AMOXICILINA 500 mg Hard Capsules

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

Do not take Amoxicillin 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 a skin rash or swelling of the face or throat.

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

Warnings and precautions

Consult your doctor or pharmacist before taking Amoxicillin 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 not sure if any of the above situations apply to you, inform your doctor or pharmacist before taking this medicine.

Blood and urine tests

If you are having:

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

Tell your doctor or pharmacist that you are taking Amoxicillin Pensa Pharma. This is because this medicine may affect the results of these types of tests.

Using Amoxicillin Pensa Pharma with other medicines

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

• If you are taking allopurinol (used to treat gout) with Amoxicillin Pensa Pharma, you may be more likely to suffer an allergic skin reaction.
• If you are taking probenecid (used to treat gout), concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.
• If you are taking anticoagulants (such as warfarin) with Amoxicillin Pensa Pharma, more blood tests may be needed.
• If you are taking other antibiotics (such as tetracycline), Amoxicillin Pensa Pharma may be less effective.
• If you are taking 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.

Pregnancy and breastfeeding

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 using machines

Amoxicillin Pensa Pharma may have side effects, and the symptoms (such as allergic reactions, dizziness, and convulsions) may make you unfit to drive.

Do not drive or operate machinery unless you are feeling well.

Amoxicillin Pensa Pharma contains Allura Red

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

3. How to take Amoxicillin Pensa Pharma

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

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

The usual dose is:

Children under 40 kg of weight

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

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

Adults, elderly patients, and children over 40 kg of weight

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 - circular pink or red rash): 4 g per day; systemic manifestations (late stage - with 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 a dose of 1 g, twice a day, for 7 days with other antibiotics and medicines to treat stomach ulcers.
• To prevent heart infection during surgery:the dose will vary depending on the type of surgery. Other medicines may be administered at the same time. Your doctor, pharmacist, or nurse can provide more details.
• The maximum recommended 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 Amoxicillin Pensa Pharma than you should

If you have taken more amoxicillin than you should, the signs may be stomach upset (nausea, vomiting, or diarrhea) or crystals in the urine, which can be seen as cloudy urine or problems urinating. Talk to your doctor as soon as possible. Bring the medicine to show them. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Amoxicillin 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 forgotten doses.

How long to take Amoxicillin Pensa Pharma

• Continue taking Amoxicillin Pensa Pharma for the time your doctor has indicated, even if you feel better. You need to take all the doses to overcome the infection. If some bacteria survive, they can cause the infection to recur.
• Once you finish the treatment, if you continue to feel unwell, you should go back to see your doctor.

Thrush (a fungal infection of the moist parts of the body that can cause pain, itching, and white discharge) may appear if you take Amoxicillin Pensa Pharma for a long time. If this happens, consult your doctor.

If you take amoxicillin for a long time, your doctor may perform additional tests to check that your kidneys, liver, and blood are working normally.

If you have any other 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.

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

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

• allergic reactions, the signs can include: itching of the skin or rash, swelling of the face, lips, tongue, body, or difficulty breathing. These can be serious and, in some cases, have been fatal
• skin rash or round red spots on the skin surface or bruising on the skin. This is due to inflammation of the blood vessel walls due to an allergic reaction. It can be associated with joint pain (arthritis) and kidney problems
• a delayed allergic reaction may appear 7 to 12 days after taking amoxicillin, some signs include: rashes, fever, joint pain, and swelling of the lymph nodes, especially under the arms
• a skin reaction called 'erythema multiforme' in which you may develop: purple or reddish patches on the skin, especially on the palms of the hands or soles of the feet, swollen areas on the skin, soft tissues on the surface of the mouth, eyes, or genitals. You may have a fever and feel very tired
• other serious skin reactions may include: change in skin color, lumps under the skin, blisters, pimples with pus, peeling, redness, pain, itching. These can be associated with fever, headache, and body pain
• flu-like symptoms with skin rash, fever, gland inflammation, 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 can be signs of a blood cell problem
• Jarisch-Herxheimer reaction that occurs during treatment with amoxicillin for Lyme disease and causes fever, chills, headache, muscle pain, and skin rash
• inflammation of the large intestine (colon) with diarrhea (sometimes with blood), pain, and fever
• serious liver effects may occur. These are mainly associated with prolonged treatments, men, and the elderly. You should tell your doctor immediately if you have:
• • severe diarrhea with bleeding
  • blisters, redness, or bruising on the skin
  • dark urine or pale stools
  • yellowing of the skin and the whites of the eyes (jaundice). See also anemia below which can cause jaundice.
• chest pain in the context of allergic reactions, which can be a symptom of allergy-induced heart attack (Kounis syndrome).
• 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.
• a skin reaction with blisters arranged in a circle with a central crust or like a string of pearls (linear IgA disease).
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).

These can occur during treatment or up to several weeks after.

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

Sometimes you may experience less severe skin reactions such as:

• a moderate rash with itching (round red patches), swollen areas with a blister-like appearance on the forearms, legs, palms, hands, or feet. This is uncommon (may affect up to 1 in 100 people).

If you have any of these, talk to your doctor as you will need to interrupt your treatment with Amoxicillin Pensa Pharma.

Other possible side effects are:

Common(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)

• thrush (fungal infection in the vagina, mouth, or skin folds), you can get treatment for thrush from your doctor or pharmacist
• kidney problems
• seizures (convulsions), observed in patients treated with high doses or with kidney problems
• dizziness
• hyperactivity
• crystals in the urine that cause acute kidney injury. Make sure to drink plenty of fluids to reduce the possibility of these symptoms
• the tongue may change color to yellow, brown, or black and may have a hairy appearance
• a severe breakdown of red blood cells that causes a type of anemia. The signs include: fatigue, headache, difficulty breathing, dizziness, paleness, and yellowing of the skin and the whites of the eyes
• low white blood cell count
• low number of cells involved in blood clotting
• the blood may take longer than normal to clot. You may notice this if you have a nosebleed or cut yourself.

Reporting of side effects

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

5. Storage of Amoxicillin Pensa Pharma

Keep this medicine out of the sight and reach of children.

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

Do not store above 25°C.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Composition of Amoxicilina Pensa Pharma

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

Product Appearance and Container Content

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

They are packaged in PVC/Aluminum and PVC/TE/PVDC/Aluminum blisters. It is 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 Last Revision of this Leaflet: January 2023

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

General Advice on 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 for this is that the bacteria that cause 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 to treat your current illness. Paying attention to the following tips will help you prevent the appearance of resistant bacteria that can make the antibiotic not work:

1. It is very important that you take the antibiotic in the correct dose, at the indicated times, and for the correct number of days. Read the instructions in the leaflet 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 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 had a similar infection to yours.
4. You should not give antibiotics that have been prescribed for you to other people.
5. If you still have antibiotic left after completing the treatment, return all unused medication to your pharmacy to ensure that disposal requirements are met.