Efferalgan Codeine

Leaflet accompanying the packaging: patient information

Efferalgan Codeine, 500 mg + 30 mg, effervescent tablets

Paracetamol + Codeine phosphate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Efferalgan Codeine and what is it 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 packaging and other information

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

Efferalgan Codeine is a pain reliever containing two active substances with analgesic effects: paracetamol, which also has antipyretic properties, and codeine phosphate (an opioid pain reliever). Paracetamol irritates the stomach mucosa less than salicylates. Codeine belongs to a group of medicines called opioid analgesics, which relieve pain. It can be used in monotherapy or in combination with other pain relievers, such as paracetamol. The combination of paracetamol and codeine results in stronger and longer-lasting analgesic effects than either of these components alone. The medicine has no effect on neuropathic pain. Indications for use: pain of moderate and severe intensity, not relieved by the use of peripheral-acting pain relievers.

2. Important information before taking Efferalgan Codeine

When not to take Efferalgan Codeine

• in children under 12 years of age due to the risk associated with the toxicity of opioid drugs due to variable and unpredictable metabolism of codeine to morphine,
• in children with a body weight below 33 kg (under 12 years of age),
• in children and adolescents (0 to 18 years of age) undergoing tonsillectomy and/or adenoidectomy as part of the treatment of obstructive sleep apnea syndrome, due to increased risk of severe and life-threatening side effects,

if the patient has severe liver dysfunction or active 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 for 14 days after the end of treatment,
• in the case of concomitant use with pain relievers with agonist-antagonist action: buprenorphine, butorphanol, nalbuphine, nalorphine, pentazocine,
• if the patient has asthma or respiratory failure,
• if the patient metabolizes codeine too quickly to morphine,
• in pregnant women in the first trimester,
• in breastfeeding women.

Warnings and precautions

Before starting treatment with Efferalgan Codeine, the patient should discuss it with their doctor, pharmacist, or nurse:

Do not give this medicine to anyone else. Do not take it without a doctor's recommendation. Efferalgan Codeine contains paracetamol and codeine - an opioid pain reliever, so it should be used with consideration of concomitant use of other medicines containing paracetamol or codeine (including those available on prescription or over-the-counter), to avoid taking a daily dose greater than recommended (see section 3. How to take Efferalgan Codeine). Long-term use of high doses of codeine may lead to dependence. It is not recommended to take the medicine for a long time. Caution should be exercised when using this medicine in patients who abuse and/or are dependent (including on drugs or alcohol) or have mental disorders (severe depression). Abuse or improper use can lead to overdose and/or death (see section 3. How to take Efferalgan Codeine. Taking a higher dose of Efferalgan Codeine than recommended). Neurogenic pain does not subside after administration of codeine and paracetamol. For pain relief in children, codeine may only be administered on a doctor's prescription. It is necessary to closely monitor the child's level of consciousness (contact with the environment): before administering the medicine, check if the child does not have excessive or abnormal drowsiness. Do not take higher doses than recommended. Taking higher doses of paracetamol than recommended carries the risk of very severe liver damage. Symptoms of liver damage usually appear 1 to 2 days after paracetamol overdose, with maximum severity usually occurring after 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 can be fatal. The doctor should be informed about skin reactions and the use of the medicine should be discontinued in case of a skin rash or any other sign of hypersensitivity. The action of opioids 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 conditions. Codeine may exacerbate existing increased intracranial pressure. Caution should be exercised when using this medicine in patients with head injuries and other intracranial injuries. It should be used with caution in patients with epilepsy. Long-term use of pain relievers, including opioid drugs, increases the risk of developing medication-overuse headache. In some people, opioid treatment, especially with prolonged use, may increase sensitivity to pain. Administration of opioids may mask symptoms of serious abdominal conditions. Codeine is converted to morphine by liver enzymes. Morphine is a substance that relieves pain. Some people have a changed enzyme and this can affect them in different ways. In some people, morphine is not produced or is produced in very small amounts, which does not provide adequate pain relief. Other people are more prone to severe side effects caused by the production of very large amounts of morphine. If the patient experiences any of the following side effects, they should stop taking the medicine and contact their doctor immediately: slow or shallow breathing, disorientation, drowsiness, small pupils, nausea or vomiting, constipation, loss of appetite. In patients after cholecystectomy, as codeine may cause acute abdominal pain related to the biliary tract or pancreas, usually accompanied by laboratory abnormalities indicating spasm of the Oddi sphincter. Caution should be exercised when using this medicine in patients with biliary tract diseases (gallstones), prostatic hyperplasia, or difficulty urinating, with hypothyroidism, adrenal insufficiency. Opioids may cause urinary retention by reducing the tone of smooth muscles in the bladder and stretching the bladder, as well as inhibiting the reflex of urination. Codeine may inhibit the cough reflex and should not be used in patients expectorating secretions. Caution should be exercised when using this medicine in patients with hormonal disorders. During treatment with the medicine, stiffness and/or alternating muscle contractions and relaxations (clonic convulsions) may occur. With long-term use of opioid drugs, tolerance to the medicine or decreased analgesic efficacy may occur. Some opioids, including morphine, may have an immunosuppressive effect. In patients with reduced blood volume and low blood pressure, who are being treated with opioids, circulatory function should be constantly monitored. Codeine may cause: constipation, which may be resistant to treatment with laxatives and require constant 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 and moderate liver dysfunction, including Gilbert's syndrome (familial hyperbilirubinemia), moderate and severe kidney dysfunction, glucose-6-phosphate dehydrogenase deficiency, chronic alcoholic disease, chronic malnutrition (low glutathione reserves in the liver), anorexia, bulimia, dehydration, hypovolemia (reduced blood volume). Alcohol should not be consumed during treatment. During treatment with Efferalgan Codeine, the doctor should be informed immediately if the patient has severe diseases, including severe kidney dysfunction or sepsis (when bacteria and their toxins are present in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a severe condition called metabolic acidosis (a blood and body fluid disorder), when they took paracetamol in regular doses for a longer period or when they took paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling of nausea (nausea) and vomiting. With long-term (over 3 months) use of pain relievers in patients with chronic headache, when taken every other day or more frequently, medication-overuse headache (MOH) may develop or worsen. MOH should not be treated by increasing the dose. In such cases, in agreement with the doctor, the use of pain relievers should be discontinued.

Use in elderly patients

Elderly patients may have an increased risk of side effects related to opioid treatment, such as respiratory depression and constipation. In these patients, it is recommended to start treatment with lower initial 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 side effects.

Children and adolescents

Do not use in children (under 12 years of age), adolescents with a body weight below 33 kg, and adolescents (up to 18 years of age) undergoing tonsillectomy and/or adenoidectomy as part of the treatment of obstructive sleep apnea syndrome (see "When not to take Efferalgan Codeine" and section 3). Codeine is not recommended for use in children with respiratory disorders, as it may exacerbate symptoms of morphine toxicity. Children and adolescents should be closely monitored for signs of central nervous system depression, such as excessive drowsiness and decreased respiratory rate. In some patients, individual variability in codeine metabolism may increase the risk of side effects or decrease the response to treatment.

Efferalgan Codeine and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. Efferalgan Codeine and other medicines may interact with each other when taken concomitantly:

• MAO inhibitors - should not be taken concomitantly with MAO inhibitors and for 2 weeks after the end of treatment with these medicines, due to the possibility of excitement and high fever.
• drugs containing salicylamide (a pain reliever also used in feverish conditions) - concomitant use prolongs the elimination of paracetamol.
• drugs that increase liver metabolism - concomitant use of paracetamol and drugs such as St. John's wort, antiepileptic drugs, barbiturates (medicines used mainly in epilepsy), rifampicin (a medicine used in tuberculosis and other infectious diseases) may lead to liver damage, even when taking recommended doses of paracetamol (see "Taking a higher dose of Efferalgan Codeine than recommended" in section 3).
• isoniazid (a medicine used in tuberculosis) and zidovudine (an antiviral medicine used in HIV infection) - caution should be exercised when taking these medicines concomitantly.
• non-steroidal anti-inflammatory drugs (NSAIDs) - concomitant use increases the risk of kidney function disorders.
• oral anticoagulants - concomitant use of paracetamol with anticoagulant medicines from the coumarin group, including warfarin, may slightly change the INR value. The frequency of INR monitoring should be increased during concomitant use and also for a week after discontinuation of paracetamol.
• phenytoin (a medicine used in epilepsy) - concomitant use may reduce the efficacy of paracetamol and increase the risk of liver toxicity. Patients treated with phenytoin should avoid high and/or prolonged doses of paracetamol. These patients should be constantly monitored for signs of liver damage.
• probenecid (a medicine used in gout) - reduces the elimination of paracetamol. The dose of paracetamol should be considered for reduction.
• flucloxacillin (an antibiotic) - the doctor or pharmacist should be informed if the patient is taking flucloxacillin, due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which must be treated urgently (see section 2).
• enzyme inducers - caution should be exercised when taking these medicines concomitantly.
• other medicines with a central nervous system depressant effect, such as barbiturates, anxiolytics (anti-anxiety medicines), and antidepressants, including tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), benzodiazepines, and sedatives, may enhance the depressant effect of codeine on the central nervous system.
• other medicines that are metabolized by the liver enzyme CYP2D6 or inhibit its activity, such as SSRIs (paroxetine, fluoxetine, bupropion, and sertraline), neuroleptics (chlorpromazine, haloperidol, levomepromazine, thioridazine), and tricyclic antidepressants (imipramine, clomipramine, amitriptyline, nortriptyline), celecoxib, quinidine, dexamethasone, and rifampicin, may reduce the analgesic effect of codeine.
• agonists and antagonists of morphine (buprenorphine, butorphanol, nalbuphine, nalorphine, pentazocine - opioid pain relievers) - concomitant use leads to a reduction in analgesic effect and an increased risk of withdrawal syndrome.
• nalmefene and naltrexone (opioid receptor antagonists) - concomitant use poses a risk of reduced analgesic effect. The doses of morphine derivatives should be increased if necessary.
• other morphine derivatives with analgesic effect (alfentanyl, dextromoramide, dextropropoxyphene, dihydrocodeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine, phenoperidine, remifentanil, sufentanil, tramadol) and morphine derivatives with antitussive effect (dextromethorphan, noscapine, pholcodine) and morphine derivatives with antitussive effect (codeine, ethylmorphine), as well as benzodiazepines (medicines with anxiolytic, sedative, hypnotic, and anticonvulsant effects), barbiturates (medicines with sedative effects, among others), methadone (an opioid pain reliever) - concomitant use increases the risk of respiratory depression in the brain, which can lead to death in case of overdose.

Tell your doctor or pharmacist if you are taking this medicine, if your doctor prescribes a test for uric acid or blood glucose. In athletes, the medicine may cause a positive result in doping tests.

Using Efferalgan Codeine with alcohol

Do not drink alcohol or take medicines containing alcohol while taking this medicine. Alcohol increases the sedative effect of opioid pain relievers. The increased effect of codeine, leading to altered consciousness, may pose a risk when driving vehicles or operating machinery. Additionally, there is a risk of toxic liver damage, especially in people who are chronically malnourished and regularly consume alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before taking this medicine. Pregnancy The medicine is contraindicated in the first trimester of pregnancy. In the second and third trimesters of pregnancy, it can be used in single doses only if necessary. Efferalgan Codeine can be given to pregnant women if necessary. The lowest effective dose should be used for the shortest possible duration. If pain is not relieved or fever does not subside, or if it is necessary to increase the frequency of administration, consult a doctor. Breastfeeding Do not take codeine while 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 associated with the use of codeine. There is no sufficient data to indicate whether paracetamol affects fertility.

Driving and using machines

This medicine may impair psychophysical fitness, and therefore, while taking it, do not drive vehicles or operate machinery.

Warnings about excipients with known effects

Each effervescent tablet contains glucose and sucrose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. The medicine contains 5 mg of fructose in each effervescent tablet. The medicine contains 0.5 mg of ethanol (alcohol) in each effervescent tablet. The amount of alcohol in this medicine is equivalent to a small amount of beer or wine (trace amounts). The small amount of alcohol in this medicine will not have noticeable effects. Each effervescent tablet contains 385 mg of sodium (the main component of table salt). This corresponds to 19% of the maximum recommended daily intake of sodium in the diet for adults. If one or more effervescent tablets are taken per day for a long time, patients, especially those controlling their sodium intake, should consult their doctor or pharmacist. Each effervescent tablet contains 300 mg of sorbitol. Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to some sugars or hereditary fructose intolerance (a rare genetic disorder in which the patient's body does not break down fructose), they should consult their doctor before taking the medicine or giving it to their 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 its improper elimination). Patients with phenylketonuria should not take 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 took this medicine during pregnancy. The product contains trace amounts of sulfites. The medicine rarely may cause severe hypersensitivity reactions and bronchospasm.

3. How to take Efferalgan Codeine

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The medicine is intended for use in adults and adolescents with a body weight of 33 kg or more (12 years of age and older). Warning! Do not take higher doses than recommended. To avoid overdose, check if other medicines taken concomitantly (including those available on prescription or over-the-counter) do not contain paracetamol or codeine. Codeine should be taken in the smallest effective dose for the shortest possible time. The recommended dose is: Adults: 1 effervescent tablet at a time. If necessary, the dose can be repeated, but not more frequently than every 6 hours. If intense pain occurs, 2 effervescent tablets can be taken at a time. Usually, it is not necessary to take a daily dose greater than 6 effervescent tablets. However, in the case of very severe pain, the daily dose can be increased to a maximum of 8 effervescent tablets. The maximum daily dose of paracetamol, taking into account all medicines containing paracetamol, is 4 g, and codeine is 240 mg. Children and adolescents Children under 12 years of age: do not take codeine due to the risk of opioid toxicity associated with variable and unpredictable metabolism of codeine to morphine (see "When not to take Efferalgan Codeine" in section 2). Adolescents with a body weight of 33 kg to 50 kg (12 years of age and older) The dose is determined based on body weight. The recommended dose of paracetamol is 10 to 15 mg/kg body weight (bw) every 4 to 6 hours, up to a maximum daily dose of 60 mg/kg bw/day (up to 3 g of paracetamol for a patient with a body weight of 50 kg). The recommended dose of codeine is 0.5 mg/kg bw to 1 mg/kg bw every 6 hours, up to a maximum daily dose of codeine 240 mg. Usually, the recommended dose of the medicine is 1 effervescent tablet (500 mg of paracetamol and 30 mg of codeine) at a time. If necessary, the dose can be repeated, but not more frequently than every 6 hours. Do not take more than 4 effervescent tablets per day (corresponding to 2 g of paracetamol and 120 mg of codeine). Adolescents with a body weight over 50 kg (12 years of age and older): 1 effervescent tablet at a time. If necessary, the dose can be repeated, but not more frequently than every 6 hours. If intense pain occurs, 2 effervescent tablets can be taken at a time. Usually, it is not necessary to take a daily dose greater than 6 effervescent tablets; however, in the case of very severe pain, the daily dose can be increased to a maximum of 8 effervescent tablets (corresponding to 4 g of paracetamol and 240 mg of codeine). Elderly patients: may have increased sensitivity to the effects of opioid pain relievers. The initial dose should be reduced by half compared to the usual recommended dose for adults. The dose can then be increased depending on the patient's tolerance and needs. Patients with renal impairment: there is a risk of accumulation of codeine and paracetamol. In patients with moderate to severe renal impairment, the recommended dose is 1 effervescent tablet (500 mg of paracetamol and 30 mg of codeine), and the minimum interval between doses should be in accordance with the following schedule: Creatinine clearance Interval between doses CrCl 10 - 50 ml/min 6 hours CrCl <10 ml min 8 hours renal impairment in adolescents with should be under close medical supervision due to the risk of accumulation codeine and paracetamol body. this regard, intervals between consecutive doses at least hours. it is also necessary consider reducing dose closely monitoring child's condition. patients liver dysfunction: medicine reduced or prolonged. following situations, maximum daily not exceed 60 mg kg bw day (should 2 g day):< p>

• in adults with a body weight below 50 kg,
• in chronic or compensated active liver disease, especially mild to moderate liver failure,
• Gilbert's syndrome (familial non-hemolytic hyperbilirubinemia),
• chronic alcoholic disease,
• chronic malnutrition (low glutathione reserves in the liver),
• dehydration. In patients with liver dysfunction, it is also necessary to consider reducing the dose of codeine.

Administration The medicine should be taken orally. Before taking, the tablet should be dissolved in water. Do not swallow or chew the tablets. Frequency of administration Systematic use of the medicine allows for the prevention of periodic exacerbations of pain or fever. The interval between doses should not be less than 6 hours. Duration of treatment The duration of treatment should be limited to 3 days, and if effective pain relief is not achieved, patients (or caregivers) should consult a doctor.

Taking a higher dose of Efferalgan Codeine than recommended

In case of taking too much of the medicine or taking it by mistake, contact a doctor immediately for appropriate advice. Paracetamol Overdose is particularly dangerous in the elderly, small children, malnourished patients, those with liver disease, and patients taking enzyme-inducing medicines, as they are at increased risk of liver damage. Symptoms: overdose may cause symptoms within a few to several hours, such as nausea, vomiting, loss of appetite, pallor, excessive sweating, drowsiness, and general weakness. These symptoms may resolve the next day, even though liver damage is beginning to develop, manifested by abdominal distension, return of nausea, and jaundice. Procedure in case of overdose: in any case of taking a single dose of paracetamol of 5 g or more, vomiting should be induced if it has not been more than an hour since ingestion, and a doctor should be contacted immediately. It is recommended to administer 60-100 g of activated charcoal orally, preferably mixed with water. Medical advice should be sought immediately. Codeine Symptoms in adults: acute respiratory depression (cyanosis, respiratory inhibition, shallow breathing), excessive sedation, and pinpoint pupils are the main symptoms of codeine and other opioid overdoses. Other symptoms related to the central nervous system may also occur, such as headache, vomiting, urinary retention, slowed bowel movements, bradycardia, and decreased blood pressure. Additionally, there may be slowed heart rate, and there may be drowsiness, rash, vomiting, itching, unsteadiness, swelling of the lungs (less frequently), pauses in breathing, seizures, symptoms of histamine release: flushing and swelling of the face, urticaria, collapse, urinary retention. Symptoms in children (toxic dose: 2 mg/kg bw taken at a time): decreased respiratory rate, pauses in breathing, pinpoint pupils, seizures, symptoms of histamine release: flushing and swelling of the face, urticaria, collapse, urinary retention. Procedure in case of overdose: the patient should be taken to the hospital immediately and their breathing should be monitored, and if necessary, respiratory support, oxygen therapy, and other symptomatic treatment should be provided, and an antidote - naloxone - should be administered. Rare cases of acute pancreatitis have been reported.

Missing a dose of Efferalgan Codeine

Do not take a double dose to make up for a missed dose. If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The frequency of side effects is defined as follows: rare: in less than 1 in 1,000 but more than 1 in 10,000 treated patients, very rare: in less than 1 in 10,000 treated patients, not known: cannot be estimated from the available data. Unknown frequency: increased liver enzyme activity, anaphylactic reaction (including hypotension), anaphylactic shock, angioedema (swelling of the deep layers of the skin and subcutaneous tissue), hypersensitivity reactions, diarrhea, abdominal pain, nausea, vomiting, thrombocytopenia (reduced platelet count), leukopenia (reduced white blood cell count), neutropenia (reduced neutrophil count), urticaria, rash, erythema, pruritus, acute generalized exanthematous pustulosis, toxic epidermal necrolysis, Stevens-Johnson syndrome; a serious condition that can cause acidification of the blood (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2). Rare: hypotension. Very rare: tachycardia, renal colic, renal papillary necrosis, acute renal failure. Very rare, requiring withdrawal of treatment, cases of hypersensitivity reactions have been reported: dyspnea, bronchospasm, excessive sweating, Codeine taken in therapeutic doses may cause side effects similar to those observed with the use of other opioids, but they occur less frequently and are milder. The following may occur: sedation, euphoria, mood changes, pinpoint pupils, urinary retention, hypersensitivity reactions (itching, urticaria, and rash), constipation, nausea, vomiting, drowsiness, dizziness, bronchospasm, respiratory depression (see section 2. "When not to take Efferalgan Codeine"), acute abdominal pain with characteristics of biliary tract or pancreatic disorders, indicating spasm of the Oddi sphincter; this mainly applies to patients after cholecystectomy. Taking codeine in doses higher than therapeutic ones is associated with a risk of abuse, dependence with prolonged use, and the occurrence of withdrawal symptoms after sudden discontinuation of the medicine. Withdrawal symptoms may occur in the treated person or in the newborn of a mother dependent on codeine. Other side effects associated with the use of Efferalgan Codeine: pancreatitis, weakness, malaise, biliary colic, hepatitis, anaphylactic reactions (severe allergic reactions), increased alkaline phosphatase levels in the blood, increased gamma-glutamyltransferase levels, rhabdomyolysis (a condition characterized by muscle damage), alternating muscle contractions and relaxations (clonic convulsions), paresthesia (tingling, numbness), syncope, tremor, confusion, drug abuse (see section 2. Important information before taking Efferalgan Codeine, Warnings and precautions), drug dependence (see section 2. Important information before taking Efferalgan Codeine, Warnings and precautions), withdrawal syndrome, hallucinations (there is a risk of withdrawal syndrome after sudden discontinuation of treatment, which can be observed in patients and newborns of mothers addicted to codeine during pregnancy (see section 2. Important information before taking Efferalgan Codeine. Pregnancy, breastfeeding, and fertility), rash, hypotension.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Efferalgan Codeine

Keep this medicine out of the sight and reach of children. Store in a temperature below 25°C, in a dry place. Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Efferalgan Codeine contains

The active substances of the medicine are paracetamol and codeine phosphate. Each effervescent tablet contains 500 mg of paracetamol and 30 mg of codeine phosphate. The other ingredients are: sodium bicarbonate, sodium carbonate, anhydrous citric acid, sorbitol (E420), sodium lauryl sulfate, sodium benzoate (E211), povidone, aspartame (E951), natural grapefruit flavor. Natural grapefruit flavor: flavoring substances: essential oils from grapefruit, juices from: lemon, orange, orange pulp, grapefruit pulp, gum arabic (E414), maltodextrin (source of glucose, fructose, sucrose), ethanol, butylhydroxyanisole (E320), sulfites.

What Efferalgan Codeine looks like and contents of the pack

Effervescent tablet. Packaging: polypropylene tube, closed with an LDPE cap with a desiccant, containing 16 effervescent tablets - 8 effervescent tablets in 2 tubes, in a cardboard box.

Marketing authorization holder

UPSA SAS 3 rue Joseph Monier 92500 Rueil-Malmaison, France

Manufacturer

UPSA SAS 304, Avenue du Dr Jean Bru 47000 Agen, France UPSA SAS 979, Avenue des Pyrénées 47520 Le Passage, France For more detailed information about this medicine, please contact the local representative of the marketing authorization holder: MagnaPharm Poland sp. z o.o. ul. Inflancka 4 00-189 Warsaw tel.: +48 22 570 27 00

Date of last revision of the leaflet