Paracetamol us pharmacia

Package leaflet: Information for the user

Paracetamol US Pharmacia
500 mg, soft capsules
Paracetamolum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
You should always take this medicine exactly as described in this patient leaflet or as your
doctor or pharmacist has advised.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Contents of the leaflet

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

Paracetamol US Pharmacia contains paracetamol, which is a pain-relieving medicine.
It also reduces fever.
This medicine is used for symptomatic relief of mild to moderate pain and (or) fever
in adults and adolescents with body weight above 55 kg (approximately over 15 years of age).
Consult your doctor if your 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:

• you are allergic to paracetamol or any of the other ingredients of this medicine (see section 6), or to peanuts and soy,
• you have liver failure.

Warnings and precautions
Before taking Paracetamol US Pharmacia, consult your doctor or pharmacist if
you have:

• liver or kidney function disorders (including moderate to severe renal impairment, mild to moderate liver impairment, or Gilbert's syndrome),
• glucose-6-phosphate dehydrogenase deficiency,
• haemolytic anaemia,
• dehydration or chronic nutritional problems (malnutrition),
• asthma or allergy to aspirin (acetylsalicylic acid),
• if you regularly consume large amounts of alcohol (risk of liver damage).

During treatment with Paracetamol US Pharmacia, inform your doctor immediately if:
you have serious medical conditions, including severe kidney disorders or sepsis
(bacteria and their toxins circulating in the blood leading to organ damage), malnutrition,
chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic).
In such cases, patients have experienced a serious condition called metabolic acidosis (abnormality in blood and body fluids) when paracetamol was taken regularly over a long period or when paracetamol was taken together with flucloxacillin.
Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.
Paracetamol US Pharmacia contains paracetamol. DO NOT take this medicine with other
medicines containing paracetamol.
Do not take more than the recommended dose, as it may cause serious liver damage.
Prolonged or frequent use is not recommended.
Consult your doctor if any of the above warnings apply to you or have applied in the past.

Children and adolescents
This medicine should not be given to children under 15 years of age.

Paracetamol US Pharmacia and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. This is particularly important if you are 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 (anticoagulants),
• zidovudine (a medicine used in the treatment of AIDS),
• salicylamide (a pain-relieving medicine),
• isoniazid (an antituberculosis medicine),
• lamotrigine (an antiepileptic medicine).

Inform your doctor or pharmacist if you are taking flucloxacillin (an antibiotic) due to the serious risk of disturbances in blood and body fluids (called metabolic acidosis), which require urgent treatment (see section 2).
Paracetamol may affect the results of various laboratory tests.

Taking Paracetamol US Pharmacia with food, drink and alcohol
Do not consume alcohol while taking Paracetamol US Pharmacia.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
If necessary, Paracetamol US Pharmacia may be used during pregnancy. Use the lowest possible dose that relieves pain and (or) fever for the shortest possible time.
Contact your doctor or midwife if pain and (or) fever do not decrease or if more frequent dosing is needed.
Although paracetamol is excreted in small amounts in breast milk, it has no harmful effect on breastfed infants. Paracetamol may be used at the recommended dose for a short period by breastfeeding women.
There are insufficient data to indicate any effect of paracetamol on fertility.

Driving and using machines
Paracetamol has no influence on the ability to drive or use machinery.

Paracetamol US Pharmacia contains sorbitol, propylene glycol, and lecithin derived from soybean oil.
The medicine contains 58.2 mg of sorbitol in one capsule.
Sorbitol is a source of fructose. If your doctor has diagnosed that you (or your child) have an intolerance to certain sugars or if you have hereditary fructose intolerance, a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before taking or receiving this medicine.
This medicine contains 6.0 mg of propylene glycol in one capsule.
If you are allergic to peanuts or soy, you 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 your
doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults and adolescents aged over 15 years (body weight >55 kg):
The usual dose is 1 to 2 capsules every 4 hours (minimum interval between doses).
Do not take more than 6 capsules within 24 hours. Swallow the capsules whole.
To relieve symptoms, use the lowest effective dose for the shortest possible time.
Consult your doctor if your condition does not improve or worsens after 3 days of treatment.
Renal impairment
In patients with kidney disease (renal failure), there is a risk of paracetamol accumulation.
Therefore, the doctor may reduce the dose. The usual dose is 1 capsule every 6 hours in patients
with moderate renal impairment or 1 capsule every 8 hours in patients with severe renal impairment.
Hepatic impairment, malnutrition or dehydration
In patients with mild or moderate hepatic insufficiency or Gilbert's syndrome, the dose should be
reduced or the dosing interval prolonged. In patients with hepatic impairment, malnutrition,
dehydration, and in adults with body weight less than 50 kg, the daily dose must not exceed
60 mg/kg/day (up to 2 grams/day).
Taking more than the recommended dose of Paracetamol US Pharmacia
Seek immediate medical advice if a patient takes more medicine than recommended, even if they
feel well. Symptoms such as nausea, vomiting, and loss of appetite may occur. Very high doses of
paracetamol may cause severe liver damage.
Missed dose of Paracetamol US Pharmacia
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Treatment should be discontinued and a doctor should be contacted if the patient experiences:

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

Possible adverse reactions include:
Rare (may occur in fewer than 1 in 1,000 people)

• various blood abnormalities, including agranulocytosis, thrombocytopenia, thrombocytopenic purpura, leukopenia, and hemolytic anemia;
• allergic reactions (other than angioedema);
• liver function disorders, liver failure, liver necrosis, and jaundice;
• itching, rash, sweating, purpura, and urticaria;
• overdose and poisoning;
• depression, disorientation, and hallucinations;
• tremor and headache;
• blurred vision;
• swelling;
• bleeding, abdominal pain, diarrhea, nausea, vomiting;
• dizziness, fever, drowsiness.

Very rare (may occur in fewer than 1 in 10,000 people)

• decreased blood cell counts;
• feeling of chest tightness due to respiratory muscle spasm (bronchospasm) in individuals allergic to acetylsalicylic acid and other non-steroidal anti-inflammatory/antipyretic drugs;
• rash;
• low blood glucose levels;
• dark urine and kidney function disorders.

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

• serious condition that may cause blood acidification (so-called metabolic acidosis) in patients with severe disease taking paracetamol (see section 2);
• acute generalized exanthematous pustulosis, toxic epidermal necrolysis, drug-induced dermatosis, 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 of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions 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, tel.: +48 (22) 492 13 01, fax: +48 (22) 492 13 09,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows additional information on the safety of the medicine to be collected.

5. How to store Paracetamol US Pharmacia

This medicine should be stored in a place inaccessible and out of sight 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 specified month.
Medicines must 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 packaging and other information

What Paracetamol US Pharmacia contains

• The active substance is paracetamol. One capsule contains 500 mg of paracetamol.
• The other ingredients (excipients) are: macrogol 400, macrogol 600, purified water, propylene glycol, povidone, colloidal anhydrous silica, gelatin, liquid sorbitol partially dehydrated, glycerol, titanium dioxide (E171). Contains trace amounts of: 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/Aluminium foil 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 Authorisation Holder and Manufacturer
US Pharmacia Sp. z o.o.
Ziębicka 40
50-507 Wrocław
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Poland: Paracetamol US Pharmacia
Estonia: APAPTEN
Lithuania: APAP Express 500 mg minkštosios kapsulės
Latvia: APAPTEN 500 mg mīkstās kapsulas