Amoxiclav quicktab 625 mg
Poland
Table of Contents
Package leaflet: Information for the patient
Amoksiklav QUICKTAB 625 mg
(500 mg + 125 mg), oral suspension tablets
Amoxicillinum + Acidum clavulanicum
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.
- Keep this leaflet so that you can read it again if necessary.
- If you have any doubts, please consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
- If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Table of contents
- What Amoksiklav 625 mg is and what it is used for
- Important information before taking Amoksiklav 625 mg
- How to take Amoksiklav 625 mg
- Possible side effects
- How to store Amoksiklav 625 mg
- Contents of the pack and other information
1. What Amoksiklav 625 mg is and what it is used for
Amoksiklav 625 mg is an antibiotic that kills bacteria causing infections.
It contains two different active substances: amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called penicillins, whose action can sometimes be blocked (inactivated).
The second active substance (clavulanic acid) counteracts 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
Do not take this medicine if you:
are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin, or to any of the other ingredients of this medicine (listed in section 6);
have ever had a severe allergic reaction (hypersensitivity) to any other antibiotic; such a reaction may include skin rash, swelling of the face or neck;
have ever had liver function disorders or jaundice (yellowing of the skin) caused by taking an antibiotic.
➔ If any of the above apply to you, do not take Amoksiklav 625 mg. If in doubt, consult your doctor or pharmacist before taking Amoksiklav 625 mg.
Warnings and precautions
Before taking this medicine, talk to your doctor or pharmacist if you:
have infectious mononucleosis,
are being treated for liver or kidney function disorders,
do not urinate regularly.
If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before taking this medicine.
In some cases, your doctor may test which type of bacteria caused the infection. Depending on the test results, you may be prescribed a different strength of Amoksiklav or another medicine.
Conditions to be aware of
Taking Amoksiklav 625 mg may worsen certain existing conditions or cause serious side effects (such as allergic reactions, seizures, or colitis). To reduce the risk of any problems, pay attention to whether certain symptoms occur during treatment (see "Conditions to be aware of" in section 4).
Blood and urine tests
If you are due to have blood tests (e.g. red blood cell count or liver function tests) or urine tests (for glucose), inform your doctor or nurse that you are taking Amoksiklav 625 mg. This medicine may affect the results of such tests.
Amoksiklav 625 mg and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including over-the-counter medicines and herbal supplements.
If you take allopurinol (used to treat gout) together with Amoksiklav 625 mg, the risk of developing a skin allergic reaction increases.
If you are taking probenecid (used to treat gout), your doctor may adjust the dose of Amoksiklav 625 mg. Concurrent use of probenecid may reduce the elimination of amoxicillin and is not recommended.
If you take medicines that reduce blood clotting (such as warfarin) together with Amoksiklav 625 mg, additional blood tests may be required.
Amoksiklav 625 mg may affect the action of methotrexate (a medicine used to treat cancer, rheumatic diseases, and severe psoriasis). Penicillins may reduce methotrexate elimination, increasing the risk of adverse effects.
If you are receiving mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs), your doctor will closely monitor your health during treatment with Amoksiklav 625 mg.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Amoksiklav 625 mg may cause side effects or symptoms that impair the ability to drive. Do not drive or operate machinery unless you feel well.
Amoksiklav 625 mg, sodium and sulphites
This medicine contains sulphites (ingredient of the sweet orange flavour). Rarely, it may cause severe hypersensitivity reactions and bronchospasm.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".
3. How to take Amoksiklav 625 mg
Always take this medicine exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Adults and children weighing 40 kg or more
Usual dose:
1 tablet three times a day
Children weighing less than 40 kg
Children under 6 years of age should preferably receive Amoksiklav as an oral suspension.
Before using Amoksiklav 625 mg tablets in children weighing less than 40 kg, consult your doctor or pharmacist.
Patients with kidney or liver disease
For patients with impaired kidney function, the dose may be adjusted. Your doctor may prescribe a different strength of the medicine or another medicine.
Patients with impaired liver function may require more frequent blood tests to monitor liver function.
How to take Amoksiklav 625 mg
Take the tablet at the beginning of a meal or just before a meal.
Maintain regular intervals of at least 4 hours between doses 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, contact your doctor again.
The tablet can be thoroughly mixed with half a glass of water.
Taking more than the recommended dose of Amoksiklav 625 mg
If you take more than the recommended dose of Amoksiklav 625 mg, symptoms such as stomach and intestinal irritation (nausea, vomiting, or diarrhoea) or seizures may occur. Contact your doctor as soon as possible. Take the medicine packaging with you to show the doctor.
Missed 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; wait approximately 4 hours before taking the next dose.
Stopping treatment with Amoksiklav 625 mg
Continue taking Amoksiklav 625 mg for the full prescribed duration, even if you start to feel better. All doses are needed to eliminate the infection. If some bacteria survive, the infection may return.
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.
Symptoms that require attention
Allergic reactions:
skin rash
inflammation of blood vessels, which may appear as red or purple raised
spots on the skin, but may also affect other parts of the body
fever, joint pain, swelling of lymph nodes in the neck, underarm, or groin
swelling, sometimes of the face or mouth (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, contact a doctor immediately.
Discontinue taking Amoksiklav 625 mg.
Colitis
Colitis, causing watery diarrhoea, usually with blood and mucus, stomach pain and (or) fever.
Acute pancreatitis
If the patient experiences severe and persistent pain in the upper abdomen, this may be a sign of acute pancreatitis.
Drug-induced enterocolitis syndrome (DIES)
Drug-induced enterocolitis syndrome has occurred mainly in children receiving amoxicillin with clavulanic acid. This is a type of allergic reaction whose main symptom is recurrent vomiting (1 to 4 hours after taking the medicine). Further symptoms may include abdominal pain, lethargy, diarrhoea and low blood pressure.
If any of these symptoms occur, seek medical advice as soon as possible.
Very common adverse effects (occurring in more than 1 in 10 people)
diarrhoea
Common adverse effects (occurring in less than 1 in 10 people)
candidiasis – fungal infection of the vagina, mouth (thrush) or skin folds
nausea, especially when high doses of the medicine are taken.
→ If nausea occurs, Amoksiklav 625 mg should be taken before meals.
vomiting
Uncommon adverse effects (occurring in less than 1 in 100 people)
skin rash, itching
raised, itchy rash (urticaria)
dyspepsia
dizziness
headache
Uncommon adverse effects that may appear in blood test results:
- increased activity of certain substances (enzymes) produced in the liver
Rare adverse effects (occurring in less than 1 in 1000 people)
skin rash, which may develop into blisters and resemble target-like lesions
(dark spot in the centre surrounded by a lighter ring with a dark border at the edge – erythema multiforme)
If the patient notices any of these symptoms, contact a doctor urgently.
Rare adverse effects that may appear in blood test results:
low number of platelets (cells involved in blood clotting)
low number of white blood cells
Other adverse effects
Other adverse effects have occurred in a very small number of people, but their exact frequency is unknown:
allergic reactions (see above)
colitis (see above)
severe skin reactions:
- widespread skin rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genital area (Stevens-Johnson syndrome) and a more severe form causing extensive peeling of the skin (affecting more than 30% of the body surface – toxic epidermal necrolysis [Lyell's syndrome])
- widespread red skin rash with small pustules (pustular exanthema)
- red, scaly rash with subcutaneous nodules and blisters (bullous pemphigoid)
- 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 often seen on both sides of the buttocks, upper inner thighs, underarms, and neck (symmetrical drug-related intertriginous and flexural exanthema, SDRIFE), crystals in urine leading to acute kidney injury, blistering rash arranged in a ring-like pattern with crusts in the centre or resembling a string of pearls (linear IgA dermatosis), inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).
If any of the above symptoms occur in the patient, contact a doctor immediately.
hepatitis
jaundice due to increased blood levels of bilirubin (a substance produced in the liver), which may cause yellowing of the skin and whites of the eyes
interstitial nephritis
prolonged blood clotting time
hyperkinesia
seizures (in people receiving high doses of Amoksiklav 625 mg or with kidney disease)
black hairy tongue
development of infection caused by overgrowth of resistant bacteria
Adverse effects that may appear in blood or urine test results:
marked decrease in white blood cells
low number of red blood cells (haemolytic anaemia)
crystals in urine
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.
5. How to store Amoksiklav 625 mg
Keep the medicine out of 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.
6. Package Contents and Other Information
What Amoksiklav 625 mg contains
The active substances are amoxicillin and clavulanic acid.
Each tablet contains 500 mg amoxicillin as amoxicillin trihydrate and 125 mg 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), silicified microcrystalline cellulose (microcrystalline cellulose and silicon dioxide), sweet orange flavour (containing propylene glycol, sodium, sulphites (as SO₂)).
What Amoksiklav 625 mg looks like and contents of the pack
The tablets are oval-shaped, yellowish-brown, speckled, approximately 11 x 22 mm in size.
They are packed in blisters containing 14 tablets.
Marketing Authorisation Holder and Manufacturer
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
For further information about this medicinal product, please contact the representative of the Marketing Authorisation Holder:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. +48 22 209 70 00
(logo of the Marketing Authorisation Holder)
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 infection. Paying attention to the following advice can help prevent the development of resistant bacteria that could interfere with the effectiveness of antibiotics.
- It is very important to take the antibiotic at the correct dose, at the right time, and for the full prescribed duration. Please read the instructions provided in the package leaflet, and if any of them are unclear, ask your doctor or pharmacist for clarification.
- 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.
- Patients should not take an antibiotic prescribed for another person, even if that person had a similar infection.
- Do not give antibiotics prescribed for you to other people.
- If any unused antibiotic remains after completing the treatment as directed by your doctor, return it to a pharmacy (which will accept it) to ensure its proper disposal.