AMOXICILLIN/CLAVULANIC ACID COMBIX 875 mg/125 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Amoxicillin/Clavulanic Acid Combix 875 mg/125 mg Film-Coated Tablets EFG

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Amoxicillin/Clavulanic Acid Combix is an antibiotic that eliminates the bacteria that cause infections. It contains two different drugs called amoxicillin and clavulanic acid. Amoxicillin belongs to the group of medicines known as "penicillins" which can sometimes lose their effectiveness (become inactivated). The other component (clavulanic acid) prevents this from happening.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or the common cold.

It is important that you follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or into the trash.

Amoxicillin/Clavulanic Acid Combix 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 you take Amoxicillin/Clavulanic Acid Combix

Do not take Amoxicillin/Clavulanic Acid Combix

• if you are allergic to amoxicillin, clavulanic acid, to penicillins 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 could include a skin rash or swelling of the face or throat
• if you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

Do not take Amoxicillin/Clavulanic Acid Combix if you are included in any of the above points. Before starting treatment with Amoxicillin/Clavulanic Acid Combix, if you are not sure, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Amoxicillin/Clavulanic Acid Combix if:

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

If you are not sure if any of the above symptoms affect you, inform your doctor or pharmacist before taking Amoxicillin/Clavulanic Acid Combix.

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 Combix or another medicine.

Symptoms to be aware of

Amoxicillin/Clavulanic Acid Combix can worsen certain existing conditions or cause serious side effects. These include allergic reactions, convulsions, and inflammation of the large intestine. You should be aware of certain symptoms while taking Amoxicillin/Clavulanic Acid Combix to reduce the risk of problems. See "Symptoms to be aware of" in section 4.

Blood and urine tests

If you are having blood tests (such as red blood cell status or liver function studies) or urine tests (to check glucose levels), inform your doctor or nurse that you are taking Amoxicillin/Clavulanic Acid Combix. This is because Amoxicillin/Clavulanic Acid Combix can alter the results of these types of tests.

Other medicines and Amoxicillin/Clavulanic Acid Combix

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 Amoxicillin/Clavulanic Acid Combix, you may be more likely to suffer an allergic skin reaction.

If you are taking probenecid (used to treat gout), your doctor may adjust the dose of Amoxicillin/Clavulanic Acid Combix. Concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.

If you are taking methotrexate (a medicine used to treat cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate and cause a potential increase in side effects.

If you are taking anticoagulants (such as warfarin) with Amoxicillin/Clavulanic Acid Combix, more blood tests will be needed.

Amoxicillin/Clavulanic Acid Combix 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Amoxicillin/Clavulanic Acid Combix may have side effects, and the symptoms may make you unfit to drive. Do not drive or operate machinery unless you are feeling well.

3. How to take Amoxicillin/Clavulanic Acid Combix

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Adults and children over 40 kg

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

Children under 40 kg

It is preferable to treat children under 6 years with the oral suspension of Amoxicillin/Clavulanic Acid or sachets.

Patients with kidney and liver problems

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

How to take Amoxicillin/Clavulanic Acid Combix

• Take with meals
• Swallow the tablets whole with a glass of water. The tablets can be broken along the score line to make them easier to swallow. You should take both halves of the tablet at the same time.
• Space out the doses during the day, at least 4 hours apart. Do not take 2 doses in 1 hour.
• Do not take Amoxicillin/Clavulanic Acid Combix for more than 2 weeks. If you are still feeling unwell, consult your doctor.

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

If you take too much Amoxicillin/Clavulanic Acid Combix, you may experience symptoms such as stomach upset (nausea, vomiting, or diarrhea) or convulsions. Consult your doctor as soon as possible. Take the pack with you to show the doctor.

You can also contact the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Amoxicillin/Clavulanic Acid Combix

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. Do not take a double dose to make up for forgotten doses.

If you stop taking Amoxicillin/Clavulanic Acid Combix

Continue taking Amoxicillin/Clavulanic Acid Combix until you finish the treatment, even if you feel better. You need to take the full treatment to cure the infection. If you do not, the bacteria that survive may cause you to become infected again.

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

4. Possible side effects

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

Symptoms to be aware of

Allergic reactions:

• skin rash
• inflammation of blood vessels (vasculitis) which can appear as red or purple spots on the skin, but can 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), which can cause difficulty breathing
• collapse.

→Contact your doctor immediately if you experience any of these symptoms. Stop taking Amoxicillin/Clavulanic Acid Combix.

Inflammation of the large intestine

Inflammation of the large intestine, which causes watery diarrhea, usually with blood and mucus, stomach pain, and/or fever.

→ Contact your doctor as soon as possiblefor advice if you have these symptoms.

Acute inflammation of the pancreas (acute pancreatitis)

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

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 – fungal infection of the vagina, mouth, or mucous membranes) nausea, especially when taking high doses

→ if this happens, take Amoxicillin/Clavulanic Acid Combix with meals

• vomiting
• diarrhea (in children).

Uncommon side effects

May affect up to 1 in 100 people

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

Uncommon side effects that may appear in your blood tests:

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

Rare side effects

May affect up to 1 in 1,000 people

• skin rash, which can form blisters that look like small targets (central dark spot 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 side effects that may appear in your blood tests:

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

Frequency not known

Frequency cannot be estimated from the available data.

• allergic reactions (see above)
• serious 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 peeling of the skin (more than 30% of the body surface – toxic epidermal necrolysis)
  • widespread rash with small blisters containing pus (bullous exfoliative dermatitis)
  • red rash with bumps under the skin and blisters (pustular psoriasis)
  • rash with blisters arranged in a circle with a central crust or like a string of pearls (linear IgA disease).
  • flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test results (such as elevated white blood cell count (eosinophilia) and liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)).
• chest pain in the context of allergic reactions, which can be a symptom of an allergic myocardial infarction (Kounis syndrome).
• drug-induced enterocolitis syndrome (DIES): DIES has been reported mainly in children receiving amoxicillin. It is a certain type of allergic reaction with the main symptom of repeated vomiting (1-4 hours after taking the medicine). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

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

• inflammation of the liver (hepatitis)
• jaundice, caused by an increase in bilirubin in the blood (a substance produced by the liver) that can make the skin and the whites of the eyes turn yellow
• inflammation of the kidney ducts
• delayed blood clotting
• hyperactivity
• convulsions (in patients taking high doses of Amoxicillin/Clavulanic Acid Combix or with kidney problems)
• black hairy tongue

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

• significant reduction in the number of white blood cells
• low red blood cell count (hemolytic anemia)
• crystals in the urine that cause acute kidney injury.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: http://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Amoxicillin/Clavulanic Acid Combix

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 carton. The expiry date refers to the last day of the month shown.

Do not store above 25°C.

Store in the original package to protect from moisture.

Do not use if the tablets are broken or damaged.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Composition of Amoxicillin/Clavulanic Acid Combix

• The active ingredients are amoxicillin and clavulanic acid. Each tablet contains 1004.40 mg of amoxicillin trihydrate, which corresponds to 875 mg of amoxicillin, and 297.81 mg of potassium clavulanate, which corresponds to 125 mg of clavulanic acid.
• The other components are: core: microcrystalline cellulose (E460), crospovidone (E1201), sodium croscarmellose (E468), anhydrous colloidal silica (E551), magnesium stearate (E470b); coating: butylated basic methacrylate copolymer, titanium dioxide (E171), talc (E553b), macrogol 6000.

Appearance of the Product and Container Content

Amoxicillin/Clavulanic Acid Combix is a white or almost white, oblong, and scored film-coated tablet.

The score line is only for fracturing and facilitating swallowing, but not for dividing into equal doses.

The tablets are available in blisters packaged in boxes of 20 or 30 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Combix Laboratories, S.L.U.

C/ Badajoz 2, Building 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

PenCef Pharma GmbH

Breitenbachstrasse 13

13509 Berlin

Germany

Date of the Last Revision of this Prospectus: April 2023

Medical Advice/Education

Antibiotics are used for the treatment of bacterial infections. They are not effective against viral infections.

Sometimes a bacterial infection does not respond to antibiotic treatment. One of the most common reasons for this is that the bacteria causing the infection are resistant to the antibiotic being taken. This means that the bacteria can survive or grow despite the antibiotic.

Bacteria can become resistant to antibiotics for many reasons. Using antibiotics properly can reduce the chances of bacteria becoming resistant to them.

When your doctor prescribes an antibiotic, it is only for the course of your illness. Paying attention to the following tips will help you prevent the appearance of resistant bacteria that can make the antibiotic ineffective.

1. You should not take an antibiotic unless it has been specifically prescribed for you, and you should only use it for the infection for which it was prescribed.
2. You should not take antibiotics that have been prescribed for other people, even if they have the same or a similar infection to yours.
3. You should not give antibiotics that have been prescribed for you to other people.
4. If you still have antibiotic left after completing the treatment, return all unused medication to your pharmacy to ensure that disposal requirements are met.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/