Penlac

Patient Information Leaflet

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

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you (or your child) only. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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

1. What Penlac is and what it is used for

Penlac is an antibiotic with bactericidal activity against bacteria causing infections. Penlac contains two different active substances: amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins", whose activity may sometimes be inhibited (inactivated). The second active component (clavulanic acid) counteracts this inactivation.
Penlac 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. Information before using Penlac

When not to use Penlac:

• 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 may include skin rash or swelling of the face or throat.
• If the patient has ever experienced liver problems or jaundice (yellowing of the skin) related to taking an antibiotic.

➔ If any of the above apply, the patient should not take Penlac.
If in doubt, consult the doctor or pharmacist before starting treatment with Penlac.
Warnings and precautions
Talk to your doctor or pharmacist before taking Penlac if the patient:

• has infectious mononucleosis,
• is being treated for liver or kidney disease,
• urinates irregularly.

If in doubt whether any of the above apply, consult the doctor or pharmacist before starting treatment with Penlac.
In some cases, the doctor may test which type of bacteria caused the infection.
Depending on the results, the patient may receive Penlac at a different dose or another medicine.
Conditions to be aware of
Treatment with amoxicillin and clavulanic acid may worsen certain diseases or cause serious adverse effects, including allergic reactions, seizures, and colitis. It is important to monitor whether the patient develops specific symptoms during treatment with amoxicillin and clavulanic acid 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 Penlac. This is because amoxicillin with clavulanic acid may affect the results of such tests.
Penlac and other medicines
Tell 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. This includes medicines purchased without a prescription and herbal medicines.
If the patient is taking:

• allopurinol (used for gout), skin allergic reactions may be more likely.
• probenecid (used for gout), the doctor may decide to adjust the dose of Penlac.
• anticoagulant medicines (such as warfarin), additional blood tests may be needed.
• methotrexate (a medicine used to treat cancer or rheumatic diseases).
• mycophenolate mofetil (a medicine used to prevent transplant rejection).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
Penlac may cause adverse effects and symptoms that could impair the ability to drive. Do not drive or operate machinery unless the patient feels well.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Penlac

This medicine should always be used as directed by the doctor. If in doubt, consult your
attending physician or pharmacist.
Adults and children with body weight of 40 kg or more
• The recommended dose is 1 tablet twice daily.
• The higher recommended dose is 1 tablet three times daily.
Children with body weight less than 40 kg

• Children aged 6 years or younger should preferably be treated with amoxicillin with clavulanic acid in the form of an oral suspension or sachets.
• Consult your attending physician or pharmacist before using Penlac tablets in children with body weight below 40 kg. 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 attending physician may prescribe a different dose or another medicine.
• If the patient has liver disease, blood tests to monitor liver function may be performed more frequently.

How to use Penlac

• Swallow the tablets whole with a glass of water at the beginning of a meal or slightly earlier. Tablets may be broken along the score 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 administered during the day. Do not take 2 doses within 1 hour.
• Do not use Penlac for longer than two weeks. If the patient still does not feel better, contact the doctor again.

Taking more Penlac than recommended
If a patient takes more Penlac than recommended, symptoms such as stomach irritation (nausea, vomiting, or diarrhea) or seizures may occur. Contact your attending physician as quickly as possible. Keep the cardboard packaging of the medicine to show it to the doctor.
Missed dose of Penlac
If a patient forgets to take a dose, take it as soon as they remember. 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 Penlac treatment
Continue taking Penlac 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 a recurrence of infection.
If you have any further doubts about using 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.
Conditions to be aware of

• Allergic reactions:
• skin rash
• vasculitis, which may appear as red or purple raised spots on the skin, but may affect other organs
• fever, joint pain, swelling of glands in the neck, underarm, or groin
• swelling, sometimes involving the face or throat (angioedema), causing difficulty in 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, seek immediate medical advice.
Discontinue use of Penlac immediately.
Colitis (inflammation of the large intestine)
Colitis causing watery diarrhoea, usually with blood and mucus, abdominal pain and (or) fever.
Acute pancreatitis (inflammation of the pancreas)
If you have severe and persistent pain in the stomach area, this may be a sign of acute pancreatitis.
Drug-induced enteritis (DIES)
Drug-induced enteritis has occurred mainly in children receiving amoxicillin. It 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.
➔ If any of these symptoms occur, contact your doctor as soon as possible for advice.
Very common: may occur in more than 1 in 10 patients

• diarrhoea (in adults)

Common: may occur in less than 1 in 10 patients

• fungal infections (candidiasis – yeast infections of the vagina, mouth, or skin folds)
• nausea, particularly when high doses are used. If nausea occurs, take Penlac with food
• vomiting
• diarrhoea (in children)

Uncommon: may occur in up to 1 in 100 patients

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

Uncommon adverse effects that may be revealed in blood tests:

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

Rare: may occur in up to 1 in 1000 patients

• skin rash, possibly with blisters and appearing as target-like lesions (dark spot in the centre surrounded by a lighter ring and a dark ring at 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

Frequency not known: frequency cannot be estimated from the available data

• allergic reactions (see above)
• colitis (see above)
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• severe skin reactions:
  • widespread skin rash, possibly with blisters and skin peeling, particularly 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 rash with small pus-filled blisters (bullous exfoliative dermatitis)
  • red, scaly rash with subcutaneous nodules and blisters (acute generalized 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)
  • red rash most commonly appearing on both sides of the buttocks, upper inner thighs, underarms, and neck (symmetrical drug-related intertriginous and flexural exanthema, SDRIFE)

➔ If the patient experiences any of these symptoms, seek immediate medical advice.

• blistering rash arranged in a ring-like pattern with crusts in the central area or resembling a string of pearls (linear IgA dermatosis)
• hepatitis (liver inflammation)
• jaundice, caused by increased levels of bilirubin (a substance produced in the liver) in the blood, which may lead to yellowing of the skin and whites of the eyes
• inflammation of the kidney tubules
• prolonged blood clotting time
• hyperkinesia (increased motor activity)
• seizures (in patients receiving high doses of Penlac or with kidney disease)
• black hairy tongue

Adverse effects that may appear in blood or urine tests:

• marked decrease in the number of white blood cells
• low number of red blood cells (haemolytic anaemia)
• crystals in the urine leading to acute kidney injury

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 effects can also be reported to the Marketing Authorisation Holder or its representative in Poland.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Penlac

Do not store above 25°C. Keep in the original packaging to protect from moisture.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container or blister after:
"EXP". The expiry date refers to the last day of the stated 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 Penlac contains:

• The active substances are amoxicillin and clavulanic acid.
• Each coated tablet contains 875 mg amoxicillin as amoxicillin trihydrate and 125 mg clavulanic acid as potassium clavulanate.
• The other ingredients are:
  • tablet core: microcrystalline cellulose, crospovidone type A, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate;
  • coating: basic butyl methacrylate copolymer, titanium dioxide (E 171), talc, macrogol 6000.

What Penlac looks like and contents of the pack
Penlac is a white to off-white, elongated, coated tablet with a score line.
Penlac is available in blisters containing 10, 12, 14, 20, 21 or 24 coated tablets.
Not all pack sizes and types may be marketed.
Marketing Authorisation Holder
Zentiva, k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic
Manufacturer
Pencef Pharma GmbH
Breitenbachstrasse 13-14
13509 Berlin
Germany
Prestige Promotion Verkaufsförderung
& Werbeservice GmbH
Borsigstraße 2
63755 Alzenau
Germany
This medicinal product is authorised in the European Economic Area countries under the following names:
Italy Amoxicillina e Acido clavulanico Zentiva Italia
Netherlands Amoxicilline/Clavulaanzuur Zentiva
Bulgaria, Czech Republic, Poland, Slovakia Penlac
Germany Amoxicillin/Clavulansäure Zentiva
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 the use of the antibiotic.
Bacteria may become resistant to antibiotics for various reasons. Careful use of antibiotics may help reduce the development of 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 hinder the effectiveness of antibiotics.

1. It is very important to take the antibiotic at the correct dose, at the right time, and for the correct number of days. Please read the instructions provided in the package leaflet and, if any are unclear, ask your doctor or pharmacist for clarification.
2. Do 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. Do not take an antibiotic prescribed for another person, even if they had a similar infection.
4. Do not give your prescribed antibiotics to other people.
5. If any antibiotic remains after completing the treatment as advised by your doctor, return it to the pharmacy for proper disposal.