Penlac

Leaflet attached to the packaging: patient information

Penlac, 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 to you (or your child) only. 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 Penlac and what is it 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 is Penlac and what is it used for

Penlac is an antibiotic that works by killing bacteria that cause infections. Penlac contains two different medicines: amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called "penicillins", which are sometimes inactivated (inhibited). The second active ingredient (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. Important information before taking Penlac

When not to take 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 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 Penlac.

In case of doubts, before starting to take Penlac, the patient should consult their doctor or pharmacist.

Warnings and precautions

Before starting to take Penlac, the patient should discuss it with their doctor or pharmacist if they:

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

In case of doubts whether the above circumstances apply to the patient, they should consult their doctor or pharmacist before starting to take Penlac.

In some cases, the doctor may examine what type of bacteria caused the patient's infection.

Depending on the results, the patient may receive Penlac in a different dose or a different medicine.

Conditions to watch out for

Taking amoxicillin with clavulanic acid can worsen the course of some diseases or cause severe side effects, including allergic reactions, seizures, and colitis.

Attention should be paid to whether the patient experiences certain symptoms during the use of amoxicillin with clavulanic acid, in order to reduce the risk of any problems.

See "Conditions to watch out for" in section 4.

Blood and urine tests

If the patient is to have blood tests (such as red blood cell tests or liver function tests) or urine tests (for glucose), they should inform their doctor or nurse that they are taking Penlac.

This is because amoxicillin with clavulanic acid may affect the results of these tests.

Penlac 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.

This includes medicines that can be bought without a prescription and herbal medicines.

If the patient is taking:

• allopurinol (used in gout), it is more likely that the patient will experience skin allergic reactions.
• probenecid (used in gout), the doctor may decide to modify the dose of Penlac.
• blood thinners (such as warfarin), additional blood tests may be necessary.
• 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, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and operating machinery

Penlac may cause side effects and symptoms that can disrupt the ability to drive vehicles.

The patient should not drive vehicles or operate machinery unless they feel well.

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

3. How to take Penlac

This medicine should always be taken as directed by the doctor.

In case of doubts, the patient should consult their doctor or pharmacist.

Adults and children with a body weight of 40 kg or more

The recommended dose is 1 tablet twice a day.

The recommended higher dose is 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 amoxicillin and clavulanic acid in the form of an oral suspension or sachets.
• The patient should consult their doctor or pharmacist before taking Penlac tablets in children with a body weight below 40 kg.
• 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 the medicine or a different medicine.
• If the patient has liver disease, blood tests to check liver function may be performed more frequently.

How to take Penlac

• Tablets should be swallowed whole with a glass of water at the beginning of a meal or shortly before.
• Tablets can be broken along the dividing line to facilitate swallowing.
• The patient should take both parts of the tablet at the same time.
• The patient should maintain equal intervals of at least 4 hours between doses taken during the day.
• The patient should not take 2 doses within 1 hour.
• The patient should not take Penlac for longer than 2 weeks.
• If the patient still does not feel well, they should contact their doctor again.

Taking a higher dose of Penlac than recommended

If the patient has taken a higher dose of Penlac than recommended, they may experience symptoms such as stomach upset (nausea, vomiting, or diarrhea) or seizures.

The patient should contact their doctor as soon as possible.

The patient should have the carton of the medicine with them to show the doctor.

Missing a dose of Penlac

If the patient forgets to take a dose, they should take it as soon as they remember.

The patient should not take the next dose too early and should wait about 4 hours before taking the next dose.

The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Penlac

The patient should continue to take Penlac until the end of the treatment, even if they feel better.

All doses of the medicine are necessary 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, Penlac can cause side effects, although not everybody gets them.

Conditions to watch out for

• 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)

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

The patient should stop taking Penlac.

Colitis

Colitis, causing watery diarrhea, usually with blood and mucus, abdominal pain, and (or) fever.

Acute pancreatitis (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.

This 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.

➔

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

Very common:may occur more frequently than in 1 in 10 patients

• diarrhea (in adults)

Common:may occur less frequently than in 1 in 10 patients

• thrush (candidiasis - fungal infections of the vagina, mouth, or skin folds)
• nausea, especially when taking large doses.
• vomiting
• diarrhea (in children)

Uncommon:may occur in no more than 1 in 100 patients

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

Uncommon side effects that may appear in blood or urine tests:

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

Rare:may occur in no more than 1 in 1,000 patients

• skin rash, which may be accompanied by blisters and look like small targets (a dark spot in the center surrounded by a lighter border 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 appear in blood tests:

• low number of blood cells involved in blood clotting
• 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, which may be accompanied by blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing widespread peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis)
• widespread red skin rash, which may be accompanied by small pus-filled blisters (bullous exfoliative dermatitis)
• red, scaly rash with thickening under the skin and blisters (acute generalized exanthematous pustulosis)
• flu-like symptoms with a rash, fever, lymph node enlargement, 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 often occurring on both sides of the buttocks, upper, inner thighs, under the arms, and on the neck (Symmetrical Drug-Related Intertriginous and Flexural Exanthema, SDRIFE)

➔

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

• skin rash with blisters arranged in a ring shape with crusts in the central part or like a string of pearls (linear IgA dermatosis)
• hepatitis
• jaundice, caused by an increase in the level of bilirubin (a substance produced in the liver) in the blood, which can cause yellowing of the skin and the whites of the eyes
• inflammation of the renal tubules
• prolonged blood clotting time
• restlessness
• seizures (in people taking high doses of Penlac or with kidney disease)
• black hairy tongue

Side effects that may appear in blood or urine tests:

• marked decrease in the number of white blood cells
• low number of red blood cells (hemolytic anemia)
• crystals in the urine leading to acute kidney damage

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist.

Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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

Side effects can also be reported to the marketing authorization holder or its representative in Poland.

Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Penlac

Do not store above 25°C. Store in the original packaging to protect from moisture.

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging or blister after:

"EXP". The expiry date refers to the last day of the month stated.

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 Penlac contains:

• The active substances of the medicine 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:
• tablet core: microcrystalline cellulose, crospovidone type A, sodium carboxymethylcellulose, silicon dioxide, magnesium stearate;
• tablet coating: basic butyl methacrylate copolymer, titanium dioxide (E 171), talc, macrogol 6000.

What Penlac looks like and contents of the pack

Penlac is white to off-white, elongated film-coated tablets with a dividing line.

Penlac is available in blisters containing 10, 12, 14, 20, 21, or 24 film-coated tablets.

Not all pack sizes and types may be marketed.

Marketing authorization holder

Zentiva, k.s.

U kabelovny 130

Dolní Mĕcholupy

102 37 Prague 10

Czech Republic

Manufacturer

Pencef Pharma GmbH

Breitenbachstrasse 13-14

13509 Berlin

Germany

This medicine is authorized in the Member States of the European Economic Area 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

Date of last revision of the leaflet:December 2024

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 phenomenon is that the bacteria are resistant to the administered antibiotic.

This means that the bacteria can survive or multiply despite the use of the antibiotic.

Bacteria can become resistant to antibiotics for many reasons.

Careful use of antibiotics can help reduce the possibility of bacteria developing resistance.

The antibiotic prescribed by the doctor is intended solely for the treatment of the current disease.

Paying attention to the following tips will help prevent the development of resistant bacteria that could inhibit the action of the antibiotic.

• 1. It is very important to take the antibiotic in the correct dose, at the right time, and for the correct number of days.
• 2. The patient should not take an antibiotic that was not prescribed specifically for them.
• 3. The patient should not take an antibiotic prescribed for another person, even if they had a similar infection.
• 4. The patient should not pass on antibiotics prescribed for them to other people.
• 5. If there are any leftover antibiotics after completing the treatment as directed by the doctor, the patient should return them to the pharmacy for proper disposal.