Інструкція із застосування KLAVOMED
Зміст інструкції
- CLAVOMED 875 mg + 125 mg film-coated tablets, 875 mg + 125 mg oral suspension powder
- CLAVOMED may have undesirable effects and the symptoms may make you unfit to
CLAVOMED 875 mg + 125 mg film-coated tablets, 875 mg + 125 mg oral suspension powder
amoxicillin + clavulanic acid
Generic medicine
Read 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 questions, ask your doctor or pharmacist,
- This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
- 1. What CLAVOMED is and what it is used for
- 2. What you need to know before you take CLAVOMED
- 3. How to take CLAVOMED
- 4. Possible side effects
- 5. How to store CLAVOMED
- 6. Contents of the pack and other information
1. WHAT IS CLAVOMED AND WHAT IT IS USED FOR
CLAVOMED is an antibiotic that works by killing the bacteria that cause infections.
It contains two different medicines called amoxicillin and clavulanic acid. Amoxicillin
belongs to a group of medicines called “penicillins”, the activity of which can sometimes be
blocked (rendered inactive). The other active component (clavulanic acid) prevents this from
happening.
CLAVOMED is used in adults and children weighing more than 40 kg 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLAVOMED
Do not take CLAVOMED:
- if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin or to any of the other ingredients of this medicine (listed in section 6);
- if you have had a severe allergic reaction (hypersensitivity) to any other antibiotic. This can include a skin rash or swelling of the face or throat;
- if you have had problems with your liver or jaundice (yellowing of the skin) when taking an antibiotic. Do not take CLAVOMED if any of the above applies to you.If you are unsure, talk to your doctor or pharmacist before taking CLAVOMED. Warnings and precautionsTalk to your doctor or pharmacist before taking this medicine if you:
- have infectious mononucleosis:
- are being treated for liver or kidney problems;
- do not urinate regularly.
If you are not sure whether any of the above applies to you, talk to your doctor or the
pharmacist before taking CLAVOMED.
In some cases, your doctor may perform a test to assess the type of bacteria that caused your
infection.
Based on the results, they may prescribe a different dose of CLAVOMED or a
different medicine.
Conditions you should pay attention to
CLAVOMED can worsen certain existing conditions, or cause serious side effects. These can include allergic reactions, convulsions and inflammation
of the intestine. You should pay attention to certain symptoms while taking
CLAVOMED, in order to reduce any risk. See “ Conditions you should pay attention to
to” in Section 4.
Blood and urine tests
If you are about to have blood tests (such as those related to red blood cells or liver function tests) or urine tests (for glucose), tell your doctor
or nurse that you are taking CLAVOMED. This is because CLAVOMED can affect the
results of these types of tests.
Other medicines and CLAVOMED
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
If you are taking allopurinol (used for gout) with CLAVOMED, this increases the
likelihood that you may have an allergic skin reaction.
If you are taking probenecid (used for gout), your doctor may decide to change your
dose of CLAVOMED.
If you are taking medicines (such as warfarin) that help to
prevent blood clots together with CLAVOMED, you may need to have additional blood
tests.
CLAVOMED can affect the mechanism of action of methotrexate (a medicine used
for the treatment of tumors or rheumatic diseases).
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using this
medicine.
Driving and operating machinery
CLAVOMED may have undesirable effects and the symptoms may make you unfit to
drive vehicles.
Do not drive vehicles or operate machinery if you do not feel well.
CLAVOMED powder for oral suspension contains sucrose.
If your doctor has diagnosed you with intolerance to certain sugars, contact them before
taking this medicine.
3. HOW TO TAKE CLAVOMED
Take this medicine following exactly the instructions of your doctor or
pharmacist. If you have doubts, consult your doctor or pharmacist.
Tablets
Adults and children weighing 40 kg or more
- Usual dose - 1 tablet twice a day
- Higher dose - 1 tablet three times a day
Sachets
Adults and children weighing 40 kg or more
- Usual dose - 1 sachet twice a day
- Higher dose - 1 sachet three times a day
Children weighing less than 40 kg
Children aged 6 years or less should preferably be treated with amoxicillin and
clavulanic acid oral suspension or sachets.
CLAVOMED 875 mg + 125 mg film-coated tablets
Ask your doctor or pharmacist for advice on administering CLAVOMED
tablets to children weighing less than 40 kg.
CLAVOMED 875 mg + 125 mg sachets are not recommended.
Patients with kidney and liver problems
- If you have kidney problems, the dose may be modified. Your doctor may choose a different dosage of CLAVOMED or a different medicine.
- If you have liver problems, more frequent blood tests may be required to check how your liver is functioning. How to take CLAVOMED
Tablets
- Swallow the tablets whole with a glass of water at the beginning of a meal or shortly before
- Space the doses regularly throughout the day, allowing at least 4 hours between them. Do not take 2 doses within one hour.
- Do not take CLAVOMED for more than 2 weeks. If you continue to feel unwell, you should return to your doctor.
Sachets
- Immediately before taking CLAVOMED, open the sachet and mix the contents with half a glass of water.
- Take the medicine at the beginning of a meal or shortly before.
- Space the doses regularly throughout the day, allowing at least 4 hours between them. Do not take 2 doses within one hour.
- Do not take CLAVOMED for more than 2 weeks. If you continue to feel unwell, you should return to your doctor. If you take more CLAVOMED than you shouldIf you take too much CLAVOMED, the signs may include stomach upset (nausea, vomiting or diarrhoea) or convulsions. Tell your doctor as soon as possible. Bring the medicine packaging or the bottle to show to the doctor. If you forget to take CLAVOMEDDo not take a double dose to make up for a missed dose. You should not take the next dose too soon, but should wait about 4 hours before taking the next dose. If you stop taking CLAVOMEDContinue to take CLAVOMED until the treatment is finished, even if you feel better. You need every dose to help you fight the infection. If some bacteria survive, they can cause the infection to return. If you have any questions about using this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Conditions you should pay attention to
Allergic reactions:
- skin rashes;
- inflammation of the blood vessels ( vasculitis) which may be visible as red or purple spots on the skin, but may affect other parts of the body;
- fever, joint pain, swelling of the lymph nodes in the neck, armpits or groin;
- swelling, sometimes of the face or throat ( angioedema), causing difficulty breathing;
- collapse;
- chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by allergy (Kounis syndrome). → Contact your doctor immediatelyif you experience any of these symptoms. Stop takingCLAVOMED.
Intestinal inflammation
Intestinal inflammation, causing watery diarrhea generally with blood and mucus, stomach pain and/or fever.
Acute inflammation of the pancreas (acute pancreatitis)
If you have severe and persistent pain in the stomach area, this could be a sign of acute pancreatitis.
Drug-induced enterocolitic syndrome (DIES)
DIES has been reported mainly in children treated with amoxicillin/clavulanate. It is a certain type of allergic reaction with the main symptom of repetitive vomiting (1-4 hours after taking the medicine). Further symptoms may include abdominal pain, lethargy, diarrhea and low blood pressure.
→If you experience these symptoms, contact your doctor as soon as possiblefor advice.
Very common side effects
May affect more than 1 in 10 people
- diarrhea (in adults).
Common side effects
May affect up to 1 in 10 people
- thrush ( candida- a fungal infection of the vagina, mouth or skin folds)
- nausea, especially when taking high doses: if you suffer from this, take CLAVOMED before food
- vomiting
- diarrhea (in children)
Uncommon side effects
May affect up to 1 in 100 people
- skin rashes, itching
- raised skin rash, with itching (urticaria)
- indigestion
- dizziness
- headache Uncommon side effects can be seen from blood tests:
- increase in some proteins ( enzymes) produced by the liver.
Rare side effects
May affect up to 1 in 1000 people
- skin rashes, which may appear as blisters and look like small targets (dark central spot surrounded by a paler area, with a dark ring around the edge - erythema multiforme) → if you notice any of these symptoms, contact your doctor urgently Rare side effects can be seen from blood tests:
- low number of cells involved in blood clotting
- low number of white blood cells
Frequency not known
The frequency cannot be estimated on the basis of available data:
- allergic reactions (see above);
- intestinal inflammation (see above);
- inflammation of the protective membranes surrounding the brain and spinal cord (aseptic meningitis);
- Severe skin reactions:
- widespread rash with blisters and peeling, especially around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome) and a more severe form, which determines extensive skin exfoliation (more than 30% of the body surface - toxic epidermal necrolysis);
- widespread red rash with small blisters containing pus ( exfoliative bullous dermatitis);
- a rash, red and scaly, with bumps forming under the skin and blisters ( pustular exanthematous);
- flu-like symptoms with rash, fever, swollen glands and abnormal blood test results (including increased number of white blood cells (eosinophilia) and elevated liver enzymes) (Drug reaction with eosinophilia and systemic symptoms)
- rash with blisters arranged in a circle with a central crust or like a string of pearls (linear IgA disease). If you experience any of these symptoms, contact your doctor immediately.
- inflammation of the liver ( hepatitis)
- jaundice, caused by an increase in bilirubin in the blood (a substance produced by the liver) which can cause the skin and whites of the eyes to appear yellow
- inflammation of the kidney tubules
- blood takes longer to clot
- hyperactivity
- convulsions (in people taking high doses of CLAVOMED or who have kidney problems)
- black tongue appearing covered in hair
- stains on teeth (in children), usually removed by brushing.
Side effects that can be seen from blood or urine tests:
- severe reduction 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 of side effects
If you get any side effect, even if not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE CLAVOMED
Store in the original packaging to protect the medicine from light and moisture.
Do not store at a temperature above 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the packaging. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What CLAVOMED contains
CLAVOMED 875 mg + 125 mg film-coated tablets
Each film-coated tablet contains:
- active substances are: amoxicillin trihydrate corresponding to amoxicillin 875 mg potassium clavulanate corresponding to clavulanic acid 125 mg.
- The other excipients are: Colloidal silicon dioxide, magnesium stearate, sodium starch glycolate, microcrystalline cellulose, hypromellose, titanium dioxide, macrogol 4000, macrogol 6000, dimethicone. CLAVOMED 875 mg + 125 mg oral suspension powderEach sachet contains: Active ingredients: amoxicillin trihydrate corresponding to amoxicillin 875 mg potassium clavulanate corresponding to clavulanic acid 125 mg. Excipients: Colloidal silicon dioxide, lemon aroma, strawberry aroma, xanthan gum, sucrose. Description of the appearance of CLAVOMED and package contentsFilm-coated tablets: pack of 12 tablets. Oral suspension powder: pack of 12 sachets. Marketing authorisation holder
NEOPHARMED GENTILI S.p.A., Via San Giuseppe Cottolengo, 15 – 20143 Milano.
Manufacturer
Tablets
Laboratorio Reig Jofré, S.A. - Jarama, 111, Polígono Industrial - 45007 Toledo - Spain
Oral suspension powder
Laboratorio Reig Jofré, S.A. - Jarama, 111, Polígono Industrial - 45007 Toledo – Spain.

- Країна реєстрації
- Лікарська формаOral suspension powder, 875 MG + 125 MG
- Код АТХJ01CR02
- Діюча речовина
- Потрібен рецептНі
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до KLAVOMEDЛікарська форма: Film-coated tablet, 875 MG + 125 MGДіюча речовина: amoxicillin and beta-lactamase inhibitorВиробник: FIDIA FARMACEUTICI S.P.A.Потрібен рецептЛікарська форма: Film-coated tablet, 875 MG + 125 MGДіюча речовина: amoxicillin and beta-lactamase inhibitorВиробник: AESCULAPIUS FARMACEUTICI SRLПотрібен рецептЛікарська форма: Film-coated tablet, 875 MG + 125 MGДіюча речовина: amoxicillin and beta-lactamase inhibitorВиробник: KONPHARMA S.R.L.Потрібен рецепт
Аналоги KLAVOMED в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог KLAVOMED у Іспанія
Аналог KLAVOMED у Польща
Аналог KLAVOMED у Україна
Лікарі онлайн щодо KLAVOMED
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на KLAVOMED онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
KLAVOMED не потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у KLAVOMED — amoxicillin and beta-lactamase inhibitor. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
KLAVOMED виробляється компанією NEOPHARMED GENTILI S.P.A.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування KLAVOMED з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати KLAVOMED у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (amoxicillin and beta-lactamase inhibitor) включають ABBA, ABIOKLAV, AKLAV. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
















