Efferalgan Codeine

Leaflet attached to the packaging: patient information

WARNING: Keep the leaflet, information on the immediate packaging in a foreign language.

Efferalgan Codeine (Cod-Efferalgan)

500 mg + 30 mg, effervescent tablets

Paracetamol + Codeine phosphate
Efferalgan Codeine Cod-Efferalganare 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 or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What Efferalgan Codeine is and what it is 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 Efferalgan Codeine is and what it is 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 (an opioid pain reliever).
Paracetamol irritates the stomach mucosa less 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 from 12 years of age, 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

• if you are allergic to paracetamol or propacetamol hydrochloride (a prodrug of paracetamol), codeine, or any of the other ingredients of this medicine (listed in section 6),
• 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 (from 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,

obstructive sleep apnea syndrome with an increased risk of severe and life-threatening side effects,

• if you have severe liver dysfunction or active liver disease,
• if you have severe kidney failure,
• if you have alcoholic disease,
• if you are being treated with MAO inhibitors (medicines used, among others, in depression) and within 14 days after the end of treatment,
• in the case of concomitant use with agonist-antagonist pain relievers: buprenorphine, butorphanol, nalbuphine, nalorphine, pentazocine,
• if you have asthma or respiratory failure,
• if you metabolize codeine to morphine too quickly,
• in women during the first trimester of pregnancy,
• in breastfeeding women.

Warnings and precautions

You should discuss the use of Efferalgan Codeine with your doctor, pharmacist, or nurse before starting treatment. Do not use 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) to avoid using 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 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.
• In order to relieve pain in children, codeine can 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 the risk of very severe liver damage. Symptoms of liver damage usually appear 1-2 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.
• Use 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 the symptoms of serious abdominal conditions.
• Codeine is converted to morphine by liver enzymes. Morphine is a substance that relieves pain. Some people have a changed enzyme and this can affect them in different ways. In some people, morphine is not produced or is produced in very small amounts, which does not provide adequate pain relief. Other people are more prone to

severe side effects caused by the production of very large amounts of morphine. If 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 may cause acute abdominal pain associated with bile ducts or pancreas, usually accompanied by laboratory abnormalities indicating spasm of the Oddi sphincter.
• Use with caution in patients with bile duct diseases (gallstones), prostatic hyperplasia, or difficulty urinating, with hypothyroidism, hypoadrenalism. Opioids can cause urinary retention by reducing the tone of the smooth muscles of 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.
• Use with caution in patients with hormonal disorders.
• During treatment, stiffness and/or alternating muscle contractions and relaxations (clonic convulsions) may occur.
• With long-term use of opioid drugs, tolerance to the drug or decreased analgesic effectiveness 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.

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, wasting of the body,
• long-term 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 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 the 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 used 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 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 recommended doses of paracetamol are used (see "Using a higher dose of Efferalgan Codeine than recommended" in section 3).
• Isoniazid (a medicine used in tuberculosis) and zidovudine (an antiviral medicine used in HIV infection) - caution should be exercised when 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. The frequency of INR monitoring should be increased during concomitant use and for one week after discontinuation of paracetamol.
• Phenytoin (a medicine used in epilepsy) - concomitant use may reduce the effectiveness of paracetamol and increase the risk of liver toxicity. Patients treated with phenytoin should avoid high and/or prolonged doses of paracetamol. These patients should be constantly monitored for signs of liver damage.
• Probenecid (a medicine used in gout) - reduces the excretion of paracetamol. When using Efferalgan Codeine concomitantly with probenecid, the dose of paracetamol should be considered for reduction.
• Flucloxacillin - caution should be exercised 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 - 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 dose 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 an anxiolytic, sedative, hypnotic, and anticonvulsant effect), barbiturates (medicines used mainly as sedatives), methadone (an opioid medicine with analgesic effect) - 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 machines.
• Concomitant administration of codeine with cholinolytic 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 Efferalgan Codeine. Alcohol increases the sedative effect of opioid pain relievers. The intensity of codeine's effect, causing impaired consciousness, may pose a risk when driving vehicles or operating machines. 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 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 during 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 machines

This medicine may impair your ability to drive or operate machines. Therefore, do not drive or operate machines while taking this medicine.

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

Each effervescent tablet contains 385 mg of sodium (the main component of table salt). This corresponds to 19% of the maximum recommended daily intake of sodium in the diet for adults. If 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, 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, you should consult your doctor or pharmacist.
The medicine is intended for use in adults and adolescents with a body weight of 33 kg or more (from 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 used in the smallest effective dose for the shortest possible time.
The recommended dose is:
Adults: one effervescent tablet at a time. If necessary, the dose can be repeated, but not more often than every 6 hours. If you experience intense pain, you can take two effervescent tablets at a time.
Usually, it is not necessary to use a daily dose greater than 6 effervescent tablets. However, in the case of very severe pain, the daily dose can be increased to a maximum of 8 effervescent tablets. The maximum daily dose of paracetamol, taking into account all medicines containing paracetamol, is 4 g, and codeine is 240 mg.
Children and adolescents:
Children under 12 years of age: 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 from 12 years of age and older (with a body weight from 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 (bw) every 4 to 6 hours, up to a maximum daily dose of 60 mg/kg bw/day (up to 3 g of paracetamol for a patient with a body weight of 50 kg).
The recommended dose of codeine is 0.5 mg/kg bw to 1 mg/kg bw every 6 hours, up to a maximum daily dose of codeine - 240 mg.
Usually, the recommended dose of Efferalgan Codeine 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 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 over 50 kg: one 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, you can take two effervescent tablets at a time.
Usually, it is not necessary to use a daily dose greater 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.
The dose should also be considered for reduction, and the child's condition should be closely monitored.
Patients with liver dysfunction: in patients with liver dysfunction, the dose of the medicine should be reduced or the intervals between consecutive doses prolonged. 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,
• long-term malnutrition (low glutathione reserves in the liver),
• dehydration. In patients with liver dysfunction, the dose of codeine should also be considered for reduction.

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 caregivers) should consult a 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 a doctor for 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 have an increased risk of liver damage.
Symptoms: overdose may cause symptoms within a few to several hours, such as nausea, vomiting, loss of appetite, pallor, excessive sweating, drowsiness, and general weakness.
These symptoms may resolve the next day, 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 paracetamol in a dose of 5 g or more, 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 attention.
Codeine
Symptoms in adults: acute respiratory depression (cyanosis, respiratory arrest, shallow breathing), excessive sedation, and miosis are the main symptoms of codeine overdose and other opioids. Other symptoms related to the central nervous system may also occur, such as headache, vomiting, urinary retention, slowed bowel movements, bradycardia, and decreased blood pressure. Additionally, there may be slowed heart rate, and respiratory depression, as well as symptoms of histamine release: flushing and swelling of the face, urticaria, hypotension, and anaphylactic shock; very rarely, respiratory arrest, convulsions, and cardiac arrest may occur.
Symptoms in children: (threshold toxic dose: 2 mg/kg bw administered at one time) decreased respiratory rate, pauses in breathing, miosis, convulsions, symptoms of histamine release: flushing and swelling of the face, urticaria, hypotension, and anaphylactic shock.
Procedure in case of overdose: the patient should be taken to the hospital immediately and monitored for breathing, and 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, Efferalgan Codeine can cause side effects, although not everybody gets them.
The frequency of side effects listed below is defined as follows:
Rare: in less than 1 in 1,000 but more than 1 in 10,000 patients treated.
Very rare: in less than 1 in 10,000 patients treated.
Rare: malaise, decreased blood pressure, increased liver transaminase 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: flushing, rash, erythema, or urticaria, angioedema (swelling of the deep layers of the skin and subcutaneous tissue), dyspnea, bronchospasm, excessive sweating, hypotension, and anaphylactic shock (a severe, life-threatening allergic reaction, its symptoms include dyspnea, swelling of the larynx and throat, itching, and flushing of the skin, headache, feeling of "tightness", dizziness, severe weakness, and loss of consciousness); as well as edema and severe skin reactions: acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis.
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 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 characteristics of biliary colic or pancreatitis, indicating spasm of the Oddi sphincter; this mainly applies to 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 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 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, drug dependence, hallucinations, flushing, hypotension.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
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 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, sodium lauryl sulfate, sodium benzoate, povidone, aspartame, natural grapefruit flavor.

What Efferalgan Codeine looks like and contents of the pack

Effervescent tablet
Packaging:
16 effervescent tablets in 4 blisters of aluminum foil, in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Spain, the country of export:

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

Manufacturer:

UPSA, 979, avenue des Pyrénées, 47520 Le Passage, France

Parallel importer:

PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged by:

Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warszawa
LABOR Przedsiębiorstwo Farmaceutyczno-Chemiczne Sp. z o.o., ul. Długosza 49, 51-162 Wrocław
CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warszawa
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
Shiraz Productions Sp. z o.o., ul. Tymiankowa 24/28, 95-054 Ksawerów
Spanish authorization number:669549.4
Parallel import authorization number:309/17
Date of approval of the leaflet: 21.09.2022