Taromentin

Patient Information Leaflet

Taromentin, 2000 mg + 200 mg, powder for solution for infusion
Amoxicillin + Clavulanic acid
Please read this leaflet carefully before using this medicine, as it contains important
information for you.

• Keep this leaflet so that you can read it again if needed.
• If you have any questions, please consult your doctor or nurse.
• This medicine has been prescribed for a specific individual only. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Table of contents

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

1. What Taromentin is and what it is used for

Taromentin is an antibiotic with bactericidal activity against bacteria causing infections.
Taromentin contains two different active substances: amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called “penicillins”, whose activity may sometimes be inhibited (inactivated). The second active ingredient (clavulanic acid) counteracts this inactivation.
Taromentin is used in adults and children to treat the following infections:

• severe ear, nose and throat infections;
• respiratory tract infections;
• urinary tract infections;
• skin and soft tissue infections, including dental infections;
• bone and joint infections;
• intra-abdominal infections;
• genital infections in women.

Taromentin is also used in adults and children for the prevention of infections associated with major surgical procedures.

2. Important information before using Taromentin

When not to use Taromentin

• If the patient has a known allergy (hypersensitivity) to amoxicillin, clavulanic acid, penicillin, or any of the other ingredients of this medicine (listed in section 6).
• If the patient has ever experienced severe allergic reactions (hypersensitivity) to any other antibiotic. These may include skin rash or swelling of the face or neck.
• If the patient has ever had liver problems or jaundice (yellowing of the skin) associated with taking an antibiotic.

➢ If any of the above conditions apply, the patient must not take Taromentin.
If in doubt, consult the doctor, pharmacist, or nurse before starting treatment with Taromentin.

Warnings and precautions

Before taking Taromentin, the patient should consult a doctor or pharmacist if they:

• Have infectious mononucleosis;
• Are being treated for liver or kidney disease;
• Experience irregular urination.

If in doubt whether any of the above conditions apply, consult a doctor, pharmacist, or nurse before starting treatment with Taromentin.

In some cases, the doctor may investigate which type of bacteria caused the infection. Depending on the results, the patient may receive Taromentin at a different dose or a different medicine.

Side effects to watch for

Treatment with Taromentin may worsen certain conditions or cause serious adverse effects, including allergic reactions, seizures, and colitis (inflammation of the large intestine). It is important to monitor for specific symptoms during treatment with Taromentin to reduce the risk of complications. See "Side effects to watch for" in section 4.

Blood and urine tests

If the patient is scheduled for blood tests (such as red blood cell count or liver function tests) or urine tests (for glucose), inform the doctor or nurse that the patient is taking Taromentin. Taromentin may affect the results of these tests.

Other medicines and Taromentin

Inform the doctor about all medicines currently used, recently taken, or planned for use, including over-the-counter medicines and herbal supplements.

• If the patient is taking allopurinol (used for gout), there may be an increased risk of skin allergic reactions when taken with Taromentin.
• If the patient is taking probenecid (used for gout), the doctor may adjust the dose of Taromentin.
• If the patient is taking anticoagulant medicines (such as warfarin) together with Taromentin, additional blood tests may be required.
• Taromentin may affect the action of methotrexate (a medicine used in cancer or rheumatic diseases).
• Taromentin may affect the action of mycophenolate mofetil (a medicine used to prevent transplant rejection).

Pregnancy and breastfeeding

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

Important information about certain ingredients in Taromentin

Taromentin contains sodium

Taromentin 2000 mg + 200 mg, powder for solution for infusion, contains 151 mg of sodium (the main component of table salt) per dose. This corresponds to 7.55% of the maximum recommended daily sodium intake in adults.

Considering the dosing schedule described in section 3, the maximum amount of sodium administered in a single maximum dose is 151 mg, equivalent to 7.55% of the WHO-recommended maximum daily sodium intake of 2 g for adults. The maximum daily dose (453 mg) corresponds to 22.65% of the WHO-recommended maximum daily sodium intake of 2 g for adults.

The sodium content from the solvent must be considered when calculating the total sodium content in the prepared dilution (see section "Information intended exclusively for healthcare professionals"). For accurate information on the sodium content of the diluent used, refer to the product information of the diluent.

Patients, especially those monitoring sodium intake in their diet, should consult a doctor or pharmacist if receiving the maximum daily dose (2000 mg + 200 mg three times daily) for a prolonged period.

Taromentin contains potassium

Taromentin 2000 mg + 200 mg, powder for solution for infusion, contains 42.02 mg (or 1.07 mmol) of potassium per dose, which should be considered in patients with impaired kidney function or those monitoring potassium intake.

Considering the dosing schedule described in section 3, the maximum amount of potassium administered in a single maximum dose is 42.02 mg (1.07 mmol), and in the maximum daily dose is 126.06 mg (3.21 mmol).

This should be taken into account in patients with impaired kidney function or those monitoring potassium intake.

The potassium content from the solvent must be considered when calculating the total potassium content in the prepared dilution (see section "Information intended exclusively for healthcare professionals"). For accurate information on the potassium content of the diluent used, refer to the product information of the diluent.

3. How to use Taromentin

The patient will never take this medicine on their own.
The medicine will be administered to the patient by qualified medical personnel, i.e. a doctor or nurse.
The recommended dosage is given below:

Adults and children with body weight equal to or greater than 40 kg
The usual dose is (1000 mg + 100 mg), administered every 8 to 12 hours.
A higher dose: (1000 mg + 100 mg), administered every 8 hours, or
(2000 mg + 200 mg), administered every 12 hours.
In very severe infections, the dose may be increased up to a maximum of 2000 mg + 200 mg,
administered every 8 hours.

Prophylaxis of infections associated with surgical procedures
Dose: (1000 mg + 100 mg) to (2000 mg + 200 mg),
administered before surgery during induction of general anesthesia.
The dose may vary depending on the type of procedure. The doctor may repeat the dose if the procedure lasts longer than 1 hour.

Children with body weight less than 40 kg
All doses are determined based on the child's body weight in kilograms.
Children aged 3 months and older: (50 mg + 5 mg) per kg of body weight, administered every 8 hours.
Children under 3 months of age or with body weight less than 4 kg: (50 mg + 5 mg) per kg of body weight, administered every 12 hours.

Patients with kidney or liver disease

• If the patient has kidney disease, the dose of the medicine may be adjusted. The treating physician may choose a different dose of Taromentin or an alternative medicine.
• If the patient has liver disease, blood tests to monitor liver function may be performed more frequently.

How Taromentin is administered

• Taromentin is intended for intravenous administration. The medicine should be given as an intravenous infusion over 30 to 40 minutes. Taromentin is not intended for intramuscular administration.
• During treatment with Taromentin, it is recommended to drink plenty of fluids.
• Usually, Taromentin is not administered for longer than 2 weeks without a follow-up medical evaluation by the physician.

Overdose of Taromentin
Administration of a dose higher than recommended is unlikely. If the patient suspects that a higher than recommended dose has been administered, contact the treating physician, pharmacist, or nurse as quickly as possible. Symptoms such as gastrointestinal irritation (nausea, vomiting, or diarrhea) or seizures may occur.

If in doubt about how the medicine should be administered, consult a doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The adverse reactions listed below may occur with this medicine.
Symptoms to be aware of
Hypersensitivity reactions:

• skin rash;
• vasculitis, which may appear as red or purple, raised spots on the skin, but may also affect other parts of the body;
• fever, joint pain, swelling of glands in the neck, armpits or groin;
• swelling, sometimes affecting the face or areas around the mouth (angioedema), causing difficulty in breathing;
• fainting;
• chest pain related to an allergic reaction, which may be a sign of an allergy leading to heart attack (Kounis syndrome).

➢ If any of these symptoms occur, seek immediate medical advice.
Discontinue use of Taromentin immediately.
Colitis
Inflammation of the large intestine causing watery diarrhoea, usually with blood and mucus, abdominal pain and (or) fever.
Acute pancreatitis
If the patient has severe and persistent pain in the stomach area, this may be a sign of acute pancreatitis.
Drug-induced enterocolitis syndrome (DIES)
Drug-induced enterocolitis has occurred mainly in children receiving amoxicillin with clavulanic acid. It is a type of allergic reaction, the main symptom of which is recurrent vomiting (1 to 4 hours after taking the medicine). Further symptoms may include abdominal pain, lethargy, diarrhoea and low blood pressure.
➢ If any of these symptoms occur, contact your doctor as soon as possible for advice.
Common adverse reactions (may occur in up to 1 in 10 patients)

• thrush (candidiasis – fungal infections of the vagina, mouth or skin folds);
• diarrhoea.

Uncommon adverse reactions (may occur in up to 1 in 100 patients)

• skin rash, itching;
• raised, itchy rash (urticaria);
• nausea, especially when high doses are used; ➢ if this occurs, take Taromentin before meals
• vomiting;
• indigestion;
• dizziness;
• headache.

Uncommon adverse reactions that may appear in blood test results:

• increased activity of certain substances (enzymes) produced in the liver.

Rare adverse reactions (may occur in up to 1 in 1000 patients)

• skin rash, which may present with blisters and resemble target lesions (dark spot in the centre surrounded by a lighter ring and a dark ring around the edge – erythema multiforme); ➢ if the patient notices any of these symptoms, urgent medical advice should be sought
• swelling and redness along a vein, which is very painful to touch.

Rare adverse reactions that may appear in blood test results:

• low number of blood cells involved in blood clotting (thrombocytes);
• low number of white blood cells.

Other adverse reactions
Other adverse reactions occurred in a very small number of people, but their exact frequency is unknown.

• Hypersensitivity reactions (see above).
• Colitis (see above).
• Inflammation of the protective membranes surrounding the brain and spinal cord (aseptic meningitis).
• Severe skin reactions:
  • widespread skin rash, with blisters and skin peeling, particularly around the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome), and a more severe form causing extensive skin peeling (over 30% of body surface – toxic epidermal necrolysis);
  • widespread red rash with small pustules (pustular exanthema);
  • red scaly rash with subcutaneous nodules and blisters (acute generalised exanthematous pustulosis);
  • influenza-like symptoms with rash, fever, swollen lymph nodes and abnormal blood test results [including increased white blood cell count (eosinophilia) and increased liver enzyme activity]; drug reaction with eosinophilia and systemic symptoms (DRESS);
  • blistering rash arranged in a ring-like pattern or like a string of pearls (linear IgA dermatosis).

➢ If any of these symptoms occur, contact a doctor immediately.

• Hepatitis.
• Jaundice, caused by increased levels of bilirubin (a substance produced in the liver) in the blood, which may cause yellowing of the skin and whites of the eyes.
• Inflammation of renal tubules.
• Prolonged blood clotting time.
• Hyperkinesis.
• Seizures (in patients receiving high doses of Taromentin or with kidney disease).

Adverse reactions that may appear in blood or urine tests:

• marked decrease in the number of white blood cells;
• low number of red blood cells (haemolytic anaemia);
• crystals in urine leading to acute kidney injury.

Reporting of adverse reactions
If any adverse reactions occur, including any 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
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Taromentin

Keep out of the sight and reach of children.
Store below 25°C. Protect from light.
Keep in the outer packaging to protect from light.
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 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 Taromentin contains
The active substances are amoxicillin (in the form of sodium amoxicillin) and clavulanic acid (in the form of potassium clavulanate).
Each vial contains 2000 mg of amoxicillin and 200 mg of clavulanic acid.
The medicine does not contain any other ingredients.

What Taromentin looks like and contents of the pack
White to cream-beige powder for reconstitution.
Packaging
1 or 10 vials in a cardboard box.
Taromentin is also available as a powder for solution for injection or infusion in strengths of (1000 mg + 200 mg) and (500 mg + 100 mg), as coated tablets, and as powder for oral suspension.

Marketing Authorisation Holder and Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga Street 2
03-176 Warsaw
Telephone number: 22 811-18-14
For further information about this medicine, please contact the Marketing Authorisation Holder.

Medical education
Antibiotics are used to treat bacterial infections. They are ineffective in treating viral infections.
Sometimes bacterial infections do not respond to antibiotic treatment.
One of the most common reasons for this is that bacteria are resistant to the antibiotic administered.
This means that bacteria can survive or multiply despite antibiotic therapy.
Bacteria may become resistant to antibiotics for various reasons. Careful use of antibiotics may help reduce the development of bacterial resistance.
The antibiotic prescribed by your doctor is intended solely for the treatment of your current illness. Observing the following advice will help prevent the development of resistant bacteria that could hinder the effectiveness of antibiotics.

1. It is very important to take the antibiotic at the correct dose, at the right time, and for the full prescribed duration. Please read the instructions provided in the package leaflet, and if any of them are unclear, ask your doctor or pharmacist for clarification.
2. Do not take an antibiotic unless it has been prescribed specifically for you. Take it only to treat the infection for which it was prescribed.
3. Do not take an antibiotic prescribed for another person, even if their infection seemed similar.
4. Do not give your prescribed antibiotics to other people.
5. If any antibiotic remains after completing the prescribed treatment, return it to a pharmacy for proper disposal.

The following information is intended solely for medical or healthcare personnel

For additional information, see the Summary of Product Characteristics.
Instructions for preparing the medicinal product for use
Route of administration
Taromentin is not intended for intramuscular administration.
Taromentin 2000 mg + 200 mg must be administered as an intravenous infusion lasting 30 to 40 minutes.
Preparation of injection solutions for intravenous use
Taromentin 2000 mg + 200 mg, powder for solution for infusion, is not intended for administration as a rapid intravenous bolus injection. It must be administered by intravenous infusion.
Preparation of intravenous infusion solutions
Taromentin 2000 mg + 200 mg, powder for solution for infusion, should be dissolved in 20 mL (this is the minimum volume) of solvent. A transient pinkish discoloration may appear during solution preparation. The prepared solutions are usually light pink in color. The prepared solution should be immediately added to 100 mL of infusion fluid using a mini-bag or an intravenous infusion set.
The following infusion fluids are recommended for dilution of Taromentin: Water for Injections, 0.9% sodium chloride solution, Ringer's solution, Ringer's lactate solution (Hartmann's solution).
Taromentin vials are not intended for multiple use.
Stability of prepared solutions
Intravenous injection solutions should be administered or further diluted for intravenous infusion immediately after preparation.
Stability of prepared infusion solutions

Parenteral forms of Taromentin must not be mixed with blood products or other protein-containing fluids, such as protein hydrolysates, or with fat emulsions intended for intravenous administration.
If Taromentin has been prescribed by a physician simultaneously with an aminoglycoside antibiotic, it must not be mixed in the same syringe, infusion fluid container, or infusion administration device due to the risk of loss of aminoglycoside antibiotic activity.
Taromentin solutions must not be mixed with preparations containing glucose, dextran, or bicarbonates.