Poindol 200 mg granules for oral solution

Patient Information Leaflet

Introduction

Patient Information Leaflet

Poindol 200 mg granules for oral solution

Ibuprofen (arginine)

Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the administration instructions provided in this leaflet or those given by your doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve, if fever persists for more than 3 days, or if pain lasts longer than 5 days.

Leaflet Contents

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

1. What Poindol is and what it is used for

Ibuprofen, the active ingredient in this medicine, works by reducing pain and fever.

It is indicated in adults and children over 8 years of age for the symptomatic relief of mild to moderate occasional pain, such as headaches, dental pain, menstrual pain, muscle pain (muscle spasms), or back pain (lumbago), as well as for feverish conditions.

2. What you need to know before taking Poindol

Do not take Poindol

• If you are allergic (hypersensitive) to ibuprofen, to other medicines in the group of non-steroidal anti-inflammatory drugs (NSAIDs), to aspirin, or to any of the other ingredients of Poindol. Signs of allergy may include: itchy skin rash, swelling of the face, lips or tongue, runny nose, breathing difficulties or asthma.
• If you have severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the digestive tract.
• If you are vomiting blood.
• If you have black stools or diarrhoea with blood.
• If you have bleeding or blood clotting disorders, or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulant medicines at the same time, your doctor will perform blood clotting tests.
• If you have severe heart failure.

If you are in the third trimester of pregnancy.

Warnings and precautions

You should consult your doctor, pharmacist, or nurse before starting to take this medicine.

• If you have oedema (fluid retention).

• If you have or have had heart problems or high blood pressure.

• If you suffer from asthma or any other respiratory disorder.

• Inform your doctor if you are being treated with Poindol, as it may mask fever, an important sign of infection, making diagnosis more difficult.

• If you have kidney or liver disease, are over 60 years old, or need to take the medicine for a prolonged period (more than 1–2 weeks), your doctor may need to carry out regular monitoring. Your doctor will advise you on how often these checks should be performed.

• If you experience symptoms of dehydration, e.g. severe diarrhoea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in such cases could lead to kidney failure as a consequence of dehydration.

• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms.

• This risk is higher when high doses and long-term treatments are used, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider adding a stomach-protective medicine.

• If your doctor has prescribed an antiplatelet medicine (to prevent blood clots) containing acetylsalicylic acid, and you are also taking Poindol, you must separate the administration of both medicines. You may follow either of the following regimens:

• Take the dose of acetylsalicylic acid and wait at least half an hour before taking the oral dose of ibuprofen.

• Take the oral dose of ibuprofen at least 8 hours before taking acetylsalicylic acid.

• If you are taking simultaneously medicines that affect blood coagulation, such as oral anticoagulants, antiplatelet agents like acetylsalicylic acid. You should also inform your doctor about the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.

• If you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in diarrhoea with blood) or ulcerative colitis, as medicines like ibuprofen may worsen these conditions.

• If you are being treated with diuretics (medicines to increase urination), because your doctor needs to monitor your kidney function.

• If you have systemic lupus erythematosus (a chronic disease affecting the immune system that may affect various vital organs, the nervous system, blood vessels, skin, and joints), as aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—without bacterial infection) may occur.

• If you have acute intermittent porphyria (a metabolic disorder affecting your blood that may cause symptoms such as reddish urine, blood in urine, or liver disease), so your doctor can assess whether treatment with ibuprofen is appropriate.

• If you suffer from headaches after prolonged treatment, do not take higher doses of the medicine.

• Allergic reactions may occur with this medicine.

• Your doctor will perform stricter monitoring if you receive ibuprofen after major surgery.

• It is advisable not to take this medicine if you have chickenpox.

• If you have an infection; see the section "Infections" below.

• Allergic reactions to ibuprofen have been reported, including breathing problems, swelling of the face and neck area (angioedema), and chest pain. Stop using Poindol immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

Poindol may mask signs of infection such as fever and pain. Therefore, Poindol may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor without delay.

It is important to use the lowest dose that relieves/controls your pain and not to take this medicine longer than necessary to control your symptoms.

Cardiovascular precautions

Anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of heart attack 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 Poindol if:

• You have heart problems, including heart failure, angina (chest pain), have had a heart attack, coronary bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked arteries), or any type of stroke (including a "mini-stroke" or transient ischaemic attack "TIA").
• You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.

Also, these types of medicines may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Skin reactions

Serious skin reactions have been reported with Poindol treatment. Stop taking Poindol and see a doctor immediately if you develop any skin rash, mucosal lesions, blisters, or other signs of allergy, as these may be early signs of a very serious skin reaction. See section 4.

Serious skin reactions such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Discontinue treatment with Poindol and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Precautions during pregnancy and in women of childbearing age

Because administration of medicines like ibuprofen has been associated with an increased risk of congenital abnormalities or miscarriage, their use is not recommended during the first and second trimesters of pregnancy unless strictly necessary. In such cases, the dose and duration should be limited to the minimum possible.

During the third trimester, administration of ibuprofen is contraindicated.

For women of childbearing age, it should be noted that medicines like ibuprofen have been associated with a reduced ability to conceive.

Interference with diagnostic tests:

If you are scheduled for any diagnostic tests (including blood or urine tests), inform your doctor that you are taking this medicine, as it may alter test results.

Use of Poindol with other medicines

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

Poindol may interact with or be affected by other medicines. For example:

• Other non-steroidal anti-inflammatory drugs such as aspirin.
• Antiplatelet agents (prevent blood clots or thrombi in blood vessels) such as ticlopidine.
• Anticoagulant medicines (e.g. for treating or preventing blood clotting problems, e.g. acetylsalicylic acid, warfarin, ticlopidine).
• Baclofen (used to treat involuntary and persistent muscle contractions).
• Lithium (a medicine used to treat depression). Your doctor may adjust the dose of this medicine.
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine.
• Mifepristone (used to induce abortion).
• Digoxin and other cardiac glycosides (used in the treatment of heart disorders).
• Hydantoins such as phenytoin (used in the treatment of epilepsy).
• Sulphonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (medicines used to increase urine elimination).
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in gout patients or together with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Ion-exchange resins such as cholestyramine (used to lower blood cholesterol levels).
• Sulfinpyrazone (for gout).
• Oral hypoglycaemic agents (sulfonylureas) such as tolbutamide (for diabetes).
• Tacrine (used in the treatment of Alzheimer's disease).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (an anti-HIV medicine).
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin-II receptor antagonists such as losartan).
• Thrombolytics (medicines that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba.

If your doctor has prescribed an antiplatelet medicine (to prevent blood clots) containing acetylsalicylic acid, and you are also taking Poindol, you must separate the administration of both medicines (see section Take special care with Poindol).

Other medicines may also interact with or be affected by treatment with Poindol. Therefore, always consult your doctor or pharmacist before using Poindol with other medicines.

Taking Poindol with food, drinks, and alcohol:

You may take Poindol with or without food. It is generally recommended to take it during meals or with milk to reduce the possibility of stomach discomfort.

Do not take ibuprofen with alcohol to avoid stomach damage.

The use of ibuprofen in patients who regularly consume alcohol (three or more alcoholic drinks—beer, wine, spirits—per day) may cause stomach bleeding.

Pregnancy, breastfeeding, and fertility:

Consult your doctor or pharmacist before using any medicine.

Do not take ibuprofen during 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 your fetus. It may affect your and your baby's tendency to bleed and may delay or prolong labour more than expected. You should not take ibuprofen during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to become pregnant, you should take the lowest effective dose for the shortest possible time. From week 20 of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is needed for longer than a few days, your doctor may recommend additional monitoring.

Breastfeeding women should consult their doctor or pharmacist before taking this medicine. Although only small amounts of the medicine pass into breast milk, prolonged use of ibuprofen during breastfeeding is not recommended.

Therefore, if you become pregnant or are breastfeeding, consult your doctor.

IMPORTANT FOR WOMEN:

If you are pregnant or think you might be, consult your doctor before taking this medicine. Taking medicines during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor.

PoindolPoindol

Driving and use of machines:

Although effects in this regard are not expected, if you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medicine, you should not drive or operate dangerous machinery. If you take only a single dose of Poindol or for a short period, no special precautions are necessary.

Poindol contains aspartame, sucrose, and sodium

This medicine contains less than 23 mg of sodium (1 mmol) per sachet, i.e., essentially "sodium-free".

This medicine contains 10 mg of aspartame per sachet. Aspartame is a source of phenylalanine, which may be harmful in individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

3. How to take Poindol

Follow exactly the instructions for use of this medicine unless your doctor has prescribed otherwise. Consult your doctor or pharmacist if you have any doubts.

The lowest effective dose should be used for the shortest duration 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 usual dose is:

• Adults and adolescents from 12 years of age: a dose of 200 mg every 4 or 6 hours, if necessary. If pain or fever does not respond to the 200 mg dose, doses of 400 mg every 6 or 8 hours may be used (in adolescents weighing more than 40 kg).

Do not exceed 1200 mg in 24 hours.

• Patients with kidney, liver, or heart disease: reduce the dose and consult your doctor.

Always use the lowest dose that is effective.

Use in children

• Children from 8 to 12 years: 1 sachet (200 mg of ibuprofen) every 6 or 8 hours, if necessary. Do not exceed 4 sachets (800 mg of ibuprofen) in 24 hours.

Do not administer to children under 8 years of age without consulting a doctor.

Use in patients over 65 years

• Patients over 65 years: the dose should be determined by the doctor, as a reduction of the usual dose may be necessary.

Elderly patients are more likely to experience adverse effects, so the dose may sometimes need to be reduced. Consult your doctor.

Method of administration:

This medicine is administered orally.

Take the medicine with food or milk, especially if gastrointestinal discomfort occurs.

Dissolve the granules from the sachet in a glass of water and stir until fully dissolved.

This preparation should only be administered when pain or fever occurs. As these symptoms subside, treatment should be discontinued.

If symptoms worsen, if fever persists for more than 3 days, or if pain persists for more than 5 days, consult your doctor.

If you take more Poindol than you should:

If you have taken more ibuprofen than you should, contact your doctor or pharmacist immediately, or call the Toxicology Information Service (telephone 91 562 04 20), stating the medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you have taken more Poindol than recommended, or if a child has accidentally ingested the medicine, consult a doctor immediately or go to the nearest hospital to assess the risk and obtain advice on the measures to be taken.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), headache, tinnitus, confusion, and involuntary eye movements. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties have been reported. In cases of severe poisoning, the doctor will take the necessary measures.

In case of ingestion of large quantities, activated charcoal should be administered. Gastric emptying should be considered if large amounts have been ingested and within 60 minutes of ingestion.

If you forget to take Poindol

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

If you forget to take your scheduled dose, take it as soon as you remember. However, if the time for the next dose is approaching, skip the missed dose and take the next dose at the usual time.

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

4. Possible adverse effects

Like all medicines, Poindol may have adverse effects, although not everyone will experience them.

Adverse effects of medicines such as Poindol are more common in people over 65 years of age.

The incidence of adverse effects is lower with short-term treatments and when the daily dose is below the recommended dose.

Stop treatment with ibuprofen and seek immediate medical attention if you notice any of the following symptoms:

• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.
• Flat reddish spots, target-shaped or circular rashes on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
• Widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Frequent (may affect up to 1 in 10 patients): fatigue, headache, gastrointestinal disorders (heartburn, diarrhea, nausea, vomiting), skin disorders (rashes, itching), and tinnitus.

Uncommon (may affect up to 1 in 100 patients): allergic reactions, asthma, rhinitis and urticaria, gastrointestinal bleeding and ulcers, sleep disturbances and mild restlessness, blurred vision, decreased visual acuity or changes in color perception, and auditory disturbances.

Rare (may affect up to 1 in 1,000 patients): edema (swelling due to fluid retention), blood disorders (leucopenia), stomach and intestinal perforation, liver disorders (including jaundice), kidney disorders such as: acute interstitial nephritis with hematuria (blood in urine), proteinuria (excretion of protein in urine), and occasionally nephrotic syndrome; depression, vision disorders (blurred vision), neck stiffness and bronchospasm (sudden sensation of suffocation), dyspnea (difficulty breathing), and angioedema (swelling of the deep layers of the skin, with swelling of the face, lips, tongue or throat, possibly causing difficulty in swallowing or breathing).

Very rare (reported in up to 1 in 10,000 patients): aseptic meningitis (inflammation of the meninges not caused by bacteria), blood disorders (aplastic anemia and hemolytic anemia) and coagulation disorders, hypertension and heart failure, severe skin disorders (cutaneous erythema), eyes and mucous membranes such as Stevens-Johnson syndrome (severe erythema multiforme) and toxic epidermal necrolysis (skin and mucous membrane lesions causing skin detachment), and erythema multiforme.

Frequency not known: a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes, and elevated eosinophils (a type of white blood cell).

Widespread red rash with bumps under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking Poindol if you experience these symptoms and seek immediate medical attention. See also section 2.

The skin becomes sensitive to light.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Poindol

No special storage conditions are required.

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. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This helps protect the environment.

6. Contents of the pack and other information

Composition of Poindol

• The active substance is ibuprofen. Each sachet contains 200 mg of ibuprofen as 369 mg of ibuprofen (arginine).
• The other components are: Arginine, aspartame (E-951), sucrose, sodium hydrogen carbonate, sodium saccharin, sodium lauryl sulfate, mint flavour composed of flavouring components (natural flavouring preparations, natural flavouring substances and nature-identical flavouring substances), non-flavouring components (containing modified maize starch (E-1450), maltodextrin, triacetin (E-1518)), and active substances (pulegone), and purified water.

Appearance of the product and contents of the pack

Sachets containing granules for oral solution. It is presented as white granules with a characteristic mint odour, packed in paper/aluminium/polyethylene sachets.

Packaged in containers containing 20 sachets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

FARMALIDER S.A.,

c/ Aragoneses 15,

28108 Alcobendas (Madrid)

Spain

Manufacturer

Toll Manufacturing Services S.L.,

c/ Aragoneses, 2.

28108 Alcobendas (Madrid)

Spain

Date of the most recent revision of this leaflet: November 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.