Medoclav 875 mg/125 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Medoclav 875 mg/125 mg film-coated tablets EFG

amoxicillin/clavulanic acid

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Medoclav is and what it is used for

Medoclav is an antibiotic that kills bacteria causing infections. It contains two different drugs 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.

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

It is important to follow your doctor's instructions regarding dosage, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

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 starting to take Medoclav

Do not take Medoclav:

• if you are allergic to amoxicillin, clavulanic acid, penicillins, or any of the other components 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 Medoclav if any of the above apply to you. Before starting treatment with Medoclav, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Medoclav 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 Medoclav.

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

Symptoms to watch for

Medoclav 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 Medoclav to reduce the risk of complications. See "Symptoms to watch for" in section 4.

Blood and urine tests

If you are having 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 Medoclav. This is because Medoclav can alter the results of these types of tests.

Use of Medoclav 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 Medoclav, you may be more likely to experience a skin allergic reaction.

• If you are taking probenecid (used for gout), your doctor may adjust your dose of Medoclav.

• If anticoagulants (such as warfarin) are taken with Medoclav, more blood tests will be required.

• Medoclav may affect the action of methotrexate (a medicine used to treat cancer or rheumatic diseases).

• Medoclav may affect how mycophenolate mofetil works (a medicine used to prevent organ rejection in transplant patients).

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 medicine.

Driving and use of machines

Medoclav may cause adverse effects, and symptoms may mean you should not drive.

Do not drive or operate machinery unless you feel well.

Medoclav contains soya lecithin. It should not be used if you are allergic to peanuts or soya.

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

3. How to take Medoclav

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

Adults and children weighing 40 kg or more

The recommended dose is:

• Standard dose – 1 tablet taken twice daily.
• Higher dose – 1 tablet taken three times daily.

Children weighing less than 40 kg

It is preferable to treat children aged 6 years or younger with Medoclav oral suspension or sachets.

Seek advice from your doctor or pharmacist when administering amoxicillin/clavulanic acid to children weighing less than 40 kg. 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 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 liver function.

How to take Medoclav

• Swallow the tablets whole with a glass of water at the beginning of meals or shortly before. The tablets may be broken along the score line to make them easier to swallow. Both halves of the tablet should be taken at the same time.
• Space your doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within one hour.
• Do not take Medoclav for longer 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, symptoms such as stomach upset (nausea, vomiting or diarrhea) 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: 91 562 04 20, stating the medicine and the amount ingested. It is recommended to bring the medicine packaging and 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 forgotten doses.

If you stop taking Medoclav

Continue taking Medoclav 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 medicine, 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 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.
• Chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by allergy (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, 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 could be a sign of acute pancreatitis.

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.

→ 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 in the vagina, mouth, or mucous membranes).
• Nausea, especially when high doses are taken.

→ if this occurs, take Medoclav with food.

• Vomiting.
• Diarrhoea (in children).

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

• Skin rash, itching.
• Worsening of 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 that may form blisters resembling small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme).

→ If you experience 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.

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

• Allergic reactions (see above).

• Inflammation of the large intestine (see above).

• Inflammation of the protective membrane surrounding the brain (aseptic meningitis).

• 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 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 experience 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.

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

• Marked reduction in the number of white blood cells.
• Low red blood cell count (haemolytic anaemia).
• Crystals in the urine causing acute kidney injury.
• 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 membranes surrounding the brain and spinal cord (aseptic meningitis).

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 Medicines: http://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Medoclav

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after
EXP. The expiry date refers to the last day of the month indicated.

Store below 25°C in the original packaging to protect from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to the Punto Sigre collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Medoclav

• The active substances 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), colloidal anhydrous silica, magnesium stearate.

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

Appearance of the product and contents of the pack

Oblong, capsule-shaped tablets, white to off-white, with core dimensions 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 certain 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

Further information about this medicinal product can be requested from the local representative of the Marketing Authorization Holder:

Medochemie Iberia S.A., Spanish Branch

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

28044 Madrid

SPAIN

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review 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 this occurs 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 appropriately can reduce the likelihood of bacteria becoming resistant to them.

When your doctor prescribes an antibiotic, it is intended solely for the course of your current illness. Paying attention to the following advice will help you prevent the development of resistant bacteria, which could make the antibiotic ineffective.

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

If you have any antibiotic left after completing your treatment, return all unused medication to your pharmacy to ensure proper disposal requirements are met.