Antigripin Complex

PATIENT INFORMATION LEAFLET: USER INFORMATION

AntyGrypin COMPLEX

500 mg + 200 mg + 4 mg, effervescent tablets
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 information leaflet or as advised by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days for fever and 5 days for pain, no improvement occurs or you feel worse, you should consult a 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. Contents of the pack 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 secretion, inhibits sneezing and tearing, and ascorbic acid, which supplements vitamin C deficiency in the body.
This medicine is used for the temporary treatment of flu, cold and flu-like conditions, such as headache, fever, sore throat, and nasal and throat congestion in adults and adolescents over 15 years of age.
If after 3 days for fever and 5 days for 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 glaucoma with a narrow angle of filtration;
• 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 to treat 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, 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 for fever and 5 days for pain, you should consult a doctor.
In case of taking this medicine in higher doses than recommended and in case of prolonged treatment, there may be a risk of dependence, mainly psychological.

The medicine contains paracetamol

Due to the risk of overdose, you should check if other medicines you are taking contain paracetamol. Overdose of paracetamol can lead to severe liver damage and even death.
To avoid the risk of overdose, do not take other medicines containing paracetamol. The risk of overdose of this medicine increases in patients with liver disease.
Caution should be exercised when using in patients with reduced glutathione levels.
There have been reports of liver failure in patients with reduced glutathione levels, especially in patients:

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

During treatment with AntyGrypin COMPLEX, you should immediately inform your doctor if you have severe diseases, including severe kidney or liver disorders or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic).
In these situations, patients have been reported to have a severe disease called metabolic acidosis (blood and 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, nausea (nausea) and vomiting.
Precautions
Paracetamol should be used with caution in patients with kidney disorders, acute hepatitis, glucose-6-phosphate dehydrogenase deficiency, hemolytic anemia, and methemoglobin reductase deficiency.
The risk of overdose of this medicine is higher in patients with non-alcoholic liver failure.
Paracetamol taken in doses greater than 6-8 g per day may damage the liver.
Liver damage can occur even at much lower doses, during concomitant administration with alcohol, liver enzyme inducers, or other medicines toxic to the liver, such as monoamine oxidase inhibitors (see section "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.
During treatment with this medicine, due to the content of chlorphenamine, you should avoid consuming alcohol and medicines containing alcohol. The medicine may affect the ability to drive vehicles and operate machinery.
Caution should be exercised in patients with asthma, chronic obstructive pulmonary disease, cardiovascular disease, hypertension, hyperthyroidism, and pyloric stenosis.
During treatment, you should avoid taking sedatives (especially barbiturates), which enhance the sedative effect of antihistamines.
Effect on laboratory test results
Administration of paracetamol may affect the results of blood uric acid tests, 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

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
During treatment with AntyGrypin COMPLEX, you should avoid taking medicines containing alcohol.
Caution should be exercised when taking:

• opioid derivatives (painkillers, antitussives, and replacement therapy),
• neuroleptics (medicines used to treat mental disorders, mainly schizophrenia and other psychoses),
• barbiturates (sleeping pills and used to treat epilepsy),
• benzodiazepines (medicines with anxiolytic, sedative, hypnotic, anticonvulsant, and muscle relaxant effects),
• anxiolytics other than benzodiazepines (e.g., meprobamate),
• sleeping pills (lorazepam, diazepam),
• antidepressants with a sedative effect (amitriptyline, doxepin, mianserin,

mirtazapine, trimipramine),

• antihistamines blocking the H receptor (medicines used to treat allergic diseases),
• antihypertensive medicines with a central nervous system effect,
• baclofen (a muscle relaxant),
• thalidomide (a medicine that affects the immune system, used to treat multiple myeloma),
• anticholinergic antiparkinsonian medicines (such as benzatropine),
• medicines similar to atropine with a spasmolytic effect (containing hyoscine),
• dyzopiramid (a medicine used to treat heart diseases),
• neuroleptics from the phenothiazine derivative group (medicines used to treat psychoses, such as chlorpromazine, thioridazine, perphenazine),
• clozapine (a medicine used to treat schizophrenia and mental disorders in Parkinson's disease),
• salicylamide (a painkiller),
• rifampicin (an antibiotic),
• antiepileptic medicines (e.g., phenytoin, carbamazepine, lamotrigine, and others),
• sleeping pills from the barbiturate group and other liver enzyme inducers,
• caffeine,
• non-steroidal anti-inflammatory medicines (aspirin, ibuprofen, diclofenac, naproxen),
• anticoagulant medicines from the coumarin group (acenocoumarol, warfarin),
• monoamine oxidase inhibitors (medicines used to treat depression),
• fluphenazine (a medicine used to treat psychosis).

Tell your doctor or pharmacist if you are taking:

• flucloxacillin (an antibiotic), due to the serious risk of blood and fluid disorders (called metabolic acidosis), which must be treated urgently (see section 2).

Using AntyGrypin COMPLEX with food, drinks, and alcohol

During treatment with 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, ask your doctor or pharmacist for advice 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 using machines

During treatment, drowsiness may occur, affecting the psychophysical fitness of drivers and machine operators.

AntyGrypin COMPLEX in effervescent tablet form contains sodium, isomalt, and glucose (a component of maltodextrin with flavor)

Isomalt and glucose (a component of maltodextrin with flavor)

One effervescent tablet contains 799 mg of isomalt, which corresponds to approximately 1.8 kcal (7.8 kJ).
If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

Sodium

Each effervescent tablet contains 254.5 mg (11.06 mmol) of sodium. This corresponds to 12.7% of the maximum recommended daily intake of sodium in the diet for adults. This should be taken into account in patients on a controlled sodium diet.

3. How to take AntyGrypin COMPLEX

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

Do not take the medicine in case of severe kidney disorder (see section "When not to take AntyGrypin COMPLEX").
Patients with liver disorders
In patients with liver disorders or Gilbert's syndrome, the dose of the medicine should be reduced or the intervals between doses prolonged.
Do not take the medicine in case of severe liver disorder (see section "When not to take AntyGrypin COMPLEX").
Elderly patients
In elderly patients with normal kidney function, the dosage is the same as for adults.
Children and adolescents under 15 years:
Do not use this medicinal product in children under 15 years of age.
Method of administration
Oral administration.
The effervescent tablet 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 for fever and 5 days for pain without consulting a doctor.

Taking a higher dose of AntyGrypin COMPLEX than recommended

In case of taking a higher dose of the medicine than recommended, immediately consult a doctor or go to the hospital, even if you feel well.
Symptoms related to chlorphenamine maleate
Overdose of chlorphenamine may cause: seizures (especially in children), disorders of 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 be fatal. Overdose of the medicine may cause symptoms within a few to several hours, such as: nausea, vomiting, excessive sweating, drowsiness, and general weakness. 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. 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, vomiting should be induced if it has not been more than an hour since taking the medicine. 60-100 g of activated charcoal should be given orally, preferably mixed with water.
Treatment of AntyGrypin COMPLEX overdose should be carried out in a hospital.

Missing a dose of AntyGrypin COMPLEX

Do not take a double dose to make up for a missed dose.
In case of any further doubts about the use of this medicine, 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:

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

• throat swelling, 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 reaction: toxic epidermal necrolysis (Lyell's syndrome), bullous erythema multiforme (Stevens-Johnson syndrome), acute generalized exanthematous pustulosis with a rash and pustules all over the body, erosions in the mouth, eyes, genitals, and skin, red spots on the torso, often with blisters in the center, large blisters bursting, exfoliation of large skin flakes, weakness, fever, and joint pain (very rare cases);
• persistent itching of the skin (pruritus), skin rash, excessive sweating, appearance of skin eruptions, hemorrhagic or vesicular (urticaria); these occur rarely;
• acute or chronic pancreatitis, bleeding, abdominal pain, diarrhea, nausea, vomiting, liver dysfunction (liver failure), irreversible liver damage (necrosis); 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).

Frequency not known

A serious condition that can cause blood acidification (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).
Paracetamol is a commonly used medicine, and the described side effects are rare and usually related to overdose.
There have been reports of dizziness.
Side effects related to chlorphenamine

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

• hypersensitivity reactions (allergic), anaphylactic reactions (severe allergic reactions during which cough, swallowing difficulties, rapid heartbeat, itching, swelling of the eyelids or eyes, face, tongue, shortness of breath, fatigue, etc. may occur);
• central nervous system depression in the form of drowsiness, nausea, and muscle weakness, which in some patients resolve 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):

• involuntary and uncontrolled facial muscle movements (dyskinesia), coordination disorders (stiffness), tremors, numbness, tingling, burning sensation, feeling like pinching with needles (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):

• blood test changes (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;
• ringing in the ears (unpleasant auditory sensations), acute labyrinthitis;
• usually, in case of overdose, cardiac rhythm disorders, palpitations, rapid heartbeat (tachycardia) may occur;
• hypotension (low blood pressure), increased blood pressure (hypertension), fluid accumulation in tissues (edema);
• chest tightness, shortness of breath;
• erectile dysfunction in men (impotence), intermenstrual bleeding.

Reporting side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring 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.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and tube. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What AntyGrypin COMPLEX contains

• The active substances of the medicine are paracetamol, ascorbic acid, and chlorphenamine maleate. Each effervescent tablet contains: 500 mg of paracetamol (Paracetamolum), 200 mg of ascorbic acid (Acidum ascorbicum), 4 mg of chlorphenamine maleate (Chlorphenamini maleas).
• Other ingredients are: citric acid, sodium bicarbonate, isomalt (E 953), macrogol 6000, sodium saccharin (E 954), lemon flavor (Tetrarome Lemon P 0551 987323: corn maltodextrin, flavoring ingredients (limonene, beta-pinene, citral, gamma-terpinene, linalool), alpha-tocopherol (E 307)), magnesium stearate.

What AntyGrypin COMPLEX looks like and contents of the pack

White to off-white, round, flat tablet with beveled edges and a line on one side. The line on the tablet is only to facilitate breaking, not to divide into equal doses.
The immediate packaging is a cylindrical, white polypropylene container with a white polyethylene cap containing a desiccant. The immediate packaging is placed together with the leaflet in an outer cardboard packaging. The outer packaging contains 10 (1 container) or 20 (2 containers) effervescent tablets.

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 last revision of the leaflet: