Polamoklav

Package leaflet: Information for the user

Polamoklav, 875 mg + 125 mg, film-coated tablets
Amoxicillinum + Acidum clavulanicum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• 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, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Polamoklav is and what it is used for
2. Important information before taking Polamoklav
3. How to take Polamoklav
4. Possible side effects
5. How to store Polamoklav
6. Contents of the pack and other information

1. What Polamoklav is and what it is used for

Polamoklav is an antibiotic with bactericidal activity against bacteria causing infections.
Polamoklav 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 ingredient (clavulanic acid) counteracts this inactivation.
Polamoklav 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 Polamoklav

When not to use Polamoklav:

• 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 to any other antibiotic. These may include skin rash or swelling of the face or throat.
• 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 the above situations apply to the patient, Polamoklav must not be taken.
➔ In case of doubt, consult the patient's doctor or pharmacist before starting Polamoklav.
Warnings and precautions
Before starting Polamoklav, discuss with the doctor 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 to the patient, consult a doctor or pharmacist before starting Polamoklav.
In some cases, the doctor may test which type of bacteria caused the patient's infection.
Depending on the results, the patient may receive Polamoklav at a different dose or another medicine.
Conditions to be aware of
Taking Polamoklav 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 experiences certain symptoms during treatment with Polamoklav to reduce the risk of complications. See “Symptoms 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 Polamoklav. Polamoklav may affect the results of such tests.
Polamoklav with other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
If allopurinol (used in gout) is taken at the same time as Polamoklav, skin allergic reactions may be more likely.
Probenecid (used in the treatment of gout) – concomitant use of probenecid may reduce the elimination of amoxicillin and is not recommended. The doctor may decide to adjust the dose of Polamoklav.
If the patient is taking anticoagulant medicines (such as warfarin) together with Polamoklav, additional blood tests may be required.
Methotrexate (used in the treatment of cancer and severe psoriasis) – penicillins may reduce methotrexate elimination, increasing the risk of adverse effects.
Polamoklav may affect the action of mycophenolate mofetil (a medicine used to prevent transplant rejection).
Pregnancy, breastfeeding, and fertility
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
Polamoklav may cause adverse effects and symptoms that may impair the ability to drive.
Do not drive or operate machinery unless the patient feels well.
Polamoklav contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning it is considered "sodium-free".

3. How to use Polamoklav

This medicine should always be used exactly as directed by the doctor. In case of doubt, consult the doctor or pharmacist.

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 Polamoklav oral suspension. Consult the doctor or pharmacist before using Polamoklav tablets in children with body weight below 40 kg. Polamoklav 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 problems, the dose of the medicine may need to be adjusted. The doctor may prescribe a different dose of Polamoklav or an alternative medicine.
• If the patient has liver problems, blood tests to monitor liver function may be performed more frequently.

How to take Polamoklav

• Take the medicine with food.
• Swallow the tablets whole with a glass of water. The tablets may be divided along the break line to facilitate swallowing. Both parts of the tablet should be taken at the same time.
• 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 Polamoklav for longer than 2 weeks. If the patient still does not feel better, he/she should contact the doctor again.

Taking more Polamoklav than recommended
If a patient takes more Polamoklav than recommended, symptoms may include stomach and intestinal irritation (nausea, vomiting, or diarrhoea) or seizures. Contact a doctor as soon as possible. Keep the cardboard packaging of the medicine to show it to the doctor.

If a dose of Polamoklav is missed
If a patient forgets to take a dose, it should be taken 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 Polamoklav treatment
Continue taking Polamoklav 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 there are any further doubts about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The adverse reactions that may occur with the use of this medicine are listed below.
Symptoms to watch for
Allergic reactions:

• Skin rash
• Vasculitis (inflammation of blood vessels), 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 throat (angioedema), causing difficulty in breathing
• Fainting
• Chest pain associated with an allergic reaction, possibly indicating an allergy leading to heart attack (Kounis syndrome).

➔ If any of these symptoms occur, contact a doctor immediately.
Discontinue Polamoklav treatment.
Colitis (inflammation of the large intestine)
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 (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 (1-4 hours after taking the medicine). Further symptoms may include abdominal pain, lethargy, diarrhoea, and low blood pressure.
Crystals in urine leading to acute kidney injury.
Bullous rash arranged in a ring-like pattern with scabs in the central part or resembling a string of pearls (linear IgA dermatosis).
Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).
➔ If any of these symptoms occur, contact your 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 less than 1 in 10 patients)

• Fungal infections (candidiasis – yeast infections of the vagina, mouth or skin folds)
• Nausea, especially when high doses are used ➔ if this occurs, take Polamoklav with food
• 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 test results:

• 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 appearing as small targets (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 reactions that may appear in blood test results:

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

Adverse reactions with unknown frequency (frequency cannot be estimated from available data)

• Allergic reactions (see above).
• Colitis (see above).
• Severe skin reactions:
  • Widespread skin rash, with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genital organs (bullous erythema multiforme – Stevens-Johnson syndrome), and a more severe form causing extensive skin peeling (over 30% of body surface – toxic epidermal necrolysis – Lyell's syndrome)
  • Widespread red skin rash with small pustules filled with pus (pustular exfoliative dermatitis)
  • Red, scaly rash with subcutaneous nodules and blisters (acute generalised exanthematous pustulosis)
  • Influenza-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).

➔ If any of these symptoms occur in the patient, contact a doctor immediately.

• Hepatitis (inflammation of the liver).
• 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.
• Nephritis (inflammation of kidney tubules).
• Prolonged blood clotting time.
• Psychomotor hyperactivity.
• Seizures (in patients receiving high doses of Polamoklav or with kidney disease).
• Black hairy tongue.

Adverse reactions 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).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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 Polamoklav

No special storage instructions are required for this medicine.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack
following "EXP". The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Following this advice helps
protect the environment.

6. Contents of the pack and other information

What Polamoklav contains

• The active substances 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: microcrystalline cellulose, sodium carboxymethyl starch (type A), colloidal anhydrous silica, magnesium stearate.
  Coating: Opadry 06B58855 White, hypromellose 5 mPa·s, titanium dioxide (E 171), polyethylene glycol 400, hypromellose 15 mPa·s.

What Polamoklav looks like and contents of the pack
Polamoklav 875 mg + 125 mg film-coated tablets are white, capsule-shaped, film-coated tablets, embossed with the letter "A" on one side and a line between the digits "6" and "5" on the other side, measuring 22.2 mm x 10.2 mm.
The line on the tablet is intended only to facilitate breaking the tablet for easier swallowing and does not indicate division into equal doses.

• The pack contains 14 film-coated tablets.

Marketing Authorisation Holder and Importer
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland
Tel.: +48 24 357 44 44
Fax: +48 24 357 45 45
e-mail: [email protected]