ALGIFAST 400 mg POWDER FOR ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Algifast 400 mg Powder for Oral Suspension

Ibuprofen (Lysine)

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

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

Contents of the Package Leaflet

1. What is Algifast and what is it used for
2. What you need to know before taking Algifast
3. How to take Algifast
4. Possible side effects
5. Storage of Algifast
6. Package contents and additional information

1. What is Algifast and what is it used for

Ibuprofen, the active ingredient in this medication, acts by reducing pain and fever.

This medication is used in adults for the symptomatic relief of occasional mild or moderate pain, such as headaches, dental pain, menstrual pain, muscle pain (cramps) or back pain (lumbago), as well as in febrile states.

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

2. What you need to know before taking Algifast

Do not take Algifast if:

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

Warnings and Precautions

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

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

• If you have suffered from stomach or intestinal diseases (e.g., ulcers), you should not consume this medication without medical supervision. Stomach or intestinal pain should not be treated with this medication.
• If you experience burning or stomach pain when taking the medication, you should stop treatment and consult your doctor.
• If you have another illness or suffer from any type of allergy, consult your doctor or pharmacist before taking this medication.
• If you have Crohn's disease or ulcerative colitis, as medications containing ibuprofen may worsen these diseases.
• If your doctor has prescribed an antiplatelet medication(to prevent blood clots) that contains acetylsalicylic acid, and you also take Algifast, you should separate the intake of both medications. To do this, you can follow either of the following guidelines:
• • Take the dose of acetylsalicylic acid and wait at least half an hourbefore taking the dose of Algifast.
  • Take the dose of this medication at least 8 hours beforetaking the acetylsalicylic acid.
• If you have high blood pressure, kidney, liver, or heart disease, blood coagulation disorders, or are being treated with anticoagulants, you should consult your doctor before taking this medication.
• Anti-inflammatory/analgesic medications like ibuprofen may be associated with a small increased risk of suffering a heart attack or stroke, especially when used in 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 medication if:
• • You have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral arteriopathy (circulation problems in the legs or feet due to narrowing or blockage of the 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 in section 3. How to take Algifast.
• You should not take ibuprofen if you have chickenpox (a common childhood illness).
• In case of dehydration due to severe diarrhea or vomiting, especially in children, take plenty of fluids and seek medical attention immediately.
• If you have acute intermittent porphyria (a rare blood disorder).

• Skin Reactions

Serious skin reactions have been reported in association with ibuprofen treatment.

Stop taking this medication and seek medical attention immediately if you experience any skin rash, lesions on the mucous membranes, blisters, or other signs of allergy, as these may be the first signs of a serious skin reaction. See section 4.

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

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Consequently, this medication may delay appropriate treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medication while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Interference with Laboratory Tests:

If you are going to have any diagnostic tests (including blood tests, urine tests, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Other Medications and Algifast

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those purchased without a prescription.

This medication may affect or be affected by other medications. For example:

• Anticoagulant medications (e.g., to treat coagulation problems/prevent blood clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Baclofen (used to treat involuntary and persistent muscle contractions)
• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
• Cyclosporin 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 for urine elimination)
• Insulin and oral hypoglycemic agents (used to decrease blood sugar levels)
• Lithium (used to treat depression)

• Methotrexate (used in the treatment of cancer and rheumatoid arthritis)
• Mifepristone (abortion inducer)
• Pentoxifylline (used in circulatory disorders)
• Probenecid (used in patients with gout or with penicillin in infections)
• Quinolones (used in infections)
• Ion exchange resins such as cholestyramine (used to decrease cholesterol levels in the blood)
• Sulfonamides (used in infections)
• Sulfinpyrazone (used in the treatment of gout)
• Tacrine (used in the treatment of Alzheimer's disease)
• Thrombolytics (medications that dissolve or break down blood clots)
• Zidovudine (used in the treatment of patients infected with the human immunodeficiency virus, the cause of AIDS)
• Do not use with other analgesic and anti-inflammatory medications (non-steroidal anti-inflammatory drugs and corticosteroids) that reduce pain and inflammation without consulting your doctor.

If your doctor has prescribed an antiplatelet medication(to prevent blood clot formation) that contains acetylsalicylic acid, and you also take this medication, you should separate the intake of both medications (see Warnings and Precautions section).

Other medications may also affect or be affected by treatment with this medication. Therefore, you should always consult your doctor or pharmacist before using Algifast with other medications.

Taking Algifast with Food, Drinks, and Alcohol

Take this medication with meals or with milk.

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

Pregnancy, Breastfeeding, and Fertility

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

The use of ibuprofen should be avoided during the first and second trimester of pregnancy. If it is considered essential, your doctor will prescribe the lowest effective dose for the shortest possible time. It should not be used in the last trimester of pregnancy.

Ibuprofen belongs to a group of medications that may decrease fertility (ability to become pregnant) in women. This effect is reversible when the medication is stopped.

Driving and Using Machines

Although it is not expected to have effects in this regard, it should be used with caution if you experience drowsiness or dizziness.

Algifast contains cyclodextrin (betadex) (E-459), tartrazine (E-102), sucrose, and sodium.

• This medication contains 2 g of cyclodextrin in each sachet.
• This medication may cause allergic reactions because it contains tartrazine. It can cause asthma, especially in patients allergic to acetylsalicylic acid.
• This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. It may cause cavities.

• This medication contains less than 1 mmol (23 mg) per sachet, which means it is essentially "sodium-free".

3. How to Take Algifast

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

Use the lowest effective dose for the shortest necessary time to relieve symptoms. If you have an infection, consult your doctor without delay if the symptoms (such as fever and pain) persist or worsen (see section 2).

Adults and adolescents from 12 years old (and over 40 kg in weight)

It is recommended to take 1 sachet (400 mg of ibuprofen) every 6-8 hours, depending on the intensity of the symptoms. Do not take more than 1200 mg of ibuprofen (3 sachets) in 24 hours.

Elderly patients

The dose should be established by the doctor, as it may be necessary to reduce the usual dose. Consult your doctor.

Patients with kidney, liver, or heart disease:

They should consult their doctor before taking this medication.

The administration of this medication is subject to the appearance of pain or fever. As these disappear, the medication should be discontinued.

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

Method of administration:

This medication is administered orally.

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

Take the medication with meals or with milk, especially if you experience digestive discomfort.

If you take more Algifast than you should

If you have taken more medication than you should, or if a child has accidentally ingested the medication, consult your doctor or pharmacist immediately or call the Toxicology Information Service (telephone 91 562 04 20) indicating the medication and the amount ingested, or go to the nearest hospital to find out about the risk and ask for advice on the measures to be taken.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, chills, and breathing problems have been reported.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Frequent (may affect up to 1 in 10 people): fatigue, headache, stomach and intestine disorders (heartburn, diarrhea, nausea, vomiting), skin disorders (rash, itching), and ringing in the ears.

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

Rare (may affect up to 1 in 1,000 people): edema (swelling due to fluid retention), blood disorders (leukopenia), stomach and intestine perforation, liver disorders (including jaundice, i.e., yellowing of the skin and eyes), kidney disorders consisting of acute interstitial nephritis with hematuria (blood in urine), proteinuria (protein elimination in urine), and occasionally nephrotic syndrome (a set of symptoms that appear as a result of kidney damage); depression, vision disorders (vision loss), neck stiffness, and bronchospasm (sudden feeling of shortness of breath), dyspnea (difficulty breathing), and angioedema (inflammation of the deep skin layers, which can cause swelling of the face, lips, tongue, or throat, potentially leading to difficulty 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 and coagulation disorders, hypertension, and heart failure, severe skin, eye, and mucous membrane disorders such as Stevens-Johnson syndrome (a severe skin condition) and toxic epidermal necrolysis (skin and mucous membrane lesions that cause skin detachment) and erythema multiforme (skin inflammation).

Frequency not known: a serious skin reaction known as DRESS syndrome may occur. The symptoms of DRESS syndrome include skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell). Generalized red scaly rash, with bumps under the skin and blisters mainly in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking Algifast if you experience these symptoms and seek medical attention immediately.

See also section 2. The skin becomes sensitive to light.

Reporting Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Algifast

No special storage conditions are required.

Once the sachet is opened, the suspension should be prepared immediately according to the instructions for use.

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

Do not use this medication after the expiration date shown on the sachet and the box after the EXP date. The expiration date is the last day of the month indicated.

Do not use this medication if you notice signs of deterioration.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Algifast

• The active ingredient is Ibuprofen lysine. Each sachet contains 400 mg of ibuprofen (supplied by 683.34 mg of ibuprofen lysine).
• The other components (excipients) are betadex (E-459), lemon flavor (contains tartrazine (E-102), corn starch, and corn maltodextrin), sodium saccharin, sodium cyclamate, sodium citrate, and sucrose.

Appearance of Algifastand Packaging Content

Fine powder, white in color and lemon-scented, presented in sachets.

Each package contains 4 or 12 sachets.

Marketing Authorization Holder and ManufacturerLABORATORIO DE APLICACIONES FARMACODINÁMICAS, S.A. (FARDI)

Grassot, 16 - 08025- Barcelona (Spain)

Phone: 932073751

Fax: 934570737

e-mail: [email protected]

Date of the Last Revision of this Leaflet:January 2021

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