Saromox

Patient Information Leaflet

Saromox 875 mg/125 mg film-coated tablets

Equivalent 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 (or your child) only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Saromox is and what it is used for

Saromox is an antibiotic that works by killing bacteria that cause infections. It contains two different active substances 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 component (clavulanic acid) prevents this from happening.
Saromox 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. What you need to know before taking Saromox

DO NOT TAKE Saromox:

• if you are allergic to amoxicillin, clavulanic acid, penicillin, or to any of the other ingredients of this medicine (listed in section 6)
• if you have ever had a severe allergic reaction (hypersensitivity) to any other antibiotic. This may include a skin rash or swelling of the face or throat

► DO NOT TAKE Saromox if any of these situations apply to you. If you are in doubt, speak with your doctor or pharmacist before taking Saromox.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine:

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

If you are unsure whether any of the above conditions apply to you, discuss this with your doctor or pharmacist before taking Saromox.
In some cases, your doctor may perform tests to identify the type of bacteria causing your infection. Based on the results, they may prescribe a different dose of Saromox or a different medicine.
Conditions you should be aware of
Saromox may worsen certain pre-existing conditions or cause serious side effects. These may include allergic reactions, seizures, and inflammation of the large intestine.
You should pay attention to certain symptoms while taking Saromox, in order to reduce any risk of complications. See section 4 “Conditions you should be aware of”.
Blood and urine tests
If you are scheduled for blood tests (for example, tests related to red blood cells or liver function) or urine tests (for glucose), inform your doctor or nurse that you are taking Saromox. This is because Saromox may affect the results of these tests.
Other medicines and Saromox
Inform 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 Saromox, you are very likely to develop a skin allergic reaction.
Probenecid (used for gout): concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.
If you are taking medicines (such as warfarin) that help prevent blood clots together with Saromox, additional blood tests may be required.
Methotrexate (used to treat tumours, rheumatic diseases, and severe psoriasis): penicillins may reduce the excretion of methotrexate, potentially increasing the risk of side effects.
Saromox may affect how mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs) works.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Saromox may cause side effects, and the symptoms may make you unfit to drive or operate machinery. Do not drive or use machines unless you feel well.
Saromox contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is essentially “sodium-free”.

3. How to take Saromox

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
Adults and children weighing 40 kg or more

• Recommended dose: 1 tablet twice daily.
• Higher dose: 1 tablet three times daily.

Children weighing less than 40 kg
Children aged 6 years or younger should preferably be treated with oral amoxicillin/clavulanic acid suspension or sachets.
Consult your doctor or pharmacist for advice before administering this medicine to children weighing less than 40 kg. The tablets are not suitable for children weighing less than 25 kg.
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 Saromox

• Swallow the tablet whole with a glass of water, taken with a meal.
• Space your doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
• Do not take Saromox for longer than 2 weeks. If you continue to feel unwell, you must return to your doctor.
• The tablet may be divided into two equal doses.

If you take more Saromox than you should
If you take too much Saromox, symptoms may include stomach disturbances (nausea, vomiting, or diarrhoea) or seizures. Contact your doctor as soon as possible. Take the medicine pack with you to show the doctor.
If you forget to take Saromox
If you forget to take a dose, take it as soon as you remember. Do not take the next dose too early, but wait approximately 4 hours before taking the next dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Saromox
Continue taking Saromox 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 doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Conditions you should be aware of
Allergic reactions:

• skin rash
• 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 lymph nodes in the neck, armpits, or groin
• swelling, sometimes of the face or throat (angioedema), causing difficulty in breathing
• collapse
• chest pain in the context of allergic reactions, which may be a symptom of allergy-induced heart attack (Kounis syndrome)

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

Inflammation of the large intestine
Inflammation of the large intestine, 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 may 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)

• candidiasis (candida – a fungal infection of the vagina, mouth, or skin folds)
• nausea, especially when taking high doses → if affected, take Saromox with food
• 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 that may 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 present as blisters and resemble small targets (dark central spots 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 that may be detected through blood tests:

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

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

• Allergic reactions (see above)
• Inflammation of the large intestine (see above)
• Crystals in the urine leading to acute kidney injury
• Skin rash with blisters arranged in a ring-shaped pattern with a central crust or resembling a string of pearls (linear IgA disease)
• Inflammation of the protective membranes surrounding the brain and spinal cord (aseptic meningitis)
• Severe skin reactions: either a widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), or a more severe form causing extensive skin detachment (more than 30% of body surface – toxic epidermal necrolysis), or a widespread red rash with small pus-filled blisters (exfoliative bullous dermatitis), or a red rash with crusts, swellings under the skin, and blisters (pustular exanthema), or flu-like symptoms with a 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)), or a red rash commonly seen on both sides of the buttocks, upper inner thighs, armpits, and neck (Symmetrical Drug-Related Intertriginous Flexural Erythema (SDRIFE))

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

• inflammation of the liver (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 Saromox or who have kidney problems)
• black, hairy-looking tongue

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

• severe reduction in white blood cell count
• low red blood cell count (haemolytic anaemia)

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 Saromox

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the carton after "Exp". The expiry date refers to the last day of that month.
Do not store above 30°C. Keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Saromox contains
The active substances are amoxicillin trihydrate and clavulanic acid.
Each film-coated tablet contains amoxicillin trihydrate equivalent to 875 mg of amoxicillin
and potassium clavulanate equivalent to 125 mg of clavulanic acid.
The other components are:
Tablet core
Anhydrous colloidal silica, magnesium stearate, talc, povidone K25, microcrystalline cellulose,
crospovidone
Tablet coating
Triethyl citrate, hypromellose, talc, titanium dioxide, ethylcellulose, cetyl alcohol, sodium lauryl sulfate

Description of the appearance of Saromox and contents of the pack
Saromox are film-coated oval tablets, white to cream-colored, with a break line on both sides (10.5 mm x 22.5 mm).
Saromox is packaged in aluminum blisters (Alu/Alu blisters) composed of an aluminum foil with a PVC coating on the inner side and an aluminum sealing foil, optionally printed (aluminum 25 µm, hard foil with a thermoplastic PVC-based lacquer on the inner side), or in aluminum sealed strips (Alu/Alu strips) composed of a soft 30 μm aluminum foil with a PE coating, printed, and a soft 30 μm aluminum foil with PE backing, unprinted.
Pack sizes: 10, 12, 14 film-coated tablets.

Marketing Authorization Holder
Hexal A/S, Edvard Thomsens Vej 14, DK-2300 København S, Denmark
Legal representative in Italy: Sandoz S.p.A., Viale Luigi Sturzo 43, 20154 Milano - Italy

Manufacturers
Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria
Lek Pharmaceuticals d.d., Verovškova ulica 57, 1526 Ljubljana, Slovenia

This medicinal product is authorized in the European Economic Area Member States under the following names:
Austria Clavamox 875 mg/125 mg – Film tablets
Italy Saromox

Advice/Medical education
Antibiotics are used to treat bacterial infections. They are not effective against 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 bacteria survive and multiply despite the antibiotic.
Bacteria become resistant to antibiotics for various reasons. By using antibiotics appropriately, you can reduce the emergence of bacterial resistance.
When your doctor prescribes you an antibiotic treatment, it is intended solely for the illness you currently have. Please pay attention to the following advice 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 correct number of days. Read the instructions in the package leaflet 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 that have been prescribed for other people, even if you have an infection similar to theirs.
4. Do not give to others antibiotics that have been specifically prescribed for you.
5. If you have leftover antibiotics after completing your treatment, return them to your pharmacist so they can be disposed of appropriately.