STEMOX 400 mg/57 mg Proszek Do Sporządzania Zawiesiny Doustnej

Treść ulotki

1. STEMOX 400 mg + 57 mg/5 ml bambini polvere per sospensione orale
   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. PACKAGE CONTENTS AND OTHER INFORMATION

STEMOX 400 mg + 57 mg/5 ml bambini polvere per sospensione orale

Amoxicillin and clavulanic acid
Generic medicine

Read 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, ask your doctor or pharmacist.
• This medicine has been prescribed for infants or children. Never give it to anyone else. In fact, this medicine may be dangerous for other individuals, even if their symptoms are the same as those of your child.
• If any side effects occur, including those not listed in this leaflet, contact 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 STEMOX IS AND WHAT IT IS USED FOR

STEMOX 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” whose activity can sometimes be blocked (rendered inactive).
The other active ingredient (clavulanic acid) prevents this from happening.
STEMOX 400 mg + 57 mg/5 ml children powder for oral suspension is used in newborns 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 NEED TO KNOW BEFORE GIVING STEMOX

Do not give STEMOX to your child:

• if they are allergic to amoxicillin, clavulanic acid or any of the other ingredients of this medicine (listed in section 6)
• if they have had an allergic reaction (hypersensitivity) to any other antibiotic. This may include a skin rash or swelling of the face or neck
• if they have had problems with their liver or jaundice (yellowing of the skin) when taking an antibiotic.

Do not give STEMOX to your child if any of these conditions apply to them.
If you are unsure, talk to your doctor or pharmacist before giving STEMOX.

Warnings and precautions
Take special care with STEMOX
Talk to your doctor or pharmacist before giving this medicine to your child if:

• they have infectious mononucleosis
• they have been treated for liver or kidney problems
• they do not urinate regularly. If you are not sure if any of the above conditions apply to your child, talk to your doctor or pharmacist before giving STEMOX. In some cases, the doctor may perform tests to assess the type of bacteria that caused your child's infection. Based on the results, they may prescribe a different dosage of STEMOX or a different medicine.

Conditions you should pay attention to
STEMOX may worsen certain existing conditions, or cause serious adverse effects.
These may include allergic reactions, convulsions and inflammation of the intestines. You should pay
attention to certain symptoms while giving STEMOX to your child, in order to reduce any
risk.
See “Conditions you should pay attention to” in Section 4.

Blood and urine tests
If your child is about to have blood tests (such as tests related to red blood cells or
liver function tests) or urine tests (for glucose), tell the doctor or nurse that they are
taking STEMOX. This is because STEMOX can affect the results of these types of tests.

Other medicines and STEMOX
Tell your doctor or pharmacist if your child is taking or has recently taken any other medicines,
including over-the-counter medicines and herbal products.
If your child is taking allopurinol (used for gout) with STEMOX, they are very likely to
have an allergic skin reaction.
If your child is taking probenecid (used for gout), the doctor may decide to adjust the dose of
STEMOX.
If STEMOX is being taken together with medicines (such as warfarin) that help prevent blood
clotting, additional blood tests may be necessary.
STEMOX can affect the mechanism of action of methotrexate (a medicine used to treat
tumors or rheumatic diseases).
STEMOX can affect the function of mycophenolate mofetil (a drug used to prevent
rejection of transplanted organs).

Pregnancy and breastfeeding
If your daughter is pregnant or breastfeeding, tell your doctor or pharmacist.
Ask your doctor or pharmacist for advice before taking any medicine.

STEMOX contains aspartame
STEMOX contains aspartame, which is a source of phenylalanine. It may be harmful to children born with a
condition called ‘phenylketonuria’.

3. HOW TO GIVE STEMOX

Always give this medicine following exactly the instructions of the doctor. If you have any doubts consult the
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 the doctor or pharmacist.

Children weighing less than 40 kg
All doses are calculated on the basis of body weight expressed in kilograms of the child. The doctor will advise you on the dose of STEMOX to give to your newborn or child.

• Take the supplied plastic measuring syringe. You will 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, administered in two divided doses.
• Highest dose - up to 70 mg/10 mg per kg of body weight per day, administered in two divided doses.

Patients with kidney and liver problems

• If your child has kidney problems, the dose may be decreased. 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 check how their liver is functioning.

How to give STEMOX

• Always shake the pack before taking each single dose
• Administer the dose at the beginning of the meal or immediately before
• Space the doses regularly during the day, at least 4 hours apart. Do not give 2 doses within 1 hour.
• Do not give your child STEMOX for more than 2 weeks. If your child does not feel well, they should return to the doctor.

If you give more STEMOX than you should
If your child takes too much STEMOX, the signs may include stomach disturbances (nausea, vomiting or
diarrhea) or convulsions. Tell the doctor as soon as possible. Bring the medicine pack or the
bottle to show to the doctor.

If you forget to give STEMOX
If you forget to give a dose to your child, give it to them as soon as you remember. You should not give your
child the next dose too soon, but you should wait about 4 hours before giving them the next
dose.

If your child stops taking STEMOX
Continue to give STEMOX to your child until the treatment is finished, even if they seem to be getting
better. Your child needs every dose to fight the infection. If some bacteria survive, they can cause the
infection to return.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Conditions you should pay attention to
Allergic reactions:

• skin rashes
• inflammation of blood vessels (vasculitis) which may be visible as red or purple spots on the skin, but which can 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 mouth (angioedema), which causes difficulty breathing
• collapse.

Contact your doctor immediately if your child presents any of these symptoms. Stop giving them
STEMOX.

Intestinal inflammation
Intestinal inflammation, which causes watery diarrhea generally with blood and mucus, stomach pain
and/or fever.
If your child presents these symptoms, contact your doctor as soon as possible for 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 your child suffers from it, give STEMOX before food
• vomiting
• children).

Uncommon side effects
May affect up to 1 in 100 people

• skin rashes, itching
• raised 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.

Other side effects
Other side 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:
• a widespread rash with blisters and detachment of the skin, particularly around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome), and a more severe form, which causes extensive detachment of the skin (more than 30% of the body surface - toxic epidermal necrolysis)
• widespread red rash with small blisters containing pus ( exfoliative bullous dermatitis)
• a rash, red, with crusts and swellings under the skin and blisters ( pustulous exanthem)
• 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).

If your child presents 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 make the skin and whites of the eyes appear yellow
• inflammation of the kidney tubules
• blood takes longer to clot
• hyperactivity
• convulsions (in people taking high doses of STEMOX or who have kidney problems)
• black tongue that appears 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.

If your child experiences side effects
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your
doctor or pharmacist. You can 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 STEMOX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and bottle after EXP.
The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25°C in the original packaging to protect the product from light and
humidity.
The oral suspension, after reconstitution, must be stored in a refrigerator for a maximum period of 7
days; after this period, any remaining product must be discarded.
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 STEMOX contains
When reconstituted, each ml of suspension contains amoxicillin trihydrate corresponding to 80 mg of amoxicillin and
potassium clavulanate corresponding 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 contents of the pack
Powder for oral suspension
1 bottle of 70 ml of suspension for reconstitution, with a 10 ml dosing syringe
1 bottle of 140 ml of suspension for reconstitution, with a 10 ml dosing syringe

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

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

Site responsible 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 for viral
infections.
Sometimes an infection caused by bacteria does not respond to antibiotic therapy. The most
common reason for this is that the bacteria causing the infection are resistant to the antibiotic being
used. This means that the bacteria survive and multiply despite the antibiotic. Bacteria
become resistant to antibiotics for various reasons. By using antibiotics appropriately, the emergence of bacterial resistance can be reduced.
When your doctor prescribes antibiotic therapy, it is only indicated for the illness you have.
Pay attention to the following advice, in order to avoid the emergence of bacterial resistance which causes the
blockage of antibiotic activity.

• 1. It is very important that you take the antibiotic at the correct dose, at the scheduled times and for the correct

to your doctor or pharmacist.

• 2. Do not take antibiotics if they have not been expressly prescribed for you and use them only for the infection for which they have been prescribed.
• 3. Do not use antibiotics that have been prescribed to other people even if you have a similar infection to theirs.
• 4. Do not give antibiotics to others that have been expressly prescribed for you.
• 5. If you have any antibiotic left over at the end of the treatment, return it to the pharmacist so that it can be disposed of appropriately.

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Instructions for reconstitution
Before use, check that the seal on the cap is intact. Shake the bottle to dissolve any lumps
of powder. Add water to the contents of the bottle just below the level indicated on the bottle,
invert, shake well and let stand for a few minutes. Then, as the preparation of the
suspension involves a reduction in volume, add further water to reach
again the level mark.
The final volume of the suspension obtained is 70 ml or 140 ml depending on the presentation.
Shake the bottle well before taking each dose.