Paracetamol and codeine Alter

Italy
Brand name Paracetamol and codeine Alter
Form tablets, effervescent
Active substance / Dosage
CODEINE PHOSPHATE
PARACETAMOL
Prescription type Prescription only – non-repeatable
ATC code
N02AJ06
Registration number 037351
Manufacturer LABORATORI ALTER S.R.L.

Table of Contents

Package leaflet: Information for the patient

Paracetamol and Codeine Alter 500 mg + 30 mg effervescent tablets

Paracetamol and Codeine Phosphate
Equivalent medicine
Please read all of this leaflet carefully before you take this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
  • If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

  1. What Paracetamol and Codeine Alter is and what it is used for
  2. What you need to know before taking Paracetamol and Codeine Alter
  3. How to take Paracetamol and Codeine Alter
  4. Possible side effects
  5. How to store Paracetamol and Codeine Alter
  6. Contents of the pack and other information

1. What Paracetamolo e Codeina Alter is and what it is used for

Paracetamolo e Codeina Alter contains the two active substances paracetamol and codeine, which act in different ways. Paracetamol belongs to a group of medicines called analgesics and antipyretics, and works by relieving pain (analgesic effect) and reducing fever (antipyretic effect). Codeine belongs to a group of medicines called opioid analgesics, which relieve pain.
Paracetamolo e Codeina Alter is indicated in patients over 12 years of age for the treatment of symptoms of acute moderate pain that does not respond to treatment with other painkillers such as paracetamol or ibuprofen used alone.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before using Paracetamol and Codeine Alter

Do not use Paracetamol and Codeine Alter
If:

  • you are allergic to paracetamol or propacetamol hydrochloride (a precursor of paracetamol), codeine, or any of the other ingredients of this medicine (listed in section 6)
  • you are under 12 years of age
  • you suffer from a lung disease (respiratory insufficiency), as codeine may worsen your condition
  • you are between 0 and 18 years of age and have undergone tonsil or adenoid removal due to a breathing disorder called obstructive sleep apnoea syndrome
  • you have a liver enzyme that causes your body to convert codeine into high levels of morphine (detected through urine testing), increasing the risk of serious adverse effects
  • you are breastfeeding (see section “Pregnancy and breastfeeding”)

Warnings and precautions
Talk to your doctor or pharmacist before using Paracetamol and Codeine Alter. Consult your
doctor if:

  • you have undergone gallbladder surgery (removal), as codeine may cause abdominal pain (acute biliary or pancreatic pain associated with spasm of the sphincter of Oddi)
    • you have mild to moderate reduction in liver function
    • you have Gilbert’s syndrome (a condition characterized by excessive bilirubin production, manifesting as yellowing of the skin and eyes)
    • you suffer from severe liver problems (severe hepatopathy)
    • you currently have acute hepatitis (acute inflammation of the liver)
    • you are taking medicines that stimulate liver enzymes (increasing liver activity)
    • you have glucose-6-phosphate dehydrogenase deficiency (an enzyme normally present in the human body; its deficiency may cause haemolytic anaemia)
    • you suffer from haemolytic anaemia (a disease caused by destruction of red blood cells)
    • you suffer from kidney disease impairing kidney function (renal insufficiency)
    • you chronically consume alcohol. Alcohol consumption during treatment is not recommended
    • you suffer from anorexia (an eating disorder characterized by food refusal)
    • you suffer from bulimia (an eating disorder involving excessive food intake followed by attempts to eliminate it)
    • you are in a state of cachexia (a condition characterized by extreme thinness, reduced muscle mass, and thinning skin due to chronic illness)
    • you suffer from chronic malnutrition
    • you suffer from dehydration (severe loss of water/fluids from the body)
    • you suffer from hypovolemia (reduced blood volume circulating in the body)
    • you are in a state of prolonged fasting
    • you have a cough with mucus production
    • you suffer from, or have a history of, opioid, alcohol, prescription medicine, or illicit substance dependence
  • you suffer from a mental disorder (e.g. major depression)
  • you have increased intracranial pressure
  • you suffer from severe conditions, including severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In patients with these conditions, a serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported when paracetamol is used regularly over a prolonged period or when paracetamol is taken concomitantly with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep, rapid breathing, drowsiness, nausea, and vomiting.
  • you experience pain or increased sensitivity to pain (hyperalgesia) that does not respond to higher doses of the medicine
  • contact your doctor if you experience severe pain in the upper abdomen that may radiate to the back, nausea, vomiting, or fever, as these may be symptoms associated with pancreatitis (inflammation of the pancreas) or disorders of the biliary tract.

Regular and prolonged use of codeine (one of the active ingredients in this medicine) may
lead to dependence and misuse, potentially resulting in overdose and even death. Do not take
this medicine longer than necessary. Do not give this medicine to anyone else.
Paracetamol may cause severe skin reactions that can be fatal. Treatment with Paracetamol and
Codeine Alter must be discontinued at the first sign of skin rash or any other sign of
hypersensitivity (allergic reaction).
Opioid therapy may cause:

  • respiratory depression (reduced breathing activity) and sedation
  • lowered seizure threshold (i.e. increased excitability of the nervous system and increased risk of seizures in epilepsy)
  • hyperalgesia (increased sensitivity to pain)
  • constipation (difficult or infrequent bowel movements)
  • nausea and vomiting
  • masking of symptoms of acute abdominal conditions (conditions characterized by severe pain and signs of abdominal irritation)
  • obstruction of bile and pancreatic juice outflow, as in certain biliary tract diseases, e.g. pancreatitis (inflammation of the pancreas) and cholelithiasis (presence of gallstones in the gallbladder)
  • increased histamine release, as in asthma (airway obstruction)
  • itching
  • reduced hormone levels
  • immunological function inhibition (i.e. suppression of the body’s defence system)
  • muscle rigidity and myoclonus (involuntary rapid muscle jerks)
  • urinary retention (difficulty emptying the bladder), particularly in patients with urethral narrowing or enlarged prostate
  • Sleep-related breathing disorders
    Paracetamol and codeine may cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep-related hypoxemia (low blood oxygen levels during sleep). Symptoms may include breathing pauses during sleep, waking up at night gasping for breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Use of high doses and/or prolonged use
High or prolonged use of paracetamol may cause liver disease (hepatopathy) and serious
alterations in the kidneys and blood.
Prolonged use of analgesics, including opioids, increases the risk of medication-overuse
headache. Additionally, in elderly patients, prolonged use may worsen pre-existing conditions.
Prolonged use of analgesics (for more than 3 months) in patients with chronic headache, especially
if frequent and recurrent, may increase or worsen headache. In such cases, medical advice should
be sought.
Tolerance, physical dependence, and psychological dependence
This medicine contains codeine, an opioid medicine. It may cause dependence and/or
tolerance.
Repeated use of opioids may lead to reduced drug effectiveness (the body becomes accustomed
to the drug, a phenomenon known as tolerance). Repeated use of Paracetamol and Codeine
Alter may also cause physical dependence, abuse, and psychological dependence, potentially
leading to life-threatening overdose. The risk of these adverse effects may increase with higher
doses and prolonged use.
Physical or psychological dependence may make you feel you have lost control over the amount
or frequency of medicine intake.
The risk of physical or psychological dependence varies from person to person. You may be at
higher risk of physical or psychological dependence on Paracetamol and Codeine Alter if:

  • you or a family member has abused or been dependent on alcohol, prescription medicines, or illegal drugs (“psychological dependence”)
  • you are a smoker
  • you have previously had mood disorders (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental illnesses

If you notice any of the following signs while taking Paracetamol and Codeine Alter, it may
indicate physical or psychological dependence:

  • you need to take the medicine longer than recommended by your doctor
  • you need to take larger amounts than the recommended dose
  • you feel the need to continue taking the medicine, even if it no longer relieves your symptoms
  • you are using the medicine for reasons other than prescribed, e.g., “to stay calm” or “to help you sleep”
  • you have made repeated unsuccessful attempts to stop or control medicine use
  • you feel unwell when stopping the medicine and feel better when taking it again (“withdrawal effects”)
    If you notice any of these signs, consult your doctor to determine the best treatment plan for you, including when and how to safely discontinue the medicine (see section 3, “If you stop taking Paracetamol and Codeine Alter”).

With prolonged opioid use, reduced analgesic effectiveness (tolerance) may occur.
Prolonged administration of codeine or doses above therapeutic levels may lead to physical and
psychological dependence (tolerance) and withdrawal syndrome upon sudden discontinuation,
which may occur both in patients and in newborns born to codeine-dependent mothers.
Paracetamol and Codeine Alter should be used with caution in patients with dependence or a
history of opioid dependence, and alternative analgesic therapies should be considered.
Elderly patients
Elderly patients may be at higher risk of adverse effects associated with opioid use, such as
respiratory depression and constipation.
Children and adolescents
Do not give codeine for pain relief in children and adolescents after tonsil or adenoid removal
for obstructive sleep apnoea syndrome.
Children and adolescents should be closely monitored for signs of central nervous system
depression associated with codeine, such as extreme drowsiness and respiratory depression.
Codeine is not recommended in children and adolescents with respiratory problems, as symptoms
of morphine toxicity may be more severe.
Other medicines and Paracetamol and Codeine Alter
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine.

  • other medicines containing paracetamol, as high doses of paracetamol may cause serious adverse effects
  • other medicines containing opioids or other substances that depress the central nervous system, to avoid the risk of overdose or serious adverse effects
  • coumarin anticoagulants including warfarin (medicines that delay blood clotting): your doctor will perform stricter monitoring of INR values (blood clotting time)
  • medicines or substances that stimulate liver enzymes (overloading liver function), for example:
    • rifampicin (an antibiotic)
  • cimetidine (a medicine used to treat stomach ulcers)
  • antiepileptic medicines (used to treat epilepsy), e.g. glutethimide, phenobarbital, carbamazepine, and phenytoin. In case of phenytoin treatment, avoid high or prolonged doses of paracetamol.
  • flucloxacillin (an antibiotic), due to a serious risk of blood and fluid imbalance (metabolic acidosis) requiring urgent treatment
  • gabapentin or pregabalin for the treatment of epilepsy or nerve-related pain (neuropathic pain)

The use of these medicines with Paracetamol and Codeine Alter requires extreme caution and should
only be done under strict medical supervision:

  • probenecid, a medicine used to treat hyperuricaemia (high uric acid levels in the blood) and gout (joint inflammation due to uric acid deposits): your doctor may advise reducing the dose of Paracetamol and Codeine Alter
  • salicylamide (an analgesic and antipyretic medicine)
  • chloramphenicol (an antibiotic): may increase the risk of possible adverse effects
  • medicines that slow stomach emptying, such as anticholinergics: these medicines delay the effect of Paracetamol and Codeine Alter
  • zidovudine (a medicine for HIV treatment)
  • potent analgesics (buprenorphine, butorphanol, nalbuphine, nalorphine, pentazocine)
  • nalmefene and naltrexone (medicines for treating dependence on alcohol and drugs, respectively)
  • antihistamines (medicines for treating allergies)
  • analgesics (alfentanil, dextromoramide, dextropropoxyphene, fentanyl, dihydrocodeine, hydromorphone, morphine, oxycodone, pethidine, phenoperidine, remifentanil, sufentanil, tramadol)
  • medicines for treating cough (dextromethorphan, noscapine, pholcodine, codeine, ethylmorphine)
  • medicines for treating psychiatric disorders (chlorpromazine, haloperidol, levomepromazine, thioridazine)
  • methadone (a medicine for treating dependence on certain narcotics)
  • meprobamate (a medicine for treating anxiety)
  • benzodiazepines and barbiturates (medicines for treating insomnia and anxiety)
  • medicines for treating depression (paroxetine, fluoxetine, bupropion, sertraline, imipramine, clomipramine, amitriptyline, nortriptyline, amitriptyline, doxepin, mirtazapine, mianserin, trimipramine, and monoamine oxidase inhibitors)
  • antihypertensives (medicines for treating high blood pressure)
  • baclofen, a medicine to relieve increased muscle tone and contractility (muscle spasms) occurring in various diseases
  • thalidomide, a medicine for treating a tumour of immune system cells (multiple myeloma)
  • celecoxib (a medicine that reduces inflammation)
  • quinidine (a medicine for treating irregular heart rhythm)
  • dexamethasone (a medicine for treating various disorders including inflammation and allergies)
  • anticholinergics (medicines for treating various conditions such as bladder problems, allergies, and depression)

Concomitant use of Paracetamol and Codeine Alter and sedative medicines such as
benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties
(respiratory depression), coma, and may be life-threatening. For this reason, concomitant use
should only be considered when alternative treatments are not possible.
If your doctor prescribes Paracetamol and Codeine Alter together with sedative medicines,
they will also adjust the dose and duration of concomitant treatment.
Inform your doctor about all sedative medicines you are taking and follow their dosage
recommendations carefully. It may be helpful to inform friends or family members to watch for
the signs and symptoms listed above. Contact your doctor if such symptoms occur.
Interference with blood tests
If you are taking this medicine and need blood tests, note that paracetamol may interfere with
the measurement of uric acid levels (uricaemia) and blood sugar levels (glycaemia).
Paracetamol and Codeine Alter and alcohol
Concomitant use of alcohol and codeine may increase sedative effects: alcohol consumption
during treatment with Paracetamol and Codeine Alter is not recommended.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult
your doctor or pharmacist before taking this medicine.
Pregnancy
Paracetamol
Clinical experience with paracetamol use during pregnancy is limited.
Codeine
Available data are insufficient to exclude an association between malformations and codeine use
during pregnancy. Maternal use of codeine at any stage of pregnancy may be associated with
planned caesarean section. Use in the third trimester may be associated with an increased risk of
emergency caesarean section, postpartum haemorrhage, and possible onset in the newborn of
opioid withdrawal symptoms, including restlessness, excessive crying, tremors, increased
muscle tone (hypertonia), increased respiratory rate (tachypnoea), fever (pyrexia), vomiting, and
diarrhoea.
Breastfeeding
Paracetamol and Codeine Alter is contraindicated during breastfeeding (see “Do not take
Paracetamol and Codeine Alter”).
Driving and using machines
Paracetamol and Codeine Alter may affect your ability to drive or operate machinery, as it may
cause adverse effects such as drowsiness and cognitive disturbances, including attention
impairment.
Paracetamol and Codeine Alter contains sodium
This medicine contains 491.4 mg of sodium (the main component of table salt) per effervescent
tablet. This corresponds to approximately 25% of the maximum daily dietary intake recommended
for an adult. Speak with your doctor or pharmacist if you need one or more doses per day for a
prolonged period, especially if you have been advised to follow a low-sodium diet.

3. How to use Paracetamol and Codeine Alter

Use this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will explain to you
what to expect from using Paracetamol and Codeine Alter, when and for how long you should
take it, when to contact your doctor, and when you should stop taking it (see also, If you stop
taking Paracetamol and Codeine Alter).
To avoid the risk of overdose, check that other medicines you are taking (with or without
prescription) do not contain paracetamol or codeine.
Accidental ingestion of an excessive dose of paracetamol may cause severe liver damage and death (see section If you use more Paracetamol and Codeine than you should).

Adults and adolescents aged 12 years and older with body weight above 60 kg
The recommended dose is 1 or 2 tablets, depending on the intensity of pain, taken 1 to 3 times daily at intervals of at least 6 hours.

Adolescents aged 12 years and older with body weight below 60 kg
Dosage should be determined based on body weight.
The recommended dose is 1 tablet per administration, up to a maximum of 4 tablets per day, at intervals of at least 6 hours.

Children under 12 years of age
Do not give Paracetamol and Codeine Alter to children under 12 years of age due to the risk of serious breathing problems.

Patients with kidney disease
If you suffer from severe kidney disease, the interval between doses should be at least 8 hours.

Patients with liver disease
If you have mild, moderate, or severe impairment of liver function, the dose should be reduced or the interval between doses prolonged.
The maximum dose must not exceed 4 tablets per day in cases of:
adult patients weighing less than 50 kg, hepatic impairment, Gilbert's syndrome, chronic alcoholism, chronic malnutrition, or dehydration.

Elderly
The initial dose should be half the recommended adult dose and may subsequently be increased based on tolerability.

Duration of treatment
This medicine should not be taken for more than 3 consecutive days. If pain does not improve after 3 days, consult your doctor.
Paracetamol and Codeine Alter should be used for the shortest duration necessary to achieve symptom relief. If you do not obtain adequate pain relief during treatment with this medicine, consult a doctor.

Method of administration
For oral use.
Dissolve the effervescent tablet in a glass of water. Do not swallow or chew.

If you use more Paracetamol and Codeine Alter than you should
In case of accidental ingestion/overdose of Paracetamol and Codeine Alter, contact your doctor immediately or go to the nearest hospital.

Paracetamol
Taking an excessive dose of paracetamol increases the risk of poisoning and can lead to death, especially if:

  • you have liver disease
  • you abuse alcohol
  • you suffer from chronic malnutrition
  • you are taking medicines or substances that stimulate liver enzymes (increasing liver workload)

Following ingestion of very high doses of paracetamol, symptoms that may appear within the first 24 hours include:

  • nausea
  • vomiting
  • anorexia (loss or reduced appetite)
  • pallor
  • malaise
  • diaphoresis (excessive sweating)

After paracetamol overdose, the following have been observed:

  • sudden inability of the kidneys to function properly (acute kidney injury)
  • condition in which small blood clots form in the bloodstream, blocking the smallest blood vessels (disseminated intravascular coagulation)
  • rare cases of acute pancreatitis, an inflammation of the pancreas

Ingestion of 7.5 g or more of paracetamol in adults and 140 mg per kg of body weight in children may result in severe liver damage, leading to abnormal blood test results (AST, ALT, lactate dehydrogenase, bilirubin, prothrombin), coma (deep unconsciousness), or death.
Liver damage symptoms typically peak after 3–4 days.

Codeine:
The maximum opioid dose varies from individual to individual.
Taking an excessive dose of codeine or other opioids may primarily cause:

  • respiratory depression, ranging from decreased respiratory rate to apnea (absence of breathing)
  • extreme sedation, ranging from stupor to coma
  • miosis (constriction of the pupils)

Other symptoms related to central nervous system effects may also occur, including:

  • headache
  • vomiting
  • urinary retention (difficulty emptying the bladder)
  • reduced intestinal motility (peristalsis)
  • bradycardia (reduced heart rate)
  • hypotension (low blood pressure)

Treatment
The doctor will provide appropriate supportive therapy based on the nature and severity of the symptoms.

If you forget to take Paracetamol and Codeine Alter
Do not take/don’t give the adolescent a double dose to make up for a forgotten dose.

If you stop taking Paracetamol and Codeine Alter
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you/your adolescent experience any of the following side effects, STOP taking this medicine immediately and contact your doctor straight away:

  • Skin reactions that may present as:
    • itching
    • urticaria (appearance of itchy skin welts)
    • skin rash
    • erythema (redness of the skin)
    • erythema multiforme (appearance of red spots on the skin with a "target-like" appearance associated with itching)
    • purpura (appearance of purplish skin patches of various sizes)
    • Stevens-Johnson syndrome (a serious skin condition with eruptions and skin peeling)
    • toxic epidermal necrolysis (a severe skin condition characterized by redness, blistering lesions, skin detachment and skin death)
    • generalized exanthematous pustulosis (eruption of hundreds of superficial pustules spread over the entire body)
    • drug-induced fixed eruption (skin rash of red/violet color)
  • Allergic reactions that may present as:
    • laryngeal edema (swelling of the throat)
  • Angioedema (swelling of hands, feet, ankles, face, lips, tongue and/or throat)
  • Quincke's edema, anaphylactic reaction (severe allergic reaction), including hypotension (low blood pressure)
  • Anaphylactic shock (severe allergic reaction)
  • Hypersensitivity
  • Bronchospasm (excessive and prolonged contraction of airway muscles causing breathing difficulties)
    • Respiratory depression (reduced breathing activity).

Additionally, the following side effects may occur, for which insufficient data are available to determine their frequency:

  • Anaemia (reduction in haemoglobin in the blood, the substance that carries oxygen to tissues)
  • Thrombocytopenia (reduced number of platelets in the blood)
  • Leucopenia/agranulocytosis/neutropenia (reduced number of white blood cells in the blood)
  • Abnormal liver function
  • Hepatitis (inflammation of the liver)
  • Biliary colic (severe pain in the upper abdomen)
  • Dizziness
  • Severe condition that may make the blood more acidic (called metabolic acidosis), in patients with serious illness taking paracetamol (see section 2)
  • Somnolence
  • Dizziness
  • Headache
  • Myoclonus (sudden involuntary muscle jerk)
  • Paraesthesia (tingling)
  • Syncope (transient loss of consciousness)
  • Tremor
  • Sedation
  • Confusional state
  • Codeine abuse
  • Codeine dependence
  • Withdrawal syndrome following sudden discontinuation of treatment
  • Withdrawal syndrome in newborns born to mothers chronically exposed to codeine during pregnancy
  • Hallucination
  • Euphoria (excitement)
  • Dysphoria (depressed mood with irritability and nervousness)
  • Hypotension (low blood pressure)
  • Acute renal failure (reduced kidney function)
  • Interstitial nephritis (inflammation of the kidneys)
  • Haematuria (blood in the urine)
  • Anuria (cessation or reduction in urine production by the kidneys)
  • Urinary retention (inability of the bladder to empty completely)
  • Diarrhoea
  • Abdominal pain
  • Nausea
  • Vomiting
  • Constipation
  • Stomach and intestinal disturbances
  • Pancreatitis (inflammation of the pancreas)
  • Dyspnoea (difficulty breathing)
  • Increased liver enzymes
  • Alteration of INR (a value used to express the time taken for blood to clot)
  • Rhabdomyolysis (severe muscle damage)
  • Asthenia (weakness)
  • Malaise
  • Miosis (constriction of the pupils)
  • Oedema (swelling due to fluid accumulation)
  • Abdominal pain, particularly if you have had gallbladder surgery (biliary or acute pancreatic pain associated with spasm of the sphincter of Oddi)
  • Problem with a valve in the intestine (dysfunction of the sphincter of Oddi)

At doses higher than recommended, following sudden discontinuation of this medicine, you may experience a need to continue taking the medicine (dependence) and side effects (withdrawal symptoms). These effects may occur both in adults and in newborns born to codeine-dependent mothers.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Paracetamolo e Codeina Alter

Keep this medicine out of the sight and reach of children.
Store the medicine in its original packaging to protect it from moisture and heat.
Store this medicine in a safe and secure place, out of reach of other people. It may cause serious harm or be fatal to individuals for whom it is not intended.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Do not store above 25°C.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Paracetamolo e Codeina Alter contains

  • The active substances are paracetamol and phosphate codeine. Each effervescent tablet contains 500 mg of paracetamol and 30 mg of codeine phosphate.
  • The other components are: sodium bicarbonate, sodium carbonate, citric acid, sodium docusate, povidone, sodium saccharin.

Description of the appearance of Paracetamolo e Codeina Alter and package contents
Pack containing 16 effervescent tablets.
Marketing Authorization Holder
Laboratori Alter s.r.l., Via Egadi, 7 - 20144 Milano
Manufacturer
Laboratorios Alter S.A., C/ Mateo Inurria, 30 – 28036 Madrid, Spain
April 2026