ZEUSEFF 500 mg/30 mg Effervescent Tablet

Зміст інструкції

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

ZEUSEFF 500 mg + 30 mg effervescent tablets

paracetamol + codeine phosphate
Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 ZEUSEFF is and what it is used for
• 2. What you need to know before you take ZEUSEFF
• 3. How to take ZEUSEFF
• 4. Possible side effects
• 5. How to store ZEUSEFF
• 6. Contents of the pack and other information

1. What ZEUSEFF is and what it is used for

ZEUSEFF 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 which work by relieving
pain. Codeine can be used alone or, as in this medicine, in combination with other
pain relievers such as paracetamol.
ZEUSEFF is indicated in adults and adolescents (from 12 to 18 years of age)for the short-term treatment of symptoms of moderate to severe acute pain, which does not respond to treatment
with other pain relievers or anti-inflammatory drugs such as paracetamol or ibuprofen used
not in combination.
See your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking ZEUSEFF

Do not take ZEUSEFF if

• you are allergic to paracetamol or propacetamol (a precursor of paracetamol), to codeine or to any of the other ingredients of this medicine (listed in section 6),
• you suffer from a lung disease (respiratory failure), as codeine may worsen the condition,
• you have a liver enzyme that allows your body to convert codeine into a high amount of morphine (detected through urine testing) with a high probability of having serious side effects,
• you are breastfeeding (see section 2 “Pregnancy and breastfeeding”),
• you suffer from phenylketonuria, i.e. your body is unable to transform a substance called phenylalanine, contained for example in sweeteners based on aspartame (see section 2 “ZEUSEFF effervescent tablets contains aspartame”).

Do not give ZEUSEFF to your child if

• they are under 12 years of age,
• they are between 0 and 18 years old and have undergone surgery to remove their tonsils and/or adenoids because they suffered from a breathing disorder called obstructive sleep apnea syndrome.

Warnings and precautions
Talk to your doctor or pharmacist before taking ZEUSEFF.
Consult your doctor if:

• you suffer from mild/moderate impairment of liver function (including Gilbert's syndrome),
• you suffer from severe liver problems,
• you suffer from acute liver inflammation (acute hepatitis),
• you are taking medicines that stimulate liver enzymes (see section “Other medicines and ZEUSEFF”),
• you suffer from glucose-6-phosphate dehydrogenase deficiency (a substance normally present in the human body),
• you suffer from hemolytic anemia, a disease due to the destruction of red blood cells,
• you suffer from kidney diseases (renal failure),
• you consume alcohol chronically or excessively (3 or more alcoholic beverages per day)
• you suffer from anorexia (an eating disorder characterized by a lack or reduction of appetite),
• you 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),
• you suffer from cachexia (a condition characterized by extreme thinness, reduction of muscle mass and thinning of the skin due to chronic diseases),
• you suffer from chronic malnutrition,
• you suffer from dehydration,
• you suffer from hypovolemia (reduced blood volume circulating in the body, which represents the most common cause of low blood pressure),
• you have undergone surgery to remove the gallbladder (the organ where bile is stored),
• you have a cough with phlegm.

Use of high doses and/or for prolonged periods
The use of high doses or prolonged use of this medicine can cause a liver disease
(hepatopathy) and serious alterations to the kidney and blood or cause dependence
(habituation).

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

Donot give codeine to relieve pain in children and adolescents after removal of the
tonsils or adenoids for obstructive sleep apnea syndrome.

Donot give codeine to children and adolescents with breathing problems, as symptoms of morphine
toxicity may be worse in these subjects.

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

Donot take ZEUSEFF if you are taking:

• potent painkillers(buprenorphine, nalbuphine, pentazocine),
• naltrexone, a medicine to treat drug addiction.

Also tell your doctor if you are taking:

• medicines containing paracetamol, as if paracetamol is taken in high doses, serious side effects may occur;
• oral anticoagulants(medicines used to make the blood more fluid); your doctor may advise you to reduce the doses;
• medicines that stimulate liver enzymes (hepatic monooxygenases) or other substancesthat may have this effect, for example:
• rifampicin (an antibiotic)
• cimetidine (a medicine used in the treatment of stomach ulcers)
• antiepileptics (medicines used to treat epilepsy), such as glutethimide, phenobarbital, carbamazepine and phenytoin. The use of these medicines with ZEUSEFF requires strict medical control. In case of prolonged treatment with these medicines, do not take ZEUSEFF;
• probenecid(a medicine used to treat gout). In this case your doctor will advise you to reduce the doses;
• medicines such as tranquilizersand sedatives;
• medicines to treat allergies, such as antihistamines;
• painkillers(such as alfentanil, destromoramide, destropropoxyphene, fentanyl, dihydrocodeine, hydromorphone, morphine, oxycodone, pethidine, phenoperidine, remifentanil, sufentanil, tramadol)
• medicines to treat cough(such as dextromethorphan, noscapine, folcodine, codeine, etimorphine);
• methadone, a medicine to treat drug addiction;
• meprobamate, a medicine to treat anxiety;
• hypnotics, medicines to treat insomnia;
• medicinesto treat depression(such as amitriptyline, doxepin, mirtazapine, mianserine, trimipramine or belonging to the barbiturate or benzodiazepine class);
• antihypertensives, medicines to treat high blood pressure;
• baclofen, a medicine to reduce and relieve excessive tension in the muscles (spasms) that occurs in various diseases;
• thalidomide, a medicine to treat a disease of the immune system, the body's defense system (multiple myeloma).

The concomitant use of ZEUSEFF and sedatives, such as benzodiazepines or related drugs,
increases the risk of drowsiness, 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
ZEUSEFF together with sedatives, the dose and duration of concomitant treatment must
be limited by the doctor. Please inform your doctor of all sedatives you are
taking and carefully follow the doctor's recommendations on dosage. It may be helpful
to inform friends or family members so that they are aware of the above signs and symptoms. Contact
your doctor if you experience these symptoms.

Laboratory tests and ZEUSEFF
If you need to have blood tests, keep in mind that the administration of paracetamol may
interfere with the determination of uric acid in the blood (using the phosphotungstic acid
method) and the amount of sugar in the blood (using the glucose-oxidase-peroxidase
method).

ZEUSEFF and alcohol
Take ZEUSEFF with caution if you consume 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 ZEUSEFF than you should”).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, ask your doctor
or pharmacist for advice before taking this medicine.

Pregnancy
During pregnancy, take ZEUSEFF only under strict medical supervision, who will assess the
risk/benefit ratio for you and recommend the dose to be taken and the duration of treatment.
If you take ZEUSEFF during pregnancy, your doctor will monitor you closely.
If you have to take ZEUSEFF at the end of pregnancy, your doctor should carefully assess
the newborn for possible respiratory side effects.

Breastfeeding

Donot take ZEUSEFF if you are breastfeeding (see section “Do not take ZEUSEFF).

Driving and operating machinery
ZEUSEFF may affect your ability to drive or operate machinery as it may cause
side effects such as drowsiness and reduced alertness.

ZEUSEFF effervescent tablets contains:

• sodium:this medicine contains 349 mg (15 mEq) of sodium per effervescent tablet. This should be taken into consideration in people with impaired kidney function or who are following a low-sodium diet. Talk to your doctor or pharmacist if you need 2 or more tablets a day for a prolonged period, especially if you have been advised to follow a low-sodium diet;
• aspartame:this medicine contains 30 mg of aspartame per effervescent tablet. Aspartame is a source of phenylalanine. It may be harmful to you if you suffer from phenylketonuria, a rare genetic disease that causes the accumulation of phenylalanine because the body cannot dispose of it properly;
• sorbitol:this medicine contains 252 mg of sorbitol per effervescent tablet. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) are intolerant to some sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients cannot transform fructose, talk to your doctor before you (or your child) take this medicine. .

3. How to take ZEUSEFF

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Adults and adolescents (from 12 to 18 years of age)
The recommended dose is 1-2 tablets, depending on the severity of the pain, to be taken 1-3 times a
day at intervals of at least 4 hours.
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.

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

Patients with kidney disease
If you suffer from a severe kidney disease (severe renal insufficiency) the interval between two
administrations must be at least 8 hours.

Method of administration
Let the effervescent tablet dissolve in a glass of water and immediately drink the
solution thus obtained.

If you take more ZEUSEFF than you should
In case of accidental ingestion/taking of an excessive dose of ZEUSEFF, immediately inform
your doctor or go to the nearest hospital.
Taking an excessive dose increases the risk of intoxication and can lead to death,
especially if:

• you suffer from liver diseases,
• you abuse alcohol,
• you suffer from chronic malnutrition,
• you are taking medicines or substances that increase the way the liver works (liver enzyme inducers). SymptomsIn case of accidental taking of very high doses of ZEUSEFF, the symptoms that you may generally experience include
• within the first 24 hours:
• nausea, vomiting, stomach pain, anorexia
• pallor, malaise
• intense sweating
• skin that turns blue due to lack of oxygen (cyanosis)
• reduced respiratory function
• drowsiness
• skin rash, itching
• alteration of the results of some blood tests (ALT, AST, lactate dehydrogenase, bilirubin, prothrombin)
• difficulty in movements (ataxia).
• liver damage, such as:
• hepatic cytolysis (destruction of liver cells)
• necrosis (death) complete and irreversible of liver cells
• hepatocellular insufficiency (loss of liver cell function)
• metabolic acidosis (increase in the amount of acid in the blood)
• encephalopathy (brain disease caused by reduced liver function)
• coma (deep unconsciousness)
• death. Liver damage reaches its maximum level after 3-4 days.

If a child accidentally takes an excessive dose of ZEUSEFF, they may experience:

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

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

Note for healthcare professional: the specific antidote in case of paracetamol poisoning is N-
acetylcysteine administered intravenously or orally, if possible, within 8 hours of ingestion.
This antidote can provide a certain degree of protection even after 16 hours.

If you forget to take ZEUSEFF
Do not take a double dose to make up for a missed dose.

If you stop taking ZEUSEFF
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
If you take ZEUSEFF at dosages higher than those therapeutic, you have a risk of dependence and withdrawal syndrome following sudden discontinuation of administration. These effects could
be reported and be visible even in your child if you were pregnant and took ZEUSEFF for a
prolonged time.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience the following side effects STOPtreatment with this medicine and
contact your doctor immediately:

• allergic reactions that may manifest with:
• laryngeal edema (swelling of the throat)
• angioedema (swelling of hands, feet, ankles, face, lips, tongue and/or throat)
• itching
• urticaria, skin rash
• low blood pressure
• anaphylactic shock (severe allergic reaction)
• slow or shallow breathing
• confusion
• pinpoint pupils (miosis)
• loss of appetite
• drowsiness
• nausea or vomiting, constipation.

The following additional side effects have been reported during treatment with ZEUSEFF, for which
the frequency cannot be estimated:

• 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 polymorphic erythema)
• severe skin disease characterized by redness, blistering lesions with areas of detachment and skin death (toxic epidermal necrolysis)
• acute generalized exanthematous pustulosis (disease characterized by the formation of red spots on the skin with accumulation of fluids and with the formation of superficial pustules)
• thrombocytopenia (reduction in the number of platelets in the blood)
• leukopenia/agranulocytosis/neutropenia (reduction in the number of white blood cells in the blood)
• anemia (reduction in hemoglobin in the blood)
• abnormal liver function
• hepatitis (inflammation of the liver)
• increased liver enzymes
• dizziness
• sedation or excitation
• depressed mood with agitation, irritability, nervousness (dysphoria)
• acute renal failure (reduction in 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)
• reactions to the stomach and intestines
• abdominal pain
• acute abdominal pain (probably due to spasm of the sphincter of Oddi, which occurs particularly in patients who have undergone cholecystectomy)
• diarrhea
• inflammation of the pancreas (pancreatitis)
• difficulty breathing (bronchospasm)
• reduction of respiratory activity (respiratory depression)
• decrease in the value used to express the time it takes for blood to clot (INR)
• increase in the value used to express the time it takes for blood to clot (INR)

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 http://www.agenziafarmaco.gov.it/content/come-
segnalare-una-sospetta-reazione-avversa
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store ZEUSEFF

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25°C and keep the tube in the box to protect the
medicine from humidity.
Do not use this medicine after the expiry date which is stated on the pack after “EXP”.
The expiry date refers to the last day of that month.
After first opening, use within 3 months.
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 ZEUSEFF contains

• The active ingredients are: paracetamol 500 mg and codeine phosphate 30 mg (equivalent to 22.5 mg of codeine).
• The other ingredients are: citric acid, sodiumhydrogen carbonate, sodiumcarbonate anhydrous, sodiumdocusate, (see section 2 “ZEUSEFF effervescent tablets contains sodium”), sorbitol(E420) (see section 2 “ZEUSEFF effervescent tablets contains sorbitol”), aspartame(E951) (see section 2 “ZEUSEFF effervescent tablets contains aspartame”), orange flavour, lemon flavour, simethicone.

Description of the appearance of ZEUSEFF and contents of the pack
ZEUSEFF is presented as effervescent tablets, white, flat and with a break line.
It is available in packs of 16 tablets in a tube containing silica gel as a desiccant in the
cap.

Marketing Authorisation Holder
Omikron Italia S.r.l.
Viale Bruno Buozzi, 5
00197 Rome (Italy)

Manufacturer
E-Pharma Trento S.p.A.
Frazione Ravina
Via Provina, 2
38123 Trento (TN)