Paracetamol Us Pharmacia

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: patient information

Paracetamol US Pharmacia

500 mg, soft capsules, Paracetamolum

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 advised 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 those not listed in this leaflet, they should inform their doctor or pharmacist. 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 Paracetamol US Pharmacia and what is it used for
• 2. Important information before taking Paracetamol US Pharmacia
• 3. How to take Paracetamol US Pharmacia
• 4. Possible side effects
• 5. How to store Paracetamol US Pharmacia
• 6. Contents of the pack and other information

1. What is Paracetamol US Pharmacia and what is it used for

Paracetamol US Pharmacia contains paracetamol, which is a pain reliever and also reduces fever.
This medicine is used for the symptomatic treatment of mild to moderate pain and/or fever in adults and adolescents over 55 kg (approximately over 15 years of age).
A doctor should be consulted if the patient's condition does not improve or if symptoms worsen after 3 days of treatment.

2. Important information before taking Paracetamol US Pharmacia

Do not take Paracetamol US Pharmacia if:

• the patient is hypersensitive to paracetamol or any of the other ingredients of this medicine (see section 6) or peanuts and soybeans,
• the patient has liver failure.

Warnings and precautions

Before taking Paracetamol US Pharmacia, the patient should consult a doctor or pharmacist if they have:

• liver or kidney disorders (including moderate to severe renal impairment and mild to moderate liver impairment or Gilbert's syndrome),
• glucose-6-phosphate dehydrogenase deficiency,
• hemolytic anemia,
• dehydration or chronic nutritional problems (malnutrition),
• asthma and hypersensitivity to aspirin (acetylsalicylic acid),
• if the patient consumes large amounts of alcohol daily (risk of liver damage).

While taking Paracetamol US Pharmacia, the patient should immediately inform their doctor if they have:

• severe illnesses, including severe kidney disorders or sepsis (when bacteria and their toxins are present 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 condition called metabolic acidosis (a blood and body 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 sick (nausea) and vomiting.
Paracetamol US Pharmacia contains paracetamol. DO NOT take this medicine with other medicines containing paracetamol.
Do not exceed the recommended dose, as this may cause serious liver damage.
Prolonged or frequent use is not recommended.
The patient should consult a doctor if any of the above warnings apply to them or have applied in the past.

Children and adolescents

Do not give this medicine to children under 15 years of age.

Paracetamol US Pharmacia and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
This is especially important if the patient is taking any of the following medicines:

• barbiturates (a group of sedative and pain-relieving medicines),
• certain antidepressants (e.g., monoamine oxidase inhibitors),
• probenecid (for gout),
• chloramphenicol (an antibiotic),
• metoclopramide or domperidone (medicines to prevent nausea and vomiting),
• cholestyramine (an anticholinergic medicine),
• warfarin and other coumarin derivatives (anticoagulant medicines),
• zydovudine (a medicine used to treat AIDS),
• salicylamide (a pain reliever),
• isoniazid (an anti-tuberculosis medicine),
• lamotrigine (an antiepileptic medicine).

The patient should inform their doctor or pharmacist if they are taking flucloxacillin (an antibiotic), due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which must be treated urgently (see section 2).
Paracetamol may affect the results of various laboratory tests.

Taking Paracetamol US Pharmacia with food, drink, and alcohol

Do not drink alcohol while taking Paracetamol US Pharmacia.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to become pregnant, they should consult their doctor or pharmacist before taking this medicine.
If necessary, Paracetamol US Pharmacia can be used during pregnancy. The patient should use the smallest possible dose that reduces pain and/or fever for the shortest possible time.
The patient should contact their doctor or midwife if pain and/or fever do not improve or if they need to take the medicine more frequently.
Although paracetamol is excreted in small amounts into breast milk, it does not have a harmful effect on breastfed babies. Paracetamol can be used in the recommended dose for a short period by breastfeeding women.
There are no sufficient data to indicate any effect of paracetamol on fertility.

Driving and using machines

Paracetamol does not affect the ability to drive or use machines.

Paracetamol US Pharmacia contains sorbitol, propylene glycol, and soybean lecithin.

The medicine contains 58.2 mg of sorbitol in one capsule.
Sorbitol is a source of fructose. If the doctor has diagnosed the patient (or child) with intolerance to some sugars or if the patient has a rare genetic disorder called hereditary fructose intolerance, they should talk to their doctor before taking or receiving this medicine.
This medicine contains 6.0 mg of propylene glycol in one capsule.
If the patient is allergic to peanuts or soybeans, they should not use this medicinal product.

3. How to take Paracetamol US Pharmacia

Always take this medicine exactly as described in this leaflet or as advised by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Adults and adolescents over 15 years of age (with a body weight >55 kg):

Usually, 1 to 2 capsules are taken every 4 hours (with a minimum interval of 4 hours between doses).
Do not take more than 6 capsules in 24 hours. The capsules should be swallowed whole.
To relieve symptoms, use the smallest possible dose for the shortest possible time.
Consult a doctor if the patient's condition does not improve or if symptoms worsen after 3 days of treatment.

Kidney disorders

In patients with kidney disease (renal impairment), there is a risk of paracetamol accumulation.
As a result, the doctor may reduce the dosage. The usual dose is 1 capsule every 6 hours in patients with moderate kidney disorders or 1 capsule every 8 hours in patients with severe kidney disorders.

Liver disorders, malnutrition, or dehydration

In patients with mild or moderate liver impairment or Gilbert's syndrome, the dose should be reduced or the interval between doses prolonged.
In patients with liver disorders, malnutrition, dehydration, and in adults with a body weight less than 50 kg, the daily dose should not exceed 60 mg/kg/day (up to 2 grams/day).

Taking a higher dose of Paracetamol US Pharmacia than recommended

The patient should immediately contact their doctor if they take more of the medicine than they should, even if they feel well. Nausea, vomiting, and loss of appetite may occur. Very high doses of paracetamol can cause serious liver damage.

Missing a dose of Paracetamol US Pharmacia

Do not take a double dose to make up for a missed dose.

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 contact their doctor if they experience:

• hypersensitivity reactions, including angioedema, breathing difficulties, sweating, nausea, hypotension, shock, and anaphylaxis;
• liver damage;
• severe skin reactions.

Side effects that may occur include:

Rare (may affect up to 1 in 1,000 people)

• various blood disorders, including agranulocytosis, thrombocytopenia, purpura, leukopenia, and hemolytic anemia;
• allergies (except angioedema);
• liver disorders, liver failure, liver necrosis, and jaundice;
• itching, rash, sweating, urticaria, and erythema;
• overdose and poisoning;
• depression, disorientation, and hallucinations;
• tremors and headaches;
• blurred vision;
• edema;
• bleeding, abdominal pain, diarrhea, nausea, vomiting;
• dizziness, fever, drowsiness.

Very rare (may affect up to 1 in 10,000 people)

• decreased blood cell count;
• feeling of chest tightness due to bronchospasm in patients allergic to aspirin and other non-steroidal anti-inflammatory/antipyretic drugs;
• rash;
• low blood sugar levels;
• dark urine and kidney disorders.

Frequency not known (cannot be estimated from the available data):

• a serious condition that can cause acidification of the blood (called metabolic acidosis), in patients with severe illness taking paracetamol (see section 2);
• acute generalized exanthematous pustulosis, toxic epidermal necrolysis, drug rash, and Stevens-Johnson syndrome.

Liver damage may occur after prolonged use of 3 to 4 grams of paracetamol per day or after a single dose of 6 grams of paracetamol.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 (22) 492 13 01, fax: +48 (22) 492 13 09,
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 gathered on the safety of the medicine.

5. How to store Paracetamol US Pharmacia

This medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date (EXP) stated on the packaging.
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 needed. This will help protect the environment.

6. Contents of the pack and other information

What Paracetamol US Pharmacia contains

• The active substance is paracetamol. One capsule contains 500 mg of paracetamol.
• The other ingredients are: macrogol 400, macrogol 600, purified water, propylene glycol, povidone, silicon dioxide, anhydrous colloidal, gelatin, liquid sorbitol, partially dehydrated, glycerol, titanium dioxide (E171). Contains in trace amounts:medium-chain triglycerides, soybean lecithin, isopropyl alcohol.

What Paracetamol US Pharmacia looks like and contents of the pack

• Paracetamol US Pharmacia is a white, elongated, soft, gelatin capsule.
• Paracetamol US Pharmacia is available in PVC/PVDC/Aluminum blisters. Each pack contains 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, or 32 capsules. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50-507 Wrocław

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

Countries:

Poland:Paracetamol US Pharmacia
Estonia:APAPTEN
Lithuania:APAP Express 500 mg soft capsules
Latvia:APAPTEN 500 mg soft capsules

Date of last revision of the leaflet: March 2025