Augmentin mff

Patient Information Leaflet: Instructions for the User

Augmentin MFF, (400 mg + 57 mg)/5 ml, powder for oral suspension
Amoxicillinum + Acidum clavulanicum
Please read this leaflet carefully before your child starts taking this medicine,
as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine is usually prescribed for children. Do not give it to others. It may harm someone else, even if their symptoms are the same as your child's.
• If your child experiences any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

1. What Augmentin is and what it is used for
2. Important information before taking Augmentin
3. How to take Augmentin
4. Possible side effects
5. How to store Augmentin
6. Contents of the pack and other information

1. What Augmentin is and what it is used for

Augmentin is an antibiotic that kills bacteria causing infections.
Augmentin contains two different active substances: amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called "penicillins," which may sometimes be inactivated by certain bacteria. The second active ingredient (clavulanic acid) prevents this inactivation.
Augmentin is used in adults 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. Important information before using Augmentin

When not to give Augmentin to a child

• If the patient has a known allergy to amoxicillin, clavulanic acid, penicillin, or any of the other ingredients of this medicine (listed in section 6).
• If the patient has ever experienced severe allergic reactions to any other antibiotic. These may include skin rash or swelling of the face or throat.
• If the patient has ever had liver function disorders or jaundice (yellowing of the skin) associated with antibiotic use.

If any of the above conditions apply to the child being treated, do not administer Augmentin.
If in doubt, consult the child's doctor or pharmacist before starting treatment with Augmentin.

Warnings and precautions

Consult the child's doctor, pharmacist, or nurse before starting treatment with Augmentin if:

• the child has infectious mononucleosis,
• the child is being treated for liver or kidney disease,
• the child urinates irregularly.

If in doubt whether any of the above conditions apply to the child being treated, consult the child's doctor or pharmacist before starting Augmentin.

In some cases, the doctor may investigate which type of bacteria caused the infection. Depending on the results, the child may receive Augmentin at a different dose or another medicine.

Symptoms to watch for

Treatment with Augmentin may worsen certain diseases or cause serious adverse effects, including allergic reactions, seizures, and colitis. It is important to monitor whether the child being treated develops specific symptoms during treatment with Augmentin to minimize the risk of complications. See 'Symptoms to watch for' in section 4.

Blood and urine tests

If the child is due to have blood tests (such as red blood cell count or liver function tests) or urine tests (for glucose), inform the doctor or nurse that the child is taking Augmentin. Augmentin may affect the results of these tests.

Augmentin and other medicines

Tell the child's doctor or pharmacist about all medicines currently being taken or recently taken, as well as any medicines the child is expected to take.

If the child is taking allopurinol (used in gout) at the same time as Augmentin, skin allergic reactions may be more likely.

If the child is taking probenecid (used in gout), the doctor may decide to adjust the dose of Augmentin.

If blood-thinning medicines (such as warfarin) are taken at the same time as Augmentin, additional blood tests may be necessary.

Augmentin may affect the action of methotrexate (a medicine used in the treatment of cancer or rheumatic diseases).

Augmentin may affect the action of mycophenolate mofetil (a medicine used to prevent transplant rejection).

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery

Augmentin may cause adverse effects and symptoms that may impair the ability to drive or operate machinery.

Patients should not drive or operate machinery unless they feel well.

Augmentin contains aspartame, benzyl alcohol, and maltodextrin

This medicine contains 2.5 mg of aspartame per 1 ml. Aspartame is a source of phenylalanine. It may be harmful for patients with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.

Augmentin contains trace amounts of benzyl alcohol. Benzyl alcohol may cause allergic reactions.

Augmentin contains maltodextrin (glucose). If the child being treated has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.

3. How to take Augmentin

This medicine should always be taken exactly as your doctor or pharmacist has advised. If you are unsure,
you should consult your doctor or pharmacist.
Adults and children with body weight of 40 kg and above

• This suspension is not usually recommended for use in adults and children weighing 40 kg or more. Please consult your doctor or pharmacist for advice.

Children with body weight below 40 kg
All doses are calculated according to the child's body weight in kilograms.

• Your doctor will determine the dose of Augmentin to be given to the child.
• The medicine may be supplied with a plastic measuring spoon or an oral dosing syringe. Use these to give the correct dose to the child. Instructions for using the dosing syringe are provided at the end of this leaflet.
• Recommended dose – (25 mg + 3.6 mg)/kg body weight/day (0.4 ml of suspension/kg body weight/day) up to (45 mg + 6.4 mg)/kg body weight/day (0.6 ml of suspension/kg body weight/day), given in two divided doses.
• Higher dose – up to (70 mg + 10 mg)/kg body weight/day (1.0 ml of suspension/kg body weight/day), given in two divided doses.

Patients with kidney or liver disease

• If the child being treated has kidney problems, the dose of medicine may need to be reduced. Your doctor may adjust the dose of Augmentin or prescribe a different medicine.
• If the child being treated has liver problems, blood tests may be performed more frequently to monitor liver function.

How to administer Augmentin

• Always shake the bottle well before administering each dose.
• Administer at the beginning of a meal or just before a meal.
• Maintain equal intervals of at least 4 hours between doses given during the day. Do not administer two doses within one hour.
• Do not give Augmentin to the child for longer than 2 weeks. If the child still does not feel better, contact your doctor again.

Overdose of Augmentin
If the child has been given more Augmentin than recommended, symptoms such as stomach and intestinal irritation (nausea, vomiting or diarrhoea) or seizures may occur. Contact your doctor as quickly as possible. Keep the medicine bottle with you to show to the doctor.
Missed dose of Augmentin
If you forget to give a dose, give it as soon as you remember. Do not give the next dose too early; wait approximately 4 hours before giving the next dose. Do not give a double dose to make up for a missed dose.
Stopping Augmentin treatment
Continue giving Augmentin for the full duration of treatment, even if the child starts to feel better. All doses are necessary to eliminate the infection. If some bacteria survive, they may cause the infection to return.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Below is a list of possible adverse reactions associated with this medicine.
Symptoms requiring attention
Allergic reactions:

• Skin rash
• Vasculitis, which may appear as red or purple raised spots on the skin, but may also affect other organs
• Fever, joint pain, swelling of glands in the neck, armpits, or groin
• Swelling, sometimes affecting the face or throat (angioedema), causing difficulty breathing
• Fainting
• Chest pain related to an allergic reaction, which may indicate an allergy leading to heart attack (Kounis syndrome).

If any of these symptoms occur in a treated child, seek immediate medical advice. Discontinue Augmentin .
Colitis
Inflammation of the large intestine causing watery diarrhoea, usually with blood and mucus, abdominal pain and (or) fever.
Drug-induced enterocolitis syndrome (DIES)
Drug-induced enterocolitis has occurred mainly in children receiving amoxicillin with clavulanic acid. This is a type of allergic reaction, the main symptom of which is recurrent vomiting (1 to 4 hours after taking the medicine). Further symptoms may include abdominal pain, lethargy, diarrhoea, and low blood pressure.
Acute pancreatitis
If the patient experiences severe and persistent pain in the stomach area, this may be a sign of acute pancreatitis.
If any of these symptoms occur in a treated child, contact the treating physician as soon as possible for advice.
Common adverse reactions
May occur in up to 1 in 10 patients:

• Thrush (candidiasis – fungal infections of the vagina, mouth, or skin folds)
• Nausea, especially when high doses are used; if this occurs, take Augmentin before meals
• Vomiting
• Diarrhoea (in children).

Uncommon adverse reactions
May occur in up to 1 in 100 patients:

• Skin rash, itching
• Raised, itchy rash (urticaria)
• Indigestion
• Dizziness
• Headache.

Uncommon adverse reactions that may be revealed in blood tests:

• Increased activity of certain substances (enzymes) produced in the liver.

Rare adverse reactions
May occur in up to 1 in 1,000 patients:

• Skin rash, possibly with blisters and appearing as target-like lesions (dark spot in the centre surrounded by a lighter ring and a dark ring around the edge – erythema multiforme). If any of these symptoms are observed in a patient, contact a doctor urgently.

Rare adverse reactions that may appear in blood test results:

• Low number of platelets (cells involved in blood clotting)
• Low number of white blood cells.

Adverse reactions with unknown frequency
Frequency cannot be estimated from the available data.

• Allergic reactions (see above).
• Colitis (see above).
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).
• Severe skin reactions:
  • Widespread skin rash, with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genital organs (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 (bullous exfoliative dermatitis)
  • Red, scaly rash with subcutaneous nodules and blisters (acute generalised exanthematous pustulosis)
  • Flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cell count (eosinophilia) and increased liver enzyme activity); drug reaction with eosinophilia and systemic symptoms (DRESS)
  • Red rash usually observed on both buttocks, inner upper thighs, armpits, and neck (symmetrical, photo-distributed, and flexural exanthema induced by drugs (SDRIFE)).

If any of these symptoms occur in a treated child, seek immediate medical attention.

• Blistering rash arranged in a ring-like pattern with crusts in the central area or resembling a string of pearls (linear IgA dermatosis).
• 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.
• Prolonged blood clotting time.
• Psychomotor hyperactivity.
• Seizures (in patients receiving high doses of Augmentin or with kidney disease).
• Black, hairy-looking tongue.
• Tooth discoloration (in children), which can usually be removed by brushing.

Adverse reactions that may appear in blood or urine tests:

• Marked decrease in white blood cell count
• Low number of red blood cells (haemolytic anaemia)
• Crystals in urine, leading to acute kidney injury.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Augmentin

Keep this medicine out of sight and reach of children.
Dry powder
Store in the original packaging to protect from moisture. Do not store
at temperatures above 25°C.
Do not use this medicine after the expiry date stated on the container after the abbreviation
"EXP". The expiry date refers to the last day of the stated month.
Reconstituted suspension
The prepared suspension (medicine after addition of water) should be stored in the refrigerator
(at 2°C to 8°C). Do not freeze.
The shelf life of the reconstituted suspension is 7 days.
Medicines must not be disposed of via the sewage system or household waste. Ask
your pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Augmentin contains

• The active substances are amoxicillin and clavulanic acid. Each ml of reconstituted oral suspension contains 80 mg amoxicillin as amoxicillin trihydrate and 11.4 mg clavulanic acid as potassium clavulanate.
• Other ingredients are: aspartame (E 951), xanthan gum, silicon dioxide, anhydrous colloidal silica, succinic acid, hypromellose, orange flavour 1 dry* (containing benzyl alcohol), orange flavour 2 dry*, raspberry flavour dry*, golden syrup flavour dry* (*also containing maltodextrin).
• For further information on aspartame, benzyl alcohol and maltodextrin, see section 2.

What Augmentin looks like and contents of the pack
Augmentin (400 mg + 57 mg)/5 ml powder for oral suspension is a white to off-white powder supplied in a colourless glass bottle. After adding water, the bottle contains 35 ml, 70 ml or 140 ml of a white to light brown mixture known as a suspension.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24,
D24 YK11, Ireland

Manufacturer
Glaxo Wellcome Production, ZI de la Peyenniere, 53100 Mayenne Cedex, France

For further information about this medicine, contact the local representative of the Marketing Authorisation Holder:
GSK Services Sp. z o.o.
Ul. Rzymowskiego 53
02-697 Warszawa
tel. (22) 576-90-00

This medicine is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Austria – Augmentin 400 mg/57 mg/5 ml Pulver zur Herstellung einer Suspension zum Einnehmen Multifruchtgeschmack
Bulgaria – Аугментин 400 mg/57 mg/5 ml прах за перорална суспензия
Croatia – Augmentin 400 mg + 57 mg/5 ml prašak za oralnu suspenziju s okusom voća
Cyprus – Augmentin Mixed Fruit
Czech Republic – Augmentin
Estonia – Augmentin Fruit
France – Augmentin 80 mg - 11.4 mg par ml Poudre pour suspension buvable
Greece – Augmentin MF
Germany – Augmentan Kindersaft
Hungary – Augmentin Duo
Ireland – Augmentin Duo Mixed Fruit
Italy – Augmentin
Latvia – Augmentin Fruit 400 mg/57 mg/5 ml pulveris iekšķīgi lietojamas suspensijas pagatavošanai
Lithuania – Augmentin
Malta – Augmentin Duo Mixed Fruit
Norway – Augmentin
Poland – Augmentin
Portugal – Augmentin Duo
Romania – Augmentin FP
Slovakia – Augmentin DUO s príchuťou miešaného ovocia
United Kingdom (Northern Ireland) – Augmentin Duo

Medical education
Antibiotics are used to treat bacterial infections. They are ineffective in treating viral infections.
Sometimes bacterial infections do not respond to antibiotic treatment.
One of the most common reasons for this is that bacteria are resistant to the antibiotic used.
This means that bacteria can survive or multiply despite the use of the antibiotic.
Bacteria may become resistant to antibiotics for various reasons. Careful use of antibiotics may help reduce the risk of development of bacterial resistance.
The antibiotic prescribed by your doctor is intended solely for the treatment of your current illness. Paying attention to the following advice will help prevent the development of resistant bacteria that could interfere with the effectiveness of antibiotics.

1. It is very important to take the antibiotic at the correct dose, at the correct time, and for the correct number of days. Read the instructions in the patient leaflet carefully, and if any are unclear, ask your doctor or pharmacist for clarification.
2. Do not take an antibiotic if it has not been prescribed specifically for you. Take it only to treat the infection for which it was prescribed.
3. Do not take an antibiotic prescribed for another person, even if they had a similar infection.
4. Do not give antibiotics prescribed for you to other people.
5. If any antibiotic remains after completing treatment as directed by your doctor, return it to a pharmacy which will dispose of it properly.

Instructions for preparing the medicine for use
Unscrew the cap. Before use, check that the protective seal on the bottle has not been broken. Screw the cap back on.

1. Shake the bottle of medicine to loosen the powder.

2. Unscrew the cap.

3. Remove the protective seal.

4. Add water (volume given below). Replace the cap, turn the bottle upside down and shake well.

An alternative method of preparing the suspension: fill the bottle with water up to a level slightly below the mark indicated on the bottle label or on the bottle. Close the cap, turn the bottle upside down and shake carefully, then top up with water exactly to the level of the mark. Close the cap, turn the bottle upside down and shake carefully again.

5. The prepared suspension (medicine after addition of water) should be stored in the refrigerator. Shake the bottle well before each use. The prepared suspension must be used within 7 days.

Instructions for use of the dosing syringe
The medicine package may be supplied with a dosing syringe. The dosing syringe is intended for oral administration of Augmentin medicine.
The syringe should only be used for administering Augmentin medicine. It must not be used for administering other medicines, as the scale printed on it is specific to the Augmentin product.
The dosing syringe is supplied with a connector that allows it to be attached to the bottle.
The dosing syringe for oral administration has a scale printed on it which enables measurement of the required dose in millilitres (ml). The child should be given the dose prescribed by the doctor.
Before use, check that there are no contaminants in the syringe or in the connector. If necessary, rinse them with clean water.

1. Shake the bottle of suspension well before each use.
2. Remove the connector from the syringe. Firmly holding the bottle, press the connector into the neck of the bottle (leave the connector in the neck of the bottle; do not remove it).

3. Push the tip of the syringe into the recess of the connector and ensure it is securely attached.

4. Turn the bottle upside down, holding the syringe. Pull the plunger of the syringe down until the prescribed dose of medicine has been drawn up.

5. Turn the bottle (neck upwards) and remove the syringe from the connector.

6. To administer the medicine to the child, carefully place the tip of the syringe into the child's mouth and then slowly press the plunger to carefully administer the suspension. (If more than one syringeful is required to administer the prescribed dose, repeat the steps described in points 3, 4, 5 and 6.)

7. After use, thoroughly rinse the syringe with clean water. Leave it to dry completely before next use.

8. Replace the cap.

9. The prepared suspension (medicine after addition of water) should be stored in the refrigerator. Shake the bottle well before each use. Shelf-life of the prepared suspension: 7 days.