Apap pzheziembienie

Leaflet attached to the packaging: patient information

APAP cold

(650 mg + 50 mg +10 mg)/ sachet
powder for oral solution preparation
(Paracetamol + Ascorbic Acid + Phenylephrine Hydrochloride)

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

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

• Keep this leaflet, you may need to read it again.
• Ask your pharmacist if you need advice or additional information.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist.
• 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 APAP cold medicine and what is it used for

2. Important information before taking the medicine

3. How to take APAP cold medicine

4. Possible side effects

5. How to store APAP cold medicine

6. Package contents and other information

1. What is APAP cold medicine and what is it used for

APAP cold, powder for oral solution, is a multi-component medicine,
containing paracetamol, ascorbic acid, and phenylephrine hydrochloride. It has antipyretic, analgesic, and decongestant effects.
It alleviates the symptoms of colds and flu.
The indication for use of the medicine is short-term relief of cold, flu, and flu-like infection symptoms, such as:
fever, headache, sore throat, muscle and joint pain, and symptoms of nasal congestion occurring in colds and flu.
If after 3 days there is no improvement or you feel worse, you should consult a doctor.

2. Important information before taking APAP cold medicine

When not to take the medicine:

• if you are allergic to any active substance, sympathomimetic amines, or any other component of this medicine (listed in point 6).
• if you have the following diseases:
• unstable coronary artery disease,
• heart rhythm disorders,
• high blood pressure,
• congenital deficiency of glucose-6-phosphate dehydrogenase and methemoglobin reductase,
• severe liver or kidney failure,
• viral hepatitis,
• alcoholic disease,
• phenylketonuria (due to the presence of aspartame),
• hyperthyroidism,
• glaucoma with a narrow angle of filtration,
• while taking monoamine oxidase inhibitor (MAOI) drugs (used to treat low blood pressure and depression) and within 14 days of stopping their use,
• in combination with tricyclic antidepressants,
• while taking zidovudine (a drug used to treat HIV infection),
• in children under 12 years of age.

Warnings and precautions

Before starting to take the medicine, consult a doctor or pharmacist if you have:

• liver and kidney failure,
• bronchial asthma,
• prostate enlargement,
• Raynaud's syndrome (pallor, followed by cyanosis of the fingers, toes, earlobes, and nose tip, often under the influence of cold or emotions),
• coronary artery disease,
• diabetes,
• intolerance to some sugars (due to the presence of sugar - sucrose). Taking the medicinal product by fasting individuals poses a risk of liver damage.

You should contact your doctor, even if the above warnings concern situations that occurred in the past.
During the use of APAP cold medicine, you should immediately inform your doctor if:
If you have severe diseases, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition,
chronic alcoholism or when you are also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a severe disease called metabolic acidosis (abnormal blood and body fluid acidity), 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

APAP cold medicine should not be given to children under 12 years of age.

APAP cold medicine and other medicines

The medicine should not be taken simultaneously with other medicines containing:

• paracetamol (an active substance found in many preparations used for colds and flu);
• phenylephrine or pseudoephedrine (used in symptomatic treatment of rhinitis, i.e. runny nose);
• other sympathomimetics or MAOIs (used to treat low blood pressure and depression);
• zidovudine (an antiviral drug used to treat HIV infection);
• tricyclic antidepressants; other anti-flu, cold, and decongestant medicines.

You should consult a doctor before taking the medicine with:

• anticoagulant medicines (warfarin, coumarin);
• antiepileptic medicines;
• barbiturates (medicines with a sedative and calming effect);
• microsomal enzyme inducers;
• medicines that lower blood pressure (guanethidine, mecamylamine, methyldopa, reserpine);
• indomethacin (a pain-relieving and anti-inflammatory medicine, used, among others, in rheumatoid arthritis);
• beta-adrenergic receptor antagonists (medicines used in hypertension and cardiovascular diseases);
• metoclopramide;
• cholinolytics.

You should inform your doctor or pharmacist if you are taking flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which requires emergency treatment (see point 2).
The ascorbic acid contained in the medicine increases the absorption of:

• aluminum (found in antacids);
• iron.

APAP cold medicine with food, drink, or alcohol

Food does not reduce the absorption of the medicine.
You should not drink alcohol while taking the medicine, due to the risk of toxic liver damage.

Pregnancy and breastfeeding

In pregnancy and during breastfeeding, or if you suspect you are pregnant, or plan to become pregnant, you should consult a doctor or pharmacist before taking this medicine.
Do not use during pregnancy.
Do not use during breastfeeding.

Driving and using machines

While taking the medicine, you should be cautious when driving vehicles and operating machinery.

The medicine contains excipients with known effects:

Aspartame

The medicine contains 20 mg of aspartame (E 951) per 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.

Sucrose and glucose (components of maltodextrin and anhydrous corn glucose syrup with flavors)

The medicine contains 1.981 g of sucrose per sachet and 11.886 g of sucrose in the maximum daily dose (6 sachets). This should be taken into account in patients with diabetes.
If you have previously been diagnosed with intolerance to some sugars, you should consult a doctor before taking the medicine.

Sodium

The medicine contains 78.13 mg of sodium (the main component of table salt) per sachet.
This corresponds to 3.9% of the maximum recommended daily intake of sodium in the diet for adults.

Sulfites - sulfur dioxide (E 220) (component of lemon juice concentrate with flavor)

The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to take APAP cold medicine

This medicine should always be taken as described in the patient leaflet or as directed by a doctor,
or pharmacist. In case of doubt, consult a doctor or pharmacist.
Adults and children over 12 years of age:
1 sachet every 4-6 hours (maximum 6 sachets per day).
The contents of the sachet should be dissolved in a glass of hot water.
If you feel that the effect of the medicine is too strong or too weak, you should consult a doctor.

Taking a higher dose of APAP cold medicine than recommended

In case of taking a higher dose of the medicine than recommended, you should stop taking the medicine and immediately contact a doctor or the nearest hospital emergency department.
You should take the leaflet and the medicine packaging with you.
Procedure after overdose:

• if the patient is conscious and it has been less than an hour since the overdose, you should induce vomiting,
• it is worth administering 60-100 g of activated charcoal orally, preferably mixed with water. Antidote: up to 24 hours after overdose N-acetylcysteine, methionine. Overdosed paracetamol may cause severe liver damage, especially in individuals who have previously fasted or abused alcohol.

Symptoms may occur, such as nausea, vomiting, excessive sweating, drowsiness, and general weakness. These symptoms may resolve on their own, but this does not rule out the development of liver damage. Symptoms such as tremors, anxiety, insomnia, increased blood pressure, significant acceleration of heart rate, pallor of the skin and mucous membranes, and urinary retention may also occur. Later, abdominal pain and jaundice may appear.

Missing a dose of APAP cold medicine

The medicine is intended for short-term relief of cold, flu, and flu-like infection symptoms.
If you miss a dose of the medicine and the symptoms persist, you should take the next dose of the medicine.
Do not take a double dose to make up for the missed dose.

Stopping the use of APAP cold medicine

In case of any further doubts about the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, APAP cold medicine can cause side effects, although not everybody gets them.
These include:

• skin and subcutaneous tissue disorders:allergic reactions (itching, hives);
• immune system disorders:hypersensitivity reactions up to anaphylactic shock symptoms (manifested by impaired consciousness, pallor, blood pressure drop, sweating, oliguria, accelerated breathing, edema);
• gastrointestinal disorders:nausea, vomiting, digestive disorders, heartburn, dry mouth;
• cardiovascular disorders:increased blood pressure, tachycardia (rapid heart rate), arrhythmias, pallor of the skin and mucous membranes;
• respiratory, thoracic, and mediastinal disorders:breathing disorders, asthma attacks;
• renal and urinary disorders:urinary disorders, renal colic, renal papillary necrosis,
• nervous system disorders:anxiety, insomnia;
• psychiatric disorders:hallucinations, anxiety, nervousness;
• blood and lymphatic system disorders:granulocytopenia (reduced number of a certain type of white blood cell), agranulocytosis (absence of a certain type of white blood cell), thrombocytopenia (reduced platelet count).

Frequency not known (cannot be estimated from available data)

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

In the case of short-term use of the medicine, side effects occur rarely.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this 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 of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: +48 (22) 492 13 01,
fax: +48 (22) 492 13 09
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 medicine

Store the medicine at a temperature below 25°C.
The medicine should be stored in a place invisible and inaccessible to children.
Do not use the medicine after the expiry date stated on the packaging.
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 used. This will help protect the environment.

• 6. Package contents and other information

What APAP cold medicine contains

One sachet contains active substances: paracetamol 650 mg, ascorbic acid 50 mg, phenylephrine hydrochloride 10 mg.
Other components of the medicine in one sachet are: sucrose, citric acid, sodium citrate, lemon flavor 87A069*,
lemon flavor 875060**, acesulfame potassium (E 950), lemon flavor 501.476/AP0504***,
lemon flavor 875928****, aspartame (E 951), quinoline yellow (E 104).
*lemon flavor 87A069 contains, among others, lemon juice concentrate (contains sulfites), natural citral (contains: citral, citronellol, geraniol, limonene, linalol), anhydrous corn glucose syrup
**lemon flavor 875060 contains, among others, natural citral, natural linalol (contains: citral, citronellol, geraniol, limonene, linalol), anhydrous corn glucose syrup, butylhydroxyanisole (E 320)
***lemon flavor 501.476/AP0504 contains, among others, corn maltodextrin
****lemon flavor 875928 contains, among others, citral, geraniol, limonene, linalol, anhydrous corn glucose syrup

What APAP cold medicine looks like and what the package contains

Sachet with powder for oral solution.
The medicine is available in packages: 5, 8, 10, or 12 sachets in a cardboard box with a leaflet.

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, you should contact:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warsaw
tel. +48 (22) 543 60 00

Date of last update of the leaflet: