Package leaflet: Information for the patient

WARNING: Keep the 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
Efferalgan Codeine and Cod-Efferalgan are different brand names of 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, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of 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 to a lesser extent 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 effect than either component alone.
Indications:
Moderate to severe pain not relieved 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 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 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 failure,
if the patient has alcoholic liver disease,
if the patient is being treated with MAO inhibitors (medicines used, among others, in depression) or within 14 days after stopping such treatment,
when used concomitantly with mixed agonist-antagonist analgesic medicines: 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 taking Efferalgan Forte, discuss it with your doctor, pharmacist, or nurse. Do not use without medical advice.

Efferalgan Codeine contains paracetamol and codeine – an opioid analgesic – therefore, take into account any 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 take 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 alternative analgesic treatment may be prescribed.
Neuropathic pain does not respond to codeine and paracetamol.
For pain relief in children, codeine should only be administered on 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 is excessively or abnormally sleepy.
Do not use doses higher than recommended. Taking paracetamol doses exceeding the recommended amount carries 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 3–4 days.
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 allergy appears.
Opioids may cause serious, life-threatening respiratory depression (suppression of respiratory function) due to their action on the central nervous system. The risk of respiratory depression may be increased by concomitant use of other medicines and by the patient's genetic predisposition.
Codeine 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 converted 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 more susceptible to severe adverse reactions 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, because 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 (gallstones), benign prostatic hyperplasia, or impaired urinary flow, hypothyroidism, or adrenal insufficiency. Opioids may cause urinary retention by reducing the tone of the bladder's smooth muscles 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 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 and/or low blood pressure treated with opioids, cardiovascular 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 is advised when using paracetamol if the patient has any of the following conditions:

mild to moderate liver dysfunction, including Gilbert's syndrome (familial hyperbilirubinemia),
moderate to severe renal dysfunction,
glucose-6-phosphate dehydrogenase deficiency,
chronic alcoholism, excessive alcohol consumption (ingestion of 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,
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 that 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 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
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Efferalgan Codeine and other medicines may interact and affect each other’s action when used simultaneously:

MAO inhibitors – do not use concomitantly 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 fever) – concomitant use prolongs the elimination time of paracetamol.
Medicines increasing hepatic metabolism – concomitant use of paracetamol with 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 "Use of higher than recommended dose of Efferalgan Codeine" in section 3).
Isoniazid (used in tuberculosis) and zidovudine (an antiviral agent 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-type anticoagulants such as warfarin may slightly alter the INR value. The frequency of INR monitoring should be increased during concomitant use and for one week after stopping paracetamol.
Phenytoin (used in epilepsy) – concomitant use may reduce the effectiveness of paracetamol and increase the risk of hepatotoxicity. Patients treated with phenytoin should avoid large and/or chronic doses of paracetamol. These patients should be continuously monitored for signs of liver damage.
Probenecid (used in gout) – reduces the elimination of paracetamol. When Efferalgan Codeine is used concomitantly with probenecid, consider reducing the dose of paracetamol. Flucloxacillin – caution is advised when flucloxacillin is used simultaneously with paracetamol due to increased risk of developing a disorder affecting blood and body fluids (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 – 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 the central nervous system depressant effects of codeine.
Other medicines metabolized 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 leads to limited analgesic effect and increased risk of withdrawal syndrome.
Naltrexone (opioid receptor antagonist/blocker) – 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), morphine derivatives suppressing cough reflex (codeine, ethylmorphine), and benzodiazepines (medicines with anxiolytic, sedative, hypnotic, anticonvulsant effects), barbiturates (medicines with, among others, hypnotic effects), methadone (opioid analgesic) – concomitant use increases the risk of respiratory centre depression in the brain, which may lead to death in case of overdose.
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), sedative H1-receptor blocking antihistamines, centrally-acting antihypertensives, baclofen, and thalidomide – concomitant use increases the risk of central nervous system depression causing disturbances in consciousness, which may pose a danger when driving vehicles 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 tests for blood uric acid or glucose levels.
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 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 vehicles 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 effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, 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 absolutely necessary.
Efferalgan Codeine may be administered to pregnant women if necessary. The lowest effective dose should be used to adequately 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 frequency of dosing becomes necessary, 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 of fertility disorders related to codeine use. There are insufficient data to indicate whether paracetamol affects fertility.

Driving and operating machinery
This medicine may impair psychomotor performance; therefore, do not drive or operate machinery while using this medicine.

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, who take 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 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.
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 life) whose mothers used this medicine during pregnancy.

3. How to use Efferalgan Codeine

This medicine should always be used according to the instructions given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Efferalgan Codeine 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 dose.
To avoid overdose, check whether other medicines you are taking concurrently (including prescription or over-the-counter medicines) 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 no 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 take more than 6 effervescent tablets per day. 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 paracetamol-containing medicines, 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 into morphine (see section 2, "When not to use Efferalgan Codeine").

Adolescents aged 12 years and older (with body weight from 33 kg to 50 kg; only approximate weight ranges related to age are provided): The dose is based on body weight.

Recommended dose of paracetamol: 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).
Recommended dose of codeine: 0.5 mg/kg b.w. to 1 mg/kg b.w. every 6 hours, up to a maximum daily dose of codeine – 240 mg.

The usual recommended dose of Efferalgan Codeine is one effervescent tablet (500 mg paracetamol and 30 mg codeine) at a time. The dose may be repeated if necessary, but no 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: One effervescent tablet at a time. The dose may be repeated if necessary, but no 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 take more than 6 effervescent tablets per day; 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 show increased sensitivity to the effects of opioid analgesics. The initial dose should be reduced by half 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 kidney 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 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 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):

Adults with body weight below 50 kg,
Chronic or compensated active liver disease, especially mild to moderate liver failure,
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 administration
Regular use of the medicine helps prevent recurrent episodes of pain or fever. The interval between doses must not be shorter than 6 hours.

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

Overdose 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 people, 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, anorexia, pallor, excessive sweating, drowsiness, and general weakness.
These symptoms may subside the next day, even though liver damage may have already begun, 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 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. Seek immediate medical advice.

Codeine
Symptoms in adults: Acute respiratory depression (cyanosis, respiratory depression, shallow breathing), excessive sedation, and pinpoint 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 hypotension. Additionally, slowed heart function may occur, along with drowsiness, rash, vomiting, itching, ataxia, pulmonary oedema (less frequently), apnoea, 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, apnoea, pinpoint pupils, seizures, and histamine release symptoms: facial flushing and swelling, urticaria, collapse, urinary retention.

Management in case of overdose: The patient must be immediately transferred to hospital. Monitor respiration and, if necessary, provide respiratory support, oxygen therapy, and other symptomatic treatment, and administer 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 any medicine, Efferalgan Codeine may cause adverse reactions, although not everyone experiences 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 treated patients.
Very rare: in less than 1 in 10,000 treated patients.

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), decreased or increased INR values (blood coagulation index).

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 anaphylactic shock symptoms (caused by severe systemic allergic reaction; symptoms include: dyspnoea, laryngeal and pharyngeal swelling, skin itching and redness, headache, "tightness" sensation, dizziness, significant weakness, up to loss of consciousness; in severe cases may be life-threatening), as well as 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, although 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, somnolence, dizziness, bronchospasm, respiratory depression (see section 2. When not to take Efferalgan Codeine), acute abdominal pain with features typical of biliary or pancreatic disorders, indicating spasm of the sphincter of Oddi; this particularly affects patients after cholecystectomy.

Using 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 person or in a newborn born to a mother dependent on codeine.

Other adverse reactions 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-glutamyl transferase levels, rhabdomyolysis (syndrome associated with damage to striated muscles), alternating muscle contractions and relaxations, paresthesia (tingling, numbness), fainting, tremor, confusion, drug abuse, drug dependence, hallucinations, erythema, hypotension.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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 reactions helps to enhance knowledge about 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:
16 effervescent tablets in 4 aluminium foil blisters, in a cardboard carton.

For further 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, 979, avenue des Pyrénées, 47520 Le Passage, France

Parallel importer:
PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged in:
Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
LABOR Przedsiębiorstwo Farmaceutyczno-Chemiczne Sp. z o.o., ul. Długosza 49, 51-162 Wrocław
CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
Shiraz Productions Sp. z o.o., ul. Tymiankowa 24/28, 95-054 Ksawerów

Marketing authorisation number in Spain, country of export: 669549.4
Parallel import authorisation number: 309/17

Efferalgan codeine