LIZYMAX 684 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Lizymax
3. 684 mg, coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Lizymax and what is it used for
5. Important information before taking Lizymax
   1. When not to take Lizymax:
   2. Warnings and precautions
   3. Lizymax and other medicines
   4. Taking Lizymax with alcohol
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
6. How to take Lizymax
   1. Taking a higher dose of Lizymax than recommended
   2. Missing a dose of Lizymax
7. Possible side effects
8. How to store Lizymax
9. Package contents and other information
   1. What Lizymax contains
   2. What Lizymax looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Medicine information
   5. Date of last revision of the leaflet: 10/2020

Leaflet attached to the packaging: patient information

Lizymax

684 mg, coated tablets

Ibuprofen lysinate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor, pharmacist, or nurse.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.
• If after 3 days (in case of fever) and 5 days (in other cases) there is no improvement or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

• 1. What is Lizymax and what is it used for
• 2. Important information before taking Lizymax
• 3. How to take Lizymax
• 4. Possible side effects
• 5. How to store Lizymax
• 6. Package contents and other information

1. What is Lizymax and what is it used for

Lizymax contains ibuprofen in the form of ibuprofen lysinate. Ibuprofen belongs to a group of non-steroidal anti-inflammatory drugs (NSAIDs) with analgesic, antipyretic, and anti-inflammatory effects. Lysine increases the solubility of ibuprofen, allowing for faster absorption.

Indications for use are:

• acute headache phase in migraine with or without aura,
• tension headache,
• painful conditions (e.g., back pain, toothache, muscle pain, joint pain, painful menstruation, neuralgia),
• pain in the course of a cold or flu,
• fever of various origins (including in the course of flu, cold, or other infectious diseases).

2. Important information before taking Lizymax

When not to take Lizymax:

• if the patient is hypersensitive to the active substance or any of the other ingredients of this medicine (listed in section 6),
• if the patient is hypersensitive to other non-steroidal anti-inflammatory drugs (NSAIDs),
• in patients with active or recurrent peptic ulcer disease, perforation (hole) or bleeding, also occurring after taking NSAIDs,

1 / 7

• in patients who have ever had allergic symptoms in the form of rhinitis, urticaria, dyspnea, or bronchial asthma while taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs,
• in patients with severe liver failure, severe kidney failure, or severe heart failure,
• in the last 3 months of pregnancy,
• if there is bleeding in the brain (cerebral hemorrhage) or other bleeding,
• if there are blood coagulation disorders, bleeding tendency, or blood formation disorders of unknown origin.

Warnings and precautions

Before starting to take Lizymax, the patient should discuss it with their doctor or pharmacist or nurse.

Particular caution should be exercised when taking Lizymax:

• if the patient is taking other painkillers from the NSAID group or acetylsalicylic acid in a daily dose above 75 mg,
• if the patient has certain skin diseases (systemic lupus erythematosus, mixed connective tissue disease),
• if the patient has gastrointestinal diseases and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
• if the patient has high blood pressure and (or) heart function disorders,
• if the patient has kidney function disorders,
• if the patient has liver diseases,
• after recent major surgery,
• if there is dehydration due to increased risk of kidney failure,
• in case of current or past asthma, chronic rhinitis, nasal polyps, or allergic diseases, it is possible to experience dyspnea,
• when taking other medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids (e.g., prednisolone), blood thinners (e.g., acenocoumarol), selective serotonin reuptake inhibitors (antidepressants), and antiplatelet agents (such as acetylsalicylic acid).

Prolonged use of painkillers may lead to persistent serious kidney problems.

The patient should avoid taking this medicine at the same time as NSAIDs, including selective cyclooxygenase-2 inhibitors.

Skin reactions

Severe skin reactions have been reported with the use of Lizymax. If the patient experiences:

any skin rash, changes in mucous membranes, blisters, or other symptoms of hypersensitivity, they should stop taking Lizymax and seek medical help immediately, as these may be the first symptoms of a very severe skin reaction. See section 4.

Taking anti-inflammatory and painkillers, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, particularly when used in high doses. The patient should not exceed the recommended dose and duration of treatment.

Before taking Lizymax, the patient should discuss their treatment with their doctor or pharmacist if:

• they have heart disease, such as heart failure, angina pectoris (chest pain), have had a heart attack, coronary artery bypass grafting, have peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked arteries), or have had any stroke (including mini-stroke or transient ischemic attack - TIA),

2 / 7

• they have high blood pressure, diabetes, high cholesterol, or a family history of heart disease or stroke, or if they smoke,
• they have an infection - see below, section entitled "Infections".

Infections

Lizymax may mask the symptoms of an infection, such as fever and pain. Therefore, Lizymax may delay the use of appropriate infection treatment and lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If the patient is taking this medicine while an infection is present, and the infection symptoms persist or worsen, they should consult their doctor immediately.

In elderly patients, there is an increased risk of adverse reactions when taking NSAIDs, particularly those affecting the stomach and intestines. Patients who have previously experienced adverse reactions in the gastrointestinal tract, especially elderly patients, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), especially in the initial treatment phase.

In patients with kidney or liver failure, during long-term administration of ibuprofen, regular monitoring of liver parameters, kidney function, and blood morphology is recommended. In patients with mild to moderate kidney or liver impairment, the dose should be as low as possible and used for the shortest duration necessary to control symptoms.

Children

Lizymax is not intended for children under 12 years of age.

Lizymax and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Lizymax may affect the action of other medicines or other medicines may affect the action of Lizymax. For example:

• corticosteroids (e.g., prednisolone), as they may increase the risk of stomach ulcers or bleeding,
• other NSAIDs (including COX-2 inhibitors, such as celecoxib or etoricoxib),
• anticoagulant medicines (i.e., blood thinners or anti-clotting agents, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine),
• blood pressure-lowering medicines (e.g., ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan),
• antiplatelet agents (such as acetylsalicylic acid) and selective serotonin reuptake inhibitors (antidepressants), as they increase the risk of adverse reactions in the gastrointestinal tract,
• medicines used to treat high blood pressure and diuretics, as NSAIDs may weaken their effect and increase the risk of kidney damage,
• lithium (a medicine used in depression), as lithium levels may increase,
• methotrexate (a medicine used in cancer or rheumatic diseases), as methotrexate levels may increase,
• tacrolimus (an immunosuppressive medicine), as the risk of toxic effects on the kidneys increases,
• cyclosporin (an immunosuppressive medicine), as there is limited data on increased risk of toxic effects on the kidneys,
• zydovudine (a medicine used in AIDS treatment), as taking Lizymax may increase the risk of bleeding into the joints or bleeding leading to swelling (in patients with hemophilia and a positive HIV antibody test),

3 / 7

• sulfonylurea derivatives (oral antidiabetic medicines): clinical interactions may occur between these medicines and NSAIDs. Blood glucose monitoring is recommended.
• probenecid and sulfinpyrazone (medicines used in gout treatment): may delay the excretion of ibuprofen,
• digitalis glycosides, phenytoin, and lithium: ibuprofen may increase the levels of these medicines in the blood,
• quinolone antibiotics: may increase the risk of seizures,
• cholestyramine: may delay and reduce the absorption of NSAIDs,
• voriconazole and fluconazole (antifungal medicines): may increase the exposure to NSAIDs.

Other medicines may also be affected or have an effect on Lizymax treatment. Therefore, before taking Lizymax with other medicines, the patient should always consult their doctor or pharmacist.

Taking Lizymax with alcohol

When taking ibuprofen in high doses and consuming alcohol at the same time, symptoms such as fatigue and headache may occur, which can lead to impaired concentration.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

During the first 6 months of pregnancy, this medicine should not be taken unless it is absolutely necessary.

During the last 3 months of pregnancy, the patient should not take this medicine, as it may increase the risk of complications in the mother and child during the perinatal period.

Breastfeeding

Ibuprofen passes into breast milk in small amounts. With short-term use of ibuprofen in recommended doses, harmful effects on breastfed infants seem unlikely.

Fertility

Ibuprofen may make it more difficult to become pregnant. If the patient plans to become pregnant or is having trouble becoming pregnant, they should inform their doctor.

Driving and using machines

Short-term use of the medicine, in accordance with the recommended dosage, has no effect or a negligible effect on the ability to drive vehicles and operate machinery.

3. How to take Lizymax

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor, pharmacist, or nurse. If in doubt, the patient should consult their doctor, pharmacist, or nurse.

The medicine is taken orally. The tablet can be divided into two equal doses.

Adults and adolescents over 12 years of age

Initial dose: half or 1 coated tablet.

Then, if necessary: half or 1 coated tablet every 4-6 hours.

Maximum daily dose: 3 coated tablets (1200 mg ibuprofen).

4 / 7

The coated tablets should be swallowed with a sufficient amount of liquid.

The patient should use the smallest effective dose for the shortest duration necessary to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should consult their doctor immediately (see section 2).

Elderly patients

There is no need to change the dosage of the medicine in elderly patients. Due to the potential side effect profile, elderly patients should be closely monitored.

Patients with kidney or liver failure

During long-term administration of ibuprofen, regular monitoring of liver parameters, kidney function, and blood morphology is recommended. In patients with mild to moderate kidney or liver impairment, the dose should be as low as possible and used for the shortest duration necessary to control symptoms.

The medicine is intended for short-term use. Without a doctor's recommendation, the patient should not take the medicine for more than 3 days (in case of fever) and 5 days (in other cases).

Use in children

Lizymax is not indicated for children under 12 years of age.

Taking a higher dose of Lizymax than recommended

If the patient has taken a higher dose of Lizymax than recommended or if a child has accidentally taken the medicine, they should always consult their doctor or go to the nearest hospital to get an opinion on the possible risk to their health and advice on what actions to take.

Symptoms may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, disorientation, and nystagmus. After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, feeling cold, and breathing problems may occur.

Other possible symptoms include: blinking, rarely low blood pressure, changes in blood composition, kidney function disorders.

It may be considered to administer activated charcoal orally within 1 hour of taking the medicine.

Missing a dose of Lizymax

The patient should not take a double dose to make up for a missed dose.

If the patient has any further doubts about taking this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Lizymax can cause side effects, although not everybody gets them.

The risk of side effects can be minimized by using the smallest effective dose for the shortest duration necessary to relieve symptoms.

The patient should stop taking the medicine and consult their doctor immediately if they experience:

• symptoms of stomach ulcers or bleeding, such as severe stomach pain, black stools, bloody vomiting;
• symptoms of allergic reactions (including rare but serious ones), such as rash and itching, worsening of asthma, respiratory symptoms (e.g., unexplained wheezing or difficulty breathing), swelling of the face, tongue, or throat, palpitations, low blood pressure;

5 / 7

• symptoms of severe skin reactions, such as a rash covering the whole body, peeling, blisters, and shedding of the skin.

Elderly patients taking this medicine are at increased risk of adverse reactions.

Common side effects (affecting 1 to 10 patients in 100):

• heartburn, stomach pain, nausea, vomiting, bloating with gas, diarrhea, constipation.

Uncommon side effects (affecting 1 to 10 patients in 1,000):

• gastritis, colitis, and worsening of Crohn's disease (inflammatory bowel disease),
• headache, dizziness, insomnia, restlessness, irritability, or fatigue,
• vision disturbances,
• stomach ulcers, which can bleed or perforate,
• mouth ulcers and (or) swelling, irritation of the mouth,
• hypersensitivity reactions with rash and itching, asthma attacks (with possible low blood pressure).

Rare side effects (affecting 1 to 10 patients in 10,000):

• tinnitus (ringing in the ears). Very rare side effects (less than 1 in 10,000 patients):
• esophagitis or pancreatitis, intestinal obstruction,
• severe skin reactions, including rash with redness and blisters, which can peel and are accompanied by fever, chills, and muscle pain, malaise, Stevens-Johnson syndrome; in exceptional cases, severe skin infections have occurred during chickenpox (chickenpox),
• reduced urine output and swelling (possible acute kidney failure or kidney inflammation); kidney damage or increased urea levels in the blood (first symptoms are: reduced urine output, cloudy urine, blood in the urine, back pain, possible swelling of the legs and general malaise),
• blood disorders (first symptoms are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and skin bleeding),
• psychotic reactions and depression,
• worsening of infectious inflammation; if infection symptoms occur or worsen while taking Lizymax, the patient should consult their doctor,
• swelling, high blood pressure, palpitations, heart failure, heart attack,
• liver function disorders or hepatitis; liver failure or damage, especially during long-term use, manifested by yellowing of the skin and eyes or pale stools and dark urine,
• very rarely, during ibuprofen use, symptoms of aseptic meningitis have been observed, including stiff neck, headache, malaise, fever, or impaired consciousness; patients with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) are more prone to adverse reactions. The patient should consult their doctor immediately if these occur.

Frequency not known:

• Severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, lymph node swelling, and an increased number of eosinophils (a type of white blood cell).
• A red scaly rash with thickening under the skin and blisters, usually located in skin folds, on the torso, and upper limbs, with fever occurring at the beginning of treatment (acute generalized pustular psoriasis). If such symptoms occur, the patient should stop taking Lizymax and seek medical help immediately. See also section 2. 6 / 7

Taking medicines like Lizymax may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products

Aleje Jerozolimskie 181C, 02-222 Warsaw

tel.: 22 49 21 301, fax: 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Lizymax

Store at a temperature below 25°C. Store in the original packaging to protect from light.

The medicine should be kept out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Lizymax contains

• The active substance of the medicine is ibuprofen lysinate. 1 coated tablet contains 684 mg of ibuprofen lysinate, which corresponds to 400 mg of ibuprofen.
• The other ingredients (excipients) are: microcrystalline cellulose, povidone K30, magnesium stearate; Opadry II 85F18422 White coating: polyvinyl alcohol, talc, macrogol, titanium dioxide (E 171).

What Lizymax looks like and contents of the pack

The coated tablets are oblong, biconvex, with a smooth, uniform surface, white in color, with a double dividing line.

One pack of the medicine contains 10, 15, 20, 30, or 50 coated tablets.

Marketing authorization holder and manufacturer

"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.

51-131 Wrocław, ul. Żmigrodzka 242 E

Medicine information

tel. 22 742 00 22

e-mail: [email protected]

Date of last revision of the leaflet: 10/2020

7 / 7