Patient Information Leaflet: Information for the Patient

PARACETAMOL AND CODEINE DOC Generics 500 mg + 30 mg Tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, 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:

What PARACETAMOL AND CODEINE DOC Generics is and what it is used for
What you need to know before taking PARACETAMOL AND CODEINE DOC Generics
How to take PARACETAMOL AND CODEINE DOC Generics
Possible side effects
How to store PARACETAMOL AND CODEINE DOC Generics
Contents of the pack and other information

1. What PARACETAMOLO E CODEINA DOC Generici is and what it is used for

PARACETAMOLO E CODEINA DOC Generici contains two active substances (paracetamol and codeine).

Paracetamol works by relieving pain (analgesic) and reducing fever (antipyretic);
Codeine belongs to a group of medicines called opioid analgesics which relieve pain.

PARACETAMOLO E CODEINA DOC Generici is indicated in patients aged over 12 years for the treatment of symptoms of acute moderate pain that does not respond to pain-relieving medicines such as paracetamol or ibuprofen used alone.
Contact your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking PARACETAMOLO E CODEINA DOC Generici

Do not take PARACETAMOLO E CODEINA DOC Generici

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);
if you are under 12 years of age;
if you suffer from a lung disease (respiratory failure), as codeine may worsen your condition;
if you are between 0 and 18 years old and have recently undergone surgery to remove your tonsils or adenoids due to a breathing disorder called obstructive sleep apnoea syndrome;
if 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;
if you are breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or pharmacist before taking PARACETAMOLO E CODEINA DOC Generici.
Consult your doctor if:

you have mild to moderate liver impairment (including Gilbert's syndrome, a condition characterised by excessive bilirubin production, causing yellowing of the skin and eyes);
you have severe liver problems;
you suffer from 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 (a substance normally present in the human body, deficiency of which may cause haemolytic anaemia);
you suffer from haemolytic anaemia (a disease caused by the destruction of red blood cells);
you have renal failure (kidney disease);
you chronically consume alcohol or drink excessively (3 or more alcoholic drinks per day);
you suffer from anorexia (an eating disorder characterised by lack or reduced appetite);
you suffer from bulimia (an eating disorder where a person consumes excessive amounts of food and then uses various methods to eliminate it to avoid weight gain);
you suffer from cachexia (a condition characterised by extreme thinness, reduced muscle mass, and thinning skin due to chronic illness);
you suffer from chronic malnutrition;
you are dehydrated (severe loss of water/fluids from the body);
you have hypovolemia (reduced blood volume circulating in the body);
you have a cough with phlegm.

During treatment with PARACETAMOLO E CODEINA DOC Generici, inform your doctor immediately if:

you suffer from serious conditions, including severe renal impairment or 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 in combination with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep, rapid breathing, drowsiness, nausea, and vomiting.
you experience severe pain in the upper abdomen that may radiate to the back, nausea, vomiting, or fever, as these could be symptoms associated with inflammation of the pancreas (pancreatitis) or the biliary tract system.
you develop pain or increased sensitivity to pain (hyperalgesia) that does not respond to higher doses of the medicine.

Paracetamol may cause severe skin reactions that can be fatal. The use of PARACETAMOLO E CODEINA DOC Generici must be stopped at the first sign of skin rash or any other sign of hypersensitivity (allergic reaction).
Opioid therapy may cause:

respiratory depression (reduced breathing function) and sedation, lowered seizure threshold (i.e., increased excitability of the nervous system, as in epilepsy);
hyperalgesia (increased sensitivity to pain);
constipation (difficult or infrequent bowel movements);
nausea and vomiting;
masking of symptoms of acute abdominal conditions (conditions characterised 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);
increased histamine release, as in asthma (airway obstruction);
itching;
reduced hormone levels;
inhibition of immunological function (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 (the final part of the urinary tract) or enlarged prostate.

Sleep-related breathing disorders
PARACETAMOLO E CODEINA DOC Generici may cause sleep-related breathing disorders such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels during sleep). Symptoms may include breathing pauses during sleep, nocturnal awakening due to shortness of 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:
Long-term or high-dose use of paracetamol may cause liver disease (hepatopathy) and serious adverse effects on 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.
Tolerance, physical dependence, and psychological dependence
This medicine contains codeine, which is an opioid medicine. It may cause dependence and/or tolerance.
Repeated use of opioids may lead to reduced effectiveness of the medicine (the body becomes accustomed to the drug through a phenomenon called tolerance). Repeated use of PARACETAMOLO E CODEINA DOC Generici may also cause physical dependence, abuse, and psychological dependence, which could lead to a potentially life-threatening overdose. The risk of these adverse effects may increase with higher doses and prolonged duration of use.
Physical or psychological dependence may make you feel that you have lost control over the amount or frequency of medicine you take.
The risk of physical or psychological dependence varies from person to person. You may be at higher risk of physical or psychological dependence on PARACETAMOLO E CODEINA DOC Generici 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 PARACETAMOLO E CODEINA DOC Generici, it could be a sign of physical or psychological dependence:

you feel the need to take the medicine longer than recommended by your doctor.
you feel the need to take higher amounts than the recommended dose.
you may feel compelled to continue taking the medicine, even if it does not help relieve your pain.
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 the use of the medicine.
you feel unwell when you stop taking the medicine and feel better when you take it again ("withdrawal effects").

If you notice any of these signs, consult your doctor to discuss the best treatment plan for you, including when and how to safely discontinue the medicine (see section 3, "If you stop taking PARACETAMOLO E CODEINA DOC Generici").
Withdrawal syndrome following sudden discontinuation may occur both in patients and in newborns born to mothers dependent on codeine.
Elderly
Elderly patients may be at increased 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 removal of tonsils or adenoids 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 worse.
Other medicines and PARACETAMOLO E CODEINA DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

other medicines containing paracetamol, as serious adverse effects may occur if paracetamol is taken in high doses;
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 (increasing liver activity), for example:
- rifampicin (an antibiotic)
- cimetidine (a medicine used to treat stomach ulcers)
- antiepileptics (medicines used to treat epilepsy), e.g., glutethimide, phenobarbital, carbamazepine, and phenytoin. If you are taking phenytoin, do not take high or prolonged doses of paracetamol.
The use of these medicines with PARACETAMOLO E CODEINA DOC Generici requires extreme caution and should only be done under strict medical supervision.
probenecid, a medicine used to treat hyperuricaemia (high blood uric acid levels) and gout (joint inflammation due to uric acid deposits): your doctor may advise reducing the dose of PARACETAMOLO E CODEINA DOC Generici;
salicylamide (an analgesic and fever-reducing medicine);
flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring urgent treatment (see section 2);
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 PARACETAMOLO E CODEINA DOC Generici;
zidovudine (a medicine for treating HIV);
potent analgesics (buprenorphine, butorphanol, nalbuphine, nalorphine, pentazocine);
naltrexone (a medicine for treating drug dependence);
antihistamines (medicines for treating allergies);
analgesics (alfentanil, dextromoramide, dextropropoxyphene, fentanyl, dihydrocodeine, hydromorphone, morphine, oxycodone, pethidine, phenoperidine, remifentanil, sufentanil, tramadol);
cough medicines (dextromethorphan, noscapine, pholcodine, codeine, ethylmorphine);
medicines for psychiatric disorders (chlorpromazine, haloperidol, levomepromazine, thioridazine);
methadone (a medicine for treating drug addiction);
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, doxepin, mirtazapine, mianserin, trimipramine, and monoamine oxidase inhibitors);
antihypertensives (medicines for treating high blood pressure);
baclofen, a medicine to reduce and relieve muscle spasms (excessive muscle tension occurring in various diseases);
thalidomide, a medicine for treating multiple myeloma (a disease of the immune system, the body's defence system);
celecoxib (a medicine that reduces inflammation);
quinidine (a medicine for treating irregular heart rhythm);
dexamethasone (a medicine for treating various disorders such as inflammation and allergies);
anticholinergics (medicines for treating various conditions such as bladder problems, allergies, and depression);
gabapentin or pregabalin for treating epilepsy or nerve-related pain (neuropathic pain).

Concomitant use of PARACETAMOLO E CODEINA DOC Generici and sedative medicines such as benzodiazepines or related substances increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may endanger the patient's life. For these reasons, concomitant use should only be considered when alternative treatments are not possible.
If your doctor prescribes PARACETAMOLO E CODEINA DOC Generici together with sedative medicines, the dose and duration of concomitant treatment must be determined by your doctor. Inform your doctor about all sedative medicines you are taking and follow your doctor's dosage recommendations carefully. It may be helpful to inform friends or family members to watch for the onset of the above-mentioned signs and symptoms. Contact your doctor if these symptoms occur.
Interference with blood tests
If the patient needs to undergo blood tests, note that paracetamol administration may interfere with the measurement of uric acid levels (uricemia) and blood sugar levels (glycemia).
PARACETAMOLO E CODEINA DOC Generici with alcohol
Concomitant use of alcohol and codeine may increase sedative effects: alcohol consumption during treatment with PARACETAMOLO E CODEINA DOC Generici is not recommended.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
PARACETAMOLO E CODEINA DOC Generici should not be used during pregnancy unless advised by your doctor.
Paracetamol
Clinical experience with paracetamol use during pregnancy is limited. If necessary, paracetamol may be used during pregnancy only when absolutely needed. It is advisable to use the lowest possible dose that relieves pain and to take it for the shortest possible time. Your doctor will carefully evaluate the need for treatment, treatment duration, and dosage. Contact your doctor if pain does not decrease or if you need to take the medicine more frequently.
Codeine
Available data are insufficient to exclude an association between congenital malformations and codeine use during pregnancy.
Maternal use of codeine at any stage of pregnancy may be associated with planned caesarean delivery. 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 (see also section "Warnings and precautions").
Breastfeeding
PARACETAMOLO E CODEINA DOC Generici is contraindicated during breastfeeding with breast milk (see also section "Do not take PARACETAMOLO E CODEINA DOC Generici").
Driving and using machines
PARACETAMOLO E CODEINA DOC Generici may affect your ability to drive or operate machinery, as it may cause adverse effects such as drowsiness and cognitive disturbances, including attention impairment.
PARACETAMOLO E CODEINA DOC Generici contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., it is essentially "sodium-free".

3. How to take PARACETAMOLO E CODEINA DOC Generici

Take 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 what you can expect from using PARACETAMOLO E CODEINA DOC Generici, 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 PARACETAMOLO E CODEINA DOC Generici).
To avoid the risk of overdose, check that other medicines you are taking (with or without prescription) do not contain paracetamol or codeine.
Accidentally taking an excessive dose of paracetamol may cause severe liver damage and death (see section If you take more PARACETAMOLO E CODEINA DOC Generici than you should).

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

Children under 12 years of age
Do not give PARACETAMOLO E CODEINA DOC Generici to children under 12 years of age.

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 impaired liver function, the dose should be reduced or the interval between doses prolonged.
The maximum daily dose must not exceed 4 tablets 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 depending 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.
PARACETAMOLO E CODEINA DOC Generici should be used for the shortest duration necessary to achieve symptom relief. If you do not obtain effective pain relief during treatment with this medicine, consult a doctor.

Method of administration
For oral use.
Swallow the tablet with a glass of water. Do not break or chew.
The break line is not intended for dividing the tablet.

If you take more PARACETAMOLO E CODEINA DOC Generici than you should
In case of accidental ingestion/overdose of PARACETAMOLO E CODEINA DOC Generici, contact your doctor immediately or go to the nearest hospital.

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

you suffer from liver disease,
you abuse alcohol,
you suffer from chronic malnutrition,
you are taking medicines or substances that induce liver enzymes (increasing liver metabolism).

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

nausea;
vomiting;
anoressia (loss or reduced appetite);
pallor;
malaise;
diaphoresis (excessive sweating).

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. Symptoms of liver damage peak after 3–4 days.

Codeine
The maximum opioid dose varies between individuals. Taking an excessive dose of codeine or other opioids may primarily cause:

respiratory depression, ranging from reduced respiratory rate to apnea (absence of breathing);
extreme sedation, ranging from drowsiness 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
Your doctor will provide appropriate supportive therapy based on the nature and severity of symptoms.

If you forget to take PARACETAMOLO E CODEINA DOC Generici
Do not take/don’t give the adolescent a double dose to make up for a forgotten dose.

If you stop taking PARACETAMOLO E CODEINA DOC Generici
If you have any doubts 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.
STOP taking this medicine and contact your doctor immediately if you experience any of the following side effects:

Skin reactions that may present as:
- itching
- urticaria (appearance of itchy skin welts)
- skin rash
- erythema (redness of the skin)
- erythema multiforme (a condition characterized by red skin spots with a "target" appearance, associated with itching)
- Stevens-Johnson syndrome (a serious skin illness with eruptions and skin peeling)
- toxic epidermal necrolysis (a serious skin disease characterized by redness, blistering lesions, and areas of skin detachment and death)
- acute generalized exanthematous pustulosis (an eruption of hundreds of superficial pustules spread over the entire body)
Allergic reactions that may present as:
- laryngeal edema (swelling of the throat)
- angioedema (swelling of hands, feet, ankles, face, lips, tongue and/or throat)
- hypotension (low blood pressure)
- anaphylactic shock (severe allergic reaction)
- hypersensitivity
Respiratory depression (reduced breathing activity)

Additionally, the following side effects may occur with unknown frequency (cannot be estimated from available data):

Severe condition that may make the blood more acidic (called metabolic acidosis), in patients with serious illness using paracetamol (see section 2)
Anaemia (reduction in haemoglobin in the blood, the substance that carries oxygen)
Thrombocytopenia (decrease in the number of platelets in the blood)
Leukopenia/agranulocytosis/neutropenia (reduction in the 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
Somnolence
Vertigo
Myoclonus (sudden involuntary muscle jerk)
Paresthesia (tingling)
Syncope (transient loss of consciousness)
Tremor
Sedation
Confusional state
Medication abuse
Drug dependence
Hallucination
Euphoria (excitement)
Dysphoria (depressed mood with irritability and nervousness)
Acute renal failure (reduced kidney function)
Interstitial nephritis (inflammation of the kidneys)
Hematuria (blood in the urine)
Anuria (cessation or reduction in urine production by the kidneys)
Urinary retention (inability of the bladder to empty completely)
Diarrhea
Abdominal pain
Nausea
Vomiting
Constipation
Stomach and intestinal reactions
Pancreatitis (inflammation of the pancreas)
Dyspnea (difficulty breathing)
Increased liver enzymes
Decrease or increase in INR (a value used to express the time taken for blood to clot)
Rhabdomyolysis (serious muscle damage)
Asthenia (weakness)
Malaise
Miosis (constriction of the pupils)
Edema (swelling due to fluid accumulation)
Problem with a valve in the intestine (Oddi sphincter dysfunction).

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 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 DOC Generici

Keep this medicine out of the sight and reach of children.
Store this medicine in a safe and secure place inaccessible to 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 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.
This medicine requires no special storage conditions.

6. Pack contents and other information

What PARACETAMOLO E CODEINA DOC Generici 500 mg + 30 mg Tablets contain

The active substances are Paracetamol and Codeine Phosphate. Each tablet contains 500 mg of Paracetamol and 30 mg of Codeine Phosphate.
The other components are: pregelatinized maize starch, stearic acid, povidone, magnesium stearate, sodium croscarmellose.

Description of the appearance of PARACETAMOLO E CODEINA DOC Generici and pack contents
White, round tablet with a score line on one side.
Pack containing 16 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan - Italy.
Manufacturer
Kern Pharma, S.L. - Venus 72, Polígono Ind. Colón II - 08228 Terrassa (Barcelona) - Spain.

Paracetamol and codeine Doc Generici