TAROMENTIN 500 mg/125 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Taromentin, 500 mg + 125 mg, film-coated tablets
   1. Please read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Taromentin and what is it used for
4. Important information before taking Taromentin
   1. When not to take Taromentin
   2. Warnings and precautions
   3. Special warnings
   4. Blood and urine tests
   5. Taromentin and other medicines
   6. Pregnancy and breastfeeding
   7. Driving and using machines
5. How to take Taromentin
   1. Adults and children over 40 kg
   2. Children under 40 kg
   3. Patients with kidney and liver disease
   4. How to take Taromentin
   5. Taking more than the recommended dose of Taromentin
   6. Missing a dose of Taromentin
   7. Stopping treatment with Taromentin
6. Possible side effects
   1. Special warnings
   2. Allergic reactions:
   3. The patient should stop taking Taromentin.
   4. Colitis
   5. Acute pancreatitis
   6. Drug-induced enterocolitis syndrome (DIES)
   7. Reporting side effects
7. How to store Taromentin
8. Contents of the pack and other information
   1. What Taromentin contains
   2. What Taromentin looks like and contents of the pack
   3. Packaging
   4. Marketing authorization holder and manufacturer
   5. Date of last revision of the leaflet:
   6. Medical education

Leaflet attached to the packaging: information for the user

Taromentin, 500 mg + 125 mg, film-coated tablets

Amoxicillin + clavulanic acid

Please read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you (or your child). 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 pharmacist. 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 may sometimes be inhibited (inactivated). The second active ingredient (clavulanic acid) counteracts this inactivation. Taromentin is used in adults and children 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 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 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 these conditions apply to the patient, they should not take Taromentin.
If in doubt before starting treatment with Taromentin, the patient should consult their doctor or pharmacist.

Warnings and precautions

Before starting treatment with 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 these conditions apply to the patient, they should consult their doctor or pharmacist before starting treatment with 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.

Special warnings

Taking Taromentin may worsen the course of some diseases or cause severe side effects, including allergic reactions, seizures, and colitis. The patient should be aware of certain symptoms during treatment with Taromentin to minimize the risk of any problems. See "Special warnings" 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 or pharmacist 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 child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Taromentin may cause side effects and symptoms that can impair the ability to drive or operate machinery.
The patient should not drive or operate machinery unless they feel well.

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 again.

Adults and children over 40 kg

The usual dose is:

• 1 tablet three times a day.

Children under 40 kg

Children under 6 years old should be treated with Taromentin oral suspension.
The patient should consult their doctor or pharmacist before giving Taromentin tablets to children under 40 kg. Taromentin tablets are not intended for use in children under 25 kg.

Patients with kidney and liver disease

• If the patient has kidney disease, the dose of Taromentin 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 often to check how their liver is working.

How to take Taromentin

• Tablets should be swallowed whole, with a glass of water, at the start of a meal or just before a meal.
• The patient should keep equal intervals of at least 4 hours between doses taken during the day. They should not take 2 doses within 1 hour.
• Taromentin should not be taken for more than 2 weeks. If the patient still does not feel well, they should consult their doctor again.

Taking more than the recommended dose of Taromentin

If the patient has taken more than the recommended dose of Taromentin, 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 tablet packaging with them to show the doctor.

Missing a dose of Taromentin

If the patient forgets to take a dose, they should take it as soon as they remember. They should not take the next dose too early; they should wait about 4 hours before taking the next dose. They should not take a double dose to make up for a missed dose.

Stopping treatment with Taromentin

The patient should continue taking Taromentin until the end of the treatment, even if they feel better. All doses of the medicine are needed to fight the infection. If some bacteria survive, they may cause the infection to come back.
If the patient has any further doubts about taking this medicine, they 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 side effects may occur with the use of this medicine.

Special warnings

Allergic 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 the lymph nodes in the neck, armpit, or groin
• swelling, sometimes including the face or mouth (angioedema), which can cause 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.

The patient should stop taking Taromentin.

Colitis

Colitis, which can cause 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)

DIES occurred mainly in children taking 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, the patient should contact their doctor as soon as possible.
Very common side effects(may occur in more than 1 in 10 patients)

• diarrhea (in adults).

Common side effects(may occur in up to 1 in 10 patients)

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

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

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

Uncommon side effects that may appear in blood or urine tests:

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

Rare side effects(may occur in up to 1 in 1,000 patients)

• skin rash, which may be blistering 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 notices any of these symptoms, they should contact their doctor urgently.

Rare side effects that may appear in blood tests:

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

Side effects with unknown frequency(frequency cannot be estimated from available data)

• 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 may include 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, which may include 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 the 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
• Hyperactivity
• Seizures (in people taking high doses of Taromentin or with kidney disease)
• Black hairy tongue, which looks like it is hairy
• Discoloration of teeth (in children), which can usually be removed by brushing.

Side effects that may appear in blood or urine tests:

• markedly decreased 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Taromentin

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
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 and blister.
The expiry date refers to the last day of the month stated.
Do not use if the tablets are broken or damaged in any way.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Taromentin contains

The active substances of Taromentin are amoxicillin and clavulanic acid.
Each film-coated tablet contains 500 mg of amoxicillin as amoxicillin trihydrate and 125 mg of clavulanic acid as potassium clavulanate.
The other ingredients are:
tablet core- povidone, crospovidone, colloidal silica, magnesium stearate, microcrystalline cellulose.
tablet coating- hypromellose, hydroxypropylcellulose, talc, medium-chain triglycerides, titanium dioxide.

What Taromentin looks like and contents of the pack

Oval, biconvex tablets, white to off-white.

Packaging

The pack contains 21 or 14 film-coated tablets.

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A.
ul. A. Fleminga 2
03-176 Warsaw
Phone: 22 811-18-14
For more detailed information on this medicine, the patient should contact the marketing authorization holder.

Date of last revision 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 is that the bacteria are resistant to the antibiotic being taken.
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 only to treat the current illness. Paying attention to the following advice will help prevent the development of resistant bacteria that could reduce the effectiveness of the antibiotic.

• 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 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 someone else, even if they had a similar infection.
• 4. The patient should not give their antibiotics to others.
• 5. If there are any leftover antibiotics after completing the treatment as directed by the doctor, the patient should return them to the pharmacy, which will accept them for proper disposal.