Paracetamol and codeine EG

Package leaflet: Information for the user

Paracetamol and Codeine EG 500 mg/30 mg tablets

Generic medicine
Please read all of this leaflet carefully before you take 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 give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including 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 taking 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 Paracetamol and Codeine EG is and what it is used for

Pharmacotherapeutic group
Paracetamol and Codeine EG is an analgesic combining the complementary actions of paracetamol and
codeine phosphate.
Therapeutic indications
Paracetamol and Codeine EG is indicated for the symptomatic treatment of moderate acute pain not
adequately controlled by paracetamol alone.
Codeine may be used in children over 12 years of age for short-term treatment of moderate pain not relieved
by other analgesics such as paracetamol or ibuprofen taken alone. This medicinal product contains codeine.
Codeine belongs to a group of medicines called opioid analgesics, which act by relieving pain. It may be used
alone or in combination with other analgesics such as paracetamol.

2. What you need to know before taking Paracetamol and Codeine EG

Do not take Paracetamol and Codeine EG

• if you are allergic to paracetamol, codeine, phenacetin, or any of the other ingredients of this medicine (listed in section 6).
• Without medical advice, if medical tests show that you suffer from severe kidney or liver disease, heart or lung disease, anaemia, increased intracranial pressure, signs of respiratory failure, acute asthma, or head trauma.
• If you are a child under 12 years of age.
• If you have phenylketonuria, you must not take the effervescent tablets. This does not apply to tablets that can be swallowed.
• Children and adolescents under 18 years of age must not take this medicine to relieve pain following surgical removal of tonsils or adenoids due to obstructive sleep apnoea.
• If you are known to metabolise codeine very rapidly into morphine.
• If you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Paracetamol and Codeine EG

• Paracetamol and Codeine EG contains paracetamol. Do not exceed the prescribed or recommended doses, and do not prolong treatment. There is a risk of severe liver damage at doses above 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, usually associated with laboratory test abnormalities suggesting spasm of the sphincter of Oddi.
• In the presence of productive cough, codeine may prevent the expectoration of phlegm.
• Paracetamol may cause serious and potentially life-threatening skin reactions. At the first sign of a skin rash or appearance of any other sign of hypersensitivity, stop treatment with Paracetamol and Codeine EG and consult your doctor.
• Paracetamol and Codeine EG should be used with caution and the dose reduced: if you have mild to moderate hepatic impairment (liver disease) or moderate to severe renal impairment; do not use Paracetamol and Codeine EG if you have severe hepatic impairment (see section 2); if you have glucose-6-phosphate dehydrogenase deficiency (which may cause anaemia due to excessive breakdown of blood cells (haemolytic anaemia)); if you suffer from chronic alcoholism or consume excessive amounts of alcohol (3 or more drinks per day); if you have anorexia, bulimia, or extreme thinness (cachexia), or suffer from chronic malnutrition; in case of dehydration or lack of blood volume (hypovolaemia); if you have epilepsy, as codeine may lower the seizure threshold; in case of long-term use; in some individuals this may lead to increased sensitivity to pain and an increased risk of medication-overuse headache; if you have asthma, as codeine use may cause histamine release; if you have hormonal disorders, as codeine may reduce hormone levels; if you have urethral narrowing or prostate enlargement, as codeine may cause urinary retention due to interruption of bladder emptying; if you are or have been opioid-dependent, as prolonged use of Paracetamol and Codeine EG may 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 in this enzyme that may affect them in different ways. Some people produce little or no morphine, which may not provide sufficient pain relief. Others are more likely to develop serious adverse effects because large amounts of morphine are produced. If you notice any of the following adverse effects, stop taking this medicine and contact your doctor immediately: slow or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, loss of appetite.
• If you suffer from serious conditions, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in situations where paracetamol is used at regular doses for prolonged periods or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea), and malaise (vomiting).

Children and adolescents up to 18 years of age

• Do not administer to children under 12 years of age.
• Use in children and adolescents up to 18 years of age after surgery: codeine must not be administered to relieve pain in children and adolescents under 18 years of age after surgical removal of tonsils or adenoids due to obstructive sleep apnoea syndrome.
• Use in children with respiratory problems: the use of codeine in children with respiratory problems is not recommended, as symptoms of morphine toxicity may worsen in these patients.
• The rate of conversion of codeine into its active substance in the body may vary from person to person. For this reason, some individuals are at higher risk of experiencing adverse effects, while others may experience few.

Elderly

• Elderly patients may be more sensitive to codeine and therefore at higher risk of experiencing adverse effects. Your doctor will prescribe a lower dose. The dose may be adjusted according to individual needs.
• It is important to note that the risk of renal and/or hepatic impairment is more common in elderly individuals.

Other medicines and Paracetamol and Codeine EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• Paracetamol and Codeine EG can be taken together with anti-rheumatic drugs. It may be combined with anticoagulants, but taking 2 g of paracetamol for a prolonged period may increase the risk of bleeding. Regular medical monitoring is therefore necessary.
• The intake of alcohol and sedatives, other medicines for nervous disorders, or strong analgesics is not recommended. In particular, do not take Paracetamol and Codeine EG until 14 days have passed since stopping treatment with MAO inhibitors.
• Concomitant use of Paracetamol and Codeine EG and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no alternative treatments are possible.
• If, however, your doctor prescribes Paracetamol and Codeine EG together with sedative medicines, the dose and duration of such concomitant treatment must be limited.
• Inform your doctor which sedatives you are taking and strictly follow their prescription. It may be helpful to inform friends or relatives about the signs and symptoms listed above. Inform your doctor if you experience these symptoms.
• Paracetamol may affect the action of chloramphenicol. Metoclopramide and oral contraceptives may also affect the action of paracetamol.
• Concomitant use of medicines such as buprenorphine, butorphanol, nalbuphine, nalorphine, pentazocine may lead to reduced analgesic effect and withdrawal symptoms.
• Caution is advised when using other medicines that may cause drowsiness.
• Other medicines metabolised by the same enzyme or that slow the activity of that enzyme may reduce the analgesic effect of codeine. These include in particular certain antidepressants (paroxetine, fluoxetine, bupropion, sertraline, imipramine, clomipramine, amitriptyline, nortriptyline), antipsychotics (chlorpromazine, haloperidol, levomepromazine, thioridazine), celecoxib and dexamethasone (anti-inflammatory drugs), quinidine (for cardiac arrhythmias), and rifampicin (an antibiotic).
• 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 thus risk stopping intestinal function.
• Concomitant use of phenytoin may lead to reduced effect of paracetamol and increased risk of liver damage. If you are taking phenytoin, avoid high doses or prolonged use of paracetamol.
• Use of probenecid and salicylamide may lead to increased concentrations of paracetamol in the blood. Your doctor may need to adjust the dose of paracetamol.
• Caution should be used when paracetamol is used together with enzyme inducers such as barbiturates (e.g., used as sedatives or anaesthetics), 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 in blood and body fluids (known as metabolic acidosis) requiring urgent treatment (see section 2).
• The paracetamol present in Paracetamol and Codeine EG may interfere with certain diagnostic tests (e.g., blood glucose levels).

Paracetamol and Codeine EG with food, drinks and alcohol
Do not drink alcohol during treatment with paracetamol.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Paracetamol and Codeine EG contains codeine and paracetamol and must not be used during pregnancy unless prescribed by a doctor.
Paracetamol and Codeine EG is contraindicated during breastfeeding. Do not take codeine if you are breastfeeding. Codeine and morphine pass into breast milk. If you metabolise codeine very rapidly (see section 2), high concentrations may be reached that could be fatal for the newborn.
No human data are available on the effects of Paracetamol and Codeine EG on fertility.
Driving and using machines
Caution is required as this medicine may cause drowsiness and loss of consciousness.
Paracetamol and Codeine EG may significantly affect your ability to drive or operate machinery. This medicine may cause dizziness or drowsiness. If this occurs, do not drive or use tools or machines. Also avoid other activities requiring prolonged attention.
Paracetamol and Codeine EG tablets contain sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.
Paracetamol and Codeine EG contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Paracetamol and Codeine EG

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
This medicine should not be taken for more than 3 days. If pain does not improve within 3 days,
consult your doctor.
Paracetamol and Codeine EG must not be taken by children under 12 years of age 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 doses.

• Do not exceed the maximum daily dose of 8 tablets in 24 hours. The maximum daily doses of paracetamol and codeine must not exceed 4 g and 240 mg, respectively, 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 should be reduced or the dosing interval prolonged. Patients with hepatic impairment, Gilbert's syndrome, or chronic alcohol consumption must not exceed a daily dose of 4 tablets.
• In patients with moderate or severe renal impairment, the dosing interval 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 dose should be adjusted according to the following table:

Adolescents weighing more than 50 kg
1 or 2 tablets up to 3 times daily. Always allow at least 6 hours between doses.
Children over 12 years of age and adolescents weighing between 33 and 50 kg:
1 tablet up to 4 times daily. Always allow at least 6 hours between doses.
The maximum daily dose of paracetamol and codeine must not exceed 60 mg/kg and 240 mg, respectively, within 24 hours.
Children under 12 years of age or weighing less than 33 kg:
Codeine must not be used in children under 12 years of age due to the risk of toxicity.
Furthermore, Paracetamol and Codeine EG is not suitable for use in children weighing less than 33 kg.
Do not use simultaneously with other medicinal products containing paracetamol.
Method of administration:
Swallow the tablet whole (without chewing) with a glass of water or another liquid.
Warning
As with any analgesic, Paracetamol and Codeine EG must not be taken at high doses for prolonged periods without medical supervision, especially if pain persists for more than a few days.
If you take more Paracetamol and Codeine EG than you should
If you have taken too much Paracetamol and Codeine EG, contact your doctor or pharmacist immediately.
Symptoms of codeine phosphate overdose initially include nausea and vomiting.
Respiratory depression leads to bluish skin, slowed breathing, deep sleep, lack of coordination, and, more rarely, pulmonary congestion. Skin rashes, itching, or skin pain may also occur. In more severe cases, respiratory arrest, seizures, pinpoint pupils, facial swelling, general collapse, and urinary retention have been reported.
Symptoms associated with excessive intake of paracetamol include nausea, vomiting, loss of appetite, abdominal pain, excessive sweating, and liver damage. In some cases, symptoms may appear only several hours or days after ingestion. In such cases, it is important to determine the number of doses taken by the patient to help the doctor establish the most appropriate treatment.
In case of severe overdose, urgent hospitalization is required.
Note for the physician
If paracetamol overdose is suspected, the patient must be immediately hospitalized and serum concentration levels should be determined as soon as possible, but not before 4 hours have elapsed since ingestion.
Serum levels exceeding 200 μg/mL after 4 hours or 50 μg/mL after 12 hours may indicate a high risk of hepatic necrosis. Standard liver function tests should be performed early and repeated at regular intervals (every 24 hours). In most cases, liver transaminases return to normal within 1 or 2 weeks, with full recovery of liver function. However, in very severe cases, liver transplantation may be necessary.
To avoid the risk of overdose, verify that other medicinal products administered (prescription or over-the-counter) do not contain paracetamol.
Administration of paracetamol in doses exceeding those recommended may result in severe liver damage. The first clinical signs of liver damage usually appear 1 or 2 days after paracetamol overdose. Symptoms of liver damage typically peak after 3 or 4 days. An antidote should be administered as early as possible.
To avoid the risk of overdose or the occurrence of serious adverse effects, check that other medications administered (prescription or over-the-counter) do not contain opioids or other central nervous system depressants.
In case of overdose, the stomach should be emptied as soon as possible, i.e., within the first 10 hours, by gastric lavage or induction of vomiting. Treatment may begin with administration of activated charcoal, but intravenous administration of N-acetylcysteine (NAC) is the primary therapeutic measure.
Two protocols for the use of NAC in paracetamol overdose have been validated, one intravenous and one oral.
Intravenous administration has the advantage of being feasible even in cases of coma or vomiting. This also allows oral administration of activated charcoal without risk of interference with NAC.
20-hour treatment:
In 3 phases:

• Loading dose: 150 mg/kg in 250 mL of 5% glucose over 30–60 minutes
• Then 50 mg/kg in 500 mL of 5% glucose over 4 hours
• Then 10 mg/kg in 1000 mL of 5% glucose over 16 hours.
  48-hour treatment:
  In cases of particularly severe overdose or if paracetamol was ingested more than 10 hours previously, NAC may be administered for 48 hours according to the following regimen:
• Loading dose: 140 mg/kg in 5% glucose over 1 hour.
• 70 mg/kg every 4 hours, each dose to be administered over 1 hour. The doses specified in this protocol apply to both adults and children.
  If NAC is administered orally, activated charcoal must not be given, 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, repeated 17 times (i.e., over 68 hours). Regular monitoring of liver function (every 24 hours) is strongly recommended.

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

If you stop treatment with Paracetamol and Codeine EG
During long-term treatment or at doses higher than therapeutic levels, codeine may cause a risk of dependence and withdrawal symptoms upon discontinuation.
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 may cause skin allergic reactions (such as redness, rash or itching), as well as respiratory allergic reactions in hypersensitive individuals. In case of allergic reactions, treatment must 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 manifesting as increased susceptibility to infections (leukopenia), reduced number of white blood cells manifesting as increased susceptibility to infections (neutropenia).

Immune system disorders:
Uncommon:
Allergic reactions; severe allergic reaction to certain substances, with rapid drop in blood pressure, pallor, restlessness, rapid and weak pulse, moist skin and reduced level of consciousness due to sudden severe vasodilation (anaphylactic shock); sudden accumulation of fluid in the skin or mucous membranes (e.g., in the throat or tongue), breathing difficulties and/or itching and skin rash, often as an allergic reaction (angioedema); hypersensitivity.

Metabolism and nutrition disorders:
Not known: a serious condition that may make the blood more acidic (metabolic acidosis) in patients with severe illness who are taking 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, epileptic seizures/seizures.
Common: drowsiness.

Eye disorders:
Uncommon: constriction of the pupils (miosis).

Ear and labyrinth disorders:
Uncommon: dizziness, coordination problems (ataxia).

Vascular disorders:
Uncommon: hypotension.

Respiratory, thoracic and mediastinal disorders:
Uncommon: breathing difficulties (bronchospasm), respiratory failure (respiratory depression).

Gastrointestinal disorders:
Common: diarrhea, constipation, nausea, vomiting.
Uncommon: abdominal pain, inflammation of the pancreas, with symptoms of severe upper abdominal pain radiating to the back, nausea and vomiting (pancreatitis); digestive disturbances 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: breathing difficulties and/or itching and rash, often as an allergic reaction (angioedema), skin redness (erythema), itching (pruritus), rash which may be accompanied by intense itching and hives, skin condition characterized by the sudden appearance of hundreds of small blisters (acute generalized exanthematous pustulosis), severe allergic reaction with symptoms of fever, skin blisters and skin peeling (toxic epidermal necrolysis), severe allergic reaction with high fever, skin blisters, joint pain and/or eye inflammation (Stevens-Johnson syndrome). Very rare cases of severe skin reactions have been reported.

Musculoskeletal and connective tissue disorders:
Uncommon: muscle breakdown, with symptoms of muscle cramps, fever and brownish-red discoloration of urine (rhabdomyolysis).

Renal and urinary disorders:
Uncommon: kidney failure, urinary retention in the bladder due to interference with urination (incomplete bladder emptying).

General disorders and administration site conditions:
Uncommon: weakness (asthenia), general malaise, fluid retention (edema).

Investigations:
Uncommon: increased transaminase levels, increased aspartate aminotransferase levels, increased alkaline phosphatase levels in blood, increased blood amylase levels, increased gamma-glutamyltransferase levels, accelerated blood coagulation (decreased INR value), delayed blood coagulation (increased 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 severe skin reactions have been reported. If you develop a rash, stop taking this medicine and contact your doctor immediately.

If in doubt, ask your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, 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 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 Paracetamol and Codeine EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Paracetamolo e Codeina EG contains

• The active substances are paracetamol and codeine phosphate hemihydrate. Each tablet contains 500 mg of paracetamol and 30 mg of codeine phosphate hemihydrate.
• The other components are: pregelatinized maize 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 package contents
Description
Paracetamolo e Codeina EG 500 mg/30 mg tablets: flat, capsule-shaped tablet, white to almost white in colour, with bevelled edges, marked with "PC2" on one side and a breakline on the other side. The capsule-shaped tablet measures approximately 17.5 mm in diameter and 7 mm in thickness.
The breakline on the tablet is intended solely to facilitate breaking for easier swallowing and not for dividing into equal doses.
Package contents
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 Authorization Holder
EG S.p.A., via Pavia 6, 20136 Milano
Manufacturer
Santa S.A., Strada Panselelor 25-29, Brasov 500419 - Romania

This medicinal product is authorized in the European Economic Area countries under the following names:
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 latest approved version of the package leaflet for this medicinal product is available by scanning the QR code on the outer packaging with a smartphone/device. The same information is available at the following URL: