Polcilin

Leaflet attached to the packaging: information for the user

Polcylin

50 mg/mL, granules for oral solution

100 mg/mL, granules for oral suspension

250 mg/mL, granules for oral solution

Phenoxymethylpenicillin potassium

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

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Polcylin and what is it used for

Polcylin contains the active substance phenoxymethylpenicillin (belonging to the group of antibiotics called penicillins). This type of medicine prevents bacteria from building a proper cell wall. Without a functioning cell wall, the bacteria die quickly.
Polcylin is used to treat throat and tonsil inflammation, sinusitis, ear infections, pneumonia, bacterial skin and soft tissue infections, Lyme disease, and dental abscesses in children.

2. Important information before taking Polcylin

When not to take Polcylin

Warnings and precautions

Before starting treatment with Polcylin, discuss it with your doctor or pharmacist:

If the patient experiences a rash, fever, and/or facial swelling, they should stop treatment and contact their doctor.

Polcylin and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans to take.
Polcylin may affect other medicines or other medicines may affect it:

• certain medicines used in cancer and immune system disorders (methotrexate)
• medicines used in gout (probenecid)

Taking Polcylin with food and drink

Although adherence to therapeutic recommendations by the patient may be better if the medicine is taken with a meal, Polcylin should be taken on an empty stomach, i.e., at least 1 hour before a meal or 2 hours after a meal. It works best then.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
There are no known risks associated with taking Polcylin during pregnancy.
Breastfeeding
Phenoxymethylpenicillin potassium passes into breast milk, but it is unlikely to affect breastfed infants.

Driving and using machines

Polcylin has no influence or negligible influence on the ability to drive and use machines.

Polcylin contains aspartame, benzoate, sodium, and sucrose

• Aspartame: This medicine contains aspartame: 50 mg/mL granules for oral solution: 5 mg aspartame/mL 100 mg/mL granules for oral suspension: 10 mg aspartame/mL 250 mg/mL granules for oral solution: 10 mg aspartame/mL Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates in the body because the body cannot remove it properly.
• Benzoate: This medicine contains sodium benzoate: 50 mg/mL granules for oral solution: 3.9 mg sodium benzoate/mL 100 mg/mL granules for oral suspension: 7.8 mg sodium benzoate/mL 250 mg/mL granules for oral solution: 1.5 mg sodium benzoate/mL Benzoate may exacerbate jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of life).
• Sucrose: 50 and 100 mg/mL contain a maximum of 6.6 g per dose. This should be taken into account in patients with diabetes. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicinal product. It may be harmful to teeth.
• Sodium: This medicine contains less than 1 mmol of sodium per mL, which means the medicine is considered "sodium-free".

3. How to take Polcylin

This medicine should always be taken according to the doctor's recommendations. In case of doubts, consult a doctor or pharmacist.
The dose is determined by the doctor. It depends on the type of infection the patient has, their body weight, and age.
Polcylin is in the form of granules before preparation.
Boiled and cooled water should be added to the granules in the bottle.
The amount of water to be added to the granules is indicated on the bottle label.
Shake well to obtain a uniform solution/suspension.
Before each use, shake the bottle well to ensure the solution/suspension is properly mixed.
Measure the dose using a 10 mL measuring cup (50 mg/mL and 100 mg/mL) or a 5 mL measuring syringe (250 mg/mL).

Taking a higher dose of Polcylin than recommended

If the patient has taken too much medicine or, for example, a child has accidentally taken the medicine, they should contact a doctor for an assessment of the risk and advice.
Symptoms of overdose are nausea, vomiting, diarrhea, changes in consciousness, electrolyte imbalance, muscle twitching, seizures, loss of consciousness (coma), severe anemia, and jaundice, as well as kidney failure.

Missing a dose of Polcylin

Do not take a double dose to make up for a missed dose.

Stopping treatment with Polcylin

Even if the patient feels better after a few days, it is essential to complete the full treatment cycle with Polcylin as recommended by the doctor. Otherwise, some bacteria may survive, start growing, and cause a new infection.
In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Polcylin can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people)

• Nausea, diarrhea
• Skin rash

Uncommon side effects (may affect up to 1 in 100 people)

• Fever
• Vomiting
• Oral thrush (infection of the mouth)
• Glossitis (inflammation of the tongue)
• Indigestion
• Joint pain
• Rash (hives), skin swelling, red spots on the skin (erythema multiforme or exfoliative dermatitis). Exfoliative dermatitis is a serious skin disease (characterized by redness and peeling of the skin), consult a doctor or hospital.
• Changes in blood morphology (high eosinophil count)

Rare (may affect up to 1 in 1,000 people)

• Anaphylactic reaction. Stop taking Polcylin and consult a doctor or hospital.

Very rare (may affect up to 1 in 10,000 people)

• Changes in blood morphology: Decreased red blood cell count causing symptoms of anemia, such as fatigue and fever (hemolytic anemia). Decreased white blood cell count, causing increased susceptibility to infections (leukopenia). Decreased platelet count (thrombocytopenia). Decreased white blood cell count, causing fever, infection symptoms, such as sore throat or urinary tract problems (agranulocytosis). These disorders can be severe. In case of fever, consult a doctor immediately.
• Positive direct Coombs test result (test for hemolytic syndromes)

Reporting side effects

If any side effects occur, including those not listed in this leaflet, tell a 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
Aleje 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 gather more information on the safety of the medicine.

5. How to store Polcylin

Keep the medicine out of sight and reach of children.
Polcylin 50 mg/mL oral solution
Polcylin 100 mg/mL oral suspension
Store the solution/suspension in a refrigerator (2°C–8°C).
Shelf life of the solution and suspension: 14 days.
Polcylin 250 mg/mL oral solution
Store the solution in a refrigerator (2°C–8°C).
Shelf life of the solution: 20 days.
Do not use this medicine after the expiry date stated on the label after "EXP".
The expiry date refers to the last day of the month.
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 packaging and other information

What Polcylin contains

• The active substance of Polcylin is phenoxymethylpenicillin potassium. After dissolution, 1 mL of the medicine:
  • 50 mg/mL oral solution contains 50 mg phenoxymethylpenicillin potassium
  • 100 mg/mL oral suspension contains 100 mg phenoxymethylpenicillin potassium
  • 250 mg/mL oral solution contains 250 mg phenoxymethylpenicillin potassium
• Other ingredients are:
  • Polcylin, 50 mg/mL, granules for oral solution: aspartame E951, flavor (orange, caramel), sodium benzoate E211, sodium citrate E331, sucrose, povidone, propylene glycol E1520

•
Polcylin, 100 mg/mL, granules for oral suspension: aspartame E951, flavor (lemon, cocoa), sodium benzoate E211, sodium citrate E331, sucrose, titanium dioxide E171, povidone, propylene glycol E1520
•
Polcylin, 250 mg/mL, granules for oral solution: aspartame E951, flavor (grapefruit, apricot), sodium benzoate E211, sodium citrate E331, sucrose, povidone

Contents of the packaging and other information

Granules for oral suspension and solution: White or almost white granules.
Suspension/Solution after reconstitution:
Polcylin, 50 mg/mL, granules for oral solution: Clear solution.
Polcylin, 100 mg/mL, granules for oral suspension: Homogeneous white or almost white suspension.
Polcylin, 250 mg/mL, granules for oral solution: Clear solution.
Package sizes:
Polcylin 50 and 100 mg/mL granules for oral solution/suspension: 60, 125, and 200 mL with a 10 mL measuring cup.
Polcylin 250 mg/mL granules for oral solution: 20 and 40 mL with a 5 mL measuring syringe.
Not all package sizes may be marketed.

Marketing authorization holder

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Phone number: (22) 811 18 14
For more detailed information about this medicine, consult the marketing authorization holder.

Importer

EQL Pharma AB
Stortorget 1
222 23 Lund
Sweden

Date of last update of the leaflet: