AMOXICILLIN ALTER 500 mg HARD CAPSULES

2. What you need to know before you take Amoxicillin Alter

Do not take Amoxicillin Alter

• if you are allergic to amoxicillin, penicillins, 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 skin rash or swelling of the face or throat.

Do not take this medicine 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 starting to take Amoxicillin Alter:

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

If you are not sure if any of the above symptoms 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. This is because amoxicillin may affect the results of these types of tests.

Taking Amoxicillin Alter with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• If you are taking allopurinol (used for gout) with amoxicillin, you may be more likely to suffer 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, more frequent blood tests may be needed.
• If you are taking other antibiotics (such as tetracycline), amoxicillin may be less effective.
• If you are taking methotrexate (used for cancer treatment 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

This medicine may cause side effects such as allergic reactions, dizziness, and convulsions that may make you unfit to drive.

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

Amoxicillin Alter contains Red Allura (E129)

This medicine may cause allergic reactions because it contains Red Allura (E129).

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

3. How to take Amoxicillin Alter

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

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

The usual dose is:

Children under 40 kg body 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 body 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 stages - circular pink or red rash): 4 g per day; systemic manifestations (later stages - with more serious 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 give you 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 Amoxicillin 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 can be seen as cloudy urine or problems urinating. Talk to your doctor as soon as possible. Bring the medicine with you to show the doctor.

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 medicine and the amount ingested.

If you forget to take Amoxicillin 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 forgotten doses.

How long to take Amoxicillin Alter

• Continue taking this medicine for the duration indicated by your doctor, 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 treatment, if you are still feeling 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 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 further questions on 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 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 (may affect up to 1 in 10,000 people)

• allergic reactions, the signs may 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 under the skin surface or bruising of the skin. This is due to 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 appear 7 to 12 days after taking amoxicillin, some signs include: rash, 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 spots 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 fever and be 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 may be associated with fever, headache, and body pain
• 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 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 treatment, males, and the elderly. You should tell your doctor immediately if you have:

• severe diarrhea with bleeding
• blisters, redness, or bruising of the skin
• dark urine or pale stools
• yellowing of the skin and the whites of the eyes (jaundice). See also anemia below which can lead to jaundice.

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

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

Sometimes you may experience less serious skin reactions such as:

• a moderate rash with itching (round pink-red spots), 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 this medicine.

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, which can appear as cloudy urine or difficulty or discomfort when urinating. 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: tiredness, 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.

Not known(cannot be estimated from the available data)

• 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.

• Crystals in the urine that cause acute kidney injury. These can appear as cloudy urine or difficulty or discomfort when urinating. Make sure to drink plenty of fluids to reduce the possibility of these symptoms.
• A skin rash 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).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects 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 Alter

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 refers to the last day of the month shown.

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amoxicillin Alter

• The active substance is amoxicillin. Each capsule contains 500 mg of amoxicillin (as amoxicillin trihydrate).
• The other ingredients are: talc, magnesium stearate, gelatin, titanium dioxide (E171). The capsule cap also contains Red Allura (E129) and Quinoline Yellow (E104).

Appearance of the product and pack contents

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

Amoxicillin Alter 500 mg is available in blister packs in containers of 20 and 30 hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

Manufacturer

Haupt Pharma Latina S.r.l

S.S. 156 Km 47,600 – 04100

Borgo San Michele

(Latina) Italy

Date of last revision of this leaflet:February 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.