Amoksiklav quicktab 1000 mg
Poland
Table of Contents
Patient Information Leaflet
Amoksiklav QUICKTAB 1000 mg
(875 mg + 125 mg), dispersible tablets for oral suspension
Amoxicillin + Clavulanic acid
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, please ask your doctor or pharmacist.
- This medicine has been prescribed for you personally. Do not pass it on to others. It may harm other people, even if their symptoms are the same as yours.
- If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.
Table of Contents
- What Amoksiklav 1000 mg is and what it is used for
- What you need to know before taking Amoksiklav 1000 mg
- How to take Amoksiklav 1000 mg
- Possible side effects
- How to store Amoksiklav 1000 mg
- Contents of the pack and other information
1. What Amoksiklav 1000 mg is and what it is used for
Amoksiklav 1000 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, which may sometimes be inactivated by bacteria.
The second active substance (clavulanic acid) prevents this inactivation.
Amoksiklav 1000 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 using Amoksiklav 1000 mg
When not to use Amoksiklav 1000 mg
if the patient is allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin, or to
any of the other ingredients of this medicine (listed in section 6);
if the patient has ever experienced a severe allergic reaction (hypersensitivity) to any
other antibiotic; such a reaction may include skin rash, swelling of the face or neck;
if the patient has ever had liver function disorders or jaundice (yellowing of the
skin) caused by taking an antibiotic.
➔ If any of the above situations apply to the patient, Amoksiklav 1000 mg should not be taken.
If in doubt, consult a doctor or pharmacist before using Amoksiklav 1000 mg.
Warnings and precautions
Before using this medicine, discuss with a doctor or pharmacist if the patient:
has infectious mononucleosis
is being treated for liver or kidney function disorders
does not urinate regularly.
If in doubt whether any of these conditions apply, consult a doctor or pharmacist before using the medicine.
In some cases, the doctor may test which type of bacteria caused the infection. Depending on the test results, the patient may be prescribed a different strength of Amoksiklav or another medicine.
Side effects to watch for
Taking Amoksiklav 1000 mg may worsen certain existing conditions or cause serious side effects (such as allergic reactions, seizures, and inflammation of the large intestine). To reduce the risk of any problems, pay attention to whether certain symptoms occur during treatment with Amoksiklav 1000 mg (see "Side effects to watch for" in section 4).
Blood and urine tests
If the patient is due to have blood tests (e.g. red blood cell count or liver function tests) or urine tests (for glucose), inform the doctor or nurse that the patient is taking Amoksiklav 1000 mg. The medicine may affect the results of such tests.
Amoksiklav 1000 mg and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines the patient plans to use, even those available without a prescription, and herbal medicines.
If allopurinol (used in the treatment of gout) is taken together with Amoksiklav 1000 mg, the likelihood of a skin allergic reaction increases.
If probenecid (used in the treatment of gout) is taken, the doctor may decide to adjust the dose of Amoksiklav 1000 mg. Concurrent use of probenecid may reduce the elimination of amoxicillin and is not recommended.
If anticoagulant medicines (such as warfarin) are taken together with Amoksiklav 1000 mg, additional blood tests may be necessary.
Amoksiklav 1000 mg may affect the action of methotrexate (a medicine used in the treatment of cancer, rheumatic diseases, and severe psoriasis). Penicillins may reduce methotrexate elimination, increasing the risk of adverse effects.
If the patient is receiving mycophenolate mofetil (a medicine used to prevent rejection of a transplanted organ), the doctor will closely monitor the patient's health during treatment with Amoksiklav 1000 mg.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she is pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
Amoksiklav 1000 mg may cause side effects and symptoms that impair the ability to drive. Do not drive or operate machinery unless the patient feels well.
Amoksiklav 1000 mg contains sodium and sulphites
The medicine contains sulphites (ingredient of sweet orange flavour). The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
3. How to use Amoksiklav 1000 mg
This medicine should always be used as directed by the doctor. If in doubt, consult the doctor or pharmacist.
Adults and children weighing 40 kg or more
Usual dose: 1 tablet twice daily
Higher dose: 1 tablet three times daily
Children weighing less than 40 kg
Children under 6 years of age should preferably receive Amoksiklav as an oral suspension.
Before using Amoksiklav 1000 mg tablets in children weighing less than 40 kg, consult a doctor or pharmacist.
Patients with kidney or liver disease
The dose may be adjusted for patients with impaired kidney function. The doctor may recommend using 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 1000 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 taken during the day. Do not take 2 doses within 1 hour.
Do not use Amoksiklav 1000 mg for longer than 2 weeks. If the patient still feels unwell, contact the doctor again.
The tablet can be thoroughly mixed with half a glass of water.
Taking more than the recommended dose of Amoksiklav 1000 mg
If the patient takes more than the recommended dose of Amoksiklav 1000 mg, symptoms such as stomach and intestinal irritation (nausea, vomiting, or diarrhoea) or seizures may occur.
Contact a doctor as soon as possible. Take the medicine packaging with you to show the doctor.
Missing a dose of Amoksiklav 1000 mg
If the patient forgets to take a dose, take it as soon as remembered. Do not take the next dose too soon, but wait approximately 4 hours before taking it.
Stopping treatment with Amoksiklav 1000 mg
Continue taking Amoksiklav 1000 mg for the full duration of treatment, even if the patient feels better.
All doses are needed to eliminate the infection. If some bacteria survive, they may cause the infection to return.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Symptoms to be aware of
Allergic reactions:
skin rash
vasculitis, 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 oral cavity (angioedema), causing difficulty 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 use of Amoxiclav 1000 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 abdominal area, 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, the main symptom of which 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 reactions (occurring in more than 1 in 10 people)
diarrhoea
Common adverse reactions (occurring in less than 1 in 10 people)
candidiasis – fungal infection of the vagina, mouth (oral thrush) or skin folds
nausea, especially when taking high doses of the medicine
→ In case of nausea, Amoxiclav 1000 mg should be taken before meals.
vomiting
Uncommon adverse reactions (occurring in less than 1 in 100 people)
skin rash, itching
raised, itchy rash (urticaria)
dyspepsia
dizziness
headache
Uncommon adverse reactions that may appear in blood test results:
increased activity of certain substances (enzymes) produced in the liver
Rare adverse reactions (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 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 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 organs (Stevens-Johnson syndrome) and a more severe form causing extensive peeling of the skin (affecting more than 30% of body surface – toxic epidermal necrolysis [Lyell's syndrome])
- widespread red skin rash with small pustules (bullous exfoliative dermatitis)
- red, scaly rash with subcutaneous nodules and blisters (pustular eruption)
- 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)
- red rash often seen on both buttocks, inner upper 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 scabs 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 the patient experiences any of the above symptoms, 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 patients receiving high doses of Amoxiclav 1000 mg or in patients with kidney disease)
black hairy tongue
development of infection caused by overgrowth of resistant bacteria
Adverse reactions 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 reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions 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 reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.
5. How to store Amoxiclav 1000 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 in use. This will help protect the environment.
6. Contents of the pack and other information
What Amoksiklav 1000 mg contains
The active substances are amoxicillin and clavulanic acid.
Each tablet contains 875 mg of amoxicillin in the form of amoxicillin trihydrate and 125 mg of clavulanic acid in the form of potassium clavulanate. Each tablet contains 25 mg of potassium.
Other ingredients: crospovidone, sucralose, magnesium stearate, silicon dioxide, iron oxide yellow (E172), microcrystalline cellulose silica (microcrystalline cellulose and silicon dioxide), sweet orange flavour (containing propylene glycol, sodium, sulphites (as SO2)).
What Amoksiklav 1000 mg looks like and contents of the pack
The tablets are oval-shaped, yellow-brown, mottled, approximately 13 x 25 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 given 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 illness. Paying attention to the following advice may help prevent the development of resistant bacteria that could impair the effectiveness of antibiotics.
- It is very important to take the antibiotic at the correct dose, at the right time, and for the proper 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.
- The patient 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.
- The patient 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 leftover 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.