Antidol 15

Leaflet attached to the packaging: patient information

ANTIDOL 15, 500 mg + 15 mg, tablets

Paracetamol + Codeine phosphate

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Antidol 15 and what is it used for
• 2. Important information before taking Antidol 15
• 3. How to take Antidol 15
• 4. Possible side effects
• 5. How to store Antidol 15
• 6. Contents of the packaging and other information

1 What is Antidol 15 and what is it used for
Antidol 15 is a combined pain reliever and antipyretic in tablet form. It contains paracetamol, which reduces pain and has an antipyretic effect, and codeine, which relieves pain and belongs to a group of medicines called opioid analgesics. Codeine can be used alone (in monotherapy) or in combination with other pain relievers, such as paracetamol. The analgesic effect of Antidol 15 lasts for about 4 hours.
Codeine can be used in patients over 12 years of age for short-term relief of moderate pain that is not relieved by other pain relievers (such as paracetamol or ibuprofen) used in monotherapy.
Indicationfor the use of Antidol 15 is pain of various origins with moderate and high intensity, e.g.: headache, tooth extraction pain, bone and joint pain (also post-traumatic), post-traumatic soft tissue pain, menstrual pain.

2. Important information before taking Antidol 15

When not to take Antidol 15

Antidol 15 should not be taken:
in people with hypersensitivity to paracetamol, codeine, opioids, or any of the other ingredients of this medicine (listed in section 6),
in patients with severe liver and kidney failure,
in people with alcoholism,
together with MAO inhibitors (medicines used, among others, in the treatment of depression) and within 2 weeks after their discontinuation,
in patients with respiratory failure,
in people with congenital deficiency of glucose-6-phosphate dehydrogenase and methemoglobin reductase (enzymes found in humans),
in children under 12 years of age,
to relieve pain in children and adolescents after tonsillectomy or adenoidectomy in connection with obstructive sleep apnea syndrome,
if the patient knows that they quickly metabolize codeine to morphine,
during breastfeeding.

Warnings and precautions

While taking Antidol 15 tablets, you should not take other medicines containing codeine or paracetamol.
Before taking Antidol 15, you should discuss it with your doctor or pharmacist if you:
have asthma (you should avoid taking the medicine during an acute asthma attack),
have severe kidney or liver dysfunction,
have alcoholic liver disease (without cirrhosis),
have intestinal obstruction or acute abdominal disease,
have had your gallbladder removed.

• have asthma (you should avoid taking the medicine during an acute asthma attack),
• have severe kidney or liver dysfunction,
• have alcoholic liver disease (without cirrhosis),
• have intestinal obstruction or acute abdominal disease,
• have had your gallbladder removed.

Special caution when taking this medicine should be exercised by patients:

• with Addison's disease,
• with hyperthyroidism,
• with prostate enlargement and difficulty urinating,
• with chronic obstructive pulmonary disease (COPD),
• elderly, especially with liver and/or kidney dysfunction,
• with head injuries (possibility of increased respiratory depression and increased intracranial pressure),
• alcohol-dependent (special risk of liver damage),
• with a history of alcohol and/or drug abuse,
• after recent surgery in the gastrointestinal tract.

Long-term use of the medicine may lead to dependence, which can cause restlessness,
and when stopping the medicine, increased irritability can be observed.
Long-term use of pain relievers for headaches can exacerbate symptoms.
In patients with kidney failure, it may be necessary to adjust the dose due to the possibility of reduced excretion of codeine and paracetamol metabolites.
Codeine can increase intracranial pressure.
Codeine is converted to morphine by liver enzymes. Morphine is a substance that relieves pain. Some people have a changed enzyme and this 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. If the patient experiences any of the following side effects, they should stop taking the medicine and immediately consult a doctor: slow or shallow breathing, disorientation, drowsiness, pupil constriction (small pupils), nausea or vomiting, constipation, loss of appetite.
While taking Antidol 15, you should immediately inform your doctor:
if the patient has severe diseases, including severe kidney or liver dysfunction, or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition,
if the patient has chronic alcoholism or is also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a severe disease called metabolic acidosis (blood and body fluid disorder), when they took paracetamol in regular doses for a longer period or when they took paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling of nausea (nausea) and vomiting.

Children and adolescents

Do not give this medicine to children under 12 years of age (see "When not to take Antidol 15").
Use in children and adolescents after surgical removal of tonsils or adenoids
Codeine should not be used to relieve pain in children and adolescents after tonsillectomy or adenoidectomy in connection with obstructive sleep apnea syndrome, due to the risk of life-threatening side effects.
Use in children and adolescents with respiratory disorders
Codeine is not recommended for children and adolescents with respiratory disorders (including neuromuscular disorders, severe heart or respiratory disease, upper respiratory tract or lung infections, multiple organ injuries, or after extensive surgical procedures), as they may experience increased symptoms of morphine toxicity.
If you are unsure whether any of the above situations apply to the patient, you should consult a doctor or pharmacist.

Antidol 15 and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
This is especially true for medicines such as:

• sedatives, including barbiturates. Concurrent use of Antidol 15 and sedatives, such as benzodiazepines or derivatives, increases the risk of drowsiness, breathing difficulties (respiratory depression) or coma, which can be life-threatening. Therefore, combined treatment should only be considered when other treatment options are not available. If Antidol 15 is used with sedatives, the doctor should limit the dose and duration of concurrent use. The patient should inform the doctor about all sedatives being taken and strictly follow the prescribed dose.
• antiepileptic drugs, including lamotrigine,
• antidepressants (tricyclic and MAO inhibitors),
• warfarin (an anticoagulant),
• metoclopramide (an antiemetic and gastrointestinal motility enhancer),
• domperidone (a medicine used, among others, in gastrointestinal disorders),
• chloramphenicol (a medicine used in the treatment of bacterial infections),
• flucloxacillin (an antibiotic), due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which must be treated urgently (see section 2).
• propantheline (a medicine that, among others, slows down gastrointestinal motility and delays gastric emptying),
• cholestyramine (a medicine that binds bile acids),
• probenecid (a medicine used in the treatment of gout),
• cimetidine, ranitidine (medicines used to reduce stomach acid secretion),
• rifampicin (an antibiotic),
• metyrapone (a medicine used in the diagnosis of certain diseases),
• phenazone, salicylamide (pain relievers, antipyretics, anti-inflammatory),
• isoniazid (a medicine used in the treatment of tuberculosis),
• propranolol (a medicine used in heart function disorders).

Codeine enhances the inhibitory effect of anesthetics on the central nervous system.
If you are unsure whether you are taking any of these medicines, you should consult a doctor or pharmacist.

Antidol 15 with food, drink, and alcohol

See also section 3.
You should not drink alcoholic beverages while taking the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Antidol 15 during pregnancy and childbirth, unless your doctor considers it absolutely necessary. There is evidence that taking codeine during pregnancy increases the frequency of respiratory system developmental disorders.
Breastfeeding
Taking the medicine during breastfeeding is contraindicated. Paracetamol, codeine, and its active metabolite, morphine, pass into breast milk (see "When not to take Antidol 15" above).

Driving and using machines

The medicine can cause dizziness and drowsiness. You should not take Antidol 15 while driving or operating machines.

3. How to take Antidol 15

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If you are unsure, you should consult a doctor or pharmacist.
The medicine should be taken in the smallest effective dose for the shortest possible time. Do not take
higher doses than recommended.
To avoid the risk of overdose, you should check if other medicines taken at the same time (including prescription and over-the-counter medicines) do not contain paracetamol or codeine.
To prevent tolerance, the medicinal product should only be administered as needed.
Taking codeine (the active substance of this medicine) regularly and for a long time can lead to dependence and improper use, which can cause overdose and/or death. You should not take this medicine for longer than necessary. You should not give this medicine to others.

Do not take the medicine for more than 3 days.

Adults and adolescents over 15 years of age
If necessary, 1-2 tablets up to 4 times a day (maximum 6 tablets per day, equivalent to 3 g of paracetamol and 90 mg of codeine phosphate per day) at intervals of at least 6 hours.
Adolescents from 12 to 15 years of age
If necessary, 1 tablet every 6 hours (maximum 4 tablets per day, equivalent to 2 g of paracetamol and 60 mg of codeine phosphate per day).
Note for adolescents from 12 to 18 years of age (see also "Children and adolescents" in section 2)
The dose of codeine in adolescents from 12 to 18 years of age depends on body weight (0.5 to 1 mg/kg body weight),
and the maximum daily dose of codeine should not exceed 240 mg.
Codeine is not recommended for adolescents from 12 to 18 years of age with respiratory disorders in the symptomatic treatment of colds.
Method of administration
Oral. The medicine should be taken after a meal, with a large amount of fluid.
The medicine should not be taken for more than 3 days. If the pain does not subside after 3 days, you should consult a doctor.
Children under 12 years of age
Taking Antidol 15 in children under 12 years of age is contraindicated due to the risk of opioid toxicity and severe respiratory disorders.
Dosing in patients with severe kidney dysfunction
In patients with severe kidney dysfunction, the intervals between doses of the medicine should be at least 8 hours.
Dosing in patients with liver dysfunction
Patients with liver dysfunction or Gilbert's syndrome should take the medicine in a lower dose or extend the intervals between doses of the medicine.
Dosing in elderly patients
There is a lack of data on the effect of the medicine in the recommended dose on the body of elderly patients.
It may be necessary to reduce the dose of the medicine.

Taking a higher dose of Antidol 15 than recommended

If you have taken a higher dose of Antidol 15 than recommended, you should immediately consult a 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 taken medicine with you.
Concurrent consumption of alcohol and taking psychotropic drugs can exacerbate overdose symptoms.
The first symptom of overdose may be: nausea, vomiting, dizziness, drowsiness, loss of appetite, paleness, abdominal pain, bronchospasm, skin reactions in the form of a rash, urticaria.
Pupil constriction can 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, hypoglycemia, brain edema, and death. Even in the absence of severe liver damage, acute kidney failure with acute tubular necrosis may develop, with back pain, hematuria, and proteinuria.
Cardiac arrhythmias and pancreatitis have also been observed.

Missing a dose of Antidol 15

You should not take a double dose to make up for a missed dose.

Stopping Antidol 15

Regularly taking codeine for a long time can lead to dependence, which can cause restlessness and irritability when stopping treatment.
If you have any further doubts about taking this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

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

You should immediately stop taking the medicine and consult a doctor in case 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 skin necrosis, exfoliation of large skin areas, and fever), Stevens-Johnson syndrome (blisters and ulcers on the skin, in the mouth, eyes, and genitals, fever, and joint pain); acute generalized exanthematous pustulosis
• shock (life-threatening allergic reaction with autoregulatory mechanism disorders, which cannot ensure proper blood flow through vital organs and tissues; manifested by confusion, weakness, and fainting).

The following side effects are possible when taking the medicine:
Common (may occur in less than 1 in 10 people):
fatigue, dizziness, headache, decreased blood pressure, fainting*, nausea, vomiting (especially at the beginning of treatment), constipation.
Uncommon (may occur in less than 1 in 100 people):
sleep disorders, rash, itching, skin redness, urticaria.
Rare (may occur in less than 1 in 1,000 people):
vision disorders or pupil constriction*, tinnitus, dyspnea, dry mouth, allergic rash.
Very rare (may occur in less than 1 in 10,000 people):
thrombocytopenia (low platelet count), leukopenia (low white blood cell count), agranulocytosis (significant deficiency or lack of a certain group of white blood cells - neutrophils), single cases of decreased white blood cell, red blood cell, 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 inadequate 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 available data):
severe allergic reaction (anaphylactic reaction), acute pancreatitis (in people after cholecystectomy), increased liver enzyme activity, excessive sweating.
A serious disease that can cause blood acidification (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).
*
after taking high doses
** single cases
***after taking higher doses or in people with increased intracranial pressure or after head injury
Reporting side effects
If you experience any side effects, including any side effects not listed in the 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://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Antidol 15

The medicine should be stored in a place invisible and inaccessible to children.
Store in a temperature below 25 ° C.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the given month.
The batch number on the packaging is marked as "Lot".
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 Antidol 15 contains

One tablet contains 15 mg of codeine phosphate and 500 mg of paracetamol (as Compap L 90% with the composition: paracetamol, corn starch, stearic acid, povidone, crospovidone).
The other ingredients are: microcrystalline cellulose, anhydrous colloidal silica, and magnesium stearate.

What Antidol 15 looks like and what the packaging contains

Aluminum/PVC film-coated tablets in a cardboard box containing 10 tablets.

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturer

Lek S.A.
ul. Podlipie 16
95-010 Stryków
Lek S.A.
ul. Domaniewska 50 C
02-672 Warszawa
To obtain more detailed information about this medicine, you should contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00

Date of last revision of the leaflet:

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