Paduden Express

1. What is Paduden Express and what is it used for

The active substance of the medicine is ibuprofen, which works by reducing pain and fever.
The medicine is indicated for use in adults and adolescents over 12 years of age to relieve symptoms of mild or moderate pain, such as headache, toothache, menstrual pain, muscle pain (cramps) or back pain (lower back pain) as well as in febrile conditions and fever and pain after vaccination.
If after 3 days in the case of fever treatment or 3 days in the case of pain treatment in adolescents, or after 5 days in the case of pain treatment in adults, the symptoms worsen or do not improve, a doctor should be consulted.

2. Important information before using Paduden Express

When not to use Paduden Express:

• If the patient is allergic to ibuprofen, other non-steroidal anti-inflammatory drugs (NSAIDs) (e.g. acetylsalicylic acid, naproxen, etc.) or any of the other ingredients of this medicine (listed in section 6). Symptoms that may indicate an allergic reaction include: itchy rash, swelling of the face, lips or tongue, runny nose, difficulty breathing or asthma.
• If the patient has ever had stomach or duodenal ulcers, bleeding or perforation of the gastrointestinal tract.
• If the patient has bloody vomiting.
• If the patient has Crohn's disease (a chronic disease in which the immune system attacks the intestines, causing inflammation, which usually leads to bloody diarrhea) or ulcerative colitis, as ibuprofen may worsen the course of these diseases.

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in the course of the disease, the immune system attacks the intestines, causing inflammation, which usually leads to bloody diarrhea) or ulcerative colitis, because ibuprofen may exacerbate the course of these diseases.

• If the patient has tarry stools or bloody diarrhea.
• If the patient has severe liver or kidney disease.
• If the patient has bleeding, blood clotting disorders, or is taking anticoagulant medications (used to "thin" the blood). In the case of the need to use anticoagulant medications at the same time, the doctor will order blood clotting tests.
• If the patient has serious heart problems.
• If the patient is in the third trimester of pregnancy.

Warnings and precautions

Before starting treatment with Paduden Express, the patient should discuss it with their doctor or pharmacist:

• If the patient has ever had stomach or duodenal ulcers, bleeding, or perforation of the stomach or duodenum, which may be manifested by severe or persistent abdominal pain and/or black stools, even without prior warning signs. The risk increases with increasing dose and duration of treatment, in patients with a history of ulcers, and in the elderly.
• If the patient has edema (fluid retention).
• If the patient has asthma or other respiratory disease.
• If the patient has heart disease or high blood pressure.
• If the patient has kidney or liver disease, is over 60 years old, or needs to take this medicine for a long time (longer than 1-2 weeks) - in this case, the doctor may regularly subject the patient to check-ups.
• If the patient is dehydrated, e.g. due to severe diarrhea or vomiting, they should drink plenty of fluids and contact their doctor immediately, as ibuprofen may cause kidney failure due to dehydration. In dehydrated adolescents, there is a risk of kidney function disorder.
• If the patient is taking medications that affect blood clotting, such as oral anticoagulants, antiplatelet agents of the acetylsalicylic acid type. It is also recommended to consult on the use of other medications that may increase the risk of bleeding, such as corticosteroids and antidepressants of the SSRI group.
• If the patient is being treated with diuretics (urine-inducing medications). The doctor should monitor the patient's kidney function.
• If the patient has systemic lupus erythematosus (a chronic autoimmune disease that can affect various organs of the body, nervous system, blood vessels, skin, and joints), as aseptic meningitis may occur.
• If the patient has acute intermittent porphyria (a metabolic disease affecting the blood and may cause symptoms such as blood in the urine or liver disease). It should be assessed whether the use of ibuprofen in the patient is appropriate.
• If the patient is being treated with ibuprofen, as it may mask fever, which is a main symptom of infection, making proper diagnosis difficult.
• If the patient experiences headache after prolonged use, they should not increase the dose of this medicine.
• It is possible to experience allergic reactions after using this medicine.
• If the patient is going to undergo major surgery, the doctor will subject them to close monitoring.
• If the patient has an infection - see below, section entitled "Infections".
• If the patient has chickenpox, the use of this medicine is not recommended.
• It is important to use the smallest effective dose to relieve/control pain and not to use this medicine for longer than necessary to control symptoms.

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Cardiovascular precautions

Taking anti-inflammatory/pain-relieving medications, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. The recommended dose should not be exceeded and the duration of treatment should not be prolonged.
Before starting treatment with Paduden Express, the patient should discuss their treatment with their doctor or pharmacist if:

• the patient has heart disease, such as heart failure and angina pectoris (chest pain), has had a heart attack, coronary artery bypass grafting, has peripheral arterial disease (poor blood circulation in the legs due to narrowing or blockage of arteries) or has had any stroke (including mini-stroke or transient ischemic attack - TIA).
• the patient has high blood pressure, diabetes, high cholesterol levels, has a history of heart disease or stroke in their family, or smokes.

Medicines of this type may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).
During treatment with ibuprofen, symptoms of an allergic reaction to this medicine have occurred, including difficulty breathing, swelling around the face and neck (angioedema), chest pain. If any of these symptoms are noticed, the patient should stop taking Paduden Express and contact their doctor or emergency medical services immediately.

Skin reactions

Severe skin reactions have been reported with the use of ibuprofen, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP). If the patient experiences any of the symptoms associated with these severe skin reactions described in section 4, they should stop taking Paduden Express and seek medical attention immediately.

Infections

Paduden Express may mask the symptoms of infection, such as fever and pain. Therefore, Paduden Express may delay the use of appropriate infection treatment and consequently lead to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient is taking this medicine during an infection and the symptoms of the infection persist or worsen, they should contact their doctor immediately.

Paduden Express with food, drink, and alcohol

This medicine can be taken with or without food.
Patient with sensitive stomach should take Paduden Express with a meal.
It is recommended to avoid taking ibuprofen with alcohol to avoid stomach damage.
Taking ibuprofen by patients who regularly consume alcohol (at least three servings of alcohol - beer, wine, spirits - per day) may cause stomach bleeding.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
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In the first and second trimester of pregnancy, ibuprofen should not be used unless it is clearly necessary, as the use of the medicine may increase the risk of developmental abnormalities or miscarriage. In such cases, the lowest dose should be used for the shortest possible time.
The use of the medicine is contraindicated in the third trimester of pregnancy.
The patient should not take ibuprofen if they are in the last 3 months of pregnancy, as it may harm the unborn baby or cause complications during delivery.
It may cause kidney and heart problems in the unborn baby. It may increase the patient's and their baby's tendency to bleed and cause delayed or prolonged labor. During the first 6 months of pregnancy, the medicine should not be used unless it is absolutely necessary and prescribed by a doctor. If treatment is necessary during this period or when trying to conceive, the smallest dose should be used for the shortest possible time. From the 20th week of pregnancy, ibuprofen may cause kidney function disorders in the unborn baby if taken for more than a few days. This may lead to a decrease in the amount of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the baby's heart. If treatment is necessary for a longer period, the doctor may recommend additional monitoring.
The medicine passes into breast milk, but it can be used during breastfeeding if it is administered in the recommended doses and for the shortest possible period.
In women of childbearing age, it should be considered that the use of medicines containing ibuprofen may cause fertility disorders. The patient should avoid taking this medicine if they are trying to conceive.

Driving and using machines

Patient who experience dizziness, vision disturbances, or other symptoms while taking this medicine should avoid driving and operating machines.

This medicine contains tartrazine

The medicine may cause allergic reactions.

This medicine contains sorbitol

The medicine contains 51.02 mg of sorbitol in each capsule, which corresponds to 0.73 mg/kg.

This medicine contains potassium

The medicine contains less than 1 mmol (39 mg) of potassium per capsule, which means the medicine is considered "potassium-free".

3. How to use Paduden Express

This medicine should always be used exactly as described in this patient leaflet or as directed by the doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted.
The recommended dose is:

• Adults and adolescents over 12 years of age (adolescents with a body weight over 40 kg): Initial dose: one or two capsules (200 mg) taken with water. If necessary, additional doses can be taken in the form of one or two capsules (200 mg), but the total dose should not exceed 6 capsules in 24 hours. The interval between consecutive doses should be at least 4 hours for a dose of 200 mg.
• Patient over 65 years of age: the doctor should determine the appropriate dosage, as it may be necessary to reduce the usual dose.

The smallest effective dose should be used for the shortest period necessary to relieve symptoms. If the symptoms of the infection (such as fever and pain) persist or worsen, the patient should contact their doctor immediately (see section 2).
Method of administration
The medicine is intended for oral use.
The capsules should be swallowed with a small amount of water. The capsules should not be chewed.
Patient with sensitive stomach should take this medicine with a meal.
The medicine is indicated for use in case of pain or fever. If these symptoms disappear, the use of the medicine should be stopped.
If after 3 days in the case of fever treatment or 3 days in the case of pain treatment in adolescents or after 5 days in the case of pain treatment in adults, the symptoms worsen or do not improve, the patient should consult their doctor.

Overdose of Paduden Express

If the patient has taken a larger dose of Paduden Express than recommended or if children have accidentally taken the medicine, they should always contact their doctor or the nearest hospital for advice on the risk and actions to be taken.
Symptoms of overdose may include nausea, abdominal pain, vomiting (which may contain blood), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, ringing in the ears, confusion, and nystagmus. It may also cause agitation, drowsiness, disorientation, or coma. Seizures may occur in some cases. After taking a large dose of the medicine, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, feeling cold, and breathing difficulties have been observed. Additionally, the prothrombin time/INR may be prolonged, probably due to the effect on the activity of circulating blood clotting factors. Acute kidney failure and liver damage may occur. In patients with asthma, worsening of asthma symptoms is possible. Furthermore, low blood pressure and slowed breathing may occur.
Activated charcoal should be administered if the patient has taken a significant amount of the medicine. Gastric lavage should be considered only within 60 minutes of taking a significant amount of the medicine.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The likelihood of side effects increases in patients over 65 years of age. The occurrence of side effects is less common in the case of short treatment duration and when the daily dose is less than the maximum recommended dose.

STOPusing this medicine and contact a doctor immediately if the patient experiences:

symptoms of gastrointestinal bleeding, such as: severe abdominal pain, black or tarry stools, and vomiting blood or dark particles resembling coffee grounds.

• symptoms of very rare but serious allergic reactions, such as: worsening of asthma, wheezing or changed breathing of unknown origin, swelling of the face, tongue, or throat, difficulty breathing, rapid heartbeat, and drop in blood pressure leading to shock. Such symptoms may occur after the first use of this medicine;
• severe skin reactions, such as: rashes all over the body, skin peeling, blistering, or shedding.
• Red, scaly rash with blisters on the skin, peeling skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).

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• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
• Red, scaly rash with bumps under the skin and blisters, usually located in skin folds, on the torso, and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis, AGEP). If such symptoms occur, the patient should stop taking Paduden Express and seek medical attention immediately. See also section 2.
• Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

The patient should consult their doctor if they experience any of the following side effects:

Frequent(may affect up to 1 in 10 people):

• gastrointestinal disorders, such as heartburn, abdominal pain, and nausea, indigestion, diarrhea, vomiting, bloating (gas), constipation, and minor gastrointestinal bleeding, which may rarely cause anemia.

Uncommon(may affect up to 1 in 100 people):

• peptic ulcers, perforation, or bleeding, oral mucosal inflammation with ulcers, worsening of symptoms of existing intestinal disease (ulcerative colitis or Crohn's disease), gastritis;
• vision disturbances;
• various skin rashes;
• hypersensitivity reactions with urticaria and itching.

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

• ringing in the ears (tinnitus);
• increased blood urea levels, pain in the sides and/or abdominal pain, blood in the urine, and fever, which may be symptoms of kidney damage (renal papillary necrosis);
• decreased hemoglobin levels.

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

• esophageal inflammation, pancreatitis, and intestinal stricture;
• heart failure, myocardial infarction, and facial and hand edema;
• decreased urine output, edema, and cloudy urine (nephrotic syndrome), interstitial nephritis (kidney disease), which may lead to acute kidney failure. If any of the above symptoms occur, the patient should stop taking Paduden Express and consult their doctor immediately, as they may be the first symptoms of kidney damage or kidney failure;
• psychotic reactions, depression;
• high blood pressure, vasculitis;
• palpitations;
• liver function disorders (the first symptom may be skin discoloration), liver damage, especially after prolonged treatment, liver failure, acute hepatitis;
• blood system disorders. The first symptoms are: fever, sore throat, superficial oral mucosal ulcers, flu-like symptoms, severe fatigue, nosebleeds, and skin bruises of unknown origin. In such cases, the treatment should be stopped immediately and the doctor consulted. The patient should not self-medicate with pain or antipyretic medications;
• in patients with chickenpox, severe skin infections and soft tissue complications may develop;
• in connection with the use of non-steroidal anti-inflammatory drugs (NSAIDs), cases of worsening of infectious inflammation (e.g. development of necrotizing fasciitis) have been reported. If symptoms of infection occur or worsen, the patient should contact their doctor immediately. The doctor will determine whether there are indications for antibiotic therapy;

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• during treatment with ibuprofen, symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever, or disorientation have been observed. The risk of such side effects may be higher in patients with autoimmune disorders (e.g. systemic lupus erythematosus (SLE), mixed connective tissue disease). If they occur, the patient should consult their doctor immediately;
• severe forms of skin reactions, such as rash with redness and blistering (e.g. Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, Lyell's syndrome) and hair loss (alopecia).

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

• respiratory system reactivity including asthma, bronchospasm, or dyspnea;
• a severe skin reaction known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin rash, swollen lymph nodes, and increased eosinophil count (a type of white blood cell);
• red, scaly rash with bumps under the skin and blisters, usually located in skin folds, on the torso, and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis, AGEP). If such symptoms occur, the patient should stop taking Paduden Express and seek medical attention immediately. See also section 2.
• the skin becomes sensitive to light;
• headache, dizziness, insomnia, agitation, irritability, and fatigue.

Taking such medicines as Paduden Express may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. During treatment with Paduden Express, prolonged bleeding time, fluid retention (edema), high blood pressure, and heart failure have also been reported.
Based on the experience with the use of NSAIDs, it cannot be excluded that cases of interstitial nephritis (kidney disease), nephrotic syndrome (a disorder characterized by the presence of protein in the urine and edema), and kidney failure may occur.

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 Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw; phone: +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, it is possible to gather more information on the safety of the medicine.

5. How to store Paduden Express

The medicine should be stored out of sight and reach of children.
Store in a temperature below 30°C.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the month stated.
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Do not use this medicine if there are visible signs of capsule damage.
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 packaging and other information

What Paduden Express contains

The active substance of the medicine is ibuprofen. Each soft capsule contains 200 mg of ibuprofen.
The other ingredients are:
Core of the capsule: macrogol 600, potassium hydroxide, purified water
Cap of the capsule: gelatin, sorbitol liquid, partially dehydrated (E 420), tartrazine (E 102), and medium-chain triglycerides

What Paduden Express looks like and contents of the pack

Paduden Express is a soft gelatin capsule, oval in shape (approximately 14 mm x 8 mm), yellow in color, filled with a clear solution.
Paduden Express is available in packs containing 10, 20, or 30 soft capsules in PVC/PVDC/Aluminum blisters in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Ranbaxy (Poland) Sp. z o.o.
ul. Idzikowskiego 16
00-710 Warsaw
phone: 22 642 07 75

Manufacturer

Laboratorios Liconsa S.A.
Pol. Ind. Miralcampo, Avenida Miralcampo nº7
19200, Azuqueca de Henares (Guadalajara)
Spain
Terapia S.A.
Strada Fabricii 124
400632 Cluj-Napoca, Cluj
Romania

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Lithuania: Ibuprofen NVT 200 mg soft capsules
Estonia: Ibuprofen NVT
Romania: PADUDEN Express 200 mg soft capsules
Poland: Paduden Express
Date of last revision of the leaflet:29.05.2025