Paramax Rapid 500 mg

Patient Information Leaflet: User Information

PARAMAX Rapid, 500 mg, tablets

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 the patient information leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If after 3-4 days there is no improvement or you feel worse, consult a doctor.

Table of Contents of the Leaflet

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

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

Paramax Rapid contains paracetamol, which acts as a pain reliever and antipyretic. The medicine is used for elevated body temperature and symptomatic treatment of mild to moderate pain, such as headaches, toothaches, joint and muscle pain, menstrual pain, and neuralgia. If after 3-4 days there is no improvement or you feel worse, consult a doctor.

2. Important information before taking Paramax Rapid

When not to take Paramax Rapid

• if you are hypersensitive to paracetamol or any of the other ingredients of this medicine (listed in section 6);
• if you have severe renal impairment;
• if you have severe hepatic impairment;
• in patients with alcoholic liver disease;
• the medicine should not be taken simultaneously with MAO inhibitors (medicines used, among others, in the treatment of depression) and within 2 weeks after the end of treatment with these medicines. The medicine should not be taken in children under 12 years of age.

Warnings and precautions

Before starting treatment with Paramax Rapid, discuss it with your doctor:

• if you have kidney disease;
• if you have liver disease;
• if you have a deficiency of glucose-6-phosphate dehydrogenase (G-6-PD).

During treatment with Paramax Rapid, immediately inform your doctor:

• if you have 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 when you are also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a severe disease called metabolic acidosis (a blood and fluid disorder), when they took paracetamol in regular doses for a longer period or when they took paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling of nausea (nausea) and vomiting. The medicine contains paracetamol.Do not take other medicines containing paracetamol (including some medicines used to relieve symptoms of colds and flu) due to the risk of overdose and associated life-threatening liver damage. It is not recommended to use the medicine for a long time or frequently. Do not take a daily dose larger than recommended. In case of overdose, contact your doctor immediately, even if you feel well. See also section 3 "Taking a higher dose of Paramax Rapid than recommended". There is a special risk of liver damage in patients who are fasting and regularly drink alcohol. Do not drink alcohol during treatment with the medicine. When taking high doses of paracetamol (>4 g in adults) for more than 3 weeks, liver damage may occur even in people who have not been previously diagnosed with liver failure. Patients with moderate or severe liver or kidney impairment should be closely monitored by a doctor. Long-term use of paracetamol increases the risk of kidney damage.

Paramax Rapid with food and drink

The medicine can be taken during or outside of meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine. Paramax Rapid can be given to pregnant women if it is clinically justified. Use the lowest possible dose that 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 subside, or if it is necessary to increase the frequency of taking the medicine, consult a doctor.

Driving and using machines

At recommended doses, paracetamol does not affect the ability to drive vehicles or operate machinery.

3. How to take Paramax Rapid

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor. In case of doubts, consult a doctor or pharmacist. The usual dose of Paramax Rapid: Adults and children over 12 years (with body weight over 40 kg) 1 or 2 tablets 1 to 3 times a day, not more often than every 4 hours. Do not take the medicine more than 4 times a day. Paramax Rapid should not be taken for more than 3 days without consulting a doctor. Patients with liver or kidney impairment: In patients with kidney or liver impairment, or Gilbert's syndrome, the dose of the medicine must be lower or the intervals between doses must be extended.

Taking a higher dose of Paramax Rapid than recommended

In case of taking a higher dose of the medicine than recommended, immediately consult a doctor, even if you feel well. If the overdose occurred no more than 1 hour ago, induce vomiting. Immediately consult a doctor, as specialized treatment in a hospital may be necessary. Accidental or intentional overdose of paracetamol may cause symptoms such as nausea, vomiting, excessive sweating, drowsiness, and general weakness within a few or several hours. These symptoms may subside the next day, despite the fact that life-threatening liver damage is developing, which will then manifest as abdominal distension, return of nausea, and jaundice.

Missing a dose of Paramax Rapid

Do not take a double dose to make up for a missed tablet; take a tablet as soon as possible and then continue taking the medicine as directed. In case of any further doubts about taking the 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 frequency of possible side effects listed below is defined as follows: frequent: (occurring in 1 to 10 people in 100): nausea, vomiting; infrequent: (occurring in 1 to 10 people in 1,000): constipation; very rare: (occurring in less than 1 person in 10,000): anaphylactic reactions, hypersensitivity reactions, skin redness, rash, erythema or urticaria, angioedema (clearly defined, localized swelling involving the deeper skin layers, including subcutaneous tissue), dyspnea, bronchospasm, decreased white blood cell count or platelet count, and agranulocytosis. Renal colic, necrosis, renal papillary necrosis, acute renal failure. Very rare cases of severe skin reactions have been reported. Frequency not known (cannot be estimated from the available data): a serious condition that can cause acidification of the blood (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell 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 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, you can help provide more information on the safety of the medicine.

5. How to store Paramax Rapid

There are no special precautions for storage. Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after: Expiry date. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Paramax Rapid contains

• The active substance is paracetamol. Each tablet contains 500 mg of paracetamol.
• The other ingredients are: povidone, microcrystalline cellulose, sodium carboxymethylcellulose, stearic acid, magnesium stearate.

What Paramax Rapid looks like and contents of the pack

White capsules-shaped tablets, 18 mm long and 7.5 mm wide, placed in blisters or an HDPE container and a cardboard box. 10 tablets (1 blister of 10 tablets) 30 tablets (3 blisters of 10 tablets) 100 tablets (1 container of 100 tablets)

Marketing authorization holder and manufacturer

Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland Tel.: +358 (3) 615600 To obtain more detailed information, contact the representative of the marketing authorization holder: Vitabalans Sp. z o.o., ul. Narbutta, nr 5, lok. 1, 02-564, Warsaw Telephone: (0-48) 22 646 6035

Date of last revision of the leaflet: