LT/H/0162/001-002/IB/008

Package leaflet: Information for the

user
Paduden Express, 200 mg, soft capsules
Ibuprofenum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
Always use this medicine exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

Keep this leaflet. You may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
If there is no improvement after 3 days of treatment for fever or 3 days of treatment for pain in adolescents, or after 5 days of treatment for pain in adults, or if symptoms worsen, consult your doctor.

Table of contents

What Paduden Express is and what it is used for
Important information before taking Paduden Express
How to take Paduden Express
Possible side effects
How to store Paduden Express
Contents of the pack and other information

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

The active substance in Paduden Express is ibuprofen, which works by reducing pain and fever.
This medicine is indicated for use in adults and adolescents over 12 years of age to relieve mild to moderate pain such as headache, toothache, menstrual pain, muscle pain (cramps), or back pain (lumbago), as well as for feverish conditions, fever, and pain following vaccination.
If symptoms persist or worsen after 3 days of treatment for fever or 3 days of treatment for pain in adolescents, or after 5 days of treatment for pain in adults, consult your doctor.

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 indicating an allergic reaction include itchy rash, facial swelling, swelling of the lips or tongue, runny nose, difficulty breathing or asthma.
If the patient has ever had gastric or duodenal ulcers, gastrointestinal bleeding or perforation.
If the patient has bloody vomiting.
If the patient suffers from Crohn's disease (a chronic condition in which the immune system attacks the intestines, causing inflammation, usually leading to bloody diarrhoea) or ulcerative colitis, as ibuprofen may worsen these conditions.
If the patient has tarry stools or bloody diarrhoea.
If the patient has severe liver or kidney disease.
If the patient has bleeding disorders, coagulation disorders, or is taking anticoagulant medicines (used to "thin" the blood). If anticoagulant therapy is necessary at the same time, the doctor will order blood coagulation 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, discuss with your doctor or pharmacist:

If the patient has ever had gastric or duodenal ulcers, bleeding from the stomach or duodenum, or perforation of the stomach or duodenum, which may present as severe or persistent abdominal pain and/or black stools, even without prior warning symptoms. The risk increases with higher doses and longer treatment duration, in patients with a history of peptic ulcer disease, and in elderly patients.
If the patient has oedema (fluid retention).
If the patient has asthma or other respiratory disorders.
If the patient has or has had heart disease or high blood pressure.
If the patient has kidney or liver disease, is over 60 years of age, or needs to take this medicine for a prolonged period (longer than 1–2 weeks) – in such cases, the doctor may perform regular monitoring.
If the patient is dehydrated, e.g. due to severe diarrhoea or vomiting, they should drink plenty of fluids and contact a doctor immediately, as ibuprofen may cause kidney failure due to dehydration. In dehydrated adolescents, there is a risk of kidney function impairment.
If the patient is concurrently taking drugs affecting blood coagulation, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. Also consult about using other medicines that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
If the patient is being treated with diuretics (water pills). The doctor should monitor kidney function.
If the patient has systemic lupus erythematosus (a chronic autoimmune disease that may affect various organs, the nervous system, blood vessels, skin and joints), as aseptic meningitis may occur.
If the patient has acute intermittent porphyria (a metabolic disorder affecting the blood, which may cause symptoms such as blood in urine or liver disease). The appropriateness of ibuprofen use should be evaluated.
If the patient is being treated with ibuprofen, as it may mask fever, a key sign of infection, potentially delaying correct diagnosis.
If the patient has headaches after long-term use, do not increase the dose of this medicine.
Allergic reactions may occur after using this medicine.
If the patient will be taking ibuprofen after major surgery, the doctor will closely monitor them.
If the patient has an infection – see the section titled “Infections” below.
If the patient has chickenpox, use of this medicine is not recommended.
It is important to use the lowest effective dose to relieve/control pain and not to use this medicine longer than necessary to control symptoms.

Cardiovascular precautions
Taking anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or duration of treatment. Before starting Paduden Express, discuss treatment with your doctor or pharmacist if:

The patient has heart diseases such as heart failure or angina (chest pain), has had a heart attack or bypass surgery, has peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked arteries), or has had any stroke (including mini-stroke or transient ischaemic attack - TIA).
The patient has high blood pressure, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or if the patient smokes.

These types of medicines may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).
Allergic reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have been reported. If any of these symptoms occur, discontinue Paduden Express immediately and contact a doctor or emergency medical services without delay.

Skin reactions
Severe skin reactions have occurred with ibuprofen use, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP). If the patient experiences any symptoms related to these severe skin reactions described in section 4, discontinue Paduden Express immediately and seek medical help.

Infections
Paduden Express may mask objective signs of infection such as fever and pain. Therefore, Paduden Express may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine during an infection and symptoms persist or worsen, consult a doctor immediately.

Paduden Express and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.
Paduden Express may affect the action of other medicines, or other medicines may affect the action of Paduden Express.
For example:

Anticoagulants (e.g. drugs preventing blood clots ("blood thinners"), such as acetylsalicylic acid (aspirin), warfarin, ticlopidine);
Medicines lowering blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan);
Antiplatelet agents (preventing blood clot formation in blood vessels), such as ticlopidine or aspirin (acetylsalicylic acid);
Other non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin;
Glucocorticosteroids, such as cortisone and prednisolone;
Selective serotonin reuptake inhibitors (medicines used for depression);
Lithium (used in the treatment of depression);
Methotrexate (used in cancer and rheumatoid arthritis treatment). The doctor may adjust the dose of this medicine;
Mifepristone (a drug with abortifacient properties);
Digoxin and other cardiac glycosides (used in heart failure);
Hydantoins, such as phenytoin (used in epilepsy treatment);
Sulphonamides, such as sulfamethoxazole and co-trimoxazole (used in bacterial infections);
Diuretics (medicines increasing urine excretion);
Pentoxifylline (used in circulatory disorders);
Probenecid (used in gout treatment or with penicillin for infections);
Quinolone antibiotics, such as norfloxacin;
Sulfinpyrazone (for gout treatment);
Insulin and oral antidiabetic medicines (used to lower blood glucose levels);
Cyclosporine and tacrolimus (used to prevent rejection of transplanted organs);
Antihypertensive medicines (lowering high blood pressure);
Thrombolytic medicines (causing dissolution or breakdown of blood clots);
Zidovudine (a medicine used in HIV infection treatment);
Aminoglycoside antibiotics, such as neomycin;
Herbal extracts: Ginkgo biloba;
Baclofen (used in treatment of involuntary and persistent muscle spasms);
Phenytoin (used in epilepsy treatment);
Ion-exchange resins, such as cholestyramine (used to lower high blood cholesterol levels);
Tacrine (used in Alzheimer's disease treatment);
Inhibitors of CYP2C9, such as voriconazole and fluconazole.

Other medicines may also influence or be influenced by treatment with Paduden Express. Therefore, always consult a doctor or pharmacist before using Paduden Express with other medicines.

Interactions with diagnostic tests
If undergoing any diagnostic tests (including blood and urine tests, skin tests with allergens, etc.), inform the doctor about current or recent use of this medicine, as it may alter test results.

Paduden Express with food, drink and alcohol
This medicine may be taken with or without food.
Patients with sensitive stomachs are advised to take Paduden Express with food.
Avoid taking ibuprofen with alcohol to prevent stomach damage.
Use of ibuprofen by patients who regularly consume alcohol (at least three alcoholic drinks – beer, wine, spirits – per day) may cause gastrointestinal bleeding.

Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Do not use ibuprofen during the first and second trimesters of pregnancy unless clearly necessary, as it may increase the risk of congenital malformations or miscarriage. In such cases, use the lowest possible dose for the shortest possible duration.
Use of this medicine is contraindicated during the third trimester of pregnancy.
Do not take ibuprofen during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. It may cause kidney and heart problems in the unborn child, increase the tendency to bleeding in both mother and child, and delay or prolong labour. Do not use this medicine during the first six months of pregnancy unless absolutely necessary and recommended by a doctor. If treatment is necessary during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. From the 20th week of pregnancy, ibuprofen may cause kidney dysfunction in the unborn child if taken for longer than a few days. This may lead to reduced amniotic fluid volume (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If treatment is required for longer than a few days, the doctor may recommend additional monitoring.
The medicine passes into breast milk but may be used during breastfeeding if taken at recommended doses and for the shortest possible duration.
In women of childbearing age, consider that use of medicines containing ibuprofen may cause fertility disorders. Avoid taking this medicine if the patient is trying to conceive.

Driving and operating machinery
Patients who experience dizziness, visual disturbances or other symptoms while taking this medicine should refrain from driving or operating machinery.

This medicine contains tartrazine
The medicine may cause allergic reactions.

This medicine contains sorbitol
The medicine contains 51.02 mg of sorbitol per capsule, equivalent to 0.73 mg/kg.

This medicine contains potassium
The medicine contains less than 1 mmol (39 mg) of potassium per capsule, meaning it is considered "potassium-free".

3. How to use Paduden Express

This medicine should always be taken exactly as described in this patient leaflet, or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dosage:

Adults and adolescents over 12 years of age (adolescents with body weight above 40 kg): Initial dose: one or two capsules (200 mg) taken with water. Additional doses of one or two capsules (200 mg) may be taken if needed; however, the total dose should not exceed 6 capsules within 24 hours. The interval between consecutive doses should be at least four hours when taking a 200 mg dose.
Patients over 65 years of age: The doctor should determine the appropriate dosage, as a reduction from the usual dose may be necessary.

The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If symptoms of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).

Method of administration
This medicine is for oral use.
Swallow the capsules whole with a small amount of water. Do not chew the capsules.
Patients with a sensitive stomach are advised to take this medicine with food.
This medicine is indicated for use when pain or fever occurs. If these symptoms resolve, stop taking the medicine.
If, after 3 days of treatment for fever or 3 days of treatment for pain in adolescents, or after 5 days of treatment for pain in adults, symptoms worsen or do not improve, consult a doctor.

Overdose of Paduden Express

If a patient takes more than the recommended dose of Paduden Express, or if children accidentally ingest the medicine, always contact a doctor or the nearest hospital for advice regarding potential risks and necessary actions.

Symptoms of overdose may include nausea, abdominal pain, vomiting (possibly with blood), gastrointestinal bleeding (see section 4 below), diarrhea, headache, tinnitus, confusion, and nystagmus. Agitation, drowsiness, disorientation, or coma may also occur. Seizures may sometimes occur in patients. After ingestion of a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been observed, as well as blood in urine, low blood potassium levels, feeling cold, and breathing difficulties. In addition, prothrombin time/INR may be prolonged, likely due to effects on circulating blood coagulation factors. Acute kidney failure and liver damage may also occur. In patients with asthma, worsening of asthma symptoms is possible. Furthermore, low blood pressure and respiratory depression may occur.

Administer activated charcoal if a significant amount of the medicine has been ingested. Gastric lavage should only be considered within 60 minutes after ingestion of a significant amount of the medicine.
LT/H/0162/001-002/IB/008

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The likelihood of adverse effects increases in patients over the age of 65. Adverse effects are less common with short-term treatment and when the daily dose is lower than the maximum recommended dose.
THIS MEDICINE MUST BE DISCONTINUED AND IMMEDIATE MEDICAL ADVICE SOUGHT IF THE PATIENT EXPERIENCES:

Symptoms of gastrointestinal bleeding, such as severe abdominal pain, black or tar-like stools, vomiting blood or dark particles resembling coffee grounds.
Symptoms of very rare but severe allergic reactions, such as worsening asthma, wheezing or altered breathing of unknown origin, swelling of the face, tongue or throat, difficulty breathing, rapid heartbeat, or drop in blood pressure leading to shock. Such symptoms may occur even after the first dose of this medicine.
Severe skin reactions, such as rashes over the entire body, skin peeling, blister formation or skin sloughing.
Red, flat, non-elevated, target-like or circular skin lesions on the trunk, often with blisters in the center, skin peeling, and ulceration in the mouth, throat, nose, genital organs 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).

LT/H/0162/001-002/IB/008

Widespread rash, high fever and enlarged lymph nodes (DRESS syndrome).
Red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).
Chest pain, which may indicate a potentially serious allergic reaction known as Kounis syndrome.

Consult a doctor if any of the following adverse effects occur:
Common (may affect up to 1 in 10 people):

Gastrointestinal disturbances such as heartburn, abdominal pain, nausea, indigestion, diarrhoea, vomiting, bloating (gas), constipation, and minor bleeding from the stomach and/or intestines, which may exceptionally lead to anaemia.

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

Peptic ulcers, perforation or bleeding, inflammation of the oral mucosa with ulceration, exacerbation of symptoms of existing bowel disease (colitis or Crohn's disease), gastritis.
Visual disturbances.
Various skin rashes.
Hypersensitivity reactions with urticaria and itching.

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

Tinnitus (ringing in the ears).
Increased blood urea levels, flank pain and/or abdominal pain, blood in urine and fever, which may indicate kidney damage (renal papillary necrosis).
Decreased haemoglobin concentration.

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

Oesophagitis, pancreatitis and development of intestinal stricture.
Heart failure, myocardial infarction and swelling of the face and hands.
Reduced urine output, swelling and cloudy urine (nephrotic syndrome), inflammatory kidney disease (interstitial nephritis), which may lead to acute kidney failure. If any of the above symptoms occur, Paduden Express must be discontinued immediately and medical advice sought, as these may be early signs of kidney damage or kidney failure.
Psychotic reactions, depression.
High blood pressure, vasculitis.
Palpitations.
Blood disorders. Initial symptoms include fever, sore throat, superficial ulceration of the oral mucosa, flu-like symptoms, marked fatigue, nosebleeds and skin bleeding, and unexplained bruising. In such cases, treatment must be stopped immediately and medical advice sought. Self-medication with analgesics or antipyretics must be avoided.
In patients with chickenpox, serious skin infections and soft tissue complications may develop.
With the use of non-steroidal anti-inflammatory drugs (NSAIDs), cases of worsening inflammation due to infections (e.g. necrotizing fasciitis) have been reported. If signs or symptoms of infection appear or worsen, the patient should seek immediate medical attention. The doctor will determine whether antibiotic therapy is indicated.
Aseptic meningitis symptoms such as neck stiffness, headache, nausea, vomiting, fever or disorientation have been observed during ibuprofen use. The risk of such adverse effects may be higher in patients with autoimmune disorders (e.g. systemic lupus erythematosus (SLE), mixed connective tissue disease). Immediate medical consultation is required if these symptoms occur.
Severe forms of skin reactions such as rash with redness and blister formation (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 available data):

Respiratory tract reactivity including asthma, bronchospasm or shortness of breath.
Severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include skin rash, swollen lymph nodes and increased eosinophil count (a type of white blood cell).
Red, scaly rash with subcutaneous nodules and blisters, predominantly in skin folds, on the trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis, AGEP). If such symptoms occur, Paduden Express must be discontinued immediately and medical help sought. See also section 2.
Skin becomes sensitive to light.
Headache, dizziness, insomnia, restlessness, irritability and fatigue.

Taking medicines such as Paduden Express may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Treatment with Paduden Express has also been associated with prolonged bleeding time, oedema (fluid retention), high blood pressure and heart failure.
Based on experience with NSAIDs, cases of interstitial nephritis (kidney disease), nephrotic syndrome (a disorder characterised by protein in the urine and body swelling) and kidney failure (sudden loss of kidney function) cannot be ruled out.
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Paduden Express

Keep this medicine out of sight and reach of children.
Store 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 stated month.
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Do not use this medicine if there are visible signs of damage to the capsules.
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 pack and other information

What Paduden Express contains
The active substance is ibuprofen. Each soft capsule contains 200 mg of ibuprofen.
The other ingredients are:
Capsule core: macrogol 600, potassium hydroxide, purified water
Capsule shell: 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 yellow, oval-shaped soft gelatin capsules (approximately 14 mm x 8 mm) filled with a clear solution.
Paduden Express is available in packs containing 10, 20 or 30 soft capsules in PVC/PVDC/Aluminium blister packs within a cardboard carton. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Lithuania: Ibuliq 200 mg minkštosios kapsulės
Romania: PADUDEN Express 200 mg capsule moi
Poland: Paduden Express

Paduden express