PARACETAMOLO 500 mg/30 mg Tablets

Зміст інструкції

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

Paracetamol and Codeine EG 500 mg/30 mg tablets

Generic medicine

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

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

Pharmacotherapeutic group
Paracetamolo e Codeina EG is an analgesic that combines the complementary actions of paracetamol and
codeine phosphate.

Therapeutic indications
Paracetamolo e Codeina EG is indicated for the symptomatic treatment of moderate acute pain that cannot be
controlled with paracetamol alone.
Codeine may be used in children over the age of 12 for the short-term treatment of
moderate pain that cannot be relieved by other painkillers such as paracetamol or
ibuprofen taken alone. This medicine contains codeine. Codeine belongs to a group of
medicines called opioid analgesics, which work by relieving pain. It can be used alone or in
combination with other painkillers such as paracetamol.

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

Do not take Paracetamolo e Codeina EG

• if you are allergic to paracetamol, codeine, phenacetin or any of the other ingredients of this medicine (listed in section 6).
• Without your doctor's advice, in cases where medical tests show that you suffer from a severe kidney or liver disease, a heart or lung disease, anemia, high intracranial pressure, shows signs of respiratory failure, acute asthma or head trauma.
• If you are a child under 12 years of age.
• If you suffer from phenylketonuria, you should not take effervescent tablets. This does not apply to tablets that can be swallowed.
• Children and adolescents under 18 years of age should not take this medicine to relieve pain following surgical removal of the tonsils or adenoids due to obstructive sleep apnea.
• If you are aware that you metabolize codeine very quickly into morphine.
• If you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Paracetamolo e Codeina EG

• Paracetamolo e Codeina EG contains paracetamol. Do not exceed the prescribed or recommended doses and do not prolong the treatment. There is a risk of serious liver damage at doses higher than those recommended. If symptoms persist, consult your doctor.
• Due to the risk of overdose, do not take other medicines containing paracetamol. This also applies to medicines available without a prescription.
• Consumption of alcoholic beverages during treatment is strongly discouraged.
• Patients who no longer have a gallbladder may experience acute abdominal pain, generally associated with abnormalities in laboratory tests suggesting a spasm of the sphincter of Oddi.
• In the presence of productive cough, codeine may prevent the expectoration of mucus.
• Paracetamol may be the cause of serious and potentially life-threatening conditions affecting the skin. At the first signs of rash or the appearance of any other signs of hypersensitivity, stop treatment with Paracetamolo e Codeina EG and consult your doctor.
• Paracetamolo e Codeina EG should be used with caution and the dose should be reduced: or if you suffer from mild to moderate hepatic insufficiency (liver disease) and moderate to severe renal insufficiency. Do not use Paracetamolo e Codeina EG if you suffer from severe hepatic insufficiency (see section 2); or if you suffer from glucose-6-phosphate dehydrogenase deficiency (which can cause anemia due to excessive blood degradation (hemolytic anemia)); or if you suffer from chronic alcoholism or consume excessive amounts of alcohol (3 or more glasses a day); or if you suffer from anorexia, bulimia or extreme thinness (cachexia), or if you suffer from chronic malnutrition; or in case of dehydration or lack of blood volume (hypovolemia); or if you suffer from epilepsy because codeine can lower the convulsive threshold; or in case of long-term use; in some people this can lead to increased sensitivity to pain and there is an increased risk of developing a medication-overuse headache; or if you suffer from asthma, as the use of codeine can cause the release of histamine; or if you suffer from hormonal disorders, as a reduction in hormone levels caused by codeine is possible; or if you suffer from a narrowing of the urethra or an enlargement of the prostate, as codeine can cause urinary retention in the bladder due to an interruption of its emptying (urinary retention); or if you are or have been addicted to painkillers, as prolonged use of Paracetamolo e Codeina EG can lead to physical and psychological dependence.
• Codeine is converted into morphine in the liver by an enzyme. Morphine is the substance that provides pain relief. Some people have a variation of this enzyme that can affect them in different ways. Some people do not produce or produce morphine in very limited quantities that do not allow sufficient pain relief. Other people are more likely to develop serious side effects because a large amount of morphine is produced. If you notice the appearance of any of the following side effects, stop taking this medicine and consult your doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, nausea or vomiting, constipation, loss of appetite.
• 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 suffer from malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported in situations where paracetamol is used at regular doses for a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea) and feeling sick (vomiting).

Children and adolescents up to 18 years of age

• Do not give to children under 12 years of age.
• Use in children and adolescents up to 18 years of age after surgery: codeine should not be given to relieve pain in children and adolescents under 18 years of age, after surgery to remove tonsils or adenoids due to obstructive sleep apnea syndrome.
• Use in children with breathing problems: the use of codeine in children with breathing problems is not recommended, as symptoms of morphine toxicity may worsen in these patients.
• The rate of conversion of codeine into the active substance in the body can vary from person to person. For this reason, some people are at greater risk of experiencing side effects, while others experience few.

Elderly

• Elderly people may be more sensitive to codeine and therefore be at greater risk of experiencing side effects. The doctor will prescribe a lower dose. The dose may be adjusted based on individual needs.
• It is important to note that the risk of kidney and/or liver failure is more common in elderly people.

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

• Paracetamolo e Codeina EG can be taken together with anti-rheumatic drugs. It can be associated with anticoagulants, but taking 2 g of paracetamol for a long period of time may increase the risk of bleeding. Therefore, regular medical monitoring is necessary.
• Taking alcohol and sedatives, other medicines for the treatment of nervous disorders or strong painkillers is not recommended. In particular, do not take Paracetamolo e Codeina EG until 14 days have passed since stopping treatment with MAO inhibitors.
• The concomitant use of Paracetamolo e Codeina EG and sedatives such as benzodiazepines or related drugs increases the risk of drowsiness, respiratory depression, coma and can be life-threatening. Therefore, concomitant use should only be considered when other alternative treatments are not possible.
• If, however, the doctor prescribes Paracetamolo e Codeina EG together with sedatives, the dose and duration of such concomitant treatment must be limited.
• Tell your doctor what sedatives you are taking and strictly adhere to their prescription. It may be helpful to inform friends or family members of the signs and symptoms listed above. Tell your doctor if you experience these symptoms.
• Paracetamol may affect the action of chloramphenicol. Metoclopramide and oral contraceptives may, however, affect the action of paracetamol.
• The concomitant use of drugs such as buprenorphine, butorphanol, nalbufin, nalorphine, pentazocine may lead to a reduction in the analgesic effect and withdrawal symptoms.
• Caution is advised when using other drugs that can cause drowsiness.
• Other drugs metabolized by the same enzyme or that slow down the activity of that enzyme may reduce the analgesic effect of codeine. These include in particular some antidepressants (paroxetine, fluoxetine, bupropion, sertraline, imipramine, chlorimipramine, amitriptyline, nortriptyline), antipsychotics (chlorpromazine, haloperidol, levomepromazine, thioridazine), celecoxib and dexamethasone (anti-inflammatory drugs), quinidine (for cardiac arrhythmias) and rifampicin (an antibiotic).
• The concomitant use of so-called anticholinergics (used, among other things, to treat gastrointestinal, urinary, prostate or respiratory disorders) may increase the inhibitory effect on intestinal function and therefore risk stopping intestinal function.
• The use of phenytoin may lead to a reduction in the effect of paracetamol and an increased risk of liver damage. If you are taking phenytoin, avoid taking high doses or prolonged use of paracetamol.
• The use of probenecid and salicylamide may determine an increase in paracetamol concentrations in the blood. The doctor may adjust the dose of paracetamol.
• Caution must be exercised when paracetamol is used together with enzyme inducers such as barbiturates (e.g. used as sedatives or anesthetics), isoniazid (used in the treatment of tuberculosis), carbamazepine (used in the treatment of epilepsy) or rifampicin (an antibiotic).
• Flucloxacillin (antibiotic), due to the serious risk of developing an abnormality of the blood and fluids (known as metabolic acidosis) that requires urgent treatment (see section 2).
• The paracetamol present in Paracetamolo e Codeina EG may falsify some diagnostic tests (e.g. blood sugar levels).

Paracetamolo e Codeina EG with food, drinks and alcohol
Do not drink alcohol during treatment with paracetamol.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
Paracetamolo e Codeina EG contains codeine and paracetamol and should not be used during pregnancy,
unless prescribed by a doctor.
Paracetamolo e Codeina EG is contraindicated during breastfeeding. Do not take codeine if you
are breastfeeding. Codeine and morphine pass into breast milk. If you metabolize codeine very
quickly (see section 2), high concentrations may be reached that can be fatal
for the newborn.

Driving and operating machinery
Caution is required as this medicine can cause drowsiness and loss of consciousness.
Paracetamolo e Codeina EG may significantly impair your ability to drive or operate machinery. This medicine can cause dizziness or drowsiness. If this happens, do not drive
vehicles or use tools or machinery. Also, do not engage in other activities that require prolonged attention.

Paracetamolo e Codeina EG tablets contain sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

Paracetamolo e Codeina EG contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking this
medicine.

3. How to take Paracetamolo and Codeina EG

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
This medicine should not be taken for more than 3 days. If the pain does not improve within 3 days,
consult your doctor.
Paracetamolo and Codeina EG should not be taken by children under the age of 12 due to the risk
of serious breathing problems.
The recommended dose is:

Adults (weighing more than 50 kg):
1 or 2 tablets up to 3 times a day. Always leave at least 6 hours between one dose and the next.

• Do not exceed the maximum daily dose of 8 tablets in 24 hours. The maximum daily dose of paracetamol and codeine should not exceed respectively 4 g and 240 mg in 24 hours.
• For adults weighing less than 50 kg, do not exceed the maximum daily dose of 60 mg of paracetamol per kg of body weight in 24 hours.
• In patients with hepatic impairment, the dose must be reduced or the interval between doses must be prolonged. Patients with hepatic impairment, Gilbert's syndrome or chronic alcohol consumption should not exceed the daily dose of 4 tablets.
• In patients with moderate or severe renal impairment, the interval between doses must be prolonged. Renal impairment increases the risk of accumulation of paracetamol and codeine. In patients with moderate or severe renal impairment, the minimum interval between each administration must be adjusted according to the following scheme:

Adolescents weighing more than 50 kg
1 or 2 tablets up to 3 times a day. Always leave at least 6 hours between one dose and the next.

Children over 12 years of age and adolescents weighing between 33 and 50 kg:
1 tablet up to 4 times a day. Always leave at least 6 hours between one dose and the next.
The maximum daily dose of paracetamol and codeine should not exceed respectively 60 mg/kg and 240
mg in 24 hours.

Children under 12 years of age or weighing less than 33 kg:
Codeine should not be used in children under the age of 12 due to the risk of toxicity.
In addition, Paracetamolo and Codeina EG is not suitable for use in children weighing less than 33 kg.
Do not use simultaneously with other medicines containing paracetamol.
Method of administration:
Swallow the tablet whole (without chewing) with a glass of water or other liquid.

Warning
As with any analgesic, Paracetamolo and Codeina EG should not be taken at high doses for
prolonged periods without medical supervision, especially if the pain persists for more than a few days.

If you take more Paracetamolo and Codeina EG than you should
If you have taken too much Paracetamolo and Codeina EG, contact your doctor or pharmacist immediately.
The symptoms that occur in case of codeine phosphate overdose initially are nausea and vomiting.
Respiratory depression leads to bluish discoloration of the skin, slowed breathing, deep sleep, lack
of coordination and, more rarely, pulmonary congestion. Skin rashes,
itching or skin pain may also occur. In the most severe cases, respiratory arrest, convulsions, constricted pupils, facial swelling, general collapse and urinary retention have been reported.
The symptoms associated with taking excessive doses of paracetamol are nausea, vomiting, loss of appetite,
abdominal pain, excessive sweating and liver damage. In some cases, symptoms appear only a few
hours or days after ingestion. In this case, it is important to establish the number of doses taken by the patient to
help the doctor establish the best treatment to follow.
In case of severe overdose, urgent hospitalization is necessary.

Note for the doctor
If a paracetamol overdose is suspected, the patient should be immediately hospitalized
and the determination of serum concentrations should be carried out as soon as possible but not
before 4 hours have elapsed since ingestion.

Values greater than 200 μg/mL after 4 hours or greater than 50 μg/mL after 12 hours may indicate a high
risk of hepatic necrosis. Routine liver function tests should be performed early and
repeated at regular intervals (24 hours). In most cases, liver transaminases return to
normal in 1 or 2 weeks with a full recovery of liver function. However, in very severe cases, a
liver transplant may be necessary.
To avoid the risk of overdose, make sure that other medicines taken (with or without
prescription) do not contain paracetamol.
The administration of paracetamol in doses higher than those recommended carries the risk of very serious liver damage. The first clinical symptoms of liver damage usually appear after 1 or 2 days from
paracetamol overdose. Symptoms of liver damage usually peak after 3 or 4
days. An antidote should be administered as soon as possible.
To avoid the risk of overdose or the occurrence of serious side effects, check that other
drugs taken (with or without a prescription) do not contain opioids or other central nervous system depressants.
In case of overdose, the stomach must be emptied as soon as possible, i.e. within the first 10 hours,
by gastric lavage or induction of vomiting. Treatment can begin with the administration of
activated charcoal, but intravenous administration of N-acetylcysteine (NAC) represents the main
therapeutic measure.
Two protocols have been validated for the use of NAC in paracetamol overdose, one for intravenous administration, the other for oral administration.
Intravenous administration has the advantage of always being possible, even in cases of coma or vomiting.
This also allows oral administration of activated charcoal, without the risk of interfering with NAC.
20-hour treatment:
In 3 phases:

• Loading dose: 150 mg/kg in 250 mL of 5% glucose for 30-60 minutes
• Subsequently 50 mg/kg in 500 mL of 5% glucose for 4 hours
• Subsequently 10 mg/kg in 1000 mL of 5% glucose for 16 hours. 48-hour treatment: In cases of particularly severe overdose or if paracetamol was taken more than 10 hours ago, NAC can be administered for 48 hours according to the following scheme:
• Loading dose: 140 mg/kg in 5% glucose for 1 hour.
• 70 mg/kg every 4 hours, each dose must be administered over 1 hour. The doses specified in this protocol apply to both adults and children. If NAC is administered orally, activated charcoal cannot be administered, as it may interfere with NAC.
• Loading dose: 140 mg/kg NAC (in a 5% solution in water or fruit juice)
• Maintenance dose: 70 mg/kg every 4 hours, to be repeated 17 times (i.e. over 68 hours). Regular monitoring of liver function (every 24 hours) is strongly recommended.

If you forget to take Paracetamolo and Codeina EG
Do not take a double dose to make up for a missed dose.
Take Paracetamolo and Codeina EG as soon as you remember and wait at least 4 hours before taking the
next tablet.

If you stop taking Paracetamolo and Codeina EG
During long-term treatments or at doses higher than therapeutic doses, codeine can cause a risk
of dependence and the appearance of withdrawal symptoms when treatment is stopped.
If you have any doubts about the use of 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.
The paracetamol contained in Paracetamolo e Codeina EG can cause allergic skin reactions
(such as redness, rash or itching), as well as allergic reactions of the respiratory tract in
hypersensitive individuals. In case of allergic reactions, treatment should be stopped immediately.
The following adverse reactions have been reported after marketing:
Blood and lymphatic system disorders:
Uncommon:
Blood disorders with symptoms such as bruising and bleeding (thrombocytopenia), blood disorder that
manifests as increased susceptibility to infections (leukopenia), reduction in the number of
white blood cells that manifests as increased susceptibility to infections (neutropenia).
Immune system disorders:
Uncommon:
Allergic reactions; severe allergic reaction to certain substances, with rapid lowering of
blood pressure, paleness, agitation, rapid and weak pulse, moist skin and reduced state of
consciousness due to a sudden strong vasodilation (anaphylactic shock); sudden accumulation of
fluid in the skin or mucous membranes (for example, in the throat or tongue), difficulty breathing and/or itching
and rash, often as an allergic reaction (angioedema); hypersensitivity.
Metabolism and nutrition disorders:
Not known: a serious condition that can make the blood more acidic (metabolic acidosis) in patients with
severe illness who use paracetamol (see section 2).
Psychiatric disorders:
Rare: confusion.
Uncommon: substance abuse, drug dependence, hallucinations.
Nervous system disorders:
Uncommon: dizziness, sudden muscle contractions (myoclonus, paresthesia), tremor, fainting,
seizures/convulsions.
Common: drowsiness.
Eye disorders:
Uncommon: narrowing of the pupils (miosis).
Ear and labyrinth disorders:
Uncommon: dizziness, problems with coordination (ataxia).
Vascular disorders:
Uncommon: hypotension.
Respiratory, thoracic and mediastinal disorders:
Uncommon: difficulty breathing (bronchospasm), respiratory failure (respiratory depression).
Gastrointestinal disorders:
Common: diarrhea, constipation, nausea, vomiting.
Uncommon: abdominal pain, inflammation of the pancreas, with symptoms of severe pain in the upper
abdomen radiating to the back, nausea and vomiting (pancreatitis); digestive disorders with a feeling of
fullness or discomfort in the stomach, nausea, vomiting and heartburn (dyspepsia).
Hepatobiliary disorders:
Uncommon: gallstones (with pain in the upper right side of the body, radiating to the shoulder),
inflammation of the liver (hepatitis), elevated liver enzymes.
Skin and subcutaneous tissue disorders:
Uncommon: difficulty breathing and/or itching and rash, often as an allergic reaction
(angioedema), redness of the skin (erythema), itching (pruritus), rash that may be
accompanied by intense itching and hives, a skin condition characterized by the sudden appearance of hundreds of small blisters (acute generalized exanthematous pustulosis), severe allergic reaction with symptoms of fever, blisters on the skin and shedding of the skin (toxic epidermal necrolysis), severe allergic reaction with high fever, blisters on the skin, joint pain and/or eye inflammation (Stevens-Johnson syndrome). Very rare cases of serious skin reactions have been reported.
Musculoskeletal and connective tissue disorders:
Uncommon: muscle breakdown, with symptoms of muscle cramps, fever and brownish-red
discoloration of the urine (rhabdomyolysis).
Renal and urinary disorders:
Uncommon: kidney failure, urinary retention in the bladder due to interference with urination
(bladder emptying).
General disorders and conditions related to the site of administration:
Uncommon: weakness (asthenia), general malaise, fluid retention (edema).
Diagnostic tests:
Uncommon: increased levels of transaminases, increased levels of aspartate aminotransferase,
increased levels of alkaline phosphatase in the blood, increased levels of amylase in the blood, increased
levels of gamma-glutamyltransferase, acceleration of blood coagulation (lowering of
the INR value), delayed blood coagulation (increase in the INR value).
The frequency and severity of these side effects depend on the duration of treatment, the dose and
the individual sensitivity of the patient.
Very rare cases of serious skin reactions have been reported. If a rash develops, stop
taking this medicine and seek medical attention immediately.
If you have any doubts, ask your doctor or pharmacist.
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 EG

Keep this medicine out of the sight and reach of children.
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.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water 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 EG contains

• The active ingredients are paracetamol and codeine phosphate hemihydrate. Each tablet contains 500 mg of paracetamol and 30 mg of codeine phosphate hemihydrate.
• The other ingredients are: pregelatinized corn starch, lactose monohydrate, talc (E553b), powdered cellulose (E460), povidone K30 (E1201), magnesium stearate (E572), stearic acid (E570).

Description of the appearance of Paracetamolo e Codeina EG and contents of the pack
Description
Paracetamolo e Codeina EG 500 mg/30 mg tablets: flat, capsule-shaped tablet, from
white to almost white in colour, with a bevelled edge with “PC2” imprinted on one side and with a score line on the other
side. The dimensions of the capsule-shaped tablet are approximately 17.5 mm in diameter and 7
mm in thickness.
The score line on the tablet is solely to aid in breaking it to make it easier to swallow and not for dividing it into equal doses.
Contents of the pack
Paracetamolo e Codeina EG tablets are available in Al/PVC blisters contained in cartons of 16, 16x1,
30 and 30x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., via Pavia 6, 20136 Milan

Manufacturer
Santa S.A., Strada Panselelor 25-29 Brasov 500419 - Romania

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
NL Paracetamol/Codeine Eurogenerics 500 mg/30 mg tabletten
BE Paracetamol/Codeine EG 500 mg/30 mg tabletten
LU Paracetamol/Codeine EG 500 mg/30 mg tabletten
IT Paracetamolo e Codeina EG
the QR code on the outer packaging with a smartphone/device. The same information is
available at the following URL: