AMOXICILLIN ALMUS 500 mg DISPERSIBLE TABLETS

Introduction

Package Leaflet: Information for the User

Amoxicillin Almus 500 mg Dispersible Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you (or your child), do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Amoxicillin Almus and what is it used for
2. What you need to know before taking Amoxicillin Almus
3. How to take Amoxicillin Almus
4. Possible side effects
5. Storage of Amoxicillin Almus
6. Contents of the pack and other information

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

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

What is it used forAmoxicillin Almus

Amoxicillin Almus is used to treat infections caused by bacteria in different parts of the body. Amoxicillin Almus can also be used in combination with other medicines to treat stomach ulcers.

2. What you need to know before taking Amoxicillin Almus

Do not take Amoxicillin 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 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 not sure, consult your doctor or pharmacist before taking amoxicillin.

Warnings and precautions

Consult your doctor or pharmacist before taking Amoxicillin 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 not sure if any of the above situations apply to you, inform your doctor or pharmacist before taking Amoxicillin Almus.

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

Using Amoxicillin Almus with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

• If you are taking allopurinol (used for gout) with Amoxicillin Almus, you may be more likely to suffer an allergic skin 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 Almus, more blood tests may be needed.
• If you are taking other antibiotics (such as tetracycline), Amoxicillin Almus may be less effective.
• If you are taking methotrexate (a medicine 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Amoxicillin Almus may have side effects and symptoms (such as allergic reactions, dizziness, and convulsions) that may make you unfit to drive.

Do not drive or operate machinery unless you feel well.

Amoxicillin Almus 500 mg contains 10 mg of aspartame in each 500 mg tablet of Amoxicillin.

Aspartame (E951) is a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

Amoxicillin Almus 500 mg contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially "sodium-free".

This medicine contains maltodextrin, a source of glucose.

If your doctor has told you that you have an intolerance to some sugars, consult him before taking this medicine.

3. How to take Amoxicillin Almus

Follow exactly the administration instructions of this medicine 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 evenly throughout the day, at least 4 hours apart.

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 Amoxicillin Almus 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 dose is 100 mg per kilogram of body weight per day.

Adults, elderly patients, and children over 40 kg of weight

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 - 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 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 provide more details.
• The maximum recommended 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 Almus 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 to show it to 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 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 forgotten doses.

How long to take Amoxicillin Almus

• 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 can make the infection come back.
• Once you finish treatment, if you continue to feel 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 appear 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 other questions about 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 Amoxicillin Almus 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: rashes, 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 rashes with itching on the skin, especially on the palms of the hands or soles of the feet, swollen areas with a raised edge on the skin, soft tissues on the surface of the mouth, eyes, or genitals. You may have a fever and feel very tired
• other serious skin reactions may include: change in skin color, lumps under the skin, blisters, pimples 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 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 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 appear. These are mainly associated with prolonged treatments, men, and the elderly. You should inform your doctor immediately if you have:

or severe diarrhea with bleeding

or blisters, redness, or bruising of the skin

or dark urine or pale stools

or 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 appear, stop taking the medicine and see your doctor immediately.

Sometimes you may experience less serious skin reactions such as:

• a moderate rash with itching (round, pink-red patches), swollen areas with a blister-like appearance on the skin of the forearms, legs, palms, hands, or feet. This is uncommon (may affect up to 1 in 100 people).

If you have any of these, talk to your doctor as you will need to interrupt your treatment with Amoxicillin Almus.

Other possible side effects are:

Common(may affect up to 1 in 10 people)

• skin rash
• nausea
• diarhea

Uncommon(may affect up to 1 in 100 people)

• vomiting

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 that cause acute kidney injury and 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
• alteration in tooth discoloration, which usually disappears with brushing (this has been reported in children)
• the tongue may change color to yellow, brown, or black and may have a hairy appearance
• a excessive breakdown of red blood cells that causes a type of anemia. The signs include: fatigue, 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 usual to clot. You may notice this if you have a nosebleed or cut yourself.
• inflammation of the membranes that surround the brain and spinal cord (aseptic meningitis)

Frequency not known(frequency 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
• blistering skin rash arranged in a circle with a central crust or like a string of pearls (linear IgA disease)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Amoxicillin Almus

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

Do not use this medicine after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.

Do not store above 25°C. Store in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Packaging Content and Additional Information

Composition ofAmoxicilina Almus

The active ingredient is amoxicillin.

Each dispersible tablet contains amoxicillin trihydrate equivalent to 500 mg of amoxicillin.

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

Strawberry flavoring components: maltodextrin (derived from corn starch), triethyl citrate, flavoring agents, propylene glycol, and benzyl alcohol.

Appearance of the Product and Packaging Content

Amoxicilina Almus 500 mg dispersible tablets.

The tablets are white or off-white, oblong in shape, 18 mm by 7 mm, with a score line on both sides.

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

Amoxicilina Almus 500 mg dispersible tablets are available in packs of 10, 12, 14, 16, 20, 24, 30, 100, and 1000 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 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 authorized in the EEA Member States under the following names:

Netherlands - Amoxicilline Centrient 500 mg dispersible tablets

Spain - Amoxicilina Almus 500 mg dispersible tablets

Date of the Last Revision of this Leaflet: June 2023

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