Buscofem

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 ask your 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 called 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 breathing difficulties, asthma, nasal congestion, or swelling 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 in the brain 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, you should discuss it with your doctor or pharmacist:
if you are taking this medicine for a type of 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 you have asthma or allergies due to the risk of breathing difficulties;
if you have hay fever, nasal polyps, or chronic obstructive pulmonary disease due to the increased risk of allergic reactions. These reactions can manifest as asthma attacks (asthma associated with painkillers), Quincke's edema, or hives;
if you have liver function disorders;
if you have kidney function disorders;
if you are taking medicines that interact with IBU-SPA, such as corticosteroids, blood thinners (such as warfarin), selective serotonin reuptake inhibitors (antidepressants), or antiplatelet agents (such as acetylsalicylic acid) (see "IBU-SPA and other medicines");
if you currently have or have had intestinal disease (ulcerative colitis or Crohn's disease);
if you have heart disease, including heart failure and angina pectoris (chest pain), if you have had a heart attack, coronary artery bypass grafting, if you have peripheral artery disease (poor blood circulation in the legs or feet due to narrowing or blockage of arteries) or if you have had any stroke (including mini-stroke or transient ischemic attack - TIA);
if you have high blood pressure, diabetes, high cholesterol, if there is a history of heart disease or stroke in your family, or if you smoke;
if you have ever had high blood pressure or heart failure;
particular monitoring of patients is recommended immediately after extensive surgical procedures;
if you have bleeding disorders;
if you have inherited blood disorders (e.g., acute intermittent porphyria);
if you have certain skin diseases (systemic lupus erythematosus or mixed connective tissue disease);
if you have chickenpox, it is recommended to avoid taking IBU-SPA;
if you have hyperthyroidism (possible increased risk of caffeine side effects);
if you are taking ibuprofen-containing medicines for a long time (regular monitoring of liver parameters, kidney function, and blood morphology may be necessary);
if an infection occurs - see "Infections" below;
if you experience a rash or skin symptoms, you should stop taking ibuprofen immediately, seek medical advice, and inform your doctor that you are taking this medicine;
if you experience objective or subjective symptoms of a drug reaction with eosinophilia and systemic symptoms (DRESS), which include skin rash, fever, and lymph node swelling, and an increase in the number of a certain type of white blood cell (eosinophilia).
Skin reactions
Severe skin reactions have been reported with the use of IBU-SPA. You should stop taking IBU-SPA and seek medical help immediately if you experience a skin rash, mucosal lesions, blisters, or other signs of allergy, as these may be the first signs of a very severe skin reaction. See section 4.
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 and consequently lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you are taking this medicine while an infection is present and its symptoms persist or worsen, you should consult your doctor immediately.
You should contact your doctor immediately:
if you experience bloody stools, black, tarry stools, or if you vomit blood or coffee grounds;
if you experience severe abdominal pain.
Side effects can be minimized by using the smallest effective dose for the shortest necessary period to relieve symptoms. 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 anti-inflammatory drugs, 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 or duration of treatment (3 days).
Patients taking IBU-SPA should inform their doctor or dentist before undergoing surgical procedures and discuss their treatment.
While taking ibuprofen, symptoms of an allergic reaction to this medicine have occurred, including difficulty breathing, facial and neck swelling (angioedema), and chest pain. If you notice any of these symptoms, you should stop taking IBU-SPA immediately and contact your doctor or emergency services.
Habitual use of painkillers, especially combinations of several active substances with pain-relieving 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 salt loss and dehydration. Therefore, this should be avoided.
Long-term use of any painkiller for headaches can exacerbate them.
If this situation occurs or is suspected, you should contact your doctor and stop treatment with this medicine.
In patients reporting eye disorders during ibuprofen treatment, therapy should be discontinued and ophthalmological examinations performed.

IBU-SPA and other medicines

You should 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:

• anticoagulant medicines (i.e., blood thinners, such as acetylsalicylic acid, warfarin, ticlopidine),
• medicines to lower 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, you should always consult your doctor or pharmacist before taking IBU-SPA with other medicines.
In particular, you should tell your doctor or pharmacist if you are taking:

Taking 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. You 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should ask your doctor or pharmacist for advice before taking this medicine.
In case of pregnancy during IBU-SPA treatment, you should inform your doctor immediately.
You should not take IBU-SPA if you are in the last 3 months of pregnancy, as it may harm the unborn child or cause problems during delivery. It may affect the baby's kidneys and heart and may cause bleeding problems for you and your child, and may lead to a longer or more difficult delivery than expected. You should not take IBU-SPA during the first 6 months of pregnancy, unless it is absolutely necessary and prescribed by your doctor. If you need treatment during this period or while trying to become pregnant, you should be given the smallest dose for the shortest possible time. IBU-SPA, taken for more than a few days, starting from the 20th week of pregnancy, may cause kidney problems in the unborn child, which can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your 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 have a negative effect on 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 vision disturbances occur, you should not drive or operate machinery. This is especially true when this medicine is used in combination 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 your doctor or pharmacist.
In case of doubt, you should ask your 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 dose should not exceed 3 coated tablets (1200 mg ibuprofen and 300 mg caffeine) in 24 hours. The interval between doses should not be less than 6 hours.
You should consult your doctor or pharmacist if the effect of this medicine is too strong or too weak.
In cases of mild pain or when treatment lasts more than 3 days, IBU-SPA is not recommended.
This 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 lasts longer than 3 days, you should consult your doctor.
The lowest effective dose should be used for the shortest time necessary to relieve symptoms.
In case of infection, you should consult your 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 an overdose of IBU-SPA or if children have taken this medicine by accident, you should always contact your doctor or the nearest hospital for advice on the risk and the 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 spinning sensation, blurred vision, low blood pressure, excitement, coma, elevated potassium levels in the blood, acute kidney failure, liver damage, depression of breathing, cyanosis, and worsening of asthma symptoms in patients with asthma have occurred.
Furthermore, the following have been reported: dizziness with a spinning sensation, blurred vision, low blood pressure, excitement, coma, elevated potassium levels in the blood, acute kidney failure, liver damage, depression of breathing, cyanosis, and worsening of asthma symptoms in patients with asthma.

Missing a dose of IBU-SPA

You should not take a double dose to make up for a forgotten dose.
In case of any further doubts about the use of this medicine, you should ask your 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 you are unsure, you should stop taking the medicine and consult your 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 individual patients.

You should STOP TAKING IBU-SPA and contact your doctor immediately if you 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 of fatigue with loss of appetite;
• excessive fatigue with reduced urine output;
• swelling of the face, feet, or ankles;
• chest pain;
• vision disturbances.

Other side effects

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

• heartburn, abdominal pain, nausea, and indigestion, vomiting, bloating (gas), diarrhea, constipation, and minor gastrointestinal bleeding, 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, mouth ulcers, stomach inflammation, black, tarry stools, vomiting blood or coffee grounds, worsening of ulcerative colitis or Crohn's disease. In particular, the risk of gastrointestinal bleeding is dose- and duration-dependent.
• excitement, rapid heartbeat, irritability, or fatigue
• vision disturbances, psychotic disorders
• allergic reactions, such as asthma attacks. You should stop taking IBU-SPA and contact your doctor immediately

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

• ringing in the ears (tinnitus), 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
• esophageal or pancreatic inflammation, the formation of membranous strictures in the small and large intestines (intestinal stricture)
• reduced urine output and swelling (especially in patients with high blood pressure and reduced kidney function); urine concentration and clouding (nephrotic syndrome); kidney inflammation (interstitial nephritis), which can lead to acute kidney failure. If any of these symptoms occur or if you feel generally unwell, you should stop taking IBU-SPA and contact your doctor immediately, as these symptoms may be the first signs of kidney damage or failure
• blood disorders; first symptoms: fever, sore throat, mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and skin bleeding. In such cases, you should stop the treatment and consult your doctor. Do not take painkillers or antipyretics (fever-reducing medicines) on your own
• depression
• in connection with the use of some painkillers (NSAIDs), worsening of infectious diseases (e.g., bacterial pneumonia) has been reported. If you experience or worsen symptoms of an infection while taking IBU-SPA, you should contact your doctor immediately. You should determine whether there are indications for antimicrobial or antibiotic treatment
• high blood pressure, heart failure, heart attack, blood vessel inflammation
• liver function disorders (the first symptom may be skin discoloration), liver damage, especially during long-term use, liver failure, acute liver inflammation
• after taking ibuprofen, symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever, or changes in consciousness have been observed. Patients with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) are at increased risk. You should contact your doctor immediately if you experience these symptoms
• severe skin reactions, such as rash with redness and blisters (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis), hair loss (alopecia), severe skin infections, and soft tissue complications have been reported during chickenpox infection
• severe, generalized allergic reactions (with symptoms such as severe allergic reaction causing facial or throat swelling, difficulty breathing, rapid heartbeat, low blood pressure, anaphylactic shock, or severe allergic reaction causing difficulty breathing or dizziness)

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

• seizures
• rapid heartbeat
• a severe skin reaction called DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin rash, fever, lymph node enlargement, and an increase in the number of eosinophils (a type of white blood cell)
• increased sensitivity to sunlight
• permanent drug rash (e.g., round or oval red patches and skin swelling, possibly with itching)
• chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome

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

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your 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, you can help provide more information on the safety of this medicine.

5. How to store IBU-SPA

The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of the month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. 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
Anhydrous colloidal 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, elongated, coated tablet with dimensions of 17.8 mm x 8.6 mm.
IBU-SPA is available in blisters.
Packaging contains 6, 10 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization 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 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:December 2023