PARACETAMOL 500 mg/15 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Paracetamol + Codeine APAP 500 mg + 15 mg, coated tablets
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
   3. The medicine is intended for adults and adolescents with a body weight of over 50 kg.
   4. It should be used only as needed, not in larger doses than recommended, and for no longer than 3 days. If pain relief is not achieved, you should consult a doctor.
3. Important information before taking Paracetamol + Codeine APAP
   1. When not to take Paracetamol + Codeine APAP
   2. Warnings and precautions
   3. Before taking Paracetamol + Codeine APAP, you should discuss it with your doctor or pharmacist:
   4. Children and adolescents
   5. Paracetamol + Codeine APAP and other medicines
   6. Taking Paracetamol + Codeine APAP with food, drink, and alcohol
   7. Pregnancy and breastfeeding
   8. Driving and using machines
   9. Warning about an excipient
4. How to take Paracetamol + Codeine APAP
   1. Warning!
   2. The medicine should be taken only as needed.
   3. You should take the smallest effective dose. If necessary, the dose can be repeated, but not more often than every 6 hours. Do not take doses larger than recommended.
   4. If the pain goes away, you should stop taking the medicine.
   5. The treatment duration should be limited to 3 days. If the pain does not go away after 3 days, you should consult your doctor. To avoid overdose, you should check if other medicines you are taking at the same time (including those available on prescription or over-the-counter) do not contain paracetamol or codeine.
   6. Taking a larger dose of Paracetamol + Codeine APAP than recommended
   7. Missing a dose of Paracetamol + Codeine APAP
   8. Stopping Paracetamol + Codeine APAP
5. Possible side effects
   1. You should stop taking the medicine and consult your doctor immediately if you experience any of the following side effects:
   2. Reporting side effects
6. How to store Paracetamol + Codeine APAP
7. Contents of the packaging and other information
   1. What Paracetamol + Codeine APAP contains
   2. What Paracetamol + Codeine APAP looks like and what the pack contains
   3. Marketing authorization holder and importer
   4. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

Paracetamol + Codeine APAP 500 mg + 15 mg, coated tablets

Paracetamol + Codeine phosphate hemihydrate

You should carefully read the contents of the leaflet before using the 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 your doctor or pharmacist.

• You should keep this leaflet so that you can read it again if you need to.
• If you need advice or further information, you should speak to your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet

• 1. What is Paracetamol + Codeine APAP and what is it 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 packaging and other information

1 What is Paracetamol + Codeine APAP and what is it used for
Paracetamol + Codeine APAP is a pain reliever. It contains two active substances with a pain-relieving effect: paracetamol and codeine. Codeine belongs to a group of medicines called opioid pain relievers, which relieve pain. It can be used alone or in combination with other pain relievers, such as paracetamol.
This medicine is used to treat moderate to severe pain of various origins, such as: headache, tooth extraction pain, bone and joint pain (also post-traumatic), post-traumatic soft tissue pain, menstrual pain, neuralgia.

The medicine is intended for adults and adolescents with a body weight of over 50 kg.

It should be used only as needed, not in larger doses than recommended, and for no longer than 3 days. If pain relief is not achieved, you should consult a doctor.

In the treatment of moderate acute pain that does not respond to other pain relievers, such as paracetamol or ibuprofen (used alone), codeine can be used in adolescents aged 12 and over.

2. Important information before taking Paracetamol + Codeine APAP

Do not take the medicine for longer than recommended. The duration of treatment should be limited to 3 days.
Taking pain relievers for headaches too frequently or for a long time can make them worse.

When not to take Paracetamol + Codeine APAP

• if you are allergic to paracetamol, codeine, opioids, or any of the other ingredients of this medicine (listed in section 6),
• in people with alcoholism or regularly consuming excessive amounts of alcohol,
• in people with increased intracranial pressure or head injury,
• in patients being treated with MAO inhibitors (medicines used, among others, in the treatment of depression) and for 2 weeks after their withdrawal,
• in patients being treated with cholestyramine (a bile acid sequestrant) within 1 hour of taking cholestyramine,
• during pregnancy or breastfeeding,
• if you are under 12 years old,
• in children and adolescents (aged 0 to 18) after tonsillectomy or adenoidectomy in connection with obstructive sleep apnea syndrome (see When not to take Paracetamol + Codeine APAP),
• if you know that you metabolize codeine to morphine very quickly,
• in patients with severe liver and/or kidney failure,
• adolescents and adults with a body weight of less than 50 kg,
• in patients with respiratory failure,
• in people with acute asthma attacks,
• the medicine contains soybean oil. Do not take if you have a known hypersensitivity to peanuts or soy.

Warnings and precautions

Before starting to take this medicine, you should discuss it with your doctor or pharmacist if you are or have ever been dependent on opioids, alcohol, prescription medicines, or illegal substances.
Taking codeine (the active substance of this medicine) regularly and for a long time can lead to dependence and misuse, which can cause overdose and/or death. Do not take this medicine for longer than necessary. Do not give this medicine to others.
While taking this medicine, do not take other medicines containing codeine or paracetamol (including those available on prescription or over-the-counter), so as not to exceed the recommended daily dose (see section 3).
Codeine is converted to morphine by liver enzymes. Morphine is a substance that relieves pain. Some people have a changed enzyme and it can affect them in different ways.
In some people, morphine is not produced or is produced in very small amounts, which does not provide adequate pain relief. Other people are more prone to severe side effects caused by the production of very large amounts of morphine (see When not to take Paracetamol + Codeine APAP). If you experience any of the following side effects, you should stop taking this medicine and consult your doctor immediately: slow or shallow breathing, disorientation, drowsiness, constricted pupils, nausea or vomiting, constipation, loss of appetite.
In the event of the above situations, you should consult your doctor or pharmacist before taking this medicine and then follow their instructions.

Before taking Paracetamol + Codeine APAP, you should discuss it with your doctor or pharmacist:

• if you have liver or kidney disease, including alcoholic liver disease, your doctor may recommend a dose reduction,
• if you have intestinal problems, including intestinal obstruction,
• if you have had your gallbladder removed,
• if you have asthma and are allergic to aspirin,
• if you have Gilbert's syndrome (familial non-hemolytic jaundice),
• if you have Addison's disease,
• if you have prostate enlargement,
• if you have been informed by your doctor that you have an intolerance to some sugars, a lack of glucose-6-phosphate dehydrogenase or glutathione,
• if you have chronic malnutrition and dehydration,
• if you are elderly or weakened or are an adolescent with a body weight below 50 kg

In the above cases, paracetamol should be taken with special caution.

Children and adolescents

Do not give this medicine to children under 12 years old due to the risk of opioid toxicity (the medicine is contraindicated).
It is not recommended to use this medicine in adolescents aged 12 to 18 with respiratory function disorders, in the symptomatic treatment of cough and/or cold.
Use in children and adolescents after surgical removal of tonsils or adenoids
The medicine should not be used to relieve pain in children and adolescents after tonsillectomy or adenoidectomy in connection with obstructive sleep apnea syndrome (see When not to take Paracetamol + Codeine APAP).

Paracetamol + Codeine APAP and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.
This is especially important for medicines such as:

• antidepressants (tricyclic and MAO inhibitors), such as moclobemide, phenelzine, or tranylcypromine,
• sleeping pills, anesthetics, sedatives (e.g., benzodiazepines and derivatives), including barbiturates,
• antiepileptic drugs,
• warfarin and coumarin derivatives (anticoagulant medicines),
• metoclopramide (an antiemetic and prokinetic medicine),
• domperidone (a medicine used, among others, in gastrointestinal disorders),
• cholestyramine (a bile acid sequestrant),
• probenecid (a diuretic medicine),
• chloramphenicol (an antibiotic),
• medicines used to treat pain, fever, or symptoms of flu or cold (which often contain paracetamol or codeine and should not be combined with Paracetamol + Codeine APAP).

Tell your doctor or pharmacist if you are taking:

• flucloxacillin (an antibiotic), due to the risk of a serious blood and fluid disorder (metabolic acidosis with a large anion gap), which requires urgent treatment and may occur especially in patients with severe kidney function disorders, sepsis (a condition in which bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, as well as in patients taking maximum daily doses of paracetamol.

Taking Paracetamol + Codeine APAP with food, drink, and alcohol

While taking the medicine, you should not drink alcoholic beverages or take medicines containing alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor or pharmacist before taking this medicine.
The medicine is contraindicated during pregnancy and breastfeeding (see When not to take Paracetamol + Codeine APAP).

Driving and using machines

The medicine can cause dizziness and drowsiness. Do not take this medicine while driving or operating machinery.

Warning about an excipient

The medicine contains 0.32 mg of soybean lecithin (E 322) per tablet. The medicine is contraindicated in case of known hypersensitivity to peanuts or soy (see When not to take Paracetamol + Codeine APAP).

3. How to take Paracetamol + Codeine APAP

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. In case of doubt, you should consult your doctor or pharmacist.

Warning!

The medicine should be taken only as needed.

You should take the smallest effective dose. If necessary, the dose can be repeated, but not more often than every 6 hours. Do not take doses larger than recommended.

If the pain goes away, you should stop taking the medicine.

The treatment duration should be limited to 3 days. If the pain does not go away after 3 days, you should consult your doctor. To avoid overdose, you should check if other medicines you are taking at the same time (including those available on prescription or over-the-counter) do not contain paracetamol or codeine.

The recommended dose is:
Adults and adolescents over 16 years old:
1 to 2 tablets up to 4 times a day, at 6-hour intervals. Maximum 6 tablets per day (which corresponds to 3000 mg of paracetamol and 90 mg of codeine phosphate per day).
Adolescents aged 12-15:
1 tablet at 6-hour intervals. Maximum 4 tablets per day (which corresponds to 2000 mg of paracetamol and 60 mg of codeine phosphate per day).
Children under 12 years old:
The medicine is contraindicated in this patient group.
Elderly patients:
In elderly and weakened patients, a dose reduction may be necessary; consult your doctor.
Patients with kidney and/or liver function disorders:
Patients diagnosed with kidney function disorders, liver function disorders, or Gilbert's syndrome must consult their doctor before taking the medicine.
Method of administration
Oral. The tablets can be broken in half to make them easier to swallow.

Taking a larger dose of Paracetamol + Codeine APAP than recommended

In case of taking a larger dose of the medicine than recommended, you should immediately consult your doctor or go to the nearest hospital, even if you feel well, due to the risk of severe liver damage, which may occur with some delay.
You should take the packaging of the medicine you have taken with you.
Concomitant consumption of alcohol and psychotropic medicines can exacerbate overdose symptoms.
The first symptoms of overdose may be: nausea, vomiting, dizziness, drowsiness, loss of appetite, pallor, abdominal pain, bronchospasm, skin reactions in the form of rash, urticaria.
Constricted pupils may be observed. Hypotension and tachycardia are possible but unlikely. Liver damage may be visible after 12 to 48 hours from ingestion. Glucose metabolism disorders may occur. In severe poisonings, liver failure can lead to metabolic acidosis, bleeding, decreased blood sugar levels (hypoglycemia), brain edema, and death. Even in the absence of severe liver damage, acute renal failure with acute tubular necrosis may develop, with loin pain, hematuria, and proteinuria.
Cardiac arrhythmias and pancreatitis have also been observed.

Missing a dose of Paracetamol + Codeine APAP

Do not take a double dose to make up for a missed dose.
In case of any further doubts about taking this medicine, you should consult your doctor or pharmacist.

Stopping Paracetamol + Codeine APAP

Regularly taking codeine for a long time can lead to dependence, which can cause anxiety and irritability when treatment is stopped.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should stop taking the medicine and consult your doctor immediately if you experience any of the following side effects:

• symptoms of an allergic reaction: skin rash, urticaria, itching, swelling of the face, lips, tongue, throat, which can cause difficulty swallowing or breathing,
• sudden high fever, sore throat, and mouth ulcers - these are symptoms of a very serious blood disorder (low white blood cell count),
• bleeding, hemorrhages, easy bruising, petechiae (due to a decrease in platelet count),
• severe skin reactions, such as: toxic epidermal necrolysis (large blisters, extensive erosions on the skin, exfoliation of large skin areas, and fever), Stevens-Johnson syndrome (blisters and erosions on the skin, in the mouth, eyes, and genitals, fever, and joint pain); acute generalized exanthematous pustulosis,
• shock (life-threatening allergic reactions that disrupt the body's autoregulatory mechanisms, which are unable to ensure proper blood flow to vital organs and tissues; characterized by confusion, weakness, and fainting).

Rare (may occur in less than 1 in 1000 people):vision disorders or constricted pupils*,
tinnitus, dyspnea, dry mouth, allergic rash.
Very rare (may occur in less than 1 in 10,000 people):decreased platelet count (thrombocytopenia), decreased white blood cell count (leukopenia), significant deficiency or lack of a certain group of white blood cells - neutrophils (agranulocytosis), single cases of decreased white blood cell count, red blood cell count, and platelet count (pancytopenia), hypersensitivity reactions, such as angioedema, dyspnea, sweating, malaise, hypotension up to shock**, respiratory depression***, euphoria or dysphoria* (mood disorders with a tendency to irritability, aggression, and explosiveness not adequate to the situation), coordination disorders*, bronchospasm, pulmonary edema* (especially in people with impaired lung function), severe skin reactions.
Frequency not known (cannot be estimated from the available data):very severe allergic reaction (anaphylactic reaction), acute pancreatitis (in people after cholecystectomy), increased liver enzyme activity, excessive sweating, dependence and tolerance (in case of long-term use).
* after taking large doses
** single cases
*** after taking larger doses or in people with increased intracranial pressure or after head injury

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz2.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Paracetamol + Codeine APAP

There are no special instructions for storing the medicine.
The medicine should be stored out of sight and reach of children.
Do not use after the expiry date stated on the carton and blister pack (month/year). The applied labeling for the blister is: EXP - expiry date, Lot - batch number.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Paracetamol + Codeine APAP contains

The active substances of the medicine are paracetamol and codeine phosphate hemihydrate.
One coated tablet contains 500 mg of paracetamol and 15 mg of codeine phosphate hemihydrate.
The other ingredients are: maize starch, povidone (K-30), microcrystalline cellulose, maize starch, crospovidone XL 10, colloidal anhydrous silica, magnesium stearate. Coating Opadry AMB white OY-B28920: polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E 171), talc, soybean lecithin (E 322), xanthan gum.

What Paracetamol + Codeine APAP looks like and what the pack contains

White or almost white, oblong, biconvex coated tablets with dimensions of 17.1 mm x 7.6 mm, with a dividing line on one side and smooth on the other. The dividing line is only for breaking the tablet to make it easier to swallow and does not divide the tablet into equal doses.
A PVC/PVDC/Aluminum blister pack containing 10 coated tablets, in a cardboard box.

Marketing authorization holder and importer

US Pharmacia Sp. z o.o.
ul. Ziębicka 40

• 50 - 507 Wrocław

To obtain more detailed information about this medicine, you should contact:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warszawa
tel.: +48 (22) 543 60 00

Date of last revision of the leaflet: