Prospecto:information for the user

Medoclav 875 mg/125 mg film-coated tablets EFG

amoxicillin/clavulanic acid

Read this prospectus carefully before starting to take this medication,because it contains important information for you.

1.What is Medoclav and what is it used for

2.What you need to knowbeforestarting totake Medoclav

3.How to take Medoclav

4.Possible adverse effects

5Storage of Medoclav

6.Contents of the package and additional information

Medoclav is an antibiotic that eliminates bacteria that cause infections. It contains two different medications called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medications known as "penicillins" that may sometimes lose their effectiveness (become inactivated). The other component (clavulanic acid) prevents this from happening.

Medoclav is used in children and adults to treat the following infections:

• Middle ear infections and nasal sinus infections
• Respiratory tract infections
• Urinary tract infections
• Skin and soft tissue infections, including dental infections
• Bone and joint infections

Do not take Medoclav:

• if you are allergic to amoxicillin, clavulanic acid, penicillins, or any of the other components of this medication (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) when taking an antibiotic.

Do not take Medoclav if you are included in any of the above points. Before starting treatment with Medoclav, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeMedoclav:

• 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 symptoms affect you, inform your doctor or pharmacist before taking Medoclav.

In some cases, your doctor may investigate the type of bacteria causing your infection. Depending on the results, they may prescribe a different presentation of amoxicillin/clavulanic acid or another medication.

Be aware of the following symptoms

Medoclav may worsen existing conditions or cause serious side effects. These include allergic reactions, seizures, and inflammation of the large intestine.

You should be aware of certain symptoms while taking Medoclav to reduce the risk of problems. See “Be aware of the following symptoms” in section 4.

Blood and urine tests

If you are having blood tests (such as red blood cell studies or liver function studies) or urine tests (to control glucose levels), inform your doctor or nurse that you are taking Medoclav. This is because Medoclav may alter the results of these types of tests.

Use of Medoclav with other medications

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

• If you are taking allopurinol (used for gout) with Medoclav, you may be more likely to have a skin allergic reaction.

• If you are taking probenecid (used for gout), your doctor may adjust the dose of Medoclav.
• If you are taking anticoagulants (such as warfarin) with Medoclav, more blood tests will be needed.
• Medoclav may affect the action of methotrexate (a medication used to treat cancer or rheumatic diseases).
• Medoclav may affect how micophenolate mofetil (a medication 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Medoclav may cause side effects and symptoms that may make you unable to drive.

Do not drive or operate machinery unless you feel well.

Medoclav contains soy lecithin.It should not be used in case of allergy to peanuts or soy.

This medication contains less than 1 mmol of sodium (23 mg) per tablet, that is, it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor.This medicationindicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

Adults and children weighing 40 kg or more

The recommended dose is:

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

Children weighing less than 40 kg

It is preferable to treat children 6 years old or less with oral suspension of Medoclav or the sachets.

Ask your doctor or pharmacist for advice when administering amoxicillin/clavulanic acid to children

who weigh less than 40 kg.The tablets are not suitable for children weighing less than 25 kg.

Patients with kidney and liver problems

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

How to take Medoclav

• Swallow the tablets whole with a glass of water at the beginning of meals or a little before. The tablets can be broken along the notch to make them easier to swallow. You should take both halves of the tablet at the same time.
• Space the doses throughout the day, at least 4 hours apart. Do not take 2 doses in one hour.
• Do not take Medoclav for more than 2 weeks. If you continue to feel unwell, consult your doctor.

If you take more Medoclav than you should

If you take too much Medoclav, you may experience symptoms such as stomach upset (nausea, vomiting, or diarrhea) or convulsions. Consult your doctor as soon as possible. Bring the packaging with you to show the doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to take Medoclav

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 the missed doses.

If you interrupt the treatment with Medoclav

Continue taking Medoclav until you complete the treatment, even if you feel better. You need to take the complete treatment to cure the infection. If you do not, the surviving bacteria may cause you to get the infection again.

If you have any other doubts about the use of thismedication, ask your doctororpharmacist.

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

Symptoms you should be aware of

Allergic reactions:

• Skin rash.
• Swelling of blood vessels (vasculitis) that may appear as red or purple spots on the skin, but can affect other parts of the body.
• Fever, joint pain, swollen lymph nodes in the neck, armpits, or groin.
• Swelling, sometimes of the face or throat (angioedema), which can cause difficulty breathing.
• Collapsing.
• Chest pain in the context of allergic reactions, which can be a symptom of an allergic-induced heart attack (Kounis syndrome).

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

Colitis:

Colitis, which causes watery diarrhea, usually with blood and mucus, stomach pain, and/or fever.

Acute pancreatitis:

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

Drug-induced enterocolitis syndrome (DIES):

DIES has mainly been reported in children taking amoxicillin. It is a certain type of allergic reaction with the main symptom of repeated vomiting (1-4 hours after taking the medication). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

→ Contact your doctor as soon as possible for advice, if you experience these symptoms.

Side effectsvery common(may affect more than 1 in 10 people)

• Diarhea (in adults).

Side effectscommon(may affect up to 1 in 10 people)

• Thrush (Candida infection in the vagina, mouth, or mucous membranes).
• Nausea, especially when taking high doses

→ If this happens, take Medoclav with meals.

• Vomiting.
• Diarhea (in children).

Side effectsuncommon(may affect 1 in 100 people)

• Skin rash, itching.
• Increased pruritic rash (urticarial rash).
• Indigestion.
• Dizziness.
• Headache.

Side effects that may appear in blood tests:

• Increased levels of certain substances (enzymes) produced by the liver.

Side effectsrare(may affect up to 1 in 1,000 people)

• Skin rash, which may form blisters that look like small darts (erythema multiforme).

→ If you experience any of these symptoms, see a doctor urgently.

Side effects that may appear in blood tests:

• Low count of cells involved in blood clotting.
• Low white blood cell count.

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

• Allergic reactions (see above).
• Colitis (see above).
• Asymptomatic meningitis.
• Severe skin reactions:

• Generalized rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and in its most severe form, causing widespread skin peeling (toxic epidermal necrolysis).
• Generalized rash with small blisters with pus (exfoliative bullous dermatitis).
• Red rash, with bumps under the skin and blisters (pustular exanthem).
• Symptoms of a flu-like illness with skin rash, fever, swollen lymph nodes, and abnormal blood test results (such as increased eosinophils and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)).

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

• Liver inflammation (hepatitis).
• Icterus, caused by increased bilirubin in the blood (a substance produced by the liver) that can turn the skin and the white of the eyes yellow.
• Renal tubular inflammation.
• Delayed blood clotting.
• Hypervigilance.
• Seizures (in patients taking high doses of amoxicillin/clavulanic acid or with renal problems).
• Black tongue that looks hairy.

Side effects that may appear in 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 damage.
• Rash with blisters arranged in a circle with a central crust or like a pearl necklace (IgA linear disease).
• Menigitis with inflammation of the membranes surrounding the brain and spinal cord.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:http://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe boxafter

CAD. The expiration date is the last day of the month indicated.

Store at a temperature below 25°C in the original packaging to protect it from light and humidity.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at thePharmacy Take-Back Point. If in doubt, ask your pharmacisthow to disposeofpackaging and medications you no longerneed. This will help protect the environment.

Composition ofMedoclav

• The active principles are amoxicillin and clavulanic acid. Each tablet contains 875 mg of amoxicillin (as amoxicillin trihydrate) and 125 mg of clavulanic acid (as potassium clavulanate).
• The other components are:

Tablet core: microcrystalline cellulose 105, sodium carboxymethyl starch (type A), anhydrous colloidal silica, magnesium stearate.

Coating:poly(vinyl alcohol), titanium dioxide (E 171), talc (E 553b), macrogol 4000, soy lecithin (E 322), purified water.

Appearance of the product and contents of the pack

Caplet-shaped tablets, white to off-white in color, with a core size of 21.5 mm x 10.0 mm.

Aluminum-PVC-aluminum blisters containing 2, 4, 12, 14, 16, 20, 24, or 30 tablets. Also available in hospital packs of 100 and 500 tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Medochemie Iberia, S.A.

Rua José Maria Nicolau, no6, 7oB,

1500 662 Lisboa, Portugal

Manufacturer

Medochemie LTD (Factory B)

48 Iapetou street,

Agios Athanassios Industrial Area,

4101 Agios Athanassios, Limassol

Cyprus

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Medochemie Iberia S.A., Branch in Spain

Avenida de las Águilas, nº 2 B; 5th floor, office 6,

28044 Madrid

SPAIN

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: January 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 likelihood 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 advice will help prevent the emergence of resistant bacteria that may make the antibiotic ineffective.

1. It is very important to take the antibiotic in the correct dose, at the indicated hours, and for the correct number of days. Read the label instructions and if you do not understand something, ask your doctor or pharmacist.
2. You should not take an antibiotic unless you have been prescribed it specifically for you and you should use it only for the infection for which it has been prescribed.
3. You should not take antibiotics that have been prescribed for other people, even if they have the same or a similar infection to yours.
4. You should not give antibiotics that have been prescribed for you to other people.

If you still have antibiotic left over after completing treatment, hand in all unused medicines to your pharmacy to ensure that the disposal requirements are met.