Amylan es

Patient Information Leaflet

Amylan ES, (600 mg + 42.9 mg)/5 mL, powder for oral suspension
Amoxicillinum + Acidum clavulanicum
Please read this leaflet carefully before giving the medicine to your child, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine is usually prescribed for infants or children. Do not give it to others. This medicine may harm another person, even if their symptoms are the same.
• If any side effects occur in the patient, including any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Amylan is and what it is used for

Amylan is an antibiotic that works by killing bacteria causing infections.
It contains two different active substances: amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called "penicillins", whose action can sometimes be blocked (inactivated).
The second active ingredient (clavulanic acid) prevents this inactivation.
Amylan is used in infants and children to treat the following infections:

• middle ear infections
• lung infections

2. Important information before using Amylan

Do not give the child Amylan:

• if the child is allergic to amoxicillin, clavulanic acid, penicillin, or to any of the other ingredients of this medicine (listed in section 6).
• if the child has ever had a severe allergic reaction to any other antibiotic. This may include skin rash, swelling of the face or neck.
• if the child has ever had liver problems or jaundice (yellowing of the skin) while taking an antibiotic.

If any of the above situations apply to the child, do not give Amylan.
If in doubt, consult a doctor or pharmacist before giving Amylan.
Warnings and precautions
Before starting to give the child Amylan, consult a doctor or
pharmacist if:

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

If in doubt whether the above conditions apply to the child, consult the doctor or pharmacist before starting treatment with Amylan.
In some cases, the doctor may test which type of bacteria caused the child's infection. Depending on the results, the patient may receive Amylan at a different dose or another medicine.
Symptoms to watch for
Taking Amylan may worsen certain diseases or cause serious side effects, including allergic reactions, seizures, and inflammation of the large intestine. Pay attention to whether the child develops certain symptoms during treatment with Amylan to reduce the risk of any problems. See 'Symptoms to watch for' in section 4.
Blood and urine tests
If the child is to undergo blood tests (such as complete blood count or liver function tests) or urine tests, inform the doctor or nurse that the patient is taking Amylan, because Amylan may affect the results of these tests.
Amylan and other medicines
Tell the doctor or pharmacist about all medicines currently or recently given to the child. This also includes medicines available without a prescription and herbal medicines.
If the child is taking allopurinol (used in gout) together with Amylan, the risk of developing allergic skin reactions may be higher.
If the patient is taking probenecid (used in gout), the doctor may decide to adjust the dose of Amylan. Concurrent use of probenecid may reduce the elimination of amoxicillin and is not recommended.
If the patient is taking anticoagulant medicines (such as warfarin) together with Amylan, additional blood tests may be needed.
Amylan may affect the action of methotrexate (a medicine used to treat cancer, severe psoriasis, or rheumatic diseases). Penicillins may reduce the elimination of methotrexate, increasing the risk of adverse effects.
Amylan may affect the action of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Before using any medicine, consult a doctor or pharmacist.
Amylan contains maltodextrin and sodium
This medicine contains maltodextrin (a source of glucose). If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicinal product.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use Amylan

This medicine should always be used according to the instructions given by the doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Adults and children with body weight equal to or greater than 40 kg

• This suspension is not usually recommended for adults and children with body weight equal to or greater than 40 kg. Consult your doctor or pharmacist for advice.

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

• The treating doctor will advise what dose of Amylan should be given to the infant or child.
• An oral dosing spoon, plastic syringe, or measuring cup is provided with the package. Use it to give the child the correct dose of the medicine.
• The usual dose is (90 mg + 6.4 mg) per kilogram of body weight per day, administered in two divided doses.

Amylan is not recommended for use in children under 3 months of age.
Patients with kidney or liver disease

• For children with impaired kidney function, the dose may be reduced. The doctor may recommend a different dose or a different medicine.
• Children with impaired liver function may require more frequent blood tests to monitor liver function.

How to administer Amylan

• Always shake the bottle well before administering each dose.
• Administer at the beginning of a meal or just before a meal.
• Maintain regular intervals of at least 4 hours between doses administered during the day. Do not administer two doses within 1 hour.
• Do not administer Amylan to the child for longer than 2 weeks. If the patient still does not feel well, contact the doctor again.

Overdose of Amylan
If the child has taken more Amylan than recommended, symptoms may include
irritation of the stomach and intestines (nausea, vomiting, or diarrhea) or seizures. Contact the
treating doctor as quickly as possible. Keep the medicine packaging available to show to the doctor.
Missed dose of Amylan
If a dose of Amylan was forgotten, give it as soon as remembered. Do
not administer the next dose too early; instead, wait approximately 4 hours before administering the
next dose.
Stopping Amylan treatment
Continue administering Amylan until the end of the prescribed treatment period, even if the child
feels better. All doses are necessary to eliminate the infection. If some bacteria survive, they may cause the infection to recur.
If you have any further questions about the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur during treatment with this medicine:
Symptoms to be aware of
Hypersensitivity reactions:

• skin rash
• vasculitis, which may appear as red or purple raised spots on the skin, but may affect other parts of the body
• fever, joint pain, swelling of lymph nodes in the neck, under the arm or in the groin
• swelling, sometimes involving the face or area around the mouth (angioedema), causing difficulty in breathing
• fainting
• chest pain related to an allergic reaction, which may be a sign of an allergy leading to myocardial infarction (Kounis syndrome)
• red rash usually observed on both sides of the buttocks, inner upper thighs, under the arms and on the neck (symmetrical drug-related intertriginous and flexural exanthema, SDRIFE) (frequency cannot be determined from available data)

If any of these symptoms occur, contact a doctor immediately.
Treatment with Amylan should be discontinued.
Colitis
Colitis causing watery diarrhoea, usually with blood and mucus, abdominal pain and (or) fever.
Acute pancreatitis
If you have severe and persistent pain in the stomach area, it may be a sign of acute pancreatitis.
Drug-induced enterocolitis syndrome (DIES)
Drug-induced enterocolitis has occurred mainly in children receiving amoxicillin with clavulanic acid. It 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.
If any of these symptoms occur, contact your doctor as soon as possible for advice.
Very common (may affect more than 1 in 10 people):

• diarrhoea (in adults)

Common (may affect up to 1 in 10 people):

• fungal infections (candidiasis - yeast infections of the vagina, mouth or skin folds)
• nausea, especially when high doses are used
  • if nausea occurs, take Amylan before meals
• vomiting
• diarrhoea (in children)

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

• skin rash, itching
• raised, itchy rash (urticaria)
• indigestion
• dizziness
• headache Uncommon adverse reactions that may be revealed in blood test results:
• increased activity of certain substances (enzymes) produced in the liver

Rare (may affect up to 1 in 1000 people):

• skin rash, which may present with blisters and appear as small targets (dark spot in the centre surrounded by a lighter ring with a dark ring around the edge - erythema multiforme)
  • if the patient notices any of these symptoms, they should 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

Other adverse reactions
Other adverse reactions occurred in a very small number of people, but their exact frequency is unknown:

• hypersensitivity reactions (see above)
• colitis (see above)
• blistering rash arranged in a ring-like pattern or like a string of pearls (linear IgA dermatosis)
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• severe skin reactions:
  • widespread skin rash, in which blisters and skin peeling may occur, 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, in which small pus-filled blisters may appear (pustular 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 number of 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, contact a doctor immediately.

• hepatitis (liver inflammation)
• jaundice due to increased bilirubin levels in the blood (a substance produced in the liver), which may cause yellowing of the skin and whites of the eyes in a child
• inflammation of the renal tubules
• prolonged blood clotting time
• hyperactivity
• seizures (in people receiving high doses of Amylan or in people with impaired kidney function)
• black hairy tongue
• tooth discoloration (in children), which can usually be removed by brushing

Adverse reactions that may appear in blood or urine test results:

• significant decrease in the number of white blood cells
• low number of red blood cells (haemolytic anaemia)
• crystals in the urine leading to acute kidney injury

If adverse reactions occur in a child, contact a doctor immediately if any of the adverse symptoms worsen or become bothersome, or if any adverse symptoms not listed in this leaflet occur.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 4921 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Amylan ES

Keep the medicine out of 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 blister, bottle, and carton after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Reconstituted suspension
Store in a refrigerator (2°C–8°C). Do not freeze.
Shelf life of the suspension after reconstitution: 7 days.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Amylan contains
Each mL of reconstituted suspension contains 120 mg of amoxicillin (as amoxicillin trihydrate) and 8.58 mg of clavulanic acid (as potassium clavulanate).
The other ingredients are: crospovidone type A (E1202), silicon dioxide, anhydrous colloidal silicon dioxide (E551), sodium carmellose (E466), xanthan gum (E415), potassium acesulfame (E950), sodium saccharin (E954), strawberry flavour [maltodextrin (from maize), triethyl citrate (E1505), propylene glycol, flavouring components, and benzyl alcohol].

What Amylan looks like and contents of the pack
Amylan (600 mg + 42.9 mg)/5 mL, powder for oral suspension, is a white or yellowish powder supplied in an amber glass type III bottle. After reconstitution, the bottle contains a white or yellowish liquid mixture known as a suspension.
The bottles are packaged together with a dosing device in the form of:

• 6 mL PE/PS syringe
• 5 mL PS measuring spoon
• 5 mL PP measuring cup.

Pack sizes: 50 mL, 100 mL.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Viatris Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN
Ireland
(logo of the marketing authorisation holder)

Manufacturer:
Haupt Pharma Latina S.r.l.
SS.156 Monti Lepini Km. 47,600
Borgo San Michele,
04100 Italy

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:
Viatris Healthcare Sp. z o.o.
Tel: +48 22 54 66 400

This medicinal product is authorised in the European Economic Area member states under the following names:
Portugal Amoxicilina + Ácido clavulânico Mylan
Poland Amylan

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 given antibiotic. This means that bacteria can survive or multiply despite antibiotic treatment.
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. Please read the instructions provided in the package leaflet, and if any of them are unclear, ask your doctor or pharmacist for clarification.

2. Do not take an antibiotic unless it has been prescribed specifically for you. You should 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 your prescribed antibiotics to other people.

5. If any antibiotic remains after completing treatment as directed by your doctor, return the unused medicine to a pharmacy, which will ensure its proper disposal.

Instructions for preparing the medicine for use
Before use, check that the cap seal has not been broken. Shake the bottle to loosen the powder.
Fill the bottle with water just below the line marked on the label.
Turn the bottle upside down and shake well. Wait for the foam to settle.
Then, add water up to the marked line, turn the bottle again and shake thoroughly.
Shake the bottle well before each dose.

Additional information on the preparation of the suspension
Table 1: Description of the total volume of water to be added to reconstitute 50 mL or 100 mL of oral suspension