Ibuprofen Codramol 200 mg oral powder

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ibuprofeno Codramol 200 mg oral powder

Read the entire leaflet carefully before starting to take this medicine, because it contains important information for you.

Follow exactly the instructions for taking this medicine provided in this leaflet or those given by your doctor or pharmacist.

• 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 or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 3 days.

Contents of the leaflet

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

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

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

This medicine is indicated for symptomatic relief in children from 7 years of age and adults:

• for the symptomatic relief of mild to moderate occasional pain
• for the treatment of fever

You should consult a doctor if symptoms worsen or do not improve after 3 days.

2. What you need to know before taking Ibuprofeno Codramol

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

Do not take Ibuprofeno Codramol:

• if you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6).
• if after taking acetylsalicylic acid or other NSAIDs you have experienced skin rash with itching, swelling of the face,
• lips or tongue, nasal discharge, breathing difficulties or asthma.
• if you have had stomach or duodenal bleeding or suffered a perforation of the gastrointestinal tract while taking an anti-inflammatory medicine.
• if you currently have or have had on more than one occasion: a stomach or duodenal ulcer or bleeding.
• if you have severe heart failure.
• if you are in the third trimester of pregnancy.
• if you have severe liver or kidney disease.
• if you have bleeding disorders or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood).
• if you have an exacerbation of ulcerative colitis or Crohn's disease.
• severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine:

• 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 prolonged treatments are used, in patients with a history of peptic ulcer, and in elderly patients. In these cases your doctor may consider prescribing a stomach-protective medicine.
• If you have had kidney or liver disease.
• If you have oedema (fluid retention).
• If you suffer from asthma or any other respiratory disorder.
• If you are taking this medicine, since ibuprofen may mask fever, an important sign of infection, making diagnosis more difficult.
• If you have or have had any heart disorder or have high blood pressure.
• 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 checks. Your doctor will advise you on the frequency of these checks.
• If you experience symptoms of dehydration, e.g. severe diarrhoea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in this specific case could lead to kidney failure as a consequence of dehydration.
• If you are taking medicines that affect blood coagulation, such as oral anticoagulants, antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
• If you have Crohn's disease or ulcerative colitis, as medicines of this type may worsen these conditions.
• If you are being treated with diuretics (medicines to increase urine production), because your doctor must monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic disease affecting the immune system that can affect various vital organs, the nervous system, blood vessels, skin and joints), as there is a higher likelihood of developing aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—not caused by bacteria).
• 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 that your doctor can assess whether treatment with ibuprofen is appropriate.
• If you suffer from headaches after prolonged treatment, you should not take higher doses of the medicine.
• Allergic reactions may occur with this medicine.
• Your doctor will carry out closer 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.

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 Ibuprofeno Codramol if:

• you have heart problems, including heart failure, angina (chest pain), or have had a heart attack, 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, this type of medicine 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 Ibuprofeno Codramol. Stop taking Ibuprofeno Codramol 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.

Infections

Ibuprofeno Codramol may mask signs of infection such as fever and pain. Therefore, Ibuprofeno Codramol 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 the infection symptoms persist or worsen, consult a doctor without delay.

Children and adolescents

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

Interference with laboratory tests:

Taking ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for up to 1 day after stopping treatment)
• Blood glucose concentration (may decrease)
• Creatinine clearance (may decrease)
• Haematocrit or haemoglobin (may decrease)
• Blood levels of urea nitrogen and serum levels of creatinine and potassium (may increase)

Liver function tests: increased transaminase values

Inform your doctor if you are undergoing clinical testing and are taking or have recently taken ibuprofen.

Consult your doctor or pharmacist before starting to take Ibuprofeno Codramol.

Using Ibuprofeno Codramol with other medicines

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

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

• Other non-steroidal anti-inflammatory drugs (NSAIDs): as this may increase the risk of adverse effects.
• Anticoagulant medicines (e.g. to treat or prevent blood clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine). Lithium (a medicine used to treat depression): as this may increase blood levels of lithium and the risk of adverse effects. If you need to take both lithium and ibuprofen, your doctor may need to adjust your lithium dose.
• Methotrexate: if you take methotrexate and ibuprofen simultaneously (within a 24-hour interval), blood levels of methotrexate and the risk of toxicity may increase. Your doctor may advise you not to take ibuprofen if you are receiving high-dose methotrexate treatment.
• Hydantoins such as phenytoin (for the treatment of epilepsy).
• Sulphonamides: as they may increase their toxic effects.
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, and angiotensin-II receptor antagonists such as losartan).
• Corticosteroids such as cortisone and prednisolone, as they may increase the risk of gastrointestinal ulcer or bleeding.
• Diuretics (medicines used to increase urine output), as they may increase the risk of kidney toxicity.

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

• Fluconazole and voriconazole (used to treat fungal infections), pentoxifylline, probenecid and sulfinpyrazone (for gout), quinolones (such as norfloxacin), mifepristone, sulphonylureas (such as tolbutamide), tacrolimus and cyclosporine (used to prevent transplant rejection), zidovudine (risk of kidney toxicity), cholestyramine (a medicine used to treat high cholesterol).
• Selective serotonin reuptake inhibitors (SSRIs) may also increase the risk of gastrointestinal bleeding.

Taking Ibuprofeno Codramol with food, drinks and alcohol

For patients with gastric discomfort, it is recommended to take the medicine during meals.

Consuming alcohol may increase the risk of adverse reactions.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Precautions during pregnancy and in women of childbearing potential

Because administration of this medicine has been associated with an increased risk of congenital abnormalities or miscarriage, its 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.

Administration during the third trimester is contraindicated.

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

Breastfeeding

Although drug levels in breast milk are negligible, it is recommended to consult your doctor during long-term treatment or when using high doses while breastfeeding.

Driving and using machines

If you experience dizziness, vertigo, visual disturbances or other symptoms while taking this medicine, you should not drive or operate machinery. If you take only a single dose of ibuprofen or for a short period, special precautions are not usually necessary.

Ibuprofen may delay your reaction time, which should be taken into account before engaging in activities requiring high alertness, such as driving and operating machinery.

Ibuprofeno Codramol contains glucose and sorbitol E420

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

3. How to take Ibuprofen Codramol

Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

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

Dosage

Adults and adolescents (>40 kg):

The recommended dose is 1 or 2 sachets 3–4 times daily, every 6–8 hours.

Do not exceed 1200 mg of ibuprofen (6 sachets) within 24 hours.

Children (under 12 years) (<40 kg):

The recommended dose of ibuprofen depends on the child's age and body weight. For children from 6 months to 12 years of age, the recommended daily dose is 7 to 10 mg/kg per single dose, up to a maximum daily dose of 30 mg per kg of body weight.

The following table provides approximate dosage guidelines:

Age	Body Weight	Individual Dose	Maximum Recommended Daily Dose (mg)
7-9 years	Approx. 21 kg to 29 kg	200 mg (1 sachet / 3 times daily)	600
10-12 years	Approx. 30 kg to 40 kg	200 mg (1 sachet / 3-4 times daily)	600-800
Adults and adolescents over 12 years	>40 kg	200 mg (2 sachets / 3 times daily)	1200

The interval between doses should be determined according to symptoms and the maximum daily dose, and may be 6 or 8 hours. The recommended maximum daily dose in the last column must not be exceeded.

The occurrence of adverse reactions can be minimized by using the lowest effective doses for the shortest duration necessary to control symptoms (see section 4.4).

This medicine is intended for short-term treatment.

If symptoms worsen, if fever persists for more than 3 days, or pain for more than 5 days (3 days in children and adolescents), consult a doctor.

The administration of this medicine depends on the occurrence of pain or fever. As these symptoms subside, the medication should be discontinued.

Special patient groups

Patients with kidney, liver, or heart disease:

Reduce the dose and consult a doctor. Ibuprofen must not be used in patients with severe renal or hepatic impairment.

Paediatric population:

This medicine must not be administered to children under 7 years of age or with body weight below 21 kg, as the dosage does not correspond to their required posology.

Method of administration

For oral use.

Empty the contents of the sachet directly into the mouth. In patients experiencing gastric discomfort, it is recommended to take the medicine during meals.

If you take more Ibuprofen Codramol than you should

If you have taken more Ibuprofen Codramol than you should, or have accidentally ingested the contents of the package, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 915620420, stating the medicine and the amount ingested. It is recommended to bring the packaging and the patient information leaflet to the healthcare professional.

If you have taken more Ibuprofen Codramol than you should, or if a child has accidentally ingested the medicine, consult a doctor 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 and dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties have been reported.

If you forget to take Ibuprofen Codramol

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

If you forget to take your scheduled dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take the next dose at your 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, this medicine can cause adverse effects, although not everyone will experience them.

The frequencies have been defined as follows:

Very common: may affect more than 1 in 10 patients

Common: may affect up to 1 in 10 patients

Uncommon: may affect up to 1 in 100 patients

Rare: may affect up to 1 in 1,000 patients

Very rare: may affect up to 1 in 10,000 patients

Frequency not known: cannot be estimated from the available data

The following adverse effects have been observed:

Gastrointestinal disorders

The most common adverse effects occurring with medicines containing this active substance are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhoea, flatulence, constipation, heartburn, abdominal pain, blood in stools, mouth ulcers, worsening of ulcerative colitis and Crohn's disease have also been observed. Gastritis has been observed less frequently.

Common: nausea, vomiting, abdominal pain, heartburn, flatulence and constipation.

Uncommon: gastrointestinal bleeding, stomach or duodenal ulcers.

Rare: gastric or intestinal perforation, inflammation of the oesophagus, and ulceration or inflammation of the intestine.

Skin and subcutaneous tissue disorders

Common: skin rash.

Uncommon: skin redness, itching or swelling of the skin, swelling of the lips, face or tongue, increased nasal discharge, and breathing difficulty.

Rare: severe allergic reactions (anaphylactic shock).

Very rare: sudden onset of intense itching or blisters on the skin, joint pain and fever (systemic lupus erythematosus), hair loss, photosensitivity skin reactions. Medicines containing this active substance may very rarely be associated with severe blistering reactions such as Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, and allergic vasculitis.

Severe allergic reaction which may present as nausea, vomiting, swelling of the face, tongue and throat, breathing difficulty, asthma, palpitations, hypotension or shock.

Frequency not known: A serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, lymph node swelling and elevated eosinophils (a type of white blood cells). Generalized red scaly rash with lumps 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 Ibuprofen Codramol if you experience these symptoms and seek immediate medical attention. See also section 2. The skin becomes sensitive to light.

Nervous system disorders

Common: headache.

Uncommon: fatigue or somnolence.

Very rare: aseptic meningitis (inflammation of the membranes covering the brain and spinal cord), mostly in patients with an underlying autoimmune disease such as systemic lupus erythematosus.

Psychiatric disorders

Common: feeling of instability and nervousness.

Uncommon: anxiety.

Rare: disorientation or confusion, depression.

Ear and labyrinth disorders

Uncommon: tinnitus (ringing or buzzing in the ears).

Rare: hearing difficulty.

Eye disorders

Uncommon: visual disturbances.

Rare: abnormal or blurred vision.

Blood and lymphatic system disorders

Very rare: prolonged bleeding time, blood cell disorders (early symptoms may include: fever, sore throat, mouth ulcers, flu-like symptoms, excessive tiredness, nosebleeds and skin bleeding).

Cardiovascular disorders

These medicines may be associated with a moderate increase in the risk of heart attack ("myocardial infarction") or stroke. Oedema (fluid retention), hypertension, and heart failure have also been observed in association with treatment using medicines of this type.

Renal and urinary disorders

Kidney disease.

Hepatobiliary disorders

Rare: hepatitis (inflammation of the liver) and jaundice (yellowing of the skin). These medicines may rarely be associated with liver injury.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can 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 Ibuprofen Codramol

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

No special storage conditions are required.

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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibuprofeno Codramol

• The active substance is ibuprofen. Each sachet contains 200 mg of ibuprofen.
• The other components (excipients) are: Isomalt 720 (contains glucose and sorbitol E420), anhydrous citric acid, acesulfame potassium (E-950), glycerol distearate (type I), and lemon flavour (natural flavourings, maltodextrin, and alpha tocopherol (E-307)).

Nature of the product and contents of the pack

Ibuprofeno Codramol is presented as a white or almost white oral powder with a pronounced lemon odour, in single-dose sachets made of polyester/aluminium/polyethylene.

Two pack sizes are available: packs of 12 units and 24 units.

Only some pack sizes may be marketed.

Marketing Authorization Holder

FARMALIDER, S.A.

C/ La Granja 1

28108 Alcobendas, Madrid

Spain

Tel: 91.661.23.35

email: [email protected]

Manufacturer

BIOFABRI, S.L.

A Relva, s/n, O Porriño

36400 Pontevedra

Spain

Or

EDEFARM, S.L

Polígono Industrial Enchilagar del Rullo, 117

46191 Villamarchante

Valencia

Spain

Or

FARMALIDER, S.A.

C/Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

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

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