Amoxicillin Tarbis Farma 1000 mg dispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amoxicilina Tarbis Farma 1,000 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you (or your child) only, 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 effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Amoxicilina Tarbis Farma is and what it is used for

What is Amoxicilina Tarbis Farma

Amoxicilina Tarbis Farma is an antibiotic. The active substance is amoxicillin. It belongs to a group of medicines called "penicillins".

What Amoxicilina Tarbis Farma is used for

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

2. What you need to know before starting to take Amoxicillin Tarbis Farma

Do not take amoxicillin:

• if you are allergic to amoxicillin, penicillins, or any of the other components 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 this medicine if:

• you have infectious mononucleosis (fever, sore throat, swollen glands, and extreme tiredness)
• 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 this medicine.

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

Taking amoxicillin 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 amoxicillin, you may be more likely to experience 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 blood tests may be needed.
• If you are taking other antibiotics (such as tetracyclines), amoxicillin 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 potentially increase 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 may cause adverse effects, and symptoms (such as allergic reactions, dizziness, and seizures) may affect your ability to drive.

Do not drive or operate machinery unless you feel well.

Amoxicillin Tarbis Farma dispersible tablets contain aspartame

This medicine contains 20 mg of aspartame per tablet. Aspartame contains 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 properly eliminate it.

Amoxicillin Tarbis Farma dispersible tablets contain glucose

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

Amoxicillin Tarbis Farma dispersible tablets contain benzyl alcohol

This medicine contains 0.003 mg of benzyl alcohol per tablet. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate and cause adverse effects (metabolic acidosis).

Benzyl alcohol has been associated with a risk of serious adverse effects, including breathing problems ("gasping syndrome"), in children. Do not give this medicine to your newborn (up to 4 weeks of age) unless advised by your doctor. This medicine should not be used for longer than one week in children under 3 years of age unless directed by your doctor or pharmacist.

3. How to take Amoxicilina Tarbis Farma

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

The usual dose is:

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 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 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 – 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, together with other antibiotics and medications for treating 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.

Kidney problems

If you have kidney problems, the dose may be lower than the usual dose.

If you take more amoxicillin 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. Bring the medicine with you for identification.

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

If you forget to take amoxicillin

• 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

• Continue taking amoxicillin for as long as your doctor has instructed, 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.

Candidiasis (a fungal infection affecting moist areas of the body that may cause pain, itching, and white discharge) may occur if amoxicillin is taken 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 monitor 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 everyone experiences them.

Stop taking amoxicillin 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 may be severe and, in some cases, have resulted in death
• skin rash or flat red pinpoint spots under the skin surface or bruising of the skin. This is due to inflammation of the walls of blood vessels 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: itchy purple or reddish spots on the skin, especially on the palms of the hands or soles of the feet, raised swollen areas on the skin, soft tissue lesions on the surface of the mouth, eyes, and genitals. You may have fever and feel very tired
• other serious skin reactions may include: change 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 occurring during treatment with amoxicillin for Lyme disease, causing fever, chills, headache, muscle pain, and skin rash
• inflammation of the large intestine (colon) with diarrhoea (sometimes with blood), abdominal pain and fever
• serious adverse effects in the liver may occur. These are mainly associated with patients undergoing prolonged treatment, males, and advanced age. You should inform your doctor immediately if you have:

o severe diarrhoea with bleeding

o blisters, redness or bruising of the skin

o dark urine or pale stools

o yellowing of the skin and whites of the eyes (jaundice). See also anaemia below, which may lead to 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:

• mild rash with itching (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 stop your treatment with amoxicillin.

Other possible adverse effects are:

Frequent (may affect up to 1 in 10 people)

• skin rash
• nausea
• diarrhoea

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 can be obtained from your doctor or pharmacist for candidiasis
• kidney problems
• seizures (convulsions), observed in patients treated with high doses or with kidney problems
• dizziness
• hyperactivity
• crystals in the urine, which may appear as cloudy urine or difficulty or discomfort when urinating. Make sure you drink plenty of fluids to reduce the likelihood of these symptoms
• change 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 appear hairy
• excessive breakdown of red blood cells causing a type of anaemia. Signs include: tiredness, 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 if you have nosebleeds or cuts.

Not known (cannot be estimated from available data)

• Chest pain in the context of allergic reactions, which may be a symptom of allergy-triggered heart attack (Kounis syndrome).
• Drug-induced enterocolitis syndrome (DIES): DIES has mainly been 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, diarrhoea, and low blood pressure.
• Crystals in the urine causing acute kidney injury.
• Rash with blisters arranged in a ring with a central crust or resembling a pearl necklace (linear IgA disease).
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).

Reporting of adverse effects

If you experience any adverse effect, talk to 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 Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Amoxicillin Tarbis Farma

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

Do not use this medicine after the expiry date stated on the container. The expiry date is 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 containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amoxicilina Tarbis Farma

The active substance is amoxicillin.

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

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

Components of the strawberry flavouring: corn maltodextrin (glucose), triethyl citrate (E1505), flavouring components, propylene glycol and benzyl alcohol.

Appearance of the product and contents of the pack

Amoxicilina Tarbis Farma 1,000 mg dispersible tablets EFG.

The tablets are white or slightly yellowish, oblong-shaped (22 mm by 10 mm), with a score line on both sides.

The tablets are packaged in PVC/PVDC/aluminium blisters.

Amoxicilina Tarbis Farma 1,000 mg dispersible tablets EFG is available in packs of 20 and 30 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona - Spain

Manufacturer

Haupt Pharma Latina S.r.L.

Strada Statale 156 Monti Lepini Km. 47,600

04100 Borgo San Michele (Latina) - Italy

Date of the most recent revision of this leaflet: January 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/