Vemonis Intense

Leaflet accompanying the packaging: patient information

Vemonis Intense, 400 mg + 60 mg + 40 mg, coated tablets

Metamizole sodium + Caffeine + Drotaverine hydrochloride

Medicine Vemonis Intense may cause an abnormally 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 ulcers in the nose, mouth, and throat, or 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 contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet so that you can read it again if necessary.
• If you need advice or additional information, you should consult your doctor or pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse, you should contact your doctor.

Table of contents of the leaflet

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

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

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

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

Vemonis Intense contains three active substances. Metamizole sodium has analgesic effects, and drotaverine hydrochloride has a spasmolytic effect on smooth muscles. Caffeine is an additive to many analgesic medicines.

2. Important information before taking Vemonis Intense

When not to take Vemonis Intense:

• if the patient has a history of significant reduction in the number of white blood cells called granulocytes caused by metamizole or other similar medicines called pyrazolones or pyrazolidines);
• if the patient has disorders of bone marrow function 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 taking certain painkillers, such as salicylates, paracetamol, diclofenac, ibuprofen, indomethacin, or naproxen, manifested by, for example, bronchospasm, urticaria, rhinitis, angioedema;
• if the patient has severe renal or hepatic impairment;
• if the patient has severe heart failure;
• if the patient has atrioventricular block of II and III degree;
• 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 been diagnosed with hypersensitivity to soy or peanuts (the medicine contains soy lecithin).

Warnings and precautions

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

• if you have asthma or intolerance associated with taking certain painkillers (see "When not to take Vemonis Intense" in section 2) manifested by urticaria, angioedema, especially if accompanied by nasal polyposis and sinusitis;
• if you have bronchial asthma, especially with concomitant sinusitis and nasal polyps;
• if you have an allergy, atopy may lead to anaphylactic shock. Therefore, when using metamizole, special caution is recommended in patients with asthma or atopy (see also "When not to take Vemonis Intense" in section 2);
• 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 by sneezing, tearing, and severe flushing of the face in response to even small amounts of alcohol; this may indicate previously undiagnosed asthma associated with taking certain painkillers (see "When not to take Vemonis Intense" in section 2);
• 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. In case of doubt whether the above circumstances apply to you, you should consult your doctor before starting to take Vemonis Intense.

Agranulocytosis
Vemonis Intense may cause agranulocytosis, a very low number of a certain type of white blood cells 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 ulcers of the mucous membranes, 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.
If metamizole is taken for fever, some symptoms of developing agranulocytosis may remain unnoticed. Similarly, symptoms may also be masked if you are taking antibiotics.
Agranulocytosis can develop at any time during treatment with Vemonis Intense, even after a short period of stopping metamizole.
Agranulocytosis can occur even if metamizole was previously taken without complications.
Abnormal blood cell count
Metamizole may cause thrombocytopenia, characterized by increased bleeding tendency, hemorrhagic spots on the skin and mucous membranes. If symptoms of thrombocytopenia occur, you should immediately stop taking the medicine and contact your 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 a doctor if they experience symptoms such as malaise, infection, persistent fever, bruising, bleeding, or pallor. If a blood test shows deviations in blood cell or platelet count, treatment should be stopped immediately and blood cell and platelet count should be monitored until they return to normal.
Liver disorders
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 Intense and contact your doctor if you experience liver disorders, 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 Intense if you have previously taken any medicinal products containing metamizole and had liver disorders.
Severe skin reactions
There is a risk of severe skin reactions characterized by blisters on the skin and mucous membranes - bullous pemphigoid, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS). If you experience any of these severe skin reactions, you should immediately stop taking Vemonis Intense and consult a doctor. Patients should immediately consult a doctor. Vemonis Intense should not be used by patients with hypersensitivity to the ingredients of this medicine (detailed description of contraindications is given above in "When not to take Vemonis Intense").
Anaphylactic reaction
An anaphylactic reaction, characterized by sudden onset of, for example, facial and throat edema, generalized urticaria, bronchospasm, and may be life-threatening. Therefore, Vemonis Intense 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 is given above in "When not to take Vemonis Intense"). 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 Intense 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, and in patients who have experienced fluid loss or dehydration (see above). In such patients, Vemonis Intense 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.
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 Intense should not be used in patients under 18 years of age (see "When not to take Vemonis Intense" in section 2).

Vemonis Intense with 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 taking Vemonis Intense with other medicines, the following interactions should be considered:

• Cyclosporine(used in patients after transplants) - cyclosporine levels in serum should be monitored, as they may decrease due to 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, concomitant use of methotrexate and Vemonis Intense should be avoided.
• Acetylsalicylic acid- metamizole may reduce the anti-aggregatory effect of low-dose acetylsalicylic acid. Patients taking low-dose acetylsalicylic acid for heart disease prevention should use Vemonis Intense with caution.
• Bupropion(an antidepressant and a medicine that helps quit smoking) - metamizole may reduce bupropion levels in the blood. Therefore, caution should be exercised when concomitantly using Vemonis Intense and bupropion;
• 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 transplantation)
• 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), 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 block caffeine metabolism, so concomitant use of Vemonis Intense 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 concomitantly using Vemonis Intense and levodopa, tremors and stiffness may worsen in patients with Parkinson's disease.

Vemonis Intense with 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 plan to have a baby, you should consult your doctor or pharmacist before taking this medicine.
Do not take Vemonis Intense during pregnancy and breastfeeding.

Driving and operating machinery

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

The medicine contains lactose monohydrate, sodium, and soy lecithin

Vemonis Intense contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

Vemonis Intense 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.

Vemonis Intense contains soy lecithin

Do not take this medicine if you have been diagnosed with hypersensitivity to peanuts or soy.

3. How to take Vemonis Intense

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. In case of doubt, you should consult your doctor or pharmacist.
The dose depends on the severity of the pain and the individual's response to Vemonis Intense.
Always the smallest dose necessary to control the pain should be chosen.
Adults
The recommended dose for adults is 1 or 2 tablets (400 or 800 mg of metamizole sodium, 60 or 120 mg of caffeine, and 40 or 80 mg of drotaverine hydrochloride) 2 or 3 times a day, not more often than every 6-8 hours. The maximum daily dose is 6 tablets (2,400 mg of metamizole sodium, 360 mg of caffeine, and 240 mg of drotaverine hydrochloride).
If symptoms do not improve or worsen after 3-5 days of taking Vemonis Intense, you should immediately consult a doctor.
Children and adolescents
Vemonis Intense should not be used in patients under 18 years of age (see "When not to take Vemonis Intense" in section 2).
Elderly patients and patients in poor general health or with renal impairment (see also "When not to take Vemonis Intense" and "Warnings and precautions" in section 2)
In elderly patients, weakened 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 Intense" 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 case of short-term use, reduction of the metamizole dose is not required. There is a lack of experience with long-term use of metamizole.
Method of administration
Orally. Tablets should be taken with a sufficient amount of liquid (e.g., a glass of water).

Overdose of Vemonis Intense

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 often symptoms from the central nervous system (dizziness, drowsiness, coma, convulsions), as well as low blood pressure. Patients may also experience discomfort in the chest, nervousness, irritability, tremors, muscle cramps, headache, insomnia, anxiety, euphoria, confusion, or agitation. Cardiac arrhythmias, heart rate disturbances, and heart problems may also occur, which can lead to fainting and cardiac arrest. Caffeine overdose may cause abdominal pain, vomiting, diuresis, tachycardia, or arrhythmias, nervous system stimulation (insomnia, anxiety, agitation, psychomotor hyperactivity, nervousness, tremors, and convulsions).
There are no known cases of drotaverine overdose.
If you have taken too much of Vemonis Intense, you should tell your doctor or pharmacist or contact the nearest hospital emergency department for further advice.

Missed dose of Vemonis Intense

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 a missed dose.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Vemonis Intense 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 if the following severe allergic reactions (anaphylactic reactions) occur:

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 drop in blood pressure, weakness, fainting) (see "Warnings and precautions" in section 2).

You should stop taking Vemonis Intense and immediately consult a doctor if you experience any of the following severe side effects:

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

• agranulocytosis (complete or almost complete disappearance of granulocytes from the blood), which can be fatal, manifested by:
• fever, chills;
• sore throat, difficulty swallowing, and inflammation of the mucous membranes of the mouth, nose, throat, genital, and anal areas;
• increased ESR;
• not always normal hemoglobin, erythrocyte, and platelet values, 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 by general malaise, fever, signs of infection, 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;
• decrease in platelet count (thrombocytopenia, usually manifested as increased bleeding tendency, hemorrhagic spots on the skin and mucous membranes).

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

• bullous pemphigoid - Stevens-Johnson syndrome (blisters turning into ulcers on the mucous membranes of the mouth, eyes, genitals, and anus);
• severe skin reactions, including toxic epidermal necrolysis - Lyell's syndrome (bullous rash on the skin and mucous membranes 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 blisters (pemphigus);
• 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 decrease in 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 Intense" in section 2), asthma attacks.

You should stop taking Vemonis Intense and immediately consult a doctor 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);
• 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, dry mouth;
• hepatitis, jaundice, increased liver enzyme activity 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);
• irritability, insomnia (associated with caffeine), nervousness, anxiety;
• psychomotor hyperactivity;
• increased cardiac contractility, irregular heart rhythm (arrhythmia), rapid heart rate (tachycardia);
• flushing of the face, neck, and décolletage;
• rashes/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 Intense and immediately consult a doctor 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, genitals, and eyes. These may be symptoms of severe skin reactions, including 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 any possible side effects not listed in this 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: 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 Intense

Do not store above 30°C. Store in the original packaging to protect from light and 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 packaging and other information

What Vemonis Intense contains

• The active substances of the medicine are: metamizole sodium in the form of metamizole sodium monohydrate, caffeine, and drotaverine hydrochloride. One coated tablet contains 400 mg of metamizole sodium, 60 mg of caffeine, and 40 mg of drotaverine hydrochloride.
• The other ingredients (excipients) are: microcrystalline cellulose, lactose monohydrate, crospovidone, talc, magnesium stearate, and the coating contains: polyvinyl alcohol, titanium dioxide (E 171), talc, soy lecithin, xanthan gum.

What Vemonis Intense looks like and contents of the pack

Coated tablets, white or almost white, oval, with the inscription "40" on one side.
Blisters of OPA/Aluminum/PVC/Aluminum foil containing 4, 6, 8, or 12 coated tablets, in a cardboard box.

Marketing authorization holder

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

Manufacturer

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

Date of last revision of the leaflet: