Efferalgan Codeine

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Efferalgan Codeine(Cod-Efferalgan)

500 mg + 30 mg, effervescent tablets

Paracetamol + Codeine phosphate hemihydrate
Efferalgan Codeine and Cod-Efferalgan are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should 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 side effects 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 an antipyretic effect, and codeine phosphate hemihydrate (an opioid pain reliever).
Paracetamol irritates the gastric mucosa less than salicylates.
Codeine belongs to a group of medicines called opioid analgesics, which relieve pain.
It can be used as monotherapy or in combination with other pain relievers, such as paracetamol.
The combination of paracetamol and codeine results in a stronger and longer-lasting analgesic effect than the effect of each of these components separately.
Indications for use: pain of moderate and severe intensity, not relieved by the use of peripheral-acting pain relievers.
In adolescents aged 12 and over, due to codeine, Efferalgan Codeine can be used for short-term relief of moderate pain that is not relieved by other pain relievers, such as paracetamol or ibuprofen used as monotherapy.

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 the 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 (aged 0 to 18) undergoing tonsillectomy and/or adenoidectomy as part of the treatment of obstructive sleep apnea syndrome due to the increased risk of severe and life-threatening side effects,
• in the case of concomitant use with pain relievers with agonist-antagonist action: buprenorphine, butorphanol, nalbuphine, nalorphine, pentazocine,
• in pregnant women in the first trimester,
• in breastfeeding women.

Warnings and precautions

Before starting to take Efferalgan Codeine, you should discuss it with your doctor, pharmacist, or nurse:

You should not give this medicine to others. You should not take it without a doctor's recommendation.
Efferalgan Codeine contains paracetamol and codeine - an opioid pain reliever, so it should be taken with consideration of concomitant use of other medicines containing paracetamol or codeine (including those available on prescription or over-the-counter), in order not to exceed the recommended daily dose (see section 3. How to take Efferalgan Codeine).
Prolonged 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 taking this medicine in patients who abuse and/or are dependent (including on drugs or alcohol) or have mental disorders (e.g., 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).
Neuropathic pain does not respond to codeine and paracetamol.
For pain relief in children, codeine may only be administered on a doctor's prescription.
Particular attention should be paid to the child's level of consciousness (contact with the environment): before administering the medicine, it should be checked whether the child is not experiencing excessive or abnormal drowsiness.
Higher doses than recommended should not be taken. Taking higher doses of paracetamol than recommended carries the risk of very severe liver damage. Symptoms of liver damage usually appear within one to two 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 effect 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 taking other medicines and due to the patient's genetic conditions.
Codeine may exacerbate existing increased intracranial pressure. Caution should be exercised when taking this medicine in patients with head injuries and other intracranial injuries.
Caution should be exercised when taking this medicine in patients with epilepsy.
Long-term use of pain relievers, including opioid medicines, increases the risk of developing medication-overuse headache (MOH).
In some people, treatment with opioids, especially with chronic use, may cause increased sensitivity to pain.
Administration of opioids may mask symptoms of severe abdominal disorders.
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 likely to experience severe side effects due to the production of very large amounts of morphine. If the patient experiences any of the following side effects, they should stop taking this 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 associated with biliary or pancreatic disorders, usually accompanied by laboratory abnormalities indicating spasm of the Oddi sphincter.
Caution should be exercised when taking this medicine in patients with biliary tract disorders (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 micturition reflex.
Codeine may inhibit the cough reflex and should not be used in patients who are expectorating secretions.
Caution should be exercised when taking this medicine in patients with hormonal disorders.
During treatment with this medicine, stiffness and/or alternating muscle contractions and relaxations (clonic convulsions) may occur.
During long-term use of opioid medicines, tolerance to the medicine or decreased analgesic effectiveness may occur.
Some opioids, including morphine, may have an immunosuppressive effect.
In patients with reduced circulating blood volume and low blood pressure, who are being treated with opioids, cardiovascular 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 taking paracetamol if the patient has any of the following conditions:

• mild and moderate liver dysfunction, including Gilbert's syndrome (familial non-hemolytic hyperbilirubinemia),
• moderate and severe kidney dysfunction,
• glucose-6-phosphate dehydrogenase deficiency,
• chronic alcoholic disease,
• chronic malnutrition (low glutathione reserves in the liver), anorexia, cachexia, bulimia,
• dehydration,
• oligemia (reduced circulating blood volume).

Alcohol should not be consumed during treatment.
During long-term (more than 3 months) use of pain relievers in patients with chronic headache, when taking them every other day or more frequently, medication-overuse headache (MOH) may develop. MOH should not be treated by increasing the dose. In such cases, the use of pain relievers should be discontinued in consultation with a doctor.

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 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

You should 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 within 2 weeks after the end of treatment with these medicines due to the possibility of excitement and high fever.
• medicines containing salicylamide (a pain reliever also used in febrile conditions)
• concomitant use prolongs the elimination of paracetamol.
• medicines that increase liver metabolism - concomitant use of paracetamol and medicines 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 the 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 anticoagulants 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 one week after discontinuation of paracetamol.
• phenytoin (a medicine used in epilepsy) - concomitant use may reduce the effectiveness 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 excretion of paracetamol. The dose of paracetamol should be considered for reduction.
• flucloxacillin - caution should be exercised when taking flucloxacillin concomitantly with paracetamol due to the increased risk of developing a disorder affecting blood and body fluids (metabolic acidosis with a large anion gap), especially in patients with risk factors for glutathione deficiency, such as severe kidney dysfunction, sepsis, malnutrition, and chronic alcoholism. Metabolic acidosis with a large anion gap is a serious disease that requires emergency treatment.
• enzyme inducers - caution should be exercised when taking them 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 (alfentanil, 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 a cough-suppressing effect (codeine, ethylmorphine), as well as benzodiazepines (medicines with anxiolytic, sedative, hypnotic, and anticonvulsant effects), barbiturates (medicines used mainly in epilepsy), 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.
• other sedative medicines: morphine derivatives (analgesic, antitussive, and used in substitution therapy), neuroleptics, barbiturates, benzodiazepines, anxiolytics other than benzodiazepines (meprobamate), sedatives, antidepressants with a sedative effect (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), antihistamines with a sedative effect, centrally acting antihypertensive medicines, baclofen, and thalidomide - concomitant use increases the risk of central nervous system depression, leading to impaired consciousness, which can pose a risk when driving vehicles or operating machinery.

You should inform your doctor about the use of 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

You should 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 impaired consciousness, can 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, you should consult your doctor 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 absolutely necessary.
Efferalgan Codeine can be administered to pregnant women if necessary. The lowest effective dose should be used, providing effective pain relief or reducing fever, and the medicine should be taken for the shortest possible time. If the pain is not relieved or the fever does not subside, or if it is necessary to increase the frequency of administration, you should consult a doctor.
Breastfeeding
You should not take codeine while breastfeeding. Codeine and morphine pass into breast milk. The medicine is contraindicated if you are breastfeeding.
Fertility
There is no conclusive evidence of fertility disorders associated with the use of codeine.
There is no available data to indicate whether paracetamol affects fertility.

Driving and using machines

This medicine may impair your ability to drive or use machines, so you should not drive or operate machinery while taking it.

Warnings about excipients with known effects

Each effervescent tablet contains glucose and sucrose. If you have been diagnosed with intolerance to some sugars, you should consult your 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 one tablet of 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 common salt). This corresponds to 19% of the maximum recommended daily intake of sodium in the diet for adults. If you take one or more effervescent tablets per day for a long time, you should consult your doctor or pharmacist, especially if you are controlling your sodium intake.
Each effervescent tablet contains 300 mg of sorbitol. Sorbitol is a source of fructose. If you or your child have been diagnosed with intolerance to some sugars or hereditary fructose intolerance (a rare genetic disorder in which the body does not break down fructose), you should consult your doctor before taking the medicine or giving it to your child.
Sorbitol may cause gastrointestinal discomfort and 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 excretion). 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 may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to take Efferalgan Codeine

You should always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, you should 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, you should check if other medicines taken concomitantly (including those available on prescription or over-the-counter) contain paracetamol or codeine.
Codeine should be taken in the smallest effective dose for the shortest possible time.
The recommended dose is:
Adults: one effervescent tablet at a time. If necessary, the dose can be repeated, but not more frequently than every 6 hours. If intense pain occurs, two effervescent tablets can be taken at a time.
Usually, it is not necessary to take a daily dose higher 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 the maximum daily dose of codeine is 240 mg.
Children and adolescents
Children under 12 years of age: codeine should not be taken due to the risk of opioid toxicity associated with the variable and unpredictable metabolism of codeine to morphine (see "When not to take Efferalgan Codeine" in section 2).
Adolescents with a body weight from 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 of 240 mg.
Usually, the recommended dose of the medicine is one 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): one effervescent tablet at a time.
If necessary, the dose can be repeated, but not more frequently than every 6 hours.
If intense pain occurs, two effervescent tablets can be taken at a time. Usually, it is not necessary to take a daily dose higher than 6 effervescent tablets, but 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).
Patients over 65 years of age: may have an increased sensitivity to the effects of opioid pain relievers. The initial dose should be reduced by half compared to the usually recommended dose for adults. The dose can then be increased depending on the patient's tolerance and needs.
Patients with kidney dysfunction: there is a risk of accumulation of codeine and paracetamol. In patients with moderate to severe kidney dysfunction, the recommended dose is one effervescent tablet (500 mg of paracetamol and 30 mg of codeine), and the minimum interval between doses should be in accordance with the following scheme:
Creatinine clearance
Interval between doses
CrCl 10 - 50 ml/min
6 hours
CrCl <10 ml min
8 hours
Kidney failure in adolescents
Adolescents with kidney failure should be under close medical supervision due to the risk of accumulation of codeine and paracetamol in the body.
Therefore, the intervals between consecutive doses should be at least 8 hours.
The dose should also be considered for reduction and the patient's condition should be closely monitored.
Patients with liver dysfunction: the dose of the medicine should be reduced or the intervals between consecutive doses should be extended. In the following situations, the maximum daily dose of paracetamol should not exceed 60 mg/kg bw/day (should not exceed 2 g/day):

• in adults with a body weight below 50 kg,
• in patients with chronic or compensated active liver disease, especially mild to moderate liver failure,
• in patients with Gilbert's syndrome (familial non-hemolytic hyperbilirubinemia),
• in patients with chronic alcoholic disease,
• in patients with chronic malnutrition (low glutathione reserves in the liver),
• in patients with dehydration.

Method of administration
Oral use. The tablet should be dissolved in water before taking. Do not swallow or chew the tablets.
Frequency of use
Regular use of the medicine allows you to prevent periodic exacerbations of pain or fever.
The interval between doses should not be less than 6 hours.
Duration of use
The duration of treatment should be limited to 3 days, and if effective pain relief is not achieved, patients (or their caregivers) should consult a doctor.

Taking a higher dose of Efferalgan Codeine than recommended

In case of overdose or accidental ingestion of Efferalgan Codeine, you should immediately contact a doctor for advice.
Paracetamol
Overdose is particularly dangerous in the elderly, small children, patients who are chronically malnourished, have liver disease, and patients taking medicines that induce liver enzymes, as these individuals have an 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, despite the fact that liver damage is beginning to develop, manifested by abdominal distension, return of nausea, and jaundice.
Procedure in case of overdose: in every case of ingestion of 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 immediate medical attention should be sought. It is recommended to administer 60-100 g of activated charcoal orally, preferably mixed with water. Immediate medical attention should be sought.
Codeine
Symptoms in adults: acute respiratory depression (cyanosis, respiratory arrest, shallow breathing), excessive sedation, and miosis are the main symptoms of codeine and other opioid overdose; other symptoms related to the central nervous system may also occur, such as headache, vomiting, urinary retention, slowing of bowel movements, bradycardia, and decreased blood pressure. Additionally, there may be a decrease in heart rate, and the following may appear: sedation, rash, vomiting, itching, and respiratory depression.
Symptoms in children (toxic dose: 2 mg/kg bw, taken at a time): decreased respiratory rate, pauses in breathing, miosis, convulsions, 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; if necessary, respiratory support, oxygen therapy, and other symptomatic treatment should be provided, and an antidote - naloxone - should be administered.
There have been rare reports of acute pancreatitis.

Missing a dose of Efferalgan Codeine

You should not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, you should 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:
common: in less than 1 in 100 patients, but more than 1 in 1,000 patients treated
rare: in less than 1 in 1,000 patients, but more than 1 in 10,000 patients treated
very rare: in less than 1 in 10,000 patients treated, including isolated reports
not known: cannot be estimated from the available data.
Frequency not known: 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 (decreased platelet count), leukopenia (decreased white blood cell count), neutropenia (decreased neutrophil count), urticaria, rash, erythema, pruritus.
Rare: hypotension.
Very rare: tachycardia, renal colic, renal papillary necrosis, acute renal failure.
There have been very rare, treatment-requiring reports of hypersensitivity reactions: dyspnea, bronchospasm, excessive sweating.
Codeine, when 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 disorders, miosis, urinary retention, hypersensitivity reactions (itching, urticaria, and rash), constipation, nausea, vomiting, drowsiness, dizziness, bronchospasm, respiratory depression (see section 2. Important information before taking Efferalgan Codeine), acute abdominal pain with biliary or pancreatic colic, indicating spasm of the Oddi sphincter; this mainly applies to patients after cholecystectomy.
Taking codeine in doses higher than therapeutic may be associated with a risk of abuse, dependence in case of long-term use, and withdrawal symptoms after sudden cessation of the medicine. Withdrawal symptoms may occur in the treated person or in the newborn of a mother addicted to codeine during pregnancy (see section 2. Important information before taking Efferalgan Codeine. Pregnancy, breastfeeding, and fertility).
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 syndrome of symptoms related to damage to striated muscles), alternating muscle contractions and relaxations (clonic convulsions), paresthesia (tingling, numbness), fainting, tremors, confusion, 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 cessation 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 side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. 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
phone: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Efferalgan Codeine

The medicine should be stored in a place inaccessible to children.
Store in the original packaging to protect from heat and moisture.
Do not use Efferalgan Codeine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. 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 hemihydrate. Each effervescent tablet contains 500 mg of paracetamol and 30 mg of codeine phosphate hemihydrate.
The other ingredients are: sodium bicarbonate, sodium carbonate, citric acid, sorbitol (E 420), sodium lauryl sulfate, sodium benzoate (E 211), povidone, aspartame (E 951), natural grapefruit flavor.

What Efferalgan Codeine looks like and contents of the pack

Aluminum blisters containing 16 effervescent tablets in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Spain, the country of export:

UPSA SAS
3 rue Joseph Monier
92500 Rueil-Malmaison
France

Manufacturer

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

Parallel importer:

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

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Spain, the country of export: 669549.4

Parallel import authorization number: 103/24

Date of leaflet approval: 13.03.2024

[Information about the trademark]