Paracetamol and codeine Pensà

Package leaflet: Information for the user

PARACETAMOL AND CODEINE PENSA 500 mg + 30 mg tablets

Generic Medicine
Please read this leaflet carefully before taking/giving this medicine to an adolescent 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What PARACETAMOL AND CODEINE PENSA is and what it is used for

PARACETAMOL AND CODEINE PENSA contains two active substances (paracetamol and codeine), which act in different ways.
Paracetamol acts by relieving pain (analgesic) and reducing fever (antipyretic).
Codeine belongs to a group of medicines called opioid analgesics which relieve pain. It may be used alone or, as in this medicine, in combination with other analgesics such as paracetamol.
The combination of paracetamol and codeine has a greater analgesic effect than either of its components taken alone, with a longer-lasting effect.
PARACETAMOL AND CODEINE PENSA is indicated in adults and adolescents over 12 years of age for the short-term treatment of moderate pain symptoms which do not respond to treatment with other pain-relieving medicines such as paracetamol or ibuprofen.
Consult a doctor if you or the adolescent do not feel better or feel worse.

2. What you should know before taking PARACETAMOLO E CODEINA PENSA

Do not take PARACETAMOLO E CODEINA PENSA

• 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 severe haemolytic anaemia (a disease caused by the destruction of certain blood cells, red blood cells),
• If you have severe liver disease (severe hepatocellular insufficiency),
• If you have active liver disease,
• If you have a lung disease (respiratory failure), as codeine may worsen your condition,
• If you are between 0 and 18 years old and have undergone surgery to remove your tonsils or adenoids due to a breathing disorder called obstructive sleep apnoea syndrome, as in such cases the risk of developing serious and life-threatening adverse reactions increases,
• If you know you have a particularly active liver enzyme called CYP2D6 (ultra-rapid metabolizer for CYP2D6), which allows your body to convert codeine into high levels of morphine (detected through urine testing), increasing the likelihood of serious adverse effects,
• If you are breastfeeding or pregnant (see section 2 “Pregnancy and breastfeeding”).

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

• Suffer from mild/moderate impairment of liver function (including Gilbert's syndrome, a condition characterized by excessive production of bilirubin, a substance causing yellowish skin and eyes),
• Have serious liver problems,
• Suffer from acute liver inflammation (acute hepatitis),
• Are taking medicines that affect how your liver works (medicines that stimulate liver enzymes),
• Experience severe upper abdominal pain that may radiate to your back, nausea, vomiting, or fever, as these could be symptoms related to pancreatitis (inflammation of the pancreas) and the biliary tract system,
• Have glucose-6-phosphate dehydrogenase deficiency (a substance normally present in the human body, whose deficiency may cause haemolytic anaemia),
• Suffer from haemolytic anaemia, a disease caused by the destruction of certain blood cells, red blood cells,
• Suffer from kidney disease (renal insufficiency),
• Chronically consume alcohol or drink excessively (3 or more alcoholic drinks per day),
• Suffer from anorexia (an eating disorder characterized by lack or reduced appetite),
• Suffer from bulimia (an eating disorder where a person ingests excessive amounts of food and then uses various methods to eliminate it to avoid weight gain),
• Suffer from cachexia (a condition characterized by extreme thinness, reduced muscle mass, and thinning skin due to chronic illness),
• Suffer from chronic malnutrition,
• Are dehydrated (severe loss of water/fluids from the body),
• Suffer from hypovolemia [reduced blood volume circulating in the body, which is the most common cause of hypotension (low blood pressure)],
• Have undergone surgical removal of the gallbladder (the organ where bile, a substance useful for digestive processes, is stored),
• Have a cough with phlegm, as expectoration may be difficult,
• Experience pain or increased sensitivity to pain (hyperalgesia) that does not respond to higher doses of the medicine.

During treatment with PARACETAMOLO E CODEINA PENSA, 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 fluids) has been reported when paracetamol is used at regular doses for prolonged periods 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.

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

• Respiratory depression (reduced respiratory 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 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 release of histamine, as in asthma (obstruction of the bronchi)
• Itching
• Reduced hormone levels
• Inhibition of immunological function (i.e., the body's defence system function)
• Muscle rigidity and myoclonus (involuntary rapid muscle jerks)
• Urinary retention (difficulty emptying the bladder), particularly in patients with urethral stricture (narrowing of the urethra) or enlarged prostate

Sleep-related breathing disorders
PARACETAMOLO E CODEINA PENSA may cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep-related hypoxaemia (low oxygen levels in the blood). Symptoms may include breathing pauses during sleep, waking up at night due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. The doctor may consider reducing the dose.
Use of high doses and/or prolonged use
Using high doses and/or prolonged use of this medicine may cause liver disease (hepatopathy) and serious alterations affecting the kidneys and blood.
Prolonged use of analgesics, including opioids, increases the risk of medication-overuse headache.
With prolonged opioid use, reduced analgesic efficacy (tolerance) may occur.
Tolerance, physical and psychological dependence
This medicine contains codeine, an opioid medicine. It may cause dependence and/or habituation.
Repeated use of opioids may lead to reduced effectiveness of the drug (the body becomes accustomed to the drug through a phenomenon called tolerance). Repeated use of PARACETAMOLO E CODEINA PENSA may also cause physical dependence, abuse, and psychological dependence, which may lead to a 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 as though you no longer have control over the amount of medicine you need to take or how often you need to take it.
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 PENSA 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 [product name], 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 larger amounts than the recommended dose.
• You may feel the need to continue taking the medicine, even if it does not help relieve 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 the use of the medicine.
• When you stop taking the medicine, you feel unwell and feel better when you take it again (“withdrawal effects”). If you notice any of these signs, consult your doctor to agree on the best treatment plan for you, including when it would be appropriate to stop and how to stop safely (see section 3, “If you stop taking PARACETAMOLO E CODEINA PENSA”).

Withdrawal syndrome following sudden discontinuation may occur both in patients and in newborns born to codeine-dependent mothers.
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 this medicine to children under 12 years of age.
Do not give PARACETAMOLO E CODEINA PENSA to relieve pain 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.
Do not give PARACETAMOLO E CODEINA PENSA to children and adolescents with respiratory problems, as symptoms of morphine toxicity may be worse.
Other medicines and PARACETAMOLO E CODEINA PENSA
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:

• Medicines containing paracetamol, as serious adverse effects may occur if paracetamol is taken at 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 (the time it takes for blood to clot),
• Medicines that, during chronic treatment, alter liver function by inducing hepatic monooxygenases (liver enzymes) or other substances that may have such an effect, 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. In case of treatment with phenytoin, do not take high or prolonged doses of paracetamol.
• Flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis with high anion gap) that must be treated urgently (see section 2),
• Gabapentin or pregabalin for the treatment of epilepsy or nerve-originated pain (neuropathic pain).

The use of these medicines with PARACETAMOLO E CODEINA PENSA requires close medical monitoring.
In case of prolonged treatment with these medicines, do not take PARACETAMOLO E CODEINA PENSA:

• Probenecid, a medicine used to treat hyperuricaemia (high concentration of uric acid in the blood) and gout (joint inflammation due to uric acid deposits). In this case, your doctor will advise you to reduce the doses,
• Medicines such as tranquillisers and sedatives,
• Salicylamide (an analgesic and antipyretic medicine),
• Strong analgesics (buprenorphine, butorphanol, nalbuphine, nalorphine, pentazocine),
• Naltrexone (a medicine used to treat drug dependence),
• Medicines for treating allergies, such as antihistamines,
• Analgesics (alfentanil, dextromoramide, dextropropoxyphene, fentanyl, dihydrocodeine, hydromorphone, morphine, oxycodone, pethidine, fentanyl, remifentanil, sufentanil, tramadol),
• Medicines for treating cough (dextromethorphan, noscapine, pholcodine, codeine, ethylmorphine),
• Medicines for treating psychiatric disorders (chlorpromazine, haloperidol, levomepromazine, thioridazine),
• Methadone, a medicine used to treat drug dependence,
• Meprobamate, a medicine used to treat anxiety,
• Hypnotics, medicines used to treat insomnia (benzodiazepines and barbiturates),
• Medicines for treating depression (amitriptyline, doxepin, mirtazapine, mianserin, trimipramine or belonging to the benzodiazepine class),
• Antihypertensives, medicines for treating high blood pressure,
• Baclofen, a medicine to reduce and relieve excessive muscle tension (spasms),
• Thalidomide, a medicine used to treat an immune system disease (multiple myeloma),
• Celecoxib (a medicine that relieves inflammation),
• Quinidine (a medicine used to treat irregular heart rhythm),
• Dexamethasone (a medicine used to treat various disorders such as inflammation and allergies),
• Anticholinergics (medicines used to treat various conditions such as bladder problems, allergies, and depression).

Laboratory tests and PARACETAMOLO E CODEINA PENSA
If you need blood tests, keep in mind that paracetamol administration may interfere with the measurement of uric acid levels (uricaemia) and blood sugar levels (glycaemia).
Concomitant use of PARACETAMOLO E CODEINA PENSA and sedative medicines such as benzodiazepines or related drugs 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 no other therapeutic options are possible.
However, if your doctor prescribes PARACETAMOLO E CODEINA PENSA together with sedative medicines, you should limit the dose and duration of concomitant treatment.
Inform your doctor about all sedative medicines you are taking and strictly follow their dosage recommendations. It may be helpful to inform friends and family to watch for the signs and symptoms mentioned above. Contact your doctor if these symptoms occur.
PARACETAMOLO E CODEINA PENSA and alcohol
Do not take PARACETAMOLO E CODEINA PENSA with alcoholic beverages, as alcohol increases sedation and causes a reduced state of alertness that may make driving and operating machinery dangerous (see section “Driving and use of machinery”).
Take PARACETAMOLO E CODEINA PENSA with caution if you chronically consume alcohol or drink excessively (3 or more alcoholic drinks per day), as there is a risk of intoxication (see sections “Warnings and precautions” and “If you take more PARACETAMOLO E CODEINA PENSA than you should”).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.
If necessary, paracetamol can be used during pregnancy. It is advisable to use the lowest possible dose that reduces pain and/or fever and to take it for the shortest possible time. Contact your doctor/midwife if pain and/or fever do not decrease or if you need to take paracetamol more frequently.
Pregnancy
PARACETAMOLO E CODEINA PENSA should not be used during pregnancy unless advised by your doctor. Regular use during pregnancy may cause withdrawal symptoms in the newborn. If used, the medicine should be taken at the lowest possible dose effective in reducing pain and/or fever and for the shortest possible duration.
Clinical experience with paracetamol use during pregnancy is limited. It appears that no adverse effects occur in pregnant women, the foetus, or newborns.
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 of opioid withdrawal symptoms in the newborn, including restlessness, excessive crying, tremors, reduced muscle tone (hypotonia), increased respiratory rate (tachypnoea), fever (pyrexia), vomiting, and diarrhoea.
Breastfeeding
Do not take PARACETAMOLO E CODEINA PENSA if you are breastfeeding, as codeine passes into breast milk.
Driving and use of machinery
PARACETAMOLO E CODEINA PENSA may affect your ability to drive or operate machinery, as it may cause adverse effects such as drowsiness and cognitive disturbances, including attention impairment.

3. How to take PARACETAMOL AND CODEINE PENSA

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 to you what to
expect from the use of PARACETAMOL AND CODEINE PENSA, when and for how long you should
take it, when you should contact your doctor, and when you should stop taking it (see also “If you stop
treatment with PARACETAMOL AND CODEINE PENSA”).
To avoid the risk of overdose, check that other medicines you are taking (with or without prescription)
do not contain paracetamol or codeine.
Adults and adolescents over 12 years of age
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 4 hours.
Elderly
The initial dose should be half the recommended adult dose and may subsequently be increased.
Patients with renal impairment
If you/the adolescent suffer from severe kidney disease, the interval between doses should be
at least 8 hours.
Patients with hepatic impairment
If you suffer from 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, liver disease, Gilbert's syndrome, chronic alcoholism, chronic malnutrition, or dehydration.
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 PENSA should be used for the shortest duration necessary to relieve symptoms. If you do not achieve effective pain relief during treatment with this
medicine, consult a doctor.
Method of administration
Oral use. The tablets should be swallowed whole with a glass of water. Do not crush or
chew. Tablets may be divided, if necessary, into two equal doses.
If you take more PARACETAMOL AND CODEINE PENSA than you should
If you accidentally take too much PARACETAMOL AND CODEINE PENSA, contact your doctor immediately or go to the nearest hospital. In hospital, appropriate intervention protocols will be applied (e.g. gastric lavage, administration of antidote).
Taking an excessive dose of paracetamol increases the risk of poisoning and can lead to death, especially if you/the adolescent:

• suffer from liver disease,
• chronically consume alcohol (chronic alcoholism),
• suffer from chronic malnutrition,
• are taking medicines or substances that increase liver enzyme activity (liver enzyme inducers).

Symptoms
If a very high dose of PARACETAMOL AND CODEINE PENSA is accidentally taken, symptoms that you/the adolescent may generally experience within the first 24 hours include:

• nausea,
• vomiting,
• anorexia,
• pallor,
• malaise,
• diaphoresis (excessive sweating).

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

In adults, an excessive dose of codeine may cause:

• bluish skin due to lack of oxygen (cyanosis),
• reduced respiratory function,
• drowsiness,
• skin rash, pruritus,
• difficulty with movement (ataxia),
• pulmonary edema (rare).

In children, an excessive dose of codeine may cause:

• breathing difficulties, even severe (reduced respiratory function, respiratory arrest),
• constricted pupils (miosis),
• uncontrolled body movements (convulsions),
• facial flushing and swelling,
• urticaria,
• collapse,
• inability to empty the bladder (urinary retention).

Treatment
The doctor will provide appropriate supportive therapy based on the nature and severity of symptoms.
The maximum opioid dose varies from individual to individual.
If you forget to take PARACETAMOL AND CODEINE PENSA
Do not take/double the dose to make up for a missed dose.
If you stop treatment with PARACETAMOL AND CODEINE PENSA
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 everyone gets them.
If you experience any of the following side effects, STOP taking this medicine immediately and contact your doctor immediately:

• Skin reactions that may present as:
  • itching, hives, skin rash
  • erythema
  • erythema multiforme (a condition characterized by red skin patches with a "target-like" appearance, associated with itching)
  • Stevens-Johnson syndrome (a severe form of polymorphic erythema)
  • toxic epidermal necrolysis (a serious skin disease characterized by redness, blistering lesions, and areas of skin detachment and death)
  • generalized exanthematous pustulosis
• 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)
• Respiratory depression (reduced breathing activity)

In addition, individuals taking this medicine may experience the following side effects.
Frequency not known (frequency cannot be estimated from the available data) :

• anaemia (reduction in haemoglobin in the blood, the substance that carries oxygen)
• thrombocytopenia (reduction in the number of platelets in the blood)
• leucopenia/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 jerks)
• paraesthesia (tingling)
• syncope (transient loss of consciousness)
• tremor
• sedation (drowsiness)
• confusion
• medication abuse
• drug dependence
• hallucination
• euphoria (excitement)
• dysphoria (depressed mood with irritability and nervousness)
• acute kidney injury (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
• gastrointestinal reactions
• pancreatitis (inflammation of the pancreas)
• problem with a valve in the intestine (dysfunction of the sphincter of Oddi)
• dyspnoea (difficulty breathing)
• increased liver enzymes
• decrease or increase in INR (a value used to express the time it takes for blood to clot)
• rhabdomyolysis (serious muscle damage)
• asthenia (weakness)
• malaise
• miosis (constriction of the pupils)
• urinary retention (inability of the bladder to empty completely)
• a serious condition that may make the blood more acidic (called metabolic acidosis), in patients with a serious illness who are taking paracetamol (see section 2)

At codeine doses higher than therapeutic doses, there is a risk of dependence and withdrawal syndrome following sudden discontinuation of treatment, which may occur both in patients and in newborns born to codeine-dependent mothers.
In case of overdose, paracetamol may cause severe liver damage (hepatic cytolysis which may progress to massive and irreversible necrosis).
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 following 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 PENSA

Keep 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.
This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP.
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste.
Ask your pharmacist how to properly dispose of medicines you no longer use.
This will help protect the environment.

6. Package contents and other information

What PARACETAMOLO E CODEINA PENSA contains

• The active substances are: paracetamol and phosphate codeine. Each tablet contains 500 mg of paracetamol and 30 mg of codeine phosphate.
• The excipients are: povidone, microcrystalline cellulose, crospovidone, magnesium stearate, pregelatinized corn starch, stearic acid.

Description of the appearance of PARACETAMOLO E CODEINA PENSA and package contents
PARACETAMOLO E CODEINA PENSA 500 mg/30 mg, white, biconvex, oblong, divisible tablets.
PARACETAMOLO E CODEINA PENSA is available in packs of 16 tablets.
Marketing Authorization Holder
Towa Pharmaceutical S.p.A.
Via E. Tazzoli, 6
20154 Milan
Italy
Manufacturer
Toll Manufacturing Services, S.L.
C/ Aragonese, 2
28108 Alcobendas - MADRID
Spain
Farmalider S.A.
C/Aragoneses, 2
28108 Alcobendas (Madrid)
Spain