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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Amoxicillin/Clavulanic Acid pensa pharma 875 mg/125 mg

film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again. If you have any questions, consult 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 could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if these are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

Amoxicillin / Clavulanic Acid Pensa Pharma is an antibiotic that kills bacteria causing infections. It contains two different active substances 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 flu or the common cold.

It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

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

Amoxicillin / Clavulanic Acid Pensa Pharma is used in children and adults to treat the following infections:

• Middle ear and paranasal 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 Amoxicillin/Clavulanic Acid Pensa Pharma

Do not take Amoxicillin/Clavulanic Acid Pensa Pharma:

• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, 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) while taking an antibiotic.

• Do not take Amoxicillin / Clavulanic Acid Pensa Pharma if any of the above apply to you. Before starting treatment with Amoxicillin / Clavulanic Acid Pensa Pharma, 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 Pensa Pharma.

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 Pensa Pharma or another medicine.

Symptoms to watch out 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 out 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 Amoxicillin / Clavulanic Acid. This is because amoxicillin / clavulanic acid may alter the results of these types of tests.

Use of Amoxicillin / Clavulanic Acid Pensa Pharma with other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription and herbal medicines.

If you are taking allopurinol (used to treat gout) with Amoxicillin / Clavulanic Acid, you may be more likely to experience a skin allergic reaction.

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

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

If anticoagulants (such as warfarin) are taken with Amoxicillin / Clavulanic Acid Pensa Pharma, more blood tests will be needed.

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.

Talk to your doctor or pharmacist before using any medicine.

Driving and using machines

Amoxicillin / Clavulanic Acid may cause adverse effects, and symptoms may mean you should not drive. Do not drive or operate machinery unless you feel well.

3. How to take Amoxicillin/Clavulanic Acid Pensa Pharma

Follow exactly the instructions for use of this medicine given by your doctor. If you have any doubts, consult your doctor or pharmacist again.

Adults and children weighing 40 kg or more

• Usual 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 amoxicillin/clavulanic acid 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 Amoxicillin / Clavulanic Acid Pensa Pharma

• Swallow the tablets whole with a glass of water at the beginning of meals or shortly before. The score line is intended only for dividing the tablet if you have difficulty swallowing it whole.
• Space your doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
• Do not take Amoxicillin / Clavulanic Acid Pensa Pharma for longer than 2 weeks. If you still feel unwell, consult your doctor.

If you take more Amoxicillin / Clavulanic Acid Pensa Pharma than you should

If you take too much Amoxicillin / Clavulanic Acid Pensa Pharma, symptoms such as stomach upset (nausea, vomiting, or diarrhea) or seizures may occur. Contact your doctor as soon as possible. Bring the packaging with you to show the 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, indicating the medicine and the amount ingested.

If you forget to take Amoxicillin / Clavulanic Acid Pensa Pharma

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 treatment with Amoxicillin / Clavulanic Acid Pensa Pharma

Continue taking Amoxicillin / Clavulanic Acid Pensa Pharma until the end of the treatment, even if you feel better. You need to complete the full course of treatment 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. The adverse effects listed below may occur when taking this medicine.

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.

• Contact your doctor immediately if you experience any of these symptoms. Stop taking Amoxicillin / Clavulanic Acid Pensa Pharma.

Inflammation of the large intestine

Inflammation of the large intestine, causing watery diarrhea, 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.

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

Very common adverse effects

May affect more than 1 in 10 people

• diarrhea (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 taking high doses. If this occurs, take Amoxicillin / Clavulanic Acid Pensa Pharma before meals
• vomiting
• diarrhea (in children).

Uncommon adverse effects

May affect up to 1 in 100 people

• skin rash, itching
• increased itchy rash (urticarial wheal)
• 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 central 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 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 the available data.

• allergic reactions (see above)

• inflammation of the large intestine (see above)

• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)

• severe skin reactions:

  • widespread rash with blisters and peeling 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 red rash with small pus-filled blisters (exfoliative bullous dermatitis)
  • exfoliative 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:

  • liver inflammation (hepatitis)
  • jaundice, caused by increased bilirubin in the blood (a substance produced by the liver), which may cause yellowing of the skin and whites of the eyes
  • inflammation of 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 resolves with brushing.

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

• significant reduction in white blood cell count
• low red blood cell count (hemolytic anemia)
• crystals in urine causing acute kidney injury.
• chest pain in the context of allergic reactions, which may be a symptom of allergy-triggered heart attack (Kounis syndrome).
• blistering rash arranged in a circular pattern with a crusted center or resembling a string of pearls (linear IgA disease).

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 of repeated vomiting (1-4 hours after taking the medicine). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

• If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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 Amoxicillin/Clavulanic Acid Pensa Pharma

Keep this medicine out of sight and reach of children.

Do not store above 25°C. Store in the original packaging to protect from moisture.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amoxicillin / Clavulanic Acid Pensa Pharma

The active substances are amoxicillin and clavulanic acid. Each tablet contains amoxicillin trihydrate equivalent to 875 mg of amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid.

The other components are:

• Tablet core: microcrystalline cellulose (E460), crospovidone type A (E1202), sodium croscarmellose, colloidal anhydrous silica (E551), magnesium stearate (E470b).
• Coating: basic butyl methacrylate copolymer, titanium dioxide (E171), talc (E553b), macrogol 6000.

Appearance of the product and contents of the pack

Amoxicillin / Clavulanic Acid Pensa Pharma 875 mg/125 mg Film-coated Tablets are white to off-white, oblong, biconvex tablets, scored on one side. They are available in packs of 20 and 30 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Towa Pharmaceutical, S.A.
C/ de Sant Martí, 75-97
08107 Martorelles (Barcelona)
Spain

Manufacturer

PenCef Pharma GmbH
Breitenbachstrasse 13-14
13509 Berlin, Germany

Date of the most recent revision of this leaflet: January 2023

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

Medical advice and 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 because the bacteria causing the infection are resistant to the antibiotic being taken. This means that the bacteria can survive or grow despite the presence of the antibiotic.

Bacteria can become resistant to antibiotics for many reasons. Using antibiotics appropriately can reduce the likelihood of bacteria becoming resistant.

When your doctor prescribes an antibiotic, it is intended solely for the treatment of your current illness. Following the advice below will help you prevent the development of resistant bacteria, which could make antibiotics ineffective.

1. It is very important to take the antibiotic at the correct dose, at the prescribed times, and for the full duration of treatment. Read the instructions on the label 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 medicines to your pharmacy to ensure proper disposal according to regulations.