Amoxicillin and clavulanic acid Almus
Italy
Table of Contents
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AMOXICILLIN AND CLAVULANIC ACID ALMUS 875 mg + 125 mg film-coated tablets
AMOXICILLIN AND CLAVULANIC ACID ALMUS 875 mg + 125 mg powder for oral suspension
Equivalent medicine
Please 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 give it to other people, even if they have the same symptoms as you, because it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What AMOXICILLIN AND CLAVULANIC ACID ALMUS is and what it is used for
- What you need to know before taking AMOXICILLIN AND CLAVULANIC ACID ALMUS
- How to take AMOXICILLIN AND CLAVULANIC ACID ALMUS
- Possible side effects
- How to store AMOXICILLIN AND CLAVULANIC ACID ALMUS
- Contents of the pack and other information
1. WHAT AMOXICILLIN AND CLAVULANIC ACID ALMUS IS AND WHAT IT IS USED FOR
AMOXICILLIN AND CLAVULANIC ACID ALMUS is an antibiotic that works by killing the bacteria causing infections. It contains two different active substances called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of antibiotic medicines known as "penicillins", whose activity can sometimes be blocked (rendered inactive). Clavulanic acid prevents this from happening.
This medicine is used in adults and children to treat the following infections:
- ear and sinus infections (otitis, sinusitis)
- respiratory tract infections (bronchitis, pneumonia)
- urinary tract infections (cystitis, pyelonephritis)
- skin and soft tissue infections, including dental infections
- bone and joint infections (osteomyelitis).
2. WHAT YOU SHOULD KNOW BEFORE TAKING AMOXICILLIN AND CLAVULANIC ACID ALMUS
Do not take AMOXICILLIN AND CLAVULANIC ACID ALMUS if:
- you are allergic to amoxicillin trihydrate, to other similar medicines (penicillins), to potassium clavulanate, or to any of the other ingredients of this medicine (listed in section 6);
- you have had a severe allergic reaction to any other antibiotic. This may include a skin rash or swelling of the face or neck;
- you have previously experienced liver problems or jaundice (yellowing of the skin and whites of the eyes) while taking an antibiotic.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine.
Do not use this medicine for a prolonged period, as antibiotic-resistant organisms may develop.
Take this medicine with caution and inform your doctor in the following cases:
- if you have a viral infection called mononucleosis and experience symptoms such as fever, fatigue, and general malaise;
- if you have or have had liver or kidney problems;
- if you have difficulty urinating.
In some cases, your doctor may perform tests to identify the type of bacteria causing your infection. Based on the results, they may prescribe a different dosage of amoxicillin and clavulanic acid or a different medicine.
AMOXICILLIN AND CLAVULANIC ACID ALMUS may worsen certain pre-existing conditions or cause serious adverse effects. These may include allergic reactions, seizures, and inflammation of the intestine. You should pay attention to certain symptoms while taking this medicine in order to reduce any risks (see section 4 “Possible side effects”).
Antibiotics are used to treat bacterial infections. They are not effective against infections caused by viruses. Sometimes, bacterial infections do not respond to treatment because the bacteria causing the infection are resistant to the antibiotic being used. This means that bacteria survive and multiply despite the antibiotic.
Bacteria become resistant to antibiotics for various reasons.
Use antibiotics appropriately to reduce the development of bacterial resistance, which can lead to loss of antibiotic effectiveness.
- It is very important that you take the antibiotic at the correct dose, at the prescribed times, and for the exact number of days. Read the instructions in the package leaflet carefully, and if anything is unclear, ask your doctor or pharmacist for clarification.
- Do not take antibiotics unless they have been specifically prescribed for you, and use them only for the infection for which they were prescribed.
- Do not use antibiotics prescribed for other people, even if you have an infection similar to theirs.
- Do not give antibiotics prescribed specifically for you to anyone else.
- If you have leftover antibiotics after completing your treatment, return them to your pharmacist for proper disposal.
Blood and urine tests
If you are scheduled for blood tests (such as checks for red blood cells or liver function tests) or urine tests (for glucose), inform your doctor or nurse that you are taking this medicine, because AMOXICILLIN AND CLAVULANIC ACID ALMUS may affect the results of these tests.
Children
The use of AMOXICILLIN AND CLAVULANIC ACID ALMUS 875 mg + 125 mg powder for oral suspension in sachets for oral solution is not recommended in children weighing less than 40 kg.
Ask your doctor or pharmacist for advice on administering AMOXICILLIN AND CLAVULANIC ACID ALMUS 875 mg + 125 mg film-coated tablets to children weighing less than 40 kg.
Other medicines and AMOXICILLIN AND CLAVULANIC ACID ALMUS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay particular attention and inform your doctor if you are taking the following medicines:
- allopurinol, a medicine used for gout, as it may cause a skin allergic reaction;
- probenecid, a medicine used for gout. In this case, your doctor may decide to adjust your dose of AMOXICILLIN AND CLAVULANIC ACID ALMUS;
- medicines that help prevent blood clots (such as warfarin). In this case, additional blood tests may be required;
- methotrexate, a medicine used to treat tumors or rheumatic diseases.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant or breastfeeding, take this medicine only if absolutely necessary and under strict medical supervision.
Driving and using machines
This medicine may cause adverse effects such as allergic reactions, dizziness, and seizures. Do not drive or operate machinery if you experience these symptoms.
AMOXICILLIN AND CLAVULANIC ACID ALMUS 875 mg + 125 mg powder for oral suspension contains sucrose
This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
3. HOW TO TAKE AMOXICILLIN AND CLAVULANIC ACID ALMUS
Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take the contents of the sachet or one tablet at the beginning of a meal or just before.
To take the contents of the sachet, you must first dissolve it in half a glass of water.
Take subsequent doses at intervals of at least 4 hours to avoid overdose. Do not take two doses within the same hour.
The recommended dose in adults and children weighing 40 kg or more is 1 sachet or 1 tablet twice daily.
In more severe cases, the dose may be increased to 1 sachet or 1 tablet three times daily.
Do not take AMOXICILLIN AND CLAVULANIC ACID ALMUS for longer than 2 weeks. If you continue to feel unwell, you must consult your doctor again.
Use in children weighing less than 40 kg
Children aged 6 years or younger should preferably be treated with oral amoxicillin and clavulanic acid suspension or pediatric sachets.
AMOXICILLIN AND CLAVULANIC ACID ALMUS 875 mg + 125 mg powder for oral suspension in sachets is not recommended in children.
Ask your doctor or pharmacist for advice on administering AMOXICILLIN AND CLAVULANIC ACID ALMUS 875 mg + 125 mg film-coated tablets to children weighing less than 40 kg.
Use in patients with kidney or liver problems
- If you have kidney problems, your dose may need to be adjusted. Your doctor may choose a different dosage or a different medicine.
- If you have liver problems, you may need more frequent blood tests to monitor liver function.
If you take more AMOXICILLIN AND CLAVULANIC ACID ALMUS than you should
If you (or someone else) have taken an excessive amount of AMOXICILLIN AND CLAVULANIC ACID ALMUS, or if you think a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
Symptoms of overdose may include stomach problems such as nausea, vomiting or diarrhoea, and seizures. Inform your doctor as soon as possible. Take the medicine packaging or sachet with you to show the doctor.
If you forget to take AMOXICILLIN AND CLAVULANIC ACID ALMUS
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.
Do not take a double dose to make up for a forgotten dose.
If you stop taking AMOXICILLIN AND CLAVULANIC ACID ALMUS
Continue taking AMOXICILLIN AND CLAVULANIC ACID ALMUS for the full duration of treatment, even if you start to feel better. If you decide to stop taking the medicine, speak to your doctor or pharmacist first.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. POSSIBLE ADVERSE EFFECTS
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Stop taking this medicine and contact your doctor immediately if you notice signs of allergic reactions and experience any of the following symptoms:
- skin rashes
- inflammation of blood vessels (vasculitis), which may appear as red or purple spots on the skin but can also affect other parts of the body
- fever, joint pain, swelling of the glands in the neck, armpits, or groin (serum sickness-like syndrome)
- swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing
- collapse
- chest pain during allergic reactions, which may be a symptom of an allergy-triggered heart attack (Kounis syndrome).
Contact your doctor as soon as possible if you experience any of these symptoms. Stop taking AMOXICILLIN AND CLAVULANIC ACID ALMUS.
Inflammation of the large intestine (colitis)
Inflammation of the large intestine causing watery diarrhoea, usually with blood and mucus, stomach pain and/or fever (pseudomembranous colitis).
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 enterocolitis syndrome (DIES)
DIES has been reported mainly in children treated with amoxicillin/clavulanate. It is a type of allergic reaction whose main symptom is repeated vomiting (1-4 hours after taking the medicine). Additional symptoms may include abdominal pain, lethargy, diarrhoea, and low blood pressure.
Other adverse effects that may occur include:
Very common (may affect more than 1 in 10 people):
- diarrhoea (in adults)
Common (may affect up to 1 in 10 people):
- oral or vaginal thrush (a fungal infection of the mouth, vagina, or skin folds)
- nausea, especially when taking high doses (if affected, take AMOXICILLIN AND CLAVULANIC ACID ALMUS before meals)
- vomiting
- diarrhoea (in children)
Uncommon (may affect up to 1 in 100 people):
- skin rash, itching
- raised, itchy skin rash (urticaria)
- indigestion
- dizziness and headache
- increased levels of certain liver enzymes
Rare (may affect up to 1 in 1,000 people):
- skin rashes, which may appear as blisters with a dark center surrounded by a paler area and a dark ring around the edge (erythema multiforme). Contact your doctor if you notice these symptoms
- low number of blood cells involved in clotting (platelets) (thrombocytopenia)
- low white blood cell count (leucopenia)
Frequency not known (frequency cannot be estimated from the available data):
- allergic reactions (see above)
- intestinal inflammation (see above)
- development of antibiotic-resistant bacteria
- severe reduction in white blood cells (agranulocytosis)
- low red blood cell count (haemolytic anaemia)
- prolonged blood clotting time
- hyperactivity
- seizures (in people taking high doses of AMOXICILLIN AND CLAVULANIC ACID ALMUS or who have kidney problems)
- black, hairy-looking tongue (black hairy tongue)
- inflammation of the liver (hepatitis)
- yellowing of the skin and whites of the eyes (jaundice)
- widespread skin rash with blisters and peeling skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing extensive skin detachment (more than 30% of body surface area – toxic epidermal necrolysis)
- widespread red rash with small pus-filled blisters (exfoliative bullous dermatitis)
- skin rash, red with crusts, swellings under the skin, and blisters (pustular exanthema)
- flu-like symptoms with rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and elevated liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms - DRESS)
- kidney inflammation (interstitial nephritis)
- problems urinating and presence of crystals in urine leading to acute kidney injury
- tooth staining (in children), usually removable by brushing
- skin rash with ring-shaped blisters with central crusting or resembling a string of pearls (linear IgA disease)
- inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE AMOXICILLIN AND CLAVULANIC ACID ALMUS
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp.:”.
The expiry date refers to the last day of that month.
Store in the original container to protect the medicine from light and moisture, at a temperature
not exceeding 25°C.
Do not dispose of medicines 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 PACKAGE AND OTHER INFORMATION
What AMOXICILLINA E ACIDO CLAVULANICO ALMUS 875 mg + 125 mg FILM-COATED TABLETS contains
- The active substances are amoxicillin and clavulanic acid. Each tablet contains amoxicillin trihydrate equivalent to 875 mg of amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid.
- The other ingredients are: colloidal silicon dioxide, magnesium stearate, sodium starch glycolate, microcrystalline cellulose, hypromellose, titanium dioxide, macrogol 4000, macrogol 6000, dimethicone.
What AMOXICILLINA E ACIDO CLAVULANICO ALMUS 875 mg + 125 mg ORAL SUSPENSION POWDER contains
- The active substances are amoxicillin and clavulanic acid. Each sachet contains amoxicillin trihydrate equivalent to 875 mg of amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid.
- The other ingredients are: colloidal silicon dioxide, lemon flavour, strawberry flavour, xanthan gum, sucrose.
Description of the appearance of AMOXICILLINA E ACIDO CLAVULANICO ALMUS and contents of the pack
Carton containing 12 film-coated tablets in blister packs.
Carton containing 12 sachets of oral suspension powder.
Marketing Authorization Holder
Almus S.r.l. - Via Cesarea 11/10 - 16121 Genoa, Italy
Manufacturer
Laboratorio Reig Jofré, S.A. - C/Jarama s/n, Poligono Industrial - 45007 Toledo (Spain)