Efferalgan Codeine

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Efferalgan Codeine(Dafalgan Codéine)

500 mg + 30 mg, effervescent tablets

Paracetamol + Codeine phosphate
Efferalgan Codeine and Dafalgan Codéine are different trade names for the same drug.

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.
• 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 that contains two active substances with analgesic effects: paracetamol, which also has antipyretic properties, and codeine phosphate (an opioid pain reliever).
Paracetamol irritates the gastric mucosa less than salicylates.
Codeine belongs to a group of drugs 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:
Moderate to severe pain 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 the toxicity of opioid drugs due to the variable and unpredictable metabolism of codeine to morphine,
• in children with a body weight of less than 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 the increased risk of severe and life-threatening side effects,
• in the case of concomitant use with agonist-antagonist pain relievers: buprenorphine, butorphanol, nalbuphine, nalorphine, pentazocine,

Warnings and precautions

Before starting treatment with Efferalgan Codeine, you should discuss it with your doctor, pharmacist, or nurse. Do 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) 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. In patients with current or previously diagnosed addiction to opioids, the doctor should administer Efferalgan Codeine with caution or may prescribe other pain relief.
Neuropathic pain does not respond to codeine and paracetamol administration.
In order to relieve pain in children, codeine can only be administered on a doctor's prescription.
It is necessary to particularly control the child's level of consciousness (contact with the environment): before administering the medicine, it should be checked whether the child has excessive or abnormal drowsiness.
Do not take higher doses than recommended. Taking higher-than-recommended doses of paracetamol 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. You should inform your doctor about skin reactions and stop taking the medicine if a skin rash or any other sign of an allergic reaction occurs.
The action 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 in the case of concomitant use of other medicines and due to the patient's genetic conditions.
Codeine may exacerbate existing increased intracranial pressure. It should be used with caution 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 headache caused by drug overuse.
In some people, treatment with opioids, especially with chronic use, may cause increased 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 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 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, because codeine can cause acute abdominal pain related to the biliary tract or pancreas, which is usually accompanied by laboratory abnormalities indicating spasm of the Oddi sphincter.
It should be used with caution in patients with biliary tract diseases (gallstones), prostatic hyperplasia, or difficulty urinating, with hypothyroidism, adrenal cortical insufficiency. Opioids can cause urinary retention by reducing the tone of the smooth muscles of the bladder and dilating the bladder, as well as inhibiting the reflex of urination.
Codeine may inhibit the cough reflex and should not be used in patients who are expectorating secretions.
It should be used 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 drugs, tolerance to the drug 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 function of the circulatory system 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, excessive alcohol consumption (consuming 3 or more alcoholic beverages per day),
• anorexia, bulimia, cachexia,
• prolonged malnutrition,
• low glutathione reserves in the liver, e.g., anorexia, cystic fibrosis, HIV infection, starvation, or cachexia, 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 of less than 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 currently taking, or have recently taken, and about any medicines you 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 time of paracetamol.
• Drugs that increase liver metabolism - concomitant use of paracetamol and drugs such as St. John's wort, antiepileptic drugs, barbiturates (drugs used mainly in epilepsy), rifampicin (a drug used in tuberculosis and other infectious diseases) may lead to liver damage, even when recommended doses of paracetamol are used (see "Use of a higher than recommended dose of Efferalgan Codeine" in section 3).
• Isoniazid (a drug used in tuberculosis) and zidovudine (an antiviral drug used in HIV infection) - caution should be exercised when taken concomitantly with these medicines.
• Non-steroidal anti-inflammatory drugs (NSAIDs) - concomitant use increases the risk of kidney function disorders.
• Oral anticoagulants - concomitant use of paracetamol with anticoagulant drugs from the coumarin group, including warfarin, may slightly change the INR value. It is recommended to increase the frequency of INR monitoring during concomitant use and for one week after discontinuation of paracetamol.
• Phenytoin (a drug 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 drug used in gout) - reduces the excretion of paracetamol. When taken concomitantly with Efferalgan Codeine and probenecid, it is recommended to consider reducing the dose of paracetamol.
• Flucloxacillin - caution should be exercised when taken concomitantly with flucloxacillin due to the increased risk of developing a blood and fluid disorder (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 - caution should be exercised when taken 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.
• Naltrexone (an opioid receptor antagonist) - concomitant use poses a risk of reduced analgesic effect. The dose of morphine derivatives may need to 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 suppressant 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, 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

Do 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 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 possible dose should be used, effectively relieving pain 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 decrease, or if it is necessary to increase the frequency of administration, you should consult your doctor.
Breastfeeding
Do 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 operating machinery

This medicine may impair your ability to drive or operate machinery, 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 19.25% 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 have a rare genetic disorder called hereditary fructose intolerance, you should consult your doctor before taking the medicine or giving it to your 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 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.

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.
This 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 that other medicines you are taking (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 often than every 6 hours. If you experience intense pain, you can take 2 effervescent tablets 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 the maximum daily dose of 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 aged 12 and over (with a body weight of 33 kg to 50 kg, only an approximate weight range is given in relation to age): the dose is determined based on body weight. The recommended dose of paracetamol is 10 to 15 mg/kg of body weight every 4 to 6 hours, up to a maximum daily dose of 60 mg/kg of body weight per 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 to 1 mg/kg every 6 hours, up to a maximum daily dose of 240 mg of codeine. The usual recommended dose 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 often than every 6 hours. Do 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 of more than 50 kg: 1 effervescent tablet at a time. If necessary, the dose can be repeated, but not more often than every 6 hours.

In the case of intense pain, 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 (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 renal impairment: in the case of impaired renal function, there is a risk of accumulation of codeine and paracetamol. In patients with moderate to severe renal impairment, the recommended dose is 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
Adolescents with renal impairment 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. It is also recommended to consider reducing the dose and closely monitoring the patient's condition.
Patients with liver dysfunction: in 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 of body weight per day (should not exceed 2 g/day):

• in adults with a body weight of less than 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 prolonged malnutrition (low glutathione reserves in the liver),
• in patients with dehydration. In patients with liver dysfunction, it is also recommended to consider reducing the dose of codeine.

Method of administration
Oral administration. Before taking, the tablet should be dissolved in water. Do not swallow or chew the tablets.
Frequency of administration
Systematic administration 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 effective pain relief is not achieved, patients (or their caregivers) should consult a doctor.

Taking a higher than recommended dose of Efferalgan Codeine

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, malnourished patients, those with liver disease, and those taking enzyme-inducing medicines, as they 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 any case of ingestion of more than 5 g of paracetamol at a time, you should induce vomiting if it has not been more than an hour since ingestion and immediately contact a 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 inhibition, 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 respiratory depression, which can lead to death in case of overdose; drowsiness, rash, vomiting, itching, ataxia, respiratory depression (see section 2. "When not to take Efferalgan Codeine"), acute abdominal pain with characteristics of biliary tract or pancreatic disease, indicating spasm of the Oddi sphincter; mainly in patients after cholecystectomy.
Symptoms in children (toxic dose: 2 mg/kg of body weight taken at a time): decreased respiratory rate, pauses in breathing, miosis, convulsions, symptoms of histamine release: flushing and swelling of the face, urticaria, anaphylactic shock, angioedema.
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 administered, as well as an antidote - naloxone.

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, 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 listed below is defined as follows:
common: in less than 1 in 100 patients, but more than 1 in 1,000 patients treated
uncommon: in less than 1 in 1,000 patients, but more than 1 in 10,000 patients treated
rare: in less than 1 in 10,000 patients, but more than 1 in 100,000 patients treated
very rare: in less than 1 in 100,000 patients, including isolated reports.
Uncommon: malaise, decreased blood pressure, increased liver transaminase activity.
Very rare: 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, requiring withdrawal of treatment, cases of allergic reactions have been reported: skin redness, rash, erythema, or urticaria, angioedema (swelling of the deep layers of the skin and subcutaneous tissue), dyspnea, bronchospasm, excessive sweating, decreased blood pressure, up to symptoms of anaphylactic shock (a severe, life-threatening allergic reaction, its symptoms include dyspnea, swelling of the larynx and throat, itching of the skin, and redness, headache, feeling of "pressure", dizziness, significant weakness, up to loss of consciousness; in severe cases, it can be life-threatening) and angioedema.
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, allergic 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 disease, indicating spasm of the Oddi sphincter; mainly in patients after cholecystectomy.
Taking codeine in doses higher than therapeutic ones is associated with the risk of dependence and the occurrence of withdrawal symptoms after sudden cessation of treatment. Withdrawal symptoms may occur in the treated person or in the newborn born to a mother addicted to codeine.
Other side effects associated with the use of Efferalgan Codeine: pancreatitis, weakness, malaise, biliary colic, liver inflammation, anaphylactic reactions (severe, rapidly progressing 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 (clonic convulsions), paresthesia (tingling, numbness), fainting, tremors, confusion, drug abuse, drug dependence, hallucinations, flushing, 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, 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

The medicine should be stored out of the sight and reach of children.
Store in the outer packaging to protect from 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 stated.
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.
1 effervescent tablet contains 500 mg of paracetamol and 30 mg of codeine phosphate.
The other ingredients are: sodium bicarbonate, sodium carbonate anhydrous, citric acid anhydrous, sorbitol, sodium lauryl sulfate, sodium benzoate, povidone, aspartame, natural grapefruit flavor.

What Efferalgan Codeine looks like and contents of the pack

Effervescent tablet.
Packaging:
Polypropylene tubes with a cap, containing 16 effervescent tablets - 8 tablets in a tube, in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in France, the country of export:

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

Manufacturer:

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

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw
Marketing authorization number in France, the country of export:3400933316778
333 167-7
Parallel import authorization number:540/12
Date of leaflet approval: 13.07.2022
[Information about the trademark]