IBUPROFEN PENSA 600 mg FILM-COATED TABLETS

Introduction

Prospectus

Ibuprofen Pensa 600 mg film-coated tablets EFG

L

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

Contentsoftheprospectus:

1. What is Ibuprofen Pensa and what is it used for
2. What you need to know before starting to take Ibuprofen Pensa
3. How to take Ibuprofen Pensa
4. Possible side effects
5. Storage of Ibuprofen Pensa
6. Package contents and additional information

1. What is Ibuprofen Pensa and what is it used for

Ibuprofen Pensa contains the active ingredient ibuprofen. Ibuprofen belongs to the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Ibuprofen relieves pain and has an anti-inflammatory effect.

It is used in adults and adolescents over 14 years of age for:

• Symptomatic treatment of pain and inflammation in arthritic diseases (e.g. rheumatoid arthritis), degenerative arthritic conditions (e.g. osteoarthritis), and painful swelling and inflammation after soft tissue injuries.
• Symptomatic treatment of moderate intensity pain.
• Symptomatic treatment of primary dysmenorrhea.

2. What you need to know before starting to take Ibuprofen Pensa

Do not take Ibuprofen Pensa

• If you are allergic to the active ingredient or any of the other components of this medicine (listed in section 6). The symptoms of an allergic reaction may be: swollen eyelids, lips, tongue, or throat.
• If you have ever had an allergic reaction (such as bronchospasm, asthma attacks, nasal discharge, swelling of the nasal passages, skin reactions, or hives) after taking acetylsalicylic acid and other similar analgesics (NSAIDs).
• If you have or have had ulcerative colitis, Crohn's disease, recurrent stomach or duodenal bleeding (peptic ulcers) or bleeding (at least 2 different episodes of ulcers or bleeding diagnosed).
• If you have had gastrointestinal bleeding or perforation of the digestive tract with previous treatments with NSAIDs.
• If you have any active bleeding.
• If you have severe liver or kidney disease or heart failure.
• If you have severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).
• If you are in the third trimester of pregnancy.
• If you are a child or adolescent under 14 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take ibuprofen.

Side effects can be reduced by using the lowest effective dose necessary to control symptoms for the shortest possible time.

With prolonged use of any analgesic, headache may occur that should not be treated by increasing the dose of the medicine.

When using NSAIDs, adverse reactions, especially those affecting the gastrointestinal tract or central nervous system, may be potentiated by concurrent consumption with alcohol.

Consult your doctor or pharmacist before starting to take ibuprofen if:

• You have or have had gastrointestinal diseases (ulcerative colitis, Crohn's disease) as they may worsen these conditions.
• You have a hereditary disease that affects your blood (e.g. acute intermittent porphyria).
• Your kidney or liver function is reduced.
• You have recently undergone major surgery.
• You are sensitive (allergic) to other substances.
• You suffer from hay fever, nasal polyps, or chronic obstructive respiratory disorders, as you have a higher risk of an allergic reaction. Allergic reactions can present as asthma attacks, rapid swelling, or hives.
• You are dehydrated.
• You have an infection: see the "Infections" section below.

Gastrointestinal effects

The combined use of ibuprofen with other non-steroidal anti-inflammatory medicines (NSAIDs), including so-called COX-2 inhibitors, should be avoided.

Gastrointestinal bleeding, ulcers, and perforation:

Gastrointestinal bleeding, ulcers, and perforations have been reported with all NSAIDs. They have occurred at any time during treatment, with or without prior warning symptoms or history of gastrointestinal events.

The risk of gastrointestinal bleeding, ulcers, and perforation is higher with increasing doses of NSAIDs and is higher in patients with a history of ulcers, especially with complications of bleeding or perforation (see section 2 "Do not take Ibuprofen Pensa"), and in elderly patients. These patients should start treatment with the lowest available dose.

For these patients, as well as for patients who require additional treatment with low doses of acetylsalicylic acid or other medicines that may increase the risk of gastrointestinal disorders, combination therapy with protective medicines (e.g. misoprostol or proton pump inhibitors) should be considered.

If you have a history of adverse effects that affect the gastrointestinal tract, especially if you are an elderly person, you should contact a doctor in case of unusual abdominal symptoms (especially gastrointestinal bleeding), particularly at the start of treatment.

Caution is recommended if you are also taking other medicines that may increase the risk of ulcers or bleeding, e.g. oral corticosteroids, anticoagulants (blood thinners) such as warfarin, selective serotonin reuptake inhibitors (used to treat psychiatric disorders, including depression), or platelet aggregation inhibitors such as acetylsalicylic acid (see section 2 "Other medicines and Ibuprofen Pensa").

Treatment should be discontinued and a doctor consulted if you experience gastrointestinal bleeding or ulcers during treatment with ibuprofen.

Cardiovascular effects

Anti-inflammatory/analgesic medicines like 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.

You should discuss your treatment with your doctor or pharmacist before taking ibuprofen if:

• You have heart problems, including heart failure, angina pectoris, or if you have had a heart attack, bypass surgery, peripheral arteriopathy, or any type of stroke.
• You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

Respiratory disorders

Ibuprofen should be used with caution when administered to patients who have or have had asthma, chronic rhinitis, or allergic diseases, as ibuprofen has been reported to cause bronchospasm, hives, or angioedema in these patients.

Heart, kidney, and liver failure

NSAIDs should be used with caution when administered to patients with heart, kidney, or liver failure, as they may worsen renal function. The concomitant use of several similar analgesics increases this risk even further. For these patients, the lowest effective dose should be used for the shortest possible time, and renal function should be monitored, especially in patients treated long-term.

Renal effects

Ibuprofen should be used with caution when administered to patients with significant dehydration. There is a risk of renal failure, especially in children, adolescents, and elderly patients who are dehydrated.

Patients at higher risk of this reaction are those with renal failure, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and elderly patients. Discontinuation of NSAID treatment is usually followed by recovery to the pre-treatment state.

Skin reactions

Severe skin reactions, 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), have been reported in association with ibuprofen treatment. Discontinue treatment with Ibuprofen Pensa and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

During chickenpox infection, the use of ibuprofen is not recommended.

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Consequently, this medicine may delay appropriate treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while having an infection and the symptoms of the infection persist or worsen, consult your doctor as soon as possible.

Hematological effects

Ibuprofen, like other NSAIDs, may interfere with platelet aggregation and prolong bleeding time in individuals.

Aseptic meningitis

Aseptic meningitis has been observed in rare cases in patients treated with ibuprofen. Although it is more likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has also been reported in patients without underlying chronic disease.

With ibuprofen, signs of an allergic reaction to this medicine, such as respiratory problems, swelling of the face and neck area, and chest pain, have been reported. Stop using Ibuprofen Pensa immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

Elderly patients

Elderly patients have a higher frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal. For this reason, close medical monitoring is required in elderly patients.

Other medicines and Ibuprofen Pensa

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Ibuprofen may affect or be affected by other medicines. For example:

• Digoxin, phenytoin, and lithium. The combined use of ibuprofen with digoxin (used to strengthen the heart), phenytoin (used to treat epilepsy), or lithium (a medicine used to treat depression) may increase the concentration of these medicines in the blood. It is necessary to monitor serum lithium levels. Monitoring of serum digoxin and phenytoin levels is recommended.
• Anticoagulant medicines (e.g. to treat blood clotting problems/prevent clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine). NSAIDs may increase the effects of anticoagulants such as warfarin.
• Diuretics and medicines for treating high blood pressure:
• • E.g. ACE inhibitors, beta-blockers, and angiotensin-II receptor antagonists. The combined use of ibuprofen with potassium-sparing diuretics may increase the level of potassium in the blood. Therefore, monitoring of serum potassium levels is recommended.
  • Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin-II receptor antagonists such as losartan). Ibuprofen may reduce the effects of ACE inhibitors (used to treat heart failure and high blood pressure). Additionally, during combined use, there is a risk of renal failure.

• Colestyramine (a medicine used to treat high cholesterol) in combination with ibuprofen may reduce the absorption of ibuprofen in the gastrointestinal tract. However, the clinical significance is unknown.
• Other analgesics: the combined use of ibuprofen with other anti-inflammatory and analgesic medicines of the NSAID group, including COX-2 inhibitors (e.g. celecoxib), may increase the risk of gastrointestinal ulcers and bleeding.
• Platelet aggregation inhibitors and certain antidepressants (selective serotonin reuptake inhibitors/SSRIs) may increase the risk of gastrointestinal bleeding.
• Methotrexate: the administration of ibuprofen in the 24 hours before or after methotrexate administration (used to treat certain types of cancer or rheumatism) may lead to an increase in methotrexate concentrations and an increase in its side effects.
• Ciclosporin and tacrolimus may cause kidney damage.
• Sulfonylureas: during the combined use of ibuprofen and sulfonylureas (medicines used to treat diabetes), monitoring of blood sugar levels is recommended as a precautionary measure.
• Zidovudine: there is evidence suggesting a higher risk of hemarthrosis (bleeding into the joints) and bruising in patients with HIV who use zidovudine (an antiviral medicine used to treat HIV infections) together with ibuprofen.
• Quinolone antibiotics: the risk of seizures (fits) may increase when quinolone antibiotics, such as ciprofloxacin, and ibuprofen are taken at the same time.
• Aminoglycosides: the combined use of ibuprofen with aminoglycosides (a type of antibiotic) may decrease the excretion of aminoglycosides.
• Voriconazole and fluconazole (CYP2C9 inhibitors) used for fungal infections, as the effect of ibuprofen may increase. A reduction in the dose of ibuprofen should be considered, particularly when high doses of ibuprofen are administered with voriconazole or fluconazole.
• Ginkgo biloba (a herbal medicine) may increase the risk of bleeding with NSAIDs.
• Mifepristone: the combined use of mifepristone with other anti-inflammatory and analgesic medicines of the NSAID group (i.e. ibuprofen) may decrease the effect of mifepristone.
• Medicines for treating inflammation (corticosteroids) due to the increased risk of gastrointestinal ulcers or bleeding.

Some other medicines may also affect or be affected by ibuprofen treatment. Therefore, you should always seek the advice of your doctor or pharmacist before using ibuprofen with other medicines.

Taking Ibuprofen Pensa with food and alcohol

It is recommended that patients with sensitive stomachs take ibuprofen with food. Alcohol may potentiate the adverse effects of ibuprofen, especially those affecting the central nervous system and gastrointestinal tract. It is preferable not to drink alcohol while taking ibuprofen.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take ibuprofen if you are in the last 3 months of pregnancy, as it may harm your baby or cause problems during delivery. It may cause kidney or heart problems in your baby. It may increase the risk of bleeding in you and your baby during delivery, delay delivery, or prolong it more than expected. You should not take ibuprofen during the first 6 months of pregnancy unless it is absolutely necessary and your doctor advises it. If you need treatment during this period or while trying to become pregnant, the lowest dose should be used for the shortest possible time. If you take it for more than a few days from the 20th week of pregnancy, ibuprofen may cause kidney problems in the fetus, which may lead to low levels of amniotic fluid surrounding the baby or narrowing of a blood vessel in the baby's heart.

Breastfeeding

The use of ibuprofen is not recommended in women during breastfeeding.

Fertility

Ibuprofen may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Driving and using machines

During treatment with ibuprofen, your reaction ability and ability to drive and use machines may be affected in individual cases. This is especially important when combined with alcohol.

Ibuprofen Pensa contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Ibuprofen Pensa contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; it is essentially "sodium-free".

3. How to take Ibuprofeno pensa

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult with your doctor or pharmacist.

The effective lowest dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, consult your doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

The recommended dose is:

Adults and adolescents over 14 years

The single dose is 300-600 mg of ibuprofen. The recommended daily dose is 1,200-1,800 mg in divided doses. You should wait for an interval of at least 6 hours between doses. Some patients may be maintained with 600-1,200 mg daily. In severe or acute conditions, it may be beneficial to increase the dose until the acute phase is controlled, as long as the daily dose does not exceed 2,400 mg in divided doses.

Special populations

If you have severe liver and kidney disease or are an elderly person, your doctor will indicate the correct dose you should take, which will be the lowest possible dose.

Use in children and adolescents

Ibuprofeno 600 mg film-coated tablets are not indicated in children or adolescents under 14 years.

Method of administration

Ibuprofen is for oral use.

Take the tablets with a glass of water.

The tablets should not be crushed, chewed, or sucked to avoid stomach or throat irritation.

It is recommended that patients with sensitive stomachs take ibuprofen with food.

Duration of treatment

The doctor will decide the duration of treatment.

In rheumatic diseases, the use of ibuprofen may be necessary for a longer period.

If you take more Ibuprofeno pensa than you should

If you take more ibuprofen than you should, or if children have taken this medication by accident, always contact a doctor or the nearest hospital to obtain an opinion on the risk and advice on the measures to take.

The symptoms may include nausea, stomach pain, and vomiting (which may contain blood). Additionally, headache, gastrointestinal bleeding, ringing in the ears, confusion, and involuntary eye movement. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, acute kidney failure, liver damage, chills, and respiratory problems have been reported.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Ibuprofeno pensa

Do not take a double dose to make up for forgotten doses.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The pattern of side effects reported for ibuprofen is similar to that of other NSAIDs.

Stop taking ibuprofen and contact a doctor immediately if you experience any of the following side effects:

• Angioedema (a rare side effect) with symptoms such as:
  • swelling of the face, tongue, or throat,
  • difficulty swallowing,
  • hives and difficulty breathing.

• An infection with symptoms such as fever and severe deterioration of your general condition, or fever with symptoms of local infection such as sore throat/pharynx/mouth or urinary problems.

Ibuprofen may cause a reduction in the number of white blood cells (agranulocytosis) with decreased resistance to infections (a rare side effect). It is essential that you inform your doctor about your medication.

• red patches, not raised, in a target or circular shape on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat ulcers, nose ulcers, genital ulcers, and eye ulcers. 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).
• Widespread, red, and scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Other side effects that may occur:

Frequent (may affect up to 1 in 10 people):

• Headache, dizziness
• Gastrointestinal side effects (indigestion, diarrhea, nausea, vomiting, abdominal pain, flatulence, constipation, black stools, stomach and intestinal bleeding, vomiting blood)
• Rash
• Fatigue

Uncommon (may affect up to 1 in 100 people):

• Rhinitis
• Hypersensitivity
• Insomnia, anxiety
• Tingling sensation
• Drowsiness
• Visual disturbances, hearing impairment
• Dizziness
• Tinnitus (ringing in the ears)
• Bronchospasm, asthma
• Dyspnea
• Mouth ulcers
• Stomach ulcers, intestinal ulcers, stomach ulcer perforation, inflammation of the stomach mucous membrane
• Hepatitis, jaundice, abnormal liver function
• Itching, small bruises on skin and mucous membranes
• Skin becomes sensitive to light
• Renal function impairment

Rare (may affect up to 1 in 1,000 people):

• Non-bacterial meningitis
• Changes in blood tests
• Anemia (a reduction in red blood cells or hemoglobin, which can make the skin pale and cause weakness)
• Anaphylactic reaction
• Depression, confusion
• Optic neuritis
• Toxic optic neuropathy
• Edema

Very rare (may affect up to 1 in 10,000 people):

• Heart failure, myocardial infarction, high blood pressure
• Pancreatitis, liver failure
• Severe skin reactions (e.g., erythema multiforme, blistering reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis)

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

• Worsening of ulcers in the large intestine (colitis) and Crohn's disease (intestinal disease)
• Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)
• Acute generalized exanthematous pustulosis (AGEP)
• Chest pain, which can be a sign of a potentially severe allergic reaction called Kounis syndrome.

Note that ibuprofen may prolong bleeding time.

Exceptionally, severe skin infections in case of chickenpox. When using an NSAID, a skin inflammation related to an infection (e.g., a condition such as necrotizing fasciitis characterized by severe pain, high fever, swollen and hot skin, blisters, and necrosis) may develop or worsen. If signs of a skin infection or worsening appear during the use of ibuprofen, it is recommended that you consult your doctor immediately.

Medications like ibuprofen may involve a slightly higher risk of suffering a heart attack or stroke.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ibuprofeno pensa

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging and blister after "CAD". The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Ibuprofeno pensa

The active ingredient is ibuprofen. Each film-coated tablet contains 600 mg of ibuprofen.

The other ingredients (excipients) are:

Core of the tablet:hypromellose, sodium croscarmellose, lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, anhydrous colloidal silica, and magnesium stearate.

Coating material: hypromellose, titanium dioxide (E-171), talc, and propylene glycol.

Appearance of the product and package contents

White, oval, biconvex film-coated tablets.

Ibuprofeno pensa 600 mg film-coated tablets are available in aluminum-PVC/PVDC blisters in packs of 20, 30, 40, or 60 tablets.

Only some pack sizes may be marketed.

Marketing authorization holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer:

ROVI PHARMA INDUSTRIAL SERVICES, S.A.

Vía Complutense 140,

28805 Alcalá de Henares (Madrid)

Spain

or

TOLL MANUFACTURING SERVICES S.L.

C/ Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

or

FARMALIDER, S.A.

C/ Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

This medication is authorized in the Member States of the European Economic Area with the following names:

Spain: Ibuprofeno pensa 600 mg film-coated tablets EFG

Italy: Ibuprofene Pensa

Portugal: Ibuprofeno Pensa

Date of the last revision of this leaflet: January 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/