AMOCLAN 875 mg/125 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user AMOclan, 875 mg + 125
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
2. WHAT IS AMOCLAN AND WHAT IS IT USED FOR
3. IMPORTANT INFORMATION BEFORE TAKING AMOCLAN
   1. When not to take AMOclan
   2. Important information about some ingredients of the medicine
   3. Conditions to watch out for
   4. Blood and urine tests
   5. AMOclan and other medicines
   6. Pregnancy, breastfeeding
   7. Driving and operating machines
4. HOW TO TAKE AMOCLAN
   1. Adults and children with a body weight of 40 kg or more
   2. Children with a body weight of less than 40 kg
   3. Patient with kidney and liver diseases
   4. How to take AMOclan
   5. Taking a higher dose of AMOclan than recommended
   6. Missing a dose of AMOclan
   7. Stopping treatment with AMOclan
5. POSSIBLE SIDE EFFECTS
   1. Conditions to watch out for
   2. Allergic reactions:
   3. You should stop taking AMOclan.
   4. Colitis
   5. Acute pancreatitis
   6. Drug-induced enterocolitis syndrome (DIES)
   7. Very common side effects
   8. Common side effects
   9. Uncommon side effects
   10. Rare side effects
   11. Other side effects
   12. Reporting side effects
6. HOW TO STORE AMOCLAN
7. CONTENTS OF THE PACKAGING AND OTHER INFORMATION
   1. What AMOclan contains
   2. What AMOclan looks like and what the packaging contains
   3. Responsible entity and manufacturer:
   4. This medicinal product is registered in the EEA member states under the following names
   5. Date of revision of the leaflet: 10/2023
   6. Medical education

Leaflet attached to the packaging: information for the user AMOclan, 875 mg + 125

mg, 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 specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. WHAT IS AMOCLAN AND WHAT IS IT USED FOR

AMOclan is an antibiotic that works bactericidally on bacteria that cause infections.
AMOclan contains two different medicines: 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 TAKING AMOCLAN

When not to take 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 a skin rash or swelling of the face or neck.
• If the patient has ever had liver function disorders or jaundice (yellowing of the skin) associated with the use of an antibiotic.

Warnings and precautions
Before starting to take AMOclan, you should discuss it with your doctor or pharmacist When
to be particularly careful when taking AMOclan
Before starting to take AMOclan, you should consult a doctor or pharmacist,
if the patient:

• has infectious mononucleosis
• is being treated for liver or kidney disease
• has irregular urination. If you are in doubt whether the above circumstances apply to you, you should consult a doctor or pharmacist before starting to take AMOclan.

In some cases, the doctor may test what type of bacteria caused the patient's infection.
Depending on the results, the patient may receive AMOclan in a different dose or a different medicine.

Important information about some 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 kidney function disorders.
If the patient has any doubts, they should consult a doctor.

Conditions to watch out for

Taking AMOclan may worsen the course of some diseases or cause severe side effects, including allergic reactions, seizures, and colitis. You should pay attention to whether the patient has certain symptoms during the use of AMOclan to reduce the risk of any problems. See ' Conditions to watch out for
insection 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 AMOclan. AMOclan may affect the results of these tests.

AMOclan and other medicines

You should tell your doctor or pharmacist about all the medicines you have taken recently, including those that are available without a prescription and herbal medicines.
If the patient is taking allopurinol (used in gout) at the same time as AMOclan, they are more likely to experience skin allergic reactions.
Probenecid (used in gout)
Concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.
If the patient is taking medicines that reduce blood clotting (such as warfarin) at the same time as AMOclan, additional blood tests may be necessary.
Methotrexate (used in the treatment of cancer and severe psoriasis and rheumatic diseases)
Penicillins may reduce the excretion of methotrexate, potentially leading to increased side effects.

Pregnancy, breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant, they should tell their doctor or pharmacist.
Before taking any medicine, you should consult a doctor or pharmacist.

Driving and operating machines

AMOclan may cause side effects and symptoms that can impair the ability to drive vehicles.
You should not drive vehicles or operate machines unless you feel well.

3. HOW TO TAKE AMOCLAN

AMOclan should always be taken in accordance with the doctor's recommendations. In case of doubts, you should contact your doctor or pharmacist again.

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

• Usual dose - 1 tablet twice a day.
• Larger dose - 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 a medicine in the form of an oral suspension.
You should consult a doctor or pharmacist before taking AMOclan in tablets in children with a body weight below 40 kg.

Patient 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 AMOclan or a different medicine.
• If the patient has liver disease, they may need to have blood tests more often to check how their liver is functioning.

How to take AMOclan

• Tablets should be swallowed whole, with a glass of water, at the beginning of a meal or just before a meal.
• You should keep equal intervals of at least 4 hours between doses taken during the day. Do not take 2 doses within 1 hour.
• You should not take AMOclan for longer than 2 weeks. If the patient still does not feel well, they should contact their doctor again.

Taking a higher dose of AMOclan than recommended

If the patient has taken a higher dose of AMOclan than recommended, symptoms may include stomach upset (nausea, vomiting, or diarrhea) or seizures. You should contact a doctor as soon as possible. You should have the carton or bottle of the medicine with you to show the doctor.

Missing a dose of AMOclan

If the patient forgets to take a dose, they should take it as soon as they remember.
You should not take the next dose too early, you should wait about 4 hours before taking the next dose.

Stopping treatment with AMOclan

You should continue taking AMOclan until the end of the treatment, even if the patient feels 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 doubts related to the use of the medicine, you should consult a doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, AMOclan can cause side effects, although not everybody gets them.

Conditions to watch out for

Allergic reactions:

• skin rash
• vasculitis, which may appear as red or purple raised spots on the skin, but may affect other parts of the body
• fever, joint pain, swelling of the lymph nodes in the neck, armpit, or groin
• swelling, sometimes involving the face or mouth (angioedema), causing difficulty breathing
• fainting
• chest pain associated with an allergic reaction, which may be a sign of an allergy leading to a heart attack (Kounis syndrome).

➔ If any of these symptoms occur, you should contact a doctor immediately.

You should stop taking AMOclan.

Colitis

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

Acute pancreatitis

If you have severe and persistent stomach pain, it may be a sign of acute pancreatitis.

Drug-induced enterocolitis syndrome (DIES)

Drug-induced enterocolitis syndrome occurred mainly in children receiving amoxicillin with clavulanic acid. It is a type of allergic reaction, the leading symptom of which is repeated vomiting (1 to 4 hours after taking the medicine). Further symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.
➔ If any of these symptoms occur, you should contact a doctor as soon as possible for advice.

Very common side effects

May occur more often than in 1 in 10 patients

• diarrhea (in adults).

Common side effects

May occur less often than in 1 in 10 patients

• thrush (candidiasis - fungal infections of the vagina, mouth, or skin folds)
• nausea, especially when taking large doses → if they occur, you should take AMOclan before eating
• vomiting
• diarrhea (in children).

Uncommon side effects

May occur no more often than in 1 in 100 patients

• skin rash, itching
• raised, itchy rash (hives)
• indigestion
• dizziness
• headache. Uncommon side effects that may appear in blood test results:
• increased activity of certain substances (enzymes) produced in the liver.

Rare side effects

May occur no more often than in 1 in 1000 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 a doctor urgently.

Rare side effects that may appear in blood test results:

• low number of cells involved in blood clotting
• low number of white blood cells.

Other side effects

Other side effects have occurred in a very small number of people, but their exact frequency is not known.

• Allergic reactions (see above).
• Colitis (see above).
• 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 an increased number of white blood cells (eosinophilia) and increased liver enzyme activity]; drug reaction with eosinophilia and systemic symptoms (DRESS). ➔ if the patient experiences any of these symptoms, they should contact a doctor immediately.
• Hepatitis.
• Jaundice, caused by an increased level of bilirubin (a substance produced in the liver) in the blood, which can cause yellowing of the skin and eyes.
• Tubulointerstitial nephritis.
• Prolonged blood clotting.
• Restlessness.
• Seizures (in people taking high doses of AMOclan or with kidney disease).
• Black hairy tongue, which looks like a hairy tongue.
• Discoloration of teeth (in children), which can usually be removed by brushing.
• Rash with blisters arranged in a ring shape with crusts in the center or like a string of pearls (linear IgA dermatosis).
• Meningitis (aseptic meningitis).

Side effects that may appear in blood or urine test results:

• significant 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 side effects occur, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
e-mail: [email protected]
By reporting side effects, you can help gather more information on the safety of the medicine.

5. HOW TO STORE AMOCLAN

The medicine should be stored in a place that is out of sight and reach of children.
You should 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 month.
Lot - batch number, EXP - expiry date.
Store in a temperature below 25 C.
Store the bottle tightly closed to protect it from moisture.
Store the blisters in the original packaging to protect them from moisture.

6. CONTENTS OF THE PACKAGING AND OTHER INFORMATION

What AMOclan contains

The active substances of the medicine are:
amoxicillin (in the form of amoxicillin trihydrate)
875 mg;
clavulanic acid (in the form of potassium clavulanate)
125 mg.
Other ingredients (excipients):
Core:sodium glycolate starch type A, magnesium stearate, anhydrous colloidal silica, microcrystalline cellulose.
Coating:propylene glycol, ethyl cellulose 10 cp, hypromellose 15 cp, titanium dioxide.

What AMOclan looks like and what the packaging contains

The packaging of AMOclan contains 10, 12, 14, 20 (2x10), 24 (2x12), 28 (2x14) and 100 (10x10)*
coated tablets – in white polyethylene bottles with a protective cap or in aluminum blisters placed in a cardboard box.
* only in closed healthcare facilities

Responsible entity and manufacturer:

Responsible entity:
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 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 phenomenon is that bacteria are resistant to the administered antibiotic.
This means that bacteria can survive or multiply despite the use of an 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. You should read the instructions in the patient information leaflet and if any of them are unclear, you should ask your doctor or pharmacist to explain.
• 2. The patient should not take an antibiotic if it was not prescribed specifically for them. They should only take it for the purpose of treating the infection for which the antibiotic was prescribed.
• 3. The patient should not take an antibiotic prescribed for another person, even if they had a similar infection.
• 4. You should not give antibiotics prescribed for one patient to other people.
• 5. If there are any remaining antibiotics after completing the treatment as recommended by the doctor, you should return them to the pharmacy to ensure their proper disposal.