Lizymax

Package leaflet: Information for the patient

Lizymax
684 mg, coated tablets
Ibuprofenum lysinum
Please read this leaflet carefully before using the medicine, as it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse.

• Keep this leaflet for possible future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days (in the case of fever) or 5 days (in other cases), or if you feel worse, consult your doctor.

Contents of the leaflet

1. What Lizymax is and what it is used for
2. Important information before taking Lizamax
3. How to take Lizymax
4. Possible side effects
5. How to store Lizymax
6. Contents of the package and other information

1. What Lizymax is and what it is used for

Lizymax contains ibuprofen in the form of ibuprofen lysinate. Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which have analgesic, antipyretic, and anti-inflammatory properties. Lysine increases the solubility of ibuprofen, enabling faster absorption.

Lizymax is indicated for:

• Acute migraine headache with or without aura,
• Tension-type headache,
• Painful conditions (e.g. back pain, toothache, muscle pain, joint pain, dysmenorrhoea, neuralgia),
• Pain associated with cold and flu,
• Fever of various origins (including fever associated with flu, cold, or other infectious diseases).

2. Important information before using Lizymax

When not to use Lizamax:

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to other non-steroidal anti-inflammatory drugs (NSAIDs),
• in patients with active or past history of gastric or duodenal ulcer, perforation (gastrointestinal perforation), or bleeding, including cases previously occurring after use of NSAIDs,
• in patients who have previously experienced allergic reactions during treatment with acetylsalicylic acid or other NSAIDs, such as rhinitis, urticaria, breathlessness, or bronchial asthma,
• in patients with severe liver failure, severe renal failure, or severe heart failure,
• during the last 3 months of pregnancy,
• if there is cerebral bleeding (intracranial hemorrhage) or any other bleeding,
• if there are blood coagulation disorders, haemorrhagic diathesis (tendency to bleed), or blood cell production disorders of unknown origin.

Warnings and precautions
Before starting treatment with Lizymax, discuss it with your doctor, pharmacist, or nurse.
Exercise particular caution when using Lizymax:

• if the patient is taking other pain-relieving medicines from the NSAID group or acetylsalicylic acid at daily doses exceeding 75 mg,
• if the patient has been diagnosed with certain skin diseases (systemic lupus erythematosus, mixed connective tissue disease),
• if the patient has gastrointestinal disorders or 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 dehydration is present due to increased risk of kidney failure,
• in patients currently or previously suffering from asthma, chronic rhinitis, nasal polyps, or allergic conditions, as breathlessness may occur,
• when taking other medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids (e.g. prednisolone), anticoagulants (e.g. acenocoumarol), selective serotonin reuptake inhibitors (antidepressants), or antiplatelet agents (such as acetylsalicylic acid).

Long-term, concomitant use of pain-relieving medicines may lead to persistent serious kidney problems.
Avoid using this medicine simultaneously with NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors.

Skin reactions
Severe skin reactions associated with the use of Lizymax have been reported. If any skin rash, mucosal lesions, blisters, or other allergic symptoms appear, stop taking Lizymax immediately and seek medical help promptly, as these may be early signs of a very serious skin reaction. See section 4.

Taking anti-inflammatory and pain-relieving 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.

Before using Lizymax, the patient should discuss treatment with a doctor or pharmacist if:

• the patient has heart diseases such as heart failure, angina (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in legs due to narrowed or blocked arteries), or history of stroke (including mini-stroke or transient ischemic attack - TIA),

• the patient has hypertension, diabetes, high cholesterol levels, a family history of heart disease or stroke, or if the patient smokes,

• the patient has an infection – see below under the section titled "Infections".

Infections
Lizymax may mask symptoms of infection such as fever and pain. Therefore, Lizymax may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine during an existing infection and infection symptoms persist or worsen, immediate consultation with a doctor is required.

Elderly patients have an increased risk of adverse effects during treatment with NSAIDs, particularly gastrointestinal effects. Patients who previously experienced adverse effects in the gastrointestinal tract, especially elderly patients, should report any unusual abdominal symptoms (particularly gastrointestinal bleeding), especially at the beginning of treatment.

In patients with kidney or liver impairment, regular monitoring of liver function, kidney function, and blood counts is recommended during prolonged ibuprofen therapy. 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 use in children under 12 years of age.

Lizymax and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
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 gastrointestinal ulceration or bleeding,
• other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib),
• anticoagulant medicines (i.e. blood thinners or those preventing clot formation, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine),
• antihypertensive medicines (ACE inhibitors such as captopril, beta-blockers such as those containing 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 gastrointestinal adverse effects,
• antihypertensive medicines and diuretics, as NSAIDs may reduce their effectiveness and increase the risk of kidney damage,
• lithium, as its effects may be enhanced,
• methotrexate (a medicine used in cancer or rheumatic diseases), as its effects may be enhanced,
• tacrolimus (an immunosuppressant), as there is increased risk of kidney toxicity,
• cyclosporine (an immunosuppressant), as limited data suggest an increased risk of kidney toxicity,
• zidovudine (a medicine used in the treatment of AIDS), as using Lizymax may increase the risk of joint bleeding or bleeding leading to swelling (in patients with hemophilia and positive HIV antibody test),
• sulfonylurea derivatives (antidiabetic medicines): clinical interactions between these medicines and NSAIDs may occur. Blood glucose monitoring is recommended.
• probenecid and sulfinpyrazone (medicines used in the treatment of gout): may delay ibuprofen excretion,
• digoxin, phenytoin, and lithium: ibuprofen may increase plasma concentrations of these medicines,
• quinolone antibiotics: may increase the risk of seizures,
• cholestyramine: may delay and reduce absorption of NSAIDs,
• voriconazole and fluconazole (antifungal medicines): may increase exposure to NSAIDs.

Other medicines may also interact with or be affected by treatment with Lizymax. Therefore, always consult a doctor or pharmacist before using Lizymax with other medicines.

Alcohol and Lizymax
When taking high doses of ibuprofen and consuming alcohol simultaneously, symptoms from the central nervous system such as fatigue and headache may occur, potentially impairing concentration.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Use of this medicine is not recommended during the first 6 months of pregnancy unless absolutely necessary.
During the last 3 months of pregnancy, this medicine must not be taken, as it may increase the risk of complications for both mother and child in the perinatal period.

Breastfeeding
Ibuprofen passes into breast milk in small amounts. With short-term use at recommended doses, harmful effects on infants appear unlikely.

Fertility
Ibuprofen may impair fertility. If the patient plans to become pregnant or has difficulty conceiving, she should inform her doctor.

Driving and operating machinery
Short-term use of this medicine according to the recommended dosage has no effect or only a negligible effect on the ability to drive or operate machinery.

3. How to use Lizymax

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

Lizymax is taken orally. The coated tablet may 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 of ibuprofen).

The coated tablets should be swallowed whole with an adequate amount of liquid.

Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If symptoms of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).

Elderly patients
No dose adjustment is required in elderly patients. However, due to the potential adverse effect profile, elderly patients should be monitored particularly carefully.

Patients with renal or hepatic impairment
With long-term ibuprofen use, regular monitoring of liver function, kidney function, and blood counts is recommended. In patients with mild to moderate impairment of kidney or liver function, the lowest possible dose should be used for the shortest duration necessary to control symptoms.

This medicine is intended for short-term use only. Without medical advice, do not use Lizymax for longer than 3 days for fever or 5 days for other symptoms.

Use in children
Lizymax is not recommended for children under 12 years of age.

Taking more Lizymax than recommended
If a patient takes more than the recommended dose of Lizymax, or if a child accidentally ingests the medicine, always contact a doctor or go to the nearest hospital to assess potential health risks and receive advice on necessary actions.

Symptoms may include nausea, stomach pain, vomiting (possibly with blood), headache, tinnitus, confusion, and nystagmus. After a large overdose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in urine, feeling cold, and breathing difficulties may occur.

Additional symptoms may include eyelid twitching, rarely low blood pressure, changes in blood composition, and kidney function disorders.

Oral activated charcoal may be considered within 1 hour of ingestion.

If you forget to take Lizymax
Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The risk of adverse reactions can be reduced by using the lowest effective dose for the shortest duration necessary to relieve symptoms.
Discontinue the medicine and seek immediate medical attention if the patient experiences:

• symptoms of gastrointestinal ulceration or bleeding, such as: severe abdominal pain, black stools, vomiting blood;
• symptoms of allergic reactions (including rare but serious reactions), such as: rash and itching, worsening asthma, respiratory problems (e.g. unexplained wheezing or difficulty breathing), swelling of the face, tongue or throat, palpitations, drop in blood pressure;

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• symptoms of severe skin reactions, such as: rash spreading over the entire body, skin peeling, formation of blisters and shedding of skin in sheets.

Elderly patients taking this medicine are at increased risk of experiencing problems related to adverse reactions.
Adverse reactions occurring frequently (in 1 to 10 patients out of 100):

• heartburn, abdominal pain, nausea, vomiting, flatulence with gas release, diarrhoea, constipation.

Adverse reactions occurring not very frequently (in 1 to 10 patients out of 1,000):

• inflammation of the stomach, large intestine, and exacerbation of Crohn's disease (inflammatory bowel disease),
• headache, dizziness, insomnia, restlessness, irritability or fatigue,
• visual disturbances,
• gastric ulcers, which may bleed or perforate,
• oral ulceration and (or) swelling, irritation of the mouth,
• hypersensitivity reactions with rash and itching, asthma attacks (possibly with low blood pressure).

Adverse reactions occurring rarely (in 1 to 10 patients out of 10,000):

• tinnitus (ringing in the ears).
  Adverse reactions occurring very rarely (less than 1 patient in 10,000):
• oesophagitis or pancreatitis, intestinal obstruction,
• severe skin reactions, including rash with redness and blisters, which may peel and are accompanied by fever, chills, muscle pain, malaise, Stevens-Johnson syndrome; in exceptional cases, severe skin infections during chickenpox (varicella) have been reported,
• reduced urine output compared to usual and swelling (possible acute kidney failure or inflammation); kidney damage or increased blood urea concentration (initial symptoms include: reduced urine output, cloudy urine, blood in urine, back pain, possible leg swelling and general malaise),
• problems related to blood cell production (early symptoms include fever, sore throat, superficial oral ulceration, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding, unexplained or unusual bruising),
• psychotic reactions and depression,
• worsening of inflammatory condition due to infection; if signs of infection occur or worsen during treatment with Lizymax, consult a doctor,
• swelling, high blood pressure, palpitations, heart failure, heart attack,
• liver function disorders or hepatitis; liver failure or damage, especially during long-term use, manifesting as yellowing of the skin and eyes, pale stools and dark urine,
• very rarely, symptoms of aseptic meningitis have been observed during ibuprofen use, including neck stiffness, headache, malaise, fever or altered consciousness; patients with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) are more susceptible to adverse reactions. Immediate medical attention should be sought if these occur.

Frequency unknown:

• Severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes, and increased eosinophil count (a type of white blood cell).
• Red, scaly rash with subcutaneous nodules and blisters, predominantly located in skin folds, trunk, and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, discontinue Lizymax immediately and seek urgent medical help. See also section 2. 6 / 7

Taking medicines such as Lizymax may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Reporting of adverse reactions
If any adverse symptoms occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Lizymax

Store below 25°C. Keep in the original packaging to protect from light.
Keep this medicine 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Package contents and other information

What Lizymax contains

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

What Lizymax looks like and contents of the pack
Film-coated, elongated, biconvex tablets with a smooth, uniform white surface and a break line on both sides.
One package contains 10, 15, 20, 30 or 50 film-coated tablets.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicinal product information
tel. 22 742 00 22
e-mail: [email protected]
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