EFFERALGAN CODEINE

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

• 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 pass it on to others. The medicine may harm someone else, 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.

Table of contents of the leaflet

1. What Efferalgan Codeine is and what it is used for
2. Important information before taking Efferalgan Codeine
3. How to take Efferalgan Codeine
4. Possible side effects
5. How to store Efferalgan Codeine
6. 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 to a lesser extent 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 produces a stronger and longer-lasting analgesic effect 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 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 effects,
• if the patient has severe liver dysfunction or active, decompensated liver disease,
• if the patient has severe renal impairment,
• 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 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. Do not use without medical advice.
Efferalgan Codeine contains paracetamol and codeine – an opioid analgesic; therefore,
concomitant use of other medicines containing paracetamol or codeine (including those available
on prescription or over-the-counter) must be considered 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 the medicine
is not recommended. In patients with current or past history of opioid dependence, Efferalgan
Codeine should be administered with caution or an alternative analgesic treatment may be
prescribed by the doctor.
Neuropathic pain does not respond to codeine and paracetamol.
To relieve pain in children, codeine may only be administered on a doctor's prescription.
The child's level of consciousness (awareness of surroundings) should be closely monitored:
before administration, check whether the child is excessively or abnormally sleepy.
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 after 3–4 days.
Paracetamol may cause severe 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 hypersensitivity appears.
Opioids' action on the central nervous system may cause severe, life-threatening respiratory depression (inhibition of respiratory function). The risk of respiratory depression may be increased when used concomitantly with other medicines and 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 opioids, 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 metabolised 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 the production of very large amounts of morphine. If any of the following adverse effects occur, discontinue use of this medicine and contact your 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 spasm of the sphincter of Oddi.
Use with caution in patients with biliary tract diseases (e.g. gallstones), prostatic hyperplasia or urinary retention, hypothyroidism, or adrenal insufficiency. Opioids may cause urinary retention by reducing the tone of the bladder's smooth muscles, bladder distension, and inhibition of the micturition reflex.
Codeine may suppress the cough reflex and therefore should not be used in patients who are 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 or low blood pressure who are being treated with opioids, cardiovascular function should be continuously monitored.
Codeine may cause: constipation, which may be resistant to treatment with laxatives and require continuous monitoring of intestinal function; nausea and vomiting; itching.
Caution is advised when administering paracetamol to patients with 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 (consuming 3 or more alcoholic drinks daily),
• anorexia, bulimia, or cachexia,
• chronic malnutrition,
• low glutathione reserves in the liver, e.g. due to eating disorders, cystic fibrosis, HIV infection, starvation, or cachexia, sepsis,
• dehydration,
• hypovolaemia (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 initial doses than usually used in adults (see section 3). Elderly patients are also more likely to be taking other concomitant 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 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 decreased 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
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
Efferalgan Codeine and other medicines may interact and affect each other's action when used concomitantly:

• MAO inhibitors – do not use concomitantly with MAO inhibitors or within 2 weeks after stopping treatment due to the risk of agitation and high fever.
• Medicines containing salicylamide (an analgesic also used in fever) – concomitant use prolongs paracetamol elimination time.
• Medicines increasing hepatic metabolism – concomitant use of paracetamol with drugs such as St. John's wort, antiepileptics, barbiturates (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) – caution is advised 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, including 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 elimination. When Efferalgan Codeine is used concomitantly with probenecid, consider reducing the paracetamol dose.
• Flucloxacillin – caution is advised when flucloxacillin is used 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 impairment, sepsis, malnutrition, and chronic alcoholism. Metabolic acidosis with high anion gap is a serious condition requiring urgent treatment.
• Enzyme-inducing substances: caution is advised 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 codeine's central nervous system depressant effects.
• Other medicines metabolised by the hepatic enzyme CYP2D6 or inhibiting its 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 codeine's analgesic effect.
• Morphine agonists and antagonists (buprenorphine, butorphanol, nalbuphine, nalorphine, pentazocine – opioid analgesics) – concomitant use leads to limited analgesic effect and increased risk of withdrawal syndrome.
• Naltrexone (an opioid receptor antagonist) – concomitant use may reduce analgesic effect. Doses of morphine derivatives may need to be increased if necessary.
• Other morphine derivatives with analgesic action (alfentanil, dextromoramide, dextropropoxyphene, dihydrocodeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine, phenoperidine, remifentanil, sufentanil, tramadol), morphine derivatives with antitussive action (dextromethorphan, noscapine, pholcodine), and morphine derivatives suppressing the cough reflex (codeine, ethylmorphine), as well as benzodiazepines (anxiolytic, sedative, hypnotic, anticonvulsant medicines), barbiturates (medicines with sedative, among others, effects), methadone (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, sedating antidepressants causing drowsiness (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), sedating H1-receptor blocking antihistamines, centrally-acting antihypertensives, baclofen, and thalidomide – concomitant use increases the risk of central nervous system depression leading to disturbances in consciousness, which may pose a danger when driving or operating machinery.
• Concomitant 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 uric acid or glucose tests.
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 Efferalgan Codeine. Alcohol enhances the sedative effect of opioid analgesics. The intensified effect of codeine, causing disturbances in consciousness, may pose a danger when driving or operating machinery. Additionally, there is a risk of toxic liver damage, particularly in individuals who are chronically malnourished and regularly consume alcohol.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor before using this medicine.
Pregnancy
The medicine is contraindicated in the first trimester of pregnancy. In the second and third trimesters, single doses may be used only if strictly necessary.
Efferalgan Codeine may be administered 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 time. If pain is not relieved or fever does not subside, or if increased dosing frequency is required, consult your doctor.
Breastfeeding
Do not take codeine during breastfeeding. Codeine and morphine pass into breast milk. The medicine is contraindicated if the patient is breastfeeding.
Fertility
There is no conclusive evidence regarding 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; therefore, driving vehicles and operating machinery should be avoided during treatment.
Efferalgan Codeine contains sodium, sorbitol (E 420), sodium benzoate (E 211), and aspartame (E 951), as well as fructose, glucose, sucrose, and sulphites, which are components of the natural grapefruit flavour.
Each effervescent tablet contains 385 mg of sodium (the main component of table salt). This corresponds to 19.25% of the maximum recommended daily sodium intake in the adult diet. If one or more effervescent tablets are taken daily for a prolonged period, patients, especially those monitoring sodium intake in their diet, should consult their doctor or pharmacist.
Each effervescent tablet contains 300 mg of sorbitol. Sorbitol is a source of fructose. If intolerance to certain sugars or hereditary fructose intolerance (a rare genetic disorder in which the patient's body does not break down fructose) has been diagnosed in the patient (or their child), the patient should consult their doctor before taking the medicine or giving it to the child. Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
The medicine contains 59 mg of sodium benzoate in each effervescent tablet. Sodium benzoate 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 life) whose mothers used this medicine during pregnancy.

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.
The medicine contains 5 mg of fructose, glucose, and sucrose in each effervescent tablet. If intolerance to certain sugars has been diagnosed in the patient, the patient should consult their doctor before taking the medicine.
The medicine contains sulphites. It may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to use Efferalgan Codeine

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The 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 being taken
concurrently (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, a daily dose exceeding 6 effervescent tablets is not necessary. 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, including all medicines containing paracetamol, is 4 g, and of codeine – 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 related to variable and unpredictable metabolism of codeine to morphine (see section 2,
“When not to use Efferalgan Codeine”).
Adolescents aged 12 years and above (with body weight from 33 kg to 50 kg; only approximate weight range
given in relation to age): dosage is based on body weight.
Recommended paracetamol dose is 10 to 15 mg/kg body weight every 4 to 6 hours, up to a maximum daily dose
of 60 mg/kg body weight/day (up to 3 g paracetamol for a patient weighing 50 kg).
Recommended codeine dose is 0.5 mg/kg body weight to 1 mg/kg body weight every 6 hours, up to a maximum
daily codeine dose 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 (corresponding to 2 g paracetamol and 240 mg codeine).
Adolescents with body weight above 50 kg: 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 severe pain, the daily dose may be increased up
to a maximum of 8 effervescent tablets (corresponding 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
halved compared to the usual recommended adult dose. 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
be as follows:
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 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: in patients with impaired liver function, the dose 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 body weight/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, codeine dose reduction 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 administration
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 has not been achieved, patients
(or caregivers) should consult a doctor.
Use of a higher than recommended dose of Efferalgan Codeine
In case of accidental ingestion of an excessive dose or overdose of Efferalgan Codeine, 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
patients have an increased risk of liver damage.
Symptoms: Overdose may cause symptoms within several to several dozen hours, such as: nausea, vomiting,
loss of appetite, pallor, excessive sweating, drowsiness, and general weakness.
These symptoms may subside the next day, even though liver damage may have started to develop, later
manifesting as upper abdominal discomfort, recurrence of nausea, and jaundice.
Management in case of overdose: in any case where a single dose of paracetamol of 5 g (10 tablets) or more has
been ingested, vomiting should be induced if less than one hour has passed since ingestion, and immediate
medical advice should be sought. Administration of 60–100 g of activated charcoal orally, preferably mixed with
water, is recommended. Immediate medical advice must 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 overdose. 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 oedema (rarely), apnoea, seizures,
and histamine release symptoms: facial flushing and swelling, urticaria, collapse, urinary retention.
Symptoms in children: (toxic threshold dose: 2 mg/kg body weight administered at once) reduced respiratory
rate, apnoea, 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
treatment 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The frequency of occurrence of the adverse reactions 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 hepatic aminotransferase activity.
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), decrease or increase in INR values (blood coagulation factor).
Very rare cases of hypersensitivity reactions requiring discontinuation of treatment 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 swelling, skin itching and redness, headache, sensation of "tightness", 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 epidermal sheets (toxic epidermal necrolysis, Stevens-Johnson syndrome).
Codeine, when 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.
Possible effects include: sedation, euphoria, mood disturbances, miosis (pupil constriction), urinary retention, hypersensitivity reactions (itching, urticaria and rash), constipation, nausea, vomiting, somnolence, dizziness, bronchospasm, respiratory centre depression (see section 2. When not to take Efferalgan Codeine), acute abdominal pain with features characteristic of biliary or pancreatic disorders, indicating spasm of the sphincter of Oddi; this mainly affects patients after cholecystectomy.
Use of codeine in doses higher than therapeutic carries a risk of dependence and withdrawal symptoms upon abrupt discontinuation of the drug. Withdrawal symptoms may occur in a treated individual or in a newborn born to a mother dependent on codeine.
Other adverse reactions associated with the use of Efferalgan Codeine: pancreatitis, asthenia, malaise, biliary colic, hepatitis, anaphylactic reactions (rapid-onset allergic reactions), increased blood alkaline phosphatase levels, 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, drug dependence, hallucinations, flushing, hypotension.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 reactions helps to provide more information on the safety of the medicine.

5. How to store Efferalgan Codeine

Keep this medicine out of sight and reach of children.
Store in the outer packaging to protect from moisture.
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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Efferalgan Codeine contains
The active substances in this medicine are paracetamol and codeine phosphate hemihydrate. Each effervescent tablet contains 500 mg of paracetamol and 30 mg of codeine phosphate hemihydrate.
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 (containing, among others, ethanol, fructose, glucose, sucrose and sulphites).

What Efferalgan Codeine looks like and contents of the pack
Effervescent tablet.
Pack:
16 effervescent tablets – 8 effervescent tablets in each of 2 polypropylene tubes, contained in a cardboard box.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.

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

Manufacturer:
UPSA SAS
979, Avenue des Pyrénées
47520 Le Passage
France
UPSA SAS
304, Avenue du Docteur Jean Bru
47000 Agen
France

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

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa

Marketing Authorisation number in France, the country of export: 34009 333 167 7 8
333 167-7
Parallel import licence number: 369/22