Package Leaflet: Information for the User

Algifast 400 mg powder for oral suspension

Ibuprofen (lysine)

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated 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 not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve, if the fever persists for more than 3 days or the pain for more than 5 days.

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. Storage of Algifast

6. Contents of the pack and additional information

The ibuprofen, active ingredient of this medication, acts by reducing pain and fever.

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

You should consult a doctor if it worsens or does not improve, if fever persists for more than 3 days or painfor more than 5 days.

Do not take Algifast if:

• You are allergic to ibuprofen or any of the other components of this medication (including those listed in section 6);
• You have had a stomach or duodenal ulcer or bleeding, or have suffered a perforation of the digestive tract;
• You have had allergic reactions of an asthmatic type when taking anti-inflammatory, acetylsalicylic acid, or other analgesics;
• You suffer or have suffered from asthma (difficulty breathing, choking, and in some cases, coughing or ringing in the ears), rhinitis (inflammation of the nasal mucosa), and urticaria (rash on the skin and intense itching);
• You have a serious liver, kidney, or heart disease (heart failure);
• You have bleeding or 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 packets per day (1200 mg of ibuprofen per day), to avoid possible cardiovascular or heart problems.

• If you have had 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 heartburn or stomach pain while taking the medication, discontinue treatment and consult your doctor.
• If you suffer from another disease or have an allergy, consult your doctor or pharmacist before taking this medication.
• If you have Crohn's disease or ulcerative colitis, as ibuprofen-containing medications may worsen these conditions.
• If your doctor has prescribed an antiplatelet medication (to prevent blood clots) containing acetylsalicylic acid, and you are also taking Algifast, you should separate the intake of both medications. You can follow either of the following guidelines:
• • Take the acetylsalicylic acid dose and wait at least half an hour for the administration of the Algifast dose.
  • Take the Algifast dose at least 8 hours before the administration of the acetylsalicylic acid dose.
• If you have hypertension, kidney, liver, or heart disease, coagulation disorders, or are taking anticoagulants, you should consult your doctor before taking this medication.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.
• 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 have had a heart attack, coronary artery bypass surgery, peripheral artery disease (circulation problems in the legs or feet due to narrowed or blocked 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 are a smoker.
• Do not exceed the recommended dose in section 3. How to take Algifast.
• If you have chickenpox (a childhood infection), you should not take ibuprofen.
• In case of dehydration, especially in children, due to severe diarrhea or vomiting, take plenty of fluids and seek medical attention immediately.
• If you have intermittent acute porphyria (a rare blood disorder).

• Skin Reactions

Severe skin reactions associated with ibuprofen treatment have been reported.

Stop taking this medication and seek medical attention immediately if you experience any skin rash, membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe 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. Therefore, this medication may delay the appropriate treatment of the infection, increasing the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to chickenpox. If you take this medication while having an infection and the infection symptoms persist or worsen, consult a doctor without delay.

Interference with diagnostic tests:

If you are to undergo any diagnostic test (including blood, urine, 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 used recently, 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 or prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Baclofen (used to treat involuntary and persistent muscle contractions).
• Medications that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin receptor antagonists like losartan).
• Ciclosporin and tacrolimus (used to prevent organ transplant rejection).
• Digoxin (used for the heart).
• Fenitoin (used to treat epilepsy).
• Furosemide and other thiazide diuretics (used to eliminate urine).
• Insulin and oral hypoglycemic agents (used to lower blood glucose).
• Lithium (used to treat depression).
• Metotrexate (used to treat cancer and rheumatoid arthritis).
• Mifepristone (induces abortion).
• Pentoxifilina (used in circulatory disorders).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolones (used in infections).
• Ion exchange resins like colestiramina (used to lower blood cholesterol).
• Sulfamides (used in infections).
• Sulfinpirazona (used to treat gout).
• Tacrina (used to treat Alzheimer's disease).
• Thrombolytics (medications that dissolve or break down blood clots).
• Zidovudina (used in patients infected with the human immunodeficiency virus, causing AIDS).
• This medication should not be used with other analgesics and anti-inflammatory medications (nonsteroidal anti-inflammatory drugs and corticosteroids) that reduce pain and inflammation, without consulting a doctor.

If your doctor has prescribed an antiplatelet medication (to prevent blood clots) containing acetylsalicylic acid, and you are also taking this medication, you should separate the intake of both medications (see Advertencias and precauciones section).

Other medications may also affect or be affected by the 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.

The consumption of 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.

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

Ibuprofen belongs to a group of medications that may reduce a woman's fertility (ability to become pregnant). This effect is reversible when the medication is stopped.

Driving and operating machinery

Although no effects are expected, use 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 packet.
• This medication may cause allergic reactions because it contains tartrazine. It may provoke asthma, especially in patients allergic to acetylsalicylic acid.
• This medication contains sucrose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication. It may cause tooth decay.

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

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

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

Adults and adolescents 12 years and older (and over 40 kg of weight)

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

Older 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 diseases:

They should consult a 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 symptoms worsen, if fever persists for more than 3 days or pain for more than 5 days, you should consult a doctor.

Administration form:

This medication is administered orally.

Empty the contents of a tablet into a half glass of water, shake, and take afterwards.

Take the medication with meals or with milk, especially if digestive discomfort is noted.

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 a doctor or pharmacist immediately or call the Toxicological Information Service (phone 91 562 04 20) indicating the medication and the amount ingested, or go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken.

The 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 of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, chills, and breathing difficulties have been reported.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Frequent (may affect up to 1 in 10 people): fatigue, headache, stomach and intestinal disorders (heartburn, diarrhea, nausea, vomiting), skin disorders (skin rashes, itching) and ear buzzing.

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

Rare (may affect up to 1 in 1,000 people): edema (swelling due to fluid retention), blood disorders (leucopenia), stomach and intestinal perforation, liver disorders (including jaundice, i.e., yellow discoloration of the skin and eyes), kidney disorders consistent of: acute interstitial nephritis with hematuria (blood in urine), proteinuria (protein elimination through urine) and occasionally nephrotic syndrome (a set of symptoms that appear as a consequence of kidney damage); depression, vision disorders (obscurement of vision), neck stiffness and bronchospasm (sudden sensation of choking), dyspnea (difficulty breathing) and angioedema (inflammation of the deep layers of the skin, which is accompanied by swelling of the face, lips, tongue or throat, which may cause difficulty swallowing or breathing).

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

Unknown frequency: a severe skin reaction known as DRESS syndrome may occur.

The symptoms of DRESS syndrome include:

a generalized red scaly rash, with bumps under the skin and localized blisters mainly on the skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (generalized acute pustular exanthema). Stop taking Algifast if you experience these symptoms and seek medical attention immediately.

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 that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

This product does not require special storage conditions.

Once the package is opened, prepare the suspension immediately according to theinstructions for use.

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

Do not use this medication after the expiration date that appears on the package and the boxafter CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the containers andmedicines you no longer need at the SIGREcollection point at the pharmacy. If in doubt, ask yourpharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Algifast

Appearance of Algifastand contents of the packaging

Fine powder, white in color and with a lemon scent that is presented in sachets.

Each package contains 4 or 12 sachets.

Holder of the marketing authorization and responsible for manufacturingLaboratorio de Aplicaciones Farmacodinámicas, S.A. (FARDI)

Grassot, 16 - 08025- Barcelona (Spain)

Telephone: 932073751

Fax: 934570737

e-mail:[email protected]

Date of the last review of this leaflet:January 2021

The detailed and updated information on this medication is available on the website of theSpanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/