Paramax Comp

Leaflet attached to the packaging: patient information

Paramax Comp, 500 mg + 65 mg, tablets

Paracetamol + Caffeine

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 the 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 possible side effects not listed in the leaflet, they should inform their doctor. See section 4.
• If there is no improvement or the patient feels worse after 3 days, they should contact their doctor.

Table of contents of the leaflet

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

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

Paramax Comp is a pain-relieving and fever-reducing medicine (analgesic and antipyretic). Paramax Comp contains 2 active substances, paracetamol and caffeine. Paracetamol relieves pain and reduces fever, while caffeine enhances its pain-relieving effect. Paramax Comp is used for the symptomatic treatment of mild to moderate pain, such as headache, toothache, menstrual pain, and/or fever.

2. Important information before taking Paramax Comp

When not to take Paramax Comp

• in children under 12 years of age.
9 points on the Child-Pugh scale).

Warnings and precautions

Before taking Paramax Comp, the patient should discuss it with their doctor:

During treatment with Paramax Comp, the patient should immediately inform their doctor:

Precautions should be taken

• when using medicinal products that affect liver function
• in cases of chronic malnutrition

Paramax Comp should not be taken without consulting a doctor if the patient is taking other painkillers containing paracetamol. Never take more than the recommended dose of paracetamol. Doses higher than recommended do not produce a stronger pain-relieving effect and increase the risk of serious liver damage. Symptoms of liver damage usually occur within a few days of taking an overdose of paracetamol. Therefore, it is essential to contact a doctor immediately after taking an overdose of the medicine, even if the patient feels well, due to the risk of liver damage (see "Taking a higher dose of Paramax Comp than recommended" in section 3).

Paramax Comp 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, including those that are available without a prescription, as medicines may interact with each other.

Special caution should be exercised when taking:

• anticoagulant medicines (medicines that prevent blood clots)
• metoclopramide and domperidone (medicines for nausea and vomiting)
• chloramphenicol (an antibiotic)
• cholestyramine (a medicine that lowers cholesterol levels)
• phenobarbital, phenytoin, and carbamazepine (medicines used to treat epilepsy)
• rifampicin (a medicine used to treat tuberculosis)
• probenecid (a medicine used to treat gout)
• zidovudine (a medicine used to treat HIV infections)
• St. John's wort (an ingredient in some natural products)
• flucloxacillin (an antibiotic) due to the risk of a serious blood and fluid disorder (called metabolic acidosis), which requires emergency treatment (see section 2).

As with other migraine treatments, too frequent use of Paramax Comp may cause daily headaches or worsen migraines. The patient should ask their doctor if they think this is the case. To solve the problem, the patient may need to stop taking Paramax Comp. If the patient is taking any of the above medicines or natural products, they should consult their doctor before taking Paramax Comp. Occasionally, Paramax Comp may be taken with anticoagulant medicines, but if the patient needs long-term use of painkillers, they should consult their doctor.

Paramax Comp with food and drink

Do not take the medicine with alcohol. The patient should limit their consumption of beverages containing caffeine (coffee, tea, cola).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Paramax Comp can be given to pregnant women if necessary. The patient should take the smallest dose that effectively relieves pain or reduces fever and take the medicine for as short a time as possible. If the pain is not relieved or the fever does not decrease, or if it is necessary to increase the frequency of taking the medicine, the patient should consult their doctor. Paramax Comp can be used during breastfeeding if taken according to standard conditions of use. However, it should only be used after a thorough assessment of the benefit-risk ratio by the doctor.

Driving and using machines

Paramax Comp does not have a known effect on the ability to drive and use machines.

3. How to take Paramax Comp

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. For oral use in the short term. Adults and children over 12 years of age: The usual dose is 1-2 tablets up to 3 times a day or as needed. A 1-2 tablet dose should not be taken more frequently than every 6 hours. The appropriate interval between doses depends on the symptoms and the maximum daily dose. Do not exceed the recommended daily dose of 6 tablets in 24 hours. If symptoms persist for more than 3 days, the patient should consult their doctor. Elderly patients: As for adults. Use in children: The medicine is not recommended for use in children under 12 years of age.

Taking a higher dose of Paramax Comp than recommended

In case of overdose and poisoning, the patient should immediately contact their doctor or go to the emergency department, even if they feel well, due to the risk of delayed, severe liver damage. Symptoms of overdose include pallor, nausea, vomiting, loss of appetite, abdominal pain, tremors, nervousness, agitation, increased urine production, gastrointestinal disorders, tachycardia, or arrhythmia.

Missing a dose of Paramax Comp

The patient should not take a double dose to make up for a missed dose. They should continue treatment according to the adopted scheme. In case of doubts related to the use of the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Paramax Comp can cause side effects, although not everybody gets them. Paramax Comp may cause a decrease in the number of white blood cells, which can reduce the patient's resistance to infections. The patient should immediately stop taking Paramax Comp and contact their doctorif they experience symptoms of infection, such as fever and severe deterioration of their general condition or fever and symptoms of local infection, such as throat or mouth ulcers or urinary disorders. Blood tests will be performed to check for possible decreased white blood cell count (agranulocytosis). The following side effects have been reported so far, presented according to their frequency:

• Frequent (may occur in 1 in 10 patients):
• nausea
• insomnia
• restlessness
• rapid heart rate (tachycardia)

Rare (may occur in 1 in 1000 patients):

• hypersensitivity reactions (including rash)

Very rare (may occur in 1 in 10,000 patients):

• disorders of blood formation, including thrombocytopenia (low platelet count, which can cause more frequent bleeding or bruising) and agranulocytosis (reduced white blood cell count)
• Anaphylactic shock (severe allergic reaction), angioedema (sudden swelling of the skin and mucous membranes, which can be life-threatening)
• very rare cases of severe skin reactions have been reported.

Unknown (frequency cannot be estimated from 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 possible side effects not listed in the leaflet, they should inform their doctor. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-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, more information can be collected on the safety of the medicine.

5. How to store Paramax Comp

There are no special precautions for storage. The medicine should be stored out of sight and reach of children. Do not use the medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the specified 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 needed. This will help protect the environment.

6. Contents of the pack and other information

What Paramax Comp contains

• The active substances are paracetamol and caffeine. One tablet contains 500 mg of paracetamol and 65 mg of caffeine.
• The other ingredients are microcrystalline cellulose, povidone 29-32, stearic acid, and magnesium stearate.

What Paramax Comp looks like and contents of the pack

White capsule-shaped tablet with a dividing line on one side, 7.5 mm wide and 18 mm long. The tablet can be divided into two equal parts. Pack sizes: 10, 20, 30, 60, and 100 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Vitabalans Oy, Varastokatu 8, 13500 Hämeenlinna, Finland, Tel.: +358 3 615 600

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

Paracut Comp: Sweden, Paramax Comp: Finland, Hungary, Poland, Slovenia, Paramax Extra: Estonia, Lithuania, Latvia, Slovakia, Para-Caf: Germany, Paramax Combi: Czech Republic, Arax Extra: Denmark

Date of last revision of the leaflet:02/2025