effervescent tablets per day (equivalent to 2 g paracetamol and 120 mg codeine).

Adolescents weighing over 50 kg (aged 12 years and above): 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, it is not necessary to use a daily dose exceeding 6 effervescent tablets; however, in cases of very severe 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 exhibit increased sensitivity to the effects of opioid analgesics. The initial dose should be reduced by half compared to the usual recommended dose for adults. The dose may then be increased depending on tolerance and need.

Patients with renal impairment: in cases of impaired renal function, 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 strict medical supervision due to the risk of accumulation of codeine and paracetamol in the body.
Therefore, the intervals 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: in patients with impaired liver function, the dose should be reduced or the intervals between doses should be 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 weighing less than 50 kg,
chronic or compensated active liver disease, especially mild to moderate hepatic impairment,
Gilbert's syndrome (familial non-haemolytic hyperbilirubinaemia),
chronic alcohol-related disease,
prolonged malnutrition (low glutathione reserves in the liver),
dehydration.
In patients with hepatic impairment, dose reduction of codeine should also be considered.

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

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

Duration of treatment
The duration of treatment should be limited to 3 days. If effective pain relief is not 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 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 disease, and patients taking drugs that induce liver enzymes, as these individuals have an increased risk of liver damage.
Symptoms: overdose may cause symptoms within several to several dozen 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 is ingested, vomiting should be induced if less than one hour has passed since ingestion, and immediate contact with a doctor is required. 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, lack of motor coordination, pulmonary oedema (less frequently), breathing pauses, seizures, and histamine release symptoms: facial flushing and swelling, urticaria, collapse, urinary retention.

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

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

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 patients treated
very rare: in less than 1 in 10,000 patients treated.
Rare: malaise, hypotension, increased activity of liver aminotransferases.
Very rare: hypersensitivity reactions, tachycardia, diarrhoea, abdominal pain, nausea, vomiting,
renal colic, renal papillary necrosis, acute renal failure, thrombocytopenia (reduced platelet count),
leukopenia (reduced white blood cell count), neutropenia (reduced neutrophil count – a type of
white blood cell), decreased or increased INR values (blood coagulation index).
Very rare, treatment-requiring hypersensitivity reactions have been reported:
skin redness, rash, erythema or urticaria, angioedema (swelling of deep skin layers and subcutaneous tissue),
dyspnoea, bronchospasm, excessive sweating, hypotension up to symptoms of anaphylactic shock
(caused by a severe systemic allergic reaction; symptoms include: dyspnoea, laryngeal and pharyngeal
edema, skin itching and redness, headache, feeling of "pressure", dizziness, significant weakness, up to
loss of consciousness; in severe cases may be life-threatening) and oedema, severe skin reactions:
acute generalized pustular rash, blisters and erosions on the skin, in the oral cavity, eyes and genital organs,
fever and joint pain, rupturing giant blisters, extensive skin erosions, peeling of large skin sheets
(toxic epidermal necrolysis, Stevens-Johnson syndrome).
Codeine used at therapeutic doses may cause adverse effects similar to those observed with other opioids,
but they occur less frequently and are milder in nature.
The following may occur: sedation, euphoria, mood disturbances, miosis (pupil constriction), urinary
retention, hypersensitivity reactions (itching, urticaria and rash), constipation, nausea, vomiting,
drowsiness, dizziness, bronchospasm, respiratory depression (see section 2. When not to use Efferalgan Codeine),
acute abdominal pain with features typical of biliary or pancreatic disorders, indicating spasm of the sphincter of Oddi;
this mainly affects patients after cholecystectomy.
Using codeine in doses higher than therapeutic is associated with the risk of abuse, dependence with long-term use,
and withdrawal symptoms after abrupt discontinuation of the medicine. Withdrawal symptoms may occur in the treated
person or in a newborn born to a mother 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 blood alkaline phosphatase levels,
increased gamma-glutamyltransferase levels, rhabdomyolysis (a syndrome related to damage of striated muscles),
alternating muscle spasms and relaxation, paresthesia (tingling, numbness), fainting, tremor, confusion, drug abuse
(see section 2. Important information before using Efferalgan Codeine, Warnings and precautions), drug dependence
(see section 2. Important information before using Efferalgan Codeine, Warnings and precautions), hallucinations
(there is a risk of withdrawal syndrome 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 using
Efferalgan Codeine. Pregnancy, breastfeeding and effects 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
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 in the original packaging to protect from moisture.
Store in a place out of sight and reach of children.
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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This 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.
Other ingredients: sodium hydrogen carbonate, sodium carbonate, citric acid, sorbitol, sodium lauryl sulfate, sodium benzoate, povidone, aspartame, natural grapefruit flavour.

What Efferalgan Codeine looks like and contents of the pack
Effervescent tablet
Pack: Aluminium blisters containing 16 effervescent tablets – 4 tablets per blister, in a cardboard box.
For more detailed information, please 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
304, avenue du Dr Jean Bru
47000 Agen
France
UPSA
979, avenue des Pyrénées
47520 Le Passage
France
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorisation number in Spain, country of export: 669549.4
Parallel import authorisation number: 136/18