Efferalgan Codeine

Leaflet attached to 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 you need to.
• If you have 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 as yours.
• If you experience any side effects, including any not listed in this leaflet, you should tell your 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 that contains 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 either of these components alone.
Indications for use:
Pain of moderate to severe intensity that does not respond to 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 opioid toxicity 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 years) 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 treatment with Efferalgan Codeine, you should discuss it with your doctor, pharmacist, or nurse:

You should not give this medicine to anyone else.
You should not use it without a doctor's recommendation.
Efferalgan Codeine contains paracetamol and codeine - an opioid pain reliever, so you should use it taking into account the 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 can lead to dependence. It is not recommended to take the medicine for a long time. You should exercise caution when using 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 can only be given on a doctor's prescription.
You should carefully monitor the child's level of consciousness (contact with the environment): before administering the medicine, you should check if the child is not experiencing excessive or abnormal drowsiness.
You should not take higher doses than recommended. Taking higher doses of paracetamol than recommended carries a risk of 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 can cause severe skin reactions (see section 4), such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal. You should inform your doctor about skin reactions and stop taking the medicine if a skin rash or any other sign of hypersensitivity occurs.
The effect of opioids on the central nervous system can 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 can exacerbate existing increased intracranial pressure. You should use it with caution in patients with head injuries and other intracranial injuries.
You should use it with caution in patients with epilepsy.
Long-term use of pain relievers, including opioid pain relievers, increases the risk of developing a headache caused by drug abuse.
In some people, opioid treatment, especially with chronic use, can cause increased sensitivity to pain.
Opioid administration can mask symptoms of severe 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 quantities, 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 you experience any of the following side effects, you should stop taking this medicine and contact your doctor immediately: slow or shallow breathing, disorientation, drowsiness, small pupils, nausea or vomiting, constipation, loss of appetite.
In patients after cholecystectomy, as codeine can cause acute abdominal pain related to the biliary tract or pancreas, usually accompanied by laboratory abnormalities indicating spasm of the Oddi sphincter.
You should use it with caution in patients with biliary tract disease (gallstones), prostatic hyperplasia, or difficulty urinating, with hypothyroidism, adrenal insufficiency. Opioids can 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 can inhibit the cough reflex and should not be used in patients who are expectorating secretions.
You should use it with caution in patients with hormonal disorders.
During treatment with the medicine, stiffness and/or alternating muscle contractions and relaxations (clonic convulsions) may occur.
During long-term use of opioid pain relievers, 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, the circulatory system should be constantly monitored.
Codeine can cause: constipation, which may be resistant to treatment with laxatives and require constant monitoring of bowel function; nausea and vomiting, itching.
You should exercise caution when using paracetamol if you have 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 alcoholism, excessive alcohol consumption (consuming 3 or more alcoholic beverages daily),
• anorexia, bulimia, cachexia,
• prolonged malnutrition,
• low glutathione reserves in the liver, e.g., anorexia, cystic fibrosis, HIV infection, starvation, or sepsis,
• dehydration,
• oligemia (reduced blood volume).

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 symptoms of morphine toxicity may worsen in these children.
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 used concomitantly:

• MAO inhibitors - you should not use them 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.
• Medicines containing salicylamide (a pain reliever used in feverish 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 using 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) - you should exercise caution when using 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. You should increase the frequency of INR monitoring during concomitant use and for one 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) - it reduces the excretion of paracetamol. When using Efferalgan Codeine concomitantly with probenecid, you should consider reducing the dose of paracetamol.
• Flucloxacillin - you should exercise caution when using flucloxacillin concomitantly with paracetamol due to the increased risk of developing a 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 urgent treatment.
• Enzyme inducers - you should exercise caution when using 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.
• Opioid agonists and antagonists (buprenorphine, butorphanol, nalbuphine, nalorphine, pentazocine - opioid pain relievers) - concomitant use leads to a reduction in analgesic effect and an increased risk of withdrawal syndrome.
• Naltrexone (an opioid receptor antagonist) - 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 as sedatives), 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, may increase the risk of central nervous system depression, leading to impaired consciousness, which can pose a risk when driving vehicles or operating machinery.

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.

• Concomitant administration of codeine with anticholinergic medicines may increase the inhibition of bowel function and lead to paralytic ileus.

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 intensity of codeine's effect, causing 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 malnourished for a long time and regularly drink 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 given to pregnant women if necessary. You should use the lowest effective dose that relieves pain or reduces fever and take the medicine 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 your 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 final 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 your ability to drive or use machines, so you should not drive or operate machinery while taking it.

Efferalgan Codeine contains sodium, sorbitol, sodium benzoate, and aspartame

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 have previously been diagnosed with intolerance to some sugars or have a rare genetic disorder, fructose intolerance, you should consult your doctor before taking the medicine or giving it to your child.
Sorbitol can cause gastrointestinal discomfort and has a mild laxative effect.
Each effervescent tablet contains 30 mg of aspartame. Aspartame is a source of phenylalanine. It can 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 can 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.

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!
You should not take higher doses than recommended. To avoid overdose, you should check if other medicines you are taking at the same time (including those available on prescription or over-the-counter) contain paracetamol or codeine.
Codeine should be used in the lowest 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 than every 6 hours. If you experience intense pain, you can take two effervescent tablets 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 codeine is 240 mg.
Children and adolescents
Children under 12 years of age: codeine should not be used in children under 12 years of age 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 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 of 240 mg.
The usual 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 than every 6 hours.
You should not take more than 4 effervescent tablets per day (which corresponds 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 than every 6 hours.
If you experience intense pain, you can take two effervescent tablets 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 (which corresponds 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 kidney dysfunction: in the case of impaired kidney function, 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 schedule:
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.
You should also consider reducing the dose and closely monitoring the child's condition.
Patients with liver dysfunction: in patients with liver dysfunction, you should reduce the dose of the medicine or prolong the intervals between consecutive doses. 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 chronic or compensated active liver disease, especially mild to moderate liver failure,
• Gilbert's syndrome (familial non-hemolytic hyperbilirubinemia),
• chronic alcoholism,
• prolonged malnutrition (low glutathione reserves in the liver),
• dehydration. In patients with liver dysfunction, you should also consider reducing the dose of codeine.

Method of administration
Oral administration. Before taking, the tablet should be dissolved in water. You should not swallow or chew the tablets.
Frequency of administration
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 treatment
The duration of treatment should be limited to 3 days, and if you do not achieve effective pain relief, you should consult your doctor.

Taking a higher dose of Efferalgan Codeine than recommended

In the event of an overdose or accidental ingestion of Efferalgan Codeine, you should immediately contact your doctor for advice.
Paracetamol
Overdose is particularly dangerous in the elderly, small children, malnourished patients, those with liver disease, and those 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, anorexia, 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 every case of ingestion of a single dose of paracetamol of 5 g or more, you should induce vomiting if it has not been more than an hour since ingestion and immediately contact your doctor. It is recommended to administer 60-100 g of activated charcoal orally, preferably mixed with water. You should immediately seek medical advice.
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 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 a decrease in heart rate, and the following may appear: sedation, euphoria, mood changes, miosis, urinary retention, allergic reactions (itching, hives, 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.
Symptoms in children: (toxic dose: 2 mg/kg bw given at one time): decreased respiratory rate, pauses in breathing, miosis, convulsions, allergic reactions: facial flushing and edema, urticaria, anaphylactic shock, urinary retention.
Procedure in case of overdose: the patient should be taken to the hospital immediately and monitored for breathing; if necessary, respiratory support, oxygen therapy, and other symptomatic treatment should be provided, as well as an antidote - naloxone.

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 but more than 1 in 1,000 patients treated
uncommon: in less than 1 in 1,000 but more than 1 in 10,000 patients treated
rare: in less than 1 in 10,000 patients treated
Common: malaise, decreased blood pressure, increased liver transaminase activity.
Uncommon: allergic reactions, tachycardia, diarrhea, abdominal pain, nausea, vomiting, renal colic, renal papillary necrosis, acute renal failure, thrombocytopenia (decreased platelet count), leukopenia (decreased white blood cell count), neutropenia (decreased neutrophil count), decreased or increased INR (blood clotting index).
Very rare: severe skin reactions, including acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal.
Codeine used 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, miosis, urinary retention, allergic reactions (itching, hives, 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 in the case of long-term 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, liver inflammation, anaphylactic reactions (severe allergic reactions), increased alkaline phosphatase levels in the blood, increased gamma-glutamyltransferase levels, rhabdomyolysis (a syndrome of symptoms related to muscle damage), alternating muscle contractions and relaxations, paresthesia (tingling, numbness), fainting, tremors, 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), 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)), flushing, hypotension.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. You can also report side effects 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
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Efferalgan Codeine

Store in the original packaging to protect from moisture.
Store out of the 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 month.
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, sodium lauryl sulfate, sodium benzoate, povidone, aspartame, natural grapefruit flavor.

What Efferalgan Codeine looks like and contents of the pack

Effervescent tablet
Packaging: Aluminum blisters containing 16 effervescent tablets - 4 pieces, 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
304, avenue du Dr Jean Bru
47000 Agen
France
UPSA
979, avenue des Pyrénées
47520 Le Passage
France

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Spanish marketing authorization number: 669549.4

Parallel import authorization number: 136/18 Date of leaflet approval: 19.04.2023

[Information about the trademark]