Antigripin

Leaflet attached to the packaging: patient information

AntyGrypin,

500 mg + 150 mg + 50 mg, effervescent tablets

Acetylsalicylic acid + Ascorbic acid + Caffeine

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this 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 this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is AntyGrypin and what is it used for

AntyGrypin contains acetylsalicylic acid, vitamin C, and caffeine.
The medicine is indicated for short-term treatment of symptoms occurring in the course of a cold or flu
(fever, headache, muscle and joint pains).
Acetylsalicylic acid has analgesic, anti-inflammatory, and antipyretic effects.
Vitamin C supplements the increased demand for ascorbic acid that occurs during a cold or flu.
Caffeine, by its direct action on cerebral blood vessels, enhances the analgesic effect of acetylsalicylic acid in headaches associated with a cold or flu.
If after 3 days there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before taking AntyGrypin

When not to take AntyGrypin:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• in the case of active gastric and (or) duodenal ulcer disease and inflammatory conditions of the gastrointestinal tract;
• in the case of a tendency to bleed;
• in the case of acid-base balance disorders (e.g., in diabetes, uraemia);
• in patients with asthma, hay fever with nasal polyps caused by the administration of salicylates or substances with similar effects, especially non-steroidal anti-inflammatory drugs;
• in patients with renal failure;
• during pregnancy and breastfeeding;
• in patients with severe liver failure;
• in severe heart failure;
• in children and adolescents under 16 years of age;
• during concurrent use of methotrexate in doses of 15 mg per week or higher.

The medicine contains sorbitol, should not be taken by patients with hereditary fructose intolerance.

Warnings and precautions

Particular caution should be exercised when taking AntyGrypin, as:

• long-term use of acetylsalicylic acid may lead to interstitial nephritis and permanent kidney function impairment;
• AntyGrypin should not be used for more than 3 days without consulting a doctor;
• acetylsalicylic acid inhibits platelet aggregation, there is an increased risk of bleeding, especially when used concurrently with anticoagulant medications;
• acetylsalicylic acid reduces the excretion of uric acid from the body, which may lead to the occurrence of a gout attack in patients with reduced uric acid excretion;
• AntyGrypin belongs to a group of medicines that may adversely affect female fertility. This effect is transient and disappears after the end of therapy.

Taking medicines containing acetylsalicylic acid may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the medicine. Do not exceed the recommended dose and duration of treatment.
In the case of heart disease, a history of stroke, or suspected risk of these disorders, such as high blood pressure, diabetes, high cholesterol, smoking, consult your doctor or pharmacist.

AntyGrypin should be used with caution:

• in patients who have had gastric and (or) duodenal ulcer disease in the past;
• in patients with glucose-6-phosphate dehydrogenase deficiency (a congenital metabolic disorder);
• in the case of hypersensitivity to anti-inflammatory and anti-rheumatic drugs or other allergizing substances;
• in patients with hypertension (due to the caffeine content).

Children and adolescents

It is not recommended to use AntyGrypin in children and adolescents under 16 years of age.

AntyGrypin and other medicines

Acetylsalicylic acid contained in AntyGrypin increases the toxicity of methotrexate to the bone marrow.
It enhances the effect of anticoagulant medications (heparin, coumarin derivatives) and the effect of antidiabetic medications (insulin, sulfonylurea derivatives), as well as increases the concentration of digoxin in the blood.
Acetylsalicylic acid used concurrently with valproic acid increases the risk of bleeding.
It weakens the effect of diuretics (e.g., spironolactone, furosemide), the effect of medications that increase uric acid excretion used in the treatment of gout (e.g., sulfinpyrazone, benzbromarone), and reduces the effect of antihypertensive medications from the group of angiotensin-converting enzyme inhibitors (e.g., captopril, enalapril).
Concurrent use of acetylsalicylic acid and other non-steroidal anti-inflammatory drugs, e.g., ibuprofen, increases the risk of gastrointestinal mucosa damage and kidney function disorders.
During concurrent use of glucocorticosteroids (except for hydrocortisone in Addison's disease), there is an increased risk of gastrointestinal mucosa damage and bleeding.
Caffeine contained in AntyGrypin may enhance the effect of medications that stimulate the central nervous system and weaken the effect of sedative and hypnotic medications.
Antacids reduce the absorption of AntyGrypin.

AntyGrypin with food, drinks, and alcohol

AntyGrypin should be taken after a meal.
Drinking alcohol during the use of AntyGrypin increases the risk of gastrointestinal mucosa damage.

Pregnancy and breastfeeding

Both acetylsalicylic acid and caffeine contained in AntyGrypin pass through the placenta and into the breast milk of nursing mothers.
AntyGrypin should not be used during pregnancy or breastfeeding.

Driving vehicles and operating machinery

AntyGrypin does not affect the ability to drive vehicles or operate machinery.

AntyGrypin contains sodium, sorbitol (E 420), and glucose (a component of maltodextrin with flavor).

Sorbitol and glucose

The medicine contains 305.3 mg of sorbitol in each tablet. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or hereditary fructose intolerance, a rare genetic disorder in which the patient's body does not break down fructose, the patient should consult a doctor before taking the medicine.
If the patient has previously been diagnosed with intolerance to some sugars, the patient should consult a doctor before taking the medicine.

Sodium

The medicine contains 460.1 mg of sodium (the main component of common salt) in each tablet. This corresponds to 23.0% of the maximum recommended daily dose of sodium in the diet for adults. This should be taken into account in patients using a sodium-controlled diet.

3. How to take AntyGrypin

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
Recommended dose of AntyGrypin
Adults: 1 to 2 tablets at a time or several times a day (no more than 5 tablets per day).
Before taking the tablet, it should be dissolved in a glass of water. The medicine should be taken after a meal.
If the symptoms worsen or do not improve after 3 days, consult a doctor.

Use in children and adolescents

It is not recommended to use AntyGrypin in children and adolescents under 16 years of age.

Using a higher dose of AntyGrypin than recommended

The following may occur: rapid breathing, nausea, vomiting, headaches, dizziness, tinnitus, fever, excessive sweating, hives, decreased blood clotting, gastrointestinal bleeding, decreased blood glucose levels, acid-base balance disorders, coma, cardiogenic shock, respiratory failure, blood in the urine, seizures.
After an overdose of caffeine, symptoms of stimulation, hand tremors, heart rhythm disturbances, insomnia, anxiety, and concentration disorders are observed. In case of taking a higher dose of the medicine than recommended, consult a doctor or pharmacist immediately. Treatment of overdose involves gastric lavage and administration of activated charcoal. The doctor will monitor the parameters of acid-base balance and conduct general symptomatic treatment.

Missing a dose of AntyGrypin

AntyGrypin is used for the temporary treatment of cold or flu symptoms. If a dose is missed and the symptoms persist, the next dose of the medicine should be taken.
Do not take a double dose to make up for the missed tablet.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

• stomach pain, nausea, vomiting;
• obvious gastrointestinal bleeding in the form of coffee grounds vomiting and black stools or hidden gastrointestinal bleeding, which may lead to iron deficiency anemia;
• ulceration of the gastric or duodenal mucosa, perforation;
• rare hypersensitivity reactions: hives, skin reactions, angioedema, asthma attack;
• rarely: decreased platelet count, blood coagulation disorders, prolonged bleeding time;
• transient increase in liver enzyme activity (aminotransferases);
• excessive sweating, dizziness, tinnitus - usually symptoms of overdose;
• uric acid stones, renal colic, renal papillary necrosis, acute renal failure;
• insomnia, anxiety, headaches, and dizziness related to caffeine contained in the medicine.

In connection with the treatment of NSAIDs (non-steroidal anti-inflammatory drugs), edema, hypertension, and heart failure have been reported.
Taking medicines such as AntyGrypin may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, inform 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
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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

Store in a temperature below 25 °C.
The medicine should be stored in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and tablet container.
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 that are no longer needed. This will help protect the environment.

6. Package contents and other information

What AntyGrypin contains

• The active substances of the medicine are: acetylsalicylic acid, ascorbic acid (vitamin C), caffeine. Each effervescent tablet contains 500 mg of acetylsalicylic acid, 150 mg of ascorbic acid, and 50 mg of caffeine.
• The other ingredients are: sodium bicarbonate, anhydrous citric acid, sorbitol (E 420), corn starch, povidone, sodium cyclamate, sodium saccharin, lemon flavor (Tetrarome Lemon P 0551 987323): corn maltodextrin, flavoring ingredients, alpha-tocopherol (E 307), quinoline yellow (E 104).

What AntyGrypin looks like and what the package contains

The medicine is in the form of effervescent tablets.
10 or 20 effervescent tablets in 1 or 2 polypropylene containers with a polyethylene cap containing silica gel, in a cardboard box.

Marketing authorization holder and manufacturer

Natur Produkt Pharma Sp. z o.o.
Podstoczysko 30
07-300 Ostrów Mazowiecka
Poland
Phone: +48 29 644 29 00

Date of last revision of the leaflet: