Taromentin

Leaflet attached to the packaging: information for the user

Taromentin, (400 mg + 57 mg)/5 mL, powder for oral suspension

Amoxicillin + clavulanic acid

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. 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, please tell your doctor, pharmacist, 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 pack 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 (made ineffective) by bacteria. The other active ingredient (clavulanic acid) stops this inactivation.
Taromentin is used in infants, children, and adults to treat the following infections:

• middle ear and sinus infections
• respiratory tract infections
• urinary tract infections
• skin and soft tissue infections, including dental infections
• bone and joint infections.

2. Important information before taking Taromentin

When not to take Taromentin

• If the patient has been diagnosed with an 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 had severe allergic reactions (hypersensitivity) to any other antibiotic. These can 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 taking an antibiotic.

➢ If any of the above applies to the patient, they should not take Taromentin.
If in doubt, the patient should consult their doctor or pharmacist before taking Taromentin.

Warnings and precautions

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

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

If in doubt whether any of the above applies to the patient, they should consult their doctor or pharmacist before taking 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 be given Taromentin in a different dose or a different medicine.

Conditions to be aware of

Taking Taromentin may worsen the course of certain diseases or cause severe side effects, including allergic reactions, seizures, and colitis. The patient should be aware of certain symptoms during Taromentin treatment to minimize the risk of any problems. See 'Conditions to be aware of' 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.

Taromentin and other medicines

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.
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 baby, they should ask their doctor for advice before taking this medicine.

Taromentin contains aspartame (E 951).

The medicine contains 1.7 mg of aspartame in each 1 mL and 8.5 mg of aspartame in each 5 mL of the prepared oral suspension.
Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria.
This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper elimination.
Considering the dosing schedule presented in section 3, the maximum amount of aspartame that can be administered to a patient in a single dose is 18.64 mg, and in a daily dose, 59.67 mg.

Taromentin contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".
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 5.99 mg, and in a daily dose, 19.19 mg.
The medicine contains 2.69 mg of sodium in 5 mL of the prepared oral suspension.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".
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 5.99 mg, and in a maximum daily dose, 19.19 mg.

Taromentin contains glucose

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

Taromentin contains potassium

The medicine contains 11.16 mg (0.29 mmol) of potassium per dose, which should be taken into account in patients with reduced kidney function and in patients controlling their potassium intake.
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 24.46 mg (0.63 mmol), and in a daily dose, 78.32 mg (2.00 mmol). This should be taken into account in patients with reduced kidney function or controlling their potassium intake.

3. How to take Taromentin

Taromentin should always be taken as directed by the doctor. If in doubt, the patient should consult their doctor or pharmacist.

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

• This suspension is not usually recommended for adults and children with a body weight of 40 kg or more. The patient should consult their doctor or pharmacist for advice.

Children with a body weight of less than 40 kg

All doses are determined based on the child's body weight in kilograms.

• The doctor will recommend the dose of Taromentin to be given to the patient.
• A measuring spoon is provided with each pack of the medicine, allowing the administration of 1.25 mL, 2.5 mL, and 5 mL of the suspension; an oral syringe is also provided with each pack of the medicine. These should be used to administer the correct dose.
• The recommended dose is from (25 mg + 3.6 mg) to (45 mg + 6.4 mg) per kilogram of body weight per day, given in two divided doses.
• A higher dose - up to (70 mg + 10 mg) per kilogram of body weight per day, given in two divided doses.

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.

The doctor may perform more frequent blood tests to check how the patient's liver is functioning.

• If the patient has liver disease, they may need to have blood tests more frequently to check how their liver is functioning.

How to administer Taromentin

• The bottle should always be shaken well before each dose.
• Take at the start of a meal or just before a meal.
• Equal intervals of at least 4 hours should be maintained between doses given during the day. Do not give 2 doses within 1 hour.
• Do not give Taromentin to the patient for more than 2 weeks. If the patient still does not feel better, they should consult their doctor again.

Overdose of Taromentin

If the patient has taken more Taromentin than they should, they may experience symptoms such as stomach and intestinal irritation (nausea, vomiting, or diarrhea) or seizures. They should contact their doctor as soon as possible. They should take the carton and the remaining medicine with them to show the doctor.

Missed dose of Taromentin

If a dose of Taromentin is missed, it should be taken as soon as possible after remembering. The next dose should not be taken too early, but the patient should wait about 4 hours before taking the next dose.

Stopping Taromentin treatment

The patient should continue taking Taromentin until the end of the treatment, even if they feel better. All doses of the medicine are necessary to combat the infection. If some bacteria survive, they may cause a relapse of the infection.
If in doubt about taking the medicine, the patient should consult their doctor or pharmacist.

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 be aware of

Allergic reactions:

• skin rash
• vasculitis, which can appear as red or purple raised spots on the skin, but can also affect other organs
• 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 can be a sign of an allergy leading to a heart attack (Kounis syndrome).

➢

If the patient experiences any of these symptoms, they should contact their doctor immediately. They should stop taking 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 stomach pain, it may be a sign of acute pancreatitis.

Drug-induced enterocolitis syndrome (DIES)

Drug-induced enterocolitis syndrome occurred mainly in children taking 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 the patient experiences any of these symptoms, they should contact their doctor as soon as possible for advice.

Very common side effects(may affect more than 1 in 10 people)

• diarrhea (in adults).

Common side effects(may affect up to 1 in 10 people)

• thrush (candidiasis - fungal infections of the vagina, mouth, or skin folds)
• nausea, especially when taking high doses ➢ if this occurs, Taromentin should be taken before meals
• vomiting
• diarrhea (in children).

Uncommon side effects(may affect up to 1 in 100 people)

• skin rash, itching
• raised, itchy rash (hives)
• 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 affect up to 1 in 1,000 people)

• skin rash, which can occur with blisters and look like small targets (a dark spot in the center surrounded by a lighter ring with a dark ring around the edge - erythema multiforme) ➢ if the patient experiences any of these symptoms, they should contact their doctor urgently. 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 patients, 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, which can occur with blisters and peeling of the skin, especially around the mouth, nose, eyes, or 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, which can occur with small pus-filled blisters (bullous exfoliative dermatitis)
• -red, scaly rash with thickening under 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 renal tubules.
• Prolonged blood clotting time.
• Restlessness.
• Seizures (in people taking high doses of Taromentin or with kidney disease).
• Black hairy tongue.
• Discoloration of teeth (in children), which can usually be removed by brushing.

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, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Taromentin

Keep out of the sight and reach of children.
Dry powder - store in a temperature below 25°C. Protect from moisture.
Oral suspension - store in the refrigerator at 2°C to 8°C for up to 7 days.
Do not take the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Taromentin contains

• The active substances are amoxicillin and clavulanic acid. Each milliliter of the prepared oral suspension contains 80 mg of amoxicillin as amoxicillin trihydrate and 11.4 mg of clavulanic acid as potassium clavulanate.
• Other ingredients are: guar gum, silicon dioxide, colloidal anhydrous silica, sodium citrate, anhydrous citric acid, orange flavor [corn maltodextrin, modified corn starch (E 1450), sodium citrate (E 331)], tropical flavor [maltodextrin, glucose, arabic gum (E 414), pectin (E 440)], lemon flavor [maltodextrin, glucose, arabic gum (E 414), pectin (E 440)], aspartame (E 951).
• Important information about some of the ingredients of Taromentin, see section 2.

What Taromentin looks like and contents of the pack

White to light yellow powder, which forms a uniform suspension after the addition of water.
Packaging:1 bottle in a cardboard box containing 6.3 g, 12.6 g, or 25.2 g of powder.
After the addition of water, the bottle contains 35 mL, 70 mL, or 140 mL of suspension, respectively.
A measuring spoon is provided with each pack of the medicine, allowing the administration of 1.25 mL, 2.5 mL, and 5 mL of the suspension. An oral syringe is also provided with each pack of the medicine, allowing the administration of up to 5 mL of the suspension with an accuracy of 0.1 mL.
Taromentin is also available in the form of powder for solution for injection or infusion and in the form of oral tablets.

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna, ul. A. Fleminga 2, 03-176 Warsaw, Phone: 22 811-18-14. For more information about this medicine, the patient should 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 the bacteria are resistant to the administered antibiotic.
This means that the bacteria can survive or multiply despite the use of the antibiotic.
Bacteria can become resistant to antibiotics for many reasons. Careful use of antibiotics can help reduce the possibility of bacteria becoming resistant.
The antibiotic prescribed by the 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. The patient should read the instructions in the patient information leaflet and, if any of them are unclear, ask their doctor or pharmacist to explain.
• 2. The patient should not take an antibiotic that was not prescribed 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. The patient should not give their antibiotics to others.
• 5. If there are any remaining antibiotics after completing the treatment as directed by the doctor, the patient should return them to the pharmacy, which will dispose of them properly. This will help protect the environment.

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Instructions for preparing the medicine for use

Preparing the suspension

Before adding the recommended amount of water, the patient should shake the bottle with the medicine to loosen the powder.

6.3 g of powder to prepare 35 mL of oral suspension

Add boiled, cooled water to the bottle containing 6.3 g of powder, up to the mark on the label (31 mL). Shake until a uniform suspension is obtained. After standing, if necessary, fill with water to the mark. This will give 35 mL of suspension.

12.6 g of powder to prepare 70 mL of oral suspension

Add boiled, cooled water to the bottle containing 12.6 g of powder, up to the mark on the label (62 mL). Shake until a uniform suspension is obtained. After standing, if necessary, fill with water to the mark. This will give 70 mL of suspension.

25.2 g of powder to prepare 140 mL of oral suspension

Add boiled, cooled water to the bottle containing 25.2 g of powder, up to the mark on the label (124 mL). Shake until a uniform suspension is obtained. After standing, if necessary, fill with water to the mark. This will give 140 mL of suspension.
The suspension should be shaken vigorously before each use.
5 mL of the suspension contains 400 mg of amoxicillin and 57 mg of clavulanic acid.
2.5 mL of the suspension contains 200 mg of amoxicillin and 28.5 mg of clavulanic acid.
1.25 mL of the suspension contains 100 mg of amoxicillin and 14.25 mg of clavulanic acid.