Antigrypin complex

AntyGrypin COMPLEX
500 mg + 200 mg + 4 mg, effervescent granules
Paracetamolum + Acidum ascorbicum + Chlorphenamini maleas
Please read this 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
physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your physician or pharmacist. See section 4.
• If there is no improvement after 3 days of treating fever or 5 days of treating pain, or if the patient feels worse, consult a physician.

Table of contents:

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

AntyGrypin COMPLEX is a combination medicine containing three active substances: paracetamol,
which has analgesic and antipyretic effects; chlorphenamine maleate, which reduces mucus secretion from the nose, suppresses sneezing reflex and eye tearing; and ascorbic acid, which replenishes vitamin C deficiency in the body.
This medicine is used for the short-term relief of symptoms of influenza, colds and flu-like conditions, such as headache, fever, sore throat, and nasal and throat catarrh in adults and adolescents over 15 years of age.
If there is no improvement after 3 days of treating fever or 5 days of treating pain, or if the patient feels worse, consult a physician.

2. Important information before taking AntyGrypin COMPLEX

When not to take AntyGrypin COMPLEX:

• if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• if the patient suffers from liver or kidney failure;
• if the patient is taking other medicines affecting liver function;
• if the patient abuses alcohol;
• if the patient suffers from narrow-angle glaucoma;
• in patients at risk of urinary retention associated with disorders of the urethral segment passing through the prostate gland;
• in patients currently or within the last two weeks taking monoamine oxidase inhibitors (MAOIs, used in the treatment of depression);
• in children and adolescents under 15 years of age.

Warnings and precautions
Before starting treatment with AntyGrypin COMPLEX, consult a doctor or pharmacist.
Warnings
If high or persistent fever occurs, bacterial superinfection develops, or symptoms persist for more than 3 days in case of fever and 5 days in case of pain, contact a doctor.
When using this medicine at doses higher than recommended or for prolonged treatment, there is a risk of dependence, mainly psychological.
To avoid the risk of overdose, do not take other medicines containing paracetamol. The risk of overdose with this medicine is increased in patients with liver disease.
Caution is advised when using in patients with reduced glutathione levels.
Cases of liver failure have been reported in patients with reduced glutathione levels, especially in patients who are:

• severely undernourished, suffering from anorexia, with low body mass index (BMI), or cachexia;
• dehydrated;
• regular alcohol drinkers (see section "When not to take AntyGrypin COMPLEX");
• with mild to moderate liver impairment or Gilbert's syndrome (familial non-hemolytic jaundice);
• with sepsis.

Paracetamol use may increase the risk of metabolic acidosis. Symptoms of metabolic acidosis include: deep, rapid, labored breathing, nausea, vomiting, and loss of appetite. Contact a doctor immediately if these symptoms occur together.
Precautions
Paracetamol should be used with caution in patients with renal dysfunction, acute hepatitis, glucose-6-phosphate dehydrogenase deficiency, hemolytic anemia, and methemoglobin reductase deficiency.
The risk of overdose with this medicine is higher in patients with liver failure not caused by alcoholic cirrhosis.
Paracetamol administered in doses exceeding 6–8 g per day may cause liver damage.
Liver damage may occur even at significantly lower doses when administered concomitantly with alcohol, liver enzyme inducers, or other medicines toxic to the liver, e.g., monoamine oxidase inhibitors (see section "When not to take AntyGrypin COMPLEX").
Long-term alcohol consumption greatly increases the risk of paracetamol-induced hepatotoxicity.
Due to the risk of hypertensive crisis, paracetamol is contraindicated in patients currently or within the last two weeks taking monoamine oxidase inhibitors (MAOIs).
During treatment with this medicine, due to the presence of chlorphenamine, alcohol and alcohol-containing medicines should be avoided. The medicine may affect the ability to drive vehicles and operate machinery.
Caution is advised in patients with bronchial asthma or chronic obstructive pulmonary disease, cardiovascular diseases, arterial hypertension, hyperthyroidism, and pyloroduodenal obstruction.
During treatment, avoid using sedatives (especially barbiturates), which may enhance the sedative effect of antihistamines.
Effect on laboratory test results
Administration of paracetamol may affect blood uric acid and blood glucose test results.
Chlorphenamine may interfere with 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
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
During treatment with AntyGrypin COMPLEX, avoid taking medicines containing alcohol.
Inform your doctor or pharmacist if the patient is taking:

• flucloxacillin (an antibiotic), due to a serious risk of blood and body fluid disorders (metabolic acidosis with high anion gap), which requires urgent treatment and may occur particularly in patients with severe renal impairment, sepsis (a condition where bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, and in patients taking maximum daily doses of paracetamol.

Use with caution when taking:

• morphine derivatives (analgesics, antitussives, and substitution therapies);

• neuroleptics (medicines used to treat psychiatric disorders, mainly schizophrenia and other psychoses);

• barbiturates (sleeping medicines and antiepileptics);

• benzodiazepines (medicines with anxiolytic, sedative, hypnotic, anticonvulsant, and muscle-relaxant effects);

• non-benzodiazepine anxiolytics (e.g., meprobamate);

• hypnotics (lorazepam, diazepam);

• sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine);

• H-receptor blocking antihistamines (medicines used in the treatment of allergic diseases);

• antihypertensive medicines acting on the central nervous system;

• baclofen (a muscle relaxant);

• thalidomide (an immunomodulatory medicine used in the treatment of multiple myeloma);

• anticholinergic antiparkinsonian drugs (e.g., benztropine);

• antispasmodic medicines with atropine-like effects (containing hyoscine);

• disopyramide (a medicine used in heart diseases);

• phenothiazine derivative neuroleptics (medicines used in the treatment of psychoses, such as chlorpromazine, thioridazine, perphenazine);

• clozapine (a medicine used in the treatment of schizophrenia and psychiatric disorders in Parkinson's disease);

• salicylamide (an analgesic);

• rifampicin (an antibiotic);

• antiepileptic medicines (e.g., phenytoin, carbamazepine, lamotrigine, and others);

• barbiturate hypnotics and other liver enzyme-inducing medicines;

• caffeine;

• non-steroidal anti-inflammatory drugs (aspirin, ibuprofen, diclofenac, naproxen);

• coumarin anticoagulants (acenocoumarol, warfarin);

• monoamine oxidase inhibitors (medicines used in the treatment of depression);

• fluphenazine (a medicine used in the treatment of psychosis).

Taking AntyGrypin COMPLEX with food, drink, and alcohol
During treatment with AntyGrypin COMPLEX, avoid consuming alcohol, as it may cause liver damage and excessive sedation.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Use of AntyGrypin COMPLEX is not recommended during pregnancy.
Breastfeeding
Use of AntyGrypin COMPLEX is not recommended during breastfeeding.
Fertility
Animal studies have not shown harmful effects of paracetamol, chlorphenamine maleate, or ascorbic acid on fertility.

Driving and operating machinery
Drowsiness may occur during treatment, which may affect the psycho-physical performance of people driving vehicles or operating machinery.

AntyGrypin COMPLEX effervescent granules contain sucrose and glucose
(maltodextrin component with flavoring).
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.
The medicine contains 3156 mg of sucrose per sachet. This should be taken into account in patients with diabetes.

AntyGrypin COMPLEX effervescent granules contain sodium.
The medicine contains 88.8 mg of sodium (main component of table salt) per sachet. This corresponds to 4.5% of the maximum recommended daily sodium intake in the diet of adults.

3. How to take AntyGrypin COMPLEX

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Use in adults and adolescents over 15 years of age:
The recommended dose is: if necessary, the contents of 1 sachet taken 30 minutes before bedtime. Do not use more than the contents of 3 sachets per day in divided doses, and doses should not be repeated more frequently than every 4 hours.
Patients with impaired kidney function
In patients with impaired kidney function, the dose of paracetamol must not exceed 500 mg:

Do not use the medicine in case of severe impairment of kidney function (see section “When not to
take AntyGrypin COMPLEX”).
Patients with liver function disorders
In patients with impaired liver function or Gilbert's syndrome, the dose of the medicine should be
reduced or the intervals between doses prolonged.
Do not use the medicine in case of severe impairment of liver function (see section “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
For oral use.
The effervescent granulate should be dissolved in a glass of cold or warm water.
Duration of treatment
This medicine should not be used for longer than 3 days in case of fever and 5 days in case of pain
without consulting a physician.
Overdose of AntyGrypin COMPLEX
Symptoms related to chlorphenamine maleate
Overdose of chlorphenamine may cause: seizures (especially in children), disturbances of
consciousness, coma.
Symptoms related to paracetamol
There is a particular risk of paracetamol poisoning in elderly people and young children (most
common causes are intake of doses higher than recommended and accidental poisoning); such
poisoning may lead to death. Overdose may cause symptoms within several to several dozen hours,
such as nausea, vomiting, excessive sweating, drowsiness, and general weakness. These symptoms
may subside the next day, despite the onset of liver damage, which subsequently manifests as
epigastric discomfort, recurrence of nausea, and jaundice. Ingestion of more than 10 g of
paracetamol in adults or 150 mg/kg body weight as a single dose in children causes complete and
irreversible necrosis of liver cells. In every case of ingestion of a single dose of paracetamol equal
to or exceeding 5 g, vomiting should be induced if less than one hour has passed since ingestion.
Oral administration of 60–100 g of activated charcoal, preferably mixed with water, should be
given.
In case of ingestion of a higher than recommended dose of the medicine, seek immediate medical
advice.
Missed dose of AntyGrypin COMPLEX
Do not take a double dose to make up for a missed dose.
If you have any further questions regarding the use of this medicine, consult your doctor or
pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects associated with paracetamol:
You should stop taking the medicine and consult a doctor immediately or go to
hospital if the following occur:

• swelling of the larynx, making breathing impossible (single cases);
• anaphylactic shock, manifested by confusion, pale skin, drop in blood pressure, sweating, low urine output, 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 characterized by blistering rash all over the body, erosions in the oral cavity, eyes, genital organs and on the skin, red spots on the trunk, often with blisters in the center, bursting giant blisters, peeling off large sheets of epidermis, weakness, fever, and joint pain (very rare cases);
• persistent skin itching (pruritus), skin rash, excessive sweating, appearance of nodular, hemorrhagic or vesicular skin lesions (purpura), allergic reaction causing swelling of tissues beneath the skin (angioedema), allergic reaction causing blister formation on the skin (urticaria); occur rarely;
• acute or chronic pancreatitis, bleeding, abdominal pain, diarrhea, nausea, vomiting, impaired liver function (liver failure), irreversible liver damage (necrosis), yellowing of the skin, mucous membranes and whites of the eyes (jaundice); occur rarely.

Other adverse effects include:
Rare (may occur in no more than 1 in 1,000 people):

• anemia due to various deficiencies, bone marrow suppression, decreased platelet count;
• fluid accumulation in tissues (edema);
• kidney dysfunction (nephropathy) and impaired reabsorption or secretion in renal tubules (tubulopathies).

Paracetamol is a commonly used medicine, and the described adverse effects are rare and usually
associated with overdose.
Isolated cases of dizziness have been observed.
Adverse effects associated with chlorphenamine
You should stop taking the medicine and consult a doctor immediately or go to
hospital if an allergic reaction occurs:

• hypersensitivity reactions (allergic), anaphylactic reactions (severe allergic reactions, during which coughing, difficulty swallowing, rapid heartbeat, itching, swelling of eyelids or around the eyes, face, tongue, shortness of breath, fatigue, etc. may occur);
• central nervous system depression manifesting as drowsiness, nausea, and muscle weakness, which in some patients resolve after 2–3 days of treatment; occurs frequently;
• blockage of bile ducts (cholestasis), liver inflammation or other liver function disorders (including upper abdominal pain or abdominal pain, dark urine color, etc.); occur rarely.

Other adverse effects include:
Frequent (may occur in no more than 1 in 10 people):

• uncoordinated and involuntary muscle movements in the face (dyskinesias), coordination disorders (rigidity), tremors, numbness, tingling, burning sensation, feeling like being pricked by needles (paresthesias);
• blurred or double vision;
• sensation of dryness in the nose and throat, drying of mucous membranes;
• dry mouth, loss of appetite, changes in taste and smell perception, gastrointestinal disturbances (nausea, vomiting, diarrhea, constipation, upper abdominal pain), which may decrease if the medicine is taken during a meal;
• excessive sweating;
• urinary retention and (or) difficulty in urination.

Rare (may occur in no more than 1 in 1,000 people):

• changes in blood tests (agranulocytosis, decreased white blood cell count, anemia due to bone marrow atrophy (aplastic anemia), or decreased platelet count (thrombocytopenia)), which may present with symptoms such as unusual bleeding, sore throat, or fatigue;
• light sensitivity, hypersensitivity to similar medicines;
• occasionally excitement, particularly when high doses are used in children or elderly people, characterized by restlessness, insomnia, nervousness, delirium, palpitations, and also convulsions;
• tinnitus (unpleasant auditory sensations), acute labyrinthitis;
• usually in cases of overdose, heart rhythm disturbances, palpitations, rapid heartbeat (tachycardia) may occur;
• low blood pressure (hypotension), increased blood pressure (hypertension), fluid accumulation in tissues (edema);
• chest tightness, labored breathing;
• inability to engage in sexual intercourse in men (impotence), intermenstrual bleeding.

Reporting of adverse effects
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, you should inform your doctor, pharmacist, or nurse. Adverse effects
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse effects can also be reported to the marketing authorization holder. By reporting
adverse effects, more information on the safety of the medicine can be collected.

5. How to store AntyGrypin COMPLEX

Do not store above 25°C.
Store in the original tightly closed packaging, protected 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 sachet.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What AntyGrypin COMPLEX contains

• The active substances in this medicine are paracetamol, ascorbic acid and chlorphenamine maleate. Each effervescent granulate sachet contains: 500 mg of paracetamol ( Paracetamolum ), 200 mg of ascorbic acid ( Acidum ascorbicum ), 4 mg of chlorphenamine maleate ( Chlorphenami\ maleas ).
• Other ingredients are: citric acid, sodium hydrogen carbonate, sucrose, magnesium citrate, sodium cyclamate (E 952), sodium saccharin (E 954), lemon flavour (Tetrarome Lemon P 0551 987323: corn maltodextrin, flavouring components (limonene, beta-pinene, citral, gamma-terpinene, linalool), alpha tocopherol (E 307)).

What AntyGrypin COMPLEX looks like and contents of the pack
The immediate packaging consists of sachets made of PAP/Aluminium/PE laminate. The immediate packaging is placed together with the leaflet in an outer cardboard box. The pack contains 10 or 20 sachets.
Marketing authorisation holder and manufacturer
Natur Produkt Pharma Sp. z o.o.
ul. Podstoczysko 30
07-300 Ostrów Mazowiecka
tel. (+48) 29 644 29 00