Ibuprofen Modafen

Leaflet attached to the packaging: patient information

Ibuprofen Pharmaclan, 200 mg, coated tablets

Ibuprofen

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.
• Adults: If there is no improvement after 3 days in the case of fever or after 4 days in the case of pain, or if the patient feels worse, they should contact a doctor. Children and adolescents: If there is no improvement after 3 days or if the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

• 1. What is Ibuprofen Pharmaclan and what is it used for
• 2. Important information before taking Ibuprofen Pharmaclan
• 3. How to take Ibuprofen Pharmaclan
• 4. Possible side effects
• 5. How to store Ibuprofen Pharmaclan
• 6. Contents of the packaging and other information

1. What is Ibuprofen Pharmaclan and what is it used for

Ibuprofen Pharmaclan contains the active substance ibuprofen, which belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), which work by reducing pain and fever.
Ibuprofen Pharmaclan is used for the short-term symptomatic treatment of mild to moderate pain, such as toothache, menstrual pain, and headache, and/or for the short-term symptomatic treatment of fever.
Ibuprofen Pharmaclan, 200 mg, coated tablets are indicated for use in adults, adolescents, and children with a body weight of 20 kg (from 7 years of age and above).
Adults: If symptoms worsen or if fever persists for more than 3 days or pain persists for more than 4 days, a doctor should be consulted.
Children and adolescents: If symptoms worsen or if fever or pain persists for more than 3 days, a doctor should be consulted.

2. Important information before taking Ibuprofen Pharmaclan

When not to take Ibuprofen Pharmaclan

• if the patient is hypersensitive to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
• if the patient has ever had an allergic reaction, such as bronchospasm, asthma, rhinitis, itching rash, or swelling of the face, lips, tongue, or throat (angioedema) after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (e.g., NSAIDs).
• if the patient has ever had bleeding or perforation of the stomach or intestines in connection with previous NSAID treatment.
• if the patient currently has an ulcer or bleeding in the stomach or small intestine (duodenum), or if the patient has had two or more such episodes of ulcers or bleeding in the stomach or duodenum (peptic ulcers).
• if the patient has unexplained blood disorders.
• if the patient has severe heart failure.
• if the patient has severe liver or kidney failure.
• if the patient is in the last three months of pregnancy.
• if the patient has severe dehydration (e.g., due to vomiting, diarrhea, or insufficient fluid intake).

Warnings and precautions

Before taking Ibuprofen Pharmaclan, the patient should discuss it with their doctor or pharmacist:

• if the patient has systemic lupus erythematosus (SLE, an autoimmune disease) or mixed connective tissue disease (an autoimmune disease affecting connective tissue).
• during chickenpox, it is recommended to avoid taking this medicine.
• if the patient has or has had gastrointestinal disorders (ulcerative colitis, Crohn's disease), as their condition may worsen.
• if the patient has certain inherited blood disorders (e.g., acute intermittent porphyria).
• if the patient has liver or kidney dysfunction.
• if the patient has undergone major surgery.
• if the patient has an allergy to other substances.
• if the patient has hay fever, nasal polyps, or chronic obstructive pulmonary disease due to increased risk of allergic reactions. Allergic reactions can manifest as asthma attacks (so-called analgesic asthma), sudden swelling (Quincke's edema), or hives.
• if the patient is dehydrated.
• if the patient has an infection - see "Infections" below. The risk of side effects increases with increasing dose of the medicine and in elderly patients. Therefore, it is necessary to start treatment with the lowest possible dose and continue treatment for the shortest possible period necessary to relieve symptoms.

Infections

Ibuprofen Pharmaclan may mask the symptoms of infection, such as fever and pain. Therefore, it is possible that Ibuprofen Pharmaclan may delay the use of appropriate infection treatment, which can lead to increased risk of complications. This has been observed in the course of pneumonia caused by bacteria 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 immediately consult a doctor.

Effect on the cardiovascular system

The use of anti-inflammatory/pain-relieving medicines, such as ibuprofen, may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.
Before taking Ibuprofen Pharmaclan, the patient should discuss their treatment with their doctor or pharmacist if:

• they have heart disease, including heart failure, angina pectoris (chest pain), or have had a heart attack, bypass surgery, or peripheral artery disease (poor blood circulation in the legs or feet due to narrowing or blockage of the arteries), or any type of stroke (including "mini-stroke" or transient ischemic attack, TIA);
• they have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or smoke.

Effect on the gastrointestinal tract

Avoid taking Ibuprofen Pharmaclan at the same time as other nonsteroidal anti-inflammatory drugs (NSAIDs), including so-called COX-2 inhibitors (cyclooxygenase-2 inhibitors).
Gastrointestinal bleeding, ulcers, and perforations:
With the use of all NSAIDs, gastrointestinal bleeding, ulcers, and perforations have been reported, sometimes resulting in death. These events can occur at any time during treatment, with or without prior warning symptoms or serious gastrointestinal events in the medical history.
The risk of gastrointestinal bleeding, ulcers, and perforations is higher with increasing doses of NSAIDs and is higher in patients with a history of ulcers, especially with complications such as bleeding or perforation (see section 2 "When not to take Ibuprofen Pharmaclan") and in elderly patients. These patients should start treatment with the lowest available dose. For these patients, as well as patients requiring additional treatment with low doses of acetylsalicylic acid or other medicines that may increase the risk of gastrointestinal disorders, concomitant treatment with protective medicines (e.g., misoprostol or proton pump inhibitors) should be considered.
Patients who have had gastrointestinal side effects in the past - especially elderly patients - should consult their doctor if they experience unusual abdominal symptoms (especially gastrointestinal bleeding), especially at the start of treatment.
Caution is advised when taking other medicines that may increase the risk of ulcers or bleeding, such as oral corticosteroids, anticoagulants (blood thinners) such as warfarin, selective serotonin reuptake inhibitors (used to treat mental disorders, including depression), or antiplatelet agents such as acetylsalicylic acid (see section 2 "Ibuprofen Pharmaclan and other medicines").
Treatment should be discontinued and a doctor consulted if gastrointestinal bleeding or ulcers occur during treatment with Ibuprofen Pharmaclan.

Skin reactions

Serious skin reactions have been reported with the use of Ibuprofen Pharmaclan. The patient should stop taking Ibuprofen Pharmaclan and seek medical help immediately if they experience a skin rash, mucosal lesions, blisters, or other signs of allergy, as these may be the first signs of a very serious skin reaction. See section 4.

Other warnings

Very rarely, severe, acute hypersensitivity reactions (e.g., anaphylactic shock) have been observed. If the patient experiences the first symptoms of a hypersensitivity reaction after taking Ibuprofen Pharmaclan, treatment should be discontinued and a doctor consulted. Medical measures required according to symptoms must be taken by a healthcare professional.
Ibuprofen may temporarily inhibit platelet function (platelet aggregation). Therefore, patients with bleeding disorders should be closely monitored.
Long-term use of any pain-relieving medicines for headaches can exacerbate them. If this occurs or is suspected, medical advice should be sought and treatment discontinued. Medication overuse headache (MOH) should be suspected in patients who experience frequent or daily headaches despite (or due to) regular use of pain-relieving medicines.
During long-term use of ibuprofen, regular monitoring of liver, kidney, and blood morphology is required.
In general, habitual use of pain-relieving medicines, especially in combination with several pain-relieving medicines, can lead to permanent kidney damage. This risk may be increased with physical exertion associated with loss of salts and dehydration. Therefore, this should be avoided.

Children and adolescents

Dehydrated children and adolescents are at risk of kidney dysfunction.
Ibuprofen Pharmaclan, 200 mg, coated tablets are not intended for children with a body weight below 20 kg or under 7 years of age.

Ibuprofen Pharmaclan and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Ibuprofen Pharmaclan may affect the action of some other medicines or other medicines may affect its action.
For example:

• anticoagulant and antiplatelet medicines (i.e., blood thinners/preventing clotting, such as acetylsalicylic acid, warfarin, ticlopidine)
• medicines that lower high blood pressure (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, or angiotensin II receptor antagonists, such as losartan) and diuretics (used to increase urine production)
• other nonsteroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors or acetylsalicylic acid - as they increase the risk of stomach or intestinal ulcers or bleeding
• digoxin (used to treat various heart conditions), as its effect may be enhanced
• lithium (used to treat depression and mania), as its effect may be enhanced
• phenytoin (used to prevent seizures), as its effect may be enhanced
• zydovudine (used to treat HIV/AIDS)
• corticosteroids (used to treat inflammatory conditions), as they may increase the risk of stomach or intestinal ulcers or bleeding
• methotrexate (used to treat certain cancers and autoimmune diseases)
• medicines known as immunosuppressants, such as cyclosporine and tacrolimus, as kidney damage may occur
• medicines known as selective serotonin reuptake inhibitors (SSRIs), used to treat depression
• quinolone antibiotics, such as ciprofloxacin, as the risk of seizures may be increased
• aminoglycoside antibiotics (a type of antibiotic), as NSAIDs may decrease the excretion of aminoglycosides
• mifepristone, as NSAIDs may reduce the effect of mifepristone
• diuretics (water pills), as the effect of diuretics may be weakened
• potassium-sparing diuretics, as this may lead to hyperkalemia
• probenecid or sulfinpyrazone (used to treat gout), as the excretion of ibuprofen may be delayed
• cholestyramine (used to lower cholesterol levels)
• medicines known as sulfonylureas, such as glibenclamide (used to treat diabetes), as they may affect blood sugar levels
• voriconazole or fluconazole (a type of antifungal medicine) (CYP2C9 inhibitors), as the effect of ibuprofen may be enhanced. It is recommended to consider reducing the dose of ibuprofen, especially when using high doses of ibuprofen with voriconazole or fluconazole.
• Ginkgo biloba (a herbal medicine), as there is an increased risk of bleeding
• ritonavir (an antiviral medicine) may increase the plasma concentration of NSAIDs
• alcohol, bisphosphonates (used for osteoporosis), or pentoxifylline (used for circulatory disorders in peripheral arteries) may enhance the adverse effects on the gastrointestinal tract and the risk of bleeding and ulcers
• baclofen (a muscle relaxant) due to increased toxicity of baclofen Some other medicines may also affect treatment with Ibuprofen Pharmaclan. Therefore, before taking Ibuprofen Pharmaclan with other medicines, the patient should always consult their doctor or pharmacist.

Ibuprofen Pharmaclan and alcohol

Alcohol should be avoided, as it may enhance the adverse effects of this medicine, especially those affecting the stomach, intestines, or brain.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Pregnancy

• Ibuprofen should not be taken if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Ibuprofen may cause kidney and heart problems in the unborn child. It may also increase the risk of bleeding in the patient and child and prolong labor.
• During the first 6 months of pregnancy, ibuprofen should not be used unless the doctor considers it absolutely necessary. If treatment is necessary during this period or during attempts to become pregnant, the lowest possible dose should be used for the shortest possible time. From
• the 20th week of pregnancy, ibuprofen may cause the unborn child to have a narrowing of the arterial duct (a blood vessel in the heart) or kidney problems, which can lead to low levels of amniotic fluid surrounding the child (oligohydramnios). If treatment is required for a longer period, the doctor may recommend additional monitoring.

Breastfeeding
Ibuprofen passes into breast milk in very small amounts and usually does not require breastfeeding to be discontinued during short-term use of ibuprofen for fever and pain.
Fertility
Ibuprofen Pharmaclan may cause difficulty becoming pregnant. The patient should inform their doctor if they plan to become pregnant or are having trouble becoming pregnant.
The medicine belongs to a group of medicines (NSAIDs) that may adversely affect female fertility. This effect is reversible after stopping the medicine.

Driving and using machines

Ibuprofen generally has no or negligible influence on the ability to drive and use machines. However, as higher doses may cause side effects from the central nervous system, such as fatigue and dizziness, the ability to react and participate actively in traffic and operate machinery may be impaired in individual cases. This is more likely when combined with alcohol.

Ibuprofen Pharmaclan contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means the medicine is essentially "sodium-free".

3. How to take Ibuprofen Pharmaclan

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The patient should take the smallest effective dose for the shortest possible period necessary to relieve symptoms. In case of infection, the patient should contact their doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
DOSAGE:

Adults and adolescents with a body weight of 40 kg (from 12 years of age and above):

The usual dose is 1 or 2 tablets (200-400 mg of ibuprofen) as a single dose or 3 to 4 times a day, depending on the needs. The interval between doses should be at least 6 hours. The maximum daily dose should not exceed 6 tablets (1200 mg) in 24 hours.

Children with a body weight of 20 kg (from 7 years of age) to 39 kg (from 11 years of age):

Children with a body weight of 20-29 kg (from 7-9 years of age): 1 tablet (200 mg of ibuprofen) 1-3 times a day depending on the needs, with at least 6-hour intervals between doses. The maximum daily dose should not exceed 3 tablets (600 mg) in 24 hours.
Children with a body weight of 30-39 kg (from 10-11 years of age): 1 tablet (200 mg of ibuprofen) 1-4 times a day depending on the needs, with at least 6-hour intervals between doses. The maximum daily dose should not exceed 4 tablets (800 mg) in 24 hours.

Duration of treatment:

If it is necessary to take this medicine in adults for more than 3 days in the case of fever or for more than 4 days in the case of pain, or if symptoms worsen, the patient should contact their doctor.
If it is necessary to take this medicine in children and adolescents for more than 3 days or if symptoms worsen, the patient should contact their doctor.
Method of administration
Ibuprofen Pharmaclan is taken orally.
The tablets should be swallowed with a glass of water. The tablets should be swallowed whole, without chewing, crushing, breaking, or sucking, to prevent discomfort in the mouth or throat irritation.
Patients with sensitive stomachs are advised to take the tablets with food.
If the medicine is taken shortly after eating, the onset of action of ibuprofen may be delayed.
Elderly patients
Elderly patients should always consult their doctor before taking Ibuprofen Pharmaclan. The patient may be more likely to experience side effects, especially bleeding, ulcers, and perforation of the gastrointestinal tract, which can be fatal.
The doctor will provide the patient with appropriate advice.
Liver or kidney dysfunction
If the patient has liver or kidney dysfunction, they should consult their doctor before taking Ibuprofen Pharmaclan. This medicine should not be taken in case of severe liver or kidney failure.

Taking a higher dose of Ibuprofen Pharmaclan than recommended

In case of taking a higher dose of Ibuprofen Pharmaclan than recommended or accidental ingestion by children, the patient should always consult their doctor or the nearest hospital for advice on the risk and actions to be taken.
Symptoms may include nausea, abdominal pain, vomiting (which may be bloody), or, less commonly, diarrhea. Additionally, headache, gastrointestinal bleeding, blurred vision, ringing in the ears, confusion, and nystagmus (eye movement disorder) may occur. At high doses, drowsiness, excitement, confusion, chest pain, palpitations, and cardiac arrhythmias have been reported. Loss of consciousness, seizures (mainly in children), vertigo of labyrinthine origin, weakness, and dizziness may also occur. Blood in the urine, low blood pressure, hyperkalemia, metabolic acidosis, prolonged prothrombin time/INR, acute renal failure, liver damage, respiratory depression, cyanosis, feeling of cold, and respiratory disorders may also occur.

Missing a dose of Ibuprofen Pharmaclan

A double dose should not be taken to make up for a missed dose.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Ibuprofen Pharmaclan can cause side effects, although not everybody gets them.
The patient can minimize the risk of side effects by taking the smallest effective dose for the shortest possible period necessary to relieve symptoms.
Regarding the following side effects, it should be considered that they are largely dose-dependent and vary from patient to patient.
The most common side effects are gastrointestinal in nature. Gastrointestinal ulcers, perforation, or bleeding may occur, sometimes leading to death, especially in elderly patients. After administration, nausea, vomiting, diarrhea, bloating, constipation, indigestion, abdominal pain, and dyspepsia have been reported. Less commonly, gastrointestinal bleeding, which can lead to anemia, has been observed. Rarely, stomach ulcers have been reported.

Other side effects

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

• gastrointestinal symptoms, such as reflux, abdominal pain, nausea, diarrhea, vomiting, bloating, and constipation
• mild gastrointestinal bleeding, which can lead to anemia in rare cases

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

• allergic reactions with rash and itching, as well as asthma attacks (probably with a drop in blood pressure)
• headache
• dizziness or feeling of fatigue
• excitement and irritability
• feeling of drowsiness
• difficulty sleeping
• feeling of vertigo (dizziness)
• various skin rashes
• stomach or intestinal ulcers, potentially with bleeding and perforation (a hole in the wall of the gastrointestinal tract)
• worsening of ulcerative colitis (inflammation of the colon) and Crohn's disease
• stomach lining inflammation
• mouth ulcers (mouth ulceration)

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

• toxic optic neuropathy
• hearing loss
• ringing in the ears (tinnitus)
• kidney tissue damage (renal papillary necrosis), elevated uric acid levels in the blood, elevated urea levels in the blood

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

• pancreatitis
• esophagitis
• formation of diaphragmatic strictures in the intestine
• liver dysfunction, liver failure, acute hepatitis, liver damage, especially with long-term treatment

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

• a severe skin reaction known as DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms) may occur. The symptoms of DRESS include: skin rash, fever, swelling of the lymph nodes, and an increase in the number of eosinophils (a type of white blood cell).
• feelings such as numbness, tingling, or prickling
• optic neuritis
• stuffy nose and runny nose
• skin becomes sensitive to light (photosensitivity reactions).

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they 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 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Ibuprofen Pharmaclan

• The medicine should be stored out of sight and reach of children.
• This medicine should not be taken after the expiration date stated on the packaging or blister after: EXP. The expiration date refers to the last day of the specified month.
• There are no special storage instructions for the medicine.
• 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 Ibuprofen Pharmaclan contains

The active substance of the medicine is ibuprofen. Each coated tablet contains 200 mg of ibuprofen.
The other ingredients are: tablet core - microcrystalline cellulose 102, maize starch, povidone K-90, sodium lauryl sulfate, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, tablet coating - hypromellose 2910, hydroxypropyl cellulose, macrogol 400, titanium dioxide (E 171).

What Ibuprofen Pharmaclan looks like and contents of the pack

White or almost white, round, coated tablets with the imprint "G2" on one side and smooth on the other. The tablet is approximately 8.52 mm in diameter and 4.60 mm in thickness.
A colorless, transparent blister pack made of PVC/Aluminum in an outer cardboard box containing 10 or 12 tablets in a blister pack.
Package sizes:
10, 12, 20, 24, 30, 40, 48 tablets.
Not all package sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization holder:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Importer:
Pharmazet Group s.r.o.
Třtinová 260/1
196 00 Prague 9
Czech Republic

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic: Ibuprofen Pharmaclan
Estonia:
Ibuprofeno Pharmaclan 200 mg film-coated tablets EFG
Germany:
Ibuprofen Pharmaclan 200 mg film-coated tablets
France:
IBUPROFENE PHARMACLAN 200 mg film-coated tablet
Finland:
Ibuprofen Pharmaclan
Poland:
Ibuprofen Pharmaclan

Date of last revision of the leaflet: