AMOKSIKLAV 500 mg/125 mg Tablets

Contents of the leaflet

1. What is Amoksiklav 625 mg and what is it used for
2. Important information before taking Amoksiklav 625 mg
   1. When not to take Amoksiklav 625 mg
   2. If any of the above applies to you, do not take Amoksiklav 625 mg
   3. Warnings and precautions
   4. Conditions to watch out for
   5. Blood and urine tests
   6. Amoksiklav 625 mg and other medicines
   7. Pregnancy and breastfeeding
   8. Driving and using machines
   9. Amoksiklav 625 mg, sodium, and sulfites
3. How to take Amoksiklav 625 mg
   1. Adults and children over 40 kg
   2. Children under 40 kg
   3. Patients with kidney and liver disease
   4. How to take Amoksiklav 625 mg
   5. Taking a higher dose of Amoksiklav 625 mg than recommended
   6. Missing a dose of Amoksiklav 625 mg
   7. Stopping treatment with Amoksiklav 625 mg
4. Possible side effects
   1. Conditions to watch out for
   2. Allergic reactions:
   3. If you experience any of these symptoms, contact your doctor immediately. Stop taking Amoksiklav 625 mg.
   4. Colitis
   5. Acute pancreatitis
   6. Drug-induced enterocolitis syndrome (DIES)
   7. If you experience any of these symptoms, consult your doctor as soon as possible.
   8. If you notice any of these symptoms, contact your doctor immediately.
   9. Other side effects
   10. If you experience any of the above symptoms, contact your doctor immediately.
   11. Reporting side effects
5. How to store Amoksiklav 625 mg
6. Contents of the pack and other information
   1. What Amoksiklav 625 mg contains
   2. What Amoksiklav 625 mg looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:
   5. Medical education

1. What is Amoksiklav 625 mg and what is it used for

Amoksiklav 625 mg is an antibiotic that kills bacteria that cause infections.
It contains two different medicines: amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called penicillins, which can sometimes be stopped from working (inactivated).
The other active substance (clavulanic acid) stops this inactivation.
Amoksiklav 625 mg 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 Amoksiklav 625 mg

When not to take Amoksiklav 625 mg

if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of this medicine (listed in section 6);
if you have ever had a severe allergic reaction (hypersensitivity) to any other antibiotic; such a reaction may include a skin rash, swelling of the face or neck;
if you have ever had liver function disorders or jaundice (yellowing of the skin), caused by taking an antibiotic.

If any of the above applies to you, do not take Amoksiklav 625 mg

Amoksiklav 625 mg.If you are unsure, consult your doctor or pharmacist before taking Amoksiklav 625 mg.

Warnings and precautions

Before taking this medicine, discuss it with your doctor or pharmacist if you:
have infectious mononucleosis
are being treated for liver or kidney problems
do not urinate regularly.
If you are unsure whether any of these statements apply to you, consult your doctor or pharmacist before taking the medicine.
In some cases, your doctor may test what type of bacteria is causing the infection. Depending on the test results, you may be given Amoksiklav at a different strength or a different medicine.

Conditions to watch out for

Taking Amoksiklav 625 mg may worsen the course of some existing diseases or cause severe side effects (such as allergic reactions, seizures and colitis). To minimize the risk of any problems, while taking Amoksiklav 625 mg, you should pay attention to whether certain symptoms occur (see "Conditions to watch out for" in section 4).

Blood and urine tests

If you are going to have a blood test (e.g. red blood cell test or liver function tests) or a urine test (for glucose), tell your doctor or nurse that you are taking Amoksiklav 625 mg. The medicine may affect the results of these tests.

Amoksiklav 625 mg and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have recently taken, as well as any medicines you plan to take, including those that are available without a prescription and herbal medicines.
If you are taking allopurinol (used to treat gout) at the same time as Amoksiklav 625 mg, the risk of a skin allergic reaction increases.
If you are taking probenecid (used to treat gout), your doctor may decide to adjust the dose of Amoksiklav 625 mg. Taking probenecid at the same time may reduce the excretion of amoxicillin and is not recommended.
If you are taking medicines that reduce blood clotting (such as warfarin) at the same time as Amoksiklav 625 mg, you may need to have additional blood tests.
Amoksiklav 625 mg may affect the action of methotrexate (a medicine used to treat cancer and severe psoriasis). Penicillins may reduce the excretion of methotrexate, potentially leading to increased side effects.
If you are receiving mycophenolate mofetil (a medicine used to prevent organ rejection), your doctor will closely monitor your health while you are taking Amoksiklav 625 mg.

Pregnancy and breastfeeding

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.

Driving and using machines

Amoksiklav 625 mg may cause side effects and symptoms that can impair your ability to drive or operate machinery. Do not drive or operate machinery unless you feel well.

Amoksiklav 625 mg, sodium, and sulfites

The medicine contains sulfites (a component of the orange flavor). The medicine can rarely cause severe hypersensitivity reactions and bronchospasm.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Amoksiklav 625 mg

Always take this medicine exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.

Adults and children over 40 kg

Usual dose:
1 tablet three times a day

Children under 40 kg

Children under 6 years of age should preferably receive Amoksiklav in the form of an oral suspension.
Before taking Amoksiklav 625 mg tablets in children under 40 kg, consult your doctor or pharmacist.

Patients with kidney and liver disease

For patients with kidney function disorders, the dose may be changed. Your doctor may prescribe a different strength or a different medicine.
Patients with liver function disorders may need to have blood tests more frequently to monitor liver function.

How to take Amoksiklav 625 mg

Take the tablet at the beginning of a meal or just before a meal.
Keep equal, at least 4-hour, intervals between doses taken during the day. Do not take 2 doses within 1 hour.
Do not take Amoksiklav 625 mg for longer than 2 weeks. If you still feel unwell, consult your doctor again.
The tablet can be mixed thoroughly with half a glass of water.

Taking a higher dose of Amoksiklav 625 mg than recommended

If you have taken a higher dose of Amoksiklav 625 mg than recommended, you may experience symptoms such as stomach and intestinal irritation (nausea, vomiting, or diarrhea) or seizures. Contact your doctor as soon as possible. Take the medicine packaging with you to show the doctor.

Missing a dose of Amoksiklav 625 mg

If you forget to take a dose, take it as soon as you remember. Do not take the next dose too soon, but wait about 4 hours before taking it.

Stopping treatment with Amoksiklav 625 mg

Take Amoksiklav 625 mg until the end of the treatment, even if you feel better. All doses are needed to combat the infection. If some bacteria survive, they may cause a relapse of the infection.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 parts of the body
fever, joint pain, swollen lymph nodes in the neck, armpit, or groin
swelling, sometimes of the face or mouth (angioedema), causing difficulty breathing
fainting
chest pain related to an allergic reaction, which can be a sign of an allergy leading to a heart attack (Kounis syndrome).

If you experience any of these symptoms, contact your doctor immediately. Stop taking Amoksiklav 625 mg.

Colitis

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

Acute pancreatitis

If you experience 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 you experience any of these symptoms, consult your doctor as soon as possible.

Very common side effects(more than 1 in 10 people)
diarrhea
Common side effects(less than 1 in 10 people)
candidiasis - fungal infection of the vagina, mouth (thrush), or skin folds
nausea, especially when taking high doses of the medicine.
→ If you experience nausea, take Amoksiklav 625 mg before meals.
vomiting
Uncommon side effects(less than 1 in 100 people)
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(less than 1 in 1000 people)
skin rash, which can change into blisters and looks like small targets (dark spot in the center surrounded by a lighter border with a dark edge - erythema multiforme)

If you notice any of these symptoms, contact your doctor immediately.

Rare side effects that may appear in blood test results:
low number of blood 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:

• extensive skin rash with blisters and peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) and a more severe form, causing extensive peeling of the skin (covering more than 30% of the body surface - toxic epidermal necrolysis [Lyell's syndrome])
• -extensive, red skin rash with small blisters filled with pus (pustular psoriasis)
• -red, scaly rash with thickening under the skin and blisters (exfoliative dermatitis)
• -flu-like symptoms with a rash, fever, swollen lymph nodes, 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) crystals in the urine leading to acute kidney damage, rash with blisters arranged in a ring shape with crusts in the center or like a string of pearls (linear IgA dermatosis), inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).

If you experience any of the above symptoms, contact your doctor immediately.

inflammation of the liver
jaundice due to increased bilirubin levels in the blood, which can cause yellowing of the skin and whites of the eyes
interstitial nephritis
prolonged blood clotting time
restlessness
seizures (in people taking high doses of Amoksiklav 625 mg or with kidney disease)
black hairy tongue, which looks like a hairy tongue
development of an infection caused by an overgrowth of non-susceptible bacteria
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

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

5. How to store Amoksiklav 625 mg

Keep the medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the packaging 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 that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Amoksiklav 625 mg contains

The active substances are amoxicillin and clavulanic acid.
One tablet contains 500 mg of amoxicillin as amoxicillin trihydrate and 125 mg of clavulanic acid as potassium clavulanate. Each tablet contains 25 mg of potassium. The other ingredients are: crospovidone, sucralose, magnesium stearate, silicon dioxide, yellow iron oxide (E172), microcrystalline cellulose (microcrystalline cellulose and silicon dioxide, orange flavor (contains propylene glycol, sodium, sulfites (as SO)).

What Amoksiklav 625 mg looks like and contents of the pack

The tablets are oval, yellow-brown, speckled, and approximately 11 x 22 mm in size.
They are packaged in blisters containing 14 tablets.

Marketing authorization holder and manufacturer

Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
For more detailed information on this medicine, contact the representative of the marketing authorization holder:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
phone: +48 22 209 70 00
(logo of the marketing authorization holder)

Date of last revision of the leaflet:

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 your doctor is intended only to treat the current illness. Paying attention to the following tips will help prevent the development of resistant bacteria that could hinder the effectiveness of the antibiotic.

• 1. It is very important to take the antibiotic in the correct dose, at the right time, and for the right number of days. Read the instructions in the patient information leaflet and if you do not understand any of them, ask your doctor or pharmacist to explain.
• 2. You should not take an antibiotic if it was not prescribed specifically for you. You should only take it to treat the infection for which the antibiotic was prescribed.
• 3. You should not take an antibiotic prescribed for someone else, even if they had a similar infection.
• 4. Do not give your antibiotics to others.
• 5. If you have any leftover antibiotic after completing the treatment as recommended by your doctor, return it to the pharmacy (which will accept it) for proper disposal.