IBUPROFEN PHARMACLAN 400 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ibuprofen Pharmaclan200 mg film-coated tablets EFG

Ibuprofen Pharmaclan400 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
• Adults: You should consult a doctor if you do not feel better or if you feel worse after 3 days for fever, or after 4 days for pain.

Children and adolescents: Consult a doctor if you do not feel better or if you feel worse after 3 days.

Contents of the pack

1. What is Ibuprofen Pharmaclan and what is it used for
2. What you need to know before you take Ibuprofen Pharmaclan
3. How to take Ibuprofen Pharmaclan
4. Possible side effects
5. Storing Ibuprofen Pharmaclan
6. Contents of the pack and other information

1. What is Ibuprofeno Pharmaclan and what is it used for

Ibuprofen Pharmaclan contains the active substance ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which act by reducing pain and fever.

Ibuprofen Pharmaclan is used for the short-term symptomatic treatment of mild to moderate pain, such as toothache, menstrual pain, and headache, and/or for the short-term symptomatic treatment of fever.

Ibuprofen Pharmaclan 200 mg film-coated tablets are indicated in adults, adolescents, and children with a body weight of at least 20 kg (from 7 years onwards).

Ibuprofen Pharmaclan 200 mg film-coated tablets

Adults: If your symptoms worsen or if the fever persists for more than 3 days, or if the pain persists for more than 4 days, you should consult a doctor.

Children and adolescents: If your symptoms worsen or if the fever or pain persists for more than 3 days, you should consult a doctor.

Ibuprofen Pharmaclan 400 mg film-coated tablets are indicated in adults and adolescents with a body weight of at least 40 kg (from 12 years onwards).

Ibuprofen Pharmaclan 400 mg film-coated tablets

Adults: If your symptoms worsen or if the fever persists for more than 3 days, or if the pain persists for more than 4 days, you should consult a doctor.

Adolescents: If your symptoms worsen or if the fever or pain persists for more than 3 days, you should consult a doctor.

2. What you need to know before you take Ibuprofen Pharmaclan

Do not take Ibuprofen Pharmaclan

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
• if you have ever had an allergic reaction such as bronchospasm, asthma, nasal discharge, itchy rash, or swelling of the lips, face, tongue, or throat (angioedema) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
• if you have ever had bleeding or perforation in the stomach or intestine related to previous treatment with NSAIDs.
• if you currently have an ulcer or bleeding in the stomach or small intestine (duodenum), or if you have had two or more of these episodes of ulcers or bleeding in the stomach or duodenum (peptic ulcers) in the past.
• if you have any unexplained blood clotting disorder.
• if you have severe heart failure.
• if you have severe liver or kidney failure.
• if you are in the last three months of pregnancy.
• if you are severely dehydrated (e.g., due to vomiting, diarrhea, or insufficient fluid intake).

Warnings and precautions

Consult your doctor or pharmacist before taking Ibuprofen Pharmaclan:

• if you have systemic lupus erythematosus (SLE, an autoimmune disease) or mixed connective tissue disease (an autoimmune disease that affects connective tissue).
• during chickenpox, it is advisable to avoid using this medicine.
• if you have or have ever had gastrointestinal disorders (ulcerative colitis, Crohn's disease), as your condition may worsen.
• if you have certain inherited blood clotting disorders (e.g., porphyria).
• if you have reduced liver or kidney function.
• if you have recently undergone major surgery.
• if you are hypersensitive (allergic) to other substances.
• if you have hay fever, nasal polyps, or chronic obstructive respiratory disorders, as you have a higher risk of allergic reactions. Allergic reactions can occur as asthma attacks (so-called analgesic asthma), sudden swelling (Quincke's edema), or hives.
• if you are dehydrated.
• if you have an infection - see the section "Infections" below.

The risk of side effects increases with the increase in the dose of the product and in elderly people. Therefore, it is necessary to start treatment with the lowest possible dose and continue treatment for the shortest time necessary to treat the symptoms.

Infections

Ibuprofen Pharmaclan may mask signs of infections such as fever and pain. Therefore, it is possible that ibuprofen may delay the appropriate treatment of the infection, which may lead to a higher risk of complications. This has been observed in bacterial pneumonia and in bacterial skin infections related to chickenpox. If you take this medicine while having an infection and your infection symptoms persist or worsen, consult a doctor immediately.

Effects on the cardiovascular system

Anti-inflammatory/analgesic medicines like ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke, particularly when used at 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 Pharmaclan:

• if you have heart problems, including heart failure, angina pectoris (chest pain), or have had a heart attack, bypass surgery, or peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries), or any type of stroke (including 'mini-stroke' or transient ischemic attack "TIA").
• if you have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.

Effects on the gastrointestinal tract

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

Gastrointestinal bleeding, ulcers, and perforations:

With all NSAIDs, gastrointestinal bleeding, ulcers, and perforations have been reported, sometimes with a fatal outcome. These have occurred at any time during therapy, with or without prior symptoms or a history of serious gastrointestinal events.

The risk of experiencing 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 Pharmaclan") 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 medications that may increase the risk of gastrointestinal disorders, combination therapy with protective medications (e.g., misoprostol or proton pump inhibitors) is recommended.

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

Cautiousness is recommended if you are also taking other medications 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 Pharmaclan”).

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

Severe 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 Ibuprofen Pharmaclan treatment and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Other warnings

Very rarely, severe acute hypersensitivity reactions (e.g., anaphylactic shock) have been observed. At the first signs of a hypersensitivity reaction after taking ibuprofen, treatment should be discontinued and a doctor consulted. Medically necessary measures, according to the symptoms, should be initiated by a healthcare professional.

Ibuprofen has been reported to cause signs of allergic reaction to this medicine, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Stop using Ibuprofen Pharmaclan immediately and contact your doctor or the emergency medical services immediately if you notice any of these signs.

Ibuprofen may temporarily inhibit platelet function (platelet aggregation). Therefore, patients with blood clotting disorders should be carefully monitored.

Prolonged use of any type of pain reliever for headaches can worsen them. If you experience or suspect this situation, you should seek medical advice and discontinue treatment. The diagnosis of medication-overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or due to) the regular use of headache medications.

During prolonged use of ibuprofen, regular monitoring of liver function tests, kidney function, and blood counts is required.

In general, the habitual intake of pain relievers, especially when combining several pain relievers, can lead to permanent kidney damage. This risk may increase under physical exertion associated with salt loss and dehydration. Therefore, it should be avoided.

Children and adolescents

Ibuprofen Pharmaclan 200 mg film-coated tablets

There is a risk of kidney failure in dehydrated children and adolescents.

Ibuprofen Pharmaclan 200 mg film-coated tablets are not intended for children who weigh less than 20 kg or are under 7 years of age.

Ibuprofen Pharmaclan 400 mg film-coated tablets

There is a risk of kidney failure in dehydrated adolescents.

Ibuprofen Pharmaclan 400 mg film-coated tablets are not intended for adolescents who weigh less than 40 kg or children under 12 years of age.

Other medicines and Ibuprofen Pharmaclan

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Ibuprofen Pharmaclan may affect or be affected by other medicines. For example:

• anticoagulants and antiplatelet agents (i.e., blood thinners/prevent blood clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine)
• medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, or angiotensin II receptor antagonists such as losartan) and diuretics (used to increase urine production)
• Other non-steroidal anti-inflammatory drugs (NSAIDs), including cyclooxygenase-2 inhibitors or acetylsalicylic acid - increased risk of ulcers or gastrointestinal bleeding
• digoxin (used to treat various heart conditions), as the effect of digoxin may be enhanced
• lithium (used to treat depression and mania), as the effect of lithium may be enhanced
• phenytoin (used to treat seizures/epilepsy), as the effect of phenytoin may be enhanced
• zidovudine (used to treat HIV/AIDS)
• glucocorticoids (used in the treatment of inflammatory conditions), as they may increase the risk of gastrointestinal ulcers or bleeding
• methotrexate (used to treat certain cancers and autoimmune diseases)
• medicines known as immunosuppressants such as cyclosporine and tacrolimus, as kidney damage may occur
• medicines known as selective serotonin reuptake inhibitors (SSRIs), used for the treatment of depression
• antibiotics called quinolones, such as ciprofloxacin, as the risk of seizures (attacks) may increase
• aminoglycosides (a type of antibiotic), as NSAIDs may decrease the excretion of aminoglycosides
• mifepristone, as NSAIDs may reduce the effect of mifepristone
• diuretics (pills), as the effect of diuretics may be weakened
• potassium-sparing diuretics, as they may cause hyperkalemia
• probenecid or sulfinpyrazone (for the treatment of gout), as the excretion of ibuprofen may be delayed
• cholestyramine (used to reduce cholesterol)
• medicines known as sulfonylureas such as glibenclamide (used to treat diabetes), as blood sugar levels may be affected
• voriconazole or fluconazole (a type of antifungal medication) (CYP2C9 inhibitors), as the effect of ibuprofen may increase. The dose of ibuprofen should be considered for reduction, particularly when using high doses of ibuprofen with voriconazole or fluconazole
• Ginkgo biloba (herbal medicine) - increased risk of bleeding.
• ritonavir (antiviral agent) may increase the plasma concentrations of NSAIDs
• alcohol, bisphosphonates (used in osteoporosis), or pentoxifylline (used in peripheral arterial circulatory disorders) may enhance the gastrointestinal side effects and the risk of bleeding and ulcers
• baclofen (a muscle relaxant) due to the high toxicity of baclofen

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

Ibuprofen Pharmaclan with food, drinks, and alcohol

Avoid drinking alcohol as it may enhance the side effects of this medicine, especially those affecting the stomach, intestine, or brain.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor 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 the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your tendency and that of your baby to bleed and make delivery delayed or longer 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 onwards, ibuprofen may cause kidney problems in the fetus that can lead to low levels of the fluid that surrounds the baby (oligohydramnios) or narrowing of a 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.

Breast-feeding

Only small amounts of ibuprofen pass into breast milk, and it is generally not necessary to interrupt breast-feeding during short-term use of ibuprofen at the recommended dose for fever and pain.

Fertility

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

The product belongs to a group of medicines (NSAIDs) that may affect fertility in women. This effect is reversible upon discontinuation of the medicine.

Driving and using machines

Generally, the influence of ibuprofen on the ability to drive and use machines is negligible or insignificant. However, since with higher doses adverse reactions on the central nervous system, such as fatigue and dizziness, may occur, in individual cases, the ability to react and actively participate in road traffic and use machines may be impaired. This applies even more when combined with alcohol.

Ibuprofen Pharmaclan contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e., it is essentially “sodium-free”.

3. How to Take Ibuprofeno Pharmaclan

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Consult your doctor or pharmacist if you are not sure.

The lowest effective dose should be taken for the shortest time necessary to relieve symptoms. If you have an infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

DOSAGE:

Ibuprofeno Pharmaclan 200 mg film-coated tablets

Adults and adolescents with a body weight of 40 kg or more (from 12 years onwards):

The usual dose is 1 to 2 tablets (200 to 400 mg of ibuprofen) as a single dose or up to 3 to 4 times a day as needed. The interval between doses should be at least 6 hours. Do not take more than 6 tablets (1200 mg) in a 24-hour period.

Children with a body weight of 20 kg to 39 kg (7 to 11 years):

Children weighing 20-29 kg (7-9 years): 1 tablet (200 mg of ibuprofen) 1-3 times a day as needed, with intervals of at least 6 hours between doses. The maximum daily dose should not exceed 3 tablets (600 mg of ibuprofen) in a 24-hour period.

Children weighing 30-39 kg (10-11 years): 1 tablet (200 mg of ibuprofen) 1-4 times a day as needed, with intervals of at least 6 hours between doses. The maximum daily dose should not exceed 4 tablets (800 mg of ibuprofen) in a 24-hour period.

Ibuprofeno Pharmaclan 400 mg film-coated tablets

Adults and adolescents with a body weight of 40 kg or more (from 12 years onwards):

The usual dose is 1 tablet (400 mg of ibuprofen) as a single dose or up to 3 times a day as needed. The interval between doses should be at least 6 hours. Do not take more than 3 tablets (1200 mg) in a 24-hour period.

Duration of treatment:

Ibuprofeno Pharmaclan 200 mg film-coated tablets

If this medicine is needed in adults for more than 3 days with fever, or for more than 4 days with pain, or if symptoms worsen, consult a doctor.

If this medicine is needed in children and adolescents for more than 3 days or if symptoms worsen, consult a doctor.

Ibuprofeno Pharmaclan 400 mg film-coated tablets

If this medicine is needed in adults for more than 3 days with fever, or for more than 4 days with pain, or if symptoms worsen, consult a doctor.

If this medicine is needed in adolescents for more than 3 days or if symptoms worsen, consult a doctor.

Method of administration

Ibuprofeno Pharmaclan is for oral use.

Take the tablets with a glass of water. The tablets should be swallowed whole, without biting, chewing, crushing, breaking, or sucking to avoid discomfort in the mouth or throat irritation.

Patients with sensitive stomachs are recommended to take the tablets with food.

If taken shortly after eating, the onset of action of ibuprofen may be delayed.

Older adults

If you are an older adult, you should always consult your doctor before using . You will be more prone to suffering from side effects, especially bleeding, ulcers, and perforation in the gastrointestinal tract, which can be fatal. Your doctor will advise you accordingly.

Reduced hepatic or renal function

If you have reduced renal or hepatic function, always consult a doctor before using Ibuprofeno Pharmaclan. Do not take this medicine if you have severe hepatic or renal failure.

If you take more Ibuprofeno Pharmaclan than you should

If you have taken more Ibuprofeno Pharmaclan than you should, or if children have taken this medicine by accident, always contact a doctor or the nearest hospital for advice on the risk and measures to be taken.

Symptoms may include nausea, stomach pain, vomiting (which may have blood streaks) or, more rarely, diarrhea. Additionally, headache, gastrointestinal bleeding, blurred vision, ringing in the ears, confusion, and eye movement tremors, and exacerbation of asthma in asthmatics. In high doses, somnolence, excitement, disorientation, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), dizziness, weakness, and dizziness, blood in the urine, low blood pressure, hyperkalemia, metabolic acidosis, increased prothrombin time/INR, acute renal failure, liver damage, respiratory depression, cyanosis, feeling of cold in the body, 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 medicine and the amount ingested.

If you forget to take Ibuprofeno Pharmaclan

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

If you have any further questions on the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. You can minimize the risk of side effects by taking the lowest effective dose for the shortest time necessary to control your symptoms.

Regarding the following side effects, it should be considered that they depend largely on the dose and vary from patient to patient.

The most frequently observed side effects are of a gastrointestinal nature. Peptic ulcers, perforation, or gastrointestinal bleeding, sometimes fatal, especially in the elderly, may occur. After administration, nausea, vomiting, diarrhea, flatulence, constipation, indigestion, abdominal pain, melena, hematemesis, ulcerative stomatitis, exacerbation of colitis, and Crohn's disease have been reported. Gastritis (inflammation of the stomach lining) has been observed less frequently.

Medicines like ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Cases of water retention (edema), high blood pressure, and heart failure have been reported in association with NSAIDs.

The list of the following side effects includes all side effects known during treatment with ibuprofen, as well as those that occur during prolonged treatment with high doses in patients with rheumatism. The frequencies indicated, which go beyond very rare reports, refer to short-term use of up to a maximum of 1200 mg of ibuprofen per day for oral formulations and a maximum of 1800 mg for suppositories.

STOP TAKING Ibuprofeno Pharmaclan and contact a doctor immediately if you experience any of these symptoms:

• Symptoms of aseptic meningitis with headache, nausea, vomiting, elevated temperature, stiff neck, or clouding of consciousness (very rare: may affect up to 1 in 10,000 people). Patients with autoimmune disorders (SLE, mixed connective tissue disease) seem to be predisposed.
• Signs of gastrointestinal bleeding, such as relatively severe epigastric pain, blood in the stool (stool/movements), or black tarry stools or vomiting blood or dark particles similar to coffee grounds (uncommon: may affect up to 1 in 100 people).
• Signs of a severe allergic reaction, such as swelling of the face, tongue, or throat, difficulty breathing, increased heart rate, decreased blood pressure to potentially life-threatening shock (very rare: may affect up to 1 in 10,000 people).
• Reddish, non-raised, target-like, or circular patches on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genitals, and eye ulcers. These severe skin reactions can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis] (very rare: may affect up to 1 in 10,000 people).
• Widespread rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome) (unknown: frequency cannot be estimated from available data).
• Widespread, red, scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis) (unknown: frequency cannot be estimated from available data).
• Vision loss, blurred vision, or altered vision (visual impairment) (uncommon: may affect up to 1 in 100 people).

Other side effects

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

• Gastrointestinal symptoms such as heartburn, stomach pain, nausea, diarrhea, vomiting, gas (flatulence), and constipation
• Minor gastrointestinal bleeding that can cause anemia in exceptional cases

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

• Hypersensitivity reactions with skin rash and itching, as well as asthma attacks (possibly with decreased blood pressure)
• Headache

• dizziness or fatigue
• restlessness and irritability

• drowsiness
• difficulty sleeping
• feeling of spinning (vertigo)
• various skin rashes
• Stomach or intestinal ulcer, potentially with bleeding and perforation (hole in the digestive tract wall)
• worsening of colitis (inflammation of the colon) and Crohn's disease
• gastritis (inflammation of the stomach lining)
• inflammation of the mucous membranes of the mouth with ulcers (ulcerative stomatitis)

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

• toxic optic neuropathy
• hearing loss
• ringing in the ears (tinnitus)
• kidney tissue damage (papillary necrosis), elevated uric acid levels in the blood, elevated urea levels in the blood

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

• pancreatitis (inflammation of the pancreas)

• esophagitis (inflammation of the esophagus)
• formation of intestinal strictures similar to diaphragms
• liver function impairment, liver failure, acute hepatitis (liver inflammation), liver damage, especially with prolonged treatment

• problems with blood cell production (anemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis) - the first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, intense exhaustion, nosebleeds, and skin bleeding. In these cases, treatment should be discontinued immediately and a doctor consulted. Do not use any self-treatment with pain relievers or fever-reducing medications.
• depression, psychotic reactions
• palpitations (feeling of having an accelerated or pounding heart), heart failure, myocardial infarction
• high blood pressure, vasculitis (inflammation of blood vessels)
• asthma, bronchospasm, dyspnea (difficulty breathing)
• alopecia (hair loss)
• swelling (edema) and cloudy urine (nephrotic syndrome); inflammatory kidney disease (interstitial nephritis) that can cause acute renal failure. Reduced urine production, fluid accumulation in the body (edema), and general malaise may be signs of kidney disease or even renal failure. If the mentioned symptoms appear or worsen, stop taking Ibuprofeno Pharmaclan and consult a doctor immediately.

Unknown (frequency cannot be estimated from available data):

• sensations such as numbness and tingling
• optic neuritis
• nasal congestion and secretion (rhinitis)
• skin becomes sensitive to light (photosensitivity reactions)
• chest pain, which can be a sign of a potentially life-threatening allergic reaction, Kounis syndrome.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist. Even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicine in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

What Ibuprofeno Pharmaclan contains

The active ingredient is ibuprofen. Each film-coated tablet contains 200 mg or 400 mg of ibuprofen.

The other ingredients are: tablet core - microcrystalline cellulose 102, pregelatinized starch (prepared from corn starch), povidone K 90, sodium lauryl sulfate, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate, film coating: hypromellose 2910, hydroxypropylcellulose, macrogol 400, titanium dioxide (E 171).

Appearance of Ibuprofeno Pharmaclan and package contents

200 mg: Film-coated tablets, round in shape, white to off-white in color, with the inscription 'G2' on one side and smooth on the other. Approximately, the diameter of the tablet is 8.52 mm and the thickness of the tablet is 4.60 mm.

400 mg: Film-coated tablets, oval in shape, white to off-white in color, with the inscription 'I 6' on one side and smooth on the other. Approximately, the dimensions of the tablet are 13.55 mm x 8.24 mm and the thickness of the tablet is 6.00 mm.

Transparent PVC/Aluminum blister pack in an outer cardboard box containing 10 or 12 tablets per blister.

Package sizes:

200 mg: 10, 12, 20, 24, 30, 40, 48, 100 tablets.

400 mg: 10, 12, 20, 24, 30, 40, 48, 100 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Pharmaclan s.r.o.

Trtinová 260/1, Cakovice

196 00, Prague 9

Czech Republic

Manufacturer:

Pharmazet Group s.r.o.

Trtinová 260/1,

196 00, Prague 9

Czech Republic

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

Date of last revision of this leaflet

November 2023.

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