MEDOCLAV 875 mg/125 mg FILM-COATED TABLETS

Introduction

Leaflet: information for the user

Medoclav 875 mg/125 mg film-coated tablets EFG

amoxicillin/clavulanic acid

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Medoclav and what is it used for
2. What you need to know before taking Medoclav
3. How to take Medoclav
4. Possible side effects

5 Conservation of Medoclav

1. Package contents and additional information

1. What is Medoclav and what is it used for

Medoclav is an antibiotic that eliminates the bacteria that cause infections. It contains two different active substances called amoxicillin and clavulanic acid. Amoxicillin belongs to the group of medications 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 essential that you follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor.

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

Medoclav 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 Medoclav

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 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 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 take Medoclav:

• 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, you may be prescribed a different formulation of amoxicillin/clavulanic acid or another medication.

Symptoms to which you should pay attention

Medoclav may worsen certain 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 "Symptoms to which you should pay attention" 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 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 recently taken, or may need to take any other medication.

• If you are taking allopurinol (used for gout) with Medoclav, you may be more likely to experience 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 the way mycophenolate 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 using machines

Medoclav may have side effects, and the symptoms may make you unfit to drive.

Do not drive or operate machinery unless you feel well.

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

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

3. How to take Medoclav

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Adults and children over 40 kg

The recommended dose is:

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

Children under 40 kg

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

Ask your doctor or pharmacist for advice when administering amoxicillin/clavulanic acid to children who weigh less than 40 kg. Tablets are not suitable for children who weigh less than 25 kg.

Patient with kidney and liver problems

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

How to take Medoclav

• Swallow the tablets whole with a glass of water at the start of meals or a little before. 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 Medoclav for more than 2 weeks. If you are still feeling unwell, consult your doctor.

If you take more Medoclav than you should

If you take too much Medoclav, symptoms such as stomach upset (nausea, vomiting, or diarrhea) or seizures may occur. Consult your doctor as soon as possible. Take the package 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 take the package and the leaflet of the medication 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 forgotten doses.

If you stop taking Medoclav

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Symptoms to which you should pay attention

Allergic reactions:

• Skin rash.
• Inflammation of blood vessels (vasculitis) that 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.
• Collapsing.
• Chest pain in the context of allergic reactions, which can be a symptom of allergy-induced heart attack (Kounis syndrome).

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

Inflammation of the large intestine

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

Acute pancreatitis (inflammation of the pancreas)

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

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 medication). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

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

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 Medoclav with meals.

• Vomiting
• Diarrhea (in children).

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

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

Uncommon side effects that may appear in your blood tests:

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

Rare side effects (may affect up to 1 in 1,000 people)

• Skin rash that can form blisters that look like small targets (erythema multiforme).

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

Rare side effects that may appear in your blood or urine 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).
• Inflammation of the large intestine (see above).
• Inflammation of the membrane that surrounds the brain and spinal cord (aseptic meningitis).
• 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 peeling of the skin (more than 30% of the body surface – toxic epidermal necrolysis).
• Widespread rash with small blisters with pus (bullous exfoliative dermatitis).
• Red rash with bumps under the skin and blisters (pustular exanthematous eruption).
• Flu-like symptoms with skin rash, fever, gland inflammation, and abnormal blood test results (such as elevated white blood cell count (eosinophilia) and liver enzyme elevation) (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) that can make the skin and the whites of the eyes turn yellow.
• Inflammation of the kidney ducts.
• Delayed blood clotting.
• Hyperactivity.
• Seizures (in patients taking high doses of amoxicillin/clavulanic acid 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 count of red blood cells (hemolytic anemia).
• Crystals in the urine that cause acute kidney injury.
• Rash with blisters arranged in a circle with a central crust or like a string of pearls (linear IgA disease).
• Inflammation of the membranes that surround the brain and spinal cord (aseptic meningitis).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: http://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Medoclav

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the box after

EXP. 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 moisture.

Medications should not be thrown away down the drain or in the trash. Deposit the packaging and medications you no longer need at the Sigre Collection Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Container Contents and Additional Information

Composition ofMedoclav

• The active ingredients 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 Container Contents

Capsule-shaped, oblong, white to off-white tablets, with core dimensions of 21.5 mm x 10.0 mm.

Aluminum-PVC-aluminum blisters with 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, no 6, 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 medication 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 medication is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet: January 2023.

Medical Advice/Education

Antibiotics are used to treat 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 advice will help you prevent the appearance of resistant bacteria that can make the antibiotic ineffective.

2. 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.
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 after completing the treatment, return all unused medication to your pharmacy to ensure that disposal requirements are met.