Spedifen 400

Leaflet attached to the packaging: patient information

Spedifen 400, 400 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.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet:

• 1. What is Spedifen 400 and what is it used for
• 2. Important information before taking Spedifen 400
• 3. How to take Spedifen 400
• 4. Possible side effects
• 5. How to store Spedifen 400
• 6. Contents of the pack and other information

1. What is Spedifen 400 and what is it used for

Spedifen 400 contains the active substance ibuprofen, which belongs to a group of medicines known as nonsteroidal anti-inflammatory drugs (NSAIDs). It has anti-inflammatory, analgesic, and antipyretic effects. The mechanism of action of the medicine, like other NSAIDs, is based on the inhibition of prostaglandin synthesis.

Spedifen 400 can be used for symptomatic relief of mild and moderate pain in the following cases:

• toothache, post-dental surgery conditions,
• headache,
• feverish conditions of various origins (including flu, colds, or other infectious diseases),
• primary dysmenorrhea.

2. Important information before taking Spedifen 400

When not to take Spedifen 400:

• if the patient is hypersensitive to the active substance or any of the other ingredients of this medicine (listed in section 6);
• hypersensitivity (allergy) to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs) in history (e.g., bronchial asthma, allergic rhinitis, or urticaria);
• past or active peptic ulcer disease of the stomach and/or duodenum, gastrointestinal bleeding (e.g., in the course of ulcerative colitis);
• past episodes of gastrointestinal bleeding, perforation (perforation) of the gastrointestinal tract, associated with the use of nonsteroidal anti-inflammatory drugs;
• bleeding into the central nervous system;
• severe renal and/or hepatic impairment;
• hemorrhagic diathesis;
• third trimester of pregnancy;
• severe heart failure.

Warnings and precautions

Do not take higher doses or longer treatment than recommended.

If symptoms persist, worsen, or do not improve after 3 days, or if new symptoms appear, consult a doctor.

When taking Spedifen 400, consult a doctor if the patient has previously been diagnosed with:

• lupus erythematosus or mixed connective tissue disease,
• symptoms of allergic reactions after taking acetylsalicylic acid,
• gastrointestinal diseases and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
• hypertension and/or heart failure,
• renal impairment,
• hepatic impairment,
• blood coagulation disorders,
• active or past asthma or symptoms of allergic reactions in the past, as taking the medicine may cause bronchial spasm in sensitive individuals,
• 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 related to these severe skin reactions described in section 4, they should stop taking Spedifen 400 and seek medical attention immediately,
• if the patient is taking other medicines (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids).

At any time during treatment, gastrointestinal bleeding may occur, which can lead to death. These complications can occur at any time during treatment, with or without warning symptoms, and regardless of previous severe gastrointestinal complications.

If gastrointestinal bleeding or ulceration occurs, the medicine should be stopped immediately. Patients with a history of gastrointestinal diseases, especially the elderly, should inform their doctor of any unusual gastrointestinal symptoms (especially bleeding), especially during the initial treatment period.

Concomitant, long-term use of different painkillers may lead to kidney damage, including renal failure (analgesic nephropathy).

Taking anti-inflammatory and analgesic 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 and duration of treatment.

During treatment with ibuprofen, symptoms of allergic reactions to this medicine have been reported, including difficulty breathing, swelling of the face and neck (angioedema), chest pain.

If the patient experiences any of these symptoms, they should stop taking Spedifen 400 and seek medical attention immediately.

Before taking Spedifen 400, the patient should discuss treatment with their doctor or pharmacist if:

• they have heart disease, such as heart failure, angina pectoris (chest pain), have had a heart attack, coronary artery bypass grafting, or have peripheral arterial disease (poor blood circulation in the legs due to narrowing or blockage of arteries) or if they have had any stroke (including mini-stroke or transient ischemic attack - TIA).
• they have high blood pressure, diabetes, high cholesterol, or a family history of heart disease or stroke, or if they smoke.
• they have an infection - see below, section "Infections".

Infections

Spedifen may mask the symptoms of infection, such as fever and pain. Therefore, Spedifen may delay the use of appropriate infection treatment, which can lead to increased risk of complications.

This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox.

If the patient takes this medicine while having an infection, and the symptoms of the infection persist or worsen, they should consult their doctor immediately.

Severe skin reactions have been reported with Spedifen 400.

The medicine belongs to a group of medicines (nonsteroidal anti-inflammatory drugs) that may adversely affect female fertility.

This effect is reversible upon cessation of therapy.

Patient with impaired vision during ibuprofen treatment should stop the medicine, consult their doctor, and undergo ophthalmological examinations.

NSAIDs may cause an increase in liver enzyme activity.

Do not take ibuprofen concomitantly with other nonsteroidal anti-inflammatory drugs, including cyclooxygenase-2 inhibitors.

Consult a doctor, even if the above warnings refer to past situations.

Children and adolescents

The medicine in tablets containing 400 mg of ibuprofen should not be given to children under 12 years of age.

Elderly patients

The risk of adverse reactions is higher in elderly patients than in younger patients.

Spedifen 400 and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Spedifen 400 may affect the action of other medicines or other medicines may affect the action of Spedifen 400.

For example:

• anticoagulant medicines (i.e., blood thinners that prevent blood clots, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine),
• medicines that lower blood pressure (ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan).
• Ibuprofen may inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when the two medicines are taken concomitantly.
• Concomitant use of ibuprofen with acetylsalicylic acid and other NSAIDs may increase the risk of adverse reactions in the gastrointestinal tract.
• The effectiveness of diuretic medicines, such as furosemide and thiazides, may be reduced, probably due to sodium retention in the body, resulting from the inhibition of prostaglandin synthesis in the kidneys.
• Ibuprofen may increase the effect of oral anticoagulants, such as warfarin.
• Ibuprofen may reduce the effectiveness of antihypertensive medicines.
• Concomitant administration of NSAIDs and ACE inhibitors, especially in patients with impaired renal function, may increase the risk of acute renal failure.
• Isolated cases of increased digoxin, phenytoin, and lithium levels in the blood have been reported in patients taking ibuprofen concomitantly.
• Ibuprofen may increase the plasma concentration of methotrexate.
• In patients with hemophilia infected with HIV, concomitant treatment with zidovudine and ibuprofen may increase the risk of bleeding and hemarthrosis.
• Concomitant use of ibuprofen and tacrolimus may increase the risk of kidney damage due to decreased prostaglandin synthesis in the kidneys.
• Ibuprofen enhances the effect of oral hypoglycemic agents and insulin.
• Ibuprofen may affect the results of diagnostic tests:
• may prolong bleeding time (persisting up to 1 day after discontinuation of the medicine),
• may cause a decrease in blood glucose levels,
• may affect the decrease in creatinine clearance,
• may contribute to a decrease in hematocrit or hemoglobin levels, - may cause an increase in urea, creatinine, and potassium levels in the blood,
• may affect an increase in liver enzyme activity.

Also, some other medicines may be affected by or have an effect on treatment with Spedifen 400.

• Therefore, before taking Spedifen 400 with other medicines, always consult a doctor or pharmacist.

Taking Spedifen 400 with food and drink

The tablet should be taken with a glass of water (about 200 ml).

In patients with gastrointestinal disorders, it is recommended to take Spedifen 400 during meals.

Pregnancy and breastfeeding

• Do not take Spedifen 400 during the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery.
• Ibuprofen and its metabolites pass into breast milk in very small concentrations.
• It is not known whether ibuprofen has a harmful effect on the child.
• Generally, it is not necessary to stop breastfeeding during short-term use of Spedifen 400 at the recommended dose for pain and fever treatment.
• Spedifen 400 may make it difficult to get pregnant.
• This effect is reversible after stopping the medicine.
• If the patient plans to become pregnant or is having trouble getting pregnant, they should inform their doctor.

Driving and using machines

Dizziness and headaches that may occur when taking NSAIDs may impair the patient's ability to drive vehicles and operate machinery.

Spedifen 400 contains 16.7 mg of sucrose in one coated tablet.

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Spedifen 400 is not recommended for patients with hereditary fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency.

Spedifen 400 contains 82.7 mg of sodium in one coated tablet.

This should be taken into account in patients with restricted sodium intake in their diet.

3. How to take Spedifen 400

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

Take the smallest effective dose for the shortest duration necessary to relieve symptoms.

If the symptoms of the infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).

Spedifen 400 is a white, coated tablet in the shape of a capsule with a dividing line on one side.

The dividing line on the tablet is only to facilitate breaking and does not divide the tablet into equal doses.

Dosage

Children under 12 years of age

Spedifen 400 should not be used in children under 12 years of age, as one coated tablet contains more ibuprofen than the recommended dose for this age group.

Adults and children over 12 years of age

The usual initial dose is one tablet; if necessary, one tablet may be taken every 6 hours.

The maximum dose is 3 tablets per day.

Elderly patients

Dose modification is not required.

If symptoms worsen or do not improve after 3 days of taking the medicine, consult a doctor.

If the patient feels that the effect of the medicine is too strong or too weak, they should consult a doctor or pharmacist.

Taking a higher dose of Spedifen 400 than recommended

In case of overdose, the following symptoms may occur: nausea, abdominal pain, vomiting with blood and diarrhea (tarry stools), dizziness, muscle spasms, nystagmus, and vision disturbances, headache, and tinnitus.

In case of severe poisoning, the following symptoms also occur: impaired renal function, decreased blood pressure, impaired consciousness, and coma, very rarely loss of consciousness.

In case of overdose, the stomach should be emptied as soon as possible, preferably by inducing vomiting, if the patient is conscious.

If the patient is unconscious, after securing the airways (intubation), gastric lavage and correction of electrolyte disturbances are recommended.

If the patient has taken a higher dose of Spedifen 400 than recommended or if a child has accidentally taken the medicine, they should always consult a doctor or go to the nearest hospital to get an opinion on possible health risks and advice on what to do in such a case.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, ringing in the ears, disorientation, and nystagmus.

It may also cause excitement, drowsiness, disorientation, or coma.

Occasionally, patients experience seizures.

After taking a large dose, 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 problems have been reported.

In addition, the prothrombin time/INR may be prolonged, probably due to the disruption of the action of circulating clotting factors.

Acute renal failure and liver damage may occur.

In people with asthma, it is possible to exacerbate it.

Additionally, low blood pressure and decreased breathing intensity may occur.

Missing a dose of Spedifen 400

Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects are ranked according to frequency, using the following categories:

Very common(occurring in more than 1 in 10 people)

Common(occurring in less than 1 in 10 people)

Uncommon(occurring in less than 1 in 100 people)

Rare(occurring in less than 1 in 1,000 people)

Very rare(occurring in less than 1 in 10,000 people)

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

If the patient experiences any of the following symptoms, they should stop taking ibuprofen and seek medical attention immediately:

• 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.
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
• Red, scaly rash with nodules under the skin and blisters, with fever, usually appearing at the beginning of treatment (acute generalized exanthematous pustulosis).

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should consult their doctor or pharmacist.

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:

Department for Monitoring of Adverse Reactions to Medicinal Products, 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, you can help provide more information on the safety of this medicine.

5. How to store Spedifen 400

No special requirements.

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging.

The expiry date refers to the last day of the month stated.

Medicines should 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 Spedifen 400 contains

The active substance of the medicine is ibuprofen (Ibuprofenum) (formed in situ L-Arginine salt).

One coated tablet contains: 400 mg of ibuprofen.

Other ingredients are: L-arginine, sodium bicarbonate, crospovidone, magnesium stearate, hypromellose, sucrose, titanium dioxide (E 171), Macrogol 4000

What Spedifen 400 looks like and contents of the pack

Spedifen 400 is a white, coated tablet in the shape of a capsule with a dividing line on one side.

Spedifen 400 is available in blisters (Al/PE/PA)/(Al/PE) in a cardboard box.

6 coated tablets (1 blister of 6)

12 coated tablets (2 blisters of 6)

24 coated tablets (4 blisters of 6)

36 coated tablets (6 blisters of 6)

Marketing authorization holder and manufacturer:

Marketing authorization holder

Zambon S.p.A.

Via Lillo del Duca, 10

20091 Bresso (MI), Italy

+39 02 665241

Manufacturer

Zambon S.p.A.

Via della Chimica, 9

36100 Vicenza, Italy

Patient leaflet in a format suitable for the blind and visually impaired is available at the marketing authorization holder's representative office.

Date of last revision of the leaflet:

November 2024