Taromentin

Package leaflet: Information for the user

Taromentin, 500 mg + 100 mg, powder for solution for injection or infusion
Taromentin, 1000 mg + 200 mg, powder for solution for injection or infusion
Amoxicillin + clavulanic acid
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• This medicine has been prescribed for you personally. 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 any not listed in this leaflet, tell your doctor or nurse. See section 4.

Leaflet contents

1. What Taromentin is and what it is used for
2. What you need to know 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 that kills bacteria causing infections.
Taromentin contains two different active substances: amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called "penicillins", whose action may sometimes be inhibited (inactivated). The second active ingredient (clavulanic acid) prevents 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 to prevent 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 apply, the patient must not take Taromentin.
If in doubt, consult the patient's 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 the patient's doctor, pharmacist, or nurse before starting Taromentin.
In some cases, the doctor may investigate which type of bacteria caused the infection. Depending on the results, the patient may be prescribed a different dose of Taromentin 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 due to have 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 taken, recently taken, or planned for use, including over-the-counter medicines and herbal remedies.

• If the patient is taking allopurinol (used for gout), there may be a higher chance of developing skin allergic reactions while taking 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 to treat 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 is planning to have a child, she should consult a doctor, pharmacist, or nurse before using this medicine.

Important information about certain ingredients in Taromentin

Taromentin contains potassium

• Taromentin 500 mg + 100 mg, powder for solution for injection or infusion contains 20.69 mg (0.53 mmol) of potassium per dose. This should be considered in patients with impaired kidney function or those monitoring potassium intake in their diet.
• Taromentin 1000 mg + 200 mg, powder for solution for injection or infusion contains 41.38 mg (1.06 mmol) of potassium per dose. This should be considered in patients with impaired kidney function or those monitoring potassium intake in their diet.

Considering the dosing regimen described in section 3, the maximum amount of potassium that may be administered in a single maximum dose is 41.38 mg (1.06 mmol), and in the maximum daily dose is 124.14 mg (3.18 mmol) of potassium.

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

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 potassium content in the diluent used, refer to the product information of the solvent used.

Taromentin contains sodium

• Taromentin 500 mg + 100 mg, powder for solution for injection or infusion contains 37.3 mg of sodium (main component of table salt) per dose. This corresponds to 1.86% of the maximum recommended daily sodium intake in adults.
• Taromentin 1000 mg + 200 mg, powder for solution for injection or infusion contains 74.6 mg of sodium (main component of table salt) per dose. This corresponds to 3.73% of the maximum recommended daily sodium intake in adults.

Considering the dosing regimen described in section 3, the maximum amount of sodium that may be administered in a single maximum dose is 74.6 mg (3.73% of the WHO-recommended maximum daily intake of 2 g sodium for adults), and in the maximum daily dose is 223.8 mg (11.19% of the WHO-recommended maximum daily intake of 2 g sodium for adults).

This should be taken into account in patients monitoring sodium intake in their diet.

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 sodium content in the diluent used, refer to the leaflet of the solvent used.

This should be taken into account in patients monitoring sodium intake in their diet.

3. How to use Taromentin

The patient will never self-administer this medicine.
The medicine will be administered to the patient by qualified personnel, i.e. a doctor or nurse.
The recommended dosing is given below.

Adults and children with body weight equal to or greater than 40 kg
The usual dose (1000 mg + 200 mg) is administered every 8 hours.
For prevention of infections associated with surgical procedures: (1000 mg + 200 mg) administered before surgery, at the time of induction of general anaesthesia.
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 according to the child's body weight in kilograms.
Children aged 3 months and above: (25 mg + 5 mg) per kg of body weight, administered every 8 hours.
Children below 3 months of age or with body weight less than 4 kg: (25 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 doctor may choose a different dose of Taromentin or an alternative medicine.
• If the patient has liver disease, blood tests may be performed more frequently to monitor liver function.

How Taromentin is administered

• Taromentin is administered by intravenous injection or intravenous infusion.
• During treatment with Taromentin, it is recommended to drink plenty of fluids.
• Taromentin is usually not administered for longer than 2 weeks without re-evaluation of the patient's health status by the doctor.

Administration of a higher than recommended dose of Taromentin
Administration of a dose higher than recommended is unlikely. However, contact the treating doctor, pharmacist, or nurse as quickly as possible if the patient suspects that a higher than recommended dose has been administered. Symptoms may include gastrointestinal irritation (nausea, vomiting, or diarrhoea) or seizures.
If in doubt about how the medicine should be administered, consult the 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, underarm, or groin;
• Swelling, sometimes affecting the face or areas around the mouth (angioedema), causing difficulty 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, contact a doctor immediately.
Discontinue use of Taromentin.
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. This is a type of allergic reaction, the main symptom of which is repeated 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 the treating doctor as soon as possible for advice.
Common adverse reactions (may occur in up to 1 in 10 patients)

• Fungal infections (candidiasis – yeast 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 nausea occurs, Taromentin should be taken before meals
• Vomiting;
• Dyspepsia;
• Dizziness;
• Headache.

Uncommon adverse reactions that may be detected 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, possibly with blisters and appearing as target-like lesions (dark spot in the centre surrounded by a lighter ring and a dark ring at 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 be detected in blood test results:

• Low number of platelets (cells involved in blood clotting);
• 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, in which blisters and skin peeling may occur, especially around the mouth, nose, eyes, and genital organs (Stevens-Johnson syndrome), and a more severe form causing extensive skin peeling (more than 30% of body surface – toxic epidermal necrolysis);
  • Widespread red rash with small pus-filled blisters (bullous exfoliative dermatitis);
  • Red, scaly rash with subcutaneous nodules and blisters (acute generalized exanthematous pustulosis);
  • Flu-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-shaped pattern or like a string of pearls (linear IgA dermatosis).

➢ If the patient experiences any of these symptoms, 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.
• Nephritis (inflammation of the kidney tubules).
• Prolonged blood clotting time.
• Psychomotor hyperactivity.
• Seizures (in patients receiving high doses of Taromentin or with kidney disease).

Adverse reactions that may appear in blood or urine test results:

• Marked decrease in white blood cell count;
• Low number of red blood cells (haemolytic anaemia);
• Crystals in the urine leading to acute kidney injury.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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 may 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 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 specified month.
Medicines must 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).
Taromentin 500 mg + 100 mg, powder for solution for injection or infusion
Each vial contains 500 mg of amoxicillin and 100 mg of clavulanic acid.
Taromentin 1000 mg + 200 mg, powder for solution for injection or infusion
Each vial contains 1000 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
A white to off-white crystalline powder.

Packaging
Taromentin 500 mg + 100 mg, powder for solution for injection or infusion
1 vial in a cardboard box.
Taromentin 1000 mg + 200 mg, powder for solution for injection or infusion
1 vial in a cardboard box.
Taromentin is also available in the form of powder for infusion (2000 mg + 200 mg), coated tablets, and oral suspension powder.

Marketing Authorisation Holder and Manufacturer
Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warszawa
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 administered antibiotic.
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. Paying attention to 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 prescribed number of days. Please read the instructions provided in the package leaflet, and if any of them are unclear, ask your doctor or pharmacist for clarification.
2. The patient should not take an antibiotic unless it has been specifically prescribed for them. It should be taken only to treat the infection for which it was prescribed.
3. The patient should not take an antibiotic prescribed for another person, even if that person had a similar infection.
4. Do not give antibiotics prescribed for you to other people.
5. If any antibiotic remains after completing treatment as directed by your doctor, return the unused medicine to a pharmacy for proper disposal.

The following information is intended for healthcare professionals only

For further information, see the Summary of Product Characteristics.
Instructions for preparing the medicinal product for use
Administration method
Taromentin is not intended for intramuscular administration.
Taromentin 500 mg + 100 mg and 1000 mg + 200 mg preparations may be administered as a slow
injection over approximately 3 to 4 minutes directly into a vein or into the tubing of an intravenous infusion set, or
as an intravenous infusion lasting 30 to 40 minutes.
Preparation of solutions for intravenous injection
500 mg + 100 mg, powder for solution for injection or infusion
The standard solvent is water for injections. Taromentin 500 mg + 100 mg should be reconstituted with 10 mL of solvent, yielding approximately 10.5 mL of solution for administration of a single dose. A pinkish discoloration may transiently occur during the reconstitution process. The prepared solutions are usually pale pink in color.
1000 mg + 200 mg, powder for solution for injection or infusion
Water for injections is the standard solvent. Taromentin 1000 mg + 200 mg should be reconstituted with 20 mL of solvent, yielding approximately 20.9 mL of solution for single use. A pinkish discoloration may transiently appear during reconstitution. The prepared solutions are usually pale pink in color.
Preparation of solutions for intravenous infusion
Taromentin 500 mg + 100 mg, powder for solution for injection or infusion
The product should be reconstituted as described above for injections. The reconstituted solution should be immediately added to 50 mL of infusion fluid using a mini-bag or burette set.
Taromentin 1000 mg + 200 mg, powder for solution for injection or infusion

As infusion fluids for diluting Taromentin, the following are recommended: water for
injections, 0.9% sodium chloride solution, Ringer's solution, Ringer's solution with lactates (Hartmann's
solution), 0.3% KCl and 0.9% NaCl solution.
Taromentin vials are not intended for multiple use.
Stability of prepared solutions
The prepared solution should be administered or further diluted immediately within 20 minutes of preparation.
Stability of diluted intravenous infusion solutions at room temperature:

The intravenous preparation may be added to a cooled infusion bag in the refrigerator containing water for injections or 0.9% NaCl solution and stored for up to 8 hours at 5°C. The infusion solution should then be administered immediately after reaching room temperature.

Pharmaceutical incompatibilities
Intravenous forms of Taromentin must not be mixed with blood products or other protein-containing solutions such as protein hydrolysates, or with fat emulsions intended for intravenous administration.

If Taromentin has been prescribed by a physician to be administered simultaneously with an aminoglycoside antibiotic, it must not be mixed in the same syringe, infusion container, or infusion administration set due to the risk of loss of activity of the aminoglycoside antibiotic.

Taromentin solutions must not be mixed with preparations containing glucose, dextran, or bicarbonates.