Ibu-spa

Leaflet attached to the packaging: information for the user

IBU-SPA, 400 mg + 100 mg, coated tablets

Ibuprofen + Caffeine

You should carefully read the contents of the leaflet before taking 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 your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any 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 their doctor.

Table of contents of the leaflet

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

1. What is IBU-SPA and what is it used for

IBU-SPA contains two active substances: ibuprofen and caffeine.
Ibuprofen belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by changing the way the body responds to pain.
Caffeine belongs to a group of medicines known as stimulants.
IBU-SPA is indicated for short-term symptomatic treatment of mild to moderate pain such as toothache or headache.
IBU-SPA is intended for adults only.
If after 3 days there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before taking IBU-SPA

When not to take IBU-SPA

if the patient is allergic to ibuprofen, caffeine, or any of the other ingredients of this medicine (listed in section 6);
if the patient has ever had difficulty breathing, asthma, hay fever, swelling, or hives after taking acetylsalicylic acid or other similar painkillers (NSAIDs);
in patients with stomach or duodenal ulcer or bleeding (or if they have had two or more episodes of such disease in the past);
if there has been bleeding or perforation of the gastrointestinal tract associated with previous use of NSAIDs;
in patients with severe liver or kidney impairment;
in patients with severe heart failure;
in patients with bleeding from blood vessels or other active bleeding;
in patients with blood disorders of unknown origin;
in patients with severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake);
in women in the last 3 months of pregnancy.

Warnings and precautions

Before starting to take IBU-SPA, the patient should discuss it with their doctor or pharmacist:
if the patient is taking this medicine for a pain other than toothache or headache, the effect of IBU-SPA may vary depending on the type of pain (e.g., its effectiveness in treating back or neck pain has not been established);
if the patient has been diagnosed with asthma or an allergy due to the risk of shortness of breath;
if the patient has been diagnosed with hay fever, nasal polyps, or chronic obstructive pulmonary disease due to the increased risk of allergic reactions. These reactions can manifest as asthma attacks (aspirin-induced asthma), Quincke's edema, or hives;
if the patient has liver function disorders;
if the patient has kidney function disorders;
if the patient is taking medicines that interact with IBU-SPA, such as corticosteroids, blood thinners (such as warfarin), selective serotonin reuptake inhibitors (used to treat depression), or antiplatelet agents (such as aspirin) (see "IBU-SPA and other medicines");
if the patient currently has or has had intestinal disease (ulcerative colitis or Crohn's disease);
if the patient has heart disease, including heart failure and angina pectoris (chest pain), if the patient has had a heart attack, coronary artery bypass grafting, if the patient has peripheral artery disease (poor blood circulation in the legs or feet due to narrowing or blockage of arteries) or if the patient has had any stroke (including mini-stroke or transient ischemic attack - TIA);
if the patient has high blood pressure, diabetes, high cholesterol, if there is a history of heart disease or stroke in the patient's family, or if the patient smokes;
if the patient has ever had high blood pressure and/or heart failure;
particular monitoring of patients is recommended immediately after extensive surgical procedures;
if the patient has blood clotting disorders;
if the patient has inherited blood disorders (e.g., acute intermittent porphyria);
if the patient has certain skin diseases (systemic lupus erythematosus or mixed connective tissue disease);
if the patient has chickenpox, it is recommended to avoid taking IBU-SPA;
if the patient has hyperthyroidism (possible increased risk of caffeine side effects);
if the patient is taking medicines containing ibuprofen for a long period (regular monitoring of liver parameters, kidney function, and blood morphology may be necessary);
if the patient has an infection - see "Infections" below;
if the patient has a rash or skin symptoms, they should stop taking ibuprofen, seek medical advice immediately, and inform their doctor that they are taking this medicine;
if the patient experiences subjective or objective signs of a drug reaction with eosinophilia and systemic symptoms (DRESS), which include skin rash, fever, and swelling of lymph nodes and an increase in the number of a certain type of white blood cell (eosinophilia).
Skin reactions
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 associated with these severe skin reactions described in section 4, they should stop taking IBU-SPA and seek medical help immediately.
Infections
IBU-SPA may mask the symptoms of an infection, such as fever and pain. Therefore, IBU-SPA 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 associated with chickenpox. If the patient is taking this medicine while an infection is present and its symptoms persist or worsen, they should consult their doctor immediately.
The patient should contact their doctor immediately:
if they experience red stools, black, tarry stools, or vomit blood or coffee grounds;
if they experience severe abdominal pain.
Side effects can be minimized by using the smallest effective dose for the shortest necessary duration. The risk of side effects is higher in elderly patients.
Taking IBU-SPA with other NSAIDs, including selective cyclooxygenase-2 inhibitors, increases the risk of side effects (see "IBU-SPA and other medicines") and should be avoided.
Taking painkillers or analgesics, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. The recommended dose should not be exceeded, and the duration of treatment should not exceed 3 days.
Patients taking IBU-SPA should inform their doctor or dentist before undergoing surgical procedures and discuss their treatment.
Ibuprofen has been associated with symptoms of an allergic reaction to this medicine, including difficulty breathing, facial and neck swelling (angioedema), and chest pain. If any of these symptoms are noticed, the patient should stop taking IBU-SPA and contact their doctor or emergency medical services immediately.
Regular use of painkillers, especially combinations of several active substances with analgesic effects, can lead to permanent kidney damage with a risk of kidney failure (analgesic nephropathy). This risk may increase in a state of physical exhaustion associated with loss of salts and dehydration. Therefore, it should be avoided.
Long-term use of any painkiller for headaches can worsen them.
If this happens or is suspected, the patient should contact their doctor and stop taking this medicine.
In patients reporting eye disorders during ibuprofen treatment, therapy should be discontinued, and ophthalmological examinations should be performed.

IBU-SPA 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.
IBU-SPA may affect the action of other medicines, and other medicines may affect the action of IBU-SPA. For example:

• anticoagulant medicines (i.e., blood thinners, such as aspirin, warfarin, ticlopidine),
• medicines for high blood pressure (ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan).

Some other medicines may also affect the action of IBU-SPA, and IBU-SPA may also affect the action of some other medicines. Therefore, the patient should always consult their doctor or pharmacist before taking IBU-SPA with other medicines.
In particular, the patient should tell their doctor or pharmacist if they are taking:

Using IBU-SPA with food, drink, and alcohol

The risk of certain side effects, such as those affecting the gastrointestinal tract and central nervous system, may be higher when IBU-SPA is taken with alcohol. The patient should avoid consuming large amounts of caffeine-containing products (e.g., coffee, tea, food products, other medicines, and beverages) while taking IBU-SPA.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
In case of pregnancy during IBU-SPA treatment, the patient should immediately inform their doctor.
IBU-SPA should not be taken if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause problems during delivery. It may cause kidney and heart problems in the unborn child. It may affect the patient's and their child's tendency to bleed and may cause late or prolonged delivery. IBU-SPA should not be taken during the first 6 months of pregnancy unless absolutely necessary and prescribed by a doctor. If the patient needs treatment during this period or while trying to conceive, the smallest dose should be used for the shortest possible time. IBU-SPA, taken for a period longer than a few days, starting from the 20th week of pregnancy, may cause kidney problems in the unborn child, which can lead to low amniotic fluid levels (oligohydramnios) or narrowing of the arterial duct (ductal constriction) in the child's heart. If the patient needs treatment for more than a few days, their doctor may recommend additional monitoring.
The active substances, ibuprofen and caffeine, pass into breast milk. Irritability and sleep problems have been reported in breastfed infants. IBU-SPA can be used by breastfeeding women only if necessary.
This 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

If this medicine is used for a short period and in the recommended doses, it has no or negligible influence on the ability to drive and use machines. However, if side effects such as dizziness, fatigue, or visual disturbances occur, the patient should not drive or operate machinery. This is especially true when IBU-SPA is taken with alcohol.

IBU-SPA contains sodium

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

3. How to take IBU-SPA

This medicine should always be used exactly as described in this patient leaflet or as directed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The recommended dose is:
Adults:
Initial dose: one coated tablet (400 mg ibuprofen and 100 mg caffeine). If necessary, an additional dose (1 coated tablet) can be taken, but the total daily dose should not exceed 3 coated tablets (1200 mg ibuprofen and 300 mg caffeine) within 24 hours. The interval between doses should not be less than 6 hours.
The patient should consult their doctor or pharmacist if the effect of the medicine is too strong or too weak.
In cases of mild pain or when treatment duration exceeds 3 days, IBU-SPA is not recommended.
The medicine is not intended for use in children and adolescents under 18 years of age, as there is no available data on its use in this age group.
Oral administration.
The tablet should be swallowed whole with a glass of water.
It is recommended that patients with sensitive stomachs take IBU-SPA with food.
For short-term use only.
Treatment duration should not exceed 3 days.
If pain worsens or persists for more than 3 days, the patient should consult their doctor.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.
In case of infection, the patient should consult their doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Taking more than the recommended dose of IBU-SPA

In case of taking more than the recommended dose of IBU-SPA or if children have taken this medicine by accident, the patient should always contact 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 contain blood), gastrointestinal bleeding, rapid heartbeat, headache, ringing in the ears, seizures, restlessness, confusion, nystagmus, or less frequently, diarrhea. Additionally, after high doses, dizziness with a feeling of spinning, blurred vision, low blood pressure, excitement, coma, elevated potassium levels in the blood, acute kidney failure, liver damage, depression of respiratory function, cyanosis, and worsening of asthma symptoms in patients with asthma have been reported.

Missing a dose of IBU-SPA

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

4. Possible side effects

Like all medicines, IBU-SPA can cause side effects, although not everybody gets them.
Any of the known side effects of NSAIDs may occur (see below). If this happens or if the patient has any doubts, they should stop taking the medicine and consult their doctor as soon as possible. The risk of side effects is higher in elderly patients.
It should be considered that the listed side effects are largely dose-dependent and vary between patients.

The patient should STOP TAKING IBU-SPA and contact their doctor immediately if they experience any of the following symptoms, as they may be signs of serious side effects:

• severe stomach problems;
• vomiting blood or coffee grounds;
• black, tarry stools or blood in urine;
• allergic reactions, such as skin rash, itching;
• difficulty breathing and/or swelling of the face or throat;
• feeling tired, combined with loss of appetite;
• excessive tiredness with reduced urine output;
• swelling of the face, feet, or ankles;
• chest pain;
• visual disturbances;
• red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling skin, ulcers in the mouth, throat, nose, genitals, 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)
• widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
• red, peeling, widespread rash with bumps under the skin and blisters, usually located in skin folds, on the torso, and upper limbs, with accompanying fever at the start of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, the patient should stop taking IBU-SPA and seek medical help immediately. See also section 2
• increased sensitivity to sunlight
• persistent drug rash (e.g., round or oval red patches and swelling of the skin, with possible itching)
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome

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

• seizures
• rapid heartbeat
• a severe skin reaction called DRESS syndrome. The symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes, and an increase in the number of a certain type of white blood cell (eosinophilia)
• red, peeling, widespread rash with bumps under the skin and blisters, usually located in skin folds, on the torso, and upper limbs, with accompanying fever at the start of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, the patient should stop taking IBU-SPA and seek medical help immediately. See also section 2

Common (occurring in no more than 1 in 10 patients)

• heartburn, stomach pain, nausea, and indigestion, vomiting, bloating (gas), diarrhea, constipation, and minor bleeding from the stomach and/or intestines, which in rare cases may contribute to the development of anemia
• dizziness, insomnia, headache

Uncommon (occurring in no more than 1 in 100 patients)

• stomach or intestinal ulcers, sometimes with bleeding and perforation, especially in elderly patients, ulcerative stomatitis, gastritis, black, tarry stools, vomiting coffee grounds, worsening of ulcerative colitis or Crohn's disease. In particular, the risk of gastrointestinal bleeding is dose- and duration-dependent.
• excitement, palpitations, or fatigue
• visual disturbances, psychotic disorders
• allergic reactions, such as asthma attacks. The patient should stop taking IBU-SPA and contact their doctor immediately

Rare (occurring in no more than 1 in 1,000 patients)

• tinnitus (ringing in the ears), hearing loss
• kidney damage (renal papillary necrosis), increased uric acid levels in the blood, increased urea levels in the blood

Very rare (occurring in no more than 1 in 10,000 patients)

• in connection with the use of NSAIDs, edema, high blood pressure (hypertension), and heart failure have been reported
• esophagitis or pancreatitis, the formation of membranous strictures in the small and large intestine (intestinal stricture), and kidney problems (nephrotic syndrome); in case of any of these symptoms or general malaise, the patient should stop taking IBU-SPA and contact their doctor immediately, as these symptoms may be the first signs of kidney damage or failure
• blood disorders; the first symptoms: fever, sore throat, superficial oral ulcers, flu-like symptoms, severe fatigue, nosebleeds, and skin bleeding. In such cases, the patient should stop the treatment and consult their doctor. The patient should not take painkillers or antipyretics on their own
• depression
• in connection with the use of some painkillers (NSAIDs), worsening of infectious diseases has been reported (e.g., necrotizing fasciitis). If the patient experiences or suspects such a situation while taking IBU-SPA, they should contact their doctor immediately. The doctor should determine whether there are indications for anti-infective or antibiotic treatment
• high blood pressure, heart failure, heart attack, vasculitis
• liver function disorders (the first symptom may be skin discoloration), liver damage, especially during long-term use, liver failure, acute hepatitis
• after taking ibuprofen, symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever, or consciousness disorders have been observed. Patients with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) are at increased risk. The patient should contact their doctor immediately if they experience these symptoms
• severe forms of skin reactions, such as rash with redness and blisters (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis), hair loss (alopecia)

(alopecia), severe skin infections and soft tissue complications have been reported during chickenpox

• severe, generalized hypersensitivity reactions (with symptoms such as severe allergic reaction causing facial or throat swelling, difficulty breathing, rapid heartbeat, low blood pressure, anaphylactic shock, or dizziness)

The use of medicines like IBU-SPA may be associated with a small increased risk of heart attack or stroke.
In a study on tooth extraction in some patients (2.8%), dry socket developed after surgery, and in some (1.4%), gingivitis occurred.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 collected on the safety of this medicine.

5. How to store IBU-SPA

The medicine should be stored out of sight and reach of children.
The patient should not use this medicine after the expiry date stated on the packaging and blister.
The expiry date refers to the last day of the month.
The medicine should not be stored above 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What IBU-SPA contains

The active substances of the medicine are ibuprofen and caffeine.
Each coated tablet contains 400 mg of ibuprofen and 100 mg of caffeine.
The other ingredients are:
Tablet core:
Microcrystalline cellulose
Sodium croscarmellose
Colloidal anhydrous silica
Magnesium stearate
Coating:
Hypromellose
Hydroxypropyl cellulose
Macrogol 6000
Talc
Titanium dioxide (E 171)

What IBU-SPA looks like and contents of the pack

IBU-SPA is a white, oblong, coated tablet with dimensions of 17.8 mm x 8.6 mm.
IBU-SPA is available in blisters.
Packaging containing 6, 10 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Tel.: +48 22 280 00 00

Manufacturer

Delpharm Reims
10 rue du Colonel Charbonneaux
51100 Reims
France

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

Bulgaria: Nospalgin 400 mg/100 mg film-coated tablets (Ношпалгин 400 mg/100 mg филмирани таблетки)
Cyprus: Buscofem Extra 400 mg/100 mg επικαλυμμένα με λεπτό υμένιο δισκία
Czech Republic: Ibalgin Plus 400 mg/100 mg potahované tablety
Germany: Ibuprofen / Coffein Sanofi 400 mg/100 mg Filmtabletten
Greece: Buscofem Extra 400 mg/100 mg επικαλυμμένα με λεπτό υμένιο δισκία
Hungary: Algoflex Duo 400 mg/100 mg filmtabletta
Italy: BUSCOACTFOKUS 400 mg + 100 mg compresse rivestite con film
Poland: IBU-SPA 400 mg + 100 mg tabletki powlekane
Portugal: Ibuprofeno + Cafeína Aspegic
Romania: Ibalgin DUO 400 mg/100 mg comprimate filmate
Slovakia: Ibalgin Plus 400 mg/100 mg filmom obalené tablety
Spain: Dolalgial Ibuprofeno/Cafeina 400mg /100mg comprimidos recubiertos con película
Date of last revision of the leaflet:April 2024