Stemox

PACKAGE LEAFLET: INFORMATION FOR THE USER

STEMOX 400 mg + 57 mg/5 ml paediatric powder for oral suspension

Amoxicillin and clavulanic acid
Generic medicine
Please read all of this leaflet carefully before giving this medicine to your child.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for infants or children. Never give it to others. It may be harmful to other individuals, even if their symptoms are the same as your child's.
• If any adverse reaction occurs, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.1.

Contents of this leaflet:

1. What STEMOX is and what it is used for
2. What you need to know before giving STEMOX
3. How to give STEMOX
4. Possible side effects
5. How to store STEMOX
6. Contents of the pack and other information

1. WHAT STEMOS IS AND WHAT IT IS USED FOR

STEMOX is an antibiotic that works by killing bacteria that cause infections. It contains two different active ingredients called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins", whose activity can sometimes be blocked (rendered inactive). The other active component (clavulanic acid) prevents this from happening.

STEMOX 400 mg + 57 mg/5 ml powder for oral suspension for children is used in infants 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. WHAT YOU SHOULD KNOW BEFORE GIVING STEMOX

Do not give STEMOX to your child:

• if he/she is allergic to amoxicillin, clavulanic acid, or any of the other ingredients of this medicine (listed in section 6)
• if he/she has had an allergic reaction (hypersensitivity) 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 STEMOX to your child if any of these cases apply to him/her.
If you have any doubts, speak with your doctor or pharmacist before giving STEMOX.
Warnings and precautions
Exercise special care with STEMOX
Talk to your doctor or pharmacist before giving this medicine to your child if:

• he/she has 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, discuss this with your doctor or pharmacist before giving STEMOX. 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 STEMOX or a different medicine.

Conditions you should watch for
STEMOX may worsen certain pre-existing conditions or cause serious adverse effects.
These may include allergic reactions, seizures, and inflammation of the intestine. You should be aware of certain symptoms during administration of STEMOX to your child in order to reduce any risk.
See “Conditions you should watch for” 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 he/she is taking STEMOX. This is because STEMOX may affect the results of these types of tests.
Other medicines and STEMOX
Inform your doctor or pharmacist if your child is taking or has recently taken any other medicines, including those obtained without a prescription and herbal products.
If your child is taking allopurinol (used for gout) together with STEMOX, it is highly likely that your child may develop a skin allergic reaction.
If your child is taking probenecid (used for gout), the doctor may decide to adjust the dose of STEMOX.
If your child is taking medicines (such as warfarin) that help prevent blood clots at the same time as STEMOX, additional blood tests may be required.
STEMOX may affect the action of methotrexate (a medicine used to treat cancers or rheumatic diseases).
STEMOX may affect the action of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).
Pregnancy and breastfeeding
If your daughter is pregnant or breastfeeding, inform your doctor or pharmacist.
Ask your doctor or pharmacist for advice before giving any medicine.
STEMOX contains aspartame
STEMOX contains aspartame, a source of phenylalanine. It may be harmful for children born with a disease called 'phenylketonuria'.

3. HOW TO ADMINISTER STEMOX

Always give this medicine exactly as prescribed by the doctor. If in doubt, 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 in doubt, 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 STEMOX to give to your infant or child.

• Use the plastic dosing syringe supplied. You will use it to give your infant or child the correct dose.
• Usual dose - from 25 mg/3.6 mg to 45 mg/6.4 mg per kg of body weight per day, administered in two divided doses.
• Higher dose - up to 70 mg/10 mg per kg of body weight per day, administered in two divided doses.

Patients with kidney or liver problems

• If your child has kidney problems, the dose may need to be reduced. The doctor may choose a different dosage or a different medicine.
• If your child has liver problems, more frequent blood tests may be required to monitor liver function.

How to administer STEMOX

• Always shake the bottle well before withdrawing each dose.
• Administer the dose at the beginning of a meal or immediately before.
• Space doses evenly throughout the day, with at least 4 hours between doses. Do not administer two doses within one hour.
• Do not let your child take STEMOX for longer than 2 weeks. If your child does not feel well, you should return to the doctor.

If you give more STEMOX than you should
If your child takes too much STEMOX, symptoms may include gastrointestinal disturbances (nausea, vomiting, or
diarrhea) or seizures. Inform the doctor as soon as possible. Bring the medicine packaging or bottle to show the doctor.
If you forget to give STEMOX
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 administering the next dose.
If your child stops treatment with STEMOX
Continue giving STEMOX to your child until the treatment is completed, even if they appear to feel 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 ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Conditions you should watch for
Allergic reactions:

• skin rashes
• inflammation of blood vessels (vasculitis), which may appear as red or purple spots on the skin, but 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 STEMOX.
Intestinal inflammation
Intestinal inflammation, causing watery diarrhoea usually with blood and mucus, stomach pain and/or fever.
If your child experiences these symptoms, contact your doctor as soon as possible for advice.
Very common adverse effects
May affect more than 1 in 10 people

• diarrhoea (in adults).

Common adverse effects
May affect up to 1 in 10 people

• oral, vaginal or skin fungal infection (candidiasis)
• nausea, especially when high doses are taken; if your child experiences this, give STEMOX before meals
• vomiting
• children).

Uncommon adverse effects
May affect up to 1 in 100 people

• skin rashes, itching
• raised, itchy skin rash (urticaria)
• indigestion
• dizziness
• headache.

Uncommon adverse effects may be detected in blood tests:

• increased levels of certain proteins (enzymes) produced by the liver.

Rare adverse effects
May affect up to 1 in 1,000 people

• skin rashes, which may appear as blisters and resemble small targets (a 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 adverse effects may be detected in blood tests:

• low number of cells involved in blood clotting (thrombocytes)
• low number of white blood cells.

Other adverse effects
Other adverse effects occur in a very limited number of people, but their exact frequency is unknown.

• Allergic reactions (see above)
• Intestinal inflammation (see above)
• Inflammation of the protective membrane surrounding the brain (aseptic meningitis)
• Severe skin reactions:
• widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing extensive peeling of the skin (more than 30% of body surface – toxic epidermal necrolysis)
• widespread red rash with small pus-filled blisters (exfoliative bullous dermatitis)
• a 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 cells (eosinophilia) and elevated liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms – DRESS).

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 in the liver) in the blood, which may cause yellowing of the skin and whites of the eyes
• inflammation of the kidney tubules
• blood takes longer to clot
• hyperactivity
• seizures (in people taking high doses of STEMOX or who have kidney problems)
• black, hairy-looking tongue
• tooth staining (in children), usually removable by brushing.

Adverse effects that may be detected in blood or urine tests:

• severe reduction in the number of white blood cells
• low number of red blood cells (haemolytic anaemia)
• crystals in the urine.

If your child experiences adverse effects
Reporting of adverse effects
If you notice any adverse effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE STEMOX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the bottle after EXP.
The expiry date refers to the last day of that month.
Store below 25°C in the original packaging to protect the product from light and moisture.
The oral suspension, after reconstitution, must be stored in the refrigerator for a maximum of 7 days; after this period, any remaining product must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What STEMOX contains
When reconstituted, each ml of suspension contains amoxicillin trihydrate equivalent to 80 mg amoxicillin and
potassium clavulanate equivalent to 11.4 mg of clavulanic acid.
The other components are: xanthan gum, aspartame, anhydrous colloidal silica, anhydrous citric acid, silicon
dioxide, hypromellose, orange flavour, raspberry flavour, golden syrup flavour.

Description of the appearance of STEMOX and pack contents
Powder for oral suspension
1 bottle of 70 ml of reconstitutable suspension, with a 10 ml dosing syringe
1 bottle of 140 ml of reconstitutable suspension, with a 10 ml dosing syringe

Marketing Authorization Holder
STEWART ITALIA S.r.l.
Via Larga, 15 – 20122 Milano, Italy

Manufacturer
Medreich Limited
12th Mile, Old Madras Road, Virgonagar
Bangalore - 560 049 – India

Responsible site for batch release
Medreich Plc
Warwick House, Plane Tree Crescent,
Feltham, TW13 7HF – United Kingdom

Behavioural hygiene
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
Sometimes, bacterial infections do 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 presence of the antibiotic. Bacteria can become resistant to antibiotics for several reasons. Using antibiotics appropriately can help reduce the development of bacterial resistance.
When your doctor prescribes you an antibiotic, it is intended only for the specific illness you have. Please follow the advice below to help prevent the emergence of bacterial resistance, which can lead to antibiotics becoming ineffective.

1. It is very important that you take the antibiotic at the correct dose, at the prescribed times, and for the full duration of treatment. Read the instructions in this leaflet carefully and, if anything is unclear, ask your doctor or pharmacist for clarification.
2. Do not take antibiotics unless they have been specifically prescribed for you, and use them only for the infection for which they were prescribed.
3. Do not use antibiotics that have been prescribed for someone else, even if you have a similar infection.
4. Do not give your prescribed antibiotics to other people.
5. If you have any antibiotic left over after completing your treatment, return it to your pharmacist for proper disposal.

Instructions for reconstitution
Before use, check that the seal on the cap is intact. Shake the bottle to loosen any powder clumps. Add water to the bottle contents just below the level mark indicated on the bottle, invert, shake well, and let stand for a few minutes. Since preparing the suspension results in a reduction in volume, add more water until the level mark is reached again.
The final volume of the reconstituted suspension will be 70 ml or 140 ml, depending on the presentation.
Shake the bottle well before taking each dose.