Spedifen 400

Patient Information Leaflet

Spedifen 400, 400 mg, coated tablets
Ibuprofenum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if you feel worse, consult your doctor.

Leaflet Contents:

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

Spedifen 400 contains an active substance called ibuprofen, which belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). It has anti-inflammatory, analgesic and antipyretic properties. Its mechanism of action, like that of other NSAIDs, involves inhibition of prostaglandin synthesis.
Spedifen 400 may be used for symptomatic relief of mild to moderate pain in the following conditions:

• Toothache, post-dental procedure conditions,
• Headaches,
• Fever of various origins (e.g. associated with influenza, colds or other infectious diseases),
• Primary dysmenorrhoea.

2. Important information before using Spedifen 400

When not to use Spedifen 400:

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

Warnings and precautions
Do not use higher doses or longer treatment duration than recommended.
If symptoms persist, worsen or do not resolve within 3 days, or if new symptoms occur,
consult a doctor.
When using Spedifen 400, consult a doctor if the patient has previously been diagnosed with:

• systemic lupus erythematosus or mixed connective tissue disease,
• allergic reactions after taking acetylsalicylic acid,
• gastrointestinal disorders and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
• hypertension and/or heart function disorders,
• renal function disorders,
• liver function disorders,
• blood coagulation disorders,
• active or past bronchial asthma or symptoms of allergic reactions in the past, as bronchospasm may occur after administration of the drug in patients with confirmed allergy,
• severe skin reactions have occurred with ibuprofen use, 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 any of the symptoms associated with these severe skin reactions described in section 4 occur, discontinue Spedifen 400 immediately and seek medical help,
• the patient is taking other medicines simultaneously (especially anticoagulants, diuretics, cardiac drugs, corticosteroids).

Gastrointestinal bleeding, which may lead to death, may occur at any time during treatment.
These complications may occur at any stage of treatment, with or without preceding symptoms, and regardless of previous history of severe gastrointestinal complications. In case of gastrointestinal haemorrhage or ulceration, discontinue the drug immediately. Patients with a history of gastrointestinal disorders, especially elderly patients, should inform their doctor about any unusual gastrointestinal symptoms (particularly bleeding), especially during the initial period of therapy.
Concurrent, long-term use of various analgesics may lead to kidney damage, including renal failure (analgesic nephropathy).
The use of anti-inflammatory and analgesic drugs such as ibuprofen may be associated with a small increased risk of myocardial infarction or stroke, particularly when used in high doses. Do not exceed the recommended dose or duration of treatment.
Allergic reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), chest pain, have been reported. If any of these symptoms are observed, discontinue Spedifen 400 immediately and contact a doctor or emergency medical services without delay.
Before using Spedifen 400, the patient should discuss treatment with a doctor or pharmacist if:

• the patient has heart diseases such as heart failure, angina pectoris (chest pain), history of heart attack, coronary artery bypass surgery, 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 ischemic attack - TIA).
• the patient has hypertension, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or if the patient smokes.
• the patient has an infection - see below, section titled "Infections".

Infections
Spedifen may mask symptoms of infection such as fever and pain. Therefore, Spedifen 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 infection symptoms persist or worsen, consult a doctor immediately.
Severe skin reactions have been reported in connection with treatment with Spedifen 400. Discontinue taking Spedifen 400 and seek immediate medical advice if skin rash, mucosal lesions, blisters, or other allergy symptoms occur, as these may be early signs of a very serious skin reaction. See section 4.
This medicine belongs to a group of drugs (non-steroidal anti-inflammatory drugs) which may adversely affect fertility in women. This effect is transient and resolves after discontinuation of therapy.
Patients who experience visual disturbances while taking ibuprofen should discontinue the drug, contact a doctor, and undergo ophthalmological examination.
NSAIDs may cause increased activity of liver enzymes.
Do not use ibuprofen simultaneously with other non-steroidal anti-inflammatory drugs, including cyclooxygenase-2 (COX-2) inhibitors.
Consult a doctor, even if the above warnings relate to conditions occurring in the past.

Children and adolescents
The 400 mg ibuprofen tablet should not be given to children under 12 years of age.

Elderly patients
In elderly patients, the risk of adverse effects is higher than in younger patients.

Spedifen 400 and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Spedifen 400 may affect the action of other medicines or other medicines may affect the action of Spedifen 400. For example:

• anticoagulant drugs (i.e. blood thinners preventing clot formation, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine),
• antihypertensive drugs (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing drugs, angiotensin II receptor antagonists such as losartan).
  • Ibuprofen may inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when both drugs are used simultaneously.
  • Concurrent use of ibuprofen with acetylsalicylic acid and other NSAIDs may increase the risk of gastrointestinal adverse effects.
  • The effectiveness of diuretics such as furosemide and thiazides may be reduced, probably due to sodium retention resulting from inhibition of renal prostaglandin synthesis.
  • Ibuprofen may enhance the effect of oral anticoagulants such as warfarin. Concurrent use is not recommended without medical advice.
  • Ibuprofen may reduce the effectiveness of antihypertensive drugs. Concurrent administration of NSAIDs and ACE inhibitors, particularly beta-adrenergic receptor blockers, may be associated with a risk of acute renal failure.
  • Isolated cases of increased serum levels of digoxin, phenytoin, and lithium have been reported in patients taking ibuprofen concurrently.
  • Ibuprofen may increase methotrexate plasma concentration.
  • In patients with haemophilia infected with HIV, concomitant treatment with zidovudine and ibuprofen may increase the risk of haematomas and joint haemorrhages.
  • Concomitant use of ibuprofen and tacrolimus may increase the risk of kidney damage due to reduced renal prostaglandin synthesis.
  • Ibuprofen enhances the effect of oral hypoglycaemic agents and insulin. Dose adjustments of these drugs may be necessary.
  • Ibuprofen may affect diagnostic test results:
    • may prolong bleeding time (persisting up to 1 day after discontinuation),
    • may cause decreased serum glucose concentration,
    • may affect decreased creatinine clearance,
    • may contribute to decreased haematocrit or haemoglobin concentration,
    • may cause increased serum urea, creatinine, and potassium levels,
    • may affect increased liver enzyme activity.

Also, some other medicines may be affected by or may affect treatment with Spedifen 400.
Therefore, always consult a doctor or pharmacist before using Spedifen 400 with other medicines.

Taking Spedifen 400 with food and drink
Take the tablet with approximately 200 ml of water.
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 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 affect bleeding tendency in both mother and child and may delay or prolong labour. Do not take Spedifen 400 during the first 6 months of pregnancy unless absolutely necessary and as advised 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. If this medicine is taken for more than a few days starting from the 20th week of pregnancy, Spedifen 400 may cause kidney problems in the unborn child, leading to reduced amniotic fluid volume surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If prolonged treatment is necessary, the doctor may recommend additional monitoring.
• Ibuprofen and its metabolites pass into human milk in very low concentrations. It is not known whether ibuprofen has harmful effects on the infant. Generally, it is not necessary to interrupt breastfeeding during short-term use of Spedifen 400 at the recommended dose for pain and fever treatment.
• Spedifen may impair fertility. This effect is reversible upon discontinuation of the drug. Inform the doctor if the patient plans to become pregnant or has difficulty conceiving.

Driving and operating machinery
Dizziness and headache, which may occur during NSAID use, may impair the patient's ability to drive or operate machinery.

Spedifen 400 contains 16.7 mg of sucrose per coated tablet.
If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this 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 per tablet.
This should be taken into account in patients on a sodium-restricted diet.

3. How to use Spedifen 400

This medicine should always be used according to the instructions in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If symptoms of an infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Spedifen 400 is a white, film-coated, capsule-shaped tablet with a break line on one side. The break line on the tablet is intended only to facilitate breaking for easier swallowing and does not ensure equal dose division.

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 adjustment is not required.

If symptoms worsen or do not improve after 3 days of treatment, consult a doctor.
If you feel the effect of Spedifen 400 is too strong or too weak, consult your doctor or pharmacist.

Overdose of Spedifen 400
Symptoms of overdose may include: nausea, epigastric pain, bloody vomiting, diarrhoea (tarry stools), dizziness, muscle spasms, nystagmus, visual disturbances, headache, and tinnitus.
In cases of severe poisoning, additional symptoms may include impaired kidney function, decreased blood pressure, disturbances of consciousness, coma, and very rarely, loss of consciousness. In case of overdose, the stomach should be emptied as quickly as possible, preferably by inducing vomiting, provided the patient is conscious.
If the patient is unconscious, after securing the airway (intubation), gastric lavage is recommended, along with correction of electrolyte imbalances.
If a patient has taken more than the recommended dose of Spedifen 400 or if a child has accidentally ingested the medicine, seek immediate medical advice from a doctor or go to the nearest hospital to assess potential health risks and receive guidance on necessary actions.

Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), gastrointestinal bleeding (see also section 4 below), diarrhoea, headache, tinnitus, disorientation, and nystagmus. Excitement, drowsiness, disorientation, or coma may also occur. Seizures have been reported rarely. After ingestion of a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in urine, low blood potassium levels, feeling cold, and breathing difficulties may occur. Additionally, prothrombin time/INR may be prolonged, likely due to interference with circulating coagulation factors. Acute renal failure and liver damage may also occur. In patients with asthma, worsening of asthma is possible. Additionally, low blood pressure and reduced breathing intensity may occur.

Missed dose of Spedifen 400
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them. Adverse reactions are listed according to frequency using the following terms:
Very common (affects more than 1 in 10 people)
Common (affects less than 1 in 10 people)
Uncommon (affects less than 1 in 100 people)
Rare (affects less than 1 in 1,000 people)
Very rare (affects less than 1 in 10,000 people)
Frequency not known (cannot be estimated from the available data)

If any of the following symptoms occur in the patient, ibuprofen should be discontinued immediately and medical help should be sought:

• Red, flat, non-raised, target-like or circular patches on the trunk, often with blisters in the center, peeling skin, and ulceration in the mouth, throat, nose, genital organs, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high fever, 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).

If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309,
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 Spedifen 400

No special requirements.
Keep the medicine out of the 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such practices help protect the environment.

6. Contents of the packaging and other information

What Spedifen 400 contains
The active substance is ibuprofen (Ibuprofenum) (L-arginine salt formed in situ).
Each coated tablet contains: 400 mg of ibuprofen.
The other ingredients are: L-arginine, sodium hydrogen carbonate, crospovidone, magnesium stearate, hypromellose, sucrose, titanium dioxide (E 171), Macrogol 4000.

What Spedifen 400 looks like and contents of the pack
Spedifen 400 is in the form of white, capsule-shaped coated tablets with a break line on one side.
Spedifen 400 is available in blisters (Al/PE/PA)/(Al/PE) packed in a cardboard box.
6 coated tablets (1 blister with 6 tablets)
12 coated tablets (2 blisters with 6 tablets each)
24 coated tablets (4 blisters with 6 tablets each)
36 coated tablets (6 blisters with 6 tablets each)

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation 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
representative of the marketing authorisation holder.
November 2024