Taromentin

Package leaflet: Information for the user

Taromentin, (400 mg + 57 mg)/5 mL, powder for oral suspension
Amoxicillin + clavulanic acid
Please read all of this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Taromentin is and what it is 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 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", the action of which may sometimes be inhibited (inactivated). The second active ingredient (clavulanic acid) counteracts this inactivation.
Taromentin is used in infants, children, and adults for the treatment of 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 you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin, or any of the other ingredients of this medicine (listed in section 6).
• If you have ever had severe allergic reactions (hypersensitivity) to any other antibiotic. These may include skin rash or swelling of the face or neck.
• If you have ever had liver problems or jaundice (yellowing of the skin) associated with taking an antibiotic.

➢ If any of the above apply to you, you must not take Taromentin.
If in doubt, consult your doctor or pharmacist before starting treatment with Taromentin.

Warnings and precautions
Before starting treatment with Taromentin, consult your doctor, pharmacist, or nurse if you:

• Have infectious mononucleosis
• Are being treated for liver or kidney disease
• Pass urine irregularly.

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before starting Taromentin.
In some cases, your doctor may test which type of bacteria caused your infection. Depending on the results, you may receive Taromentin at a different dose or a different medicine.

Conditions to be aware of
Treatment with Taromentin may worsen certain conditions or cause serious adverse effects, including allergic reactions, seizures, and colitis. You should monitor for specific symptoms during treatment with Taromentin to reduce the risk of complications. See "Conditions to be aware of" in section 4.

Blood and urine tests
If you are due to have blood tests (such as red blood cell count or liver function tests) or urine tests (for glucose), inform your doctor or nurse that you are taking Taromentin. Taromentin may affect the results of such tests.

Taromentin with other medicines
Tell your doctor about all medicines you are currently taking, have recently taken, or plan to take.

• If you are taking allopurinol (used for gout), you may be more likely to develop skin allergic reactions while taking Taromentin.
• If you are taking probenecid (used for gout), your doctor may decide to adjust the dose of Taromentin.
• If you are taking anticoagulants (blood-thinning medicines such as warfarin) at the same time as Taromentin, additional blood tests may be needed.
• 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 you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using 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 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 improper excretion.
Considering the dosing regimen described in section 3, the maximum amount of aspartame that may be administered to a patient in a single maximum dose is 18.64 mg, and in the daily dose is 59.67 mg.

Taromentin contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".
Considering the dosing regimen described in section 3, the maximum amount of sodium that may be administered to a patient in a single maximum dose is 5.99 mg, and in the daily dose is 19.19 mg.
The medicine contains 2.69 mg of sodium in 5 mL of prepared oral suspension.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".
Considering the dosing regimen described in section 3, the maximum amount of sodium that may be administered to a patient in a single maximum dose is 5.99 mg, and in the daily dose is 19.19 mg.

Taromentin contains glucose
If you have previously been diagnosed with intolerance to certain sugars, you should consult your doctor before taking this 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 impaired kidney function and in patients controlling potassium intake in their diet.
Considering the dosing regimen described in section 3, the maximum amount of potassium that may be administered to a patient in a single maximum dose is 24.46 mg (0.63 mmol), and in the daily dose is 78.32 mg (2.00 mmol). This should be taken into account in patients with impaired kidney function or those monitoring potassium intake in their diet.

3. How to use Taromentin

Taromentin should always be used as directed by the physician. If in doubt, consult your doctor or pharmacist again.

Adults and children with body weight of 40 kg and above

• This suspension is not usually recommended for use in adults and children weighing 40 kg or more. Please consult your doctor or pharmacist for advice.

Children with body weight less than 40 kg
All doses are determined according to the child's body weight in kilograms.

• Your doctor will prescribe the dose of Taromentin to be administered.
• Each package of the medicine includes a measuring spoon allowing administration of 1.25 mL, 2.5 mL, and 5 mL of the suspension; additionally, an oral syringe dosing device is included in each package. These should be used to administer the correct dose.
• Recommended dose – from (25 mg + 3.6 mg) to (45 mg + 6.4 mg) per kilogram of body weight per day, given in two divided doses.
• Higher dose – up to (70 mg + 10 mg) per kilogram of body weight per day, given in two divided doses.

Patients with kidney or liver disease

• If the patient has kidney problems, the dose of the medicine may be adjusted. Your doctor may prescribe a different dose of Taromentin or an alternative medicine.

• If the patient has liver problems, blood tests to monitor liver function may be performed more frequently.

How to administer Taromentin

• Always shake the bottle well before administering each dose.
• Administer at the beginning of a meal or just before a meal.
• Maintain regular intervals of at least 4 hours between doses administered during the day. Do not administer two doses within one hour.
• Do not administer Taromentin for longer than 2 weeks. If the patient still does not feel better, contact the doctor again.

Accidental overdose of Taromentin
If a patient has taken more Taromentin than recommended, symptoms such as stomach and intestinal irritation (nausea, vomiting, or diarrhoea) or seizures may occur. Contact your doctor as quickly as possible. Keep the cardboard packaging of the medicine to show it to the doctor.

Missed dose of Taromentin
If a dose of Taromentin has been missed, administer it as soon as remembered. Do not administer the next dose too early; wait approximately 4 hours before administering the next dose.

Stopping Taromentin treatment
Continue administering Taromentin for the full duration of treatment, even if the patient feels better. All doses are necessary to eliminate the infection. If some bacteria survive, they may cause the infection to return.

If you have any doubts about how to use the medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Below are the adverse reactions that 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 affect other organs
• fever, joint pain, swelling of glands in the neck, under the arms or in the 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 indicate an allergy leading to heart attack (Kounis syndrome).

➢ If any of these symptoms occur in the patient, contact a doctor immediately.
Discontinue Taromentin treatment.
Colitis
Colitis 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, it 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 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 in the patient, contact the treating doctor as soon as possible for advice.
Very common adverse reactions (may occur in more than 1 in 10 patients)

• diarrhoea (in adults).

Common adverse reactions (may occur in no more than 1 in 10 patients)

• oral, vaginal or skin fold fungal infections (candidiasis)
• nausea, especially when high doses are used ➢ if this occurs, take Taromentin before meals
• vomiting
• diarrhoea (in children).

Uncommon adverse reactions (may occur in no more than 1 in 100 patients)

• skin rash, itching
• raised, itchy rash (urticaria)
• indigestion
• dizziness
• headache. Uncommon adverse reactions that may be revealed in blood tests:
• increased activity of certain substances (enzymes) produced in the liver.

Rare adverse reactions (may occur in no more than 1 in 1000 patients)

• skin rash, possibly with blisters and resembling target lesions (dark spot in the centre surrounded by a lighter ring and a dark ring at the edge – erythema multiforme) ➢ if any of these symptoms occur in the patient, contact a doctor urgently. Rare adverse reactions that may appear in blood test results:
• low number of cells involved in blood clotting (platelets)
• low number of white blood cells.

Other adverse reactions
Other adverse reactions occurred in a very small number of patients, 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, within which blisters and skin peeling may occur, 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 pus-filled blisters (bullous exfoliative dermatitis)

• red scaly rash with subcutaneous nodules and blisters (acute generalised 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 rings or like a string of pearls (linear IgA dermatosis). ➢ If any of these symptoms occur in the patient, contact a doctor immediately.

  • Hepatitis.
  • Jaundice, caused by increased bilirubin (a substance produced in the liver) levels in the blood, which may cause yellowing of the skin and whites of the eyes.
  • Inflammation of the kidney tubules.
  • Prolonged blood clotting time.
  • Hyperkinesia.
  • Seizures (in patients receiving high doses of Taromentin or with kidney disease).
  • Black hairy tongue.
  • Tooth discoloration (in children), which can usually be removed by brushing.

Adverse reactions that may appear in blood or urine tests:

• severe reduction 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 a 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 sight and reach of children.
Dry powder – store below 25°C. Protect from moisture.
Oral suspension – store in the refrigerator for up to 7 days (at a temperature of 2°C to 8°C).
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not dispose of medicines via the sewage system or household waste. Ask a pharmacist what to do with medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Taromentin contains

• The active substances are amoxicillin and clavulanic acid. Each millilitre of the reconstituted 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, anhydrous trisodium citrate, anhydrous citric acid, orange flavour [corn maltodextrin, modified corn waxy starch (E 1450), sodium citrate (E 331)], tropical flavour [maltodextrin, glucose, gum arabic (E 414), pectin (E 440)], lemon flavour [maltodextrin, glucose, gum arabic (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 pale yellow powder, which forms a homogeneous suspension after addition of water.
Packaging: 1 bottle in a cardboard box containing 6.3 g, 12.6 g or 25.2 g of powder.
After addition of water, the bottle contains 35 mL, 70 mL or 140 mL of suspension, respectively.
Each pack size includes a measuring spoon with markings allowing administration of 1.25 mL, 2.5 mL and 5 mL of suspension. Additionally, each pack size includes an oral syringe dispenser allowing administration of up to 5 mL of suspension with 0.1 mL accuracy.
Taromentin is also available as a powder for preparation of solution for injection and infusion, and as an oral dosage form in tablets.

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 on this medicinal product, 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 prescribed antibiotic.
This means that bacteria can survive or multiply despite the use of the antibiotic.
Bacteria may become resistant to antibiotics for many reasons. Careful use of antibiotics may help reduce the risk of 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 interfere with the effectiveness of antibiotics.

1. It is very important to take the antibiotic at the correct dose, at the correct time, and for the correct number of days. Read the instructions provided in the package leaflet, and if any are unclear, ask your doctor or pharmacist for clarification.
2. Do not take an antibiotic that has not been prescribed specifically for you. You should 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 was similar.
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 it to a pharmacy for proper disposal.

Instructions for preparing the medicine for use
Preparation of the suspension
Before adding the recommended amount of water, shake the bottle to loosen the powder.

6.3 g powder for preparation of 35 mL oral suspension
Add boiled, cooled water to the bottle containing 6.3 g of powder up to the mark indicated on the label (31 mL). Shake until a homogeneous suspension is obtained. After standing, if necessary, top up with water to the mark. This yields 35 mL of suspension.

12.6 g powder for preparation of 70 mL oral suspension
Add boiled, cooled water to the bottle containing 12.6 g of powder up to the mark indicated on the label (62 mL). Shake until a homogeneous suspension is obtained. After standing, if necessary, top up with water to the mark. This yields 70 mL of suspension.

25.2 g powder for preparation of 140 mL oral suspension
Add boiled, cooled water to the bottle containing 25.2 g of powder up to the mark indicated on the label (124 mL). Shake until a homogeneous suspension is obtained. After standing, if necessary, top up with water to the mark. This yields 140 mL of suspension.

The suspension must be shaken vigorously before each use.

5 mL of suspension contains 400 mg of amoxicillin and 57 mg of clavulanic acid.
2.5 mL of suspension contains 200 mg of amoxicillin and 28.5 mg of clavulanic acid.
1.25 mL of suspension contains 100 mg of amoxicillin and 14.25 mg of clavulanic acid.