Posmox

Patient Information Leaflet: Instructions for the User

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

amoxicillin + clavulanic acid
Generic medicine
Please read all of this leaflet carefully before 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 taking 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 bacteria that cause infections.
It contains two different active substances called amoxicillin and clavulanic acid. Amoxicillin is an
antibiotic belonging to a group of medicines known as "penicillins", whose activity can sometimes
be blocked (rendered inactive). The other active substance (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);
• if you have had a serious allergic reaction (hypersensitivity) to any other antibiotic. This may include a skin rash or swelling of the face or throat;
• if you have had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

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→Do not take POSMOX if any of these apply to you. If you are in doubt, speak with your doctor or pharmacist before taking POSMOX.
Warnings and precautions
Talk to your doctor or pharmacist before taking POSMOX.
Speak with your doctor or pharmacist before taking this medicine if:

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

If you are unsure whether any of the above conditions apply to you, talk to your doctor or pharmacist before taking POSMOX.
In some cases, your doctor may perform tests to identify the type of bacteria causing your infection.
Based on the results, your doctor may prescribe a different dosage of POSMOX or a different medicine.
Conditions you should watch for
POSMOX 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 POSMOX in order to reduce any risk. See “Conditions you should watch for ” in section 4.
Blood and urine tests
If you are about to have blood tests (for example, tests concerning red blood cells or liver function tests) or urine tests (for glucose), inform your doctor or nurse that you are taking POSMOX. This is because POSMOX may 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) together with POSMOX, 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 POSMOX.
If you are taking medicines together with POSMOX (such as warfarin) that help prevent blood clots, additional blood tests may be required.
POSMOX may affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works.
POSMOX may affect the action of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).
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Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
POSMOX may cause side effects, and symptoms may affect your ability to drive or operate machinery.
Do not drive or operate machinery unless you feel well.
POSMOX 875 mg+125 mg oral suspension powder in sachets contains aspartame (E951)
This medicine contains 12.5 mg of aspartame (E951) per sachet, which is a source of phenylalanine.
It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot eliminate it properly.
POSMOX 875 mg + 125 mg film-coated tablets contain 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 exactly as directed by your doctor or pharmacist.
If you have any 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 daily.
• The maximum dose is 1 tablet three times daily.

POSMOX 875 mg/125 mg powder for oral suspension

• The recommended dose is 1 sachet twice daily.
• The highest dose is 1 sach 125 mg three times daily.

Use in children weighing less than 40 kg
Children aged 6 years or younger should preferably be treated with amoxicillin and clavulanic acid oral suspension or pediatric sachets.
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.
POSMOX 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 POSMOX
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Tablets:

• Swallow the tablet whole with a glass of water at the beginning of a meal or immediately before.
• Space your doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
• Do not take POSMOX for longer than 2 weeks. If you continue to feel unwell, you should see your doctor.

Sachets:

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

If you take more POSMOX than you should
If you take too much POSMOX, symptoms may include stomach disturbances (nausea, vomiting, or diarrhoea) or seizures. Contact your doctor as soon as possible. Bring the medicine packaging or container to show your doctor.
If you forget to take POSMOX
If you forget to take a dose, take it as soon as you remember, but only if at least four hours have passed since the last dose.
Do not take a double dose to make up for a forgotten dose.
If you stop treatment with POSMOX
Continue taking POSMOX for the full duration of treatment, even if you 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 questions about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

Conditions to 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 glands in the neck, armpits or groin,
• swelling, sometimes of the face or throat (angioedema), causing difficulty in breathing,
• collapse (severe drop in blood pressure), 4/8
• chest pain occurring as part of an allergic reaction, which may be a symptom of an allergy-triggered heart attack (Kounis syndrome).

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

Intestinal inflammation
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 specific type of allergic reaction, the main symptom of which is 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.

Tell your doctor if any of the following side effects occur:

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 affected, take POSMOX with meals,
• vomiting,
• diarrhoea (in children).

Uncommon side effects (may affect up to 1 in 100 people)

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

Uncommon side effects may be detected through blood tests:

• increase in 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 look like 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 be detected through blood tests:

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

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

• allergic reactions (see above),
• intestinal inflammation (see above),
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).
• severe skin reactions:
  • widespread rash with blisters and peeling, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing extensive skin peeling (more than 30% of body surface area, toxic epidermal necrolysis),
  • widespread red rash with small blisters containing pus (exfoliative bullous dermatitis),
  • red rash with crusts, swellings under the skin and blisters (pustular exanthema),
  • 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 (DRESS)),
  • a red rash commonly seen on both sides of the buttocks, upper inner thighs, armpits, and neck (Symmetrical Drug-Related Intertriginous Flexural Exanthema (SDRIFE)).

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

• skin rash with blistering arranged in a ring with a central crust or resembling a string of pearls (linear IgA disease),
• liver inflammation (hepatitis),
• jaundice, caused by increased levels of bilirubin (a substance produced in the liver) in the blood, 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 POSMOX or who have kidney problems),
• black hairy tongue, appearing as if covered with hair,
• tooth staining (in children), usually removable by brushing.

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

• severe reduction in white blood cells (leucopenia),
• low number of red blood cells (haemolytic anaemia),
• crystals in the urine leading to acute kidney damage.

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 .
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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 stated on the carton 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 above 25°C.
Do not dispose of any medicine via wastewater 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 substances are: each tablet contains amoxicillin trihydrate equivalent to 875 mg amoxicillin and potassium clavulanate equivalent to 125 mg clavulanic acid.
• Other components are: anhydrous colloidal silica, magnesium stearate, sodium starch glycolate, microcrystalline cellulose, hypromellose, talc, titanium dioxide, diethyl phthalate, dimethicone.

POSMOX 875 mg + 125 mg powder for oral suspension

• The active substances are: each sachet contains amoxicillin trihydrate equivalent to 875 mg amoxicillin and potassium clavulanate equivalent to 125 mg clavulanic acid.
• Other components are: hydrated colloidal silica, orange flavour, aspartame.

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

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pharmacare Srl
Via Marghera, 29
20149 Milan
Italy

Manufacturer
Elpen SA
95 Marathonos Avenue
19009 Pikermi Attika
Greece
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For “Powder for Oral Suspension” only, also:
LA.FA.RE. S.r.l.
Via S. Benedetto Cozzolino, 77
80056 Ercolano (NA)
Italy

Behavioural hygiene
Antibiotics are used to treat bacterial infections and are not effective against viral infections.
Sometimes, bacterial infections do not respond to antibiotic treatment. 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. By using antibiotics appropriately, you can help reduce the development of bacterial resistance.
When your doctor prescribes an antibiotic treatment, it is intended solely for the illness you currently have. Please pay attention to the following advice to help prevent the emergence 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 this 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.
4. Do not give your prescribed antibiotics to other people.
5. If you have any unused antibiotic remaining after completing your treatment, return it to your pharmacist for proper disposal.

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