Augmentin mff

Package leaflet: Information for the user

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Augmentin MFF (Augmentin DUO)
(400 mg + 57 mg)/5 ml, powder for the preparation of oral suspension
Amoxicillin + Clavulanic acid
Augmentin MFF and Augmentin DUO are different trade names for the same medicine.
Please read this leaflet carefully before starting treatment with this medicine in a child,
as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine is usually prescribed for children. Do not give it to others. This medicine may harm another person, even if their symptoms are the same as those of the child.
• If any adverse reactions occur in the child, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What Augmentin MFF is and what it is used for

Augmentin MFF is an antibiotic that kills bacteria causing infections. Augmentin MFF contains two different active substances: amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called "penicillins", whose action may sometimes be inhibited (inactivated). The second active ingredient (clavulanic acid) counteracts this inactivation.
Augmentin MFF 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. Important information before using Augmentin MFF

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

Warnings and precautions
Before starting to give the child Augmentin MFF, consult a doctor, pharmacist, or nurse 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, consult a doctor or pharmacist before starting treatment with Augmentin MFF.

In some cases, the doctor may test which type of bacteria caused the infection.
Depending on the results, the child may receive Augmentin MFF at a different dose or another medicine.
Conditions to watch for
Treatment with Augmentin MFF may worsen the course of certain diseases or cause
serious adverse effects, including allergic reactions, seizures, and colitis.
Care should be taken to monitor whether the child being treated develops specific symptoms during treatment with Augmentin MFF, in order to reduce the risk of complications. See
"Conditions to watch for" in section 4.
Blood and urine tests
If the child is due to have blood tests (such as red blood cell counts or liver function tests) or urine tests (for glucose), inform the doctor or nurse that the child is taking Augmentin MFF. Augmentin MFF may affect the results of these types of tests.
Augmentin MFF and other medicines
Tell the child's doctor or pharmacist about all medicines currently being given to the child, recently used medicines, and any medicines the child is expected to take.
If allopurinol (used in gout) is taken at the same time as Augmentin MFF, the child may be more likely to develop skin allergic reactions.
If the child is taking probenecid (used in gout), the doctor may decide to adjust the dose of Augmentin MFF.
If blood-thinning medicines (such as warfarin) are taken at the same time as Augmentin MFF, additional blood tests may be necessary.
Augmentin MFF may affect the action of methotrexate (a medicine used in the treatment of cancer or rheumatic diseases).
Augmentin MFF 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 a doctor or pharmacist before using this medicine.
Driving and operating machinery
Augmentin MFF may cause adverse effects and symptoms that may impair the ability to drive.
Patients should not drive or operate machinery unless they feel well.
Augmentin MFF contains aspartame (E 951), benzyl alcohol, and maltodextrin

• This medicine contains 2.5 mg of aspartame (E 951) per 1 ml. Aspartame (E 951) is a source of phenylalanine. It may be harmful to patients with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates in the body due to improper excretion.
• Augmentin MFF contains trace amounts of benzyl alcohol. Benzyl alcohol may cause allergic reactions.
• Augmentin MFF contains maltodextrin (glucose). If the treated child has previously been diagnosed with intolerance to certain sugars, contact a doctor before taking this medicine.

3. How to use Augmentin MFF

This medicine should always be used exactly as directed by your doctor or pharmacist. If you have any doubts,
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 with body weight equal to or greater than 40 kg. You should consult your doctor or pharmacist for advice.

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

• Your doctor will determine the dose of Augmentin MFF to be given to the child.
• The medicine may be supplied with a plastic measuring spoon or an oral dosing syringe. You should use either of these to administer 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 impaired kidney function, the dose of medicine may need to be reduced. Your doctor may prescribe a different dose of Augmentin MFF or an alternative medicine.
• If the child being treated has liver disease, blood tests may be performed more frequently to monitor liver function.

How to administer Augmentin MFF

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

Overdose of Augmentin MFF
If a child has been given more Augmentin MFF than recommended, symptoms such as gastrointestinal irritation (nausea, vomiting or diarrhoea) or seizures may occur. You should contact your doctor as soon as possible. Keep the medicine bottle with you to show to the doctor.

Missed dose of Augmentin MFF
If you forget to give a dose, administer 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 MFF treatment
You should continue giving Augmentin MFF for the full duration of treatment, even if the child feels 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Below are listed the adverse effects of this medicine that may occur.
Symptoms to be aware of
Allergic reactions:

• skin rash
• vasculitis, which may appear as red or purple raised spots on the skin, but may affect other organs
• fever, joint pain, swelling of glands in the neck, under the arms or in the groin
• swelling, sometimes affecting the face or throat (angioedema), causing difficulty breathing
• fainting.
  • If any of these symptoms occur in a child being treated, contact a doctor immediately. Augmentin MFF treatment must be discontinued.

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
repeated vomiting (1 to 4 hours after taking the medicine). Further symptoms may include abdominal
pain, lethargy, diarrhoea and low blood pressure.
Acute pancreatitis
If you have severe and persistent pain in the stomach area, it may be a sign of acute pancreatitis.

• If any of these symptoms occur in a child being treated, contact the doctor in charge as soon as possible for advice.

Common adverse effects
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 nausea occurs, take Augmentin MFF before meals
• vomiting
• diarrhoea (in children).

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

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

Uncommon adverse effects that may be revealed in blood test results:

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

Rare adverse effects
May occur in up to 1 in 1000 patients:

• skin rash, which may include blisters and resemble target-like lesions (dark spot in the centre surrounded by a lighter ring with a dark ring around the edge – erythema multiforme)
  • if any of these symptoms are observed in a patient, contact a doctor urgently.

Rare adverse effects that may appear in blood test results:

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

Adverse effects with unknown frequency
Frequency cannot be estimated from 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 genitals (Stevens-Johnson syndrome), and a more severe form causing extensive skin peeling (over 30% of body surface – 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 cells (eosinophilia) and increased liver enzyme activity); drug reaction with eosinophilia and systemic symptoms (DRESS)
  • If any of these symptoms occur in a child being treated, contact a doctor immediately.
• Blistering rash arranged in rings or like 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.
• Hyperkinesia.
• Seizures (in people receiving high doses of Augmentin MFF or with kidney disease).
• Black hairy tongue.
• Tooth discoloration (in children), which can usually be removed by brushing.
  • Adverse effects that may appear in blood or urine test results:
• marked decrease in the number of white blood cells
• low number of red blood cells (haemolytic anaemia)
• crystals in urine leading to acute kidney injury.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects
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.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Augmentin MFF

Keep the medicine out of the sight and reach of children.
Dry powder
Store in the original container to protect from moisture. Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Reconstituted suspension
The reconstituted suspension (medicine after addition of water) should be stored in the refrigerator (at a temperature of 2°C to 8°C). Do not freeze.
The reconstituted suspension should be used within 7 days of preparation.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Augmentin MFF 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, anhydrous colloidal silica, hydrated colloidal silica, succinic acid, hypromellose, orange flavour 1, dry (containing maltodextrin and benzyl alcohol), orange flavour 2, dry (containing maltodextrine), raspberry flavour (containing maltodextrin), golden syrup flavour, dry (containing maltodextrin).
• For further information on aspartame (E 951), benzyl alcohol and maltodextrin – see section 2.

What Augmentin MFF looks like and contents of the pack
Augmentin MFF, (400 mg + 57 mg)/5 ml, powder for oral suspension, is a white to off-white powder available in colourless glass bottles. After adding water, the bottle contains 70 ml of an off-white mixture known as a suspension.
For more detailed information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder in Portugal, country of export:
GlaxoSmithKline – Produtos Farmacêuticos, Lda.
Rua Dr. António Loureiro Borges, 3
Arquiparque – Miraflores
1495-131 Algés
Portugal
Manufacturer:
Glaxo Wellcome Production
ZI de la Peyennière
53100 Mayenne
France
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Portugal, country of export: 5738422
Parallel import authorisation number: 266/23
This medicinal product is authorised in the Member States of the European Economic Area and in 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 MFF
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 being used.
This means that bacteria can survive or multiply despite the use of the antibiotic.
Bacteria may become resistant to antibiotics for many reasons. Careful use of antibiotics may help reduce the risk of bacteria developing 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, which 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 of them are unclear, ask your doctor or pharmacist for clarification.
2. Patients should not take an antibiotic unless it has been prescribed specifically for them. It should be taken only to treat the infection for which it was prescribed.
3. Patients should not take an antibiotic prescribed for another person, even if that person 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 for proper disposal.

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 to loosen the powder.

2. Unscrew the cap.

3. Remove the protective seal.

4. Add water (volume indicated below). Screw the cap back on, invert the bottle and shake well.

Second method of preparing the suspension: fill the bottle with water to a level slightly below the mark indicated on the bottle label. Close the bottle with the cap, turn the bottle upside down and shake thoroughly, then add water exactly up to the level of the marked line. Close the bottle with the cap, turn the bottle upside down and shake thoroughly again.

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

Dosage syringe instructions
The medicine package may be supplied with a dosing syringe. The dosing syringe is intended for oral administration of Augmentin MFF.
The syringe should be used only for administering Augmentin MFF. It must not be used for other medicines, as the scale printed on it is specific to Augmentin MFF.
The dosing syringe is supplied with a connector allowing it to be attached to the bottle.
The dosing syringe for oral administration has a scale printed on it enabling 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 connector. If necessary, rinse them with clean water.

1. Shake the suspension bottle well before each use.
2. Remove the connector from the syringe. Holding the bottle firmly, press the connector firmly onto the bottle neck (leave the connector in the bottle neck, do not remove it).

3. Press the tip of the syringe into the depression of the connector and ensure it is securely attached.

4. Turn the bottle upside down, holding the syringe. Pull the plunger of the syringe downwards 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 slowly press the plunger to carefully administer the suspension. (If more than one syringeful is required to deliver 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. Close the bottle with the cap.

9. The prepared suspension (medicine after adding water) must be stored in the refrigerator. Shake the bottle before each use. The prepared suspension must be used within 7 days.