Amoxicillin/clavulanic acid Sandoz 875 mg/125 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amoxicillin/Clavulanic acid Sandoz 875 mg/125 mg film-coated tablets EFG

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Amoxicillin/Clavulanic Acid Sandoz is and what it is used for

Amoxicillin/Clavulanic Acid is an antibiotic that kills bacteria causing infections. It contains two different medicines called amoxicillin and clavulanic acid.

Amoxicillin belongs to a group of medicines known as "penicillins" which can sometimes lose their effectiveness (become inactivated). The other component (clavulanic acid) prevents this from happening.

Amoxicillin/clavulanic acid is used in children and adults 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 Amoxicillin/Clavulanic Acid Sandoz

Do not take Amoxicillin/Clavulanic Acid Sandoz

• 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 ever had a severe allergic reaction (hypersensitivity) to any other antibiotic. This could include skin rash or swelling of the face or throat,
• if you have ever had liver problems or jaundice (yellowing of the skin) while taking an antibiotic.

?Do not take Amoxicillin/Clavulanic Acid Sandoz if any of the above apply to you. Before starting treatment with amoxicillin/clavulanic acid, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine if:

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

If you are unsure whether any of the above conditions apply to you, inform your doctor or pharmacist before taking amoxicillin/clavulanic acid.

In some cases, your doctor may investigate the type of bacteria causing your infection. Depending on the results, you may be prescribed a different formulation of amoxicillin/clavulanic acid or another medicine.

Symptoms to watch for

Amoxicillin/Clavulanic Acid may worsen certain existing conditions or cause serious adverse effects. These include allergic reactions, seizures, and inflammation of the large intestine. You should be aware of certain symptoms while taking amoxicillin/clavulanic acid to reduce the risk of complications. See “Symptoms to watch for” in section 4.

Blood and urine tests

If you are undergoing blood tests (such as studies of red blood cell status or liver function tests) or urine tests (to monitor glucose levels), inform your doctor or nurse that you are taking amoxicillin/clavulanic acid. This is because amoxicillin/clavulanic acid may alter the results of these types of tests.

Use of Amoxicillin/Clavulanic Acid Sandoz with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

If you are taking allopurinol (used for gout) with amoxicillin/clavulanic acid, you may be more likely to experience a skin allergic reaction.

Probenecid (used to treat gout): concomitant use with probenecid may reduce the excretion of amoxicillin and is not recommended.

If anticoagulants (such as warfarin) are taken with amoxicillin/clavulanic acid, more blood tests will be needed.

Methotrexate (a medicine used to treat cancer and severe psoriasis): penicillins may reduce methotrexate excretion and potentially increase adverse effects.

Amoxicillin/clavulanic acid may affect how mycophenolate mofetil (a medicine used to prevent organ rejection in transplant patients) works.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Amoxicillin/Clavulanic Acid may cause adverse effects, and the symptoms may mean you should not drive.

Do not drive or operate machinery unless you feel well.

Amoxicillin/Clavulanic Acid Sandoz contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; essentially "sodium-free".

3. How to take Amoxicillin/Clavulanic Acid Sandoz

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Adults and children weighing 40 kg or more

• Usual dose – 1 tablet taken twice a day.
• Higher dose – 1 tablet taken three times a day.

Children weighing less than 40 kg

It is preferable to treat children aged 6 years or younger with Amoxicillin/Clavulanic Acid Sandoz oral suspension or sachets.

Ask your doctor or pharmacist for advice when administering amoxicillin/clavulanic acid to children weighing less than 40 kg.

Patients with kidney or liver problems

• If you have kidney problems, your dose may be adjusted. Your doctor may choose a different formulation or another medicine.
• If you have liver problems, you will have blood tests more frequently to monitor how well your liver is working.

How to take Amoxicillin/Clavulanic Acid Sandoz

• Swallow the tablets whole with a glass of water at the start of meals or shortly before.
• Space your doses evenly throughout the day, at least 4 hours apart. Do not take two doses within one hour.
• Do not take Amoxicillin/Clavulanic Acid for longer than 2 weeks. If you still feel unwell, consult your doctor.

If you take more Amoxicillin/Clavulanic Acid Sandoz than you should

If you take too much amoxicillin/clavulanic acid, symptoms such as stomach upset (nausea, vomiting, or diarrhoea) or seizures may occur. Contact your doctor as soon as possible.

Take the packaging with you to show your doctor.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Amoxicillin/Clavulanic Acid Sandoz

If you forget to take a dose, take it as soon as you remember. Do not take the next dose too soon; wait at least 4 hours before taking the next dose.

If you stop taking Amoxicillin/Clavulanic Acid Sandoz

Continue taking Amoxicillin/Clavulanic Acid for the full duration of treatment, even if you feel better. You need to complete the full course to cure the infection. If you do not, surviving bacteria may cause the infection to return.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Symptoms to watch for

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, swollen glands in the neck, armpits, or groin,
• swelling, sometimes of the face or throat (angioedema), causing difficulty breathing,
• collapse.

?Contact your doctor immediately if you experience any of these symptoms.

Stop taking Amoxicillin/Clavulanic Acid Sandoz.

Inflammation of the large intestine

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

?Contact your doctor as soon as possible for advice if you have these symptoms.

Very common adverse effects (may affect more than 1 in 10 people):

• diarrhoea (in adults).

Common adverse effects (may affect up to 1 in 10 people):

• thrush (candida – fungal infection of the vagina, mouth, or mucous membranes),
• nausea, especially when high doses are taken,

?if this happens, take Amoxicillin/Clavulanic Acid Sandoz with food,

• vomiting,
• diarrhoea (in children).

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

• skin rash, itching,
• increased itchy rash (urticarial wheals),
• indigestion,
• dizziness,
• headache.

Uncommon adverse effects that may appear in your blood tests:

• increase in certain substances (enzymes) produced by the liver.

Rare adverse effects

(may affect up to 1 in 1,000 people):

skin rash, which may form blisters resembling small targets (dark center surrounded by a paler area, with a dark ring around the edge – erythema multiforme).

?If you have any of these symptoms, consult a doctor urgently.

Rare adverse effects that may appear in your blood tests:

• low count of cells involved in blood clotting,
• low white blood cell count.

Adverse effects of unknown frequency (cannot be estimated from available data)

Other adverse effects that have occurred in a very small number of patients and whose exact frequency is unknown:

• • allergic reactions (see above),
  • inflammation of the large intestine (see above),
  • inflammation of the protective membrane surrounding the brain (aseptic meningitis),
• chest pain occurring in the context of allergic reactions, which may be a symptom of an allergic-triggered heart attack (Kounis syndrome),
• drug-induced enterocolitis syndrome (DIES): DIES has been reported mainly in children receiving amoxicillin. It is a type of allergic reaction with the main symptom being repeated vomiting (1–4 hours after taking the medicine). Other symptoms may include abdominal pain, lethargy, diarrhoea, and low blood pressure,
• crystals in the urine causing acute kidney injury,
• blistering rash arranged in circles with central crusts or resembling a string of beads (linear IgA disease),
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis),
• 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,
• severe skin reactions:
• widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and in its most severe form, causing widespread skin peeling (more than 30% of body surface – toxic epidermal necrolysis),
• widespread rash with small pus-filled blisters (exfoliative bullous dermatitis),
• red rash with bumps under the skin and blisters (exanthematous pustulosis),
• flu-like symptoms with skin rash, fever, swollen glands, and abnormal blood test results (such as increased white blood cells (eosinophilia) and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)),

?Contact a doctor immediately if you have any of these symptoms.

• inflammation of the liver (hepatitis),
• jaundice, caused by increased bilirubin in the blood (a substance produced by the liver), which may cause the skin and whites of the eyes to turn yellow,
• inflammation of the kidney tubules,
• delayed blood clotting,
• hyperactivity,
• seizures (in patients taking high doses of amoxicillin/clavulanic acid or who have kidney problems),
• black, hairy-looking tongue,
• stained teeth (in children), which usually disappear with brushing.

Adverse effects that may appear in your blood or urine tests:

• significant reduction in the number of white blood cells,
• low red blood cell count (haemolytic anaemia).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Amoxicillin/Clavulanic Acid Sandoz

Do not store above 25°C.

Keep in the original packaging to protect from light and moisture.

Keep this medicine out of the sight and reach of children.

Do not use Amoxicillin/Clavulanic Acid after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not use this medicine if you notice any change in colour. If the tablet is divided, it should be taken immediately, as exposure to the environment under these conditions may cause colour changes.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amoxicillin/Clavulanic Acid Sandoz

• The active substances are amoxicillin and clavulanic acid. Each tablet contains 875 mg of amoxicillin (as trihydrate) and 125 mg of clavulanic acid (as potassium clavulanate).
• The other components (excipients) are:
  Tablet core: anhydrous colloidal silica, magnesium stearate, talc, povidone (K 25), sodium croscarmellose, microcrystalline cellulose.
  Coating: triethyl citrate, ethylcellulose, hypromellose, talc, titanium dioxide, purified water.

Appearance of the medicinal product and contents of the pack

Film-coated tablet, white or pale yellow, oblong, scored on both sides.

Packaged in packs containing 20, 30 and 500 film-coated tablets in Al/PVC/Al blisters and Al/PE/Al aluminum strips.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
Sandoz Farmacéutica, S.A.
Parque Norte Business Park
Roble Building
C/ Serrano Galvache, 56
28033 Madrid
Spain

Manufacturer:
Sandoz GmbH
Biochemiestrasse, 10
A-6250 (Kundl)
Austria

Date of most recent review of this package leaflet: February 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/