Benlek

Package Leaflet: Information for the Patient

Benlek

500 mg + 38.75 mg + 50 mg, tablets

Metamizole sodium monohydrate + Thiamine hydrochloride + Caffeine

The Benlek medicine may cause a severely low number of white blood cells (agranulocytosis), which can lead to severe and life-threatening infections (see section 4).

Stop taking the medicine and contact your doctor immediately if you experience any of the following symptoms: fever, chills, sore throat, painful mouth ulcers, or ulcers in the genital or anal area.

If the patient has ever had agranulocytosis while taking metamizole or similar medicines,

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Benlek and what is it used for

Benlek is a combination medicine that contains three active substances: metamizole, vitamin B, and caffeine. Metamizole belongs to a group of non-opioid analgesics with pyrazolone derivatives, which have analgesic and antipyretic effects. It also has a spasmolytic effect on smooth muscles.
Caffeine stimulates the central nervous system; constricts blood vessels and reduces intracranial pressure; enhances the effect of metamizole by penetrating the central nervous system.
Vitamin B has a beneficial effect on inflammatory processes in the central nervous system. It facilitates nerve conduction and improves metabolism.
Benlek is used for severe pain of various origins, fever, when the use of other medicines is contraindicated or ineffective.
Consult your doctor if the pain does not subside or worsens.

2. Important information before taking Benlek

When not to take Benlek:

• - If the patient has a history of significantly reduced white blood cell count caused by metamizole or other similar medicines called pyrazolones or pyrazolidines
• - if the patient has bone marrow disorders or diseases that affect blood cell production or function
• if the patient is allergic to metamizole, other pyrazolone and pyrazolidine derivatives (e.g., propyphenazone, phenazone, or phenylbutazone), thiamine, and caffeine, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has analgetic asthma syndrome or known intolerance to painkillers, manifested by urticaria, angioedema (swelling of the face, lips, and/or tongue), i.e., patients who react with bronchospasm or other anaphylactoid reactions to salicylates, paracetamol, or other non-opioid analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs) such as diclofenac, ibuprofen, indomethacin, or naproxen;
• if the patient has changes in blood morphology,
• if the patient is taking a medicine from the group of pyrazolone and pyrazolidine derivatives (e.g., phenylbutazone, propyphenazone);
• if the patient has acute renal or liver failure, acute porphyria;
• if the patient has a congenital deficiency of glucose-6-phosphate dehydrogenase.

Benlek should not be taken during pregnancy and breastfeeding.
Use in children and adolescents is contraindicated.

Warnings and precautions

Before starting treatment with Benlek, discuss it with your doctor:

Agranulocytosis (severely low number of white blood cells)

Benlek may cause agranulocytosis, a severely low number of a certain type of white blood cell called granulocytes, which play an important role in fighting infections (see section 4). Stop taking metamizole and contact your doctor immediately if you experience any of the following symptoms, as they may indicate possible agranulocytosis: chills, fever, sore throat, and painful mouth ulcers, especially in the mouth, nose, and throat, or in the genital or anal area. Your doctor will order a laboratory test to check your blood cell count.

Due to the risk of life-threatening reactions, Benlek should be stopped immediately and medical help sought in case of symptoms of an allergic reaction (anaphylaxis), such as:

• swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing or breathing;
• severe bronchospasm;
• skin and mucous membrane changes, such as itching, burning, redness, urticaria;
• anaphylactic shock (life-threatening drop in blood pressure, weakness, fainting). Patients with a history of allergic reactions or other immunological reactions to metamizole are also at risk of a similar reaction to other pyrazolones and pyrazolidines and other non-opioid analgesics.

Patients with allergies may experience anaphylactic shock. Therefore, during treatment with the medicine, special caution is recommended for patients with asthma or atopy (e.g., atopic dermatitis or mucosal allergies, hay fever, allergic asthma).
Patients with an increased risk of reactions similar to severe allergic reactions should only be given metamizole after careful consideration of the benefit-to-risk ratio. If necessary, it should be administered under close medical supervision, with the possibility of providing emergency care.
The medicine should be stopped immediately and medical help sought if symptoms occur:

• - agranulocytosis, such as elevated body temperature (fever) combined with chills, sore throat, difficulty swallowing, and mouth ulcers in the mouth, nose, throat, genital or anal area. The medicine should not be taken for more than 3 days.

In case of prolonged use of Benlek, the doctor will definitely recommend laboratory tests to assess blood morphology, as metamizole may cause bone marrow damage.
Patients who have experienced agranulocytosis in response to metamizole treatment are particularly at risk of a similar reaction when taking other pyrazolones and pyrazolidines (see "When not to take Benlek" in section 2).

• thrombocytopenia, e.g., petechiae on the skin and mucous membranes, ecchymoses, recurrent bleeding from the gums, nose, gastrointestinal tract;
• pancytopenia (significant reduction in the number of all blood cells: red and white blood cells and platelets), e.g., general malaise, fever, signs of infection, bleeding, anemia.

Severe skin reactions
Metamizole treatment has been associated with severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). If the patient experiences any of these severe skin reactions, stop taking metamizole and seek medical attention immediately.
If the patient has ever experienced severe skin reactions, they should never be re-treated with Benlek (see section 4).
Liver disorders
Patients taking metamizole have experienced liver inflammation, with symptoms appearing within days to months after starting treatment.
Stop taking Benlek and contact your doctor if you experience liver disorders, such as malaise (nausea or vomiting), fever, fatigue, loss of appetite, dark urine, pale stools, yellowing of the skin or whites of the eyes, itching, rash, or pain in the upper abdomen. Your doctor will check your liver function.

Do not take Benlek if you have previously taken medicines containing metamizole and experienced liver disorders.
Due to the presence of caffeine in the combination medicine Benlek, a 12-hour interval should be maintained before administering adenosine or dipyridamole, as caffeine may affect the test result. Benlek should not be taken with other non-steroidal anti-inflammatory drugs or with metamizole.

Children and adolescents

Benlek is contraindicated in children and adolescents.

Benlek and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Concomitant use of Benlek is contraindicated:

• with medicines from the group of pyrazolone and pyrazolidine derivatives (phenylbutazone, propyphenazone).

Inform your doctor about the use of:

• anticoagulant medicines (e.g., warfarin);
• oral antidiabetic medicines;
• phenytoin (an antiepileptic medicine);
• sulfonamides (antibacterial medicines);
• cyclosporine, tacrolimus (immunosuppressants used, e.g., to prevent transplant rejection);
• barbiturates (e.g., phenobarbital - used, e.g., in epilepsy);
• monoamine oxidase inhibitors (e.g., selegiline, moclobemide - used, e.g., in depression);
• chlorpromazine (used, e.g., in schizophrenia);
• lithium, sertraline (antidepressants);
• bupropion (used in depression or as an aid to smoking cessation);
• blood pressure-lowering medicines (e.g., captopril);
• diuretics (e.g., triamterene);
• methotrexate (used in cancer treatment);
• efavirenz (used in HIV/AIDS treatment);
• methadone (used in opioid dependence treatment);
• valproate (used in epilepsy or bipolar disorder treatment).

Metamizole may reduce the effect of acetylsalicylic acid on platelets.
Caution is advised when concomitantly administering acetylsalicylic acid used to prevent heart disease.

Taking Benlek with food, drinks, and alcohol

Alcohol may affect the efficacy of the medicine (see section 3).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Benlek is contraindicated during pregnancy and breastfeeding.

Driving and using machines

Within the recommended dose range, no impairment of attention and reaction time has been observed. However, when taking higher doses, caution is advised, and you should refrain from operating machinery, driving, or performing activities that involve risk.
Warnings about excipients
Wheat starch
One tablet contains no more than 15 mg of wheat starch.
This medicinal product contains very small amounts of gluten (from wheat starch) and is considered "gluten-free".
It is very unlikely to cause any problems in patients with celiac disease.
Patient with wheat allergy (other than celiac disease) should not take this medicine.

3. How to take Benlek

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Recommended dose

Adults
Dosage is dependent on the severity of pain or fever and individual patient sensitivity to the medicine. Always use the smallest effective dose.
The medicine should always be taken as directed by your doctor. Usually, 1 to 2 tablets are taken, no more than three times a day, administered no more frequently than every 6-8 hours.
The maximum single oral dose of metamizole is 1000 mg (i.e., 2 tablets), and the maximum daily dose of metamizole is 3000 mg (i.e., 6 tablets). If you feel that the effect of the medicine is too strong or too weak, contact your doctor or pharmacist.
Tablets should be taken orally with a sufficient amount of liquid (e.g., a glass of water).
The medicine should be taken during or immediately after meals.
Do not take the medicine for more than 3 days.
Elderly patients, patients in poor general condition, and patients with reduced creatinine clearance
(indicating impaired kidney function)
For elderly patients, patients in poor general condition, and patients with reduced creatinine clearance, the dose should be reduced due to slowed metabolism of the medicine.
Patient with liver and kidney disorders
Patient with liver disorders should avoid high doses administered repeatedly, as the elimination of the medicine and its metabolites is slowed in these conditions. Short-term use of the medicine does not require dose reduction. There are no data on long-term use of metamizole in patients with severe liver and kidney disorders.
Children and adolescents
Benlek is not intended for use in children and adolescents.

Overdose of Benlek:

In case of overdose, contact your doctor or pharmacist immediately.
Overdose may cause dizziness, tinnitus, hearing disturbances, psychomotor agitation, impaired consciousness, coma, oliguria or anuria, tonic-clonic seizures, or decreased blood pressure, arrhythmias (tachycardia).
Metamizole overdose may also cause abdominal pain, vomiting, gastric mucosa erosion, bleeding, perforation, liver cell damage, and interstitial nephritis, as well as allergic bronchospasm. Cases of rash, urticaria, angioedema, and toxic epidermal necrolysis have been reported.
There have also been reports of blood morphology disorders, such as leukopenia or agranulocytosis, thrombocytopenia, or aplastic anemia, sometimes fatal. There is no antidote for metamizole.
In case of overdose, contact your doctor immediately.

Missed dose of Benlek

Do not double the dose to make up for a missed dose.
Take the next dose at the right time, without increasing the dose.

4. Possible side effects

Like all medicines, Benlek can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined using the following classification: very common (affects 1 to 10 users in 100); common (affects 1 to 10 users in 1,000); uncommon (affects 1 to 10 users in 10,000); frequency not known (cannot be estimated from the available data).

Due to the risk of life-threatening reactions, stop taking the medicine and seek medical help immediately if you experience any of the following severe allergic reactions (anaphylaxis):

• rarely occurring swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing or breathing;
• very rarely occurring severe bronchospasm;
• frequency not known: skin and mucous membrane changes, such as itching, burning, redness, urticaria; anaphylactic shock (life-threatening drop in blood pressure, weakness, fainting).

Stop taking the medicine and seek medical help immediately if you experience any of the following very rare but serious side effects:

• Stevens-Johnson syndrome (blisters that progress to ulcers, on the mucous membranes of the mouth, eyes, genitals, or anus);
• toxic epidermal necrolysis (a condition where the skin peels off in large areas);
• pancytopenia (a significant reduction in the number of all blood cells: red and white blood cells and platelets), which may cause general malaise, fever, signs of infection, bleeding, anemia;
• agranulocytosis (a complete or almost complete loss of granulocytes in the blood), which may cause fever, chills, sore throat, difficulty swallowing, and inflammation of the mucous membranes of the mouth, nose, throat, genitals, or anus, elevated OB, including cases resulting in death;

Frequency not known

Severe skin reactions

Stop taking metamizole and seek medical attention immediately if you experience any of the following severe side effects:

• red, flat patches on the torso, in a target-like shape or round, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, or eyes. The occurrence of such serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• widespread rash, high fever, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Stop taking Benlek and seek medical help immediately if you experience any of the following symptoms:

• malaise (nausea or vomiting), fever, fatigue, loss of appetite, dark urine, pale stools, yellowing of the skin or whites of the eyes, itching, rash, or pain in the upper abdomen. These may be symptoms of liver damage. See also section 2 "Warnings and precautions".

Other side effects:

Consult your doctor if you experience any of the following side effects:
Uncommon (less than 1 in 100 users) include:

• drug rash (transient rash of various types: papular, macular, pustular, erythematous);
• excessive decrease in blood pressure.

Rare (less than 1 in 1,000 users) include:

• maculopapular skin changes;
• leukopenia (reduced white blood cell count).

Very rare (less than 1 in 10,000 users) include:

• analgetic asthma (see "When not to take Benlek" in section 2), asthma attacks;
• thrombocytopenia (petechiae, bleeding);
• sudden worsening of kidney function with proteinuria, oliguria, or anuria;
• acute kidney failure;
• interstitial nephritis.

Frequency not known (frequency cannot be estimated from the available data):

• nausea, vomiting, abdominal pain, gastric irritation, diarrhea, dry mouth;
• liver damage;
• hepatitis, jaundice, elevated liver enzyme activity in the blood;
• headache, dizziness;
• hemolytic anemia, aplastic anemia, bone marrow damage, sometimes fatal. In patients with glucose-6-phosphate dehydrogenase deficiency, the medicine causes hemolysis of red blood cells;
• red discoloration of urine (after taking very high doses of metamizole).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 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, you can help provide more information on the safety of this medicine.

5. How to store Benlek

Keep out of the sight and reach of children.
Store in a temperature below 25°C. Store in the original package to protect from light.
Do not use Benlek after the expiry date stated on the carton and blister after: Expiry date (EXP) and EXP. The expiry date refers to the last day of the month stated.
No special precautions for storage of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Benlek contains

One tablet contains the active substances:

• 500 mg of metamizole sodium monohydrate
• 38.75 mg of thiamine hydrochloride
• 50 mg of caffeine

The other ingredients are: microcrystalline cellulose, wheat starch, povidone K 25, gelatin, colloidal silica, anhydrous, magnesium stearate, talc.

What Benlek looks like and contents of the pack

White or almost white, round, and flat tablets with a notch on one side.
Tablets can be divided into two equal halves.
The pack contains blisters of PVC/Aluminum foil with a leaflet in a cardboard box, 20 tablets (2 blisters of 10 tablets).

Marketing authorization holder and manufacturer

Marketing authorization holder

Solinea Sp. z o.o. Sp. k.
Elizówka 65
21-003 Ciecierzyn
Tel: +48 81 463 48 82

Manufacturer

Adipharm EAD
130, Simeonovsko shosse Blvd.
Sofia 1700
Bulgaria

Date of last revision of the leaflet: