Ibu-spa

Patient Information Leaflet

IBU-SPA, 400 mg + 100 mg, coated tablets
Ibuprofen + Caffeine
Please read this leaflet carefully before taking this medicine because it contains important information for you.
This medicine should always be taken exactly as described in this patient 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 effects, including any not listed in this leaflet, please 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 IBU-SPA is and what it is 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 pack and other information

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

IBU-SPA contains two active substances: ibuprofen and caffeine.
Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs relieve pain by altering the body's response to it.
Caffeine belongs to a group of medicines known as stimulants.
IBU-SPA is indicated for short-term symptomatic treatment of mild to moderate acute pain, such as toothache or headache.
IBU-SPA is intended for use in adults only.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

2. Important information before using IBU-SPA

When not to use IBU-SPA

• if the patient is allergic to ibuprofen, caffeine, or any of the other ingredients of this
  medicinal product (listed in section 6);
• if the patient has ever experienced breathlessness, asthma, rhinitis, angioedema, or urticaria after
  taking acetylsalicylic acid or other similar pain-relieving medicines (NSAIDs);
• in patients with gastric or duodenal ulcer disease or gastrointestinal bleeding (or if there
  have been two or more episodes of such disease in the past);
• if there has been gastrointestinal bleeding or perforation in the past related to previous
  use of NSAIDs;
• in patients with severe liver or kidney failure;
• in patients with severe heart failure;
• in patients with cerebral hemorrhage or any other active bleeding;
• in patients with blood formation disorders of unknown origin;
• in patients with severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake);
• in women during the last three months of pregnancy.

Warnings and precautions
Before starting treatment with IBU-SPA, consult your doctor or pharmacist:

• if the patient is using this medicine for a type of pain other than toothache or headache, as the effect of IBU-
  SPA may vary depending on the type of pain (e.g., efficacy has not been established in treating back or neck pain);
• if the patient has asthma or allergies due to the risk of breathlessness;
• if the patient suffers from hay fever, nasal polyps, or chronic obstructive pulmonary disease due to an increased risk of allergic reactions. These reactions may manifest as asthma attacks (drug-induced asthma), Quincke's edema, or urticaria;
• 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, anticoagulants (e.g., warfarin), selective serotonin reuptake inhibitors (medicines used to treat depression), or antiplatelet agents (e.g., acetylsalicylic acid) (see section "IBU-SPA with other medicines");
• if the patient currently has or has ever had intestinal disease (ulcerative colitis or Crohn's disease);
• if the patient has heart diseases, including heart failure and angina pectoris (chest pain), if the patient has had a heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in legs or feet due to narrowed or blocked 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 levels, if there is a family history of heart disease or stroke, or if the patient smokes;
• if the patient has ever had high blood pressure and/or heart failure;
• patients should be closely monitored immediately after major surgical procedures;
• if the patient has blood clotting disorders;
• if the patient has hereditary blood formation disorders (e.g., intermittent acute porphyria);
• if the patient has certain skin diseases (systemic lupus erythematosus or mixed connective tissue disease);
• if the patient has chickenpox, the use of IBU-SPA is not recommended;
• if the patient has hyperthyroidism (possible increased risk of caffeine-related adverse effects);
• if the patient uses ibuprofen-containing medicines for a long time (regular monitoring of liver function, kidney function, and blood counts may be necessary);
• if the patient develops an infection – see section "Infections" below;
• if the patient develops a rash or skin symptoms, ibuprofen use must be stopped immediately, medical advice should be sought without delay, and the doctor must be informed about taking this medicine;
• if the patient experiences objective or subjective symptoms of drug reaction with eosinophilia and systemic symptoms (DRESS), which include skin rash, fever, lymph node swelling, and increased number of certain white blood cells (eosinophilia).

Skin reactions
Serious 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 any of the symptoms associated with these serious skin reactions described in section 4 occur, IBU-SPA must be discontinued immediately and medical help should be sought.

Infections
IBU-SPA may mask signs of infection such as fever and pain. Therefore, IBU-SPA may delay appropriate treatment of infections 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 ongoing infection and symptoms persist or worsen, immediate consultation with a doctor is necessary.

Contact your doctor immediately:

• if the patient passes bright red stools, black tarry stools, or vomits blood or coffee-ground-like material;
• if the patient experiences severe upper abdominal pain.

Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to relieve symptoms. The risk of adverse effects is higher in elderly patients.

Concomitant use of IBU-SPA with other NSAIDs, including selective cyclooxygenase-2 inhibitors, increases the risk of adverse effects (see section "IBU-SPA with other medicines"), and such combination should be avoided.

Taking anti-inflammatory or pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. The recommended dose or duration of treatment (3 days) should not be exceeded.

Patients using IBU-SPA should inform their doctor or dentist before undergoing surgical procedures and discuss appropriate management.

Allergic reactions to ibuprofen have been reported, including difficulty breathing, facial and neck swelling (angioedema), and chest pain. If any of these symptoms occur, IBU-SPA should be discontinued immediately and medical attention should be sought without delay.

Chronic use of painkillers, especially combinations of multiple active substances with analgesic effects, may lead to permanent kidney damage with risk of kidney failure (analgesic nephropathy). This risk may increase under conditions of physical stress associated with salt loss and dehydration. Therefore, such use should be avoided.

Long-term use of any painkiller for headaches may worsen them. In case of occurrence or suspicion of such a situation, contact a doctor and discontinue treatment with this medicine.

In patients reporting visual disturbances during ibuprofen treatment, therapy should be discontinued and ophthalmological examination performed.

IBU-SPA with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

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

• anticoagulants (i.e., blood-thinning medicines that prevent blood clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine),
• medicines used to treat high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, 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 certain other medicines. Therefore, always consult your doctor or pharmacist before using IBU-SPA together with other medicines.

In particular, inform your doctor or pharmacist if you are taking:

Use of IBU-SPA with food, drink and alcohol
The risk of certain adverse effects, such as those affecting the gastrointestinal tract and central nervous system, may be increased when IBU-SPA is taken together with alcohol. Consumption of large amounts of products containing caffeine (e.g. coffee, tea, foodstuffs, other medicines and drinks) should be avoided while taking IBU-SPA.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
If pregnancy occurs while taking IBU-SPA, the doctor should be informed immediately.

IBU-SPA must not be used 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 also affect the tendency to bleed in both the mother and her child and may result in delivery occurring later or lasting longer than expected. IBU-SPA should not be taken during the first six months of pregnancy unless absolutely necessary and recommended by a doctor. If treatment is required during this period or when trying to become pregnant, the lowest effective dose should be used for the shortest possible duration. Use of IBU-SPA for longer than a few days starting from week 20 of pregnancy may cause kidney problems in the unborn child, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If longer-term treatment is needed, the doctor may recommend additional monitoring.

The active substances, ibuprofen and caffeine, pass into breast milk. Irritability and sleep disturbances have been reported in breastfed infants. IBU-SPA may be used by breastfeeding women only if absolutely necessary.

This medicine belongs to a group of medicines (NSAIDs) which may impair female fertility. This effect is reversible after discontinuation of the medicine.

Driving and operating machinery
When used short-term at recommended doses, this medicine has no effect or has negligible effect on the ability to drive and operate machinery. However, if adverse effects such as dizziness, fatigue or visual disturbances occur, driving and operating machinery should be avoided. This is particularly important when this medicine is taken together with alcohol.

IBU-SPA contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free".

3. How to take IBU-SPA

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:
Initial dose: one coated tablet (400 mg ibuprofen and 100 mg caffeine). If necessary, an additional dose (1 coated tablet) may be taken, but the total dose should not exceed that contained in 3 coated tablets (1200 mg ibuprofen and 300 mg caffeine) within 24 hours. The interval between doses should not be less than 6 hours.
Consult a doctor or pharmacist if the effect of this medicine is too strong or too weak.
IBU-SPA is not recommended for mild pain or when treatment duration exceeds 3 days.
This medicine is not intended for use in children and adolescents under 18 years of age, as there are no available data on its use in this age group.
Oral administration.
The tablet should be swallowed whole with a glass of water.
Patients with a sensitive stomach are advised to take IBU-SPA with food.
For short-term use only.
The duration of treatment should not exceed 3 days.
If pain worsens or persists for more than 3 days, medical advice should be sought.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.
In case of infection, seek immediate medical advice if symptoms (such as fever and pain) persist or worsen (see section 2).
Taking more IBU-SPA than recommended
If more than the recommended dose of IBU-SPA has been taken, or if children have accidentally ingested this medicine, always contact a doctor or the nearest hospital for advice regarding potential risks and necessary actions.
Symptoms may include nausea, abdominal pain, vomiting (possibly with blood), gastrointestinal bleeding, rapid heartbeat, headache, tinnitus, seizures, restlessness, confusion, nystagmus, or less frequently, diarrhoea. Additionally, after large doses, dizziness with a spinning sensation, blurred vision, low blood pressure, agitation, coma, elevated blood potassium levels, acute kidney failure, liver damage, respiratory depression, cyanosis, and worsening of asthma symptoms in patients with asthma have been reported, as well as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in urine, feeling cold, and breathing difficulties.
If you miss a dose of IBU-SPA
Do not take a double dose to make up for a missed dose.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
Any of the known adverse effects associated with NSAIDs (see below) may occur. If this happens, or if
you have any doubts, stop taking the medicine immediately and consult a doctor as soon as possible.
The risk of adverse effects is higher in elderly patients.
Please note that the adverse effects listed below are largely dose-dependent and may vary between
individual patients.
STOP TAKING IBU-SPA IMMEDIATELY and contact a doctor if the patient experiences any of the
following symptoms, as they may indicate serious adverse effects:

• severe stomach discomfort;
• vomiting blood or material resembling coffee grounds;
• black, tarry stools or blood in the urine;
• allergic reactions such as skin rash, itching;
• difficulty breathing and/or swelling of the face or throat;
• feeling of fatigue accompanied by loss of appetite;
• excessive tiredness together with reduced urine output;
• swelling of the face, feet or legs;
• chest pain;
• vision disturbances;
• red, flat, non-raised, target-like or circular skin lesions on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital or eye ulcers. 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 body temperature and swollen lymph nodes (DRESS syndrome).
• red, scaly, widespread rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Other adverse effects
Common (affects up to 1 in 10 patients)

• heartburn, abdominal pain, nausea and indigestion, vomiting, bloating (gas), diarrhoea, constipation and minor gastrointestinal bleeding, which in rare cases may contribute to the development of anaemia
• dizziness, insomnia, headache

Uncommon (affects up to 1 in 100 patients)

• gastric or intestinal ulcers, sometimes with bleeding and perforation, particularly in elderly patients, ulcerative stomatitis, gastritis, black tarry stools, vomiting of material resembling coffee grounds, exacerbation of colitis or Crohn's disease. The risk of gastrointestinal bleeding is particularly dependent on dose and duration of treatment.
• restlessness, palpitations, irritability or fatigue
• visual disturbances, psychotic disorders
• allergic reactions such as asthma attacks. Discontinue use of IBU-SPA and contact a doctor immediately

Rare (affects up to 1 in 1,000 patients)

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

Very rare (affects up to 1 in 10,000 patients)

• NSAID use has been associated with fluid retention, high blood pressure (hypertension), and heart failure

• oesophagitis or pancreatitis, formation of membrane-like strictures in the small and large intestine (intestinal diaphragm disease)

• reduced urine output and swelling (particularly in patients with high blood pressure and reduced kidney function); oedema and cloudy urine (nephrotic syndrome); kidney inflammation (interstitial nephritis), which may lead to acute kidney failure. If any of the above symptoms occur or if general malaise develops, discontinue use of IBU-SPA immediately and contact a doctor without delay, as these symptoms may be early signs of kidney damage or failure

• problems with blood cell production; initial symptoms: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nosebleeds and skin bleeding. In such cases, discontinue treatment immediately and consult a doctor. Do not self-medicate with painkillers or antipyretics

• depression

• worsening of infectious inflammatory diseases (e.g. necrotizing fasciitis) has been reported with some painkillers (NSAIDs). If signs of infection appear or worsen during treatment with IBU-SPA, contact a doctor immediately. It should be determined whether antimicrobial or antibiotic treatment is indicated

• high blood pressure, heart failure, myocardial infarction, vasculitis

• liver function disorders (skin discoloration may be the first sign), liver damage, particularly during long-term use, liver failure, acute hepatitis

• aseptic meningitis symptoms (such as neck stiffness, headache, nausea, vomiting, fever or altered consciousness) have been observed after ibuprofen use. Patients with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) are at increased risk. Contact a doctor immediately if these symptoms occur

• severe forms of skin reactions, such as rash with redness and blisters (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis / Lyell's syndrome), hair loss (alopecia), severe skin infections and soft tissue complications reported during varicella virus infection

• severe, generalized hypersensitivity reactions (with symptoms such as severe allergic reaction causing facial or throat swelling, breathing difficulties, rapid heartbeat, drop in blood pressure, anaphylactic shock, i.e. severe allergic reaction causing breathing difficulties or dizziness)

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

• seizures
• rapid heartbeat
• a severe skin reaction called DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes, and increased eosinophil count (a type of white blood cell)
• red, scaly, widespread 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). If such symptoms occur, discontinue use of IBU-SPA immediately and seek medical help without delay. See also section 2
• increased sensitivity to sunlight
• persistent drug-induced erythema (e.g. circular or oval red spots and skin swelling, possibly with itching)
• chest pain, which may indicate a potentially serious allergic reaction called Kounis syndrome

Use of medicines such as IBU-SPA may be associated with a small increased risk of heart attack or
stroke.
In a study on tooth extraction, alveolar osteitis developed postoperatively in some patients (2.8%), and
gingivitis occurred in others (1.4%).
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the
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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.
5. How to store IBU-SPA
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack.
The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Do not dispose of medicines via the sewage system 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 IBU-SPA contains
The active substances in IBU-SPA 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
Tablet coating:
Hydroxypropylmethylcellulose
Hydroxypropylcellulose
Macrogol 6000
Talc
Titanium dioxide (E 171)

What IBU-SPA looks like and contents of the pack
IBU-SPA is a white, elongated coated tablet measuring 17.8 mm x 8.6 mm.
IBU-SPA is available in blister packs.
Pack sizes: 6 and 10 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised 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