Paduden express forte

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Package leaflet: Information for the user

Paduden Express Forte, 400 mg, soft capsules
Ibuprofen
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 leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please contact 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 of treatment for fever or 3 days of pain treatment in adolescents, or after 5 days of pain treatment in adults, or if your condition worsens, consult your doctor.

Contents of the leaflet

1. What Paduden Express Forte is and what it is used for
2. Important information before taking Paduden Express Forte
3. How to take Paduden Express Forte
4. Possible side effects
5. How to store Paduden Express Forte
6. Contents of the pack and other information

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

The active substance in Paduden Express Forte is ibuprofen, which works by reducing pain and fever.
This medicine is indicated for use in adults and adolescents over 12 years of age for the relief of mild to moderate pain such as headache, toothache, menstrual pain, muscle pain (cramps), back pain (lumbar region), as well as for feverish conditions.
If symptoms worsen or do not improve after 3 days of treatment for fever or 3 days of pain treatment in adolescents, or after 5 days of pain treatment in adults, consult a doctor.

2. Important information before using Paduden Express Forte

When not to use Paduden Express Forte:

• 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 may include itchy rash, swelling of the face, lips or tongue, runny nose, difficulty breathing or asthma.
• If the patient has ever experienced 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, which usually

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leads 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, blood clotting disorders, or is taking anticoagulant medicines (used to "thin" the blood). If anticoagulant medicines must be used simultaneously, 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 Forte, discuss this 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 problems, is over 60 years of age, or needs to take this medicine for a long time (longer than 1-2 weeks) – in such cases, the doctor may perform regular monitoring examinations.
• 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. Dehydrated adolescents are at risk of impaired kidney function.
• If the patient is concurrently taking medicines 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 the patient's 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 and potentially causing 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 symptom of infection, potentially delaying correct diagnosis.
• If the patient has headache due to prolonged 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 below, section titled "Infections".
• 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.

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

Such medicines may cause fluid retention, especially in patients with
heart failure and/or high blood pressure (hypertension).
Allergic reactions to ibuprofen have occurred, including
difficulty breathing, facial and neck swelling (angioedema), chest pain. If any of these symptoms occur, immediately discontinue Paduden Express Forte and contact a doctor or emergency medical services without delay.
Skin reactions
Severe skin reactions have occurred 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 symptoms related to these severe skin reactions described in section 4, immediately discontinue Paduden Express Forte and seek medical help.
Infections
Paduden Express Forte may mask signs of infection such as fever and pain.
Therefore, Paduden Express Forte 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, they should immediately consult a doctor.
Paduden Express Forte and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Paduden Express Forte may affect the action of other medicines, or other medicines may affect the action of Paduden Express Forte.
For example:

• anticoagulants (e.g. preventing blood clots ("thinning the blood"), such as acetylsalicylic acid (aspirin), warfarin, ticlopidine);
• blood pressure-lowering medicines (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;

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• glucocorticosteroids, such as cortisone and prednisolone;
• selective serotonin reuptake inhibitors (medicines used for 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 medicine;
• mifepristone (a medicine 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);
• diuretics (medicines increasing urine excretion);
• pentoxifylline (used in circulatory disorders);
• probenecid (used in the treatment of gout or infections in combination with penicillin);
• quinolone antibiotics, such as norfloxacin;
• sulfinpyrazone (for the treatment of gout);
• 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 the treatment of HIV infection);
• aminoglycoside antibiotics, such as neomycin;
• herbal extracts: Ginkgo biloba (Japanese maidenhair tree);
• 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 blood cholesterol levels);
• tacrine (used in the treatment of Alzheimer's disease);
• inhibitors of CYP2C9, such as voriconazole and fluconazole.

Some other medicines may also be affected by or affect treatment with Paduden
Express Forte. Therefore, always consult a doctor or pharmacist before using Paduden Express Forte with other medicines.
Interactions with diagnostic tests
If undergoing any diagnostic tests (including blood, 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 Forte with food, drink and alcohol
This medicine can be taken with or without food. It is recommended to take the medicine with meals to reduce the possibility of gastrointestinal disturbances.
Avoid taking ibuprofen together 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.
During the first and second trimesters of pregnancy, ibuprofen should not be used unless clearly
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necessary, as its use may increase the risk of developmental abnormalities or miscarriage. In such cases, the lowest possible dose should be used for the shortest possible duration.
Use of this medicine is contraindicated during the third trimester of pregnancy.
Do not use 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. It may increase the tendency to bleeding in both the mother and her child and may delay or prolong labour. Do not use this medicine during the first 6 months of pregnancy unless absolutely necessary and prescribed 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 week 20 of pregnancy, ibuprofen may cause kidney function disturbances in the unborn child if taken for longer than a few days. This may lead to reduced amniotic fluid volume surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby'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 administered at recommended doses and for the shortest possible duration.
In women of childbearing age, it should be considered 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 and operating machinery.
This medicine contains sorbitol
The medicine contains 72.4 mg of sorbitol per capsule, equivalent to 1.03 mg/kg.
This medicine contains potassium
The medicine contains less than 1 mmol (39 mg) of potassium per capsule, meaning 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 information leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Recommended dose:

• Adults and adolescents over 12 years of age: 1 capsule of 400 mg every 6–8 hours as necessary. Do not take more than 3 capsules (1200 mg) in 24 hours.
• 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 a reduction from the usual dose may be necessary.

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

Use in children and adolescents under 12 years of age
This medicine should not be used in children under 12 years of age due to the presence of ibuprofen in a 400 mg dose. Other strengths of the medicine are available that are suitable for this age group.
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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 the treatment of pain or fever. If these symptoms resolve, discontinue use of the medicine.
If symptoms do not improve or worsen after 3 days in adolescents aged 12 to 18 years, consult a doctor.
If symptoms persist for more than 3 days when treating fever, or more than 5 days when treating pain in adults, consult a doctor.

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

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

Activated charcoal should be administered if a significant amount of the medicine has been ingested. Gastric lavage should only be considered within 60 minutes of ingestion of a significant overdose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The likelihood of adverse reactions increases in patients aged
over 65 years. Adverse reactions are less common with short-term
treatment and when the daily dose is lower than the maximum recommended dose.
THIS MEDICINE SHOULD BE DISCONTINUED AND IMMEDIATE MEDICAL ADVICE SOUGHT 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 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 a 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, formation of blisters or shedding of the skin.
• Red, flat, non-elevated, target-like or circular spots on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genital organs and eyes. These severe skin rashes may be preceded by fever and

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flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).

• Widespread rash, high body temperature and swollen 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 be a sign of a potentially serious allergic reaction known as Kounis syndrome.

Consult a doctor if any of the following adverse reactions occur:
Common (may occur in less than 1 in 10 people):

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

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

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

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

• Oesophagitis, pancreatitis and development of intestinal strictures;
• Heart failure, myocardial infarction and swelling of the face and hands;
• Reduced urine output, oedema and cloudy urine (nephrotic syndrome), inflammatory kidney disease (interstitial nephritis), which may lead to acute kidney failure. If any of the above symptoms occur, treatment with Paduden Express Forte should be stopped 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;
• Liver function disorders (skin discoloration may be the first sign), liver damage, especially after long-term treatment, liver failure, acute hepatitis;
• 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 should be stopped immediately and medical advice sought. Self-medication with painkillers or antipyretics should not be used;
• 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 inflammatory conditions due to infections (e.g. necrotizing fasciitis) have been reported. If signs of infection appear or worsen, the patient

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should seek immediate medical advice. The doctor will determine whether antibiotic treatment is indicated;

• During ibuprofen use, symptoms of aseptic meningitis such as 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). In case of occurrence, immediate medical advice should be sought;
• 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 reactions 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, mainly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis, AGEP). If such symptoms occur, Paduden Express Forte should be discontinued immediately and medical help sought without delay. See also section 2.
• Skin becomes sensitive to light;
• Headache, dizziness, insomnia, restlessness, irritability and fatigue.

Taking medicines such as Paduden Express Forte may be associated with a small
increased risk of heart attack (myocardial infarction) or stroke. Treatment with
Paduden Express Forte 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 characterized by protein in the urine and body swelling) and kidney failure (sudden loss of kidney function) cannot be excluded.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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 helps to provide more information on the safety of the medicine.

5. How to store Paduden Express Forte

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
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following "EXP". The expiry date refers to the last day of the stated month.
Do not use this medicine if there are visible signs of capsule damage.
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 Forte contains
The active substance is ibuprofen. Each soft capsule contains 400 mg of ibuprofen.
The other ingredients are:
Capsule core: macrogol 600, potassium hydroxide, purified water
Capsule shell: gelatin, liquid sorbitol, 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, oval-shaped gelatin capsule (approximately 16 mm x 10 mm), colourless or slightly yellow, filled with a clear solution.
Paduden Express Forte is available in packs containing 10, 20 or 30 soft capsules in blisters made of PVC/PVDC/Aluminium foil, packed in a cardboard box. 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 Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Lithuania: Ibuliq 400 mg minkštosios kapsulės
Latvia: Ibuliq 400 mg minkštosios kapsulės
Estonia: Ibuliq 400 mg minkštosios kapsulės
Romania: PADUDEN Express Forte 400 mg capsule moi
France: Ibuprofene Biogaran Conseil 400 mg, capsule molle
Poland: Paduden Express Forte
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