PARAMAX 500 mg Powder

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Paramax Quick, 500 mg, powder for oral solution, in a sachet
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Paramax Quick and what is it used for
4. Important information before taking Paramax Quick
   1. When not to take Paramax Quick
   2. Warnings and precautions
   3. Paramax Quick and other medicines
   4. The patient should consult a doctor when taking the following medicines:
   5. Paramax Quick with food, drinks, and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. What Paramax Quick contains
5. How to take Paramax Quick
   1. Taking a higher dose of Paramax Quick than recommended
   2. Missing a dose of Paramax Quick
6. Possible side effects
   1. The patient should stop taking the medicine and consult a doctor immediately if they experience:
   2. Reporting side effects
7. How to store Paramax Quick
8. Contents of the packaging and other information
   1. What Paramax Quick contains
   2. What Paramax Quick looks like and what the packaging contains
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:

Leaflet attached to the packaging: information for the user

Paramax Quick, 500 mg, powder for oral solution, in a sachet

Paracetamol

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 directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 5 days for pain and 3 days for fever there is no improvement or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

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

1. What is Paramax Quick and what is it used for

Paramax Quick is a powder in sachets for the preparation of a hot oral solution. The active substance of the medicine is paracetamol, which has analgesic and antipyretic effects. Paramax Quick is used for the short-term treatment of mild or moderate pain (headache, muscle and joint pain, toothache, and menstrual cramps) and fever in the course of a cold and flu. The medicine is intended for use in adults and adolescents over 12 years of age.

2. Important information before taking Paramax Quick

When not to take Paramax Quick

• if the patient is allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6).
• if the patient has severe liver failure.

Warnings and precautions

Before starting to take Paramax Quick, the patient should discuss it with their doctor or pharmacist if:

• the patient has reduced kidney function
• the patient has reduced liver function (including Gilbert's syndrome, a mild form of jaundice)
• the patient has a deficiency of glucose-6-phosphate dehydrogenase (an enzyme deficiency)
• the patient has hemolytic anemia (abnormal breakdown of red blood cells).

While taking Paramax Quick, the patient should immediately inform their doctor if:

• the patient has severe diseases, including severe kidney or liver disorders, sepsis (when bacteria and their toxins are present in the blood, leading to organ damage), malnutrition, chronic alcoholism, or is taking flucloxacillin (an antibiotic). There have been reports of a serious disease called metabolic acidosis (a blood and fluid disorder) in patients who have taken paracetamol regularly for a long time or have taken paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

Do not exceed the daily dose of the medicine given in section 3. Higher doses than recommended do not ensure stronger analgesic effects; they can cause very severe liver damage. Symptoms of liver damage usually appear within a few days. In case of overdose of Paramax Quick, the patient should immediately contact a doctor, even if they have no symptoms of overdose. Do not take any other products containing paracetamol with Paramax Quick, due to the risk of exceeding the maximum daily dose of paracetamol. When taking Paramax Quick, before taking other medicines, the patient should check their composition. Generally, habitual use of painkillers, especially the combination of several painkillers, can lead to permanent kidney damage with a risk of kidney failure. Without a doctor's recommendation, patients who abuse alcohol or have liver damage should not take Paramax Quick, and the medicine should not be used simultaneously with alcohol consumption. The sedative effect of alcohol is not increased by adding Paramax Quick. The patient should avoid drinking alcohol while taking this medicine. Paramax Quick should be used with caution if the patient is malnourished or dehydrated. Caution should be exercised in patients with asthma, sensitive to acetylsalicylic acid, as mild bronchospasm (a cross-reaction) has been reported during paracetamol use. Long-term treatment with painkillers taken every other day or more frequently may cause or worsen headache. Headache caused by painkiller abuse should not be treated by increasing the dose. In such cases, the patient should stop taking painkillers in consultation with a doctor.

Paramax Quick and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Do not take Paramax Quick with other medicinal products containing paracetamol. There is a risk of exceeding the maximum daily dose of paracetamol.

The patient should consult a doctor when taking the following medicines:

• anticoagulant medicines (e.g., warfarin). Occasional doses of Paramax Quick do not have a significant effect on bleeding tendency. However, the patient should contact their doctor in case of frequent use of Paramax Quick.
• metoclopramide, domperidone (used against nausea and vomiting).
• cholestyramine (in the treatment of, e.g., high cholesterol levels). Medicines should be taken at least 1 hour apart. probenecid (in the treatment of gout).
• carbamazepine, phenytoin, phenobarbital (in the treatment of epilepsy).
• rifampicin and isoniazid (antibiotics used in the treatment of tuberculosis).
• common horsetail (a herbal medicinal product).
• chloramphenicol (an antibiotic) administered by injection.
• flucloxacillin (an antibiotic) due to the serious blood and fluid disorder (called metabolic acidosis), which requires emergency treatment (see section 2).

Paramax Quick with food, drinks, and alcohol

The patient should avoid consuming alcoholic beverages while taking this medicine. Concurrent use of alcohol and paracetamol may cause severe liver damage.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine. Paramax Quick can be used during pregnancy if justified. The patient should take the lowest possible dose that reduces pain and (or) fever, for the shortest possible time, and as infrequently as possible. The patient should consult a doctor if pain and (or) fever do not decrease or if they need to take the medicine more frequently. Paracetamol passes into breast milk in small amounts. This medicine can be used during breastfeeding. The patient should not exceed the recommended daily dose stated in this leaflet.

Driving and using machines

Paramax Quick has no or negligible influence on the ability to drive and use machines.

What Paramax Quick contains

• Mannitol, where the medicine may have a mild laxative effect
• Xylitol (1665 mg per sachet), where the medicine may have a laxative effect. Energy value 2.4 kcal/g xylitol

3. How to take Paramax Quick

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult a doctor or pharmacist. If pain persists for more than 5 days or fever lasts for more than 3 days or worsens, the patient should contact a doctor. Warning! Overdose of paracetamol may lead to severe liver damage. The patient should not exceed the daily dose stated below. The patient should always use the smallest possible dose that reduces pain and (or) fever and use it for the shortest possible time. The recommended dose is: Adults and adolescents over 12 years of age:Patients with a body weight of 34-60 kg: 1 sachet every 4-6 hours as needed. The maximum daily dose is 4 sachets in 24 hours (2000 mg of paracetamol in 24 hours). Patients with a body weight over 60 kg: 1-2 sachets every 4-6 hours as needed. The maximum daily dose is 6 sachets in 24 hours (3000 mg of paracetamol in 24 hours). The patient should leave at least 4 hours between doses. Children under 12 years of age and adolescents with a body weight below 34 kg:This product should not be used in children under 12 years of age and adolescents with a body weight below 34 kg, as the dose is not recommended for this age group and (or) body weight. Patients with kidney or liver disordersIn patients with liver or kidney disorders, the dose must be reduced or the intervals between doses extended. Before taking this medicine, the patient should consult a doctor. Method of administration: The contents of the sachet should be dissolved in a cup or mug of hot, but not boiling, water and stirred well. The solution should be drunk within 30 minutes.

Taking a higher dose of Paramax Quick than recommended

Overdose of paracetamol is potentially fatal due to irreversible liver damage. In case of overdose or accidental ingestion, the patient should immediately seek medical help. Prompt medical attention is critical, even if the patient feels well, due to the risk of serious liver damage. The shorter the time between ingestion and the administration of an antidote (the smaller the number of hours), the greater the likelihood that liver damage can be prevented.

Missing a dose of Paramax Quick

The patient should not take a double dose to make up for a missed dose. The patient should not take the next dose in less than the recommended time. The patient should always leave at least 4 hours between doses. If the patient has any further questions about the use of this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The patient should stop taking the medicine and consult a doctor immediately if they experience:

• infections with symptoms such as fever and severe deterioration of general condition, or fever with symptoms of local infection, such as sore throat/pharynx/oral cavity or urinary problems. The patient should have a blood test to check for a possible decrease in white blood cell count (agranulocytosis). Paramax Quick may cause a decrease in white blood cell count, and the patient's resistance to infections may decrease. These side effects are rare (may affect up to 1 in 1,000 people).
• severe allergic reactions (anaphylactic shock), including difficulty breathing, swelling of the face, lips, tongue, or throat (angioedema). These side effects are very rare (may affect up to 1 in 10,000 people).
• skin rash (including hives, itching), redness of the skin, peeling of the skin, blisters, or ulcers of the mouth. These may be symptoms of serious, life-threatening skin disorders (Stevens-Johnson syndrome, toxic epidermal necrolysis). Such side effects have been reported rarely.

Rarely:may affect up to 1 in 1,000 people

• decrease in the number of certain blood cells, bleeding disorders, bone marrow disorders (disorders of blood-forming cells in the bone marrow), hemolytic anemia (abnormal breakdown of red blood cells)
• allergic reactions
• increased body temperature (hyperthermia)
• itching, rash, hives, skin swelling (edema)
• depression, confusion, hallucinations, vision disturbances
• tremors, headache
• abdominal pain, diarrhea, gastrointestinal bleeding, nausea, vomiting
• abnormal liver function, liver failure, jaundice

Very rarely:may affect up to 1 in 10,000 people

• bronchospasm (sudden narrowing of the airway muscles)
• blood disorders, including unusual bleeding and bruising
• low blood sugar levels
• dizziness (except for vertigo), general malaise, sedation, drug interactions not specified elsewhere
• liver function disorders (symptoms may include: weakness, weight loss, nausea, and jaundice)
• kidney function disorders and cloudy urine
• yellowing of the skin or eyes. These are symptoms of liver function disorders
• very rare cases of serious skin reactions have been reported
• acute generalized exanthematous pustulosis
• very rare cases of blood and fluid disorders (metabolic acidosis with a large anion gap), which occur when there is an increase in blood acidity, during the use of flucloxacillin with paracetamol, usually in the presence of risk factors (see section 2).

Unknown(frequency cannot be estimated from the available data):

• A serious condition that can make the blood more acidic (called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their 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 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, the patient can help provide more information on the safety of the medicine.

5. How to store Paramax Quick

The medicine should be stored out of the sight and reach of children. Store in a temperature below 30 °C. Store in the original packaging (in a sachet) to protect from light. Do not use this medicine after the expiry date stated on the carton and sachet after: EXP. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Paramax Quick contains

The active substance is paracetamol in a dose of 500 mg per sachet. The other ingredients are: mannitol (E 421), xylitol (E 967), blackcurrant flavor (maltodextrin, dextrose, triacetin, gum arabic, sodium dioctan), beetroot powder (beetroot juice concentrate, maltodextrin, citric acid). steviol glycoside (Rebaudioside A) and peppermint flavor (maltodextrin, dextrose, silicon dioxide, gum arabic, pulegone).

What Paramax Quick looks like and what the packaging contains

Paramax Quick is a pink powder with a blackcurrant flavor, packaged in single sachets. After dissolution in hot water, the solution is red and clear. The packaging contains 5, 6, 10, 12, 20, 24, and 30 sachets in cardboard boxes. Not all pack sizes may be marketed.

Marketing authorization holder

Vitabalans Oy Varastokatu 8 FI-13500 Hämeenlinna Finland Tel. +358 3 615 600

Manufacturer

Vitabalans Oy Varastokatu 7-9 FI-13500 Hämeenlinna Finland

This medicine is authorized in the Member States of the European Economic Area under the following names:

Arax: Lithuania, Latvia Arax Hot: Denmark Paracut: Sweden Paramax: Estonia, Finland, Slovenia Paramax Heißgetränk: Germany Paramax Horký nápoj: Czech Republic Paramax horúci nápoj: Slovakia Paramax Hot: Hungary Paramax Quick: Poland Date of last revision of the leaflet:01/2025