Taromentin

Patient Information Leaflet

Taromentin, 500 mg + 125 mg, film-coated tablets
Amoxicillin + Clavulanic acid
Please read all of this leaflet carefully before taking this medicine, because 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 or pharmacist.
• This medicine has been prescribed for you (or your child). 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, tell your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Taromentin is and what it is used for
2. What you need to know 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 that kills bacteria causing infections.
Taromentin contains two different active substances: amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called “penicillins”, whose action 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 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 function disorders or jaundice (yellowing of the skin) related to the use of an antibiotic.

➢ If any of the above circumstances apply to the patient, Taromentin must not be taken.
If in doubt, consult the treating physician or pharmacist before starting Taromentin.

Warnings and precautions

Before starting Taromentin, consult a 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 conditions apply, consult the treating physician or pharmacist before starting Taromentin.
In some cases, the doctor may test which type of bacteria caused the patient's infection.
Depending on the results, the patient may receive Taromentin at a different dose or another medicine.

Conditions to be aware of

Taking 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 or has recently taken, as well as any medicines the patient 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 treating physician may decide to adjust the dose of Taromentin.
• If the patient is taking anticoagulant medicines (such as warfarin) at the same time as Taromentin, additional blood tests may be required.
• Taromentin may affect the action of methotrexate (a medicine used in the treatment of 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 child, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery

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

3. How to take Taromentin

Taromentin should always be taken according to the doctor's instructions. If in doubt, contact your doctor or pharmacist again.
Adults and children with body weight of 40 kg or more
The usual dose is:

• 1 tablet three times a day.

Children with body weight less than 40 kg
Children aged 6 years or younger should preferably be treated with Taromentin oral suspension.
Consult your doctor or pharmacist before administering Taromentin tablets to children with body weight below 40 kg. Taromentin tablets are not intended for use in children with body weight 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 doctor may prescribe a different dose of Taromentin or an alternative medicine.
• If the patient has liver disease, blood tests may be performed more frequently to monitor liver function.

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 taken during the day. Do not take 2 doses within 1 hour.
• Do not take Taromentin for longer than 2 weeks. If the patient still does not feel well, contact the doctor again.

Taking more Taromentin than recommended
If the patient takes 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.
Missing a dose of Taromentin
If the patient forgets to take a dose, take it as soon as remembered. Do not take the next dose too early; 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 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 further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Below is a list of adverse effects that may occur with the use of 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 also affect other organs
• fever, joint pain, swelling of glands in the neck, armpits or groin
• swelling, sometimes affecting the face or area around the mouth (angioedema), causing difficulty breathing
• fainting
• chest pain related to 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, 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 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 affect more than 1 in 10 people)

• diarrhoea (in adults)

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

• 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 effects (may affect up to 1 in 100 people)

• 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 affect up to 1 in 1,000 people)

• skin rash, possibly with blisters and resembling target-like lesions (a dark spot in the centre surrounded by a lighter ring and 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 blood cells involved in blood clotting (thrombocytes)
• low number of white blood cells

Adverse effects with unknown frequency (frequency cannot be estimated from 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, within which blisters and skin peeling may occur, especially 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 skin rash, within which small pustular blisters may appear (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 ring-like patterns or like a string of pearls (linear IgA dermatosis)

➢ if the patient experiences any of these symptoms, contact a doctor immediately.

• Hepatitis (liver inflammation)
• 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
• Inflammation of the kidney tubules
• Prolonged blood clotting time
• Hyperkinesis (increased motor activity)
• Seizures (in people 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 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 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
Adverse effects can also be reported to the responsible entity.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Taromentin

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Keep in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date (EXP) stated on the cardboard box and blister pack. The expiry date refers to the last day of the stated month.
Do not use if the tablets are chipped 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 in this medicine are amoxicillin and clavulanic acid.
Each coated tablet contains 500 mg amoxicillin as amoxicillin trihydrate and 125 mg clavulanic acid as potassium clavulanate.
Other ingredients are:
tablet core – povidone, crospovidone, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose.
tablet coating – hypromellose, hydroxypropyl cellulose, talc, medium-chain saturated triglycerides, titanium dioxide.

What Taromentin looks like and contents of the pack
Oval, biconvex tablets of white to slightly cream colour.
Packaging
The pack contains 21 or 14 coated tablets.

Marketing Authorisation Holder and Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga Street 2
03-176 Warsaw, Poland
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 antibiotic treatment.
Bacteria may become resistant to antibiotics for various reasons. Careful use of antibiotics can help reduce the risk of developing bacterial resistance.
The antibiotic prescribed by your doctor is intended solely for the treatment of your current illness. Observing the following advice will help prevent the development of resistant bacteria that could interfere with antibiotic effectiveness.

1. It is very important to take the antibiotic at the correct dose, at the correct 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. You should not take an antibiotic unless it has been prescribed specifically for you. You should take it only to treat the infection for which it was prescribed.
3. You should not take an antibiotic prescribed for another person, even if that person had a similar infection.
4. Do not give your prescribed antibiotics to other people.
5. If, after completing the treatment as directed by your doctor, you have any leftover antibiotic, return it to a pharmacy, which will dispose of it properly to ensure safe destruction.