Apap pzheziembienie iunior

Leaflet attached to the packaging: patient information

APAP Cold Junior

(300 mg + 20 mg + 5 mg)/sachet, powder for oral solution, in a sachet
Paracetamol+ Ascorbic acid+ Phenylephrine hydrochloride

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 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 APAP Cold Junior and what is it used for

2.

Important information before taking APAP Cold Junior

3.

How to take APAP Cold Junior

4.

Possible side effects

5.

How to store APAP Cold Junior

6.

Contents of the packaging and other information

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

APAP Cold Junior is a combination medicine containing paracetamol, phenylephrine, and ascorbic acid (vitamin C). Paracetamol acts as an antipyretic and analgesic, phenylephrine reduces swelling and congestion of the mucous membranes.
The medicine is indicated for short-term use in the treatment of cold and flu symptoms, such as: fever and chills, headache, muscle and joint pain, sore throat, nasal congestion and sinus pain accompanied by pain, rhinitis (runny nose).
The medicine is indicated for use in adults and children over 6 years old.
If there is no improvement after 3 days or the patient feels worse, they should consult a doctor.

2. Important information before taking APAP Cold Junior

When not to take APAP Cold Junior

• If the patient is allergic to any of the active substances or any of the other ingredients of this medicine (listed in section 6).
• If the patient has any of the following conditions:
• unstable coronary artery disease,
• arrhythmias,
• high blood pressure,
• inborn deficiency of certain enzymes: glucose-6-phosphate dehydrogenase or methemoglobin reductase,
• severe liver or kidney failure,
• viral hepatitis,
• alcoholism,
• angle-closure glaucoma,
• anatomically narrow angle of the anterior chamber.

APAP Cold Junior should not be taken during treatment with MAO inhibitors and for 2 weeks after stopping treatment with these medicines.
APAP Cold Junior should not be taken during treatment with zidovudine (a medicine used to treat HIV infection).
Do not take with other medicines containing paracetamol or other cold and flu medicines, or medicines that reduce congestion of the mucous membranes (so-called sympathomimetics).

Warnings and precautions

Before starting treatment with APAP Cold Junior, you should discuss it with your doctor or pharmacist if:

• you have: liver or kidney failure, pheochromocytoma, asthma, prostatic hyperplasia, hyperthyroidism, Raynaud's syndrome (pallor, followed by cyanosis of the fingers, toes, earlobes, and nose tip, often occurring under the influence of cold or emotions), coronary artery disease, hypertension, diabetes;
• you are taking anticoagulant medicines.

Cases of liver failure have been reported in patients who are severely malnourished, suffering from anorexia, have a low body mass index (BMI), and regularly consume alcohol.
Paracetamol may increase the risk of metabolic acidosis. Symptoms of metabolic acidosis include:

• deep, rapid, and labored breathing,
• nausea, vomiting, and loss of appetite,
• general malaise. You should contact your doctor immediately if you experience any of these symptoms.

Children and adolescents

The medicine should not be used in children under 6 years old.

APAP Cold Junior 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.
Do not take APAP Cold Junior with other medicines containing:

• paracetamol (the active substance found in many cold and flu medicines), as paracetamol overdose can lead to liver failure, which can result in the need for a liver transplant or death;
• phenylephrine or pseudoephedrine (medicines from the group of so-called sympathomimetics, used in the symptomatic treatment of rhinitis, i.e., runny nose);
• other sympathomimetics or MAO inhibitors (used in the treatment of hypotension or depression);
• zidovudine (an antiviral medicine used to treat HIV infections).

You should consult your doctor or pharmacist before taking APAP Cold Junior with the following medicines:

• anticoagulant medicines (warfarin, coumarin);
• antiepileptic medicines;
• barbiturates (medicines with a sedative and hypnotic effect);
• other medicines that induce liver microsomal enzymes (e.g., isoniazid, rifampicin, anti-tuberculosis medicines);
• metoclopramide (an antiemetic medicine);
• cholinolytics (medicines used in asthma, treatment of stomach ulcers and reflux, as antiemetics, in spastic conditions of the digestive tract, in the symptomatic treatment of Parkinson's disease);
• flucloxacillin (an antibiotic), due to the serious risk of a blood and fluid disorder (metabolic acidosis with a large anion gap), which requires urgent treatment and may occur especially in patients with severe kidney dysfunction, sepsis (a condition where 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;
• medicines that lower blood pressure (guanethidine, mecamylamine, methyldopa, reserpine);
• beta-adrenergic receptor antagonists (medicines used in hypertension and cardiovascular diseases);
• tricyclic antidepressants;
• ergot alkaloid derivatives, e.g., bromocriptine, cabergoline, lisuride, pergolide (medicines used in the treatment of migraines);
• bromocriptine and cabergoline (medicines that lower prolactin levels);
• medicines that accelerate labor;
• salicylates (e.g., acetylsalicylic acid);
• antacids;
• medicines or dietary supplements containing iron;
• stimulants;
• appetite suppressants;
• psychostimulant medicines from the amphetamine derivative group (e.g., used in the treatment of hyperactivity with attention disorders).

If you are unsure whether you are taking any of these medicines, you should consult your doctor or pharmacist.
Effect on laboratory test results
Paracetamol may be the cause of false results in some laboratory tests (e.g., glucose or uric acid measurement).

APAP Cold Junior with food, drink, or alcohol

The medicine can be taken regardless of meals.
Drinking alcohol during treatment with the medicine is contraindicated due to the risk of toxic liver damage.

Pregnancy, breastfeeding, and fertility

Do not use during pregnancy and breastfeeding.

Driving and using machines

During treatment with the medicine, you should exercise caution when driving vehicles and operating mechanical equipment.

Warnings regarding excipients

The medicine contains less than 1 mmol (23 mg) of sodium per sachet, which means the medicine is considered "sodium-free".
The medicine contains no more than 0.005 mg of benzyl alcohol in 1 sachet. Benzyl alcohol may cause allergic reactions. Patients with liver or kidney disease, as well as pregnant or breastfeeding women, should consult their doctor before taking a medicine containing benzyl alcohol, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).
The medicine contains glucose (as a component of dextrose and glucose syrup with flavorings). One sachet contains 46 mg of glucose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains 1.83 g of mannitol (E 421) in 1 sachet.
The medicine may have a mild laxative effect.

3. How to take APAP Cold Junior

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, you should consult your doctor or pharmacist.

Use in children from 6 to 12 years old

If necessary, 1 sachet, not more often than every 4 to 6 hours, up to a maximum of 4 sachets per day.
Maximum daily dose of paracetamol used in children: 60 mg/kg body weight per 24 hours, administered in divided doses up to 4 times a day at 15 mg/kg body weight.

Adults and adolescents over 12 years old

If necessary, 1 or 2 sachets, not more often than every 4 to 6 hours, up to a maximum of 6 sachets per day.

Method of administration

The medicine should be taken orally. The contents of the sachet should be poured into hot water (100 ml) and mixed thoroughly until the powder is completely dissolved.
The liquid should be consumed within 15 minutes of preparation.
Do not use for more than 3 days without consulting a doctor.

Dosing of APAP Cold Junior in special patient groups

Kidney failure
In patients with kidney failure, it is recommended to reduce the dose of paracetamol and extend the interval between doses as follows:
Adults
Do not use the medicine in case of severe kidney failure (glomerular filtration: below 10 ml/min, see "When not to take APAP Cold Junior").
Liver failure
In patients with liver failure or Gilbert's syndrome, the dose of paracetamol should be reduced or the interval between doses extended. Do not exceed the maximum daily dose of paracetamol of 2 g per day.
Elderly patients
So far, experience has shown that the paracetamol dosage recommended for adults is suitable for this patient group.
However, in elderly patients, it may be appropriate to reduce the dose or frequency of administration.
If the medicine is not used under medical supervision, do not exceed a daily dose of more than 2 g in patients:

• with a body weight of less than 50 kg
• with liver failure (see also above)
• with alcoholism
• dehydrated
• malnourished.

Taking a higher dose of APAP Cold Junior than recommended

In case of taking a higher dose than recommended, you should immediately consult a doctor, even if no side effects occur.
Due to paracetamol overdose, symptoms such as nausea, vomiting, excessive sweating, drowsiness, and general weakness may occur. These symptoms may resolve on their own, but this does not rule out the possibility of liver damage, which may then manifest as abdominal pain, recurrence of nausea, and jaundice.
It is recommended to administer 60-100 g of activated charcoal orally, preferably mixed with water.
Overdose of phenylephrine is manifested by circulatory disorders (too frequent heartbeat, increased blood pressure), vascular collapse with respiratory arrest.

Missing a dose of APAP Cold Junior

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

4. Possible side effects

Like all medicines, APAP Cold Junior 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 symptoms:

• allergic reactions(hypersensitivity) such as: skin rash or itching, sometimes accompanied by difficulty breathing or swelling of the lips, tongue, throat, or face; rare,
• severe skin reactionsmanifested by a rash all over the body, ulcers in the mouth, eyes, genitals, and skin, red spots on the torso, often with blisters in the center, large blisters bursting, skin peeling, weakness, fever, and joint pain; very rare,
• breathing problems, if similar problems occurred in the past when taking acetylsalicylic acidor other nonsteroidal anti-inflammatory medicines; very rare,
• vision loss, which may be caused by excessively high intraocular pressure, especially in people with angle-closure glaucoma; rare,
• unusual rapid heartbeator feeling of irregular heart rhythm; frequency not known,
• difficulty urinating; frequency not known,
• jaundice, acute liver damage, most often due to overdose, liver failure (which may be indicated by yellowing of the skin and eyes, liver tenderness), liver necrosis; very rare,
• hypoglycemia(excessive decrease in blood sugar levels); very rare,
• metabolic acidosiswith a large anion gap (decrease in blood pH caused by the accumulation of excessive amounts of acidic substances in the blood with concurrent electrolyte disturbances); frequency not known,
• dizziness, rapid heartbeat, tendency to bruise (bone marrow suppression- decrease in the number of bone marrow cells producing blood cells) and coagulation disorders; rare.

Side effects that occur rarely (may occur less frequently than in 1 in 1,000 patients):

• depression, confusion;
• tremors;
• pupil dilation;
• edema;
• diarrhea, abdominal pain;
• increased activity of liver enzymes (transaminases), abnormal liver function;
• itching, sweating;
• malaise, fever, excessive drowsiness.

Side effects that occur very rarely (may occur less frequently than in 1 in 10,000 patients):

• anemia (decrease in the number of red blood cells);
• leukopenia, neutropenia (decrease in the number of one type of white blood cell in the blood - leukocytes or neutrophils), agranulocytosis (absence of one type of white blood cell in the blood), thrombocytopenia (decrease in the number of platelets);
• pigmentary purpura;
• sterile pyuria (cloudy urine).

Side effects with unknown frequency (cannot be estimated from available data):

• anxiety, nervousness, restlessness, hallucinations;
• dizziness, headache, insomnia;
• increased blood pressure;
• pallor;
• nausea, vomiting, digestive disorders, heartburn, dry mouth, acute or chronic pancreatitis.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 provide more information on the safety of the medicine.

5. How to store APAP Cold Junior

Store the medicine at a temperature below 25°C, in the original packaging to protect it from light and moisture.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack (month/year). The applied labeling for the sachet is: EXP - expiry date, Lot - batch number. The expiry date refers to the last day of the specified 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 APAP Cold Junior contains

The active substances of the medicine are :paracetamol, ascorbic acid, and phenylephrine hydrochloride.
1 sachet contains 300 mg of paracetamol, 20 mg of ascorbic acid, and 5 mg of phenylephrine hydrochloride.
The other ingredients of the medicine are: mannitol (E421), citric acid, sodium citrate, sodium cyclamate, sodium saccharin, calcium gluconate, orange flavor (contains, among others: linalool, citral, benzyl alcohol, citronellol, dextrose (corn/wheat), anhydrous glucose syrup (corn), butylhydroxyanisole (E320)) and strawberry flavor (contains, among others: anhydrous glucose syrup (corn)).

What APAP Cold Junior looks like and what the pack contains

White or almost white powder with a strawberry-like odor.
The packaging contains: 6 or 12 sachets.

Marketing authorization holder

US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50-507 Wrocław

Manufacturer

Chemax Pharma Ltd.
8A, Goritsa Str.
Sofia 1618
Bulgaria
To obtain more detailed information about this medicine, you should contact:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warsaw
tel.+48 (22) 543 60 00.

Date of last revision of the leaflet: