Antigripin Complex

PATIENT LEAFLET: USER INFORMATION

AntyGrypin COMPLEX

500 mg + 200 mg + 4 mg, effervescent granules
Paracetamol + Ascorbic Acid + Chlorphenamine Maleate

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 advised by your doctor or pharmacist.

• You should keep this leaflet to be able to read it again if needed.
• If you need advice or additional information, you should consult a 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 in the case of fever and 5 days in the case of pain, no improvement occurs or you feel worse, you should contact your doctor.

Table of Contents of the Leaflet:

• 1. What is AntyGrypin COMPLEX and what is it used for
• 2. Important information before taking AntyGrypin COMPLEX
• 3. How to take AntyGrypin COMPLEX
• 4. Possible side effects
• 5. How to store AntyGrypin COMPLEX
• 6. Package contents and other information

1. What is AntyGrypin COMPLEX and what is it used for

AntyGrypin COMPLEX is a combination medicine containing three active substances: paracetamol, which acts as a pain reliever and antipyretic, chlorphenamine maleate, which reduces nasal discharge, inhibits sneezing and tearing of the eyes, and ascorbic acid, which supplements vitamin C deficiency in the body.
This medicine is used for the symptomatic treatment of flu, colds, and flu-like conditions, such as headache, fever, sore throat, and nasal and throat inflammation in adults and adolescents over 15 years of age.
If after 3 days in the case of fever and 5 days in the case of pain, no improvement occurs or you feel worse, you should consult a doctor.

2. Important information before taking AntyGrypin COMPLEX

When not to take AntyGrypin COMPLEX:

• if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if you have liver or kidney failure;
• if you are taking other medicines that affect liver function;
• if you abuse alcohol;
• if you have narrow-angle glaucoma;
• in patients with a risk of urinary retention, associated with disorders of the urethra passing through the prostate gland;
• in patients taking monoamine oxidase inhibitors (MAOIs, used in the treatment of depression), currently or in the last two weeks;
• in children and adolescents under 15 years of age.

Warnings and precautions

Before starting to take AntyGrypin COMPLEX, you should discuss it with your doctor or pharmacist.
Warnings
In case of high or persistent fever, starting bacterial superinfection, persistence of symptoms for more than 3 days in case of fever and 5 days in case of pain, you should contact your doctor.
In case of taking this medicine in doses higher than recommended and in case of prolonged treatment, there may be a risk of dependence, mainly psychological.
To avoid the risk of overdose, you should not take other medicines containing paracetamol. The risk of overdose of this medicine increases in patients with liver disease.
You should be careful when using in patients with reduced glutathione levels.
There have been reports of liver failure in patients with reduced glutathione levels, especially in patients who are:

• severely malnourished, suffering from anorexia, having a low body mass index (BMI), being emaciated,
• dehydrated,
• regularly drinking alcohol (see "When not to take AntyGrypin COMPLEX"),
• with mild to moderate liver failure, Gilbert's syndrome (familial non-hemolytic jaundice),
• with sepsis.

Paracetamol may increase the risk of metabolic acidosis. Symptoms of metabolic acidosis include: deepened, accelerated, labored breathing, nausea, vomiting, loss of appetite. You should immediately contact your doctor if you experience any of these symptoms together.
Precautions
Paracetamol should be used with caution in people with kidney function disorders, acute liver inflammation, glucose-6-phosphate dehydrogenase deficiency, hemolytic anemia, and methemoglobin reductase deficiency.
The risk of overdose of this medicine is greater in people with non-alcoholic liver cirrhosis.
Paracetamol taken in doses higher than 6-8 g per day may damage the liver.
Liver damage may occur even at much lower doses, during concomitant administration with alcohol, liver enzyme inducers, or other medicines that are toxic to the liver, such as monoamine oxidase inhibitors (see "When not to take AntyGrypin COMPLEX").
Long-term alcohol consumption significantly increases the risk of toxic liver damage from paracetamol.
Due to the risk of hypertensive crisis, paracetamol is contraindicated in patients taking monoamine oxidase inhibitors currently or in the last two weeks.
While taking this medicine, due to the content of chlorphenamine, you should avoid consuming alcohol and medicines containing alcohol. The medicine may affect your ability to drive vehicles and operate machinery.
You should be careful in patients with asthma or chronic obstructive pulmonary disease, cardiovascular diseases, hypertension, hyperthyroidism, and pyloric stenosis.
During treatment, you should avoid taking sedatives (especially barbiturates), which enhance the sedative effect of antihistamines.
Effect on laboratory tests
Administration of paracetamol may affect the results of uric acid tests in the blood, as well as glucose tests. Chlorphenamine may affect the results of skin tests using allergens. It is recommended to discontinue the product at least 3 days before starting skin tests.

Children and adolescents

This medicine is contraindicated in children and adolescents under 15 years of age.

AntyGrypin COMPLEX and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
While taking AntyGrypin COMPLEX, you should avoid medicines containing alcohol.
You should inform your doctor or pharmacist if you are taking:

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

You should be careful when taking:

• opioid derivatives (pain relievers, antitussives, and replacement medicines),
• neuroleptics (medicines used in the treatment of mental disorders, mainly schizophrenia and other psychoses),
• barbiturates (sleeping pills and medicines used in the treatment of epilepsy),
• benzodiazepines (medicines with anxiolytic, sedative, hypnotic, anticonvulsant, and muscle relaxant effects),
• anxiolytic medicines other than benzodiazepines (e.g., meprobamate),
• sleeping pills (lorazepam, diazepam),
• antidepressant medicines with a sedative effect (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine),
• antihistamine medicines blocking H receptors (medicines used in the treatment of allergic diseases),

and

• antihypertensive medicines acting on the central nervous system,
• baclofen (a muscle relaxant),
• thalidomide (a medicine affecting the immune system, used in the treatment of multiple myeloma),
• anticholinergic antiparkinsonian medicines (such as benzatropine),
• medicines similar to atropine with antispasmodic effects (containing hyoscine),
• dyzopyramide (a medicine used in heart diseases),
• neuroleptics from the phenothiazine derivative group (medicines used in the treatment of psychoses, such as chlorpromazine, thioridazine, perphenazine),
• clozapine (a medicine used in the treatment of schizophrenia and mental disorders in Parkinson's disease),
• salicylamide (a pain reliever),
• rifampicin (an antibiotic),
• antiepileptic medicines (e.g., phenytoin, carbamazepine, lamotrigine, and others),
• sleeping pills from the barbiturate group and other medicines inducing liver enzymes,
• caffeine,
• nonsteroidal anti-inflammatory medicines (aspirin, ibuprofen, diclofenac, naproxen),
• anticoagulant medicines from the coumarin group (acenocoumarol, warfarin),
• monoamine oxidase inhibitors (medicines used in the treatment of depression),
• flufenazine (a medicine used in the treatment of psychosis).

Taking AntyGrypin COMPLEX with food, drink, and alcohol

While taking AntyGrypin COMPLEX, you should avoid consuming alcohol, as it may cause liver damage and excessive sedation.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
It is not recommended to take AntyGrypin COMPLEX during pregnancy.
Breastfeeding
It is not recommended to take AntyGrypin COMPLEX during breastfeeding.
Fertility
Animal studies have not shown any harmful effects of paracetamol, chlorphenamine maleate, or ascorbic acid on fertility.

Driving and operating machinery

While taking this medicine, you may experience drowsiness that affects your psychophysical fitness to drive vehicles and operate machinery.

AntyGrypin COMPLEX in the form of effervescent granules contains sucrose and glucose (a component of maltodextrin with aroma).

If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.
The medicine contains 3156 mg of sucrose in one sachet. This should be taken into account in patients with diabetes.
AntyGrypin COMPLEX in the form of effervescent granules contains sodium.

The medicine contains 88.8 mg of sodium (the main component of table salt) in each sachet. This corresponds to 4.5% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take AntyGrypin COMPLEX

This medicine should always be taken exactly as described in this patient leaflet or as advised by your doctor or pharmacist. In case of doubt, you should consult your doctor or pharmacist.
Administration in adults and adolescents over 15 years of age:
The recommended dose is: if necessary, the contents of 1 sachet 30 minutes before bedtime. Do not take more than the contents of 3 sachets per day in divided doses, with a minimum interval of 4 hours between doses.
Patients with kidney function disorders
In case of kidney function disorders, the dose of paracetamol should not exceed 500 mg:

Do not take the medicine in case of severe kidney function disorder (see "When not to take AntyGrypin COMPLEX").
Patients with liver function disorders
In patients with liver function disorders or Gilbert's syndrome, the dose of the medicine should be reduced or the intervals between consecutive doses prolonged.
Do not take the medicine in case of severe liver function disorder (see "When not to take AntyGrypin COMPLEX").
Elderly patients
In elderly patients with normal kidney function, the dosage is the same as in adults.
Children and adolescents under 15 years of age
This medicinal product should not be used in children under 15 years of age.
Method of administration
Oral administration.
The effervescent granules should be dissolved in a glass of cold or warm water.
Duration of treatment
This medicine should not be taken for more than 3 days in case of fever and 5 days in case of pain without consulting a doctor.

Taking a higher dose of AntyGrypin COMPLEX than recommended

Symptoms related to chlorphenamine maleate
Overdose of chlorphenamine may cause: seizures (especially in children), impaired consciousness, coma.
Symptoms related to paracetamol
There is a particular risk of paracetamol poisoning in the elderly and in small children (the most common causes are taking higher doses than recommended and accidental poisoning); these poisonings can lead to death. Overdose of the medicine may cause symptoms such as nausea, vomiting, excessive sweating, drowsiness, and general weakness within a few to several hours. These symptoms may subside the next day, despite the fact that liver damage is beginning to develop, which then manifests as abdominal distension, return of nausea, and jaundice. Taking more than 10 g of paracetamol in adults or 150 mg/kg body weight in a single dose in children causes complete and irreversible liver cell necrosis. In every case of taking paracetamol in a dose of 5 g or more, you should induce vomiting if it has not been more than an hour since taking the medicine. You should take 60-100 g of activated charcoal orally, preferably mixed with water.
In case of taking a higher dose of the medicine than recommended, you should immediately consult a doctor.

Missing a dose of AntyGrypin COMPLEX

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects related to paracetamol:

You should stop taking the medicine and immediately consult a doctor or go to the hospital if you experience:

• pharyngeal edema, which makes breathing difficult (single cases);
• anaphylactic shock, manifested by confusion, paleness, blood pressure drop, sweating, oliguria, rapid breathing, weakness, and fainting (single cases);
• erythema multiforme (single cases);
• severe skin reactions: toxic epidermal necrolysis (Lyell's syndrome), bullous erythema multiforme (Stevens-Johnson syndrome), acute generalized exanthematous pustulosis, characterized by a rash with pustules all over the body, erosions in the mouth, eyes, genitals, and skin, red spots on the torso, often with large blisters, peeling of large skin flakes, weakness, fever, and joint pain (very rare cases);
• persistent itching of the skin (pruritus), rash on the skin, excessive sweating, appearance of lumps, hemorrhagic or vesicular eruptions (papular rash), allergic reaction resembling angioedema (angioedema); these occur rarely;
• acute or chronic pancreatitis, bleeding, abdominal pain, diarrhea, nausea, vomiting, liver dysfunction (liver failure), irreversible liver damage (liver necrosis), jaundice; these occur rarely.

Other side effects include:

Rare (may occur in less than 1 in 1000 people):

• anemia caused by various deficiencies, bone marrow suppression, decreased platelet count;
• fluid accumulation in tissues (edema);
• kidney dysfunction (nephropathy) and impaired absorption or excretion of renal tubules (tubulopathy).

Paracetamol is a widely used medicine, and the described side effects are rare and usually related to overdose.
Single cases of dizziness have been observed.
Side effects related to chlorphenamine

You should stop taking the medicine and immediately consult a doctor or go to the hospital if you experience an allergic reaction:

• hypersensitivity reactions (allergic reactions), anaphylactic reactions (severe allergic reactions, which may cause coughing, difficulty swallowing, rapid heartbeat, itching, swelling of the eyelids or eyes, face, tongue, dyspnea, fatigue, etc.);
• inhibition of the central nervous system in the form of drowsiness, nausea, and muscle weakness, which in some patients subsides after 2-3 days of treatment; this occurs frequently;
• bile duct obstruction (cholestasis), hepatitis, or other liver function disorders (including abdominal pain or stomach pain, dark urine, etc.); these occur rarely.

Other side effects include:

Frequent (may occur in less than 1 in 10 people):

• uncoordinated and involuntary muscle movements in the face (dyskinesia), coordination disorders (stiffness), tremors, numbness, tingling, burning, sensation of pinpricks (paresthesia);
• blurred or double vision;
• feeling of dryness in the nose and throat, drying of mucous membranes;
• feeling of dryness in the mouth, loss of appetite, changes in taste and smell, gastrointestinal disorders (nausea, vomiting, diarrhea, constipation, abdominal pain), which may decrease if the medicine is taken during meals;
• increased sweating;
• urinary retention and (or) difficulty urinating.

Rare (may occur in less than 1 in 1000 people):

• changes in blood tests (lack of granulocytes, decreased white blood cell count, anemia caused by bone marrow atrophy (aplastic anemia) or decreased platelet count (thrombocytopenia)) which may be accompanied by symptoms such as unusual bleeding, sore throat, or fatigue;
• photosensitivity, hypersensitivity to similar medicines;
• sometimes excitement, especially when taking large doses in children or the elderly, characterized by restlessness, insomnia, nervousness, hallucinations, palpitations, and seizures;
• tinnitus (unpleasant auditory sensations), acute labyrinthitis;
• usually, in case of overdose, there may be cardiac arrhythmias, palpitations, rapid heartbeat (tachycardia);
• hypotension, increased blood pressure, fluid accumulation in tissues (edema);
• chest tightness, difficulty breathing;
• erectile dysfunction in men (impotence), intermenstrual bleeding

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:
Jerozolimskie Avenue 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 this medicine.

5. How to store AntyGrypin COMPLEX

Do not store above 25°C.
Store in the original package, in order to protect from light and moisture.
The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and sachet.
The expiry date refers to the last day of the 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. Package contents and other information

What AntyGrypin COMPLEX contains

• The active substances of the medicine are paracetamol, ascorbic acid, and chlorphenamine maleate. Each sachet of effervescent granules contains: 500 mg of paracetamol (Paracetamolum), 200 mg of ascorbic acid (Acidum ascorbicum), 4 mg of chlorphenamine maleate (Chlorphenamini maleas).
• The other ingredients are: citric acid, sodium bicarbonate, sucrose, magnesium citrate, sodium cyclamate (E 952), sodium saccharin (E 954), lemon aroma (Tetrarome Lemon P 0551 987323: corn maltodextrin, flavoring ingredients (limonene, beta-pinene, citral, gamma-terpinene, linalool), alpha-tocopherol (E 307)).

What AntyGrypin COMPLEX looks like and what the package contains

The immediate packaging is sachets made of PAP/Aluminum/PE laminate. The immediate packaging is placed together with the leaflet in an outer cardboard packaging. The packaging contains 10 or 20 sachets.

Marketing authorization holder and manufacturer

Natur Produkt Pharma Sp. z o.o.
Podstoczysko 30
07-300 Ostrów Mazowiecka
tel. (+48) 29 644 29 00

Date of the last update of the leaflet: