PARACETAMOLO 500 mg/30 mg Coated Tablet

Содержание инструкции

1. PARACETAMOLO E CODEINA PENSA 500 mg + 30 mg tablets
   1. What is PARACETAMOLO E CODEINA PENSA and what is it used for
   2. What you need to know before taking PARACETAMOLO E CODEINA PENSA
   3. How to take PARACETAMOLO E CODEINA PENSA
   4. Possible side effects
   5. How to store PARACETAMOLO E CODEINA PENSA
   6. Contents of the pack and other information

PARACETAMOLO E CODEINA PENSA 500 mg + 30 mg tablets

Equivalent Medicine

Read this leaflet carefully before taking/giving thismedicine to an adolescent because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any doubts, ask 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 dangerous.
• If any side effects occur, including those not listed in this leaflet, ask your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

PARACETAMOLO E CODEINA PENSA contains two active ingredients (paracetamol and codeine), which work in different ways.
Paracetamol works by relieving pain (analgesic) and reducing fever (antipyretic).
Codeine belongs to a group of medicines called opioid analgesics that relieve pain. It can be used alone or, as in this medicine, in combination with other painkillers such as paracetamol.
The combination of paracetamol and codeine has a greater analgesic activity than that of its individual components, with a more prolonged effect over time.
PARACETAMOLO E CODEINA PENSA is indicated in adults and adolescents over the age of 12for the short-term treatment of symptoms of moderate pain, which does not respond to treatment with other painkillers such as paracetamol or ibuprofen.
See your doctor if you/the adolescent do not feel better or if you feel worse.

2. What you need to 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), to codeine or to 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 hemolytic anemia (a condition due to the destruction of some blood cells, red blood cells)
• If you suffer from a severe liver disease (severe hepatocellular insufficiency)
• If you suffer from active liver diseases
• 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 undergone tonsillectomy or adenoidectomy because you suffered from a breathing disorder called obstructive sleep apnea syndrome, as, in such conditions, the risk of developing serious and life-threatening adverse reactions increases.
• If you know you have a liver enzyme, called CYP2D6, particularly active (ultrarapid metabolizer for CYP2D6), which allows your body to transform codeine into a high amount of morphine (detected through urine testing) with a high probability of having serious side effects,
• If you are breastfeeding or are pregnant (see section 2 “Pregnancy and breastfeeding”).

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

• suffer from mild/moderate reduction of liver function (including Gilbert's syndrome, a condition characterized by excessive production of bilirubin, a substance that causes a yellowish tinge to the skin and eyes),
• suffer from severe liver problems,
• suffer from acute liver inflammation (acute hepatitis),
• are taking medicines that change the way the liver works (medicines that stimulate liver enzymes),
• suffer from glucose-6-phosphate dehydrogenase deficiency (a substance normally present in the human body, the deficiency of which can cause hemolytic anemia),
• suffer from hemolytic anemia, a condition due to the destruction of some blood cells, red blood cells, • suffer from kidney diseases (renal insufficiency),
• use alcohol chronically or excessively (3 or more alcoholic beverages per day),
• suffer from anorexia (an eating disorder characterized by lack or reduction of appetite),
• suffer from bulimia (an eating disorder in which a person ingests an excessive amount of food and then resorts to various methods to eliminate it in order not to gain weight),
• suffer from cachexia (a condition characterized by extreme thinness, reduction of muscle mass and thinning of the skin due to chronic diseases),
• suffer from chronic malnutrition,
• suffer from dehydration (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 and produce phlegm, as expectoration may be difficult.

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

• suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage) or malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). In patients in these situations, a serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken in association with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with rapid deep breathing, drowsiness, nausea and vomiting.

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

• respiratory depression (reduction of respiratory function) and sedation
• lowering of the convulsive threshold (i.e. increased excitability of the nervous system, as in the case of epilepsy)
• hyperalgesia (increased sensitivity to pain) constipation (difficult or infrequent evacuation)
• nausea and vomiting
• masking of the symptoms of acute abdominal conditions (conditions characterized by severe pain and signs of irritation of the abdomen)
• obstruction of the outflow of bile and pancreatic juice, as in the case of some diseases of the biliary tract, for example pancreatitis (inflammation of the pancreas) and cholelithiasis (presence of gallstones in the gallbladder)
• increased release of histamine, as in the case of asthma (bronchial obstruction)
• itching
• reduction of hormone levels
• inhibition of immunological function (i.e. the function of the body's defense system)
• muscle rigidity and myoclonus (rapid involuntary muscle twitch)
• urinary retention (difficulty emptying the bladder) particularly in patients with narrowing of the urethra (the last part of the urinary tract) or with enlargement of the prostate

Use of high doses and/or for prolonged periods
The use of high doses and/or prolonged use of this medicine can cause a liver disease
(hepatopathy) and serious alterations to the kidney and blood.
Prolonged use of analgesics, including opioids, increases the risk of headache (headache)
from drug abuse.
With prolonged use of opioids, a reduction in analgesic efficacy (tolerance) may occur.
Prolonged administration of codeine or at doses higher than therapeutic doses can cause dependence
physical and psychological (addiction) and withdrawal syndrome following sudden interruption of
administration which can be observed in both patients and infants born to codeine-dependent mothers. PARACETAMOLO E CODEINA PENSA should be used with caution in patients with
dependence or with a history of opioid dependence, and alternative analgesic therapies should be considered.

Elderly
Elderly patients may be at greater risk of side effects associated with the use of
opioids, such as respiratory depression and constipation.

Children and adolescents
Donot give this medicine to children under 12 years of age.

Donot give PARACETAMOLO E CODEINA PENSA to relieve pain in children and adolescents
after tonsillectomy or adenoidectomy for obstructive sleep apnea syndrome.
Children and adolescents should be carefully monitored for signs of central nervous system depression associated with codeine, such as extreme drowsiness and respiratory depression.

Donot give PARACETAMOLO E CODEINA PENSA to children and adolescents with respiratory problems,
as the symptoms of morphine toxicity may be worse.

Other medicines and PARACETAMOLO E CODEINA PENSA
Tell your doctor or pharmacist if you are taking, have recently taken or
may take any other medicines.
In particular, tell your doctor if you are taking:

• medicines containing paracetamol, as if paracetamol is taken in high doses, serious side effects may occur
• other medicines containing opioids or other substances that depress the central nervous system, to avoid the risk of overdose or serious side effects
• coumarin anticoagulants including warfarin (medicines that delay blood clotting): the doctor will carry out more rigorous monitoring of INR values (time taken for blood to clot)
• medicines that in chronic treatment alter liver function, inducing liver monooxygenases (liver enzymes) or other substances that may have such an effect, for example:
• rifampicin (an antibiotic)
• cimetidine (a medicine used in the treatment of stomach ulcers)
• antiepileptics (medicines used to treat epilepsy), for example glutethimide, phenobarbital, carbamazepine and phenytoin. If treated with phenytoin, do not take high doses or prolonged doses of paracetamol.
• flucloxacillin (antibiotic), due to a serious risk of alterations in blood and fluids (called metabolic acidosis with elevated anion gap) which must be treated urgently (see section 2).

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

• probenecid, a medicine used to treat hyperuricemia (high concentration of uric acid in the blood) and gout (inflammation of the joints due to uric acid deposits). In this case, the doctor will advise you to reduce the doses
• medicines such as tranquilizers and sedatives
• salicylamide(a pain reliever and fever reducer)
• potent painkillers(buprenorphine, butorphanol, nalbuphine, nalorphine, pentazocine, fentanyl, dihydrocodeine, hydromorphone, morphine, oxycodone, pethidine, phenoperidine, remifentanil, sufentanil, tramadol)
• naltrexone, a medicine to treat drug addiction
• medicines to treat allergies, such as antihistamines
• analgesics(alfentanil, destromoramide, destropropoxyphene, fentanyl, dihydrocodeine, hydromorphone, morphine, oxycodone, pethidine, phenoperidine, remifentanil, sufentanil, tramadol)
• medicines to treat cough(dextromethorphan, noscapine, folcodine, codeine, etimorphine)
• medicines to treat psychiatric disorders(chlorpromazine, haloperidol, levomepromazine, thioridazine)
• methadone, a medicine to treat drug addiction
• meprobamate, a medicine to treat anxiety
• hypnotics, medicines to treat insomnia (benzodiazepines and barbiturates)
• medicinesto treat depression(amitriptyline, doxepin, mirtazapine, mianserin, trimipramine or belonging to the benzodiazepine class)
• antihypertensives, medicines to treat high blood pressure
• baclofen, a medicine to reduce and relieve excessive tension in the muscles (spasms)
• thalidomide, a medicine to treat an immune system disease, the body's defense system (multiple myeloma).
• celecoxib(a medicine that relieves inflammation)
• quinidine(a medicine to treat irregular heartbeat)
• dexamethasone(a medicine to treat various disorders such as inflammation and allergies)
• anticholinergics(medicines to treat various conditions such as bladder problems, allergies and depression).

Laboratory tests and PARACETAMOLO E CODEINA PENSA
If you need to have blood tests, keep in mind that the administration of paracetamol may interfere
with the determination of uricemia (the amount of uric acid in the blood) and glycemia (the amount of
sugar in the blood).
The concomitant use of PARACETAMOLO E CODEINA PENSA and sedative medicines such as
benzodiazepines or related drugs increases the risk of drowsiness, difficulty breathing
(respiratory depression), coma and may be life-threatening. For this reason, concomitant use
should be considered only when other therapeutic options are not possible.
However, if your doctor prescribes PARACETAMOLO E CODEINA PENSA together with sedative medicines,
you must limit the dose and duration of concomitant treatment.
Inform your doctor of all sedative medicines you are taking and strictly follow their
recommendation on the dose. It may be helpful to inform friends and family to be aware of the signs and
symptoms reported above. Contact your doctor when these symptoms occur

PARACETAMOLO E CODEINA PENSA and alcohol
Do not take PARACETAMOLO E CODEINA PENSA together with alcoholic beverages, as alcohol
increases sedation and causes a state of reduced alertness that can make driving and operating
machinery dangerous (see section “Driving and using machines”).
Take PARACETAMOLO E CODEINA PENSA with caution if you use alcohol chronically or excessively (3 or more alcoholic beverages 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 are pregnant or are planning a pregnancy, ask your doctor or
pharmacist for advice before taking this medicine.
If necessary, paracetamol can be used during pregnancy. It is appropriate to use the lowest possible
dose that reduces pain and/or fever and take it for the shortest possible time. Contact your
doctor/midwife if the pain and/or fever does not decrease or if you have to take paracetamol more
often.

Pregnancy
PARACETAMOLO E CODEINA PENSA should not be used during pregnancy unless
advised by your doctor. Regular use during pregnancy can cause withdrawal symptoms to appear in the
newborn. If used, the medicine should be taken at the lowest possible dose useful
to reduce pain and/or fever and for the shortest possible duration.
Clinical experience with the use of paracetamol during pregnancy is limited. It appears that no
undesirable effects occur in pregnant women, the fetus and newborns.
Maternal use of codeine at any stage of pregnancy may be associated with scheduled cesarean delivery.
Use in the third trimester may be associated with an increased risk of urgent cesarean delivery, postpartum
hemorrhage and the possible onset of opioid withdrawal symptoms in the newborn, including restlessness,
excessive crying, tremors, decreased muscle tone
(hypotonia), increased respiratory rate (tachypnea), fever (pyrexia), vomiting and diarrhea.

Breastfeeding

Do nottake PARACETAMOLO E CODEINA PENSA if you are breastfeeding, as codeine passes
into breast milk.

Driving and operating machinery
PARACETAMOLO E CODEINA PENSA can affect your ability to drive vehicles or operate
machinery, as it may cause side effects such as drowsiness and cognitive disturbances, such as
impaired attention.

3. How to take PARACETAMOLO E CODEINA PENSA

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist. To avoid the risk of overdose, check that other medicines you are taking (with or without a 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 the pain, to be taken 1 to 3 times a day at intervals of at least 4 hours.

Elderly
The initial dose should be halved compared to the recommended dosage for adults and may subsequently be increased.

Patients with kidney failure
If you/the adolescent suffer from a severe kidney disease, the interval between two administrations must be at least 8 hours.

Patients with hepatic impairment
If you suffer from an alteration of liver function, the dose must be reduced or the interval between two administrations prolonged. The maximum dose should not exceed 4 tablets per day in case of: adult patients weighing less than 50 kg, liver disease, Gilbert's syndrome, chronic alcoholism, chronic malnutrition or dehydration.
Duration of treatment
The medicine should not be taken for more than 3 days in a row. If the pain does not improve after 3 days, consult your doctor.
Method of administration
Oral use. The tablets must be swallowed whole with a glass of water. Do not break or chew. The tablets can be divided, if necessary, into two equal doses.

If you take more PARACETAMOLO E CODEINA PENSA than you should
In case of accidental ingestion/taking of an excessive dose of PARACETAMOLO E CODEINA PENSA, immediately inform your doctor or go to the nearest hospital. In hospital, you will be subjected to appropriate intervention protocols (e.g. gastric lavage, administration of the 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 abuse alcohol (chronic alcoholism),
• suffer from chronic malnutrition,
• are taking medicines or substances that increase the way the liver works (liver enzyme inducers). SymptomsIn case of accidental ingestion of very high doses of PARACETAMOLO E CODEINA PENSA, the symptoms that you/the adolescent may generally experience within the first 24 hours include:
• nausea,
• vomiting,
• anorexia,
• pallor,
• malaise,
• diaphoresis (profuse sweating)

In case of ingestion of 7.5 g or more of paracetamol in adults and 140 mg per kg of body weight in children, you/the adolescent may experience serious liver damage resulting in alteration of some blood test results (AST, ALT, lactic dehydrogenase, bilirubin, prothrombin), coma (deep unconsciousness) or death. The symptoms of liver damage reach their peak after 3-4 days.
Taking an excessive dose of codeine can cause:

• respiratory depression ranging from decreased respiratory rate to apnea (cessation of breathing)
• extreme sedation ranging from drowsiness to coma
• miosis (constriction of the pupils). Other symptoms related to effects on the central nervous system may also occur, including:
• headache
• vomiting
• urinary retention (difficulty emptying the bladder)
• reduced intestinal motility (peristalsis)
• bradycardia (decreased heart rate)
• hypotension (low blood pressure).

In adults, an excessive dose of codeine can cause:

• skin that becomes blue due to lack of oxygen (cyanosis)
• reduced respiratory function
• drowsiness
• skin rash, itching
• difficulty with movements (ataxia)
• pulmonary edema (rare)

In children, an excessive dose of codeine can cause:

• difficulty breathing, even severe (reduced respiratory function, respiratory arrest),
• constriction of the pupils (miosis),
• uncontrolled body movements (convulsions),
• facial redness and swelling,
• hives,
• collapse,
• inability to empty the bladder (urinary retention).

Treatment
The doctor, based on the nature and severity of the symptoms, will carry out the appropriate supportive therapy.
The maximum dose of opioids varies from individual to individual.

If you forget to take PARACETAMOLO E CODEINA PENSA
Do not take/give the adolescent a double dose to make up for a missed dose.

If you stop taking PARACETAMOLO E CODEINA 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 will experience them.
If you experience the following side effects STOPtreatment with this medicine and contact

immediatelyyour doctor:

• skin reactions that may manifest with:
• itching, urticaria, skin rash
• erythema
• erythema multiforme (condition characterized by the appearance of red spots on the skin with a "bull's-eye" appearance associated with itching)
• Stevens Johnson syndrome (severe form of polymorphous erythema)
• toxic epidermal necrolysis (severe skin disease characterized by redness, blistering lesions with areas of detachment and skin death) acute generalized exanthematous pustulosis
• allergic reactions that may manifest with:
• 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 (reduction of respiratory activity)

In addition, those taking the medicine may experience the following side effects.

Frequency not known(frequency cannot be defined based on available data):

• anemia (reduction of hemoglobin in the blood, a substance that carries oxygen in the blood)
• thrombocytopenia (reduction 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
• drowsiness
• vertigo
• myoclonus (rapid involuntary muscle twitch)
• paresthesia (tingling)
• syncope (transient loss of consciousness)
• tremor
• sedation (drowsiness)
• confusional state
• drug abuse
• drug dependence
• hallucination
• euphoria (excitement)
• dysphoria (depressed mood with irritability and nervousness)
• acute renal failure (reduction of kidney function)
• interstitial nephritis (inflammation of the kidneys)
• hematuria (blood in the urine)
• anuria (cessation or reduction of urine production by the kidney)
• urinary retention (inability of the bladder to empty completely)
• diarrhea
• abdominal pain
• nausea
• vomiting
• constipation
• reactions to the stomach and intestines
• pancreatitis (inflammation of the pancreas)
• dyspnea (difficulty breathing)
• increased liver enzymes
• decrease or increase of INR (value used to express the time it takes for blood to coagulate)
• rhabdomyolysis (severe muscle damage)
• asthenia (weakness)
• malaise
• miosis (constriction of the pupils)
• urinary retention (inability of the bladder to empty completely)
• severe condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see paragraph 2)

At codeine dosages higher than therapeutic levels there is a risk of dependence and withdrawal syndrome following abrupt discontinuation of administration, which can be observed in both patients and newborns born to codeine-dependent mothers.
In case of overdose, paracetamol can cause serious liver damage (hepatic cytolysis which can evolve towards massive and irreversible necrosis).

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

5. How to store PARACETAMOLO E CODEINA PENSA

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 that is reported on the package after SCAD.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use.
This will help protect the environment.

6. Contents of the pack and other information

What PARACETAMOLO E CODEINA PENSA contains

• The active ingredients are: paracetamol and codeine phosphate. 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 contents of the pack
PARACETAMOLO E CODEINA PENSA 500 mg/30 mg divisible tablets of white color,
biconvex, oblong.
PARACETAMOLO and CODEINA PENSA is available in packs of 16 tablets.

Marketing Authorisation 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