Buscofem

Package leaflet: Information for the user

IBU-SPA, 400 mg + 100 mg, coated tablets
Ibuprofen + Caffeine
Please read all of this leaflet carefully before taking this medicine because it contains information
important for you.
This medicine should always be used 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 consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if you feel worse, you should consult a doctor.

Contents of the leaflet

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 provide relief by altering 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 acute pain such as toothache or headache.
IBU-SPA is intended only for use in adults.
If there is no improvement after 3 days, or if you feel worse, you should consult a doctor.

2. Important information before using the medicine IBU-SPA

When not to use IBU-SPA medicine
• 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 experienced asthma, breathlessness, rhinitis, angioedema, or urticaria after
taking acetylsalicylic acid or other similar pain-relieving medicines (NSAIDs);
• in patients with peptic ulcer or duodenal ulcer disease or gastrointestinal bleeding (or if
two or more episodes of such disease occurred in the past);
• if gastrointestinal bleeding or perforation occurred 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 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 to take IBU-SPA medicine, discuss this with your doctor or pharmacist:
• if the patient is taking this medicine for a different type of pain than toothache or headache, 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 been diagnosed with asthma or allergies due to the risk of breathlessness;
• if the patient has been diagnosed with 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 been diagnosed with liver function disorders;
• if the patient has been diagnosed with 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 and other medicines");
• if the patient currently has or has ever had intestinal disease in the past (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 myocardial infarction, coronary artery bypass surgery, if the patient has 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 hypertension, diabetes, high cholesterol levels, if heart disease or stroke runs in the family, 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 been diagnosed with blood clotting disorders;
• if the patient has been diagnosed with inherited blood production disorders (e.g., acute intermittent porphyria);
• if the patient has been diagnosed with certain skin diseases (systemic lupus erythematosus or mixed connective tissue disease);
• if the patient has chickenpox, it is recommended to avoid using IBU-SPA;
• if the patient has hyperthyroidism (possible increased risk of caffeine-related adverse effects);
• if the patient takes ibuprofen-containing medicines for a long time (regular monitoring of liver parameters, kidney function, and blood morphology may be necessary);
• if the patient develops an infection – see section "Infections" below;
• if the patient develops a rash or skin symptoms, ibuprofen should be discontinued immediately, medical advice should be sought promptly, and the doctor should be informed about taking this medicine;
• if the patient develops 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 types of white blood cells (eosinophilia).

Skin reactions
Severe skin reactions have been reported in association with the use of IBU-SPA. The use of IBU-SPA should be discontinued and immediate medical help should be sought if skin rash, mucosal lesions, blisters, or other signs of allergy occur, as these may be early signs of a very serious skin reaction. See section 4.

Infections
IBU-SPA may mask symptoms of infection, such as fever and pain. Therefore, IBU-SPA may delay the initiation of appropriate treatment for 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 if the patient 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 NSAIDs containing selective cyclooxygenase-2 inhibitors increases the risk of adverse effects (see section "IBU-SPA and 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 myocardial infarction or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment (3 days).
Patients taking IBU-SPA should inform their doctor or dentist before surgical procedures and discuss management with them.
Allergic reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have occurred during treatment. If any of these symptoms are observed, IBU-SPA should be discontinued immediately and medical help should be sought without delay.
Regular use of painkillers, especially combinations of several active substances with analgesic effects, may lead to permanent kidney damage with risk of kidney failure (analgesic nephropathy). This risk may increase under physical stress associated with salt loss and dehydration. Therefore, this should be avoided.
Long-term use of any painkiller for headaches may worsen them.
If such a situation occurs or is suspected, contact a doctor and discontinue treatment with 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
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 for lowering high blood pressure (ACE inhibitors such as captopril, beta-blockers such as medicines containing 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 certain other medicines. Therefore, always consult your doctor or pharmacist before taking 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 a patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to become pregnant, 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 if the patient is in the last 3 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 6 months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment is needed during this period or when trying to conceive, the lowest effective dose should be used for the shortest possible time. 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 could lead to low levels of amniotic fluid surrounding the child (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child'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) that may impair female fertility. This effect is reversible upon discontinuation of the medicine.

Driving and operating machinery
When used short-term at recommended doses, this medicine has no effect or 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 used together with alcohol.

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

3. How to take IBU-SPA

This medicine should always be taken exactly as described in this patient 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 is insufficient data available 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 beyond 3 days, medical advice must be sought.

Use the lowest effective dose for the shortest duration necessary to relieve symptoms.

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

Overdose of IBU-SPA
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 on 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 commonly, diarrhea. Additionally, after large doses, dizziness with a spinning sensation, blurred vision, low blood pressure, excitation, coma, elevated blood potassium levels, acute kidney failure, liver damage, respiratory depression, cyanosis, and worsening of asthma symptoms in asthmatic patients may occur, 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.

Missed 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 all medicines, 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
any doubts arise, treatment should be discontinued and medical advice should be sought as soon as possible.
The risk of adverse effects is higher in elderly patients.
It should be noted that the adverse effects listed below are largely dose-dependent and may vary between individual patients.
IMMEDIATELY DISCONTINUE TREATMENT WITH IBU-SPA and contact a doctor if
the patient experiences any of the symptoms listed below, as they may indicate
serious adverse effects:

• Severe gastrointestinal discomfort;
• Vomiting blood or material resembling coffee grounds;
• Black, tarry stools or blood in the urine;
• Allergic reactions, such as skin rash, itching;
• Breathing difficulties and (or) swelling of the face or throat;
• Feeling of fatigue accompanied by loss of appetite;
• Excessive tiredness associated with reduced urine output;
• Swelling of the face, feet or legs;
• Chest pain;
• Vision disturbances.

Other adverse effects
Common (occurring in no more than 1 in 10 patients)

• Heartburn, abdominal pain, nausea and dyspepsia, vomiting, flatulence (gas), diarrhoea, constipation and minor blood loss from the stomach and (or) intestines, which in rare cases may contribute to anaemia
• Dizziness, insomnia, headache

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

• Gastric or intestinal ulcers, sometimes with bleeding and perforation, particularly in elderly patients, ulcerative stomatitis, gastritis, black tarry stools, vomiting material resembling coffee grounds, exacerbation of colitis or Crohn's disease. In particular, the risk of gastrointestinal bleeding depends on the dose and duration of treatment.
• Restlessness, palpitations, irritability or fatigue
• Visual disturbances, psychotic disorders
• Allergic reactions, such as asthma attacks. Treatment with IBU-SPA should be discontinued and immediate medical advice sought

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

• In connection with the use of NSAIDs, oedema, high blood pressure (hypertension) and heart failure have been reported
• Oesophagitis or pancreatitis, formation of membrane-like strictures in the small and large intestine (intussusception-like intestinal stricture)
• Reduced urine output and oedema (especially in patients with high blood pressure and reduced kidney function); oedema and cloudy urine (nephrotic syndrome); kidney inflammatory disease (interstitial nephritis), which may lead to acute kidney failure. If any of the above symptoms occur or if general malaise develops, treatment with IBU-SPA should be discontinued immediately and immediate medical advice sought, as these symptoms may be the first signs of kidney damage or kidney failure
• Problems with blood cell production; initial symptoms: fever, sore throat, superficial ulceration of the oral cavity, flu-like symptoms, severe exhaustion, nosebleeds and skin bleeding. In such cases, treatment should be stopped immediately and medical advice sought. Do not self-medicate with analgesics or antipyretics
• Depression
• In connection with the use of certain analgesics (NSAIDs), worsening of inflammatory conditions associated with infection (e.g. necrotizing fasciitis) has been reported. If signs of infection appear or worsen during treatment with IBU-SPA, immediate medical advice should be sought. 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 prolonged use, liver failure, acute hepatitis
• Aseptic meningitis symptoms (including neck stiffness, headache, nausea, vomiting, fever or disturbances of consciousness) have been observed after ibuprofen administration. Patients with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) are at increased risk. Immediate medical advice should be sought 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, the use of IBU-SPA should be stopped immediately and immediate medical help sought. See also section 2
• Increased sensitivity to sunlight
• Persistent drug-induced erythema (e.g. round or oval red patches and skin swelling, possibly with itching)
• Chest pain, which may indicate a potentially serious allergic reaction called Kounis syndrome

The use of medicines such as IBU-SPA may be associated with a small increased risk of myocardial infarction or
stroke.
In a study on tooth extraction, alveolar osteitis (dry socket) developed in some patients (2.8%) after surgery, and gingivitis occurred in some (1.4%).
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse effects can
be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 .
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the 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.
Medicines must not be disposed of via the sewage system or household waste. Ask a pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What IBU-SPA contains
The active substances 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. Bonifraterska 17
00-203 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 European Economic Area countries 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