Amilan

Leaflet attached to the packaging: patient information

Amylan, 500 mg + 125 mg, coated tablets

Amoxicillin + Clavulanic Acid

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Amylan and what is it 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 packaging and other information

1. What is Amylan and what is it used for

Amylan is an antibiotic that works bactericidally on bacteria that cause infections.
It contains two different medicines: amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called "penicillins", whose action can sometimes be inhibited (inactivated). The second active ingredient (clavulanic acid) counteracts this inactivation.
Amylan 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 taking Amylan

When not to take Amylan

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

If the above circumstances apply to the patient, they should not take Amylan.

In case of doubt before starting to take Amylan, consult a doctor or pharmacist.

Warnings and precautions

Before starting to take Amylan, consult a doctor or pharmacist if the patient:

• has infectious mononucleosis,
• is being treated for liver or kidney disease,
• has irregular urination.

In case of doubt whether the above circumstances apply to the patient, consult a doctor or pharmacist before starting to take Amylan.
In some cases, the doctor may examine what type of bacteria caused the patient's infection.
Depending on the results, the patient may receive Amylan in a different dose or a different medicine.

Conditions to pay attention to

Taking amoxicillin with clavulanic acid can worsen the course of some diseases or cause severe side effects, including allergic reactions, seizures, and colitis. Pay attention to whether the patient experiences certain symptoms while taking amoxicillin with clavulanic acid to reduce the risk of any problems. See section 4 "Possible side effects".

Blood and urine tests

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

Amylan and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans to take, including those available without a prescription and herbal medicines.

• Allopurinol (a medicine used to treat gout), it is more likely that the patient will experience skin allergic reactions.
• Probenecid (another medicine used to treat gout), the doctor may decide to modify the dose of Amylan. Concurrent use of probenecid may reduce the excretion of amoxicillin and is not recommended.
• Blood thinning medicines (such as acenocoumarol or warfarin), additional blood tests may be necessary.
• Methotrexate (a medicine used to treat cancer, severe psoriasis, or rheumatic diseases), penicillins may reduce the excretion of methotrexate, potentially leading to increased side effects.
• Mycofenolate mofetil (a medicine used to prevent rejection of transplanted organs).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Pregnancy
The medicine may harm the unborn child and should be avoided during pregnancy, unless necessary. The doctor will discuss this with the patient.
Breastfeeding
Amoxicillin and clavulanic acid may pass into breast milk. If the patient is breastfeeding while taking this medicine, the child may experience diarrhea or a fungal infection.
In such a case, it may be necessary to stop breastfeeding. The patient should only take this medicine while breastfeeding if recommended by a doctor.

Driving and operating machinery

Amylan may cause side effects that can lead to inability to drive vehicles.
Do not drive vehicles or operate machinery unless the patient feels well.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means the medicine is considered "sodium-free".

3. How to take Amylan

This medicine should always be taken as directed by the doctor. In case of doubt, consult a doctor or pharmacist.

Adults and children with a body weight of 40 kg or more

• The recommended dose is 1 tablet three times a day.

Children with a body weight of less than 40 kg

• Children under 6 years of age or with a body weight of less than 25 kg should preferably be treated with amoxicillin and clavulanic acid in the form of an oral suspension or sachets.
• Consult a doctor or pharmacist before taking Amylan tablets in children with a body weight of less than 40 kg. Tablets are not suitable for children with a body weight of less than 25 kg.

Patients with kidney and liver diseases

• If the patient has kidney disease, the dose of the medicine may be changed. The doctor may choose a different dose of the medicine or a different medicine.
• If the patient has liver disease, they may need to have blood tests more frequently to check how the liver is functioning.

How to take Amylan

• Take during meals.
• Swallow the tablets whole, with a glass of water. The tablets can be divided along the break line to make them easier to swallow. Take both parts of the tablet at the same time.
• Maintain equal intervals of at least 4 hours between doses taken during the day. Do not take 2 doses at an interval of 1 hour from each other.
• Maintain proper 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 the urine.
• Do not take Amylan for longer than 2 weeks. If the patient still does not feel well, they should contact their doctor again.

Taking a higher dose of Amylan than recommended

If the patient has taken a higher dose of Amylan than recommended, they may experience symptoms such as stomach and intestinal irritation (nausea, vomiting, or diarrhea) or seizures. Contact a doctor as soon as possible. Have the carton or bottle of medicine with you to show the doctor.

Missing a dose of Amylan

If the patient forgets to take a dose, they should take it as soon as they remember. Do not take the next dose too early, wait about 4 hours before taking the next dose. Do not take a double dose to make up for a missed dose.

Stopping treatment with Amylan

Continue taking Amylan until the end of the treatment, even if the patient feels better. All doses of the medicine are needed to combat the infection. If some bacteria survive, they can cause a recurrence of the infection.
In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Pay particular attention to the following symptoms

• severe allergic reactions, such as:
• skin rash
• vasculitis, which can be visible as red or purple raised spots on the skin, but can also affect other organs
• fever, joint pain, swelling of the lymph nodes in the neck, armpit, or groin
• swelling of the face or throat (angioedema), causing difficulty breathing or swallowing
• fainting
• chest pain associated with an allergic reaction, which can be a sign of an allergy leading to a heart attack (Kounis syndrome)

Contact a doctor immediately if any of the following symptoms occur. Stop taking Amylan

Colitis

Colitis, causing watery diarrhea usually with blood and mucus, stomach pain, and (or) fever.

Acute pancreatitis

If you have severe and persistent stomach pain, it may be a sign of acute pancreatitis.

Drug-induced enterocolitis syndrome (DIES)

Drug-induced enterocolitis syndrome occurred mainly in children receiving amoxicillin with clavulanic acid. It is a type of allergic reaction, the leading symptom of which is repeated vomiting (1 to 4 hours after taking the medicine). Further symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

Contact a doctor as soon as possible if any of the following symptoms occur

Very common side effects(may occur more often than in 1 in 10 patients)

• diarrhea (in adults)

Common side effects(may occur less often than in 1 in 10 patients)

• thrush (candidiasis - fungal infections of the vagina, mouth, or skin folds)
• feeling sick (nausea), especially when taking high doses. If it occurs, take Amylan during meals
• vomiting
• diarrhea (in children)

Uncommon side effects(may occur less often than in 1 in 100 patients)

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

Uncommon side effects that can be detected in blood tests

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

Rare side effects(may occur less often than in 1 in 1000 patients)

• skin rash, which can occur with blisters and resemble small targets (dark spot in the center surrounded by a lighter border with a dark ring around the edge - erythema multiforme)

Contact a doctor immediately if any of the following symptoms occur

Rare side effects that can be detected in blood tests

• low number of blood cells that help the blood to clot
• low number of white blood cells.

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

• allergic reactions (see above)
• colitis (see above)
• rash with blisters arranged in a ring or like a string of pearls (linear IgA dermatosis)
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• other severe skin reactions, such as:
• -widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) and a more severe form causing widespread peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis)
• -widespread red rash on the skin with small pus-filled blisters (bullous pemphigoid)
• -red scaly rash with thickening under the skin and blisters (acute generalized exanthematous pustulosis)
• -flu-like symptoms with a rash, fever, swelling of the lymph nodes, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes (drug reaction with eosinophilia and systemic symptoms (DRESS)))

Contact a doctor immediately if any of the following symptoms occur

• hepatitis
• jaundice caused by an increase in bilirubin (a substance produced in the liver), which can cause yellowing of the skin and eyes
• inflammation of the renal tubules
• prolonged blood clotting time
• restlessness
• seizures (in people taking high doses of Amylan or having kidney problems)
• black hairy tongue

Side effects that can be detected in blood tests

• decrease in the number of white blood cells
• low number of red blood cells (hemolytic anemia)
• crystals in the urine leading to acute kidney damage

Reporting side effects

If side effects occur, including those not listed in this leaflet, tell a doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49 21 301
Fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Amylan

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

What Amylan contains

• The active substances of the medicine 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.
• The other ingredients are: Tablet core: crospovidone type A, sodium carmellose, colloidal anhydrous silica, magnesium stearate. Tablet coating: basic butyl methacrylate copolymer, titanium dioxide (E 171), talc, macrogol 6000.

What Amylan looks like and what the pack contains

Amylan is white to off-white, elongated, capsule-shaped, coated tablets with a break line.
Amylan is available in blisters in a pack (carton) containing 14 coated tablets.

Marketing authorization holder

Viatris Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN
Ireland

Manufacturer

PenCef Pharma GmbH
Breitenbachstrasse 13-14
13509 Berlin
Germany
To obtain more detailed information about this medicine, contact the local representative of the marketing authorization holder:

Mylan Healthcare Sp. z o.o.

Phone: +48 22 54 66 400

This medicine is authorized in the Member States of the European Economic Area under the following names:

Hungary
Amoxicillin/Clavulanic Acid Mylan 500 mg/125 mg filmtabletta
Poland
Amylan
Slovakia
Amoxicillin/Clavulanic Acid Mylan 500 mg/125 mg filmom oblané tablety

Date of last revision of the leaflet:

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 phenomenon is that the bacteria are resistant to the administered antibiotic.
This means that the bacteria can survive or multiply despite the use of the antibiotic.
Bacteria can become resistant to antibiotics for many reasons. Careful use of antibiotics can help reduce the risk of bacteria developing resistance.
The antibiotic prescribed by the doctor is intended solely for the treatment of the current illness. Paying attention to the following advice will help prevent the development of resistant bacteria that could inhibit the action of the antibiotic.

• 1. It is very important to take the antibiotic in the correct dose, at the right time, and for the correct number of days. Read the instructions in the patient information leaflet and if any of them are unclear, ask a doctor or pharmacist to explain.
• 2. The patient should not take an antibiotic if it was not prescribed specifically for them. They should only take it for the treatment of an infection for which the antibiotic was prescribed.
• 3. The patient should not take an antibiotic prescribed for another person, even if they had a similar infection.
• 4. Do not pass on antibiotics prescribed for one patient to other people.
• 5. If there are any remaining antibiotics after completing the treatment as directed by the doctor, return them to the pharmacy, which will accept them for proper disposal.