Leaflet: information for the user

Amoxicilina Almus 1000 mg dispersible tablets EFG

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you (or your child) only, and should not be given 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 leaflet. See section 4.

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

2. What you need to know before you start taking Amoxicilina Almus

3. How to take Amoxicilina Almus

4. Possible side effects

5. Storage of Amoxicilina Almus

6. Contents of the pack and additional information

What is Amoxicilina Almus

Amoxicilina Almus is an antibiotic. The active ingredient is amoxicilina. This belongs to a group of medicines called “penicillins”.

What is Amoxicilina Almus used for

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

Do not take Amoxicilina Almus:

• 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 amoxicillin.

Warnings and precautions

Consult your doctor or pharmacist before taking Amoxicilina Almus if:

• you have infectious mononucleosis (fever, sore throat, swollen lymph nodes, 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 Amoxicilina Almus.

Blood and urine tests

If you are having:

• urine tests (glucose in urine) or blood tests for liver function
• estrone tests (used during pregnancy to check if the baby is developing normally).

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

Use of Amoxicilina Almus with other medications

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 Amoxicilina Almus, you may be more likely to experience a skin rash.
• If you are taking probenecid (used to treat gout), the concurrent use of probenecid may reduce the excretion of amoxicillin and is not recommended.
• If you are taking anticoagulants (such as warfarin) with Amoxicilina Almus, more blood tests may be necessary.
• If you are taking other antibiotics (such as tetracycline), Amoxicilina Almus 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 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

Amoxicilina Almus may cause adverse effects, and symptoms (such as allergic reactions, dizziness, and seizures) may make it unsafe to drive.

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

Amoxicilina Almus 1000 mg contains 20 mg of aspartame in each Amoxicilina 1000 mg tablet.

Aspartame (E951) is 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 Almus 1000 mg contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

This medication contains maltodextrin, a source of glucose.

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

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, or they can be taken directly with a sufficient amount of water. The tablets can be broken to facilitate swallowing.
• 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 tell you how much Amoxicilina Almus 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 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 Amoxicilina 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 infections: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: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 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 Almus than you should

If you have taken more Amoxicilina than you should, the signs may be stomach discomfort (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 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 compensate for the missed doses.

How long should you take Amoxicilina Almus

• Continue taking amoxicilina 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 amoxicilina for a prolonged period. If this happens, consult your doctor.

If you take amoxicilina 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.

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

Stop taking Amoxicilina Almus 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 or flat, round, red spots like the tip of a pin 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, pustules with pus, peeling, redness, pain, itching, exfoliation. These may be associated with 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 amoxicillin treatment 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 treatments, men, and advanced age. Inform your doctor immediately if you have:

orsevere diarrhea with bleeding

orblistering, redness, or bruising on the skin

ordark urine or pale stools

oryellowing of the skin and the white of the eyes (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.

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 the forearms, legs, palms, hands, or feet. This is rare (it may affect up to 1 in 100 people).

If you experience any of them, talk to your doctor as you will need to interrupt your treatment with Amoxicilina Almus.

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 (vaginal, oral, or skin fungal infection), you can obtain treatment from your doctor or pharmacist for candidiasis
• Kidney problems
• Seizures (convulsions), observed in patients treated with high doses or kidney problems
• Dizziness
• Hypersensitivity
• Crystals in the urine that cause acute kidney damage and may appear as cloudy urine or difficulty or discomfort urinating. Make sure to drink plenty of liquid to reduce the risk of these symptoms
• Alteration in tooth color, which usually disappears with brushing (this has been reported in children)
• The tongue may change color to yellow, brown, or black and may appear hairy
• Excessive red blood cell breakdown that causes a type of anemia. Symptoms include: fatigue, headache, difficulty breathing, dizziness, paleness, and yellowing of the skin and the 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.
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)

Unknown frequency(frequency 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 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
• Rash with blisters arranged in a circle with a central crust or like a pearl necklace (IgA linear disease).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist,even if it is a possibleside effect that does not appear in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: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 use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

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

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 unused packaging and medications. By doing so, you will help protect the environment.

Composition ofAmoxicilina Almus

The active ingredient is amoxicilina.

Each dispersible tablet contains amoxicilina trihydrate equivalent to 1000 mg amoxicilina.

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

Components of the strawberry flavor: maltodextrin (derived from cornstarch), triethyl citrate, flavoring agents, propylene glycol, and benzyl alcohol.

Appearance of the product and contents of the package

Amoxicilina Almus 1000 mg dispersible tablets.

The tablets are white or off-white, oblong in shape, 22 mm by 10 mm, with a notch on both faces.

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

Amoxicilina Almus 1000 mg dispersible tablets are available in packages of 3, 6, 8, 10, 12, 14, 16, 20, 24, 30, 100, and 1000 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email:[email protected]

Responsible 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 medicine is authorized in the EEA member states with the following names:

Netherlands - Amoxicilline Centrient 1000 mg dispersible tablets

Spain - Amoxicilina Almus 1000 mg dispersible tablets

France – Amoxicilline Almus 1 g, dispersible tablet

United Kingdom (Northern Ireland) – Amoxicillin 1000 mg dispersible tablets

Last review date of this leaflet: June 2023

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/