Paramax quick

Patient Information Leaflet

Paramax Quick, 500 mg, effervescent powder for oral solution in a sachet
Paracetamolum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement after 5 days of treatment for pain or 3 days for fever, or if you feel worse, you should contact your doctor.

Contents of the leaflet

1. What Paramax Quick is and what it is 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 pack and other information

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

Paramax Quick is an effervescent powder in sachets used to prepare a hot solution for oral administration.
The active substance in this medicine is paracetamol, which has analgesic (pain-relieving) and antipyretic (fever-reducing) properties.
Paramax Quick is used for the short-term treatment of mild to moderate pain (such as headache, muscle and joint pain, toothache, and menstrual pain) and fever associated with colds and flu.
This 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 impairment.

Warnings and precautions
Before starting to take Paramax Quick, consult a doctor or pharmacist if:

• the patient has reduced kidney function
• the patient has reduced liver function (including Gilbert's syndrome (mild jaundice))
• the patient has glucose-6-phosphate dehydrogenase deficiency (enzyme deficiency)
• the patient has haemolytic anaemia (abnormal breakdown of red blood cells).

During treatment with Paramax Quick, immediately inform the doctor if:

• the patient has serious illnesses, 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). Cases of a serious condition called metabolic acidosis (abnormality in blood and body fluids) have been reported in patients who take paracetamol regularly for a prolonged period or who take paracetamol together 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 stated in section 3. Doses higher than recommended will not provide stronger pain relief; however, they may cause severe liver damage. Symptoms of liver damage usually appear within a few days. In case of overdose of Paramax Quick, contact a doctor immediately, even if the patient has no symptoms of overdose.
Do not take any other products containing paracetamol together with Paramax Quick due to the risk of exceeding the maximum daily dose of paracetamol. When using Paramax Quick, check the composition of any other medicines before taking them.
Generally, habitual use of painkillers, especially the combination of several painkillers, may 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 intoxicating effect of alcohol is not increased by adding Paramax Quick. Alcohol consumption should be avoided during treatment with this medicine.
Paramax Quick should be used with caution if the patient is malnourished or dehydrated.
Caution is advised in patients with asthma who are sensitive to acetylsalicylic acid, as mild bronchospasm (cross-reaction) has been reported during paracetamol use.
Long-term treatment with painkillers taken every other day or more frequently may cause the occurrence or worsening of headaches. Headaches caused by overuse of painkillers should not be treated by increasing the dose. In such cases, discontinuation of painkillers should be discussed with a doctor.

Paramax Quick and other medicines
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.
Do not take Paramax Quick together with other medicinal products containing paracetamol. There is a risk of exceeding the maximum daily dose of paracetamol.
Consult a doctor if taking any of the following medicines:

• anticoagulants (e.g. warfarin). Occasional doses of Paramax Quick do not have a significant effect on bleeding tendency. However, contact a doctor if Paramax Quick is used frequently.
• metoclopramide, domperidone (used for nausea and vomiting).
• cholestyramine (used, for example, in the treatment of high cholesterol levels). Medicines should be taken at least one hour apart. Probenecid (used in the treatment of gout).
• carbamazepine, phenytoin, phenobarbital (used in the treatment of epilepsy).
• rifampicin and isoniazid (antibiotic used in the treatment of tuberculosis).
• St. John's wort (herbal medicinal product).
• chloramphenicol (antibiotic) administered by injection.
• flucloxacillin (antibiotic) due to a serious abnormality in blood and body fluids (called metabolic acidosis), which requires urgent treatment (see section 2).

Paramax Quick with food, drink and alcohol
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, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Paramax Quick may be used during pregnancy if justified. The lowest effective dose that reduces pain and (or) fever should be taken for the shortest possible time and as infrequently as possible. Consult a doctor if pain and (or) fever do not subside or if the patient needs to take the medicine more frequently.
Paracetamol passes into breast milk in small amounts. This medicine may be used during breastfeeding. Do not exceed the daily dose recommended in this leaflet.

Driving and using machines
Paramax Quick has no effect or has a negligible effect on the ability to drive and operate machinery.

Paramax Quick contains:

• Mannitol, which may have a mild laxative effect
• Xylitol (1665 mg per sachet), which may have a laxative effect. Calorific value: 2.4 kcal/g of 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. If in doubt, consult a doctor or pharmacist.
If pain persists for more than 5 days or fever lasts for more than 3 days, or if symptoms worsen, consult a doctor.
Warning! Paracetamol overdose can lead to severe liver damage. Do not exceed the daily dose stated below. Always use the lowest effective dose that relieves pain and (or) fever, and use it for the shortest possible time.
Recommended dose:
Adults and adolescents over 12 years of age:
Patients weighing 34–60 kg: 1 sachet every 4–6 hours when necessary. Maximum daily dose is 4 sachets within 24 hours (2000 mg paracetamol within 24 hours).
Patients weighing over 60 kg: 1–2 sachets every 4–6 hours when necessary. Maximum daily dose is 6 sachets within 24 hours (3000 mg paracetamol within 24 hours).
At least 4 hours should be maintained between consecutive doses.
Children under 12 years of age and adolescents weighing less than 34 kg:
This product should not be used in children under 12 years of age and adolescents weighing less than 34 kg, as the dose is not recommended for this age group and (or) body weight.
Patients with impaired kidney or liver function:
In patients with impaired liver or kidney function, the dose should be reduced or the dosing intervals extended. Consult a doctor before using this medicine.
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 consumed within 30 minutes.
Taking more Paramax Quick than recommended
Paracetamol overdose is potentially fatal due to irreversible liver damage. In case of overdose or accidental ingestion, seek immediate medical help. Prompt medical treatment is crucial, even if the patient feels well, due to the risk of severe liver damage.
The shorter the time interval between ingestion and administration of the antidote (the fewer hours), the greater the likelihood of preventing liver damage.
If you miss a dose of Paramax Quick
Do not take a double dose to make up for a missed dose. Do not take the next dose sooner than recommended. Always maintain at least a 4-hour interval between doses.
If you have any further questions about 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 everybody will experience them.
You should stop taking the medicine immediately and consult a doctor if any of the following occur:

• Infections with symptoms such as fever and severe worsening of general condition, or fever with signs of local infection such as sore throat/larynx/oral cavity or problems with urination. Blood tests should be performed to check for possible reduction in white blood cell count (agranulocytosis). Paramax Quick may reduce the number of white blood cells, and resistance to infections may decrease. These adverse effects are rare (may affect 1 in 1,000 people).
• Severe allergic reactions (anaphylactic shock), including shortness of breath, swelling of the face, lips, tongue or throat (angioedema). These adverse effects are very rare (may affect 1 in 10,000 people).
• Skin rash (including urticaria, itching), redness of the skin, skin peeling, blisters, ulcers or oral ulcers. These may be symptoms of serious, life-threatening skin disorders (Stevens-Johnson syndrome, toxic epidermal necrolysis). Such adverse effects have been reported sporadically.

Rare: may affect 1 in 1,000 people

• Reduction in the number of certain blood cells, coagulation disorders, disorders of stem cells (blood cell formation disorders in the bone marrow), hemolytic anemia (abnormal breakdown of red blood cells)
• Allergic reactions
• Increased body temperature (hyperthermia)
• Itching, rash, urticaria, skin edema (swelling)
• Depression, confusion, hallucinations, visual disturbances
• Tremor, headache
• Abdominal pain, diarrhea, gastrointestinal bleeding, nausea, vomiting
• Liver function abnormalities, liver failure, jaundice

Very rare: may affect 1 in 10,000 people

• Bronchospasm (sudden constriction of muscles in the bronchial walls)
• Blood disorders, including unusual bleeding and bruising
• Low blood glucose levels
• Dizziness (excluding vertigo), general malaise, sedation, unspecified drug interactions
• Liver function disorders (symptoms may include: fatigue, 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 high anion gap), which occur when plasma acidity increases during concomitant use of flucloxacillin and paracetamol, usually in the presence of risk factors (see section 2).

Unknown (frequency cannot be estimated from available data):

• Serious condition that may cause blood to become more acidic (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. 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
Phone: +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.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Paramax Quick

Keep this medicine out of sight and reach of children.
Store below 30 °C.
Store in the original packaging (in the sachet) to protect from light.
Do not use this medicine after the expiry date stated on the carton and sachet following EXP.
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 help protect the environment.

6. Contents of the pack and other information

What Paramax Quick contains
The active substance is paracetamol, 500 mg per sachet.
The other ingredients are: mannitol (E 421), xylitol (E 967), blackcurrant flavour (maltodextrin,
dextrose, triacetin, gum arabic, sodium diacetate), beetroot powder (beetroot juice concentrate,
maltodextrin, citric acid), steviol glycosides (Rebaudioside A), and menthol flavour (maltodextrin,
dextrose, silicon dioxide, gum arabic, pulegone).

What Paramax Quick looks like and contents of the pack
Paramax Quick is a pink powder with a blackcurrant scent, packed in individual sachets. When dissolved in hot water, the solution is red, clear and transparent.
The pack contains 5, 6, 10, 12, 20, 24 or 30 sachets in cardboard boxes.
Not all pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area countries 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