Apap pzheziembienie Max

Leaflet attached to the packaging: patient information

APAP Cold MAX

(1000 mg + 50 mg + 12.2 mg)/sachet, powder for oral solution, in a sachet
Paracetamol + Caffeine + Phenylephrine hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

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

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

Table of contents of the leaflet:

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

1. What is APAP Cold MAX and what is it used for

APAP Cold MAX is a combination medicine. It contains three active substances: paracetamol, caffeine, and phenylephrine. Caffeine increases the effectiveness of paracetamol in treating pain and accelerates its onset of action.
The indication for using APAP Cold MAX is the short-term treatment of cold and flu symptoms, such as: nasal congestion and sinusitis, runny nose, and headache, sore throat, muscle aches, and fever, feeling unwell, fatigue.
If symptoms worsen or do not improve after 3 days, consult a doctor.

2. Important information before taking APAP Cold MAX

When not to take APAP Cold MAX:

• if the patient is allergic (hypersensitive) to paracetamol, caffeine, phenylephrine, or other medicines with similar action or to any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe liver or kidney failure,
• if the patient has had stomach ulcers,
• if the patient has cardiovascular disease,
• if the patient has heart rhythm disorders,
• if the patient has high blood pressure,
• if the patient has diabetes,
• if the patient has been diagnosed with a pheochromocytoma (a tumor of the adrenal gland),
• if the patient has been diagnosed with glaucoma,
• if the patient has hyperthyroidism,

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• if the patient has been diagnosed with prostate enlargement,
• if the patient has a congenital deficiency of glucose-6-phosphate dehydrogenase or methemoglobin reductase,
• in the case of taking monoamine oxidase inhibitors (MAOIs) (used in the treatment of low blood pressure and depression) and within 14 days of stopping their use,
• in the case of taking tricyclic antidepressants (used in the treatment of mental disorders),
• in the case of taking zidovudine (AZT, a medicine used in HIV infection),
• during pregnancy and breastfeeding,
• in children under 12 years of age.

Warnings and precautions

Before taking the medicine, consult a doctor or pharmacist.
The medicine contains paracetamol. Due to the risk of overdose, check if other medicines being taken contain paracetamol.
Do not drink alcohol while taking the medicine. Taking the medicine by people with liver failure, alcohol abusers, or those who are fasting poses a risk of toxic liver damage.
During treatment with APAP Cold MAX, immediately inform your doctor if:
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, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). In these situations, patients have developed a severe condition called metabolic acidosis (a blood and body fluid disorder), which must be treated urgently (see section 2).

Caution in patients:

• with liver or kidney failure (should monitor liver enzyme activity and kidney function),
• with arteriosclerotic disease,
• with Raynaud's syndrome (characterized by blanching, followed by cyanosis of the fingers, toes, earlobes, and tip of the nose, often caused by cold or emotions),
• with stable coronary artery disease,
• with respiratory failure,
• with asthma,
• with increased intraocular pressure,
• taking anxiolytics,
• taking beta-adrenergic blockers (used, for example, in the treatment of high blood pressure),
• taking anticoagulants.

It is recommended to consult a doctor even if the above warnings refer to past situations.

Children and adolescents

Do not use in children under 12 years of age.

APAP Cold MAX and other medicines

Tell your doctor or pharmacist about all medicines being taken currently or recently, as well as any medicines the patient plans to take.

Interaction of APAP Cold MAX with other medicines results from the interaction of the active substances contained in the medicine.

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Paracetamol

• The medicine should not be taken simultaneously with other medicines containing paracetamol.
• Medicines that accelerate gastric emptying (e.g., metoclopramide) accelerate the absorption of paracetamol.
• Medicines that delay gastric emptying (e.g., propanteline) may delay the absorption of paracetamol.
• Taking paracetamol at the same time as MAO inhibitors (used in the treatment of, among other things, low blood pressure and depression) and within 14 days of stopping their use may cause a state of excitement and fever.
• Concomitant use of paracetamol with zidovudine (AZT, a medicine used in HIV infection) may increase the toxic effect of zidovudine on the bone marrow.
• Paracetamol may increase the effect of anticoagulant medicines (coumarin derivatives).
• Concomitant use of paracetamol and medicines that increase liver metabolism, such as certain sedatives or antiepileptic medicines (e.g., phenobarbital, phenytoin, carbamazepine), as well as rifampicin (used in the treatment of, among other things, tuberculosis), may lead to liver damage, even when taking the recommended doses of paracetamol. Therefore, before taking the medicine, consult a pharmacist or doctor.
• Drinking alcohol during paracetamol treatment can lead to liver failure.
• Cholestyramine reduces the absorption of paracetamol and should not be taken within the first hour after paracetamol administration.
• Concomitant use of probenecid reduces the excretion of paracetamol and prolongs its duration of action.
• Inform your doctor or pharmacist if the patient is taking 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).

Caffeine

Particular caution should be exercised when taking APAP Cold MAX with the following medicines:

• sedatives and hypnotics (e.g., barbituric acid derivatives or antihistamines), as caffeine inhibits their action,
• medicines that cause more frequent heart contractions (e.g., thyroxine), as caffeine increases their action,
• theophylline (a medicine used in the treatment of asthma and allergic conditions), as caffeine inhibits its excretion,
• oral contraceptives, cimetidine, and disulfiram, as they inhibit caffeine metabolism in the liver,
• barbituric acid derivatives (sedatives), as they accelerate caffeine metabolism,
• certain antibiotics, as they may delay caffeine excretion and its metabolite.

Smoking accelerates caffeine metabolism.
Caffeine increases the risk of dependence on substances with effects similar to ephedrine (contained in nasal decongestants).

Phenylephrine

• MAO inhibitors (medicines used in low blood pressure and depression) may increase the effect of phenylephrine. Avoid concomitant use with phenylephrine or administer phenylephrine at least 14 days after their discontinuation.
• Phenylephrine may increase the anticholinergic effect of tricyclic antidepressants (medicines used in mental disorders).
• Phenylephrine may weaken the hypotensive effect of guanethidine, mecamylamine, methyldopa, reserpine (medicines used in the treatment of high blood pressure).
• Phenylephrine used concomitantly with indomethacin (a pain and anti-inflammatory medicine used in rheumatic diseases), beta-adrenergic receptor antagonists (medicines used, for example, in the treatment of high blood pressure), or methyldopa (a medicine used, for example, in the treatment of high blood pressure) may cause a hypertensive crisis.

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APAP Cold MAX with food, drink, and alcohol

The medicine can be taken regardless of meals.
Do not drink alcohol while taking the medicine.
Excessive consumption of coffee or tea while taking the medicine may cause a feeling of tension and irritability.
Drinking alcohol during paracetamol treatment leads to the formation of a toxic metabolite that can cause liver cell necrosis, which can lead to liver failure.

Pregnancy and breastfeeding

Do not use during pregnancy.
Do not use during breastfeeding.

Driving and using machines

While taking APAP Cold MAX, be cautious when driving vehicles and operating machines.
Warnings regarding excipients

The medicine contains 1.875 g of sucrose in one sachet and glucose (an ingredient of maltodextrin and anhydrous corn glucose syrup).

This should be taken into account in patients with diabetes. If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medicine.

The medicine contains 33 mg of aspartame (E951) in one sachet.

Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.
The medicine contains 2.5 mg of sorbitol (an ingredient of sorbitol syrup) in one sachet, which corresponds to 10 mg/4 sachets (maximum daily dose).
The medicine contains 117.2 mg of sodium (the main ingredient of common salt) in one sachet. This corresponds to 5.9% of the maximum recommended daily dose of sodium in the diet for adults.
The medicine contains a colorant - orange yellow E110)
The medicine may cause allergic reactions.

The medicine contains sulfites - sulfur dioxide (E220)

The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

The medicine contains 0.0033 mg of benzyl alcohol in one sachet.

Benzyl alcohol may cause allergic reactions.
Pregnant or breastfeeding women and patients with liver or kidney disease should consult a doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause adverse effects (so-called metabolic acidosis).

3. How to take APAP Cold MAX

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
The recommended dose is:
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adults and adolescents over 12 years of age: 1 sachet, if necessary, the dose can be repeated, but not more often than every 4-6 hours. Do not take more than 4 sachets in 24 hours. Do not take for more than 3 days without consulting a doctor.
The medicine is taken orally.
The contents of one sachet should be dissolved in a glass of hot, but not boiling, water. Stir until dissolved. Let it cool to a temperature that allows drinking. The liquid should be drunk when it is warm.
After dissolution, the liquid has the form of an opalescent solution with a yellow color, a characteristic mint-citrus flavor, and no sediment.

Use in children and adolescents

Do not use in children under 12 years of age.

Taking a higher dose of APAP Cold MAX than recommended

Immediately consult a doctor or pharmacist. The medicine contains three active substances. Symptoms of overdose may result from the action of one or all of the active substances.

Accidental or intentional overdose of the medicine may cause, within a few or several hours, symptoms such as

nausea, vomiting, excessive sweating, drowsiness, general weakness, anxiety, tremors, palpitations, high blood pressure, seizures, difficulty urinating, and shortness of breath. These symptoms may resolve the next day, despite the fact that liver damage is beginning to develop, which will then manifest as abdominal distension, return of nausea, and jaundice.
In case of overdose, immediately consult a doctor, even if the patient feels well, due to the risk of delayed, severe liver damage.
Do not take with other medicinal products with a similar composition.
Treatment should be carried out in a hospital. It involves accelerating the elimination of the medicine's components from the body and maintaining vital functions. In the case of paracetamol overdose, it may be necessary to administer an antidote: N-acetylcysteine and/or methionine.

Missing a dose of APAP Cold MAX

Do not take a double dose to make up for a missed dose.

4. Possible side effects

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

The frequency of side effects has been classified as follows:
Common - may affect 1-10 in 100 treated patients;
Rare - may affect 1-10 in 10,000 treated patients;
Very rare - may affect less than 1 in 10,000 patients;
Frequency not known - cannot be estimated from the available data.

If any of the side effects get worse or any side effects not listed in this leaflet occur, tell your doctor.

Possible side effects of the medicine due to the presence of paracetamol:

Rare:

• anemia, bone marrow suppression, thrombocytopenia (low platelet count), agranulocytosis (lack of granulocytes in the blood), leukopenia (decreased white blood cell count), neutropenia (decreased neutrophil count),
• edema,
• acute and chronic pancreatitis, bleeding, abdominal pain, diarrhea, nausea, vomiting,
• itching, rash, sweating, urticaria, angioedema,

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• nephropathy and tubulopathy (kidney and urinary tract diseases).

Very rare:

liver failure, liver necrosis, jaundice.

Frequency not known (cannot be estimated from the available data):

• a serious condition that can cause blood acidification (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Single cases of toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, laryngeal edema, anaphylactic shock, and dizziness have been observed.
Possible side effects of the medicine due to the presence of phenylephrine:
Nephrotoxic effects are rare and have not been reported to be related to therapeutic doses, except in cases of chronic use of the medicine.

Common:

• nausea, vomiting, digestive disorders, anorexia.

Rare:

• itching, urticaria,
• allergic reactions and hypersensitivity up to anaphylactic shock and bronchospasm,
• increased blood pressure, tachycardia, arrhythmias, palpitations, pallor.

Very rare:

• anxiety, nervousness, tremors, insomnia, irritability, dizziness, and headaches, hallucinations.

Frequency not known:

• urinary retention.

After taking caffeine, the following have been reported: palpitations, sudden flushing, high blood pressure, tachycardia.

Reporting side effects

If any side effects occur, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store APAP Cold MAX

Store in a temperature below 25°C. The medicine should be stored in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging (month/year).
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines that are no longer needed.
This will help protect the environment.
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6. Contents of the packaging and other information

What APAP Cold MAX contains

The active substances of the medicine are: paracetamol 1000 mg, caffeine 50 mg, and phenylephrine hydrochloride 12.2 mg.
Other ingredients are: sucrose, sodium citrate, citric acid, acesulfame potassium (E950), aspartame (E951), quinoline yellow (E104), citrus flavor 87A069 (including sulfites, citral, citronellol, geraniol, limonene, linalol, anhydrous corn glucose syrup), citrus flavor 875060 (including citral, citronellol, geraniol, limonene, linalol, anhydrous corn glucose syrup), citrus flavor 501.476 AP0504 (including limonene, citral, linalol, geraniol, citronellol, farnesol, corn maltodextrin (contains glucose)), mint flavor 550469 TP0300 (including limonene), peppermint flavor SC447995 (including limonene, linalol, citronellol, eugenol, geraniol, benzyl alcohol, corn maltodextrin (contains glucose), sorbitol syrup, sulfites), orange yellow FCF (E110).

What APAP Cold MAX looks like and what the packaging contains

APAP Cold MAX is a yellow, powdery powder with a characteristic mint-citrus flavor.
Packaging:5, 8, 12 sachets in a cardboard box.

Marketing authorization holder and manufacturer

US Pharmacia Sp. z o.o.
ul. Ziębicka 40,
50-507 Wrocław
To obtain more detailed information about this medicine, 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:

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