Amoxicillin Pensa Pharma 1000 mg dispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amoxicilina Pensa Pharma 1000 mg dispersible tablets EFG

Read the entire 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.

  1. 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 adverse 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 Amoxicilina Pensa Pharma is

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 by flushing them down the sink or into 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 starting to take Amoxicilina Pensa Pharma

Do not take Amoxicilina Pensa Pharma:

• if you are allergic to amoxicillin, penicillins, or to 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 not sure, consult your doctor or pharmacist before taking Amoxicilina Pensa Pharma.

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 tiredness)
• 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 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 Amoxicilina Pensa Pharma may alter the results of these types of tests.

Taking Amoxicilina Pensa Pharma with other medicines

Tell 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, additional blood tests may be required.
• If you are taking other antibiotics (such as tetracycline), 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 plan 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 aspartame

This medicine may be harmful for people with phenylketonuria, as it contains aspartame, a source of phenylalanine.

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.

The tablets can be used in two ways. They can be swallowed with water, or the tablets can be dispersed in water first and then the dispersion drunk. The tablets may be broken to facilitate swallowing.

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

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 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 Amoxicilina Pensa Pharma is 250 mg to 500 mg three times a day or 750 mg to 1000 mg every 12 hours, depending on the severity and type of infection.

• Severe infections: 750 mg to 1000 mg 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 a dose of 1000 mg 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 administered at the same time. Your doctor, pharmacist, or nurse can provide further details.
• The recommended maximum dose is 6 g per day.

Renal 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, stating 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 forgotten doses.

How long to 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 doses to fully 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 Amoxicilina Pensa Pharma for a prolonged period, your doctor may perform additional 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 experiences 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 can be severe and, in some cases, have led to death
• skin rash or flat, round red spots like the tip of a pin beneath the skin surface, or skin bruising. This is due to inflammation of the walls of blood vessels 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 starting 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: itchy purple or reddish spots on the skin, 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: change in skin color, 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, 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))
• fever, chills, sore throat or other signs of infection, or easy bruising. These may be signs of a problem with your blood cells
• 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), abdominal pain, and fever
• serious 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 of 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 a heart attack triggered by an allergic reaction (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 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 "pearl necklace" (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 after.

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

Sometimes you may experience less severe skin reactions such as:

• a moderate itchy rash (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 discontinue treatment with Amoxicilina Pensa Pharma.

Other possible adverse 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)

• candidiasis (fungal infection in the vagina, mouth, or skin folds); treatment is available from your doctor or pharmacist for candidiasis
• kidney problems
• epileptic seizures (convulsions), observed in patients receiving high doses or with 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
• change in tooth coloration, which usually disappears with brushing (this has been reported in children)
• the tongue may turn yellow, brown, or black and may appear hairy
• excessive breakdown of red blood cells causing a type of anemia. Signs include: fatigue, headache, difficulty breathing, dizziness, paleness, and yellowing of the skin and whites of the eyes
• low white blood cell count
• low count of cells involved in blood clotting
• blood may take longer than normal to clot. This may be noticeable if you have nosebleeds or cuts that bleed excessively

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 can 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 the sight and reach of children.

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

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

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 empty containers and unused medicines at the SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amoxicillin Pensa Pharma

• The active substance is amoxicillin. Each dispersible tablet contains 1000 mg of amoxicillin.
• The other components are: crospovidone, microcrystalline cellulose, aspartame, magnesium stearate and strawberry flavour (corn maltodextrin, triethyl citrate, propylene glycol, flavouring components).

Appearance of the product and contents of the pack

Amoxicillin Pensa Pharma 1000 mg are dispersible tablets, white to yellowish in colour, oblong-shaped, scored on both sides. They are packed in blisters, in packs of 20 and 30 dispersible tablets.

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

Haupt Pharma Latina S.r.L.

SS. 156 Monti Lepini Km. 47,600

04100 Borgo S. Michele (Latina)

Italy

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 for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/