Taromentin

Package leaflet: Information for the user

Taromentin, 875 mg + 125 mg, film-coated tablets
Amoxicillin + clavulanic acid
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for the adult patient (or child). Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

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”, whose activity may sometimes be inhibited (inactivated). The second active component (clavulanic acid) counteracts this inactivation.
Taromentin is used in adults and children 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 using Taromentin

When not to use Taromentin

• If the patient is allergic 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) related to taking an antibiotic.

➢ If any of the above situations apply, the patient should not take Taromentin.
If in doubt, consult the doctor or pharmacist before starting Taromentin.

Warnings and precautions

Before starting Taromentin, consult the doctor or pharmacist if the patient:

• has infectious mononucleosis;
• is being treated for liver or kidney disease;
• urinates irregularly.

If in doubt whether any of the above situations apply, consult the doctor or pharmacist before starting Taromentin.
In some cases, the doctor may test which type of bacteria caused the infection. Depending on the results, the patient may receive Taromentin at a different dose or another medicine.

Conditions to be aware of

Treatment with Taromentin may worsen certain diseases or cause serious adverse effects, including allergic reactions, seizures, and inflammation of the large intestine. It is important to monitor whether the patient develops 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 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.

Taromentin and other medicines

Inform the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

• If the patient is taking allopurinol (used for gout), skin allergic reactions may be more likely when taken together with Taromentin.
• If the patient is taking probenecid (used for gout), the doctor may decide to adjust the dose of Taromentin.
• If the patient is taking anticoagulant medicines (such as warfarin) together with 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 the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery

Taromentin may cause adverse effects and symptoms that could impair the ability to drive.
Do not drive or operate machinery unless the patient feels well.

3. How to use Taromentin

Taromentin should always be used as directed by the physician. In case of doubt, contact the
attending physician or pharmacist again.
Adults and children with body weight of 40 kg or more

• Usual dose – 1 tablet twice daily.
• Higher dose – 1 tablet three times daily.

Children with body weight below 40 kg
Children aged 6 years or younger should preferably be treated with Taromentin oral suspension.
Consult the attending physician or pharmacist before administering Taromentin tablets to children with body weight below 40 kg. Taromentin tablets are not intended for use in children weighing less than 25 kg.
Patients with kidney or liver disease

• If the patient has kidney disease, the dose of the medicine may be adjusted. The attending physician may prescribe a different dose of Taromentin or an alternative medicine.
• If the patient has liver disease, blood tests to monitor liver function may be performed more frequently.

How to take Taromentin

• Swallow the tablets whole with a glass of water, 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 take 2 doses within 1 hour.
• Do not use Taromentin for longer than 2 weeks. If the patient still does not feel better, they should contact the physician again.

Taking more Taromentin than recommended
If the patient takes more Taromentin than recommended, symptoms such as irritation of the stomach and intestines (nausea, vomiting, or diarrhoea) or seizures may occur. Contact the attending physician as quickly as possible. Bring the cardboard packaging of the medicine to show to the doctor.
Missed dose of Taromentin
If the patient forgets to take a dose, take it as soon as they remember. Do not take the next dose too soon; wait approximately 4 hours before taking the next dose. Do not take a double dose to make up for a missed dose.
Stopping Taromentin treatment
Continue taking Taromentin for the full duration of treatment, even if the patient starts to feel better. All doses are necessary to eliminate the infection. If some bacteria survive, they may cause the infection to return.
If there are any further doubts regarding the use of this medicine, consult the physician or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The adverse effects that may occur with the use of this
medicine are listed below.
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 organs
• fever, joint pain, swelling of glands in the neck, under the arm or in the groin
• swelling, sometimes affecting the face or area around the mouth (angioedema), causing difficulty in breathing
• fainting
• chest pain associated with 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 symptom 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.
Very common adverse effects (may occur in more than 1 in 10 patients)

• diarrhoea (in adults).

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

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

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

• skin rash, itching
• raised, itchy rash (urticaria)
• indigestion
• dizziness
• headache.

Uncommon adverse effects that may be revealed in blood test results:

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

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

• skin rash, which may present with blisters and resemble target lesions (dark spot in the centre surrounded by a lighter ring with a dark ring around the edge – erythema multiforme) ➢ if the patient notices any of these symptoms, they should contact a doctor urgently.

Rare adverse effects that may appear in blood test results:

• low number of platelets (cells involved in blood clotting)
• low number of white blood cells.

Adverse effects occurring with unknown frequency (frequency cannot be estimated from the available data)

• 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, with blisters and skin peeling, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing extensive skin peeling (over 30% of body surface area – toxic epidermal necrolysis)
  • widespread red skin rash with small pustules (pustular 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 a ring-like pattern 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 levels of bilirubin (a substance produced in the liver) in the blood, which may cause yellowing of the skin and whites of the eyes
• Tubulointerstitial nephritis
• 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 effects 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 urine leading to acute kidney injury.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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
e-mail: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Taromentin

Keep the medicine out of sight and reach of children.
Store below 25ºC.
Store in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date (EXP) stated on the carton box and blister pack.
The expiry date refers to the last day of the stated month.
Do not use if the tablets are broken or otherwise damaged.
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 and clavulanic acid.
Each coated tablet contains 875 mg of amoxicillin as amoxicillin trihydrate and
125 mg of clavulanic acid as potassium clavulanate.
The other ingredients are:
tablet core – povidone, crospovidone, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose.
tablet coating – hypromellose, calcium carbonate, talc, medium-chain saturated triglycerides, hydroxypropylcellulose.

What Taromentin looks like and contents of the pack
Oval, biconvex tablets, white to slightly cream in colour.
Pack
The pack contains 14 or 21 coated 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 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 prescribed antibiotic.
This means that bacteria can survive or multiply despite the use of the antibiotic.
Bacteria may become resistant to antibiotics for various reasons. Careful use of antibiotics
can help reduce the likelihood of bacterial resistance developing.
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 right time, and for the correct 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. Patients should not take an antibiotic unless it has been prescribed specifically for them. It should be taken only to treat the infection for which it was prescribed.
3. Patients 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 the prescribed treatment, return it to a pharmacy for proper disposal.