Amoxicillin Pensapharma 500 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amoxicilina pensa pharma 500 mg hard capsules EFG

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you (or your child) only, and you should 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Amoxicilina Pensa Pharma is and what it is used for

What is Amoxicilina Pensa Pharma

Amoxicilina Pensa Pharma is an antibiotic. The active substance is amoxicillin. It belongs to a group of medicines called "penicillins".

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

What Amoxicilina Pensa Pharma is used for

Amoxicilina Pensa Pharma is used to treat bacterial infections in different parts of the body. Amoxicilina Pensa Pharma may also be used in combination with other medicines to treat stomach ulcers.

2. What you need to know before taking Amoxicilina Pensa Pharma

Do not take Amoxicilina Pensa Pharma:

• if you are allergic to amoxicillin, penicillin, or any of the other ingredients of this medicine (listed in section 6)
• if you have ever had an allergic reaction to any other antibiotic. This could include skin rash or swelling of the face or throat.

Do not take Amoxicilina Pensa Pharma if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Amoxicilina Pensa Pharma if:

• you have infectious mononucleosis (fever, sore throat, swollen glands, and extreme fatigue)
• you have 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 this medicine.

Blood and urine tests

If you are undergoing:

• urine tests (urine glucose) or blood tests for liver function
• estriol tests (used during pregnancy to check whether the baby is developing normally),

inform your doctor or pharmacist that you are taking Amoxicilina Pensa Pharma. This is because this medicine may alter the results of these types of tests.

Taking Amoxicilina Pensa Pharma with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

• If you are taking allopurinol (used to treat gout) with Amoxicilina Pensa Pharma, you may be more likely to experience a skin allergic reaction.
• If you are taking probenecid (used to treat gout), concomitant use with probenecid may reduce the excretion of amoxicillin and is not recommended.
• If you are taking anticoagulants (such as warfarin) with Amoxicilina Pensa Pharma, more frequent blood tests may be needed.
• If you are taking other antibiotics (such as tetracyclines), Amoxicilina Pensa Pharma may be less effective.
• If you are taking methotrexate (a medicine used to treat cancer and severe psoriasis), penicillins may reduce methotrexate excretion and potentially increase adverse effects.

Pregnancy and breastfeeding

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.

Driving and using machines

Amoxicilina Pensa Pharma may cause adverse effects, and symptoms (such as allergic reactions, dizziness, and seizures) may mean you should not drive.

Do not drive or operate machinery unless you feel well.

Amoxicilina Pensa Pharma contains Allura Red

This medicine may cause allergic reactions as it contains Allura Red. It may provoke asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Amoxicilina Pensa Pharma

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

• Swallow the capsules with water, without opening them.
• Space the doses evenly throughout the day, at least 4 hours apart.

The usual dose is:

Children weighing less than 40 kg

All doses are based on the child's body weight in kilograms.

• Your doctor will tell you how much amoxicillin to give your baby or child.
• The usual dose is 40 mg to 90 mg per kilogram of body weight per day, given in two or three divided doses.
• The recommended maximum dose is 100 mg per kilogram of body weight per day.

Adults, elderly patients, and children weighing 40 kg or more

The usual dose of amoxicillin is 250 mg to 500 mg three times a day or 750 mg to 1 g every 12 hours, depending on the severity and type of infection.

• Severe infections: 750 mg to 1 g three times a day.
• Urinary tract infection: 3 g twice a day for one day.
• Lyme disease (an infection caused by parasites called ticks): isolated erythema migrans (early stage – single circular pink or red rash): 4 g per day; systemic manifestations (late stage – more severe symptoms or when the disease spreads throughout the body): up to 6 g per day.
• Stomach ulcers: a dose of 750 mg or 1 g twice a day for 7 days, together with other antibiotics and medications for treating stomach ulcers.
• To prevent heart infection during surgery: the dose will vary depending on the type of surgery. Other medications may be given at the same time. Your doctor, pharmacist, or nurse can provide further details.
• The recommended maximum dose is 6 g per day.

Kidney problems

If you have kidney problems, the dose may be lower than the usual dose.

If you take more Amoxicilina Pensa Pharma than you should

If you have taken more amoxicillin than you should, symptoms may include stomach upset (nausea, vomiting, or diarrhea) or crystals in the urine, which may appear as cloudy urine or difficulty urinating. Contact your doctor as soon as possible. Bring the medicine with you to show them. You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Amoxicilina 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.
• Do not take a double dose to make up for missed doses.

How long you should take Amoxicilina Pensa Pharma

• Continue taking Amoxicilina Pensa Pharma for as long as your doctor has told you, even if you feel better. You need to take all the doses to overcome the infection. If some bacteria survive, the infection may return.
• After completing the treatment, if you still feel unwell, you should see your doctor again.

Candidiasis (a fungal infection in moist areas of the body that may cause pain, itching, and white discharge) may occur if Amoxicilina Pensa Pharma is taken for a prolonged period. If this happens, consult your doctor.

If you take amoxicillin for a prolonged period, your doctor may perform additional blood tests to check that your kidneys, liver, and blood are functioning normally.

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.

Stop taking Amoxicilina Pensa Pharma and see a doctor immediately if you experience any of the following serious adverse effects – you may need urgent medical treatment:

The following adverse effects are very rare (may affect up to 1 in 10,000 people):

• allergic reactions, signs may include: skin itching or rash, swelling of the face, lips, tongue, body, or difficulty breathing. These may be severe and, in some cases, have led to death
• skin rash or flat, round red spots like pinpricks under the skin surface or skin bruising. This is due to inflammation of blood vessel walls caused by an allergic reaction. It may be associated with joint pain (arthritis) and kidney problems
• a delayed allergic reaction may occur 7 to 12 days after taking amoxicillin; some signs include: rashes, fever, joint pain, and swollen lymph nodes, especially under the arms
• a skin reaction called 'erythema multiforme', in which you may develop: purple or reddish itchy skin lesions, especially on the palms of the hands or soles of the feet, swollen raised areas on the skin, soft tissue lesions on the surface of the mouth, eyes, and genitals. You may also have fever and feel very tired
• other serious skin reactions may include: skin color changes, lumps under the skin, blisters, pus-filled pimples, peeling, redness, pain, itching. These may be associated with fever, headache, and body pain
• flu-like symptoms with skin rash, fever, gland swelling, and abnormal blood test results (such as increased white blood cells (eosinophilia) and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS))
• fever, chills, sore throat or other signs of infection, or easy bruising. These may be signs of a blood cell disorder
• Jarisch-Herxheimer reaction occurring during treatment with amoxicillin for Lyme disease, causing fever, chills, headache, muscle pain, and skin rash
• inflammation of the large intestine (colon) with diarrhea (sometimes bloody), pain, and fever
• severe adverse effects in the liver may occur. These are mainly associated with patients undergoing prolonged treatment, males, and advanced age. You should contact your doctor immediately if you experience:
  • severe diarrhea with bleeding
  • blisters, redness, or bruising on the skin
  • dark urine or pale stools
  • yellowing of the skin and whites of the eyes (jaundice). See also anemia below, which may lead to jaundice.
• chest pain in the context of allergic reactions, which may be a symptom of an allergic-triggered heart attack (Kounis syndrome)
• 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, diarrhea, and low blood pressure
• blistering rash arranged in circles 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)

These may occur during treatment or up to several weeks afterwards.

If any of the above symptoms appear, stop taking the medicine and see your doctor immediately.

Sometimes you may experience less severe skin reactions such as:

• moderate rash with itching (round, pink-red spots), swollen areas resembling blisters on forearms, legs, palms, hands, or feet. This is uncommon (may affect up to 1 in 100 people).

If you have any of these, speak to your doctor, as you will need to stop treatment with Amoxicilina Pensa Pharma.

Other possible adverse effects are:

Frequent (may affect up to 1 in 10 people)

• skin rash
• nausea
• diarrhea

Uncommon (may affect up to 1 in 100 people)

• vomiting

Very rare (may affect up to 1 in 10,000 people)

• candidiasis (fungal infection in the vagina, mouth, or skin folds); treatment is available from your doctor or pharmacist for candidiasis
• kidney problems
• seizures (convulsions), observed in patients treated with high doses or who have kidney problems
• dizziness
• hyperactivity
• crystals in the urine causing acute kidney injury. Make sure to drink plenty of fluids to reduce the likelihood of these symptoms
• the tongue may change color to yellow, brown, or black and may appear hairy
• excessive breakdown of red blood cells causing a type of anemia. Signs include: fatigue, headache, shortness of breath, dizziness, paleness, and yellowing of the skin and whites of the eyes
• low number of white blood cells
• low number of cells involved in blood clotting
• blood may take longer than normal to clot. You may notice this if you have nosebleeds or cuts.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Amoxicillin Pensa Pharma

Keep this medicine out of sight and reach of children.

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

Do not store above 25°C.

Do not use this medicine if you notice any visible signs of deterioration.

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

6. Package contents and other information

Composition of Amoxicilina Pensa Pharma

• The active substance is amoxicillin. Each capsule contains 500 mg of amoxicillin (as amoxicillin trihydrate).
• The other components are: capsule contents: talc, magnesium stearate (E-572). Capsule composition: gelatin, quinoline yellow (E-104), allura red (E-129), titanium dioxide (E-171).

Appearance of the product and contents of the pack

Amoxicilina Pensa Pharma 500 mg are cylindrical, opaque hard gelatin capsules, with a red cap and a white body, rounded ends, and filled with white to off-white granular powder.

It is packaged in PVC/aluminum blisters and PVC/TE/PVDC/aluminum blisters. Available in packs of 20 and 30 capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

S.C. Antibiotice, S.A.

Valea Lupului, 1

707410 Iasi (Romania)

Or

HAUPT Pharma Latina S.r.L.

Strada Statale 156 Monti Lepini Km. 47,600

04100 Borgo S. Michele (Latina), Italy

Date of latest revision of this leaflet: January 2023

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

General advice regarding the use of antibiotics

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 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 treating 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 in the leaflet carefully, and if you do not understand something, ask your doctor or pharmacist.
2. Do not take an antibiotic unless it has been specifically prescribed for you, and use it only for the infection it was prescribed for.
3. Do not take antibiotics prescribed for other people, even if they had an infection similar to yours.
4. Do not give your prescribed antibiotics to other people.
5. If you have leftover antibiotics after completing your treatment, return all unused medicines to your pharmacy to ensure proper disposal.