TAROMENTIN 1000 mg/200 mg Powder

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Taromentin, 500 mg + 100 mg, powder for solution for injection or infusion
3. Taromentin, 1000 mg + 200 mg, powder for solution for injection or infusion
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Taromentin and what is it used for
5. Important information before using Taromentin
   1. When not to use Taromentin
   2. Warnings and precautions
   3. Conditions to watch out for
   4. Blood and urine tests
   5. Other medicines and Taromentin
   6. Pregnancy and breastfeeding
   7. Important information about some ingredients of Taromentin
   8. Taromentin contains potassium
   9. Taromentin contains sodium
6. How to use Taromentin
   1. Adults and children with a body weight of 40 kg or more
   2. Children with a body weight of less than 40 kg
   3. Patients with kidney and liver diseases
   4. How Taromentin is administered
   5. Using more than the recommended dose of Taromentin
7. Possible side effects
   1. Conditions to watch out for
   2. Allergic reactions:
   3. Discontinue Taromentin use.
   4. Colitis
   5. Acute pancreatitis
   6. Drug-induced enterocolitis syndrome (DIES)
   7. Other side effects
   8. Reporting side effects
8. How to store Taromentin
9. Contents of the packaging and other information
   1. What Taromentin contains
   2. What Taromentin looks like and what the pack contains
   3. Packaging
   4. Marketing authorization holder and manufacturer
   5. Medical education
   6. The following information is intended exclusively for healthcare professionals
   7. To obtain additional information, see the Summary of Product Characteristics.
   8. Instructions for preparing the medicine for use
   9. The method of administration of Taromentin is not intended for intramuscular injection.
   10. Preparing solutions for intravenous injections
   11. Preparing solutions for intravenous infusions
   12. Stability of prepared solutions
   13. Incompatibilities

Leaflet accompanying the packaging: 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

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a 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.
• If the patient experiences any side effects, including any side effects 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 using Taromentin
• 3. How to use 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 bactericidally on bacteria that cause infections.
Taromentin contains two different medicines: amoxicillin and clavulanic acid. Amoxicillin belongs to
the group of medicines called "penicillins", which may sometimes be inactivated (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 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 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. They 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 the above circumstances apply to the patient, they should not take Taromentin.
In case of doubts before starting Taromentin, consult a doctor, pharmacist or nurse.

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;
• have irregular urination.

In case of doubts whether the above circumstances apply to the patient, consult a doctor, pharmacist or nurse before starting Taromentin.
In some cases, the doctor may examine what type of bacteria 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

Using Taromentin may worsen the course of some diseases or cause severe side effects, including allergic reactions, seizures and colitis. Pay attention to whether the patient has certain symptoms during Taromentin use 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 have 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

Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to use. This also applies to over-the-counter medicines and herbal medicines.
If the patient is taking allopurinol (used in gout) at the same time as Taromentin, they may be more likely to experience skin allergic reactions.
If the patient is taking probenecid (used in gout), the doctor may decide to modify the dose of Taromentin.
If the patient is taking blood thinning medicines (such as warfarin) at the same time as Taromentin, additional blood tests may be necessary.
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 a doctor, pharmacist or nurse before using this medicine.

Important information about some ingredients of 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, which should be taken into account in patients with reduced kidney function or those controlling 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, which should be taken into account in patients with reduced kidney function or those controlling potassium intake in their diet.
Considering the dosing schedule presented in section 3, the maximum amount of potassium that can be administered to a patient in a single dose is 41.38 mg, which corresponds to 1.06 mmol of potassium, and in the maximum daily dose, 124.14 mg, which corresponds to 3.18 mmol of potassium.
This should be taken into account in patients with reduced kidney function or those controlling potassium intake in their diet.
The potassium content from the solvent should be taken into account when calculating the total potassium content in the prepared product dilution (see "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.

Taromentin contains sodium

Taromentin, 500 mg + 100 mg, powder for solution for injection or infusion contains
37.3 mg of sodium (the main component of common salt) per dose. This corresponds to 1.86% of the maximum recommended daily intake of sodium in the diet for adults.
Taromentin, 1000 mg + 200 mg, powder for solution for injection or infusion contains
74.6 mg of sodium (the main component of common salt) per dose. This corresponds to 3.73% 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 a patient in a single dose is 74.6 mg, which corresponds to 3.73% of the WHO-recommended maximum 2 g daily intake of sodium for adults, and in the maximum daily dose, 223.8 mg, which corresponds to 11.19% of the WHO-recommended maximum 2 g daily intake of sodium for adults.
This should be taken into account in patients controlling sodium intake in their diet.
The sodium content from the solvent should be taken into account when calculating the total sodium content in the prepared product dilution (see "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.
This should be taken into account in patients controlling sodium intake in their diet.

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 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 + 200 mg), administered every 8 hours
Prevention of infections associated with surgical procedures
(1000 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
(25 mg + 5 mg) per kilogram of body weight,
administered every 8 hours
Children under 3 months of age or with a body weight
less than 4 kg
(25 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 have blood tests performed more frequently to check how the liver is functioning.

How Taromentin is administered

• Taromentin is administered by intravenous injection or infusion.
• During Taromentin use, 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 by a doctor.

Using more than the recommended dose of Taromentin

Administering a dose higher than recommended is unlikely. Consult a doctor, pharmacist or nurse as soon as possible if the patient believes they have been given a higher dose than recommended. Symptoms such as stomach and intestinal irritation (nausea, vomiting or diarrhea) or seizures may occur.
In case of doubts about the method of administration, consult a doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur with this medicine.

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 (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, consult a doctor immediately.

Discontinue Taromentin use.

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, the leading symptom of which is repeated vomiting (1 to 4 hours after taking the medicine). Further symptoms may include abdominal pain, lethargy, diarrhea and low blood pressure.
➢ If any of these symptoms occur, consult a 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 they occur, Taromentin should be taken before meals
• vomiting,
• indigestion,
• dizziness,
• headache.

Uncommon side effects that may appear in blood 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 accompanied by blisters and resemble small targets (a 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 immediately.
• 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 blood 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).
• Meningitis (aseptic meningitis) caused by an allergic reaction.
• Severe skin reactions:
• widespread skin rash, which may be accompanied by 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 rash, which may be accompanied by small pus-filled blisters (bullous exfoliative dermatitis);
• red, scaly rash with thickening of the skin and blisters (acute generalized exanthematous pustulosis);
• symptoms similar to flu 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 increased level of bilirubin (a substance produced in the liver) in the blood, which can cause yellowing of the skin and eyes.
• Interstitial nephritis.
• 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 side effects not listed in this leaflet, tell a doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring, 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 this medicine.

5. How to store Taromentin

Store out of sight and reach of children.
Store at 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 a pharmacist how to dispose of unused medicines. 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 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 other ingredients.

What Taromentin looks like and what the pack contains

White to cream-colored 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 solution for infusion with a strength of (2000 mg + 200 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 leaflet approval:{MM/RRRR}

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 disease. Paying attention to the following advice will help prevent the development of resistant bacteria that 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 package leaflet and if any of them are unclear, ask a doctor or pharmacist to explain.
• 2. The patient should not take an antibiotic that has not been 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 another person, 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 leftover antibiotics after completing the treatment as recommended by the doctor, return them to the pharmacy, which will ensure their proper disposal.

The following information is intended exclusively for healthcare professionals

To obtain additional information, see the Summary of Product Characteristics.

Instructions for preparing the medicine for use

The method of administration of Taromentin is not intended for intramuscular injection.

Taromentin 500 mg + 100 mg and 1000 mg + 200 mg can be administered by slow intravenous injection lasting about 3 to 4 minutes directly into a vein or into a drip infusion device, or by intravenous infusion lasting 30 to 40 minutes.

Preparing solutions for intravenous injections

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 dissolved in 10 mL of solvent, resulting in approximately 10.5 mL of solution for single-dose administration. During preparation, the solution may temporarily turn pink. The prepared solutions are usually light yellow.
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 dissolved in 20 mL of solvent, resulting in approximately 20.9 mL of solution for single-dose use. During preparation, the solution may temporarily turn pink. The prepared solutions are usually light yellow.

Preparing solutions for intravenous infusions

Taromentin, 500 mg + 100 mg, powder for solution for injection or infusion
The product should be dissolved as described above for injections. The prepared solution should be added immediately after preparation to 50 mL of infusion fluid, using a mini-bag or burette set for infusions.
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.
The Taromentin vials are not intended for multiple use.

Stability of prepared solutions

The prepared solution should be administered or diluted immediately within 20 minutes of preparation.
The stability of diluted solutions for intravenous infusion at room temperature:

Incompatibilities

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