Vemonis Ultra

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Vemonis Ultra, 400 mg + 60 mg + 80 mg, coated tablets

Metamizole sodium + Caffeine + Drotaverine hydrochloride

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

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

If the patient has ever had agranulocytosis while taking metamizole or similar medicines, they should never take this medicine again (see section 2).

You should carefully read the leaflet 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 directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult your pharmacist.
• If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.
• If you do not feel better or if you feel worse, you should contact your doctor.

Table of contents of the leaflet

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

1. What is Vemonis Ultra and what is it used for

Vemonis Ultra is intended for use in adults for the symptomatic treatment of:

• pain associated with smooth muscle spasms of mild to moderate to severe intensity:
• urinary and reproductive system (kidney colic, painful menstruation),
• gastrointestinal tract (intestinal colic, irritable bowel syndrome),
• bile ducts (cholecystitis, cholangitis).
• pain of various origins of moderate intensity, when the use of other medicines is contraindicated or ineffective.

Vemonis Ultra is a combination medicine with analgesic action. Metamizole sodium has analgesic action, caffeine has a stimulating effect on the nervous system and a vasodilating effect, and drotaverine hydrochloride has a spasmolytic effect on smooth muscles. If you do not feel better or if you feel worse, you should contact your doctor.

2. Important information before taking Vemonis Ultra

When not to take Vemonis Ultra:

• if the patient has a history of a significant decrease in the number of white blood cells called granulocytes, caused by metamizole or other similar medicines called pyrazolones or pyrazolidines;
• if the patient has a bone marrow disorder or a disease that affects the production or function of blood cells;
• if the patient is allergic to metamizole, caffeine, drotaverine, pyrazolone derivatives (e.g., phenazone, propyphenazone) or pyrazolidine (e.g., phenylbutazone, oxyphenbutazone) or any of the other ingredients of this medicine (listed in section 6);
• if the patient has asthma or intolerance associated with the use of certain painkillers, such as salicylates, paracetamol, diclofenac, ibuprofen, indomethacin, or naproxen, manifested as bronchospasm, urticaria, rhinitis, or angioedema;
• if the patient has severe renal or hepatic impairment;
• if the patient has severe heart failure;
• if the patient has a second- or third-degree atrioventricular block;
• if the patient has certain metabolic disorders (porphyria, glucose-6-phosphate dehydrogenase deficiency);
• if the patient has anemia;
• if the patient is under 18 years of age;
• if the patient is pregnant or breastfeeding;
• if the patient has a known hypersensitivity to soy or peanuts (the medicine contains soy lecithin).

Warnings and precautions

Before starting to take Vemonis Ultra, you should discuss it with your doctor or pharmacist:

• if you have asthma or intolerance associated with the use of certain painkillers (see "When not to take Vemonis Ultra") manifested as urticaria, angioedema, especially if it is accompanied by nasal polyposis and sinusitis;
• if you have bronchial asthma, especially if it is accompanied by sinusitis and nasal polyps;
• if you have an allergy, atopy may lead to anaphylactic shock. Therefore, during the use of metamizole, special caution is recommended in patients with asthma or atopy (see also "When not to take Vemonis Ultra");
• if you have chronic urticaria;
• if you have intolerance to certain dyes (e.g., tartrazine) or preservatives (e.g., benzoates);
• if you have alcohol intolerance, manifested as sneezing, tearing, and severe flushing of the face in response to even small amounts of alcohol; this may indicate previously undiagnosed asthma associated with the use of certain painkillers (see "When not to take Vemonis Ultra");
• if you have low blood pressure, circulation problems, or have experienced fluid loss or dehydration;
• if you have high blood pressure;
• if you have a high fever;
• if you have kidney or liver problems;
• if you are over 65 years of age, in poor general health, or with renal impairment;
• if you have hypersensitivity to other substances;
• if you have a hereditary intolerance to galactose, lactase deficiency, or glucose-galactose malabsorption syndrome.

In case of doubt whether the above circumstances apply to you, you should consult your doctor before starting to take Vemonis Ultra.
Agranulocytosis (severely low number of white blood cells)
Vemonis Ultra may cause agranulocytosis, a severely low number of a type of white blood cell called granulocytes, which play an important role in fighting infections (see section 4). You should stop taking metamizole and immediately contact your doctor if you experience any of the following symptoms, as they may indicate possible agranulocytosis: chills, fever, sore throat, and painful mouth sores, especially in the mouth, nose, and throat or in the genital or anal area.
Your doctor will order a blood test to check your blood cell count. If metamizole is taken for fever, some symptoms of developing agranulocytosis may remain unnoticed. Similarly, symptoms may also be masked if the patient is taking antibiotics.
Agranulocytosis can develop at any time during the use of Vemonis Ultra, and even for a short time after stopping the use of metamizole.
Agranulocytosis can occur even if metamizole was previously taken without complications.
Abnormal blood cell count
Metamizole may cause thrombocytopenia, manifested as increased bleeding tendency, and the occurrence of bloody spots on the skin and mucous membranes. If symptoms of thrombocytopenia occur, the patient should immediately stop taking the medicine and contact their doctor.
During treatment, a serious decrease in the number of red and white blood cells, as well as platelets, called pancytopenia, may also occur. Patients should immediately consult their doctor if they experience symptoms such as malaise, infection, persistent fever, bruising, bleeding, or pallor. If a blood test shows abnormalities in blood cell or platelet count, treatment should be stopped immediately and the blood cell and platelet count should be monitored until they return to normal.
Liver problems
In patients taking metamizole, cases of hepatitis have occurred, with symptoms appearing within a few days to several months after starting treatment.
You should stop taking Vemonis Ultra and contact your doctor if you experience liver problems, such as malaise (nausea or vomiting), fever, fatigue, loss of appetite, dark urine, light-colored 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.
You should not take Vemonis Ultra if you have previously taken medicinal products containing metamizole and had liver problems.
Severe skin reactions
There is a risk of severe skin reactions characterized by the occurrence of blisters on the skin and mucous membranes - bullous erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS). If you experience any of these symptoms related to severe skin reactions mentioned in section 4, you should immediately stop taking Vemonis Ultra and consult your doctor. Patients should also immediately consult their doctor. Vemonis Ultra should not be used by patients with hypersensitivity to the ingredients of this medicine (detailed description of contraindications can be found above in "When not to take Vemonis Ultra").
Anaphylactic reaction
An anaphylactic reaction, characterized by symptoms such as facial and throat swelling, generalized urticaria, bronchospasm, and may be life-threatening. Therefore, Vemonis Ultra should not be used by patients with hypersensitivity to the ingredients of this medicine or by patients with a history of allergic reactions to other painkillers (detailed description of contraindications can be found above in "When not to take Vemonis Ultra"). Patients who have had an anaphylactic reaction or other immunological reaction to metamizole are also at risk of a similar reaction to other pyrazolones and pyrazolidines.
Low blood pressure
Vemonis Ultra may cause low blood pressure (hypotension), which is likely to be dose-dependent. The risk of severe hypotension increases in patients with previously low blood pressure, circulation problems, or those who have experienced fluid loss or dehydration (see above). In such patients, Vemonis Ultra should be used with caution and only after consulting a doctor.
Elderly patients
See section 3.
Patients with kidney or liver problems
See section 3.
Patients with other allergies
Patients with allergies (manifested as skin changes or itching) to other substances (e.g., supplements, preservatives) should use Vemonis Ultra with caution.
Due to the caffeine contained in the medicine, you should avoid excessive consumption of caffeine (e.g., coffee, tea, and some other beverages) while taking this medicine.
The medicine should not be taken just before bedtime.

Children and adolescents

Vemonis Ultra should not be used in patients under 18 years of age (see "When not to take Vemonis Ultra" in section 2).

Vemonis Ultra and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
When using Vemonis Ultra with other medicines, the following interactions should be considered:

• Cyclosporine(used in the treatment of patients after transplants) - cyclosporine levels in the blood should be monitored, as they may decrease due to the interaction with metamizole;
• Methotrexate(a medicine used to treat certain types of cancer) - metamizole may increase the toxicity of methotrexate to the bone marrow (where new blood cells are produced), especially in elderly patients. Therefore, the concomitant use of methotrexate and Vemonis Ultra should be avoided;
• Acetylsalicylic acid- metamizole may reduce the anti-aggregatory effect of low-dose acetylsalicylic acid. Patients taking low-dose acetylsalicylic acid for the prevention of heart disease should use Vemonis Ultra with caution;
• Bupropion(an antidepressant and a medicine used to help quit smoking) - metamizole may reduce the levels of bupropion in the blood. Therefore, caution should be exercised when using Vemonis Ultra and bupropion concomitantly;
• Efavirenz(a medicine used to treat HIV infection (AIDS)) - metamizole may reduce the levels of this medicine in the blood and limit its clinical effectiveness;
• Methadone(a medicine used to treat opioid addiction) - metamizole may reduce the levels of this medicine in the blood and limit its clinical effectiveness;
• Valproate(a medicine used to treat epilepsy or bipolar disorder) - metamizole may reduce the levels of this medicine in the blood and limit its clinical effectiveness;
• Tacrolimus(a medicine used to prevent organ rejection in patients after transplants) - metamizole may reduce the levels of this medicine in the blood and limit its clinical effectiveness;
• Sertraline(a medicine used to treat depression) - metamizole may reduce the levels of this medicine in the blood and limit its clinical effectiveness;
• Medicines metabolized by the liver(e.g., clarithromycin, ethinyl estradiol, sertraline) - caffeine may increase their levels in the blood;
• Salicylates- caffeine may increase their absorption;
• Cimetidine(a medicine that reduces stomach acid production), oral contraceptives, ciprofloxacin and enoxacin(used to treat infections), mexiletine(used to treat heart rhythm disorders) - these medicines may increase caffeine levels in the blood;
• Muscle relaxants- some muscle relaxants may block caffeine metabolism, so concomitant use of Vemonis Ultra with these medicines is not recommended;
• Nicotine- increases caffeine excretion;
• Disulfiram(used to treat alcoholism), ethinyl estradiol(used to treat menstrual disorders and as a contraceptive) - may increase the effect of caffeine;
• Levodopa(used to treat Parkinson's disease) - the effect of levodopa may be reduced, so when using Vemonis Ultra and levodopa concomitantly, tremors and stiffness may worsen in patients with Parkinson's disease.

Vemonis Ultra and alcohol

Concomitant consumption of alcohol may affect concentration and reaction time (see "Driving and operating machinery").

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine.
Do not take Vemonis Ultra during pregnancy and breastfeeding.

Driving and operating machinery

Within the recommended dose range, no effect of Vemonis Ultra on concentration and reaction time has been observed. However, at higher doses of metamizole or after alcohol consumption, concentration and reaction time may be impaired, or drotaverine may cause dizziness, and caffeine may cause psychomotor agitation and nervousness or fatigue, which can pose a risk in situations where they are particularly important (e.g., when driving vehicles and operating machinery).

The medicine contains lactose monohydrate, soy lecithin, and sodium

Vemonis Ultra contains lactose monohydrate

If you have been diagnosed with an intolerance to some sugars, you should consult your doctor or pharmacist before taking this medicine.

Vemonis Ultra contains soy lecithin

Do not take this medicine if you are allergic to peanuts or soy.

Vemonis Ultra contains sodium

Each coated tablet contains 27.6 mg of sodium (the main component of common salt) per tablet, which corresponds to 1.4% of the WHO-recommended maximum daily intake of 2 g of sodium for adults.

3. How to take Vemonis Ultra

This medicine should always be taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist. In case of doubt, you should consult your doctor or pharmacist.
Adults
The recommended dose for adults is 1 tablet 2 or 3 times a day. The maximum daily dose is 3 tablets.
Children and adolescents
Vemonis Ultra should not be used in patients under 18 years of age (see "When not to take Vemonis Ultra" in section 2).
Elderly patients and patients in poor general health or with renal impairment (see also "When not to take Vemonis Ultra" and "Warnings and precautions" in section 2)
In elderly patients, debilitated patients, and patients with impaired renal function, the dose of metamizole should be reduced due to the possibility of prolonged elimination of metamizole metabolites.
In elderly patients with poor general health and reduced creatinine clearance, a lower dose of drotaverine is recommended due to the slow metabolism of this active substance.
Patients with kidney or liver impairment (see also "When not to take Vemonis Ultra" and "Warnings and precautions" in section 2).
Due to the reduced elimination rate of metamizole in patients with kidney or liver impairment, multiple administration of high doses of metamizole should be avoided. In the case of short-term use, dose reduction of metamizole is not required. There is a lack of experience with long-term use of metamizole.
Method of administration
Oral administration.

Overdose of Vemonis Ultra

After taking very high doses, the elimination of a harmless metabolite from the body may cause red discoloration of the urine.
Acute overdose may cause nausea, vomiting, abdominal pain, worsening of kidney function, or acute kidney failure, and less frequently, symptoms from the central nervous system (dizziness, drowsiness, coma, seizures), as well as low blood pressure. Patients may also experience discomfort in the chest, nervousness, irritability, tremors, muscle cramps, headache, insomnia, anxiety, euphoria, confusion, disorientation, or agitation. Additionally, palpitations, arrhythmias, and heart problems may occur, which can lead to fainting and cardiac arrest. Overdose of caffeine may cause symptoms such as abdominal pain, vomiting, diuresis, tachycardia, or arrhythmias, nervous system stimulation (insomnia, restlessness, agitation, psychomotor agitation, nervousness, tremors, and seizures).
There are no known cases of drotaverine overdose.
In case of overdose, you should tell your doctor or pharmacist or contact the nearest hospital emergency department for further advice.

Missed dose of Vemonis Ultra

If you miss a dose, you should take it as soon as you remember, unless it is time for the next dose. You should not take a double dose to make up for the missed dose.
In case of any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Vemonis Ultra can cause side effects, although not everybody gets them.
Due to the risk to life, the medicine should be stopped immediately and medical help should be sought in case of severe allergic reactions (anaphylactic reactions).
Rare side effects (less than 1 in 1,000 patients):

• swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing or breathing;
• skin and mucous membrane changes, such as itching, burning, redness, rash, urticaria.

Very rare side effects (less than 1 in 10,000 patients):

• severe bronchospasm.

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• anaphylactic shock (life-threatening low blood pressure, weakness, fainting) (see "Warnings and precautions" in section 2).

You should stop taking Vemonis Ultra and immediately seek medical help if you experience any of the following severe side effects:

• agranulocytosis (complete or almost complete disappearance of granulocytes from the blood), which can be fatal, manifested as high fever, chills, sore throat, difficulty swallowing, and inflammatory conditions of the mucous membranes of the mouth, nose, throat, genital and anal areas, elevated OB, not always normal hemoglobin, erythrocytes, and platelets, although they are usually normal, slightly enlarged lymph nodes and spleen, although they are usually unchanged;
• pancytopenia (significant decrease in the number of all blood cells: red and white blood cells and platelets), manifested as general malaise, infection, persistent fever, bruising, bleeding, pallor (see "Warnings and precautions" in section 2);
• hemolytic anemia, aplastic anemia, bone marrow damage, sometimes fatal. In patients with glucose-6-phosphate dehydrogenase deficiency, the medicine may cause hemolysis of red blood cells;
• thrombocytopenia (usually manifested as increased bleeding tendency, and the occurrence of bloody spots on the skin and mucous membranes).

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• bullous erythema multiforme - Stevens-Johnson syndrome (blisters that turn into ulcers on the mucous membranes of the mouth, eyes, genitals, and anus);
• severe skin reactions, including toxic epidermal necrolysis - Lyell's syndrome (skin and mucous membrane lesions leading to peeling of large areas of skin and exposure of large areas of skin) (see "Warnings and precautions" in section 2);
• acute generalized exanthematous pustulosis;
• skin blistering;
• acute kidney failure, which may be accompanied by oliguria, anuria, or proteinuria, acute interstitial nephritis, red discoloration of urine;
• Kounis syndrome (acute coronary syndrome);
• liver damage;
• excessive low blood pressure (occurs with unknown frequency for metamizole, rarely for drotaverine; see "Warnings and precautions" in section 2);
• analgesic asthma (see "When not to take Vemonis Ultra" in section 2), asthma attacks.

You should stop taking Vemonis Ultra and immediately seek medical help if you experience any of the following symptoms:

malaise (nausea or vomiting), fever, fatigue, loss of appetite, dark urine, light-colored 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:

Uncommon (less than 1 in 100 patients):

• drug rash (transient rash of various types: papular, macular, pustular, erythematous).

Rare (less than 1 in 1,000 patients):

• maculopapular skin changes;
• leukopenia (decrease in white blood cell count in the blood);
• insomnia (associated with drotaverine);
• tremors;
• palpitations.

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

• gastrointestinal disorders, peptic ulcers, and bleeding, vomiting, heartburn, bloating, nausea, abdominal pain, constipation, diarrhea, dry mouth;
• hepatitis, jaundice, elevated liver enzyme levels in the blood;
• headache, dizziness;
• red discoloration of urine (after taking very high doses of metamizole);
• changes in blood glucose levels (high and low blood glucose levels);
• irritability, insomnia (associated with caffeine), nervousness, anxiety;
• psychomotor agitation;
• increased cardiac contractility, irregular heart rhythm (arrhythmia), rapid heart rate (tachycardia);
• flushing of the face, neck, and décolletage;
• rashes/skin eruptions of various types, exudative changes, excessive sweating;
• muscle cramps;
• fatigue;
• low blood pressure;
• withdrawal syndrome (the most common symptom of caffeine withdrawal is headache), nervousness;
• increased heart rate, increased urine flow, increased creatinine clearance, increased sodium and calcium excretion.

Severe skin reactions
You should stop taking Vemonis Ultra and immediately seek medical help if you experience any of the following severe side effects:

• red, flat spots 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, and eyes. The occurrence of such severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. 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, you can help provide more information on the safety of this medicine.

5. How to store Vemonis Ultra

Do not store above 30°C. Store in the original packaging to protect from moisture.
The medicine should be kept out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Vemonis Ultra contains

• The active substances of the medicine are: metamizole sodium in the form of metamizole sodium monohydrate, caffeine, drotaverine hydrochloride.
• The other ingredients (excipients) are: microcrystalline cellulose (type 112), lactose monohydrate, crospovidone (type A), talc, magnesium stearate, polyvinyl alcohol, titanium dioxide (E 171), yellow iron oxide (E 172), soy lecithin, xanthan gum.

What Vemonis Ultra looks like and contents of the pack

Coated tablets, yellowish, oval, with the inscription "80" engraved on one side.
Blisters of PA/Aluminum/PVC/Aluminum foil containing 4, 6, 8, 12, or 24 coated tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel.: +48 22 732 77 00

Manufacturer

Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice

Date of last revision of the leaflet: