Introduction

Package Insert: Information for the Patient

Amoxicilina Alter 500 mg Hard Capsules EFG

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

Keep this package insert, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What isAmoxicilina Alterand what is it used for

2. What you need to know before starting to takeAmoxicilina Alter

3. How to takeAmoxicilina Alter

4. Possible side effects

5. Storage ofAmoxicilina Alter

6. Contents of the pack and additional information

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

What is Amoxicilina Alter

Amoxicilina Alter is an antibiotic. The active ingredient is amoxicilina. This belongs to a group of medicines known as “penicilins”.

Antibiotics are used to treat bacterial infections and do not work for viral infections such as the flu or a cold.

It is essential to follow the instructions regarding the dose, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after treatment, return it to the pharmacy for proper disposal. Do not dispose of the medication through the drain or in the trash.

What is Amoxicilina Alter used for

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

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

Do not take Amoxicilina Alter

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 skin rash or swelling of the face or throat.

Do not take this medication if any of the above points affect you. If you are unsure, consult your doctor or pharmacist before taking this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Amoxicilina Alter:

if you have infectious mononucleosis (fever, sore throat, swollen lymph nodes, and extreme fatigue)
if you have kidney problems
if you do not urinate regularly.

If you are unsure whether any of the above symptoms affect 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
estriol tests (used during pregnancy to check if the baby is developing normally).

Inform your doctor or pharmacist that you are taking amoxicillin. This is because amoxicillin can alter the results of these types of tests.

Taking Amoxicilina Alter with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

Pregnancy and breastfeeding

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 seizures) that may make you unable to drive.

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

Amoxicilina Alter contains Red 40 (E129)

This medication may cause allergic reactions because it contains Red 40 (E129).

It may cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How Amoxicilina Alter

Follow exactly the administration instructions of this medication 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 the doses 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 tell you 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 recommended dose is 100 mg per kilogram of body weight per day.

Adults, elderly patients, and children 40 kg or more 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 infections:3 g twice a day for one day.
Lyme disease (a parasitic infection caused by ticks):erythema migrans (early stages – circular pink or red rash): 4 g per day; systemic manifestations (late stages – with more serious symptoms or when the disease spreads throughout the body): up to 6 g per day.
Stomach ulcers:one dose of 750 mg or one 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 daily 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 Alter 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 may be observed as cloudy urine or difficulty urinating. Talk to your doctor as soon as possible. Bring the medication to show them.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Amoxicilina Alter

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 the missed doses.

How long should you take Amoxicilina Alter

Continue taking this medication 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 have finished the treatment, if you continue to feel unwell, you should go back to see your doctor.

You may develop candidiasis (a fungal infection of the moist parts of the body that can cause pain, itching, and white discharge) if you take amoxicillin 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 or pharmacist.

4. Possible Adverse Effects

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

Stop taking this medicine 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 (can 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 include: skin color change, lumps under the skin, blisters, pus-filled pimples, peeling, redness, pain, itching. These may be associated with fever, headache, and body pain
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 side effects in the liver. These are mainly associated with prolonged treatments, men, and advanced age. 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 medicine and see your doctor immediately.

At times, 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 (can affect up to 1 in 100 people).

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

Other possible side effects are:

Frequent(can affect up to 1 in 10 people)

Skin rash
Nausea
Diarrhea

Rare(can affect up to 1 in 100 people)

Vomiting

Very rare(can 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
Crystals in the urine, which may appear as cloudy urine or difficulty or discomfort urinating. Make sure to drink plenty of liquid to reduce the possibility of these symptoms
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 skin and eye color
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(cannot be estimated from available data)

Chest pain in the context of allergic reactions, which may be a symptom of allergic-induced heart attack (Kounis syndrome).
Drug-induced enterocolitis syndrome (DIES):

DIES has been mainly reported 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.

Crystals in the urine that cause acute kidney injury. They may appear as cloudy urine or difficulty or discomfort urinating. Make sure to drink plenty of liquid to reduce the possibility 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.

5. Conservation of Amoxicilina Alter

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

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

Store below 25°C.

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

6. Contents of the packaging and additional information

Composition of Amoxicilina Alter

The active ingredient is amoxicilina. Each capsule contains 500 mg of amoxicilina (as amoxicilina trihydrate).
The other components are: talc, magnesium stearate, gelatin, titanium dioxide (E171). The capsule cap also contains red allura (E129) and yellow quinoline (E104).

Appearance of the product and contents of the packaging

Amoxicilina Alter 500 mg is presented in the form of hard gelatin capsules, with a white body and a red cap, containing a white or off-white granular powder.

Amoxicilina Alter 500 mg is available in blisters in packaging of 20 and 30 hard capsules.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

Responsible for manufacturing

Haupt Pharma Latina S.r.l

S.S. 156 Km 47,600 – 04100

Borgo San Michele

(Latina) Italy

Last review date of this leaflet:February 2023

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