Amylan

Package leaflet: Information for the patient

Amylan, 500 mg + 125 mg, film-coated tablets
Amoxicillinum + Acidum clavulanicum
Please read this leaflet carefully before using the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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 with bactericidal activity against bacteria causing infections.
It contains two different active substances: amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called “penicillins”, whose activity may sometimes be inhibited (inactivated). The second active component (clavulanic acid) counteracts this inactivation.
Amylan is used in adults and children for the treatment of 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 Amylan

When not to use Amylan

• If the patient has hypersensitivity 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, neck, or throat.
• If the patient has ever had liver problems or jaundice (yellowing of the skin) associated with the use of an antibiotic.

If any of the above conditions apply to the patient, Amylan must not be used.
If in doubt, consult a doctor or pharmacist before starting treatment with Amylan.

Warnings and precautions
Before starting treatment with Amylan, consult a doctor or pharmacist if the patient:

• Has infectious mononucleosis,
• Is being treated for liver or kidney disease,
• Urinates irregularly.

If in doubt whether any of the above conditions apply, consult a doctor or pharmacist before starting Amylan.
In some cases, the doctor may test which type of bacteria caused the infection.
Depending on the results, the patient may receive Amylan at a different dose or another medicine.

Conditions to be aware of
Treatment with amoxicillin and clavulanic acid may worsen certain diseases or cause serious side effects, including allergic reactions, seizures, and inflammation of the colon (colitis). It is important to monitor whether the patient develops specific symptoms during treatment with amoxicillin and clavulanic acid to reduce the risk of complications. See section 4 "Possible side effects".

Blood and urine tests
If the patient is due to have blood tests (such as red blood cell count or liver function tests) or urine tests (for glucose), the patient should inform the doctor or nurse that they are taking Amylan. Amoxicillin with clavulanic acid may affect the results of these tests.

Interaction of Amylan with other medicines
Tell the doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient plans to take, including those available without prescription and herbal medicines.

• Allopurinol (a medicine used in the treatment of gout) – increased likelihood of skin allergic reactions.
• Probenecid (another medicine used in the treatment of gout) – the doctor may decide to adjust the dose of Amylan. Concurrent use of probenecid may reduce the excretion of amoxicillin and is not recommended.
• Medicines that reduce blood clotting (such as acenocoumarol or warfarin) – additional blood tests may be required.
• Methotrexate (a medicine used in the treatment of cancer, severe psoriasis, or rheumatic diseases) – penicillins may reduce the excretion of methotrexate, increasing the risk of side effects.
• 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 child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
This medicine may harm the unborn child and should be avoided during pregnancy unless clearly necessary. The doctor will discuss this with the patient.

Breastfeeding
Amoxicillin and clavulanic acid may pass into human milk. If the patient is breastfeeding while taking this medicine, diarrhea or fungal infection may occur in the infant. In such cases, breastfeeding may need to be discontinued. The patient should use this medicine during breastfeeding only if recommended by a doctor.

Driving and operating machinery
Amylan may cause side effects that could impair the ability to drive.
Do not drive or operate machinery unless the patient feels well.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is considered "sodium-free".

3. How to use Amylan

This medicine should always be taken exactly as directed by the physician. If in doubt, consult your doctor or pharmacist.

Adults and children with body weight 40 kg or more

• The recommended dose is 1 tablet three times daily.

Children with body weight less than 40 kg

• Children aged 6 years or younger, or with body weight less than 25 kg, should preferably be treated with amoxicillin combined with clavulanic acid in the form of an oral suspension or sachets.
• Consult a doctor or pharmacist before using Amylan tablets in children with body weight less than 40 kg. The tablets are not suitable for children with body weight less than 25 kg.

Patients with kidney or liver disease

• If the patient has kidney disease, the dose of the medicine may need to be adjusted. The physician may choose a different dose or alternative treatment.
• If the patient has liver disease, blood tests may be performed more frequently to monitor liver function.

How to use Amylan

• Take during meals.
• Swallow the tablets whole with a glass of water. Tablets may be divided along the break line to make swallowing easier. Both parts of the tablet should be taken at the same time.
• Maintain regular intervals of at least 4 hours between doses administered throughout the day. Do not take two doses within 1 hour of each other.
• Maintain adequate hydration throughout the day by drinking plenty of fluids, especially if the patient is taking high doses of this medicine, to reduce the risk of crystal formation in urine.
• Do not take Amylan for longer than 2 weeks. If the patient still does not feel better, they should contact their doctor again.

Taking more Amylan than recommended
If the patient has taken more Amylan than recommended, symptoms such as gastrointestinal irritation (nausea, vomiting, or diarrhoea) or seizures may occur. Contact a doctor as soon as possible. Keep the cardboard packaging or the medicine bottle available to show to the doctor.

Missed dose of Amylan
If the patient forgets to take a dose, take it as soon as remembered. Do not take the next dose too soon—wait approximately 4 hours before taking the next dose. Do not take a double dose to make up for a missed dose.

Stopping Amylan treatment
Continue taking Amylan for the full duration of the prescribed treatment, even if the patient 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 or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Particular attention should be paid to the following symptoms:

• Severe allergic reactions, such as:
  • 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, under the arms, or in the groin
  • Swelling of the face or throat (angioedema), causing difficulty breathing or swallowing
  • Fainting
  • Red rash typically observed on both sides of the buttocks, inner thighs, underarms, and neck (symmetrical, intertriginous, and flexural exanthema induced by drugs (Symmetrical Drug-Related Intertriginous and Flexural Exanthema, SDRIFE)) (frequency cannot be determined from available data)
  • Chest pain associated with an allergic reaction, which may indicate an allergy leading to heart attack (Kounis syndrome)

Seek immediate medical advice if any of the following symptoms occur.
You must stop taking Amylan.

Colitis
Inflammation of the large intestine causing watery diarrhoea, usually with blood and mucus, stomach pain, and (or) fever.

Acute pancreatitis
If you have severe and persistent pain in the abdominal area, this may be a sign of acute pancreatitis.

Drug-induced enterocolitis syndrome (DIES)
Drug-induced enterocolitis has mainly been reported 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). Other symptoms may include abdominal pain, lethargy, diarrhoea, and low blood pressure.
Seek immediate medical advice if any of the following symptoms occur.

Very common adverse reactions (may occur in more than 1 in 10 patients)

• Diarrhoea (in adults)

Common adverse reactions (may occur in less than 1 in 10 patients)

• Fungal infections (candidiasis – yeast infections of the vagina, mouth, or skin folds)
• Nausea, especially when high doses are used. If this occurs, take Amylan with food
• Vomiting
• Diarrhoea (in children)

Uncommon adverse reactions (may occur in less than 1 in 100 patients)

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

Uncommon adverse reactions that may be detected in blood tests:

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

Rare adverse reactions (may occur in less than 1 in 1000 patients)

• Skin rash, which may present with blisters and resemble small targets (a dark spot in the center surrounded by a lighter ring and a dark ring around the edge – erythema multiforme).
  Seek immediate medical advice if these symptoms occur.

Rare adverse reactions that may be detected in blood tests:

• Low number of platelets (thrombocytopenia)
• Low number of white blood cells (leukopenia)

Frequency not known (frequency cannot be determined from available data)

• Allergic reactions (see above)
• Colitis (see above)
• Blistering rash arranged in a ring-like pattern or resembling a string of pearls (linear IgA dermatosis)
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• Other serious skin reactions, such as:
  • Widespread blistering rash with peeling skin, especially 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 generalized exanthematous pustulosis)
  • Flu-like symptoms with rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes (drug reaction with eosinophilia and systemic symptoms, DRESS))

Seek immediate medical advice if any of the following symptoms occur:

• Liver inflammation
• Jaundice caused by elevated bilirubin (a substance produced in the liver), which may cause yellowing of the skin and whites of the eyes
• Inflammation of the kidney tubules
• Prolonged blood clotting time
• Restlessness
• Seizures (in patients taking high doses of Amylan or with kidney problems)
• Black, hairy-looking tongue

Adverse reactions that may be detected in blood tests:

• Decreased number of white blood cells
• Low number of red blood cells (hemolytic anaemia)
• Crystals in urine leading to acute kidney injury

Reporting of adverse reactions
If any adverse effects occur, including any 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: 22 49 21 301
Fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Amylan

Do not store above 25°C. Keep in the original packaging to protect from moisture.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister pack after EXP.
The expiry date refers to the last day of the stated month.
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. Package contents and other information

What Amylan contains

• The active substances are amoxicillin and clavulanic acid.
• Each coated tablet contains amoxicillin trihydrate equivalent to 500 mg of amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid.
• Other components are:
  Tablet core: crospovidone type A, sodium croscarmellose, anhydrous colloidal silicon dioxide, magnesium stearate.
  Tablet coating: basic butyl methacrylate copolymer, titanium dioxide (E 171), talc, macrogol 6000.

What Amylan looks like and contents of the pack
Amylan is a white to off-white, elongated, capsule-shaped coated tablet with a score line.
Amylan is available in blisters within a cardboard carton containing 14 coated tablets.

Marketing Authorisation Holder
Viatris Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN
Ireland

Manufacturer
PenCef Pharma GmbH
Breitenbachstrasse 13-14
13509 Berlin
Germany

For more detailed information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
Tel: +48 22 54 66 400

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 prescribed antibiotic.
This means that bacteria can survive or multiply despite the use of the antibiotic.
Bacteria may become resistant to antibiotics for various reasons. Proper use of antibiotics may help reduce the likelihood of bacterial resistance development.
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 hinder the effectiveness of antibiotics.

1. It is very important to take the antibiotic at the correct dose, at the right time, and for the prescribed 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. Patients should not take an antibiotic unless it has been specifically prescribed for them. It should be used exclusively 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 your prescribed antibiotics to other people.
5. If any antibiotic remains after completing the treatment as directed by your doctor, return it to a pharmacy for proper disposal.