Amoxicillin and clavulanic acid Teva Group
Italy
Table of Contents
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Amoxicillin and Clavulanic Acid Teva Group 80 mg/11.4 mg/ml powder for oral suspension
oral
amoxicillin/clavulanic acid
Generic medicine
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 questions, ask your doctor or pharmacist.
- This medicine has been prescribed for a newborn or child. Never give it to others. It could be harmful to other individuals, even if their symptoms appear identical to those of your child.
- If your child experiences any side effects, or if you notice any side effect not listed in this leaflet, inform your child's doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Amoxicillin and Clavulanic Acid Teva Group is and what it is used for
- What you need to know before using Amoxicillin and Clavulanic Acid Teva Group
- How to use Amoxicillin and Clavulanic Acid Teva Group
- Possible side effects
- How to store Amoxicillin and Clavulanic Acid Teva Group
- Contents of the pack and other information
1. What Amoxicillin and Clavulanic Acid Teva Group is and what it is used for
Amoxicillin and Clavulanic Acid Teva Group is an antibiotic that works by killing bacteria causing infections. It contains two different active ingredients called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins", whose action can sometimes be interrupted (inactivated). The other active ingredient in this medicine (clavulanic acid) prevents this from happening.
Amoxicillin and Clavulanic Acid Teva Group is used in infants and children to treat the following infections:
- 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 should know before using Amoxicillin and Clavulanic Acid Teva Group
Do not give Amoxicillin and Clavulanic Acid Teva Group to your child:
- if he/she is allergic to amoxicillin, clavulanic acid, penicillins, or any of the excipients of this medicine (listed in section 6).
- if he/she has had an allergic reaction to any other antibiotic. This may include a skin rash or swelling of the face or neck.
- if he/she has had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.
→ Do not give Amoxicillin and Clavulanic Acid Teva Group to your child if any of these apply.
If you have any doubts, speak with your doctor or pharmacist before giving Amoxicillin and Clavulanic Acid Teva Group to your child.
Warnings and precautions
Talk to your doctor or pharmacist before giving this medicine to your child if:
- he/she has glandular fever (infectious mononucleosis)
- he/she has been treated for liver or kidney problems
- he/she does not urinate regularly.
If you are unsure whether any of the above conditions apply to your child, speak with your doctor or pharmacist before giving Amoxicillin and Clavulanic Acid Teva Group.
In some cases, the doctor may carry out tests to identify the type of bacteria causing your child's infection.
Based on the results, he/she may prescribe a different dose of Amoxicillin and Clavulanic Acid Teva Group or a different medicine.
Conditions to be aware of
Amoxicillin and Clavulanic Acid Teva Group may worsen certain pre-existing conditions or cause serious side effects. These may include allergic reactions, seizures, and inflammation of the large intestine. You should watch for certain symptoms while your child is taking Amoxicillin and Clavulanic Acid Teva Group, in order to reduce any risk. See "Conditions requiring special attention" in section 4.
Blood and urine tests
If your child is due to have blood tests (such as checks for red blood cells or liver function tests) or urine tests (for glucose), inform the doctor or nurse that your child is taking Amoxicillin and Clavulanic Acid Teva Group. This is because Amoxicillin and Clavulanic Acid Teva Group may affect the results of these tests.
Other medicines and Amoxicillin and Clavulanic Acid Teva Group
Tell the doctor or pharmacist if your child is using/taking, has recently used/taken, or might use/take any other medicines, including those available without a prescription and herbal products.
If your child is taking allopurinol (used for gout) together with Amoxicillin and Clavulanic Acid Teva Group, he/she is more likely to develop a skin allergic reaction.
If your child is taking probenecid (used for gout), the doctor may decide to adjust the dose of Amoxicillin and Clavulanic Acid Teva Group.
If your child is taking medicines such as warfarin (which help prevent blood clots) together with Amoxicillin and Clavulanic Acid Teva Group, additional blood tests may be needed.
Amoxicillin and Clavulanic Acid Teva Group may affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works.
Pregnancy and breastfeeding
If your daughter who is about to take this medicine is pregnant or breastfeeding, consult your doctor or pharmacist before giving her this medicine.
Amoxicillin and Clavulanic Acid Teva Group contains aspartame, glucose and sucrose.
Amoxicillin and Clavulanic Acid Teva Group contains aspartame, a source of phenylalanine. This may be harmful for children born with a condition called "phenylketonuria".
Amoxicillin and Clavulanic Acid Teva Group contains glucose and sorbitol. If your doctor has informed you that your child has an intolerance to certain sugars, consult your doctor before giving this medicine to your child.
3. How to use Amoxicillin and Clavulanic Acid Teva Group
Always take this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Adults and children weighing 40 kg or more
This suspension is not recommended for adults and children weighing 40 kg or more. If you
have any doubts, consult your doctor or pharmacist.
Children weighing less than 40 kg
All doses are calculated based on the child's body weight expressed in kilograms.
Your doctor will advise you on the appropriate dose of Amoxicillin and Clavulanic Acid Teva Group to give your
newborn or child.
- You must use a plastic dosing spoon or an oral dosing syringe. Use it to give your newborn or child the correct dose.
- Usual dose – from 25 mg/3.6 mg up to 45 mg/6.4 mg per kg of body weight per day, given in two divided doses.
- Higher dose – up to 70 mg/10 mg per kg of body weight per day, given in two divided doses.
Patients with kidney or liver problems
- If your child has kidney problems, the dose may need to be reduced. Your doctor may choose a different dosage or an alternative medicine.
- If your child has liver problems, more frequent blood tests may be required to monitor liver function.
How to administer Amoxicillin and Clavulanic Acid Teva Group
- To prepare an oral suspension ready for use, open the bottle, completely and carefully remove the seal and discard it. Fill the bottle with water up to just below the mark on the label and shake well immediately. Then, add water up to exactly the mark and shake again vigorously.
- Shake the bottle well before each use.
- Administer the dose at the beginning of a meal or just before.
- Space the doses evenly throughout the day, at least 4 hours apart. Do not give two doses within one hour.
- Do not let your child take Amoxicillin and Clavulanic Acid Teva Group for longer than 2 weeks. If your child does not feel well, return to the doctor.
If you give more Amoxicillin and Clavulanic Acid Teva Group than you should
If your child takes too much Amoxicillin and Clavulanic Acid Teva Group, symptoms may include
gastrointestinal disturbances (nausea, vomiting, or diarrhoea) or seizures. Speak to your doctor as soon
as possible. Bring the medicine packaging or the bottle to show the doctor.
If you forget to give Amoxicillin and Clavulanic Acid Teva Group
If you forget to give a dose to your child, give it as soon as you remember. Do not give the
next dose too early; wait approximately 4 hours before giving the next dose.
If your child stops treatment with Amoxicillin and Clavulanic Acid Teva Group
Continue giving Amoxicillin and Clavulanic Acid Teva Group to your child until the
treatment is complete, even if your child seems to be feeling better. Your child needs every
dose to fight the infection. If some bacteria survive, they may cause the infection to return.
If you have any doubts about using this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Conditions requiring special attention
Allergic reactions
- skin rash
- inflammation of blood vessels ( vasculitis ), appearing as raised red or purple spots on the skin, but which may also affect other parts of the body
- fever, joint pain, swelling of the glands in the neck, armpits, or groin
- swelling, sometimes of the face or mouth ( angioedema ), causing difficulty in breathing
- collapse.
→ Contact your doctor immediately if your child experiences any of these symptoms. Stop giving
Amoxicillin and Clavulanic Acid Teva Group to your child.
Inflammation of the large intestine
Inflammation of the large intestine, causing watery diarrhoea, usually with blood and mucus, stomach pain and/or fever.
→ If your child has these symptoms, contact your doctor as soon as possible for advice.
Very common side effects (may affect more than 1 in 10 people)
- diarrhoea (in adults)
Common side effects (may affect up to 1 in 10 people)
- candidiasis ( candida – a fungal infection that may affect the vagina, mouth or skin folds)
- feeling unwell (nausea), especially when taking high doses
→ if affected, take Amoxicillin and Clavulanic Acid Teva Group before meals
- vomiting
- diarrhoea (in children)
Uncommon side effects (may affect up to 1 in 100 people)
- skin rash, itching sensation
- itchy rash (urticaria)
- indigestion
- dizziness
- headache.
Uncommon side effects may be detected through blood tests:
- increased levels of certain proteins ( enzymes ) produced by the liver.
Rare side effects (may affect up to 1 in 1,000 people)
- skin rash possibly developing into blisters resembling small targets (dark central spots surrounded by a lighter area with a dark ring around the edge - erythema multiforme ) → if you notice any of these symptoms, contact your doctor urgently.
Rare side effects that may be detected through blood tests: - low number of cells involved in blood clotting
- low number of white blood cells
Other side effects
Other side effects have been reported in a very small number of individuals, but their exact frequency is unknown (frequency cannot be estimated from the available data).
- Allergic reactions (see previous section)
- Inflammation of the large intestine (see previous section)
- Severe skin reactions:
- widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome ), and a more severe form causing extensive skin peeling (affecting more than 30% of the body surface - toxic epidermal necrolysis )
- widespread rash with redness and small blisters containing pus ( bullous exfoliative dermatitis )
- a scaly, red rash 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 cell count (eosinophilia) and elevated liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms)
- aseptic meningitis.
→ If your child experiences any of these symptoms, contact your doctor immediately.
- inflammation of the liver ( hepatitis )
- jaundice, caused by increased levels of bilirubin (a substance produced by the liver) in the blood, resulting in yellowing of your child’s skin and the whites of the eyes
- inflammation of the kidney tubules
- prolonged blood clotting time
- hyperactivity
- seizures (in individuals taking high doses of Amoxicillin and Clavulanic Acid Teva Group or who have kidney problems)
- black hairy tongue
- tooth staining (in children), usually removable with brushing
Side effects that may be detected through blood or urine tests:
- severe reduction in the number of white blood cells
- low number of red blood cells ( haemolytic anaemia )
- presence of crystals in the urine.
Reporting of side effects
If your child experiences any side effect, including those not listed in this leaflet,
please talk to your doctor or pharmacist. You may also report side effects directly
through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects, you can help provide more information on the safety of
this medicine.
5. How to store Amoxicillin and Clavulanic Acid Teva Group
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging and
label, following the word “Exp.”.
The expiry date refers to the last day of the stated month.
The reconstituted suspension must be stored in the refrigerator (2°-8°C) and used within 7 days.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Amoxicillin and Clavulanic Acid Teva Group contains
The active substances are amoxicillin and clavulanic acid.
1 ml of reconstituted suspension contains 80 mg of amoxicillin (as amoxicillin trihydrate) and 11.4 mg
of clavulanic acid (as potassium clavulanate).
The excipients are:
Citric acid, Trisodium citrate, Aspartame (E951), Talc, Galactomannan, Silicon dioxide,
Lemon flavour (natural flavourings, flavourings similar to natural ones, glucose, maltodextrin,
butylhydroxyanisole E320), Peach-apricot flavour (natural flavourings, flavourings similar to natural
ones, maltodextrine, butylhydroxyanisole E320; sorbitol syrup E420), Orange flavour (e.g. maltodextrin, concentrated orange oil, concentrated lemon oil, vanillin, absolute neroli essence).
Description of the appearance of Amoxicillin and Clavulanic Acid Teva Group and contents of the pack
Cream-coloured, almost white powder, which turns into a cream-coloured, almost white suspension when mixed with water.
Amoxicillin and Clavulanic Acid Teva Group is available in packs containing 5.6 g, 8.0 g, 9.6 g,
11.2 g, 12.0 g, 16.0 g and 22.4 g of powder.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
ratiopharm GmbH - Graf-Arco Strasse 3 - 89079 Ulm (Germany)
Responsible manufacturer for batch release
Sandoz GmbH – Biochemiestrasse, 10- A-6250 Kundl (Austria)
Merckle GmbH – Ludwig-Merckle-Str. 3– 89143 Blaubeuren (Germany)
This medicinal product is authorised in the European Economic Area countries under the following names:
Finland: Amoxi comp 80 mg/ml jauhe oraalisuspensiota varten
Portugal: Amoxicilina + Ácido Clavulânico ratiopharm 400mg/5ml + 57mg/5ml pó para suspensão oral
Iceland: Amoxin comp 80mg/ml mixtúruduft, dreifa
Behavioural hygiene
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
Sometimes, a bacterial infection does not respond to antibiotic treatment. The most common reason for this is that 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. Using antibiotics appropriately can reduce the development of bacterial resistance.
When your doctor prescribes an antibiotic treatment, it is intended solely for the illness your child currently has. Please follow the advice below to help prevent the emergence of bacterial resistance, which may lead to failure of antibiotic activity.
- It is very important that you give your child the antibiotic at the correct dose, at the prescribed times, and for the exact number of days indicated. Read the instructions in the package leaflet carefully and, if anything is unclear, ask your doctor or pharmacist for clarification.
- Do not give your child an antibiotic unless it has been specifically prescribed for them, and use it only for the infection for which it was prescribed.
- Do not give your child antibiotics that have been prescribed for other people, even if they appear to have a similar infection.
- Do not give to others antibiotics that have been specifically prescribed for your child.
- If you have any antibiotic left over after completing the treatment, return it to your pharmacist for proper disposal.