Algifast 400 mg powder for oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Algifast 400 mg powder for oral suspension

Ibuprofen (lysine)

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

Always follow exactly the instructions for use provided in this leaflet or as advised by your doctor or pharmacist.

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

Contents of the leaflet

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

1. What Algifast is and what it is used for

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

This medicine is used in adults for the symptomatic relief of mild to moderate occasional pain, such as headaches, toothaches, menstrual pain, muscle pain (muscle strains), or back pain (lumbago), as well as for feverish conditions.

You should consult a doctor if your symptoms worsen or do not improve, if fever persists for more than 3 days, or if pain lasts for more than 5 days.

2. What you need to know before starting to take Algifast

Do not take Algifast if:

• You are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6);
• You have had a stomach or duodenal ulcer (last part of the small intestine), gastrointestinal bleeding, or have experienced a perforation of the digestive tract;
• You have had allergic reactions such as asthma after taking anti-inflammatory drugs, acetylsalicylic acid, or other painkillers;
• You suffer from or have suffered from asthma (difficulty breathing, shortness of breath, and in some cases coughing or wheezing), rhinitis (inflammation of the nasal mucosa), or urticaria (skin rash and intense itching);
• You have severe liver, kidney, or heart disease (heart failure);
• You have bleeding disorders or blood coagulation problems;
• You vomit blood, have black stools, or suffer from bloody diarrhea;
• You are in the third trimester of pregnancy.

Warnings and precautions

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

• Do not take more than 3 sachets per day (1200 mg of ibuprofen per day) to avoid possible circulatory or heart problems.

• If you have previously suffered from stomach or intestinal diseases (e.g., ulcer), you should not take this medicine without medical supervision. Stomach or intestinal pain should not be treated with this medicine.

• If you experience stomach burning or pain while taking the medicine, stop treatment and consult your doctor.

• If you suffer from another illness or have any type of allergy, consult your doctor or pharmacist before taking this medicine.

• If you have Crohn's disease or ulcerative colitis, as ibuprofen-containing medicines may worsen these conditions.

• If your doctor has prescribed an antiplatelet agent (to prevent blood clot formation) containing acetylsalicylic acid, and you are also taking Algifast, you must separate the administration times of both medicines. To do this, follow one of the following regimens:

  • Take the dose of acetylsalicylic acid and wait at least half an hour before taking the dose of Algifast.
  • Take the dose of this medicine at least 8 hours before taking acetylsalicylic acid.

• If you have hypertension, kidney, liver, or heart disease, blood coagulation disorders, or are being treated with anticoagulants, you must consult your doctor before taking this medicine.

• Anti-inflammatory/painkiller 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 this medicine if:

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

• Do not exceed the recommended dose stated in section 3. How to take Algifast.

• If you have chickenpox (a childhood infectious disease), you should not take ibuprofen.

• In case of dehydration due to severe diarrhea or vomiting, especially in children, drink plenty of fluids and seek immediate medical attention.

• If you suffer from acute intermittent porphyria (a rare blood disorder).

• Skin reactions

Serious skin reactions have been reported with ibuprofen treatment.

Stop taking this medicine and contact your doctor immediately if you develop any skin rash, lesions on mucous membranes, blisters, or other signs of allergy, as these may be early signs of a very serious skin reaction. See section 4.

• If you have an infection, see the "Infections" heading below.

Infections

Ibuprofen may mask signs of infection such as fever and pain. Therefore, this medicine 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.

Interference with diagnostic tests:

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

Other medicines and Algifast

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines, including those obtained without a prescription.

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

• Anticoagulant medicines (e.g., to treat coagulation disorders/prevent clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Baclofen (used to treat involuntary and persistent muscle contractions)
• 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).
• Cyclosporine and tacrolimus (used to prevent organ transplant rejection)
• Digoxin (used for heart conditions)
• Phenytoin (used in the treatment of epilepsy)
• Furosemide and other thiazide diuretics (used to increase urine elimination)
• Insulin and oral hypoglycemics (used to lower blood glucose)
• Lithium (used to treat depression)
• Methotrexate (used in the treatment of cancer and rheumatoid arthritis)
• Mifepristone (abortion-inducing agent)
• Pentoxifylline (used in circulatory disorders)
• Probenecid (used in patients with gout or together with penicillin in infections)
• Quinolones (used for infections)
• Ion-exchange resins such as cholestyramine (used to reduce blood cholesterol levels)
• Sulfonamides (used for infections)
• Sulfinpyrazone (used for the treatment of gout)
• Tacrine (used in the treatment of Alzheimer's disease)
• Thrombolytics (medicines that dissolve or break down blood clots)
• Zidovudine (used in the treatment of patients infected with the human immunodeficiency virus, HIV, which causes AIDS)
• Should not be used together with other painkillers and anti-inflammatory medicines (non-steroidal anti-inflammatory drugs and corticosteroids) without consulting your doctor.

If your doctor has prescribed an antiplatelet agent (to prevent blood clot formation) containing acetylsalicylic acid, and you are also taking this medicine, you must separate the administration times of both medicines (see section Warnings and precautions).

Other medicines may also affect or be affected by treatment with this medicine. Therefore, always consult your doctor or pharmacist before using Algifast with other medicines.

Taking Algifast with food, drinks, and alcohol

Take this medicine with food or milk.

Consuming alcohol during treatment may increase the risk of gastrointestinal adverse reactions.

Pregnancy, breastfeeding, and fertility

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

The use of ibuprofen should be avoided during the first and second trimesters of pregnancy. If its use is considered essential, your doctor will prescribe the lowest effective dose for the shortest possible duration. It must not be used during the third trimester of pregnancy.

Ibuprofen belongs to a group of medicines that may reduce fertility (ability to become pregnant) in women. This effect is reversible upon discontinuation of the medicine.

Driving and using machines

Although effects in this regard are not expected, use with caution if you experience drowsiness or dizziness.

Algifast contains cyclodextrin (betadex) (E-459), sucrose, and sodium.

• This medicine contains 2 g of cyclodextrin per sachet.

• This medicine may cause allergic reactions as it contains tartrazine. It may cause asthma, especially in patients allergic to acetylsalicylic acid.

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

3. How to take Algifast

Follow exactly the instructions for use provided in this leaflet or those given 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 without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

Adults and adolescents aged 12 years and older (and weighing more than 40 kg)

Recommended dose: 1 sachet (400 mg of ibuprofen) every 6 to 8 hours, depending on the intensity of symptoms. Do not exceed 1200 mg of ibuprofen (3 sachets) within 24 hours.

Elderly patients

The dose should be determined by the doctor, as a reduction from the usual dose may be necessary. Consult your doctor.

Patients with kidney, liver, or heart disease:

Must consult a doctor before taking this medicine.

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

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

Method of administration:

This medicine is taken orally.

Pour the contents of one sachet into half a glass of water, stir, and take immediately.

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

If you take more Algifast than you should

If you have taken more medicine than recommended, or if a child has accidentally ingested the medicine, consult a doctor or pharmacist immediately, call the Toxicology Information Service (telephone 91 562 04 20), stating the name of the medicine and the amount ingested, or go to the nearest hospital to assess the risk and receive advice on the necessary measures.

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, chills, and breathing difficulties have been reported.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Frequent (may affect up to 1 in 10 people): tiredness, headache, gastrointestinal disorders (indigestion, diarrhoea, nausea, vomiting), skin disorders (rashes, itching) and tinnitus (ringing in the ears).

Uncommon (may affect up to 1 in 100 people): allergic reactions, asthma, rhinitis (inflammation of the nasal mucosa) and urticaria (skin rash and intense itching), gastrointestinal bleeding and ulcers, sleep disturbances and mild restlessness, blurred vision, decreased visual acuity or changes in color perception, and hearing disturbances.

Rare (may affect up to 1 in 1,000 people): oedema (swelling due to fluid retention), blood disorders (leucopenia), gastrointestinal perforation, liver disorders (including jaundice, i.e. yellowing of the skin and eyes), kidney disorders such as acute interstitial nephritis with haematuria (blood in urine), proteinuria (excretion of proteins in urine), and occasionally nephrotic syndrome (a group of symptoms resulting from kidney damage); depression, visual disturbances (blurred vision), neck stiffness, bronchospasm (sudden sensation of suffocation), dyspnoea (difficulty breathing), and angioedema (inflammation of the deeper layers of the skin, causing swelling of the face, lips, tongue or throat, which may cause difficulty in swallowing or breathing).

Very rare (may affect up to 1 in 10,000 people): aseptic meningitis (inflammation of the meninges not caused by bacteria), blood disorders (aplastic anaemia and haemolytic anaemia) and coagulation disorders, hypertension and heart failure, severe skin reactions such as erythema, eye and mucosal disorders including Stevens-Johnson syndrome (a serious skin condition), toxic epidermal necrolysis (skin and mucosal lesions causing skin detachment), and erythema multiforme (skin inflammation).

Frequency not known: a serious 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 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 Algifast 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 adverse effects, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects 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 Algifast

No special storage conditions are required.

Once the sachet has been opened, the suspension must be prepared immediately according to the instructions for use.

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

Do not use this medicine after the expiry date stated on the sachet and the outer carton after EXP. The expiry date refers to the last day of the month indicated.

Do not use this medicine if you notice any signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Algifast

• The active substance is Ibuprofen lysine. Each sachet contains 400 mg of ibuprofen (provided by 683.34 mg of ibuprofen lysine).
• The other components (excipients) are betadex (E-459), lemon flavour (containing arabic gum (E-414), ascorbic acid (E-300) and corn maltodextrin), sodium saccharin, sodium cyclamate, sodium citrate and sucrose.

Appearance of Algifast and contents of the pack

Fine white powder with lemon scent, presented in sachets.

Each pack contains 4 or 12 sachets.

Marketing Authorization Holder and Manufacturer

LABORATORIO DE APLICACIONES FARMACODINÁMICAS, S.A. (FARDI)
Grassot, 16 - 08025- Barcelona (Spain)
Telephone: 932073751
Fax: 934570737
e-mail: [email protected]

Date of the most recent revision of this leaflet: January 2021

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/