Paracetamol + codeine apap

Package leaflet: Information for the patient

Paracetamol + Codeine APAP 500 mg + 15 mg, coated tablets
Paracetamolum + Codeini phosphas hemihydricus
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if you feel worse, contact your doctor.

Table of contents

1. What Paracetamol + Codeine APAP is and what it is used for
2. Important information before taking Paracetamol + Codeine APAP
3. How to take Paracetamol + Codeine APAP
4. Possible side effects
5. How to store Paracetamol + Codeine APAP
6. Contents of the pack and other information

1. What Paracetamol + Codeine APAP is and what it is used for
Paracetamol + Codeine APAP is an analgesic medicine. It contains two active substances with analgesic properties: paracetamol and codeine. Codeine belongs to a group of medicines called opioid analgesics, which relieve pain. It may be used as monotherapy or in combination with other analgesics such as paracetamol.
This medicine is used to treat moderate to severe pain of various origins, e.g., headache, pain after tooth extraction, bone and joint pain (including post-traumatic), soft tissue trauma pain, menstrual pain, and neuralgia.
This medicine is intended for adults and adolescents with body weight above 50 kg.
Use only on an occasional basis; do not use doses higher than recommended or for longer than 3 days. If adequate pain relief is not achieved, consult a doctor.
For the treatment of acute moderate pain unresponsive to other analgesics such as paracetamol or ibuprofen (used as monotherapy), codeine may be used in adolescents aged 12 years and older.

2. Important information before taking Paracetamol + Codeine APAP

Do not take this medicine for longer than recommended. The duration of treatment should be limited to 3 days.
Frequent or prolonged use of analgesics for headaches may worsen the headache.
When not to use Paracetamol + Codeine APAP

• if you are allergic to paracetamol, codeine, opioids, or to any of the other ingredients of this medicine (listed in section 6),
• in patients with alcoholism or those who regularly consume excessive amounts of alcohol,
• in patients with increased intracranial pressure or head injury,
• in patients being treated with MAO inhibitors (medicines used, among others, in the treatment of depression) and within 2 weeks after discontinuation of such treatment,
• in patients treated with cholestyramine (a bile acid-binding agent) within one hour of taking cholestyramine,
• during pregnancy or breastfeeding,
• if you are under 12 years of age,
• in children and adolescents (aged 0 to 18 years) following tonsillectomy or adenoidectomy due to obstructive sleep apnoea syndrome,
• if you know that you metabolize codeine to morphine very rapidly,
• in patients with severe hepatic and/or renal impairment,
• adolescents and adults with body weight below 50 kg,
• in patients with respiratory insufficiency,
• in patients with acute asthma attack,
• the medicine contains soybean oil. Do not use if you have a known hypersensitivity to peanuts or soy.

Warnings and precautions
Before starting this medicine, discuss with your doctor or pharmacist if you are or have ever been dependent on opioids, alcohol, prescription medicines, or illegal substances.
Regular and prolonged use of codeine (an active ingredient of this medicine) may lead to dependence and misuse, which may result in overdose and/or death. Do not use this medicine longer than necessary. Do not give this medicine to other people.
While using this medicine, do not take other medicines containing codeine or paracetamol (including those available by prescription or over-the-counter) to avoid exceeding the recommended daily dose (see section 3).
Codeine is converted to morphine by liver enzymes. Morphine is the substance that relieves pain. Some individuals have altered enzyme activity, which may affect them differently. In some people, morphine is not produced or is produced in very small amounts, resulting in inadequate pain relief. Others are at higher risk of severe adverse effects due to the production of very large amounts of morphine (see When not to use Paracetamol + Codeine APAP). If you experience 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.
In the above situations, consult your doctor or pharmacist before taking this medicine and follow their advice.
Before using Paracetamol + Codeine APAP, consult your doctor or pharmacist if:

• you have liver or kidney disease, including alcoholic liver disease; your doctor may recommend a reduced dose,
• you have gastrointestinal problems, including intestinal obstruction,
• you have undergone surgery to remove the gallbladder,
• you have asthma and aspirin (acetylsalicylic acid) allergy,
• you have Gilbert's syndrome (familial non-haemolytic jaundice),
• you have Addison's disease,
• you have benign prostatic hyperplasia,
• you have been informed by your doctor of intolerance to certain sugars, glucose-6-phosphate dehydrogenase deficiency, or glutathione deficiency,
• you have chronic malnutrition and dehydration,
• you are elderly or debilitated, or are an adolescent with body weight below 50 kg.

In the above cases, paracetamol should be used with particular caution.
While using Paracetamol + Codeine APAP, inform your doctor immediately if:
You have severe illnesses, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In these situations, severe illness called metabolic acidosis (a blood and body fluid imbalance) has been reported in patients taking paracetamol regularly over a prolonged period or taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.
Children and adolescents
Do not give this medicine to children under 12 years of age due to the risk of opioid toxicity (the medicine is contraindicated).
Use of this medicine is not recommended in adolescents aged 12 to 18 years with respiratory disorders, for symptomatic treatment of cough and/or cold.
Use in children and adolescents after surgery
This medicine should not be used for pain relief in children and adolescents after tonsillectomy or adenoidectomy due to obstructive sleep apnoea syndrome (see When not to use Paracetamol + Codeine APAP).
Paracetamol + Codeine APAP and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
This especially includes:

• antidepressants (tricyclic antidepressants and MAO inhibitors), such as moclobemide, phenelzine, or tranylcypromine,
• sleeping pills, anaesthetics, sedatives (e.g., benzodiazepines and derivatives), including barbiturates,
• antiepileptic drugs,
• warfarin and coumarin derivatives (anticoagulants),
• metoclopramide (an antiemetic and prokinetic agent),
• domperidone (a medicine used, among others, for gastrointestinal disorders),
• cholestyramine (a bile acid-binding agent),
• probenecid (a uricosuric agent),
• chloramphenicol (a medicine used to treat infections),
• medicines used to treat pain, fever, flu or cold symptoms (these often contain paracetamol or codeine and should not be combined with Paracetamol + Codeine APAP).

Inform your doctor or pharmacist if you are taking:

• flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disturbances (called metabolic acidosis), which require urgent treatment (see section 2).

Using Paracetamol + Codeine APAP with food, drink, and alcohol
Do not drink alcoholic beverages or take medicines containing alcohol while using this medicine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
This medicine is contraindicated during pregnancy and breastfeeding (see When not to use Paracetamol + Codeine APAP).
Driving and operating machinery
This medicine may cause dizziness and drowsiness. Do not use this medicine when driving or operating machinery.
Warning regarding excipients
The medicine contains 0.32 mg of soya lecithin (E 322) per tablet. The medicine is contraindicated in case of known hypersensitivity to peanuts or soya (see When not to use Paracetamol + Codeine APAP).

3. How to use Paracetamol + Codeine APAP

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Warning!
This medicine should only be used on an as-needed basis.
The lowest effective dose should be used. The dose may be repeated if necessary,
but no more frequently than every 6 hours. Do not exceed the recommended dose.
If pain subsides, treatment with this medicine should be discontinued.
Treatment duration should be limited to 3 days. If pain persists after 3 days, consult your doctor. To avoid overdose, check whether other medicines you are taking (including those prescribed or obtained without a prescription) contain paracetamol or codeine.

Recommended dose:
Adults and adolescents aged 16 years and over:
1 to 2 tablets up to 4 times daily, at intervals of 6 hours. Maximum 6 tablets per day (equivalent to 3000 mg paracetamol and 90 mg codeine phosphate per day).

Adolescents aged 12–15 years:
1 tablet every 6 hours. Maximum 4 tablets per day (equivalent to 2000 mg paracetamol and 60 mg codeine phosphate per day).

Children under 12 years of age:
This medicine is contraindicated in this patient group.

Elderly patients:
Dosage reduction may be necessary in elderly or debilitated patients; medical advice is recommended.

Patients with renal and/or hepatic impairment:
Patients diagnosed with renal impairment, hepatic dysfunction, or Gilbert's syndrome must consult a doctor before taking this medicine.

Method of administration
For oral use. Tablets may be broken in half to facilitate swallowing.

Taking more Paracetamol + Codeine APAP than recommended
If you take more than the recommended dose, seek immediate medical attention at a doctor's office or nearest hospital, even if you feel well, due to the risk of severe liver damage, which may occur with delay.
Bring the medicine packaging with you.
Concurrent alcohol consumption and use of psychotropic drugs may worsen overdose symptoms.
Initial signs of overdose may include: nausea, vomiting, dizziness, drowsiness, loss of appetite, pallor, abdominal pain, bronchospasm, skin reactions such as rash or urticaria.
Constricted pupils may be observed. Hypotension and tachycardia are possible but unlikely. Liver damage may become apparent 12 to 48 hours after ingestion. Glucose metabolism disturbances may occur. In severe poisoning, liver failure may lead to metabolic acidosis, hemorrhage, hypoglycemia, cerebral edema, and death. Even in the absence of severe liver damage, acute renal failure with acute tubular necrosis may develop, presenting with lumbar pain, hematuria, and proteinuria.
Cardiac arrhythmias and pancreatitis have also been observed.

If you miss a dose of Paracetamol + Codeine APAP
Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

Stopping Paracetamol + Codeine APAP
Regular, long-term use of codeine may lead to dependence, which may cause feelings of anxiety and irritability upon discontinuation.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
You must immediately stop taking the medicine and contact a doctor if any of the following adverse reactions occur:

• symptoms of an allergic reaction: skin rash, hives, itching, swelling of the face, lips, tongue, or throat, which may cause difficulty swallowing or breathing,
• sudden high fever, sore throat, and mouth ulcers – symptoms of a very serious blood disorder (low number of white blood cells),
• bleeding, hemorrhage, easy bruising, petechiae (due to reduced platelet count),
• severe skin reactions such as toxic epidermal necrolysis (blistering, extensive skin erosions, shedding of large sheets of skin, and fever), Stevens-Johnson syndrome (blisters and erosions on the skin, inside the mouth, eyes, and genital organs, fever, and joint pain), acute generalized exanthematous pustulosis,
• anaphylactic shock (life-threatening allergic reaction causing failure of the body's autoregulatory mechanisms to maintain adequate blood flow to vital organs and tissues; symptoms include confusion, weakness, and fainting).

Rare (may affect fewer than 1 in 1,000 people): visual disturbances or miosis*, tinnitus, dyspnea, dry mouth, allergic rash.
Very rare (may affect fewer than 1 in 10,000 people): reduced platelet count (thrombocytopenia), reduced white blood cell count (leukopenia), severe deficiency or absence of neutrophils (agranulocytosis), isolated cases of reduced white blood cells, red blood cells, and platelets (pancytopenia), hypersensitivity reactions such as angioedema, dyspnea, profuse sweating, malaise, hypotension up to shock**, respiratory depression***, euphoria or dysphoria* (mood disturbances with irritability, aggression, and inappropriate outbursts), disturbances in visuomotor coordination*, bronchospasm, pulmonary edema* (especially in individuals with impaired lung function), severe skin reactions.
Frequency not known (cannot be estimated from available data): severe allergic reaction (anaphylactic reaction), acute pancreatitis (in individuals after cholecystectomy), increased liver enzyme activity, excessive sweating, dependence and tolerance (with long-term use), serious condition that may cause blood acidification (so-called metabolic acidosis) in patients with severe disease taking paracetamol (see section 2).
* after administration of high doses
** isolated cases
*** after administration of higher doses or in individuals with increased intracranial pressure or head injury

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Paracetamol + Codeine APAP

No special storage conditions are required for this medicinal product.
The medicine should be stored out of sight and reach of children.
Do not use after the expiry date stated on the carton and immediate packaging (month/year).
Blister labelling: EXP – expiry date, Lot – batch number.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Paracetamol + Codeine APAP contains
 The active substances are paracetamol and codeine phosphate hemihydrate.
Each coated tablet contains 500 mg of paracetamol and 15 mg of codeine phosphate
hemihydrate.
 The other ingredients are: pregelatinized maize starch, povidone (K-30), microcrystalline
cellulose, maize starch, crospovidone XL 10, colloidal anhydrous silica, magnesium stearate.
Coating Opadry AMB white OY-B28920: partially hydrolysed polyvinyl alcohol, titanium dioxide (E 171), talc, soya lecithin (E 322), xanthan gum.

What Paracetamol + Codeine APAP looks like and contents of the pack
White or almost white, elongated, biconvex coated tablets measuring 17.1 mm x 7.6 mm, with a break line on one side and smooth on the other side. The break line is intended only for breaking the tablet to facilitate swallowing and does not divide the tablet into equal doses.
PVC/PVDC/Aluminium blister pack containing 10 coated tablets, in a cardboard carton.

Marketing Authorisation Holder and Importer
US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50 - 507 Wrocław
For further information about this medicinal product, please contact:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warszawa
tel.: +48 (22) 543 60 00