Polcilin

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Table of Contents of the Package 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 pack and other information

1. What is Polcylin and what is it used for

Polcylin contains the active substance phenoxymethylpenicillin (belonging to a group of antibiotics called penicillins). This type of medicine prevents bacteria from building a proper cell wall. Without a functioning cell wall, the bacterium dies quickly.
Polcylin is used to treat throat and tonsil infections, 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 taking Polcylin, discuss with your doctor or pharmacist:

If you experience a rash, fever, and/or facial swelling, stop treatment and contact your doctor.

Polcylin and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might 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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice 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 babies.

Driving and using machines

Polcylin has no 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 properly remove it.
• 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 you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. It may be harmful to teeth.
• Sodium: This medicine contains less than 1 mmol sodium per mL, i.e., the medicine is considered "sodium-free".

3. How to take Polcylin

This medicine should always be taken exactly as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
The dose is determined by your doctor. It depends on the type of infection you have, your body weight, and age.
Polcylin is in the form of granules before preparation.
Add the appropriate amount of boiled, cooled water to the bottle with granules.
The amount of water to be added to the granules is given 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 well mixed.
Measure the dose using a measuring cup with a capacity of 10 mL (50 mg/mL and 100 mg/mL) or a dosing syringe with a capacity of 5 mL (250 mg/mL).

Overdose of Polcylin

If you have taken too much of this medicine or if, for example, a child has taken this medicine by mistake, contact your 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 forgotten dose.

Stopping treatment with Polcylin

Even if you feel better after a few days, it is important to take the full course of treatment with Polcylin as directed by your doctor. Otherwise, some bacteria may survive, start to grow again, and cause a new infection.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

• Nausea, diarrhea
• Skin rash

Uncommon (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 condition (characterized by redness and peeling of the skin), contact your 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 contact your 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, signs of infection, such as sore throat or urinary problems (agranulocytosis). These disorders can be serious. If you experience fever, contact your doctor immediately.
• Positive direct Coombs test (test for hemolytic syndromes)

Reporting side effects

If you experience any side effects, including those not listed in this 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
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Polcylin

Keep this medicine out of the sight and reach of children.
Polcylin 50 mg/mL oral solution
Polcylin 100 mg/mL oral suspension
Store the oral 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 oral 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 pack and other information

What Polcylin contains

• The active substance 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 pack 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/oral suspension: 60, 125, and 200 mL with a measuring cup of 10 mL.
Polcylin 250 mg/mL granules for oral solution: 20 and 40 mL with a dosing syringe of 5 mL.
Not all pack sizes may be marketed.

Marketing authorization holder

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

Importer

EQL Pharma AB
Stortorget 1
222 23 Lund
Sweden

Date of last revision of the package leaflet: