POLAMOKLAV 875 mg/125 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Polamoklav, 875 mg + 125 mg, film-coated tablets
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Polamoklav and what is it used for
4. Important information before taking Polamoklav
   1. When not to take Polamoklav:
   2. If the above circumstances apply to the patient, they should not take Polamoklav.
   3. Warnings and precautions
   4. Conditions to be aware of
   5. Blood and urine tests
   6. Polamoklav and other medicines
   7. Pregnancy, breastfeeding, and fertility
   8. Driving and using machines
   9. Polamoklav contains sodium
5. How to take Polamoklav
   1. Adults and children with a body weight of 40 kg or more
   2. Children with a body weight of less than 40 kg
   3. Patients with kidney and liver diseases
   4. How to take Polamoklav
   5. Taking a higher dose of Polamoklav than recommended
   6. Missing a dose of Polamoklav
   7. Stopping treatment with Polamoklav
6. Possible side effects
   1. Symptoms to be aware of
   2. Allergic reactions:
   3. If any of these symptoms occur, the patient should contact their doctor immediately. They should stop taking Polamoklav.
   4. Colitis
   5. Acute pancreatitis
   6. Drug-induced colitis (DIES)
   7. If any of these symptoms occur, the patient should contact their doctor as soon as possible.
   8. If the patient experiences any of these symptoms, they should contact their doctor immediately.
   9. Reporting side effects
7. How to store Polamoklav
8. Contents of the pack and other information
   1. What Polamoklav contains
   2. What Polamoklav looks like and contents of the pack
   3. Marketing authorization holder and importer
   4. Date of last revision of the leaflet:

Leaflet attached to the packaging: information for the user

Polamoklav, 875 mg + 125 mg, film-coated tablets

Amoxicillin + Clavulanic acid

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

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed for a specific person. 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 Polamoklav and what is it 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 is Polamoklav and what is it used for

Polamoklav is an antibiotic that works by killing bacteria that cause infections.
Polamoklav contains two different medicines: amoxicillin and clavulanic acid. Amoxicillin belongs to
a group of medicines called "penicillins", which can sometimes be inactivated (neutralized). 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 taking Polamoklav

When not to take 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 had severe allergic reactions to any other antibiotic. These can 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 the above circumstances apply to the patient, they should not take Polamoklav.

➔
In case of doubt, before starting treatment with Polamoklav, the patient should consult their doctor or pharmacist.

Warnings and precautions

Before starting treatment with Polamoklav, the patient should discuss it with their doctor if they:

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

In case of doubt as to whether the above circumstances apply to the patient, they should consult their doctor or pharmacist before starting treatment with Polamoklav.
In some cases, the doctor may test what type of bacteria caused the patient's infection.
Depending on the results, the patient may receive Polamoklav in a different dose or a different medicine.

Conditions to be aware of

Taking Polamoklav 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 Polamoklav to minimize the risk of any problems. See "Symptoms to be aware of"in section 4.

Blood and urine tests

If the patient is to have blood tests (such as red blood cell count or liver function tests) or urine tests (for glucose), they should inform their doctor or nurse that they are taking Polamoklav. Polamoklav may affect the results of these tests.

Polamoklav 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 in gout) at the same time as Polamoklav, they may be more likely to experience skin allergic reactions.
Probenecid (used to treat gout) - concurrent use of probenecid may reduce the excretion of amoxicillin and is not recommended. The doctor may decide to modify the dose of Polamoklav.
If the patient is taking blood thinning medicines (such as warfarin) at the same time as Polamoklav, they may need to have additional blood tests.
Methotrexate (used to treat cancer and severe psoriasis) - penicillins may reduce the excretion of methotrexate, potentially leading to increased side 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, 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

Polamoklav 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.

Polamoklav contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means that the medicine is considered "sodium-free".

3. How to take Polamoklav

This medicine should always be taken as directed by the doctor. In case of doubt, the patient should consult their 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 Polamoklav in the form of an oral suspension. The patient should consult their doctor or pharmacist before taking Polamoklav tablets in children with a body weight below 40 kg. Polamoklav tablets are not intended for use in children with a body weight of less than 25 kg.

Patients with kidney and liver diseases

• If the patient has kidney disease, the dose of the medicine may be changed. The doctor may choose a different dose of Polamoklav 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 Polamoklav

• The medicine should be taken with food.
• The tablets should be swallowed whole with a glass of water. The tablets can be broken in half along the break line to make them easier to swallow. Both halves of the tablet should be taken at the same time.
• The patient should maintain equal intervals of at least 4 hours between doses taken during the day. They should not take 2 doses within 1 hour.
• The patient should not take Polamoklav for longer than 2 weeks. If they still do not feel well, they should contact their doctor again.

Taking a higher dose of Polamoklav than recommended

If the patient has taken a higher dose of Polamoklav than recommended, symptoms may include stomach and intestinal irritation (nausea, vomiting, or diarrhea) or seizures. The patient should contact their doctor as soon as possible. They should have the carton of the medicine with them to show the doctor.

Missing a dose of Polamoklav

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, but 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 Polamoklav

The patient should continue taking Polamoklav until the end of the treatment, even if they feel better. All doses of the medicine are needed to combat the infection. If some bacteria survive, they may cause a relapse of the infection.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Polamoklav can cause side effects, although not everybody gets them.
The following side effects may occur in connection with the use of this medicine.

Symptoms to be aware of

Allergic reactions:

• skin rash
• vasculitis, which can appear as red or purple, raised spots on the skin, but can also affect other organs
• fever, joint pain, swelling of the lymph nodes in the neck, armpit, or groin
• swelling, sometimes involving the face or throat (angioedema), causing difficulty breathing
• fainting
• chest pain associated with an allergic reaction, which can 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. They should stop taking Polamoklav.

Colitis

Colitis, causing 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 colitis (DIES)

Drug-induced colitis occurred mainly in children receiving amoxicillin with clavulanic acid. It is a type of allergic reaction, the leading symptom of which is repeated vomiting (1-4 hours after taking the medicine). Further symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.
Crystals in the urineleading to acute kidney damage.
Blistering rasharranged in a ring shape with crusts in the center or like a string of pearls (linear IgA dermatosis).
Meningitis(aseptic meningitis).
➔

If any of these symptoms occur, the patient should contact their doctor as soon as possible.

Very common side effects(may occur more often than in 1 in 10 patients)

• diarrhea (in adults).

Common side effects(may occur less often than in 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 Polamoklav with food
• vomiting
• diarrhea (in children).

Uncommon side effects(may occur less often than in 1 in 100 patients)

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

Uncommon side effects that may be revealed by blood tests:

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

Rare side effects(may occur less often than in 1 in 1000 patients)

• skin rash, which can occur with blisters and look like small targets (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 be revealed by 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 the available data)

• Allergic reactions (see above).
• Colitis (see above).
• Severe skin reactions:
• -widespread skin rash, which can occur with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (bullous erythema multiforme - Stevens-Johnson syndrome), and a more severe form causing widespread peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis - Lyell syndrome)
• -widespread red skin rash, which can occur with 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 increased white blood cell count (eosinophilia) and increased liver enzyme activity); drug reaction with eosinophilia and systemic symptoms (DRESS).

➔

If the patient experiences any of these symptoms, they should contact their doctor immediately.

• Hepatitis.
• Jaundice, caused by an increase in bilirubin (a substance produced in the liver) in the blood, which can cause yellowing of the skin and eyes.
• Tubulointerstitial nephritis.
• Prolonged blood clotting time.
• Hyperactivity.
• Seizures (in people taking high doses of Polamoklav or with kidney disease).
• Black hairy tongue.

Side effects that may be revealed by blood or urine tests:

• significantly reduced number of white blood cells
• low number of red blood cells (hemolytic anemia).

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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
Website: 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 the medicine.

5. How to store Polamoklav

There are no special precautions for storing the medicine.
The medicine should be stored out of sight and reach of children.
The patient should not use this medicine after the expiry date stated on the carton and blister after: "EXP". The expiry date refers to the last day of the month.
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 Polamoklav contains

• The active substances of the medicine are amoxicillin and clavulanic acid. One 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 carboxymethylcellulose (type A), colloidal anhydrous silica, magnesium stearate. Coating: Opadry 06B58855 White, hypromellose 5 mPa s, titanium dioxide (E 171), macrogol 400, hypromellose 15 mPa s

What Polamoklav looks like and contents of the pack

Polamoklav, 875 mg + 125 mg, film-coated tablets are white film-coated tablets in the shape of a capsule with the inscription "A" on one side and a line between the numbers "6" and "5" on the other side of the tablet, with dimensions of 22.2 mm x 10.2 mm.
The line on the tablet is only to facilitate breaking it, for easier swallowing, and not for dividing into equal doses.

• The pack contains 14 film-coated tablets.

Marketing authorization holder and importer

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Polska (Poland)
Phone: +48 24 357 44 44
Fax: +48 24 357 45 45
e-mail: [email protected]

Date of last revision of the leaflet: