BAMKLA 600 mg /42,9 Mg/5 Ml Proszek Do Sporządzania Zawiesiny Doustnej

Treść ulotki

1. Bamkla 600 mg/42,9 mg/5 ml powder for oral suspension
   1. What is Bamkla and what is it used for
   2. What you need to know before giving Bamkla to your child
   3. How to administer Bamkla
   4. Possible side effects
   5. How to store Bamkla

Bamkla 600 mg/42,9 mg/5 ml powder for oral suspension

amoxicillin/clavulanic acid
Generic medicine

Read this leaflet carefully before giving this medicine to your child 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 only for an infant or a child. Do not give it to other people, even if they have the same symptoms as your child, 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 Bamkla is and what it is used for
• 2. What you need to know before giving Bamkla
• 3. How to give Bamkla
• 4. Possible side effects
• 5. How to store Bamkla
• 6. Contents of the pack and other information

1. What is Bamkla and what is it used for

Bamkla 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”, which can sometimes be interrupted (rendered inactive). The other active component (clavulanic
acid) prevents this from happening.
Bamkla is used in newborns and children to treat the following infections:

• middle ear infections
• respiratory tract infections

2. What you need to know before giving Bamkla to your child

Do not give Bamkla to your child:

• if they are allergic to amoxicillin, clavulanic acid, penicillins or any of the other ingredients of this medicine (listed in section 6);
• if they have ever had a severe allergic reaction to any other antibiotic. Allergic reactions can include skin rash or swelling of the face or throat;
• if they have ever had problems with their liver or jaundice (yellowing of the skin) while taking an antibiotic. If any of these conditions apply to your child, do not give them Bamkla.

If you are not sure, ask your doctor or pharmacist before giving Bamkla.

Warnings and precautions
Talk to your doctor or pharmacist before giving this medicine to your child if:

• they suffer from glandular fever;
• they are being treated for liver or kidney problems;
• they do not urinate regularly.

If you are not sure if any of these conditions apply to your child, ask your doctor or pharmacist before
giving Bamkla.
In some cases, the doctor may analyze the type of bacteria causing your child's infection. Depending on the
results, your child may be prescribed a different formulation of amoxicillin/clavulanic acid or
another medicine.

Situations that require attention
Bamkla can worsen some pre-existing conditions or cause serious side effects. These
include allergic reactions, convulsions (seizures) and inflammation of the large intestine.
While your child is being treated with Bamkla, you should pay attention to certain symptoms, in order to
reduce the risk of any problems. See “ Situations that require particular attention”,
in section 4.

Blood and urine tests
If your child needs to have blood tests (such as tests of the red blood cell count or liver function tests) or urine
tests (for glucose), tell the doctor or nurse that they are taking Bamkla. This is because Bamkla can alter the
results of these types of tests.

Other medicines and Bamkla
Tell your doctor or pharmacist if your child is taking, has recently taken or might take
any other medicine.
If your child is taking allopurinol(used to treat gout) at the same time as Bamkla, they may
be more likely to develop an allergic skin reaction.
If your child is taking probenecid(used to treat gout), the doctor may decide to
adjust the dose of Bamkla.
If medicines that help prevent blood clots (such as warfarin) are taken at the same time as Bamkla, additional
blood tests may be necessary.
Bamkla can affect the way methotrexate(a medicine used to treat cancer or
rheumatic diseases) works.
Bamkla can affect the way mycophenolate mofetil(a medicine used to prevent
organ rejection after transplantation) works.

Pregnancy and breastfeeding
If your daughter, who needs to take this medicine, is pregnant, suspects she might be pregnant or is planning
a pregnancy, or if she is breastfeeding, ask your doctor or pharmacist for advice before giving this
medicine.

Bamkla contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially ‘sodium-free’.

Bamkla contains benzyl alcohol
This medicine contains 0.017 mg of benzyl alcohol in 5 ml (equivalent to 1.5 g of powder for
suspension). Benzyl alcohol can cause allergic reactions. Do not use for more than one week in small children
(under 3 years of age), unless otherwise recommended by your doctor or pharmacist. Ask your doctor or
pharmacist if your child has a liver or kidney problem or if your daughter is pregnant or breastfeeding. This is
because large amounts of benzyl alcohol can build up in the body and cause unwanted effects (such as
metabolic acidosis’).

Bamkla contains ethanol
This medicine contains less than 0.004 mg of alcohol (ethanol) per 5 ml (equivalent to 1.5 g of powder for
suspension). The amount in 5 ml of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not have any noticeable effects.

Bamkla contains sulphites
This medicine contains less than 0.000017 mg of sulphites per 5 ml (equivalent to 1.5 g of powder for
suspension). Rarely, it can cause serious hypersensitivity reactions and bronchospasm.

3. How to administer Bamkla

Administer this medicine following the doctor's instructions exactly at all times. If you have any doubts, consult
your doctor or pharmacist.

Adults and children weighing 40 kg or more

• This suspension is generally not recommended for adults and children weighing 40 kg or more. Ask your doctor or pharmacist for advice.

Children weighing less than 40 kg
All doses are established based on the child's body weight in kilograms.

• Your doctor will tell you how much Bamkla to administer to the newborn or child.
• The package contains a dosing syringe. You must use it to administer the correct dose to the newborn or child.
• Usual dose - 90 mg/6.4 mg per each kilogram of body weight per day, administered in two separate doses. Bamkla is not recommended for newborns under 3 months of age.

Patients with kidney and liver problems

• If your child suffers from kidney problems, the dose may be modified. The doctor may choose a different dosage or medicine.
• If your child suffers from liver problems, blood tests may need to be performed more frequently than usual to check liver function.

How to administer Bamkla

• Administer with a meal.
• Drink a glass of water after taking the medicine.
• Always shake the bottle well before administering each dose.
• Divide the doses evenly throughout the day, at least 4 hours apart. Do not administer 2 doses within one hour.
• Do not administer Bamkla to your child for more than 2 weeks. If they still feel unwell, your child should be seen by a doctor again.

If you administer more Bamkla than you should
If you administer an excessive amount of Bamkla to your child, symptoms may include stomach upset
(feeling unwell, vomiting or diarrhea) or convulsions. Consult a doctor as soon as possible. Bring
the medicine bottle with you to show the doctor.

If you forget to administer Bamkla
If you forget to administer a dose to your child, do so as soon as you remember. However, you should not
administer the next dose too early; wait about 4 hours before administering the next dose.
Do not administer a double dose to compensate for the missed dose.

If the child stops treatment with Bamkla
Continue to administer Bamkla to your child until the end of the treatment, even if they feel better. Your
child needs every dose to fight the infection. The survival of some bacteria can cause the
infection to recur.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects below may occur with this medicine.

Situations that require particular attention
Allergic reactions:

• skin rash;
• inflammation of the blood vessels (vasculitis), which may be visible as raised 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 throat (angioedema), which causes difficulty breathing;
• collapse.

If the child shows any of these symptoms, contact a doctor immediately. Stop
administering Bamkla.

Inflammation of the large intestine
Inflammation of the large intestine, which causes watery diarrhoea, usually with blood and mucus,
stomach pain and/or fever.
If your child shows these symptoms, consult a doctor as soon as possible.

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)

• thrush (candida- a fungal infection of the vagina, mouth or skin folds);
• feeling sick (nausea), especially when taking high doses. In this case, take Bamkla with a meal;
• vomiting;
• diarrhoea (in children). Uncommon side effects(may affect up to 1 in 100 people):
• skin rash, itching;
• itchy, raised rash (urticaria);
• indigestion;
• dizziness;
• headache.

Uncommon side effects that can be highlighted by blood tests:

• increase in certain substances (enzymes) produced by the liver.

Rare side effects(may affect up to 1 in 1,000 people):

• skin rash, possibly with blisters, appearing as small “targets” (dark central spots surrounded by a lighter area, with a dark ring around the edge - erythemamultiforme). If you notice any of these symptoms, consult a doctor urgently.

Rare side effects that can be highlighted by blood tests:

• low count of cells involved in blood clotting;
• low white blood cell count.

Frequency not known(the frequency cannot be estimated from the available data):

• allergic reactions (see above);
• inflammation of the large intestine (see above);
• inflammation of the protective membrane around the brain (aseptic meningitis);
• 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, which causes extensive skin shedding (more than 30% of the body surface area, toxic epidermal necrolysis); widespread red rash, with small blisters containing pus (exfoliative bullous dermatitis); red and scaly rash, with the formation of bumps under the skin and blisters (pustulosisexanthematosa); 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 (DRESS)).

If the child shows any of these symptoms, consult a 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 turn yellow;
• inflammation of the tubules in the kidney;
• increased bleeding time;
• hyperactivity;
• convulsions (in subjects taking high doses of Bamkla or who have kidney problems);
• black tongue, with a hairy appearance;
• stained teeth (in children), a problem that usually resolves with brushing.

Side effects that can be highlighted by blood or urine tests:

• severe reduction in white blood cell count;
• low red blood cell count (hemolytic anemia);
• crystals in the urine.

Reporting of side effects
If your child experiences any side effect, including those not listed in this leaflet, please
contact your doctor or pharmacist. You can also report side effects directly through the national
reporting system at http://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 Bamkla

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 pack and the bottle after ‘Exp’. The
expiry date refers to the last day of that month.
Store at a temperature below 25° C. Keep in the original container to protect the medicine
from humidity.
After preparation of the ready-to-use suspension:
Store in a refrigerator (2°C -8°C) and use within 10 days.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6Contents of the pack and other information
What Bamkla contains
The active ingredients are: amoxicillin and clavulanic acid.
Each ml of reconstituted suspension (equivalent to 0.3 g of powder) contains 120 mg of amoxicillin
(as amoxicillin trihydrate) and 8.58 mg of clavulanic acid (as potassium clavulanate). Each 5 ml
of reconstituted suspension contains 600 mg of amoxicillin (as amoxicillin trihydrate) and 42.9
mg of clavulanic acid (as potassium clavulanate).
The other ingredients are: citric acid, sodium citrate, microcrystalline cellulose, sodium carboxymethylcellulose
xanthan gum, anhydrous colloidal silica, silicon dioxide, raspberry flavour (containing artificial flavours, corn
maltodextrin, propylene glycol, glycerol triacetate, benzyl alcohol, ethanol and
sodium), orange flavour (containing artificial and natural flavours, corn maltodextrin, corn starch,
sodium and sulphites), caramel flavour (containing artificial flavours, corn maltodextrin, triethylcitrate,
ethanol and sodium), sodium saccharin (E954).
See paragraph 2 for further information regarding benzyl alcohol, ethanol and sulphites.

Description of the appearance of Bamkla and contents of the pack
Bamkla 600 mg/42.9 mg/5 ml powder for oral suspension is a powder of colour from white to whitish-
yellowish.
Contents of the pack: Amber glass bottles (Type III) of 100 and 180 ml closed with a screw HDPE cap
and packaged with a graduated syringe with a polystyrene plunger and an LDPE body. The dosage
graduation of the graduated syringe ranges from 0.4 to 5 ml. Each blue mark represents 0.1 ml.
Pack sizes:
1 bottle of 17.30 g of powder (for preparing 50 ml of suspension)
1 bottle of 33.10 g of powder (for preparing 100 ml of suspension)
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz B.V.
Veluwezoom 22
1327 AH Almere
The Netherlands
Legal Representative in Italy:
Sandoz S.p.A.,
L.go U. Boccioni 1,
21040 Origgio (VA),
Italy

Manufacturer
Lek Pharmaceuticals d.d.
Perzonali 47
2391 Prevalje
Slovenia

This medicinal product is authorised in the Member States of the EEA under the following denominations
Bulgaria Amoksiklav ES 600 mg/42.9 mg/5 ml powder for oral suspension
Italy Bamkla
Poland Amoksiklav ES
Portugal Amoxicilina + Ácido Clavulânico Sandoz
Romania Amoksiklav 600 mg/ 42.9 mg/5 ml, Pulbere pentru suspensie orală
Slovakia Amoksiklav 600 mg/42.9 mg/5 ml
Slovenia Amoksiklav 600 mg/42.9 mg v 5 ml prašek za peroralno suspenzijo
Spain Amoxicilina/ Ácido clavulánico Sandoz 600 mg/42.9 mg/5 ml polvo para suspensión
oral

Behavioural hygiene/ medical education
Antibiotics are used for the treatment of 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 why this happens 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. Using antibiotics appropriately
can help reduce the emergence of bacterial resistance.
When the doctor prescribes antibiotic therapy, this is indicated only for your current illness. Pay
attention to the following advice, in order to prevent the emergence of bacterial resistance that causes the blocking
of antibiotic activity.

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

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 prescribed expressly for you to others.
• 5. If after following the antibiotic cycle as indicated by the doctor, there is antibiotic left, return it to the pharmacist so that it can be disposed of appropriately.

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Instructions for reconstitution
At the time of administration, the dry powder must be reconstituted to form an oral suspension,
as specified below:
Ensure that the seal on the bottle cap is intact before use. Shake the bottle until the powder
flows freely. Add about 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend the powder. Add the remaining part of the water and shake
again vigorously.
Alternative reconstitution: Shake the bottle until the powder flows freely. Fill the bottle with
water just below the mark on the bottle label. Close with the cap, turn the bottle upside down and shake
vigorously. Then, add water to the bottle exactly up to the mark. Close again
with the cap, turn the bottle upside down and shake vigorously.
After reconstitution, the medicine appears as a homogeneous suspension of colour from white to yellowish.
Shake the bottle vigorously before each dose.