HOMER 875 mg/125 mg Oral Suspension Powder

Зміст інструкції

1. HOMER 875 mg /125 mg
2. HOMER 875 mg / 125 mg
   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

HOMER 875 mg /125 mg

Film-coated tablets

HOMER 875 mg / 125 mg

Oral suspension powder
amoxicillin / clavulanic acid
Generic medicine
Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 the bacteria that cause infections. It contains two different
medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines
called “penicillins” whose activity can sometimes be blocked (rendered inactive).
The other active ingredient (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 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 had problems with your liver or jaundice (yellowing of the skin) when taking an antibiotic.

→Do not take Homer if any of these apply to you.
If you are unsure, talk to your doctor or pharmacist before taking Homer.

Take special care with Homer
Consult your doctor or pharmacist before taking Homer if you:

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

If you are not sure whether any of the above applies to you, talk to your doctor or pharmacist before
taking Homer.
In some cases, the doctor may perform an investigation to assess the type of bacteria that caused your infection.
Based on the results, they may prescribe a different dosage of Homer or a different medicine.

Conditions you should be aware of
Homer can worsen certain existing conditions or cause serious adverse effects.
These may include allergic reactions, convulsions and inflammation of the intestine. You should pay
attention to certain symptoms while taking Homer in order to reduce any risk. See
“ Conditions you should be aware of”in Section 4.
Blood and urine tests
If you are about to have blood tests (such as tests related to red blood cells or liver function tests) or urine tests (for glucose), tell your doctor or nurse that you
are taking Homer. This is because Homer can affect the results of these types of tests.

Other medicines and Homer
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including over-the-counter medicines and herbal products.
If you are taking allopurinol (used for gout) with Homer, you are very likely to have 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 medicines (such as warfarin) that help prevent blood clots together with Homer, you may need to have additional blood tests.
Homer can affect the way methotrexate (a medicine used to treat cancer or rheumatic diseases) works.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Homer may have side effects and the symptoms may make you unfit to drive vehicles.
Do not drive vehicles or use machines unless you feel well.

Homer 875 mg/125 mg oral suspension powder in sachetscontains 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. To be considered in people
affected by diabetes mellitus.

Homer 875 mg/125 mg oral suspension powder in sachetscontains 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 tabletscontains sodium
This medicine contains less than 1 mmol (23mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How to take Homer

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask 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 a day
• Higher dose - 1 tablet three times a day

Homer 875 mg/125 mg powder for oral suspension in sachets

• Usual dose - 1 sachet twice a day
• Higher dose - 1 sachet three times a day

Children weighing less than 40 kg
Children 6 years of age 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 sachetsare not recommended.

Patients with kidney and liver problems

• If you have kidney problems, the dose may be adjusted. Your doctor may choose a different dosage or a different medicine.
• If you have liver problems, you may be required to have more frequent blood tests to check how your liver is functioning.

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 immediately before.
• Space the doses regularly 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.

• Drink at the beginning of a meal or immediately before
• Space the doses regularly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.

Do not take Homer for more than 2 weeks. If you continue to feel unwell, you should return to your doctor.

If you take more Homer than you should
If you take too much Homer, symptoms may include stomach upset (nausea, vomiting or diarrhoea)
or convulsions. Tell your doctor as soon as possible. Bring the medicine packaging or bottle with you
to show the doctor.

If you forget to take Homer
Do not take a double dose to make up for a missed dose.
If you forget to take a dose, take it as soon as you remember. You should not take the next dose
too soon, but should wait about 4 hours before taking the next dose.

If you stop taking Homer
Continue to take Homer until the treatment is finished, even if you feel better. You need
every dose to help you fight the infection. If some bacteria survive, they can cause the infection to return.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Homer can cause side effects, although not everybody gets them.
manifest.

Conditions you should pay attention to
Allergic reactions:

• skin rashes
• inflammation of the blood vessels ( vasculitis) which can be visible as red or purple spots on the skin, but which can 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), which causes difficulty breathing
• collapse
• chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by allergy (Kounis syndrome)
• Contact your doctor immediatelyif you experience any of these symptoms. Stop taking Homer.

Inflammation of the large intestine
Intestinal inflammation, causing watery diarrhea generally 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 reported mainly in children treated with amoxicillin/clavulanate. It is a certain type of
allergic reaction with the main symptom of repetitive vomiting (1-4 hours after taking the medicine).
Further symptoms may include abdominal pain, lethargy, diarrhea and low blood
pressure.

• If you experience these symptoms, contact your doctor as soon as possiblefor advice.

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

• diarrhea (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 you suffer from this, take Homer before food
• vomiting
• diarrhea (in children).

Uncommon side effects
May affect up to 1 in 100 people

• skin rashes, itching
• raised rash, with itching ( urticaria)
• indigestion
• dizziness
• headache. Uncommon side effects can be seen from blood tests:
• increase in some 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 look like small targets (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 can be seen from 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 limited number of people, but their exact frequency
is unknown (frequency cannot be estimated on the basis of available data)

• Allergic reactions (see above)
• Intestinal inflammation (see above)
• Severe skin reactions:
• a widespread 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 peeling of the skin (more than 30% of the body surface area - toxic epidermal necrolysis)
• widespread red rash with small blisters containing pus ( bullous exfoliative dermatitis)
• a rash, red, with scabs and swellings under the skin and blisters (exanthematouspustulosis)
• Flu-like symptoms with rash, fever, swollen glands and abnormal blood test results (including increased number of white blood cells (eosinophilia) and increased liver enzymes) (Drug reaction with eosinophilia and systemic symptoms)
• Rash with blisters arranged in circles with a central crust or like 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 an increase in bilirubin in the blood (a substance produced by the liver) which can make the skin and whites of the eyes appear yellow
• 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 tongue that appears covered in hair
• stains on teeth (in children), generally removed by brushing.

Side effects that can be seen from blood or urine tests:

• severe reduction in the number of white blood cells
• low number of red blood cells ( hemolytic anemia)
• crystals in the urine (leading to acute kidney injury).

If you get side effects

• If any of the side effects gets worse or becomes troublesome,or if you notice any

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 which is reported on the package after Exp.
The expiry date refers to the last day of the month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines that you no longer use. This will help protect the environment.
Store in the original packaging to protect the product from light and humidity 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 ingredients: amoxicillin trihydrate corresponding to amoxicillin 875 mg,
potassium clavulanate corresponding to clavulanic acid 125 mg.
Excipients: Colloidal silicon dioxide, magnesium stearate, sodium starch glycolate, microcrystalline cellulose,
hydroxypropylmethylcellulose, titanium dioxide, macrogol 4000, macrogol 6000, dimethicone, purified water.
Homer 875 mg + 125 mg oral suspension powder
Each sachet contains:
Active ingredients: amoxicillin trihydrate corresponding to amoxicillin 875 mg,
potassium clavulanate corresponding to clavulanic acid 125 mg.
Excipients: Colloidal silicon dioxide, lemon aroma, strawberry aroma, xanthan gum, sucrose.

Description of the appearance of Homer and contents of the pack
Film-coated tablets: Pack of 12 tablets.
Oral suspension powder: Pack of 12 sachets.

Marketing authorisation 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 for viral infections.
Sometimes an infection caused by bacteria does 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 the bacteria survive and multiply despite the antibiotic.
Bacteria become resistant to antibiotics for various reasons. Using antibiotics appropriately can reduce the emergence of bacterial resistance.
When your doctor prescribes antibiotic therapy, it is indicated only for the current illness.
Pay attention to the following advice, in order to avoid the emergence of bacterial resistance which causes the
blockage of antibiotic activity.

• 1. It is very important that you take the antibiotic at the correct dose, at the scheduled times and for the correct

doctor or pharmacist.

• 2. Do not take antibiotics if they have not been expressly prescribed for you and use them only for the infection for which they have been prescribed.
• 3. Do not use antibiotics that have been prescribed to other people even if you have a similar infection to theirs.
• 4. Do not give antibiotics to others that have been expressly prescribed for you.
• 5. If you have any antibiotic left over at the end of the treatment, return it to the pharmacist so that it can be disposed of properly.