Bamkla

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Bamkla 600 mg/42.9 mg/5 ml powder for oral suspension

amoxicillin/clavulanic acid
Equivalent 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, consult your doctor or pharmacist.
• This medicine has been prescribed only for a newborn or child. Do not give it to others, even if their symptoms are the same as your child's, because it could be harmful.
• If any side effect occurs, including those not listed in this leaflet, contact 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 Bamkla is and what it is used for

Bamkla is an antibiotic that works by killing bacteria causing infections. It contains two different medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins", which can sometimes be interrupted (inactivated). The other active component (clavulanic acid) prevents this from happening.
Bamkla is used in infants and children to treat the following infections:

• middle ear infections
• respiratory tract infections

2. What you should know before administering Bamkla

Do not administer Bamkla to your child:

• if he/she is allergic to amoxicillin, clavulanic acid, penicillins, or any of the other ingredients of this medicine (listed in section 6);
• if he/she has ever had a severe allergic reaction to any other antibiotic. Allergic reactions may include skin rash or swelling of the face or throat;
• if he/she has ever had liver problems or jaundice (yellowing of the skin) while taking an antibiotic.

If any of these conditions apply to your child, do not administer Bamkla to your child.
If you are unsure, consult your doctor or pharmacist before administering Bamkla.
Warnings and precautions
Talk to your doctor or pharmacist before administering this medicine to your child if:

• he/she has glandular fever;
• he/she is being treated for liver or kidney problems;
• he/she does not urinate regularly.

If you are unsure whether any of these conditions apply to your child, consult your doctor or pharmacist before administering Bamkla.
In some cases, the doctor may test the type of bacteria causing your child's infection. Depending on the results, a different formulation of amoxicillin/clavulanic acid or another medicine may be prescribed for your child.
Situations requiring attention
Bamkla may worsen certain pre-existing conditions or cause serious side effects. These include allergic reactions, seizures (epileptic fits), 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 potential problems. See "Situations requiring special attention", in section 4.
Blood and urine tests
If your child is due to have blood tests (such as tests for red blood cell status or liver function tests) or urine tests (for glucose), inform the doctor or nurse that your child is taking Bamkla. This is because Bamkla may alter the results of these types of tests.
Other medicines and Bamkla
Inform your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.
If your child is taking allopurinol (used to treat gout) together with Bamkla, he/she may be more likely to develop a skin allergic reaction.
If your child is taking probenecid (used to treat gout), concomitant use with Bamkla may reduce the excretion of amoxicillin and is not recommended.
If medicines that help prevent blood clots (such as warfarin) are taken together with Bamkla, additional blood tests may be required.
Methotrexate (used to treat cancer, rheumatic diseases, and severe psoriasis), penicillins may reduce the excretion of methotrexate, potentially increasing its side effects.
Bamkla may affect how mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs) works.
Pregnancy and breastfeeding
If your daughter, who is to take this medicine, is pregnant, suspects she may be pregnant, is planning to become pregnant, or is breastfeeding, ask your doctor or pharmacist for advice before administering this medicine.
Bamkla contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., 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 may cause allergic reactions. Do not use for more than one week in young children (under 3 years of age), unless otherwise recommended by the doctor or pharmacist. Consult your doctor or pharmacist if your child has liver or kidney disease, or if your daughter is pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in the body and cause undesirable 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 produce significant 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 may cause severe hypersensitivity reactions and bronchospasm.

3. How to take Bamkla

Take this medicine exactly as your doctor has told you. 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. Please consult your doctor or pharmacist for advice.

Children weighing less than 40 kg
All doses are determined according to the child's body weight in kilograms.

• Your doctor will tell you how much Bamkla to give your infant or child.
• The package contains a graduated syringe. You must use it to administer the correct dose to your infant or child.
• Usual dose – 90 mg/6.4 mg per kilogram of body weight per day, given in two divided doses. Bamkla is not recommended for infants under 3 months of age.

Patients with kidney or liver problems

• If your child has kidney problems, the dose may need to be adjusted. Your doctor may choose a different dosage or a different medicine.
• If your child has liver problems, blood tests may need to be performed more frequently than usual to monitor liver function.

How to administer Bamkla

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

If you give more Bamkla than you should
If you give your child too much Bamkla, symptoms may include stomach pain (feeling sick, vomiting or diarrhoea) or seizures. Contact your doctor as soon as possible. Take the medicine bottle with you to show the doctor.

If you forget to give Bamkla
If you forget to give a dose to your child, give it as soon as you remember. However, do not give the next dose too soon; wait approximately 4 hours before giving the next dose. Do not give a double dose to make up for a forgotten dose.

If the child stops treatment with Bamkla
Continue giving Bamkla to your child for the full duration of treatment, even if he/she feels better. Your child needs every dose to fight the infection. Survival of some bacteria may cause the infection to return.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The following side effects may occur with this medicine.
Situations requiring special attention
Allergic reactions:

• skin rash;
• inflammation of blood vessels ( vasculitis ), which may appear 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 ), causing difficulty breathing;
• collapse;
• chest pain occurring during allergic reactions, which may be a symptom of an allergy-triggered heart attack (Kounis syndrome).

If the child experiences any of these symptoms, contact a doctor immediately . Stop administering Bamkla .
Inflammation of the large intestine
Inflammation of the large intestine, causing watery diarrhoea, usually with blood and mucus, stomach pain and/or fever.
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 with the main symptom being repeated vomiting (1-4 hours after taking the medicine). Additional symptoms may include abdominal pain, lethargy, diarrhoea, and low blood pressure.
If your child experiences these symptoms, consult your 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):

• oral, vaginal or skin fold fungal infection ( candidiasis );
• feeling unwell (nausea), especially when taking high doses. In this case, take Bamkla with food;
• vomiting;
• diarrhoea (in children).

Uncommon side effects (may affect up to 1 in 100 people):

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

Uncommon side effects that may be detected by blood tests:

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

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

• rash, possibly with blisters, appearing as 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, consult a doctor urgently.

Rare side effects that may be detected by blood tests:

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

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

• allergic reactions (see above);
• inflammation of the large intestine (see above);
• crystals in the urine leading to acute kidney injury;
• blistering rash arranged in a ring with a central crust or resembling a string of pearls (linear IgA disease);
• inflammation of the protective membranes surrounding the brain and spinal cord (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 skin peeling (more than 30% of body surface area, toxic epidermal necrolysis ); widespread red rash with small pus-filled blisters ( exfoliative bullous dermatitis ); red, scaly rash with bumps under the skin and blisters ( exanthematous pustulosis ); 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 (DRESS)); a red rash commonly seen on both sides of the buttocks, upper inner thighs, armpits, and neck ( Symmetrical Drug-Related Intertriginous Flexural Exanthema (SDRIFE)).

If the child experiences any of these symptoms, consult a doctor immediately .

• inflammation of the liver ( hepatitis );
• jaundice, caused by increased bilirubin in the blood (a substance produced by the liver), which may cause the child's skin and whites of the eyes to turn yellow;
• inflammation of the tubules in the kidney;
• prolonged blood clotting time;
• hyperactivity;
• seizures (in patients taking high doses of Bamkla or who have kidney problems);
• black, hairy-looking tongue;
• stained teeth (in children), a condition that usually resolves with toothbrushing.

Side effects that may be detected by blood tests:

• severe reduction in white blood cell count;
• low red blood cell count ( haemolytic anaemia );

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 via 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 stated on the carton and bottle after 'Exp.'.
The expiry date refers to the last day of that month.
Store below 25°C. Keep in the original container to protect the medicine from moisture.
After reconstitution of the ready-to-use suspension:
Store in the refrigerator (2°C - 8°C) and use within 10 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 Bamkla contains
The active substances are: amoxicillin and clavulanic acid.
Each ml of reconstituted suspension (equivalent to 0.3 g of powder) contains 120 mg amoxicillin (as amoxicillin trihydrate) and 8.58 mg clavulanic acid (as potassium clavulanate). Each 5 ml of reconstituted suspension contains 600 mg amoxicillin (as amoxicillin trihydrate) and 42.9 mg clavulanic acid (as potassium clavulanate).

The other components are: citric acid, sodium citrate, microcrystalline cellulose, sodium carmellose, xanthan gum, anhydrous colloidal silica, silicon dioxide, raspberry flavour (containing artificial flavours, maltodextrin from maize, propylene glycol, glyceryl triacetate, benzyl alcohol, ethanol and sodium), orange flavour (containing artificial and natural flavours, maltodextrine from maize, maize starch, sodium and sulphites), caramel flavour (containing artificial flavours, maltodextrin from maize, triethyl citrate, ethanol and sodium), sodium saccharin (E954).
See section 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 ranging in colour from white to light yellow.

Pack contents: Amber glass bottles (type III) of 100 and 180 ml, closed with a screw cap made of polypropylene with a sealing membrane or with a screw cap made of polypropylene/polyethylene with a sealing membrane, packaged with a graduated oral syringe with a barrel made of polypropylene and a plunger and cap made of polyethylene. The graduated syringe has markings from 0.5 to 5 ml. Each black mark represents 0.1 ml.

Pack sizes:
1 bottle containing 17.7 g of powder (to prepare 50 ml of suspension)
1 bottle containing 33.8 g of powder (to prepare 100 ml of suspension)

It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder
Sandoz B.V.
Hospitaaldreef 29,
1315 RC Almere
The Netherlands

Legal representative in Italy:
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturer
Sandoz GmbH
Biochemiestraße 10
6250 Kundl
Austria

This medicine is authorised in the European Economic Area Member States under the following names:
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 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 the bacteria survive and multiply despite the antibiotic.

Bacteria become resistant to antibiotics for various reasons. Using antibiotics appropriately can help reduce the development of bacterial resistance.

When your doctor prescribes an antibiotic treatment, it is intended only for your current illness. Please pay attention to the following advice 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 number of days. 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 prescribed for other people, even if you have a similar infection.
4. Do not give your antibiotics to others, even if they have a similar infection.
5. If you have leftover antibiotic after completing the prescribed course, return it to your pharmacist for proper disposal.

Instructions for reconstitution
At the time of administration, the dry powder must be reconstituted to form an oral suspension, as specified below:
Ensure the bottle cap seal is intact before use. Shake the bottle until the powder flows freely. Add approximately two-thirds of the total amount of water required for reconstitution (see table below), and shake vigorously to suspend the powder. Add the remaining water and shake again vigorously.

Alternative reconstitution method: Shake the bottle until the powder flows freely. Fill the bottle with water just below the mark indicated on the bottle label. Close with the cap, invert the bottle, and shake vigorously. Then, add water to the bottle exactly up to the mark. Close again with the cap, invert the bottle, and shake vigorously.

After reconstitution, the medicine appears as a homogeneous suspension ranging in colour from white to yellow.

Shake the vial vigorously before each dose.