AMOXICILLIN/CLAVULANIC ACID PENSA PHARMA 875 mg/125 mg FILM-COATED TABLETS

2. What you need to know before you take Amoxicillin/Clavulanic Acid Pensa Pharma

Do not take Amoxicillin/Clavulanic Acid Pensa Pharma:

• if you are allergic (hypersensitive) 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 Pensa Pharma if you are included in any of the above points. Before starting treatment with Amoxicillin/Clavulanic Acid Pensa Pharma, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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 symptoms affect 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, you may be prescribed a different formulation of Amoxicillin/Clavulanic Acid Pensa Pharma or another medicine.

Symptoms to be aware of

Amoxicillin/Clavulanic Acid can 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 amoxicillin/clavulanic acid 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. This is because amoxicillin/clavulanic acid can alter the results of these types of tests.

Using Amoxicillin/Clavulanic Acid Pensa Pharma with other medicines

Tell your doctor or pharmacist if you are using or have recently used 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 cause a potential increase in adverse effects.

If you are taking anticoagulants (such as warfarin) 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

3. How to take Amoxicillin/Clavulanic Acid Pensa Pharma

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

Adults and children over 40 kg

• 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 6 years or younger with the oral suspension of amoxicillin/clavulanic acid 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.

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 Pensa Pharma

• Swallow the tablets whole with a glass of water at the start of meals or a little before. The score line is only to facilitate breaking the tablet if you find it difficult to swallow it whole.
• 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 Pensa Pharma for more than 2 weeks. If you continue to 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, you may experience symptoms such as stomach upset (nausea, vomiting, or diarrhea) or seizures. Consult your doctor as soon as possible. Bring 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 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 taking Amoxicillin/Clavulanic Acid Pensa Pharma

Continue taking Amoxicillin/Clavulanic Acid Pensa Pharma until you finish 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 have the infection again.

If you have any further questions about 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 described below may occur when taking this medicine.

Symptoms to be aware of

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
• collapse.

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

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.

• Contact your doctor as soon as possiblefor 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 in the vagina, mouth, or mucous membranes)
• nausea, especially when taking high doses. If this happens, take Amoxicillin/Clavulanic Acid before meals
• vomiting
• diarrhea (in children).

Uncommon side effects

May affect up to 1 in 100 people

• skin rash, itching
• increased itchy rash (urticarial rash)
• 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 that 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 anyof these symptoms, consult a doctor urgently

Rare side effects that may appear in your blood or urine tests:

• significant decrease in the number of white blood cells
• low red blood cell count (hemolytic anemia)

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 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)
  • generalized red rash with small blisters containing pus (bullous exfoliative dermatitis)
  • red exfoliative 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 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) 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
  • stained teeth (in children), which usually disappears with brushing.

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

• significant decrease in the number of white blood cells
• low red blood cell count (hemolytic anemia)
• crystals in the urine that cause acute kidney injury.
• chest pain in the context of allergic reactions, which can be a symptom of allergy-induced heart attack (Kounis syndrome).
• rash with blisters arranged in a circle with a central crust or like a string of pearls (linear IgA disease).

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.

• If you think you are experiencing any of the side effects, tell your doctor or pharmacist.

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 Pharmacovigilance System for Human Use Medicines: 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 Pensa Pharma

Keep this medicine out of the 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 packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Composition of Amoxicillin / Clavulanic Acid Pensa Pharma

The active ingredients 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:

• Core of the tablet: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 Container Content

Amoxicillin / Clavulanic Acid Pensa Pharma 875 mg/125 mg Film-Coated Tablets are white to off-white, oblong, and scored tablets. 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 Last Revision of this Leaflet:January 2023

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

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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 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 not work.

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.