AGRYPIN 325 mg/30 mg /10 Mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Agrypin
3. 325 mg + 30 mg + 10 mg,
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Agrypin and what is it used for
5. Important information before taking Agrypin
   1. When not to take Agrypin:
   2. Warnings and precautions
   3. Agrypin and other medicines
   4. Agrypin with food, drinks, and alcohol
   5. Pregnancy and breastfeeding
   6. Driving vehicles and operating machinery
   7. Agrypin contains 3.9 mg of lactose monohydrate in 1 coated tablet
6. How to take Agrypin
   1. Taking a higher dose of Agrypin than recommended
   2. Missing a dose of Agrypin
7. Possible side effects
   1. You should immediately stop taking Agrypin and seek medical help
8. How to store Agrypin
9. Contents of the packaging and other information
   1. What Agrypin contains
   2. What Agrypin looks like and what the packaging contains
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of the last leaflet update:

Leaflet attached to the packaging: information for the user

Agrypin

325 mg + 30 mg + 10 mg,

coated tablets
Paracetamol + Pseudoephedrine hydrochloride + Dextromethorphan hydrobromide

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

This medicine should always be used exactly as described in the 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 ask a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

• 1. What is Agrypin and what is it used for
• 2. Important information before taking Agrypin
• 3. How to take Agrypin
• 4. Possible side effects
• 5. How to store Agrypin
• 6. Contents of the packaging and other information

1. What is Agrypin and what is it used for

Agrypin contains three active substances: paracetamol, pseudoephedrine, and dextromethorphan. It has analgesic, antipyretic, and anti-inflammatory effects, reduces nasal congestion, and has an antitussive effect. Agrypin is intended for the treatment of adults and children over 6 years of age and adolescents. The indication for the use of Agrypin is the short-term treatment of symptoms of colds, flu, flu-like conditions, and sinusitis (fever, runny nose, cough, headache, sore throat, muscle and joint pain).

2. Important information before taking Agrypin

When not to take Agrypin:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if the patient is taking other medicines containing paracetamol;
• if the patient is taking MAO inhibitors (medicines used, among others, in depression), as well as within 2 weeks of stopping their use;
• if the patient has a congenital deficiency of glucose-6-phosphate dehydrogenase;
• if the patient has severe liver failure;
• if the patient has severe acute (sudden) or chronic (long-term) kidney disease or kidney failure;
• if the patient has very high blood pressure (severe hypertension) or uncontrolled hypertension;
• if the patient has coronary heart disease;
• if the patient has alcoholism;
• if the patient has asthma. Do not use during pregnancy and breastfeeding. Do not use in children under 6 years of age.

Warnings and precautions

Before starting Agrypin, you should consult a doctor or pharmacist. Pseudoephedrine, one of the active substances of Agrypin, can be abused, and high doses of pseudoephedrine can be toxic. Continuous use can lead to taking higher doses of Agrypin than the recommended dose to achieve the desired effect, which increases the risk of overdose. Do not take a dose higher than the recommended maximum dose or exceed the treatment duration (see section 3). Taking this medicine can lead to dependence. Therefore, treatment should be short-term. NOTE! The medicine contains paracetamol. Do not use simultaneously with medicines containing paracetamol. In case of overdose, contact a doctor immediately, even if no symptoms have occurred, as it may lead to life-threatening liver damage. Do not use Agrypin with medicines containing dextromethorphan, pseudoephedrine, or other sympathomimetics (such as medicines used to treat bronchospasm, e.g., in asthma, reducing nasal congestion, appetite suppressants, or psychostimulants with an effect similar to amphetamine).

• Taking the medicine by people with liver failure, alcohol abusers, and fasting individuals poses a risk of liver damage.
• Use with caution in patients with hypertension, cardiac arrhythmias, pulmonary emphysema, increased intraocular pressure, prostatic hyperplasia, hyperthyroidism, diabetes, and those taking anxiolytic, tricyclic antidepressant medications.
• The medicine should not be used in patients with kidney failure and in cases of chronic cough with expectoration. The medicine should not be used in patients with respiratory failure, asthma, or those at risk of respiratory failure.
• The medicine should be used with caution in people taking anticoagulant medications.
• You should consult a doctor even if the above warnings apply to past situations.

Before taking Agrypin, you should talk to a doctor or pharmacist:

• If the patient is taking such medicines as certain antidepressants or antipsychotics, Agrypin may interact with them, causing changes in mental state (e.g., excitement, hallucinations, coma) and other symptoms, such as body temperature above 38°C, increased heart rate, unstable blood pressure, and exaggerated reflexes, muscle stiffness, lack of coordination, and (or) symptoms related to the digestive system (e.g., nausea, vomiting, diarrhea).

During Agrypin use, sudden abdominal pain or rectal bleeding may occur due to inflammation of the colon (ischemic colitis). If such gastrointestinal symptoms occur, Agrypin use should be discontinued, and medical help should be sought immediately. See section 4. During Agrypin use, a decrease in blood flow in the optic nerve may occur. If sudden vision loss occurs, Agrypin use should be discontinued, and medical help should be sought immediately. See section 4. While taking Agrypin, you should immediately inform your doctor if the patient experiences 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 if the patient is also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a severe disease called metabolic acidosis (blood and body fluid disorder), when they took paracetamol in regular doses for a longer period or took paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling of nausea (nausea) and vomiting. After taking pseudoephedrine-containing medicines, cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported. PRES and RCVS are rare diseases that may be associated with reduced blood flow to the brain. If symptoms that may be symptoms of PRES or RCVS occur, Agrypin use should be discontinued immediately, and medical help should be sought immediately (symptoms, see section 4 "Possible side effects").

Agrypin and other medicines

You should tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. The interaction of Agrypin with other medicines results from the interaction of the active substances contained in the medicine: Paracetamol

• The medicine should not be used simultaneously with other medicines containing paracetamol.
• Medicines that accelerate gastric emptying (e.g., metoclopramide) accelerate paracetamol absorption, while medicines that delay its emptying (e.g., propanteline) may delay paracetamol absorption.
• Taking paracetamol simultaneously with MAO inhibitors (used in the treatment of, among others, depression) and within 2 weeks after stopping treatment with these medicines may cause a state of excitement and fever.
• Concomitant use of paracetamol with zidovudine (AZT, a medicine used in HIV infection) may enhance the toxic effect of zidovudine on the bone marrow.
• Paracetamol may enhance the effect of anticoagulant medicines (coumarin derivatives).
• Concomitant use of paracetamol and medicines that increase liver metabolism, i.e., certain sedatives or antiepileptic medicines, e.g., phenobarbital, phenytoin, carbamazepine, as well as rifampicin (used in the treatment of, among others, tuberculosis), may lead to liver damage, even when using the recommended paracetamol doses.
• Concomitant administration with chloramphenicol (a broad-spectrum antibacterial antibiotic) may increase chloramphenicol serum levels.
• You should inform your doctor or pharmacist if the patient is taking:
• flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which must be urgently treated (see section 2).
• 2).

Pseudoephedrine

• The medicine should not be used with other sympathomimetics (see "Warnings and precautions" above), as it may cause increased blood pressure.
• Concomitant use with albuterol (used, among others, in the treatment of asthma) may enhance the vasoconstrictive effect.
• Do not use simultaneously with amitriptyline (used, among others, in depression).
• Ammonium chloride prolongs the action of pseudoephedrine.
• Antacids (used to alleviate heartburn and indigestion) may increase pseudoephedrine absorption.
• MAO inhibitors (used in the treatment of depression) cause slower elimination of pseudoephedrine from the body and increase its bioavailability.
• Do not use simultaneously with furazolidone (an antibacterial medicine).
• Pseudoephedrine reduces the effect of antihypertensive medicines and may modify the effect of digitalis glycosides (used in heart failure).

Dextromethorphan

• Use with MAO inhibitors (medicines used in the treatment of depression) is contraindicated (see When not to take Agrypin).

Agrypin with food, drinks, and alcohol

During Agrypin use, you should not drink alcohol. Drinking alcohol during paracetamol treatment leads to liver cell necrosis and subsequent liver failure.

Pregnancy and breastfeeding

In pregnancy and breastfeeding or if there is a suspicion that the woman is pregnant or plans to become pregnant, Agrypin use should be consulted with a doctor or pharmacist. Agrypin use during pregnancy and breastfeeding is contraindicated.

Driving vehicles and operating machinery

Agrypin affects the ability to drive vehicles and operate machinery. You should be cautious while taking the medicine.

Agrypin contains 3.9 mg of lactose monohydrate in 1 coated tablet

The medicine contains lactose monohydrate. If the patient has been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medicine.

3. How to take Agrypin

This medicine should always be taken as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, you should consult a doctor or pharmacist. Agrypin should be taken orally. Adults and adolescents over 12 years of age: 1 to 2 tablets, 3-4 times a day. Do not take more than 8 tablets per day. Children 6 to 12 years of age: 1 tablet, 3-4 times a day. Do not take a dose higher than 4 tablets per day. If symptoms worsen or do not improve after 3 days, you should contact a doctor.

Taking a higher dose of Agrypin than recommended

In case of taking a higher dose of Agrypin than recommended, you should immediately consult a doctor or pharmacist. The medicine contains three active substances. Overdose symptoms may result from the action of one or all active substances. If the patient takes a higher dose of Agrypin than recommended, the following symptoms may occur: nausea and vomiting, involuntary muscle contractions, excitement, confusion, drowsiness, impaired consciousness, involuntary rapid eye movements, cardiac disorders (rapid heartbeat), coordination disorders, psychosis with visual hallucinations, and increased excitability (see section 4. Possible side effects). Other symptoms of a large overdose may include: coma, severe respiratory disorders, and seizures. Accidental or intentional overdose of the medicine may cause, within a few or several hours, additional symptoms such as: excessive sweating, general weakness, anxiety, tremors. Increased blood pressure, difficulty urinating, and shortness of breath may also occur. 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. If any of the above symptoms occur, you should immediately consult a doctor or go to the hospital. Treatment should be carried out in a hospital and involves accelerating the removal of the medicine's components from the body and maintaining vital functions. In case of paracetamol overdose, it may be necessary to administer an antidote: N-acetylcysteine and (or) methionine. Pseudoephedrine elimination can be accelerated by using forced diuresis or dialysis therapy. To counteract the toxic effect of dextromethorphan on the central nervous system, naloxone is used. Children and adolescents In case of overdose in children, severe side effects may occur, including neurological disorders. Caregivers should not administer a dose higher than recommended.

Missing a dose of Agrypin

Agrypin is intended for the short-term treatment of symptoms of colds, flu, and flu-like conditions. If a dose is missed and symptoms persist, the next dose of Agrypin should be taken. Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Agrypin can cause side effects, although not everybody gets them. Frequency not known: frequency cannot be estimated from the available data

• a serious disease that can cause blood acidification (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2);
• severe diseases affecting the blood vessels in the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).

You should immediately stop taking Agrypin and seek medical help

immediately, if symptoms occur that may indicate posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• severe headache with a sudden onset,
• nausea,
• vomiting,
• confusion,
• seizures,
• vision changes.

Uncommon side effects (occurring in 1 to 10 out of 1,000 patients taking the medicine):

• fatigue, dizziness;
• nausea and vomiting.

Rare side effects (occurring in 1 to 10 out of 10,000 patients taking the medicine):

• type I hypersensitivity reactions: allergic edema (i.e., edema of the skin and soft tissues, often on the face, e.g., lips, tongue, eyelids), anaphylactic reaction (i.e., shortness of breath, sweating, decreased blood pressure to shock symptoms);
• skin allergic reactions, redness of the skin, rash.

Very rare side effects (occurring less frequently than in 1 out of 10,000 patients taking the medicine):

• blood cell production disorders: granulocytopenia (decreased granulocyte count in the blood), agranulocytosis (lack of granulocytes in the blood), thrombocytopenia (decreased platelet count);
• asthma attack;
• liver damage, most often due to overdose;
• kidney colic, renal papillary necrosis, acute kidney failure, kidney stones;
• hallucinations.

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• drowsiness;
• rapid heartbeat (tachycardia);
• mild increase in blood pressure;
• urination disorders, urinary retention, especially in patients with prostatic hyperplasia;
• colon inflammation caused by insufficient blood flow (ischemic colitis);
• reduced blood flow in the optic nerve (ischemic optic neuropathy).

Reporting side effects If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products. Al. Jerozolimskie 181C, 02-222 Warsaw, phone: (22) 49 21 301, fax: (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 gather more information on the safety of the medicine.

5. How to store Agrypin

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after: "EXP". The expiry date refers to the last day of the month. Store in a temperature below 25°C, in the original packaging. Protect from light. Medicines should not be disposed of via wastewater or household waste. You should ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Agrypin contains

• The active substances of the medicine are paracetamol, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide. One Agrypin coated tablet contains 325 mg of paracetamol, 30 mg of pseudoephedrine hydrochloride, and 10 mg of dextromethorphan hydrobromide.
• The other ingredients are: microcrystalline cellulose, stearic acid, crospovidone, povidone K-25, colloidal silica, anhydrous.
• Coating: lactose monohydrate, hypromellose 6cP, titanium dioxide (E 171), macrogol 6000.

What Agrypin looks like and what the packaging contains

Agrypin is a white to light cream-colored, oblong, coated tablet with a dividing line on one side. The dividing line on the tablet is not intended for breaking the tablet. PVC/PVDC//Aluminum blisters contain 10, 12, 20, or 24 coated tablets, in a cardboard box.

Marketing authorization holder

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna ul. A. Fleminga 2 03-176 Warsaw Phone: 22 811-18-14

Manufacturer

Polfarmex S.A. ul. Józefów 9 99-300 Kutno Poland

Date of the last leaflet update: