Homer

Patient Information Leaflet

HOMER 875 mg /125 mg

Film-coated tablets
HOMER 875 mg / 125 mg
Powder for oral suspension
amoxicillin /clavulanic acid
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Homer is and what it is used for

Homer is an antibiotic that works by killing bacteria that cause infections. It contains two different medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as “penicillins”, whose activity can sometimes be blocked (rendered inactive).
The other active component (clavulanic acid) prevents this from happening.
Homer is used in adults and children to treat the following infections:

• ear and sinus infections
• respiratory tract infections
• urinary tract infections
• skin and soft tissue infections, including dental infections
• bone and joint infections

2. What you need to know before taking Homer

Do not take Homer:

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

→Do not take Homer if any of these cases apply to you.
If you are unsure, speak with your doctor or pharmacist before taking Homer.
Take special care with Homer
Talk to your doctor or pharmacist before taking Homer if you:

• have infectious mononucleosis
• have previously been treated for liver or kidney problems
• do not urinate regularly.

If you are unsure whether any of the conditions listed above apply to you, discuss this with your doctor or pharmacist before taking Homer.
In some cases, your doctor may carry out tests to identify the type of bacteria causing your infection.
Based on the results, they may prescribe a different dose of Homer or a different medicine.
Conditions you should be aware of
Homer may worsen certain pre-existing conditions or cause serious side effects.
These may include allergic reactions, seizures, and inflammation of the intestine. You should pay attention to certain symptoms while taking Homer in order to reduce any risks. See “Conditions you should be aware of” in Section 4.
Blood and urine tests
If you are scheduled to have blood tests (such as red blood cell counts or liver function tests) or urine tests (for glucose), inform your doctor or nurse that you are taking Homer.
This is because Homer may affect the results of these types of tests.
Other medicines and Homer
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines, including those available without a prescription and herbal products.
If you are taking allopurinol (used for gout) together with Homer, you are very likely to develop a skin allergic reaction.
If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of Homer.
If you are taking medications (such as warfarin) that help prevent blood clots together with Homer, additional blood tests may be required.
Homer may affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Homer may cause side effects that could affect your ability to drive safely.
Do not drive or operate machinery unless you feel well.
Homer 875 mg/125 mg powder for oral suspension in sachets contains sucrose
Contains 4 g of sucrose (sugar) per sachet. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine. This should be considered in patients with diabetes mellitus.
Homer 875 mg/125 mg powder for oral suspension in sachets contains propylene glycol
This medicine contains 2.2 mg of propylene glycol per sachet, equivalent to 0.03 mg/kg.
Homer 875 mg/125 mg film-coated tablets contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.

3. How to take Homer

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults and children weighing 40 kg or more
Homer 875 mg/125 mg film-coated tablets

• Usual dose - 1 tablet twice daily
• Higher dose - 1 tablet three times daily

Homer 875 mg/125 mg oral suspension powder in sachets

• Usual dose - 1 sachet twice daily
• Higher dose - 1 sachet three times daily

Children weighing less than 40 kg
Children aged 6 years or younger should preferably be treated with amoxicillin and clavulanic acid oral
suspension or sachets.
Homer 875 mg/125 mg film-coated tablets
Ask your doctor or pharmacist for advice on administering amoxicillin and clavulanic acid tablets to children weighing less than 40 kg.
Homer 875 mg/125 mg sachets are not recommended.
Patients with kidney or liver problems

• If you have kidney problems, your dose may need to be adjusted. Your doctor may choose a different dosage or a different medicine.
• If you have liver problems, you may require more frequent blood tests to monitor liver function.

How to take Homer
Homer 875 mg/125 mg film-coated tablets

• Swallow the tablet whole with a glass of water at the beginning of a meal or just before.
• Space your doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.

Homer 875 mg/125 mg sachets
Immediately before taking Homer, open the sachet and mix the contents with half a glass of water.

• Take at the beginning of a meal or just before
• Space your doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.

Do not take Homer for longer than 2 weeks. If you continue to feel unwell, you should see your doctor.
If you take more Homer than you should
If you take too much Homer, symptoms may include stomach disturbances (nausea, vomiting, or diarrhoea)
or seizures. Contact your doctor as soon as possible. Take the medicine package or container with you to show the doctor.
If you forget to take Homer
Do not take a double dose to make up for a forgotten dose.
If you forget to take a dose, take it as soon as you remember. Do not take the next dose too soon; instead, wait approximately 4 hours before taking the next dose.
If you stop taking Homer
Continue taking Homer for the full duration of treatment, even if you start to feel better. You need every dose to help fight the infection. If some bacteria survive, they may cause the infection to return.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Homer can cause side effects, although not everybody will experience them.

Conditions you should pay attention to

Allergic reactions:

• skin rashes
• inflammation of blood vessels ( vasculitis ), which may appear as red or purple spots on the skin, but may also affect other parts of the body
• fever, joint pain, swelling of the lymph nodes in the neck, armpits, or groin
• swelling, sometimes of the face or mouth ( angioedema ), causing difficulty in breathing
• collapse
• chest pain during allergic reactions, which may be a symptom of heart attack triggered by allergy (Kounis syndrome)

Contact your doctor immediately if you experience any of these symptoms. Stop taking Homer.

Inflammation of the large intestine
Intestinal inflammation causing watery diarrhoea, usually with blood and mucus, stomach pain and/or fever.

Acute inflammation of the pancreas (acute pancreatitis)
If you have severe and persistent pain in the stomach area, this could be a sign of acute pancreatitis.

Drug-induced enterocolitis syndrome (DIES):
DIES has been mainly reported in children treated with amoxicillin/clavulanate. It is a type of allergic reaction with the main symptom being repeated vomiting (1-4 hours after taking the medicine). Additional symptoms may include abdominal pain, lethargy, diarrhoea, and low blood pressure.
If you experience these symptoms, contact your doctor as soon as possible for advice.

Very common side effects
May affect more than 1 in 10 people

• diarrhoea (in adults)

Common side effects
May affect up to 1 in 10 people

• thrush ( candida – a fungal infection of the vagina, mouth, or skin folds)
• nausea, especially when taking high doses: if this occurs, take Homer before meals
• vomiting
• diarrhoea (in children)

Uncommon side effects
May affect up to 1 in 100 people

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

Uncommon side effects may also be detected through blood tests:

• increased levels of certain proteins ( enzymes ) produced by the liver

Rare side effects
May affect up to 1 in 1,000 people

• skin rashes, which may appear as blisters and resemble small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme ). If you notice any of these symptoms, contact your doctor urgently.

Rare side effects may also be detected through blood tests:

• low number of cells involved in blood clotting
• low number of white blood cells

Other side effects
Other side effects occur in a very small number of people, but their exact frequency is unknown (frequency cannot be estimated from the available data)

• Allergic reactions (see above)
• Intestinal inflammation (see above)
• Severe skin reactions:
  • widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing extensive skin detachment (more than 30% of body surface – toxic epidermal necrolysis)
  • widespread red rash with small pustule-filled blisters ( exfoliative bullous dermatitis )
  • red, crusted rash with swellings under the skin and blisters ( pustular exanthema )
  • flu-like symptoms with rash, fever, swollen glands, and abnormal blood test results (including increased white blood cell count (eosinophilia) and elevated liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms – DRESS)
• Skin rash with blistering in a ring pattern with a central crust or resembling a string of pearls (linear IgA disease)
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)

If you experience any of these symptoms, contact your doctor immediately.

• inflammation of the liver ( hepatitis )
• jaundice, caused by increased blood levels of bilirubin (a substance produced in the liver), which may cause yellowing of the skin and whites of the eyes
• inflammation of the kidney tubules
• blood takes longer to clot
• hyperactivity
• seizures (in people taking high doses of Homer or who have kidney problems)
• black hairy tongue, appearing covered in hair-like projections
• tooth staining (in children), usually removable by brushing

Side effects that may be detected through blood or urine tests:

• severe reduction in the number of white blood cells
• low number of red blood cells ( haemolytic anaemia )
• crystals in the urine (which may lead to acute kidney damage)

If you experience side effects
If any of the side effects worsen or become bothersome, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Homer

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp.
The expiry date refers to the last day of the month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Store in the original packaging to protect the product from light and moisture, at a temperature not exceeding 25°C.

6. Contents of the pack and other information

What Homer contains
Homer 875 mg / 125 mg Film-coated Tablets
Each tablet contains:
Active substances: amoxicillin trihydrate corresponding to 875 mg amoxicillin,
potassium clavulanate corresponding to 125 mg clavulanic acid.
Excipients: Colloidal silicon dioxide, magnesium stearate, sodium starch glycolate, microcrystalline cellulose,
hydroxypropylmethylcellulose, titanium dioxide, polyethylene glycol 4000, polyethylene glycol 6000, dimethicone, purified water.
Homer 875 mg + 125 mg powder for oral suspension
Each sachet contains:
Active substances: amoxicillin trihydrate corresponding to 875 mg amoxicillin,
potassium clavulanate corresponding to 125 mg clavulanic acid.
Excipients: Colloidal silicon dioxide, lemon flavour, strawberry flavour, xanthan gum, sucrose.

Description of the appearance of Homer and contents of the pack
Film-coated tablets: Carton containing 12 tablets.
Powder for oral suspension: Carton containing 12 sachets.

Marketing Authorization Holder and Manufacturer
So.Se.PHARM S.r.l.
Via Dei Castelli Romani, 22 - 00071 Pomezia (RM)

Manufacturer
Laboratorio Reig Jofrè, S.A. – C/Jarama s/n, Poligono Industrial – 45007 Toledo Spain

Behavioural hygiene
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
Sometimes, bacterial infections do not respond to antibiotic therapy. The most common reason for this is that the bacteria causing the infection are resistant to the antibiotic being used. This means that bacteria survive and multiply despite the presence of the antibiotic.
Bacteria become resistant to antibiotics for various reasons. Using antibiotics appropriately can reduce the emergence of bacterial resistance.
When your doctor prescribes an antibiotic treatment, it is intended solely for the illness you currently have. Please follow the advice below to help prevent the development of bacterial resistance, which can lead to failure of antibiotic therapy.

1. It is very important that you take the antibiotic at the correct dose, at the prescribed times, and for the exact number of days indicated. Read the instructions in the package leaflet carefully, and if anything is unclear, ask your doctor or pharmacist for clarification.
2. Do not take antibiotics unless they have been specifically prescribed for you, and use them only for the infection for which they were prescribed.
3. Do not use antibiotics prescribed for other people, even if you believe your infection is similar to theirs.
4. Do not give antibiotics prescribed specifically for you to other people.
5. If you have any antibiotic left over after completing your treatment, return it to the pharmacist for proper disposal.