IBUPROFEN PHARMACLAN 600 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ibuprofeno Pharmaclan 600 mgfilm-coated tablets EFG

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• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

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

Ibuprofeno Pharmaclan contains the active substance ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

Ibuprofen is used for the 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.

Ibuprofeno Pharmaclan 600 mg film-coated tablets are indicated in adults and adolescents with a body weight of at least 50 kg (from 15 years of age onwards).

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

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• 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 an NSAID.

• if you currently have an ulcer or bleeding in the stomach or small intestine (duodenum), or if you have had two or more 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).

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Consult your pharmacist or doctor:

• if you have systemic lupus erythematosus (SLE, an autoimmune disease) or a connective tissue disease (an autoimmune disease)
• it is advisable to avoid using this medicine during chickenpox.
• if you have or have had gastrointestinal disorders (ulcerative colitis, Crohn's disease), as your condition may worsen.
• if you have certain hereditary blood clotting disorders (e.g., acute intermittent 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 diseases, 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 skin rash.
• if you are dehydrated.
• if you have an infection, see the heading "Infections" below.

The risk of side effects increases with increasing dose of the product and in elderly people. Therefore, treatment should be initiated with the lowest possible dose and continued for the shortest time necessary to treat the symptoms.

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Ibuprofen may mask signs of infection, such as fever and pain. Therefore, Ibuprofeno Pharmaclan may delay appropriate treatment of the infection, which may lead to a higher 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 your infection symptoms persist or worsen, consult a doctor without delay.

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Anti-inflammatory/pain-relieving medicines like ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke, especially 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 if:

• you have heart problems, including heart failure, angina (chest pain), or have had a heart attack, bypass surgery, or peripheral arterial 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").

• you have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.

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The combined use of Ibuprofeno Pharmaclan 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 fatal outcomes. These have occurred at any time during therapy, with or without prior warning symptoms or history of serious gastrointestinal events.

The risk of experiencing gastrointestinal bleeding, ulcers, and perforation is higher with increasing doses of the NSAID and is higher in patients with a history of ulcers, especially with complications of bleeding or perforation (see section 2 "Do not take Ibuprofeno 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.

Cautious use 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 Ibuprofeno Pharmaclan").

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

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Severe skin reactions have been reported with Ibuprofeno Pharmaclan. You should stop taking Ibuprofeno Pharmaclan and seek immediate medical attention if you develop any skin rash, mucosal lesions, blisters, or other signs of allergy, as these can be the first signs of a severe skin reaction. See 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 Ibuprofeno Pharmaclan, treatment should be discontinued and a doctor consulted. Medically necessary measures, according to symptoms, should be initiated by a healthcare professional.

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 may worsen them. If this situation is experienced or suspected, medical advice should be sought and treatment discontinued. The diagnosis of medication-overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or due to) 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.

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There is a risk of kidney failure in dehydrated adolescents.

Ibuprofeno Pharmaclan 600 mg is not intended for adolescents who weigh less than 50 kg or for children and adolescents under 15 years of age.

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Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Ibuprofeno 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) 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. Monitoring of digoxin serum levels is recommended.

• lithium (used to treat depression and mania), as the effect of lithium may be enhanced.

It is necessary to monitor lithium serum levels.

• phenytoin (used to treat seizures/epilepsy), as the effect of phenytoin may be enhanced.

Monitoring of phenytoin serum levels is recommended.

• zidovudine (used to treat HIV/AIDS)
• corticosteroids (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 (fits) 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 (water tablets), 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 medicine) (CYP2C9 inhibitors), as the effect of ibuprofen may increase. A reduction in the dose of ibuprofen should be considered, particularly when high doses of ibuprofen are used with voriconazole or fluconazole.
• ginkgo biloba (herbal medicine) - increased risk of bleeding.
• ritonavir (antiviral agent) may increase 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 (muscle relaxant) due to the high toxicity of baclofen

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

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

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If you are pregnant or breastfeeding, 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.
• Do not take ibuprofen during the first 6 months of pregnancy unless absolutely necessary and as indicated by your doctor. 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 taken for more than a few days from the 20th week of pregnancy onwards, ibuprofen may cause kidney problems in the fetus, which may 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.

If you have taken this medicine while pregnant, you should immediately talk to your doctor/midwife so that appropriate follow-up can be considered.

Breastfeeding

Only small amounts of ibuprofen pass into breast milk, and it is generally not necessary to interrupt breastfeeding during short-term use of ibuprofen at the recommended dose for fever and pain. However, if prolonged treatment or higher doses are prescribed, early weaning should be considered.

Fertility

Ibuprofeno 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.

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Generally, the influence of ibuprofen on the ability to drive and use machines is negligible or minimal. However, since higher doses may cause adverse reactions on the central nervous system, such as fatigue and dizziness, in individual cases, the ability to react and actively participate in driving and using machines may be impaired. This applies to a greater extent in combination with alcohol.

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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 your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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

DOSAGE:

The single maximum dose should not exceed 600 mg of ibuprofen for adolescents and adults with a body weight of at least 50 kg (from 15 years of age onwards).

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The recommended dose is 1200-1800 mg per day in divided doses. Allow at least 6 hours between doses. Your doctor may prescribe lower doses. Due to the nature and severity of your condition, your doctor may choose to increase your medication to one 600 mg tablet, taken 4 times a day. The maximum daily dose should not exceed 2400 mg in a 24-hour period.

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The recommended daily dose is 20 mg/kg up to a maximum of 40 mg/kg of body weight, divided into 3-4 partial doses. Allow at least 6 hours to pass between doses. The total daily maximum dose should not exceed 2400 mg in a 24-hour period.

Use in children and adolescents

The dose of ibuprofen in adolescents depends on the patient's age and body weight.

Ibuprofeno Pharmaclan 600 mg is not intended for adolescents who weigh less than 50 kg or for children and adolescents under 15 years of age.

Advanced age

If you are an elderly person, you should always consult your doctor before using Ibuprofeno Pharmaclan. You will be more prone to suffering side effects, especially bleeding 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 medication if you have severe hepatic or renal failure.

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, crushing, breaking, or sucking to avoid discomfort in the mouth or throat irritation.

Patients with sensitive stomachs are recommended to take the tablets with meals. If taken shortly after eating, the onset of action of ibuprofen may be delayed.

Duration of treatment:

The duration of treatment is determined by the treating physician.

In rheumatic diseases, it may be necessary to take ibuprofen for a prolonged period.

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If you have taken 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 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 tremulous eye movements, and exacerbation of asthma in asthmatics. At 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 medication and the amount ingested.

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience 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. Less frequently, inflammation of the stomach lining (gastritis) has been observed.

Medications 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.

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, neck stiffness, or slight 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 intense epigastric pain, blood in the stool (stool/movements) or black, tarry stools, or vomiting blood or dark particles similar to coffee grounds (frequent: may affect up to 1 in 10 people).
• Signs of a severe allergic reaction, such as swelling of the face, tongue, or throat, difficulty breathing, increased heart rate, decreased blood pressure, potentially leading to mortal shock (very rare: may affect up to 1 in 10,000 people).
• Severe skin eruptions covering the entire body with blisters on the skin, especially on the legs, arms, hands, and feet, which can also affect the face and lips (erythema multiforme, Stevens-Johnson syndrome). This can become even more severe, with blisters increasing in size and spreading, and parts of the skin may slough off (Lyell syndrome) (very rare: may affect up to 1 in 10,000 people). There can also be a severe infection with destruction (necrosis) of the skin, subcutaneous tissue, and muscles (necrotizing fasciitis) (very rare: may affect up to 1 in 10,000 people).
• A red, scaly, and generalized eruption with bumps under the skin and localized blisters mainly on the skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis) (frequency unknown: cannot be estimated from available data). Stop using Ibuprofeno Pharmaclan if you develop these symptoms and seek medical attention immediately. See also section 2.
• Vision loss, blurred vision, or altered vision (visual impairment) (uncommon: may affect up to 1 in 100 people).

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Very common (may affect more than 1 in 10 people)

• Gastrointestinal symptoms such as acidity, stomach pain, nausea, diarrhea, vomiting, gas (flatulence), and constipation.
• Mild gastrointestinal bleeding that may cause anemia in exceptional cases.

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• headache
• feeling of dizziness or fatigue
• agitation and irritability
• feeling of somnolence
• difficulty sleeping
• feeling of spinning (vertigo)
• 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
• inflammation of the stomach lining (gastritis)
• Inflammation of the mucous membranes of the mouth with ulcers (ulcerative stomatitis).

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• hypersensitivity reactions with skin rash and itching, as well as asthma attacks (possibly with decreased blood pressure).
• various skin rashes
• 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 kidney failure. If the mentioned symptoms appear or worsen, stop taking Ibuprofeno Pharmaclan and consult your doctor immediately.

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

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• 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 in case of prolonged treatment
• Blood cell production problems (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first signs are: fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, intense exhaustion, nosebleeds, and skin bleeding. In these cases, treatment should be interrupted 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)

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• A severe skin reaction known as DRESS syndrome may occur. The symptoms of DRESS include: skin rash, fever, lymph node inflammation, and increased eosinophils (a type of white blood cell).
• optic neuritis
• sensations such as numbness, tingling
• skin becomes sensitive to light (photosensitivity reactions)
• nasal congestion and secretion (rhinitis)

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If you experience any type of side effect, consult your doctor or pharmacist. Even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Ibuprofeno Pharmaclan

• Keep this medication out of sight and reach of children.
• Do not use this medication after the expiration date stated on the carton or blister after 'EXP'. The expiration date is the last day of the month indicated.
• This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

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The active ingredient is ibuprofen. Each film-coated tablet contains 600 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 (E171).

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Film-coated tablets, white to off-white in color, capsule-shaped, with the inscription 'I7' on one side and smooth on the other. The tablet dimensions are approximately 17.19 mm x 9.23 mm and the thickness is 6.60 mm.

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

Package sizes:

20, 24, 30, 40, 50, 100 tablets.

Not all package sizes may be marketed.

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Pharmaclan s.r.o.

Trtinová 260/1, Cakovice

196 00, Prague 9

Czech Republic

Manufacturer:

Pharmazet Group s.r.o.

Trtinová 260/1, Cakovice

196 00, Prague 9

Czech Republic

This medication is authorized in the member states of the European Economic Area under the following names:

Date of the last revision of this leaflet:

November 2023

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