PARACETAMOLO 500 mg/30 mg Effervescent Tablet

Зміст інструкції

1. Paracetamolo e Codeina Alter 500 mg + 30 mg effervescent tablets
   1. What is Paracetamolo e Codeina Alter and what is it used for
   2. What you need to know before taking Paracetamolo e Codeina Alter
   3. How to take Paracetamol and Codeine Alter
   4. Possible side effects
   5. How to store Paracetamolo e Codeina Alter
   6. Contents of the pack and other information

Paracetamolo e Codeina Alter 500 mg + 30 mg effervescent tablets

Paracetamolo e Codeina Fosfato

Generic medicine

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Paracetamolo e Codeina Alter contains two active ingredients: paracetamol and codeine.

• Paracetamol belongs to a group of medicines called analgesics and antipyretics that work by relieving pain and inflammation (analgesic and anti-inflammatory action) and lowering body temperature in case of fever (antipyretic action);
• Codeine belongs to a group of medicines called opioid analgesics that work by relieving pain.

Paracetamolo e Codeina Alter is used in adults and children over 12 years of age,
for the treatment of moderate to severe pain that has not been relieved by previous
treatments with other medicines, such as paracetamol or ibuprofen alone.
See your doctor if you do not feel better or if you feel worse after 3 days.

2. What you need to know before taking Paracetamolo e Codeina Alter

Do not take Paracetamolo e Codeina Alter

• if you are allergic to paracetamol, to propacetamol, to codeine, to similar medicines or to any of the other components of this medicine (listed in section 6);
• if you have a hereditary condition characterized by a deficiency of an enzyme known as glucose-6-phosphate dehydrogenase;
• if the number of red blood cells in your blood is very low (severe hemolytic anemia);
• if you suffer from active liver disease;
• if you suffer from severe liver problems (hepatocellular insufficiency);
• if you suffer from breathing problems (respiratory failure);
• if the patient is between 0 and 18 years of age and has undergone surgery to remove the tonsils and/or adenoids (tonsillectomy and/or adenoidectomy) to treat sleep breathing disorders (obstructive sleep apnea); in this case, dangerous life-threatening side effects may occur (see section “Possible side effects”);
• if you are breastfeeding;
• if you have certain particular genetic characteristics (CYP2D6 ultra-rapid metabolizer, see section “Warnings and precautions”), because this medicine, at the recommended doses, may be less effective.

Warnings and precautions
Talk to your doctor or pharmacist before taking Paracetamolo e Codeina Alter.
Pay particular attention before taking Paracetamolo e Codeina Alter and consult your
doctor if:

• you have undergone surgery on the gallbladder (removal), as codeine can cause abdominal pain (acute biliary or pancreatic pain associated with spasm of the sphincter of Oddi);
• you are being treated for long periods (chronic treatment) with medicines that cause changes in the levels of certain enzymes produced by the liver (induction of hepatic monooxygenases) or are exposed to substances that can have this effect (paracetamol). Avoid taking Paracetamolo e Codeina Alter if you are taking these medicines.
• you are taking other medicines containing paracetamol as high doses can cause even serious side effects;
• increase in internal pressure in the head (intracranial hypertension). If you take high doses of this medicine or take it for a long time, the following may occur:
• severe liver problems (hepatopathy);
• disorders, even serious, to the kidneys or blood;
• the need to continue taking Paracetamolo e Codeina Alter (codeine dependence, see section “If you stop taking Paracetamolo e Codeina Alter”).
• During treatment with Paracetamolo e Codeina Alter, immediately inform your doctor if: you have liver or kidney problems (renal or hepatic insufficiency, hepatitis);
• you habitually drink alcohol (3 or more alcoholic beverages per day) or if you have an alcohol dependence (chronic alcoholism);
• you suffer from nutritional problems (anorexia, bulimia, cachexia) or suffer from chronic malnutrition (low hepatic glutathione reserves);
• you have a low level of fluids (dehydration);
• you have a low blood volume (hypovolemia);
• you have a cough with phlegm, as codeine can make it difficult to clear the phlegm;
• If you 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). Patients in these situations have been reported to have a serious condition called metabolic acidosis (an abnormality of the blood and fluids) when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken in combination with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with rapid deep breathing, drowsiness, nausea and vomiting.

During treatment with this medicine, you may experience:

• allergic reactions; in this case, stop treatment immediately and consult your doctor;

If you have certain particular genetic characteristics (CYP2D6 ultra-rapid metabolizer), for
which you metabolize this medicine very quickly, you may experience the following side
effects (opioid toxicity):

• confusion, drowsiness;
• rapid and shallow breathing (superficial);
• constriction of the pupils (miotic pupil);
• nausea and vomiting;
• constipation;
• loss of appetite;
• in the most severe cases, difficulty breathing (respiratory depression) and problems with blood circulation that can be life-threatening and very rarely fatal.

Taking this medicine may alter the results of some laboratory tests such as the
measurement of uric acid (uricemia) or sugar (glycemia) in the blood.

Children
This medicine should not be used in children under 12 years of age.
This medicine should not be administered to relieve pain in children and
adolescents after removal of the tonsils or adenoids because life-threatening side effects may occur
(see section “Do not take Paracetamolo e Codeina Alter”).
This medicine should not be administered to children with breathing problems
(impaired respiratory function), therefore inform your doctor if the child:

• suffers from muscle problems (neuromuscular disorders);
• suffers from severe heart or breathing problems;
• has respiratory or lung infections;
• has suffered multiple traumas;
• has undergone extensive surgery.

Other medicines and Paracetamolo e Codeina Alter
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.

• flucloxacillin (antibiotic), due to a serious risk of alterations in blood and fluids (so-called metabolic acidosis with high anion gap) that need to be treated urgently.

Paracetamolo e Codeina Alter contains sodium
This medicine contains 219.6 mg (or 9.5 milliequivalents) of sodium per tablet. This should be
taken into consideration in people with impaired kidney function or who are following a low-sodium
diet.

Do not takeParacetamolo e Codeina Alterif you are taking:

• medicines used for the treatment of pain (agonists and antagonists of morphine, such as buprenorphine, nalbufine, pentazocine);
• naltrexone, a medicine used for the treatment of opioid dependence.

Take this medicine with caution and inform your doctor if you are taking the following
medicines:

• oral anticoagulants, medicines used to thin the blood, the doctor may reduce the dose;
• rifampicin, an antibiotic used to treat some bacterial infections;
• cimetidine, a medicine used to treat stomach and intestinal problems such as acidity or the presence of lesions (ulcers);
• antiepileptic medicines, used to treat seizures (glutethimide, phenobarbital, carbamazepine);
• phenytoin, a medicine used to treat seizures (epilepsy) because it can cause liver problems; the doctor will need to perform periodic checks of liver function. Avoid taking this medicine at high doses and for prolonged treatments simultaneously with phenytoin;
• probenecid, a medicine used to treat high levels of uric acid (gout); the doctor will assess whether to reduce the dose of Paracetamolo e Codeina Alter;
• salicylamide, a medicine used to reduce pain. Pay particular attention and consult your doctor if you are taking the following medicines because breathing problems may occur, which may be fatal in case of an overdose:
• other medicines for the treatment of pain (alfentanil, destromoramide, destropropoxyphene, fentanyl, dihydrocodeine, hydromorphone, morphine, oxycodone, pethidine, phenoperidine, remifentanil, sufentanil, tramadol) and in general morphine-derived medicines;
• medicines used to relieve cough (morphine derivatives, such as dextromethorphan, noscapine, folcodine, codeine, etimorphine);
• medicines used to treat anxiety and insomnia (benzodiazepines);
• barbiturates;
• methadone, used to treat opioid dependence.

Pay particular attention and consult your doctor if you are taking the following medicines
(sedative medicines) as they may alter your ability to drive or operate machinery:

• morphine-derived medicines (analgesics, cough suppressants and substitution treatments);
• tranquilizers (neuroleptics);
• medicines used to treat epilepsy (barbiturates);
• medicines used to treat anxiety (meprobamate) and/or insomnia (benzodiazepines, hypnotics);
• medicines used to treat depression (sedative antidepressants, such as amitriptyline, doxepin, mirtazapine, mianserin, trimipramine);
• medicines used to treat allergies (H antihistamines with sedative action);
• medicines used to treat high blood pressure (central antihypertensives);
• baclofen, a medicine used to treat some muscle problems (hypertonia and spasticity);
• thalidomide, used for the treatment of a form of cancer (multiple myeloma).

The concomitant use of Paracetamolo e Codeina Alter and sedative medicines such as benzodiazepines
or related drugs increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can be
life-threatening. For this reason, concomitant use should only be considered when other treatment options are not
possible.
However, if your doctor prescribes Paracetamolo e Codeina Alter together with sedative medicines, the
dose and duration of concomitant treatment must be limited by your doctor.
Inform your doctor about all the sedative medicines you are taking and carefully follow
your doctor's recommendation on the dose. It may be helpful to inform friends or family members to pay
attention to the signs and symptoms listed above. Consult your doctor if you experience these symptoms.

Paracetamolo e Codeina Alter with alcohol
Avoid consuming beverages containing alcohol during treatment with this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this
medicine.
If necessary, Paracetamolo e Codeina Alter can be used during pregnancy. It is advisable to use
the lowest possible dose that relieves pain and take it for the shortest possible time.
Contact your doctor if the pain does not decrease or if you need to take the medicine more often.
Do not take this medicine if you are breastfeeding as codeine passes into breast milk. The
child may experience serious, potentially fatal, side effects, especially if they have
certain particular genetic characteristics (CYP2D6 ultra-rapid metabolizer, see the
section “Warnings and precautions”).

Driving and using machinery
This medicine can cause drowsiness, especially if you are taking other medicines that
cause sedation (see section “Other medicines and Paracetamolo e Codeina Alter”). If
this should occur, avoid driving or operating machinery.

3. How to take Paracetamol and Codeine Alter

Take this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts, consult your doctor or pharmacist.
Dissolve the tablets in a glass of water and drink the resulting solution.

Use in adults and children over 12 years
The recommended dose is 1-2 tablets, maximum 3 times a day. At least 4 hours must pass between doses. In case of severe renal impairment, the interval must be at least
8 hours.

Use in the elderly
If you are an elderly person, the recommended dose is half the dose for adults. The doctor
may decide to increase the dose subsequently based on your health conditions.

Use in children under 12 years of age
This medicine should not be used in children under 12 years of age (see
paragraph “Children”).

If you take more Paracetamol and Codeine Alter than you should
The risk of intoxication, which can also lead to death, is greater if you suffer from liver problems (liver disease), if you habitually consume alcohol (chronic alcoholism), if you suffer from
problems of malnutrition (chronic malnutrition) and if you are taking other medicines (enzymatic inducers).
Effects due to paracetamol:
In case of intoxication, the following symptoms may appear within the first 24 hours:

• nausea, vomiting;
• reduced appetite (anorexia), pale face, malaise;
• sweating.

For ingestion of a dose equal to 7.5 g or more in adults and 140 mg per kilogram of body weight
in children, causes serious liver problems (hepatic cytolysis) which may worsen up to
death of liver cells (complete and irreversible necrosis), decreased
liver function (hepatocellular insufficiency), increased blood acidity
(metabolic acidosis) and brain damage (encephalopathy) that can lead to coma and death.
Simultaneously, there is an increase in the levels of some enzymes produced by the liver
(AST, ALT) and other substances (lactic dehydrogenase, bilirubin), a decrease in the levels of a
substance important for blood coagulation (prothrombin) which may occur from 12 hours
up to 48 hours after ingestion.
The symptoms that indicate liver damage usually appear after 1-2 days and reach the
maximum intensity after 3-4 days.
Effects due to codeine:
In case of overdose, the symptoms that may appear in adults are:

• breathing problems (reduced respiratory function), bluish discoloration of the skin (cyanosis);
• drowsiness;
• skin irritation (rash), itching;
• vomiting;
• movement disorders (ataxia);
• fluid accumulation in the lungs (pulmonary edema).

In case of overdose, the symptoms that may appear in children are:

• breathing problems (reduced respiratory function), cessation of breathing (respiratory arrest);
• pupil constriction (miosis);
• convulsions;
• redness and swelling of the face, skin irritation (urticaria), marked decrease in blood pressure (collapse) and decreased urine production (urinary retention; these symptoms are associated with increased levels of histamine).

In case of ingestion/accidental intake of an excessive dose of Paracetamol and Codeine
Alter, immediately inform your doctor or go to the nearest hospital.

If you forget to take Paracetamol and Codeine Alter
Do not take a double dose to make up for the missed dose.

If you stop taking Paracetamol and Codeine Alter
Following the use of doses higher than those recommended and the sudden interruption of
treatment with this medicine, some symptoms (withdrawal syndrome) may appear,
especially after prolonged treatment (see paragraph “Warnings and precautions”).
Inform your doctor before stopping treatment with this medicine.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur due to paracetamol:

Frequency not known(frequency cannot be estimated on the basis of the available data):

• severe skin disorders characterized by the presence of lesions (erythema multiforme, Stevens-Johnson syndrome and epidermal necrolysis);
• allergic reactions such as swelling of the face, especially around the lips and eyes (angioedema or Quincke's edema), swelling of the throat (laryngeal edema), due to fluid accumulation;
• severe allergic reaction (anaphylactic shock);
• decrease in the number of platelets (thrombocytopenia), decrease in the number of white blood cells (leukopenia, agranulocytosis, neutropenia), decrease in the number of red blood cells (anemia);
• alterations in liver function and liver inflammation (hepatitis);
• kidney problems (acute renal failure, interstitial nephritis);
• presence of red blood cells in the urine (hematuria), reduced urine production (anuria);
• problems with the stomach and intestines;
• dizziness;
• diarrhea, abdominal pain;
• increased levels of enzymes produced by the liver;
• alteration of the results of some blood tests (decrease or increase in INR);
• skin rash, erythema, urticaria;
• decrease in blood pressure associated with severe allergic reaction (hypotension due to anaphylactic shock).
• severe condition that can make the blood more acidic (called metabolic acidosis), in patients suffering from a serious illness who use paracetamol (see paragraph 2) The following side effects may occur due to codeine:
• constipation, nausea, vomiting;
• sedation;
• changes in behavior (euphoria, dysphoria);
• constriction of the pupil (miosis);
• decreased urine production (urinary retention);
• allergic-type reactions such as itching, skin rash, urticaria;
• drowsiness;
• dizziness;
• breathing problems (bronchospasm, respiratory depression);
• abdominal pain, especially if you have had gallbladder surgery (acute biliary or pancreatic abdominal pain associated with spasm of the sphincter of Oddi).

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through 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 Alter

Keep this medicine out of the sight and reach of children.
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 at a temperature above 25°C.
Store in the original packaging to protect the medicine from moisture and heat.
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 Alter contains

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

Description of the appearance of Paracetamolo e Codeina Alter and contents of the pack
Pack of 16 effervescent tablets.

Marketing Authorisation Holder
Laboratori Alter s.r.l. Via Egadi, 7 -20144 Milano

Manufacturer
Laboratorios Alter S.A., C/ Mateo Inurria, 30 – 28036 Madrid, Spain