POSMOX 875 mg/125 mg Film-Coated Tablets

Зміст інструкції

1. POSMOX 875 mg + 125 mg film-coated tablets, 875 mg + 125 mg oral suspension powder
   1. What POSMOX is and what it is used for
   2. What you need to know before taking POSMOX
   3. How to take POSMOX
   4. Possible side effects
   5. How to store POSMOX
   6. Package contents and other information

POSMOX 875 mg + 125 mg film-coated tablets, 875 mg + 125 mg oral suspension powder

Amoxicillin + Clavulanic acid
Generic medicine

Read this leaflet carefully before you start 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 their symptoms are the same as yours, as it could 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 POSMOX is and what it is used for
• 2. What you need to know before you take POSMOX
• 3. How to take POSMOX
• 4. Possible side effects
• 5. How to store POSMOX
• 6. Contents of the pack and other information

1. What POSMOX is and what it is used for

POSMOX is an antibiotic that works by killing the bacteria that cause infections.
It contains two different active ingredients called amoxicillin and clavulanic acid. Amoxicillin is an
antibiotic belonging to the group of medicines called “penicillins” whose activity can sometimes
be blocked (rendered inactive). The other active ingredient (clavulanic acid) prevents this
from happening.
POSMOX 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 POSMOX

Do not take POSMOX

• if you are allergic to amoxicillin, clavulanic acid, penicillins or any of the other ingredients of this medicine (listed in section 6);

1/8

• 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 throat;
• if you have had problems with your liver or jaundice (yellowing of the skin) when you have taken an antibiotic. Do not take POSMOX if either of these applies to you.If you are unsure, talk to your doctor or pharmacist before taking POSMOX.

Warnings and precautions
Talk to your doctor or pharmacist before taking POSMOX.
Talk to your doctor or pharmacist before taking this medicine if:

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

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before
taking POSMOX.
In some cases, your doctor may do a test to assess the type of bacteria that caused your
infection.
Based on the results, they may prescribe a different dose of POSMOX or a different medicine.

Conditions you should pay attention to
POSMOX can worsen certain existing conditions, or cause serious side effects.
These may include allergic reactions, convulsions and inflammation of the intestine. You should
pay attention to certain symptoms while taking POSMOX, in order to reduce any
risk. See “ Conditions you should pay attention to”in section 4.

Blood and urine tests
If you are about to have blood tests (such as those related to red blood cells or
liver function tests) or urine tests (for glucose), tell your doctor or
nurse that you are taking POSMOX. This is because POSMOX can affect the results of
these types of tests.

Other medicines and POSMOX
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
If you are taking allopurinol (used for gout) with POSMOX, you are very likely to have an
allergic skin reaction.
If you are taking probenecid (used for gout), your doctor may decide to change your dose
of POSMOX.
2/8
If you are taking medicines (such as warfarin) that help prevent blood clots together with POSMOX, then you may need to have additional blood tests.
POSMOX can affect the way methotrexate (a medicine used to treat
tumors or rheumatic diseases) works.
POSMOX can affect the function of mycophenolate mofetil (a drug used to
prevent rejection of transplanted organs).

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

Driving and using machines
POSMOX can have side effects and the symptoms can affect your ability to drive
vehicles and use machines.
Do not drive vehicles or use machines unless you feel well.

POSMOX 875 mg+125 mg powder for oral suspension in sachets contains aspartame (E951)
This medicine contains 12.5 mg of aspartame (E951) per sachet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a
rare genetic disorder that causes a build-up of phenylalanine because the body cannot process it
correctly.

POSMOX 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 POSMOX

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.

Use in adults and children weighing 40 kg or more
POSMOX 875 mg/125 mg film-coated tablets

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

POSMOX 875 mg/125 mg oral suspension powder

• The recommended dose is 1 sachet twice a day.
• The maximum dose is 1 sachet three times a day.

Use in children weighing less than 40 kg
Children aged 6 years or less should preferably be treated with amoxicillin and
clavulanic acid oral suspension or paediatric sachets.
3/8
Ask your doctor or pharmacist for advice on administering POSMOX 875
mg/125 mg film-coated tablets to children weighing less than 40 kg. The tablets are not
suitable for children weighing less than 25 kg.
The sachets of POSMOX 875 mg/125 mg are 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 POSMOX

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

Sachets:

• Immediately before taking POSMOX, open the sachet and mix the contents with half a glass of water.
• Take with meals.
• Space the doses regularly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
• Do not take POSMOX for more than 2 weeks. If you continue to feel unwell, you should return to your doctor.

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

If you forget to take POSMOX
If you forget to take a dose, take it as soon as you remember, but not before
four hours have passed since the last dose.
Do not take a double dose to make up for a missed dose.

If you stop taking POSMOX
Continue to take POSMOX 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 questions about using this medicine, ask your doctor or pharmacist.
4/8

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The side effects that may occur with this medicine are listed below.

Conditions to which you should pay attention
Allergic reactions:

• skin rashes (appearance of red spots on the skin),
• inflammation of the blood vessels (vasculitis) which may be visible as red or purple spots on the skin, but may 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 (severe drop in blood pressure),
• 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
POSMOX.
Intestinal inflammation
Intestinal inflammation causing watery diarrhea generally with blood and mucus, stomach pain and/or fever.

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

Drug-induced enterocolitic 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.

Tell your doctor if any of the following side effects occur:
Very common(may affect more than 1 in 10 people)

• diarrhea (in adults).

Common(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 it, take POSMOX before food, 5/8
• vomiting,
• diarrhea (in children).

Uncommon(may affect up to 1 in 100 people)

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

Uncommon side effects may be visible from blood tests:

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

Rare(may affect up to 1 in 1000 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 may be visible from blood tests:

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

Not known(frequency cannot be estimated from available data)

• allergic reactions (see above),
• intestinal inflammation (see above),
• severe skin reactions:
• widespread rash with blisters and peeling, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form, which determines extensive skin exfoliation (more than 30% of the body surface area, toxic epidermal necrolysis),
• widespread red rash with small blisters containing pus (exfoliative bullous dermatitis),
• red and scaly rash with bumps forming under the skin and blisters (pustulous exanthematous)rash with blisters arranged in a circle with a central crust or like a string of pearls (linear IgA disease),
• flu-like symptoms with rash, fever, swollen glands and abnormal blood test results (including increased number of white blood cells (eosinophilia) and elevated liver enzymes) (Drug reaction with eosinophilia and systemic symptoms),
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).

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

• liver inflammation (hepatitis),

6/8

• jaundice, caused by an increase in bilirubin in the blood (a substance produced by the liver) which can cause the skin and whites of the eyes to appear yellow,
• inflammation of the kidney tubules,
• blood takes longer to clot,
• hyperactivity,
• seizures (in people taking high doses of POSMOX or who have kidney problems),
• black tongue that appears covered in hair,
• stains on teeth (in children), generally removed by brushing.

Side effects that may be visible from blood or urine tests:

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 POSMOX

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

6. Package contents and other information

What POSMOX contains
POSMOX 875 mg + 125 mg film-coated tablets

• The active ingredients are: each tablet contains amoxicillin trihydrate corresponding to amoxicillin 875 mg and potassium clavulanate corresponding to clavulanic acid 125 mg.
• The other ingredients are colloidal anhydrous silica, magnesium stearate, sodium starch glycolate, microcrystalline cellulose, hydroxypropylmethylcellulose, talc, titanium dioxide, diethyl phthalate, dimethicone.

7/8
POSMOX 875 mg + 125 mg oral suspension powder

• The active ingredients are: each sachet contains amoxicillin trihydrate corresponding to amoxicillin 875 mg and potassium clavulanate corresponding to clavulanic acid 125 mg.
• The other ingredients are hydrated colloidal silica, orange flavour, aspartame.

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

Marketing authorisation holder and manufacturer

Marketing authorisation holder
Pharmacare Srl
Via Marghera, 29
20149 Milano
Italy

Manufacturer
Elpen SA
95 Marathonos Avenue
19009 Pikermi Attika
Greece

Only for “Oral Suspension Powder”:
LA.FA.RE. S.r.l.
Via S. Benedetto Cozzolino, 77
80056 Ercolano (NA)
Italy

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.
8/8
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 illness you have
currently. Pay attention to the following advice, in order to avoid the emergence of bacterial resistance
which causes the blocking of antibiotic activity.

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

ask your doctor or pharmacist for explanations.

• 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 that have been expressly prescribed for you to others.
• 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 appropriately.

9/8