Taromentin

Leaflet accompanying the packaging: information for the user

Taromentin, 2000 mg + 200 mg, powder for solution for infusion

Amoxicillin + clavulanic acid

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Taromentin and what is it used for

Taromentin is an antibiotic that works by killing bacteria that cause infections. Taromentin contains two different medicines: amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called "penicillins", which are sometimes inactivated (neutralized) by bacteria. 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 used in adults and children to prevent infections associated with major surgical procedures.

2. Important information before taking Taromentin

When not to take Taromentin

• If the patient has been found to be allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin, or any of the other ingredients of this medicine (listed in section 6).
• If the patient has ever had 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 function disorders or jaundice (yellowing of the skin) associated with the use of an antibiotic.

➢ If any of the above circumstances apply to the patient, they should not take Taromentin.
If in doubt before starting Taromentin, consult your doctor, pharmacist, or nurse.

Warnings and precautions

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

• have infectious mononucleosis;
• are being treated for liver or kidney disease;
• have irregular urination.

If in doubt whether any of the above circumstances apply to the patient, they should consult their doctor, pharmacist, or nurse before starting Taromentin.
In some cases, the doctor may test the type of bacteria that caused the patient's infection. Depending on the results, the patient may receive Taromentin in a different dose or a different medicine.

Conditions to watch out for

Taking Taromentin may worsen the course of certain diseases or cause severe side effects, including allergic reactions, seizures, and colitis. Attention should be paid to whether the patient experiences certain symptoms during Taromentin treatment to minimize the risk of any problems. See "Conditions to watch out for" in section 4.

Blood and urine tests

If the patient is to undergo blood tests (such as red blood cell tests or liver function tests) or urine tests (for glucose), they should inform their doctor or nurse that they are taking Taromentin. Taromentin may affect the results of these tests.

Other medicines and Taromentin

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes medicines that are available without a prescription and herbal medicines.
If the patient is taking allopurinol (used for gout) at the same time as Taromentin, they may be more likely to experience skin allergic reactions.
If the patient is taking probenecid (used for gout), their doctor may decide to adjust the dose of Taromentin.
If the patient is taking blood-thinning medicines (such as warfarin) at the same time as Taromentin, they may need to have additional blood tests.
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 or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor, pharmacist, or nurse before taking this medicine.

Important information about some ingredients of Taromentin

Taromentin contains sodium

Taromentin, 2000 mg + 200 mg, powder for solution for infusion, contains 151 mg of sodium (the main component of common salt) per dose. This corresponds to 7.55% of the maximum recommended daily intake of sodium in the diet for adults.
Considering the dosing schedule presented in section 3, the maximum amount of sodium that can be administered to the patient in a single dose is 151 mg, which corresponds to 7.55% of the WHO-recommended maximum daily intake of 2 g of sodium for adults, and in the maximum daily dose, 453 mg, which corresponds to 22.65% of the WHO-recommended maximum daily intake of 2 g of sodium for adults.
The sodium content from the solvent should be taken into account when calculating the total sodium content in the prepared dilution of the product (see the section "Information intended exclusively for healthcare professionals"). To obtain accurate information about the sodium content in the solution used to dilute the product, refer to the package leaflet of the solvent used.

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 taken into account in patients with reduced kidney function or those controlling their potassium intake.
Considering the dosing schedule presented in section 3, the maximum amount of potassium that can be administered to the patient in a single dose is 42.02 mg, which corresponds to 1.07 mmol of potassium, and in the maximum daily dose, 126.06 mg, which corresponds to 3.21 mmol of potassium.
This should be taken into account in patients with reduced kidney function or those controlling their potassium intake. This should be taken into account in patients with reduced kidney function or those controlling their potassium intake.
The potassium content from the solvent should be taken into account when calculating the total potassium content in the prepared dilution of the product (see the section "Information intended exclusively for healthcare professionals"). To obtain accurate information about the potassium content in the solution used to dilute the product, refer to the package leaflet of the solvent used.

3. How to take Taromentin

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

Adults and children with a body weight of 40 kg or more

Usual dose
(1000 mg + 100 mg), administered every 8 to 12 hours
Larger 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 to a maximum of 2000 mg + 200 mg,
administered every 8 hours.
Prevention of infections associated with surgical procedures
Dose (1000 mg + 100 mg) to (2000 mg + 200 mg),
administered before the procedure during the introduction 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 a body weight of 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 kilogram of body weight, administered every 8 hours
Children under 3 months of age or with a body weight of less than 4 kg:
(50 mg + 5 mg) per kilogram of body weight, administered every 12 hours.

Patients with kidney and liver diseases

• If the patient has kidney disease, the dose of the medicine may be changed. The doctor may choose a different dose of Taromentin or a different medicine.
• If the patient has liver disease, they may need to have blood tests more frequently to check how their liver is functioning.

How Taromentin is administered

• Taromentin is intended for intravenous administration. The medicine should be administered by intravenous infusion over 30 to 40 minutes. Taromentin is not intended for intramuscular administration.
• During Taromentin treatment, it is recommended to drink plenty of fluids.
• Usually, Taromentin is not administered for more than 2 weeks without re-examining the patient's health status by the doctor.

Overdose of Taromentin

Administering a dose higher than recommended is unlikely. If the patient thinks they have been given a higher dose than recommended, they should contact their doctor, pharmacist, or nurse as soon as possible. Symptoms may include stomach and intestinal irritation (nausea, vomiting, or diarrhea) or seizures.
If in doubt about the method of administration, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Taromentin can cause side effects, although not everybody gets them.
The following are side effects of Taromentin that may occur.

Conditions to watch out for

Allergic 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 the lymph nodes in the neck, armpit, or groin;
• swelling, sometimes involving the face or mouth area (angioedema), causing difficulty breathing;
• fainting;
• chest pain associated with an allergic reaction, which may be a sign of an allergy leading to a heart attack (Kounis syndrome).

➢ If any of these symptoms occur, the patient should contact their doctor immediately.

Discontinue Taromentin.

Colitis

Colitis, causing watery diarrhea, usually with blood and mucus, abdominal pain, and (or) fever.

Acute pancreatitis

If the patient has severe and persistent abdominal pain, it may be a sign of acute pancreatitis.

Drug-induced enterocolitis syndrome (DIES)

Drug-induced enterocolitis syndrome occurred mainly in children receiving amoxicillin with clavulanic acid. It is a type of allergic reaction, with recurring vomiting (1 to 4 hours after taking the medicine) as the leading symptom. Further symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.
➢ If any of these symptoms occur, the patient should contact their doctor as soon as possible for advice.
Common side effects(may occur in up to 1 in 10 patients)

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

Uncommon side effects(may occur in up to 1 in 100 patients)

• skin rash, itching;
• raised, itchy rash (hives);
• nausea, especially when taking high doses; ➢ if these occur, Taromentin should be taken before meals
• vomiting,
• indigestion,
• dizziness,
• headache.

Uncommon side effects that may appear in blood or urine test results:

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

Rare side effects(may occur in up to 1 in 1000 patients)

• skin rash, which may be blistering and look like small targets (dark spot in the center surrounded by a lighter border with a dark ring around the edge - erythema multiforme) ➢ if the patient notices any of these symptoms, they should contact their doctor urgently.
• swelling and redness along the vein, which is very painful to the touch.

Rare side effects that may appear in blood test results:

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

Other side effects

Other side effects have occurred in a very small number of people, but their exact frequency is not known.

• Allergic reactions (see above).
• Colitis (see above).
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• Severe skin reactions:
• widespread skin rash, with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing widespread skin peeling (more than 30% of the body surface - toxic epidermal necrolysis);
• widespread red skin rash, with small pus-filled blisters (pustular exfoliative dermatitis);
• red, scaly rash with thickening of the skin and blisters (acute generalized exanthematous pustulosis);
• flu-like symptoms with a rash, fever, swollen lymph nodes, and abnormal blood test results [including an increased number of white blood cells (eosinophilia) and increased liver enzyme activity]; drug reaction with eosinophilia and systemic symptoms (DRESS);
• rash with blisters arranged in a ring or like a string of pearls (linear IgA dermatosis).

➢ If the patient experiences any of these symptoms, they should contact their doctor immediately.

• Hepatitis .
• Jaundice, caused by an increase in bilirubin (a substance produced in the liver) in the blood, which can cause yellowing of the skin and eyes.
• Inflammation of the kidney tubules.
• Prolonged blood clotting time.
• Restlessness.
• Seizures (in people taking high doses of Taromentin or with kidney disease).

Side effects that may appear in blood or urine test results:

• significant decrease in the number of white blood cells;
• low number of red blood cells (hemolytic anemia);
• crystals in the urine leading to acute kidney damage.

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. 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
Phone: +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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Taromentin

Keep out of the sight and reach of children.
Store in a temperature below 25°C. Protect from light.
Store in the outer packaging to protect from light.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. 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 Taromentin contains

The active substance of Taromentin is amoxicillin (in the form of amoxicillin sodium) and clavulanic acid (in the form of clavulanic acid potassium).
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-colored powder.

Packaging

1 or 10 vials in a cardboard box.
Taromentin is also available in the form of powder for solution for injection or infusion of strength (1000 mg + 200 mg) and (500 mg + 100 mg), film-coated tablets, and powder for oral suspension.

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Phone number: 22 811-18-14
To obtain more detailed information about this medicine, contact the marketing authorization holder.

Date of approval of the leaflet:

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 phenomenon is that bacteria are resistant to the administered antibiotic.
This means that bacteria can survive or multiply despite the use of an antibiotic.
Bacteria can become resistant to antibiotics for many reasons. Careful use of antibiotics can help reduce the possibility of bacteria developing resistance.
An antibiotic prescribed by a doctor is intended solely for the treatment of the current illness. Paying attention to the following tips will help prevent the development of resistant bacteria, which could render the antibiotic ineffective.

• 1. It is very important to take the antibiotic in the correct dose, at the right time, and for the right number of days. Read the instructions in the patient information leaflet and if any of them are unclear, ask your doctor or pharmacist to explain.
• 2. The patient should not take an antibiotic if it was not prescribed specifically for them. They should only take it to treat the infection for which the antibiotic was prescribed.
• 3. The patient should not take an antibiotic prescribed for someone else, even if they had a similar infection.
• 4. Do not pass on antibiotics prescribed for one patient to other people.
• 5. If there are any remaining antibiotics after completing the treatment as recommended by the doctor, they should be returned to the pharmacy, which will ensure their proper disposal.

The following information is intended exclusively for healthcare professionals or healthcare workers

For more information, see the Summary of Product Characteristics.

Instructions for preparing the medicine for use

Taromentin is not intended for intramuscular administration.

Taromentin 2000 mg + 200 mg should be administered by intravenous infusion over 30 to 40 minutes.

Preparation of solutions for intravenous injection

Taromentin, 2000 mg + 200 mg, powder for solution for infusion, is not intended for rapid intravenous injection. It should be administered by intravenous infusion.

Preparation of solutions for intravenous infusion

Taromentin, 2000 mg + 200 mg, powder for solution for infusion, should be dissolved in 20 mL (this is the minimum volume) of solvent. During preparation, the solution may temporarily turn pink. The prepared solutions are usually light yellow in color. The prepared solution should be added immediately after preparation to 100 mL of infusion fluid using a mini-bag or burette of the infusion set.
Recommended infusion fluids for diluting Taromentin include: water for injections, 0.9% sodium chloride solution, Ringer's solution, Ringer's solution with lactates (Hartmann's solution).
Taromentin vials are not intended for multiple use.

Stability of prepared solutions

Solutions for intravenous injection should be administered or diluted for infusion immediately after preparation.
Stability of solutions prepared for infusion

Taromentin intravenous formulations should not be mixed with blood products or other fluids containing proteins, such as hydrolysates, and with fat emulsions for intravenous administration.
If Taromentin has been prescribed by a doctor at the same time as an aminoglycoside antibiotic, it should not be mixed in a syringe, infusion fluid container, or infusion fluid transfer device due to the risk of losing the activity of the aminoglycoside antibiotic.
Taromentin solutions should not be mixed with preparations containing glucose, dextran, or bicarbonates.