Taromentin

Package Leaflet: Information for the User

Taromentin, 875 mg + 125 mg, Film-Coated Tablets

Amoxicillin + Clavulanic Acid

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

• Keep this package leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you (or your child). Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 package 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 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 you are allergic 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 function disorders or jaundice (yellowing of the skin) associated with taking an antibiotic.

➢ If any of these conditions apply to you, do not take Taromentin.
If you are unsure, consult your doctor or pharmacist before taking Taromentin.

Warnings and precautions

Before taking Taromentin, consult your doctor or pharmacist if you:

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

If you are unsure whether these conditions apply to you, consult your doctor or pharmacist before taking Taromentin.
In some cases, your doctor may test the type of bacteria that caused your infection.
Depending on the results, you may be given Taromentin in a different dose or a different medicine.

Conditions to watch out for

Taking Taromentin may worsen the course of some diseases or cause severe side effects, including allergic reactions, seizures, and colitis. You should be aware of certain symptoms to minimize the risk of any problems. See "Conditions to watch out for" in section 4.

Blood and urine tests

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

Taromentin and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
If you are taking allopurinol (used for gout) with Taromentin, you may be more likely to experience skin allergic reactions.
If you are taking probenecid (used for gout), your doctor may decide to adjust the dose of Taromentin.
If you are taking blood-thinning medicines (such as warfarin) with Taromentin, you 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Taromentin may cause side effects and symptoms that can impair your ability to drive or operate machinery.
Do not drive or operate machinery unless you feel well.

3. How to take Taromentin

Always take Taromentin exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

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

• Usual dose - 1 tablet twice a day.
• Larger dose - 1 tablet three times a day.

Children with a body weight of less than 40 kg

Children under 6 years of age should preferably be treated with Taromentin in the form of an oral suspension.
Consult your doctor or pharmacist before giving Taromentin tablets to children with a body weight below 40 kg. Taromentin tablets are not intended for use in children with a body weight of less than 25 kg.

Patients with kidney and liver diseases

• If you have kidney disease, your doctor may adjust the dose of Taromentin.
• If you have liver disease, you may need to have more frequent blood tests to check how your liver is working.

How to take Taromentin

• Swallow the tablets whole with a glass of water, at the start of a meal or just before a meal.
• Keep equal intervals of at least 4 hours between doses taken during the day. Do not take 2 doses within 1 hour.
• Do not take Taromentin for more than 2 weeks. If you still do not feel better, consult your doctor.

Taking a higher dose of Taromentin than recommended

If you take more Taromentin than you should, you may experience symptoms such as stomach and intestinal irritation (nausea, vomiting, or diarrhea) or seizures. Contact your doctor as soon as possible. Have the carton of the medicine with you to show the doctor.

Missing a dose of Taromentin

If you forget to take a dose, take it as soon as you remember. Do not take the next dose too early; wait about 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 until you finish your treatment, even if you 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 you have any further doubts about taking this medicine, consult your 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 when taking this medicine.

Conditions to watch out for

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 the lymph nodes in the neck, armpit, or groin
• swelling, sometimes involving 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 you experience any of these symptoms, contact your doctor immediately.

Stop taking Taromentin.

Colitis

Colitis, which can cause watery diarrhea, usually with blood and mucus, abdominal pain, and (or) fever.

Acute pancreatitis

If you have 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 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 you experience any of these symptoms, contact your 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, take Taromentin before meals
• 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 1000 patients)

• skin rash, which may be accompanied by blisters and look like small targets (dark spot in the center surrounded by a lighter border with a dark ring around the edge - erythema multiforme) ➢ if you notice any of these symptoms, contact your 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)

• Hypersensitivity 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, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing widespread skin peeling (more than 30% of body surface - toxic epidermal necrolysis)
• widespread red skin rash, which may include small pus-filled blisters (bullous 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 increased white blood cell count (eosinophilia) and increased liver enzyme activity]; drug reaction with eosinophilia and systemic symptoms (DRESS)
• rash with blisters arranged in a ring or as a string of pearls (linear IgA dermatosis).

➢ If you experience any of these symptoms, contact your doctor immediately.

• Hepatitis
• Jaundice, caused by increased bilirubin levels 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 a hairy tongue
• Discoloration of teeth (in children), which can usually be removed by brushing.

Side effects that may appear in blood or urine tests:

• significantly 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 you experience any side effects, including those not listed in this package leaflet, tell your 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
e-mail: https://smz.ezdrowie.gov.pl
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

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Store in the original package 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.
Do not use if the tablets are crushed or damaged in any way.
Medicines should 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 package and other information

What Taromentin contains

The active substances of Taromentin are amoxicillin and clavulanic acid.
Each film-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 silica, magnesium stearate, microcrystalline cellulose.
tablet coating- hypromellose, calcium carbonate, talc, medium-chain triglycerides, hydroxypropylcellulose.

What Taromentin looks like and contents of the package

Oval, biconvex tablets, white to off-white.

Packaging

The package contains 14 or 21 film-coated 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 detailed information on this medicine, contact the marketing authorization holder.

Date of last revision of the package 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 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 developing resistance.
The antibiotic prescribed by your doctor is intended only to treat your current illness. 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 right dose, at the right time, and for the right number of days. Read the instructions in the package leaflet and if you do not understand any of them, ask your doctor or pharmacist to explain.
• 2. You should not take an antibiotic that was not prescribed for you. You should only take it to treat the infection for which it was prescribed.
• 3. You should not take an antibiotic prescribed for someone else, even if they had a similar infection.
• 4. Do not give your antibiotics to others.
• 5. If you have any leftover antibiotic after completing your treatment as directed by your doctor, return it to the pharmacy, which will dispose of it properly.