Efferalgan Codeine

LEAFLET INCLUDED IN THE PACKAGING: PATIENT INFORMATION

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Efferalgan Codeine(Dafalgan Codéine)

500 mg + 30 mg, effervescent tablets

Paracetamol + Codeine phosphate hemihydrate
Efferalgan Codeine and Dafalgan Codéine 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.
• 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 as yours.
• If the patient experiences any side effects, including any side effects not listed in the 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 a pain-relieving effect: paracetamol, which also has an antipyretic effect, and codeine phosphate hemihydrate (an opioid pain reliever).
Paracetamol irritates the stomach mucosa to a lesser extent than salicylates.
Codeine belongs to a group of medicines called opioid pain relievers, 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 pain-relieving 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 agonist-antagonist pain relievers: 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. Do not take it without a doctor's recommendation.
Efferalgan Codeine contains paracetamol and codeine - an opioid pain reliever, so it should be used taking into account the concomitant use of other medicines containing paracetamol or codeine (including those available on prescription or over-the-counter), so as not to exceed the recommended daily dose (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 dependence on opioids, the doctor should administer Efferalgan Codeine with caution or may prescribe other pain relief treatment.
Neuropathic pain does not respond to codeine and paracetamol administration.
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.
Do not take higher doses than recommended. Taking higher doses of paracetamol than recommended carries a 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 within 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 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 used concomitantly with 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 medication-overuse headache.
In some people, opioid treatment, 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 amounts, which does not provide adequate pain relief. Other people are more likely to experience severe side effects caused by the production of very large amounts of morphine. If the patient experiences any of the following side effects, they should stop taking the medicine and contact their doctor immediately: slow or shallow breathing, disorientation, drowsiness, small pupils, nausea or vomiting, constipation, loss of appetite.
In patients after cholecystectomy, because codeine may 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 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 urination reflex.
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, 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 circulatory system 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 administering paracetamol to a patient who 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 alcoholism, excessive alcohol consumption (consuming 3 or more alcoholic beverages daily),
• anorexia, bulimia, cachexia,
• prolonged malnutrition,
• low glutathione reserves in the liver, e.g. due to 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 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 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 feverish conditions) - concomitant use prolongs the elimination time of paracetamol.
• Medicines that increase liver metabolism - concomitant use of paracetamol and medicines such as St. John's wort, antiepileptic drugs, barbiturates (a medicine used mainly in epilepsy), rifampicin (a medicine 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 medicine used in tuberculosis) and zidovudine (an antiviral medicine used in HIV infection) - caution should be exercised when used 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 medicines 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 paracetamol is discontinued.
• Phenytoin (a medicine used in epilepsy) - concomitant use may reduce the efficacy of paracetamol and increase the risk of liver toxicity. Patients treated with phenytoin should avoid high and/or prolonged doses of paracetamol. These patients should be constantly monitored for signs of liver damage.
• Probenecid (a medicine used in gout) - reduces the elimination of paracetamol. When Efferalgan Codeine is used concomitantly with probenecid, the dose of paracetamol should be considered for reduction.
• Flucloxacillin - caution should be exercised when flucloxacillin is used concomitantly with paracetamol, due to the increased risk of developing a disorder affecting the 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 urgent treatment.
• Enzyme inducers: caution should be exercised when used 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 doses of morphine derivatives should be increased if necessary.
• Other morphine derivatives with an analgesic effect (alfentanil, dextromoramide, dextropropoxyphene, dihydrocodeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine, phenoperidine, remifentanil, sufentanil, tramadol) and morphine derivatives with an antitussive effect (dextromethorphan, noscapine, pholcodine) and morphine derivatives with a cough-suppressing effect (codeine, ethylmorphine), as well as benzodiazepines (medicines with an anxiolytic, sedative, hypnotic and anticonvulsant effect), 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 medicines with a sedative effect: 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 that block H1 receptors with a sedative effect, centrally acting antihypertensive medicines, baclofen and thalidomide - concomitant use increases the risk of central nervous system depression, leading to disorders of consciousness that 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

While taking Efferalgan Codeine, you should not drink alcohol or take medicines containing alcohol. Alcohol increases the sedative effect of opioid pain relievers. The intensity of codeine's effect, causing disorders of consciousness, may pose a risk when driving vehicles or operating machinery. Additionally, there is a risk of toxic liver damage, especially in people who are 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 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 decrease, 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 related to 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 and use machines, so you should not drive or operate machinery while taking it.

Efferalgan Codeine contains sodium, sorbitol (E 420), sodium benzoate (E 211) and aspartame (E 951), as well as fructose, glucose, sucrose and sulfites, which are components of the natural grapefruit flavor.

Each effervescent tablet contains 385 mg of sodium (the main component of table 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 previously been diagnosed with intolerance to some sugars or hereditary fructose intolerance (a rare genetic disease 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 may have a mild laxative effect. The medicine contains 59 mg of sodium benzoate in each effervescent tablet. Sodium benzoate in the medicine may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of life) whose mothers took this medicine during pregnancy.

• 4. If the mother took the medicine during pregnancy.

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 disease in which phenylalanine accumulates in the body due to its improper excretion). Patients with phenylketonuria should not take this medicine. The medicine contains 5 mg of fructose, glucose and sucrose in each effervescent tablet. If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine. The medicine contains 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 and above (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) 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: single dose - 1 effervescent tablet. 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 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 - 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 body weight every 4 to 6 hours, up to a maximum daily dose of 60 mg/kg body weight/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 body weight to 1 mg/kg body weight every 6 hours, up to a maximum daily dose of codeine - 240 mg.
Usually, the recommended dose of the medicine is a single dose - 1 effervescent tablet (500 mg of paracetamol and 30 mg of codeine). 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 240 mg of codeine).
Adolescents with a body weight over 50 kg: single dose - 1 effervescent tablet. If necessary, the dose can be repeated, but not more often than every 6 hours.
In the case of intense pain, you can take 2 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 effect 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 body weight/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, 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
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 effective pain relief is not achieved, patients (or their caregivers) should consult a doctor.

Use of a higher than recommended dose of Efferalgan Codeine

In case of overdose or accidental ingestion of Efferalgan Codeine, you should immediately consult a doctor for appropriate advice.
Paracetamol
Overdose is particularly dangerous in the elderly, small children, patients who are malnourished for a long time, have liver disease, and patients taking medicines that induce liver enzymes, as these individuals are at increased risk of liver damage.
Symptoms: Overdose of the medicine may cause symptoms such as nausea, vomiting, loss of appetite, pallor, excessive sweating, drowsiness and general weakness within a few to several hours. These symptoms may resolve the next day, despite the fact that liver damage is developing, which will then manifest as abdominal distension, return of nausea and jaundice.
Procedure in case of overdose: in every case of single ingestion of paracetamol in a dose of 5 g (10 tablets) 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 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 the following may occur: drowsiness, rash, vomiting, itching, unsteady gait, bronchospasm (less frequently), respiratory pauses, convulsions, symptoms of histamine release: flushing and swelling of the face, urticaria, collapse, urinary retention.
Symptoms in children: (the threshold toxic dose is 2 mg/kg body weight, administered in a single dose) 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 used, and an antidote - naloxone - should be administered.

Missing a dose of Efferalgan Codeine

You should not take a double dose to make up for a missed dose.
In case of 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:
rare: in less than 1 in 1,000 but more than 1 in 10,000 treated patients
very rare: in less than 1 in 10,000 treated patients
Rare: malaise, decreased blood pressure, increased liver enzyme activity.
Very rare: hypersensitivity 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 hypersensitivity reactions have been reported: skin redness, rash, flushing or urticaria, angioedema (swelling of the deep layers of the skin and subcutaneous tissue), dyspnea, bronchospasm, excessive sweating, decreased blood pressure up to anaphylactic shock (a severe, life-threatening allergic reaction, its symptoms include dyspnea, swelling of the larynx and throat, itching and redness of the skin, headache, feeling of "pressure", dizziness, significant weakness, up to loss of consciousness); as well as severe skin reactions: acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis.
Codeine, when 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 disorders, miosis, urinary retention, hypersensitivity reactions (itching, urticaria and rash), constipation, nausea, vomiting, drowsiness, dizziness, bronchospasm, respiratory depression (see section 2. "When not to take Efferalgan Codeine"), acute abdominal pain with symptoms characteristic of biliary tract or pancreatic disorders, indicating spasm of the Oddi sphincter; this mainly applies to patients after cholecystectomy.
Use of codeine in doses higher than therapeutic may be associated with a risk of dependence and the occurrence of withdrawal symptoms after sudden cessation of the medicine. Withdrawal symptoms may occur in the treated person or in a newborn born to a mother dependent on codeine.
Other side effects associated with the use of Efferalgan Codeine: pancreatitis, weakness, malaise, biliary colic, hepatitis, anaphylactic reactions (severe, rapidly progressing allergic reactions), increased alkaline phosphatase levels in the blood, increased gamma-glutamyltransferase levels, rhabdomyolysis (a set 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 the 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 this medicine 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 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 docusate, sodium benzoate (E 211), povidone, aspartame (E 951), natural grapefruit flavor (containing, among others, ethanol, fructose, glucose, sucrose and sulfites).

What Efferalgan Codeine looks like and contents of the packaging

Effervescent tablet.
Packaging:
16 effervescent tablets - 8 effervescent tablets in 2 polypropylene tubes, in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or 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:

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

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Marketing authorization number in France, the country of export: 34009 333 167 7 8
333 167-7
Parallel import authorization number: 369/22
Date of leaflet approval: 05.10.2022
[Information about the reserved trademark]