Package Insert: Information for the User

Amoxicilina SUN 1000 mg Dispersible Tablets EFG

amoxicilina

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you (or your child), and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

1. What is Amoxicilina SUN and for what it is used

2. What you need to know before starting to take Amoxicilina SUN

3. How to take Amoxicilina SUN

4. Possible adverse effects

5. Storage of Amoxicilina SUN

6. Contents of the package and additional information

This medication is an antibiotic. The active ingredient is amoxicilina. It belongs to a group of medications known as “penicilinas”.

What is Amoxicilina SUN used for

Amoxicilina is used to treat infections caused by bacteria in different parts of the body. Amoxicilina may also be used in combination with other medications to treat stomach ulcers.

Do not take Amoxicilina SUN

• 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 if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking this medication.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking this medication 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 having:

- urine tests (glucose in urine) or blood tests for liver function,

- blood tests for estriol (used during pregnancy to check if the baby is developing normally).

Inform your doctor or pharmacist that you are taking Amoxicilina SUN. This is because amoxicillin may affect the results of these types of tests.

Other medications and Amoxicilina SUN

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

• If you are taking allopurinol (used for gout) with amoxicillin, you may be more likely to have a skin allergic reaction.
• If you are taking probenecid (used to treat gout), the concurrent use of probenecid may reduce the excretion of amoxicillin and is not recommended. Your doctor may need to adjust the dose of this medication.
• If you are taking anticoagulants (such as warfarin), you may need more blood tests.
• If you are taking other antibiotics (such as tetracycline), amoxicillin may be less effective.
• If you are taking methotrexate (a medication used to treat cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate and cause a potential increase in adverse effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

This medication may have adverse effects and symptoms (such as allergic reactions, dizziness, and convulsions) that may make it unsafe to drive.

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

Amoxicilina SUN contains aspartame

This medication contains 20 mg of aspartame per dispersible tablet, equivalent to 20 mg/1000 mg.

Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Amoxicilina SUN contains maltodextrin

Maltodextrin is absorbed as glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Amoxicilina SUN contains benzyl alcohol

This medication contains 0.003 mg of benzyl alcohol per dispersible tablet, equivalent to 0.003 mg/1000 mg.

Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Benzyl alcohol has been linked to the risk of severe adverse effects that include respiratory problems ("breathing difficulty") in children.

Do not administer this medication to your newborn (up to 4 weeks old) unless your doctor has recommended it.

This medication should not be used for more than a week in children under 3 years of age unless your doctor or pharmacist has advised you to do so.

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

• The tablets can be used in two ways. They can be suspended in water to drink, shaking well the mixture until it is homogeneous. Or they can be taken directly with a sufficient amount of water. The tablets can be divided into equal doses.
• Space the doses uniformly throughout the day, at least separated by 4 hours.

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 indicate how much amoxicillin you should 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 40 kg of weight 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 (a disease caused by some parasites called ticks): erythema migrans isolated (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 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.

Renal problems

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

If you take more Amoxicilina SUN than you should

If you have taken more amoxicillin than you should, the signs may be stomach discomfort (feeling of nausea, nausea, or diarrhea) or crystals in the urine, which may be observed as cloudy urine or difficulty urinating. Talk to your doctor as soon as possible. Bring the medication to show them.

If you have taken more amoxicillin than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forgot to take Amoxicilina SUN

• 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 compensate for the missed doses.

How long should you take Amoxicilina SUN

• Continue taking amoxicillin for the time 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, they may cause the infection to recur.
• Once you finish the treatment, if you continue to feel unwell, you should go back to see your doctor.

Candidiasis (a fungal infection of the moist parts of the body that can cause pain, itching, and white discharge) may appear if you take Amoxicilina SUN for a prolonged period. If this happens, consult your doctor.

If you take amoxicillin 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 other doubts about the use of this medication, ask your doctor, pharmacist, or nurse

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking amoxicillin and see a doctor immediately if you experience any of the following severe side effects – you may need urgent medical treatment:

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

• Allergic reactions, symptoms may include: skin itching or rash, facial swelling, lip, tongue, body, or difficulty breathing. These can be severe and, in some cases, have been fatal,
• Rash on the skin or flat, round, red spots like the tip of a needle under the skin's surface or bruises on the skin. This is due to the inflammation of the blood vessel walls due to 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 symptoms include: rashes, fever, joint pain, and lymph node enlargement, 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, and genitals. You may have a fever and feel very tired,
• Other severe skin reactions may be: changes in skin color, lumps under the skin, blisters, pustules, peeling, redness, pain, itching, exfoliation. They may be accompanied by fever, headache, and body pain,
• Flu-like symptoms with skin rash, fever, gland inflammation, and abnormal blood test results (such as increased eosinophils and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)),
• Fever, chills, sore throat, or other signs of infection, or the appearance of bruises easily. These may be signs of a problem with your blood cells,
• 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,
• You may experience severe liver side effects. These are mainly associated with prolonged treatment, men, and advanced age.

You should inform your doctor immediately if you have:

• Severe diarrhea with bleeding,
• Blisters, redness, or bruises on the skin,
• Dark urine or pale stools,
• Skin and white of the eyes yellowish (jaundice). See anemia below, which may cause jaundice.

These may occur during treatment or several weeks after.

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

Occasionally, you may experience milder skin reactions such as:

• A moderate rash with itching (round, pink-red spots), swollen areas with blister-like appearance on forearms, legs, palms, hands, or feet. This is rare (it may affect up to 1 in 100 people).

If you have any of them, talk to your doctor as you will need to interrupt your amoxicillin treatment.

Other possible side effects are:

Frequent(they may affect up to 1 in 10 people)

• Skin rash,
• Nausea,
• Diarrhea.

Rare(they may affect up to 1 in 100 people)

• Vomiting.

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

• Candidiasis (fungal infection in the vagina, mouth, or skin folds), you can get treatment from your doctor or pharmacist for candidiasis,
• Kidney problems,
• Seizures (convulsions), observed in patients treated with high doses or kidney problems,
• Dizziness,
• Hyperactivity,
• Discoloration of teeth, which usually disappears with brushing (this has been reported in children),
• Your tongue may change color to yellow, brown, or black and may appear hairy,
• Excessive breaking of red blood cells that causes a type of anemia. Symptoms include: fatigue, headache, difficulty breathing, dizziness, paleness, and yellowish color of the skin and white of the eyes,
• Low white blood cell count,
• Low count of cells involved in blood clotting,
• Blood may take longer than usual to clot. You may notice this if you bleed from the nose or cut yourself.

Unknown frequency(cannot be estimated from available data)

• Chest pain in the context of allergic reactions, which may be a symptom of an allergic-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 administering the medication). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

• Crystals in the urine (which cause acute kidney injury), which may appear as cloudy urine or difficulty or discomfort urinating. Make sure to drink plenty of liquid to reduce the risk of these symptoms.
• Rash with blisters arranged in a circle with a central crust or like a pearl necklace (IgA linear disease).
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine

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

Do not store at a temperature above 25°C. Store in the original packaging to protect it from humidity.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

The active principle is amoxicillin.

Each dispersible tablet contains 1000 mg of amoxicillin as amoxicillin trihydrate.

The other components are: magnesium stearate (E470b), microcrystalline cellulose (E460), crospovidone (E1202), strawberry aroma, aspartame (E951)

Components of the strawberry aroma: cornstarch maltodextrin (glucose), triethyl citrate (E1505), flavoring agents, propylene glycol, and benzyl alcohol.

Appearance of the product and contents of the packaging

Amoxicilina SUN 1000 mg dispersible tablets EFG

The tablets are oblong in shape, white to yellowish in color, with a groove on both faces and dimensions of 22 x 10 mm

The tablets are packaged in transparent PVC/PVDC/Aluminum blisters or in opaque PVC/TE/PVDC/Aluminum blisters.

Amoxicilina SUN 1000 mg dispersible tablets EFG is available in packaging of 12, 20, and 30 tablets

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and Responsible for manufacturing

Holder of the marketing authorization

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Responsible for manufacturing:

PenCef Pharma GmbH Breitenbachstrasse 13-14

13509 Berlin, Germany

or

HAUPT Pharma Latina S.r.L.

Strada Statale 156 Monti Lepini Km. 47,600 04100 Borgo S. Michele (Latina), Italy

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 – Barcelona

Spain

Phone: +34 93 342 78 90

This medication is authorized in the member states of the European Economic Area with the following names:

Spain: Amoxicilina SUN 1000 mg dispersible tablets EFG.

Last review date of this leaflet: November 2024

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