Amoclan

Package leaflet: Information for the user AMOclan, 875 mg + 125 mg, film-coated tablets

Amoxicillinum + Acidum clavulanicum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this 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 personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

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

1. WHAT AMOCLAN IS AND WHAT IT IS USED FOR

AMOclan is an antibiotic with bactericidal activity against bacteria causing infections.
AMOclan contains two different active substances: amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called "penicillins", whose action may sometimes be inhibited (inactivated).
The second active ingredient (clavulanic acid) counteracts this inactivation.
AMOclan 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 USING AMOCLAN

When not to use AMOCLAN

• If the patient is allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin, or any of the other ingredients of AMOCLAN (listed in section 6).
• If the patient has ever had a severe allergic reaction (hypersensitivity) to any other antibiotic. This may include skin rash or swelling of the face or neck.
• If the patient has ever experienced liver problems or jaundice (yellowing of the skin) associated with taking an antibiotic.

Warnings and precautions
Before starting treatment with AMOCLAN, discuss this with your doctor or pharmacist.

When to exercise special caution when using AMOCLAN
Before starting treatment with AMOCLAN, consult your doctor or pharmacist if the patient:

• Has infectious mononucleosis.
• Is being treated for liver or kidney disease.
• Is urinating irregularly.

If in doubt whether any of the above conditions apply, consult your doctor or pharmacist before starting AMOCLAN.

In some cases, the doctor may test which type of bacteria caused the infection.
Depending on the results, the patient may receive AMOCLAN at a different dose or another medication.

Important information about certain ingredients of the medicine
This medicinal product contains 0.65 mmol (25.3 mg) of potassium per tablet and may be unsuitable for patients on a potassium-controlled diet or with impaired kidney function.
If in doubt, consult your doctor.

Conditions to be aware of
Treatment with AMOCLAN may worsen the course of certain diseases or cause serious adverse effects, including allergic reactions, seizures, and colitis. Be vigilant for specific symptoms during treatment with AMOCLAN 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 AMOCLAN. AMOCLAN may affect the results of such tests.

AMOCLAN and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, including those obtained without a prescription and herbal medicines.

• If the patient is taking allopurinol (used for gout) together with AMOCLAN, skin allergic reactions may be more likely.
• Probenecid (used for gout):
  Concomitant use of probenecid may reduce the elimination of amoxicillin and is not recommended.
• If the patient is taking anticoagulant medicines (such as warfarin) together with AMOCLAN, additional blood tests may be necessary.
• Methotrexate (used in the treatment of cancer, severe psoriasis, and rheumatic diseases):
  Penicillins may reduce the elimination of methotrexate, increasing the risk of adverse effects.

Pregnancy and breastfeeding
If the patient is pregnant or suspects she may be pregnant, or if she is breastfeeding, she should inform her doctor or pharmacist.
Consult a doctor or pharmacist before taking any medicine.

Driving and operating machinery
AMOCLAN may cause adverse effects and symptoms that may impair the ability to drive.
Do not drive or operate machinery unless the patient feels well.

3. HOW TO USE AMOCLAN

AMOclan should always be taken as directed by the doctor. If in doubt, consult the doctor or pharmacist again.

Adults and children with body weight of 40 kg or more

• Usual dose – 1 tablet twice daily.
• Higher dose – 1 tablet three times daily.

Children with body weight below 40 kg
Children aged 6 years and younger should preferably be treated with an oral suspension formulation.
Consult a doctor or pharmacist before administering AMOclan tablets to children with body weight below 40 kg.

Patients with kidney or liver disease

• If the patient has kidney disease, the dosage may need to be adjusted. The doctor may prescribe a different dose of AMOclan or an alternative medicine.
• If the patient has liver disease, blood tests to monitor liver function may be performed more frequently.

How to use AMOclan

• Swallow the tablets whole with a glass of water, at the beginning of a meal or just before a meal.
• Maintain regular intervals between doses, with at least 4 hours between each dose. Do not take two doses within one hour.
• Do not take AMOclan for longer than 2 weeks. If the patient still does not feel better, they should contact the doctor again.

Taking more AMOclan than recommended
If a patient takes more AMOclan than recommended, symptoms may include stomach irritation (nausea, vomiting or diarrhoea) or seizures. Contact a doctor immediately. Keep the carton or bottle of the medicine and show it to the doctor.

Missed dose of AMOclan
If a patient forgets to take a dose, they should take it as soon as they remember. Do not take the next dose too soon; wait approximately 4 hours before taking the next dose.

Stopping AMOclan treatment
Continue taking AMOclan for the full duration of treatment, even if the patient starts to feel better. All doses are necessary to eliminate the infection. If some bacteria survive, they may cause the infection to return.

If in doubt about the use of this medicine, consult the doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like any medicine, AMOclan may cause adverse reactions, although not everyone experiences them.

Symptoms that require attention

Hypersensitivity reactions:

• Skin rash
• Vasculitis, which may present as red or purple raised spots on the skin, but may affect other parts of the body
• Fever, joint pain, swelling of glands in the neck, armpits or groin
• Swelling, sometimes involving the face or areas around the mouth (angioedema), causing difficulty in breathing
• Fainting
• Chest pain related to an allergic reaction, which may indicate an allergy leading to heart attack (Kounis syndrome)

➔ If any of these symptoms occur, seek immediate medical advice.
Discontinue use of AMOclan immediately.

Colitis
Inflammation of the large intestine causing watery diarrhoea, usually with blood and mucus, abdominal pain and (or) fever.

Acute pancreatitis
If you experience severe and persistent pain in the upper abdomen, this may be a sign of acute pancreatitis.

Drug-induced enterocolitis syndrome (DIES)
Drug-induced enterocolitis has occurred mainly in children receiving amoxicillin with clavulanic acid. This is a type of allergic reaction, the main symptom of which is recurrent vomiting (1 to 4 hours after taking the medicine). Other 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 adverse reactions
May occur in more than 1 in 10 patients

• Diarrhoea (in adults)

Common adverse reactions
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 this occurs, take AMOclan before meals
• Vomiting
• Diarrhoea (in children)

Uncommon adverse reactions
May occur in no more than 1 in 100 patients

• Skin rash, itching
• Raised, itchy rash (urticaria)
• Dyspepsia
• Dizziness
• Headache

Uncommon adverse reactions that may be revealed in blood tests:

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

Rare adverse reactions
May occur in no more than 1 in 1000 patients

• Skin rash, possibly with blisters and appearing as small targets (dark spot in the center surrounded by a lighter ring and a dark ring at the edge – erythema multiforme) ➔ if the patient notices any of these symptoms, urgent medical advice should be sought.

Rare adverse reactions that may appear in blood test results:

• Low number of platelets (cells involved in blood clotting)
• Low number of white blood cells

Other adverse reactions
Other adverse reactions occurred in a very small number of people, but their exact frequency is unknown.

• Hypersensitivity reactions (see above)
• Colitis (see above)
• Severe skin reactions:
  • Widespread skin rash, in which blisters and skin peeling may occur, particularly around the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome), and a more severe form causing extensive skin peeling (more than 30% of body surface – toxic epidermal necrolysis)
  • Widespread red rash with small pustules filled with pus (pustular exanthematous 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 number of white blood cells (eosinophilia) and increased liver enzyme activity]; drug reaction with eosinophilia and systemic symptoms (DRESS) ➔ if the patient develops any of these symptoms, seek immediate medical attention.
• Hepatitis (inflammation of the liver)
• 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
• Interstitial nephritis (inflammation of the kidney tubules)
• Prolonged blood clotting time
• Psychomotor hyperactivity
• Seizures (in patients receiving high doses of AMOclan or with kidney disease)
• Black, hairy-looking tongue
• Tooth discoloration (in children), which can usually be removed by brushing
• Bullous rash arranged in a ring-like pattern with crusts in the center or resembling a string of pearls (linear IgA dermatosis)
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)

Adverse reactions that may appear in blood or urine tests:

• Marked decrease in white blood cell count
• Low number of red blood cells (hemolytic anaemia)
• Crystals in urine leading to acute kidney injury

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
e-mail: [email protected]
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. HOW TO STORE AMOCLAN MEDICINE

Keep the medicine out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging and on the blister after EXP. The expiry date refers to the last day of the stated month.
LOT - batch number, EXP - expiry date.
Store below 25°C.
Keep the bottle tightly closed to protect from moisture.
Store blisters in the original packaging to protect from moisture.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What AMOclan contains
The active substances are:
amoxicillin (as amoxicillin trihydrate) 875 mg;
clavulanic acid (as potassium clavulanate) 125 mg.
Other ingredients (excipients):
Tablet core: sodium starch glycolate type A, magnesium stearate, colloidal anhydrous silica,
microcrystalline cellulose.
Tablet coating: propylene glycol, ethylcellulose 10 cp, hypromellose 15 cp, titanium dioxide.

What AMOclan looks like and contents of the pack
The AMOclan pack contains 10, 12, 14, 20 (2x10), 24 (2x12), 28 (2x14), and 100 (10x10)*
film-coated tablets – in white polyethylene bottles with a protective cap or in aluminum blisters
placed in a cardboard box.
* for hospital use only

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Hikma Farmaçeutica S.A.
Estrada do Rio da Mó 8, 8A e 8B - Fervença
2705-906 Terrugem SNT
Portugal

Manufacturer:
Hikma Farmaçeutica S.A.
Estrada do Rio da Mó 8, 8A e 8B - Fervença
2705-906 Terrugem SNT
Portugal
hameln rds s.r.o.,
Horná 36,
900 01 Modra,
Slovakia

This medicinal product is registered in the EEA member states under the following names:
Austria - Amoxacid 875 mg/125mg Filmtabletten
Germany - Amoxicillin/Clavulansäure Hikma 875mg/125mg Filmtabletten

Date of latest revision of the leaflet: 10/2023

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 antibiotic administered.
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
can help reduce the risk of development of antibiotic resistance.
The antibiotic prescribed by your doctor is intended solely for the treatment of your current condition.
Paying attention to the following advice can 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 of them are unclear, ask your doctor or pharmacist for clarification.
2. Patients should not take an antibiotic unless it has been specifically prescribed for them. It should be taken only to treat the infection for which it was prescribed.
3. Patients should not take an antibiotic prescribed for another person, even if that person had a similar infection.
4. Do not give your prescribed antibiotics to other people.
5. If any antibiotic remains after completing the prescribed treatment, return it to the pharmacy for proper disposal.