AMOXICILLIN PENSA PHARMA 750 mg DISPERSIBLE TABLETS

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

Do not take Amoxicillin Pensa Pharma:

• if you are allergic to amoxicillin, penicillins, or any of the other components of this medication (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 points apply to you. If you are unsure, consult your doctor or pharmacist before taking Amoxicillin Pensa Pharma.

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 unsure whether any of the above situations apply to you, inform your doctor or pharmacist before taking this medication.

Blood and urine tests

If you are undergoing:

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

Inform your doctor or pharmacist that you are taking Amoxicillin Pensa Pharma. This is because this medication can alter the results of these types of tests.

Using Amoxicillin Pensa Pharma with other medications

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

• If you are taking allopurinol (used to treat gout) with Amoxicillin Pensa Pharma, you may be more likely to experience a skin allergic 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 necessary.
• If you are taking other antibiotics (such as tetracycline), Amoxicillin Pensa Pharma may be less effective.
• If you are taking methotrexate (a medication used to treat cancer and severe psoriasis), penicillins can reduce the excretion of methotrexate and cause a potential increase in side 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 medication.

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 feel well.

Amoxicillin Pensa Pharma contains aspartame

This medication may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

3. How to take Amoxicillin Pensa Pharma

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The tablets can be used in two ways. They can be swallowed with water or dispersed in water beforehand and then drunk. The tablets can be broken to facilitate swallowing.

Space the doses evenly throughout the day, at least 4 hours apart.

The usual dose is:

Children under 40 kg in weight

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

• Your doctor will indicate how much amoxicillin to administer 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 dose is 100 mg per kilogram of body weight per day.

Adults, elderly patients, and children over 40 kg in 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 - pink or red circular 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 medications to treat stomach ulcers.
• To prevent heart infection during surgery:the dose will vary depending on the type of surgery. Other medications 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 medication to show them. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medication 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 still 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 occur 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 functioning normally.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Stop taking Amoxicillin Pensa Pharma and go 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 flat red spots on the skin 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 rashes with itching 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 problem with your blood cells
• Jarisch-Herxheimer reaction, which 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 inform 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 myocardial infarction (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 medication). 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 necklace (linear IgA disease).
• inflammation of the membranes that surround 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 medication and go see your doctor immediately.

Sometimes you may experience less severe skin reactions such as:

• a moderate rash with itching (round, pink-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 experience any of these, talk to your doctor, as you will need to interrupt your treatment with Amoxicillin Pensa Pharma.

Other possible side 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)

• 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
• discoloration of the teeth, which usually disappears with brushing (this has been reported in children)
• the tongue may change color to yellow, brown, or black and may have a hairy appearance
• a excessive 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 usual to clot. You may notice this if you have a nosebleed or cut yourself.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Amoxicillin Pensa Pharma

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

Do not use this medication after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

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

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

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

6. Package contents and additional information

Composition of Amoxicillin Pensa Pharma

• The active ingredient is amoxicillin. Each dispersible tablet contains 750 mg of amoxicillin.
• The other components are: crospovidone, microcrystalline cellulose, aspartame, magnesium stearate, and strawberry flavor (corn maltodextrin, triethyl citrate, propylene glycol, flavoring agents).

Appearance of the product and package contents

Amoxicillin Pensa Pharma 750 mg are white to yellowish dispersible tablets, oblong, scored on both sides. They are packaged in blisters, in packs of 20 and 30 dispersible tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Haupt Pharma Latina S.r.L.

SS. 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 medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/