Paduden Express Forte

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

The active substance of the medicine is ibuprofen, which acts 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), back pain (lower back pain), as well as in febrile conditions.
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 a doctor.

2. Important information before taking Paduden Express Forte

When not to take Paduden Express Forte:

• If the patient is allergic to ibuprofen, other nonsteroidal 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 exacerbate the course of these diseases.

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leading to bloody diarrhea) or if the patient has a history of bleeding or perforation of the stomach or intestines.

• 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 necessary use of 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 Forte, 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 control tests.
• 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. The patient should also consult about 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 (diuretic 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 that affects the blood and can cause symptoms such as blood in the urine or liver disease). The doctor should assess 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 it difficult to diagnose properly.
• If the patient experiences headache after long-term use, they should not increase the dose of this medicine.
• It is possible to experience allergic reactions after taking this medicine.
• If the patient will be taking ibuprofen after undergoing major surgery, the doctor will subject them to close monitoring.
• If the patient has an infection - see below, the section titled "Infections".
• If the patient has chickenpox, taking this medicine is not recommended.
• It is essential to use the smallest effective dose to relieve/control pain and not to take 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 slight increase in the risk of heart attack or stroke, especially when taken in high doses. Do not exceed the recommended dose and duration of treatment.
Before starting treatment with Paduden Express Forte, 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, has undergone 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 family history of heart disease or stroke, or smokes.

Medications 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 allergic reactions to this medicine have been observed, including difficulty breathing, swelling of the face and neck (angioedema), chest pain. If any of these symptoms are noticed, the patient should stop taking Paduden Express Forte and contact their doctor or emergency medical services immediately.

Skin reactions

Severe skin reactions have been reported with 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 symptoms associated with these severe skin reactions described in section 4, they should stop taking Paduden Express Forte and seek medical attention immediately.

Infections

Paduden Express Forte may mask the symptoms of infection, such as fever and pain.
Therefore, Paduden Express Forte 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 consult their doctor immediately.

Paduden Express Forte and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
Paduden Express Forte may affect the action of other medications or other medications may affect the action of Paduden Express Forte.
For example:

• anticoagulant medications (e.g., blood thinners, such as acetylsalicylic acid (aspirin), warfarin, ticlopidine);
• blood pressure-lowering medications (ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan);
• antiplatelet agents (preventing blood clots in blood vessels), such as ticlopidine or aspirin (acetylsalicylic acid);
• other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin;

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• corticosteroids, such as cortisone and prednisolone;
• selective serotonin reuptake inhibitors (medications used in depression);
• lithium (used in the treatment of depression);
• methotrexate (used in the treatment of cancer and rheumatism). The doctor may adjust the dose of this medication;
• mifepristone (a medication with abortifacient action);
• digoxin and other cardiac glycosides (used in heart failure);
• hydantoins, such as phenytoin (used in the treatment of epilepsy);
• sulfonamides, such as sulfamethoxazole and cotrimoxazole (used in bacterial infections);
• diuretic medications (medications that increase urine production);
• pentoxifylline (used in circulation disorders);
• probenecid (used in the treatment of gout or infections in combination with penicillin);
• quinolone antibiotics, such as norfloxacin;
• sulfinpyrazone (used in the treatment of gout);
• insulin and oral antidiabetic medications (used to lower blood glucose levels);
• cyclosporine and tacrolimus (used to prevent rejection of transplanted organs);
• antihypertensive medications (medications that lower high blood pressure);
• thrombolytic medications (medications that cause dissolution or breakdown of blood clots);
• zidovudine (a medication used in the treatment of HIV infection);
• aminoglycoside antibiotics, such as neomycin;
• herbal extracts: Ginkgo biloba;
• baclofen (used in the treatment of involuntary and persistent muscle spasms);
• phenytoin (used in the treatment of epilepsy);
• ion exchange resins, such as cholestyramine (used to lower high cholesterol levels in the blood);
• tacrine (used in the treatment of Alzheimer's disease);
• CYP2C9 inhibitors, such as voriconazole and fluconazole.

Also, some other medications may be affected or have an effect on treatment with Paduden Express Forte. Therefore, before taking Paduden Express Forte with other medications, the patient should always consult their doctor or pharmacist.
Interactions with analytical tests
In the case of performing any diagnostic tests (including blood tests, urine tests, skin tests with allergens, etc.), the patient should inform their doctor about taking this medicine, as it may change the results.

Paduden Express Forte with food, drink, and alcohol

This medicine can be taken with or without food. It is recommended to take the medicine during meals to reduce the possibility of stomach disorders.
The patient should 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.
Taking this medicine with food may reduce the risk of stomach ulcers.

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.
In the first and second trimester of pregnancy, ibuprofen should not be taken unless it is clearly necessary, as taking the medicine may increase the risk of developmental abnormalities or miscarriage. In such cases, the patient should take the lowest dose for the shortest possible time.
Taking 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 risk of bleeding in the patient and their baby and cause delayed or prolonged labor. During the first 6 months of pregnancy, the patient should not take the medicine unless it is absolutely necessary and recommended by a doctor. If treatment is necessary during this period or during attempts to become pregnant, the patient should take the smallest dose for the shortest possible time. After the 20th week of pregnancy, ibuprofen may cause kidney problems 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 taken during breastfeeding if it is taken in the recommended doses and for the shortest possible period.
In women of childbearing age, it should be considered that taking medications containing ibuprofen may cause fertility disorders. The patient should avoid taking this medicine if they are trying to become pregnant.

Driving and using machines

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

This medicine contains sorbitol

The medicine contains 72.4 mg of sorbitol in each capsule, which corresponds to 1.03 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 take Paduden Express Forte

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

• Adults and adolescents over 12 years of age: 1 capsule of 400 mg taken every 6-8 hours as needed. Do not take more than 3 capsules (1200 mg) per day.
• Patients with kidney, liver, or heart disease should consult their doctor, as dose reduction may be necessary.
• Patients over 65 years of age: the doctor should determine the appropriate dosage, as it may be necessary to reduce the usual dose.

The patient should take the smallest effective dose 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 consult their doctor immediately (see section 2).

Use in children and adolescents under 12 years of age.

The medicine should not be taken by children under 12 years of age due to the content of 400 mg of ibuprofen. Other strengths of the medicine are available for this age group.
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.
It is recommended that patients with sensitive stomachs take this medicine with food.
The medicine is indicated for use in case of pain or fever. If these symptoms disappear, the patient should stop taking the medicine.
If after 3 days in adolescents between 12 and 18 years of age the symptoms do not improve or worsen, the patient should consult their doctor.
If after 3 days in the case of fever treatment and 5 days in the case of pain treatment in adults the symptoms persist, the patient should consult their doctor.

Overdose of Paduden Express Forte

If the patient has taken a larger dose of Paduden Express Forte 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 have been observed in some patients. 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 action of circulating blood clotting factors. Acute kidney failure and liver damage may occur. In patients with asthma, worsening of asthma symptoms is possible. Apart from that, low blood pressure and slow breathing may occur.

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.

STOP taking this medicine and contact your doctor immediately if you

experience:

• 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, lips, or tongue, difficulty breathing, rapid heartbeat, and low 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, peeling of the skin, blistering, or shedding of the skin.
• Red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling of the 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).

• A red, scaly rash with nodules 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).
• Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

Contact your doctor if you experience any of the following side effects:

Frequent(may occur in less than 1 in 10 people):

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

Uncommon(may occur in less than 1 in 100 people):

• peptic ulcers, perforation, or bleeding, inflammation of the mouth with ulcers, worsening of existing intestinal disease (ulcerative colitis or Crohn's disease), gastritis;
• visual disturbances;
• various skin rashes;
• allergic reactions with urticaria and itching.

Rare(may occur in less than 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 occur in less than 1 in 10,000 people):

• esophagitis, 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 Forte 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 long-term treatment, liver failure, acute hepatitis;
• blood system disorders. The first symptoms are: fever, sore throat, superficial oral mucosa ulcers, flu-like symptoms, significant fatigue, nosebleeds, and skin bruises of unknown origin. In such cases, the patient should stop the treatment and consult their doctor immediately. The patient should not treat themselves with pain-relieving or antipyretic medications;
• in patients with chickenpox, severe skin infections and soft tissue complications may develop;
• in connection with the use of nonsteroidal anti-inflammatory drugs (NSAIDs), cases of exacerbation of inflammatory conditions caused by infections (e.g., development of necrotizing fasciitis) have been reported. If symptoms of infection worsen or appear, the patient should immediately consult their doctor. The doctor will determine whether there are indications for antibiotic therapy;
• during treatment with ibuprofen, symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever, or disorientation have been observed. The risk of such adverse reactions may be higher in patients with autoimmune disorders (e.g., systemic lupus erythematosus (SLE), mixed connective tissue disease). If they occur, the patient should immediately consult their doctor;
• 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. The symptoms of DRESS syndrome include: skin rash, swollen lymph nodes, and an increased number of eosinophils (a type of white blood cell);
• a red, scaly rash with nodules 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 Forte and seek medical attention immediately. See also section 2.
• skin sensitivity to light;
• headache, dizziness, insomnia, agitation, irritability, and fatigue.

Taking such medications as Paduden Express Forte may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke. In connection with treatment with Paduden Express Forte, prolonged bleeding time, fluid retention (edema), high blood pressure, and heart failure have also been reported.
Based on the experience with the use of nonsteroidal anti-inflammatory drugs (NSAIDs), it is not possible to exclude cases of interstitial nephritis (kidney disease), nephrotic syndrome (a disorder characterized by the presence of protein in the urine and edema), or kidney failure. If any of the above symptoms occur, the patient should stop taking Paduden Express Forte and consult their doctor immediately.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell 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;
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, it is possible to gather more information on the safety of the medicine.

5. How to store Paduden Express Forte

The medicine should be stored out of sight and reach of children.
Store at 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.
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 unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Paduden Express Forte contains

The active substance of the medicine is ibuprofen. Each soft capsule contains 400 mg of ibuprofen.
The other ingredients are:
Core of the capsule: macrogol 600, potassium hydroxide, purified water
Shell of the capsule:gelatin, sorbitol liquid, partially dehydrated (E 420), and medium-chain triglycerides

What Paduden Express Forte looks like and contents of the pack

Paduden Express Forte is a soft gelatin capsule, oval in shape (approximately 16 mm x 10 mm), colorless or slightly yellow, filled with a clear solution.
Paduden Express Forte 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
tel. 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 400 mg soft capsules
Latvia: Ibuprofen NVT 400 mg soft capsules
Estonia: Ibuprofen NVT
Romania: PADUDEN Express Forte 400 mg soft capsules
France: Ibuprofene Biogaran Conseil 400 mg, soft capsules
Poland: Paduden Express Forte
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Date of last revision of the leaflet:29.05.2025