Amoxicillin Almus 750 mg dispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amoxicilina Almus 750 mg dispersible tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you (or your child), 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 Almus is and what it is used for
2. What you need to know before taking Amoxicilina Almus
3. How to take Amoxicilina Almus
4. Possible side effects
5. How to store Amoxicilina Almus
6. Contents of the pack and other information

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

What is Amoxicilina Almus

Amoxicilina Almus is an antibiotic. The active substance is amoxicillin. This belongs to a group of medicines called "penicillins".

What Amoxicilina Almus is used for

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

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

Do not take Amoxicilina Almus:

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Amoxicilina Almus 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 conditions apply to you, inform your doctor or pharmacist before taking Amoxicilina Almus.

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 Almus. This is because this medicine may alter the results of these types of tests.

Use of Amoxicilina Almus with other medicines

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

• If you are taking allopurinol (used for gout) with Amoxicilina Almus, 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 amoxicillin excretion and is not recommended.
• If you are taking anticoagulants (such as warfarin) with Amoxicilina Almus, more frequent blood tests may be required.
• If you are taking other antibiotics (such as tetracyclines), Amoxicilina Almus 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Amoxicilina Almus 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 Almus 750 mg contains 15 mg of aspartame per Amoxicillin 750 mg tablet.

Aspartame (E951) is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

Amoxicilina Almus 750 mg contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".

This medicine contains maltodextrin, a source of glucose.

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Amoxicillin Almus

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

• The tablets can be used in two ways. They can be dispersed in water for drinking, or they can be taken directly with a sufficient amount of water. The tablets may be divided to facilitate swallowing.
• Space the doses evenly throughout the day, at least 4 hours apart.

Usual dose

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 Almus 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 Amoxicillin Almus 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 – single pink or red circular 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 1 g twice a day for 7 days, in combination with other antibiotics and medications used 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 further details.
• The maximum recommended 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 Amoxicillin Almus 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. Take the medicine with you to show it.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Amoxicillin Almus

• 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 a missed dose.

How long to take Amoxicillin Almus

• Continue taking amoxicillin for the length of time prescribed by your doctor, even if you feel better. You need to take all the doses to completely eliminate 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.

You may develop candidiasis (a fungal infection in moist areas of the body that can cause pain, itching, and white discharge) if you take amoxicillin for a prolonged period. If this occurs, consult your doctor.

If you take amoxicillin for a prolonged period, your doctor may perform additional blood 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 everybody will experience them.

Stop taking Amoxicilina Almus 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 red, round spots like the tip of a pin beneath the skin surface, or skin bruising. This is due to inflammation of the blood vessel walls 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 taking 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: purple or reddish itchy patches on the skin, especially on the palms of the hands or soles of the feet, raised swollen areas on the skin, soft tissue lesions in the mouth, eyes, and genital areas. You may also have fever and feel very tired
• other serious skin reactions may include: changes in skin color, lumps under the skin, blisters, pus-filled pimples, peeling, redness, pain, itching, exfoliation. 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, which occurs during amoxicillin treatment for Lyme disease and causes 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 prolonged treatment, male gender, and advanced age. You should contact your doctor immediately if you experience:

o severe diarrhea with bleeding

o blisters, redness, or bruising on the skin

o dark urine or pale stools

o yellowing of the skin or whites of the eyes (jaundice). See also anemia below, which may also cause jaundice

These may occur during treatment or up to several weeks afterwards.

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 Almus.

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
• seizures (convulsions), observed in patients treated with high doses or who have kidney problems
• dizziness
• hyperactivity
• crystals in the urine causing acute kidney injury, which may appear as cloudy urine or difficulty or discomfort when urinating. Make sure to drink plenty of fluids to reduce the likelihood of these symptoms
• changes in tooth discoloration, which usually disappear 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 number of white blood cells
• low number of cells involved in blood clotting
• blood may take longer than normal to clot. This may be noticed as nosebleeds or prolonged bleeding from cuts
• inflammation of the membranes covering the brain and spinal cord (aseptic meningitis)

Frequency not known (frequency cannot be estimated from available data)

• chest pain in the context of allergic reactions, which may be a symptom of an allergic-triggered heart attack (Kounis syndrome)
• Drug-induced enterocolitis syndrome (DIES): DIES has been reported mainly in children receiving amoxicillin. It is a 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 a circular pattern with a central crust or resembling a "pearl necklace" (linear IgA disease)

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, 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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Amoxicillin Almus

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging. 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.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Amoxicilina Almus

The active substance is amoxicillin.

Each dispersible tablet contains amoxicillin trihydrate equivalent to 750 mg of amoxicillin.

The other components are: magnesium stearate, microcrystalline cellulose, crospovidone, strawberry flavouring, and aspartame (E951).

Components of the strawberry flavouring: maltodextrin (derived from corn starch), triethyl citrate, flavouring components, propylene glycol, and benzyl alcohol.

Appearance of the product and contents of the container

Amoxicilina Almus 750 mg dispersible tablets

The tablets are white or almost white, oblong in shape, 22 mm by 8 mm, with a score line on both sides.

The tablets are packaged in PVC/PVDC/aluminum or PVC/TE/PVDC/aluminum blisters.

Amoxicilina Almus 750 mg dispersible tablets are available in pack sizes of 4, 10, 12, 14, 16, 20, 24, 30, 100, and 1000 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Almus Farmacéutica, S.A.U.
Marie Curie, 54
08840 Viladecans (Barcelona), Spain
Telephone: 93 739 71 80
Email: [email protected]

Manufacturer

PenCef Pharma GmbH
Breitenbachstrasse 13
13509 Berlin (Germany)

or

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

This medicinal product is authorised in the Member States of the EEA under the following names:

Netherlands – Amoxicilline Centrient 750 mg dispergeerbare tabletten
Spain – Amoxicilina Almus 750 mg comprimidos dispersables

Date of the most recent revision of this leaflet: June 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/