Amoxicillin Tarbis Farma 500 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amoxicilina Tarbis Farma 500 mg hard capsules 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.

  1. If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you (or your child) only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are 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

Amoxicilina Tarbis Farma is an antibiotic. The active substance is amoxicillin. This belongs to a group of medicines known as "penicillins".

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow the instructions regarding dose, dosing interval, and duration of treatment as directed by your doctor.

Do not store or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Medicines should not be disposed of via wastewater or household waste.

What Amoxicilina Tarbis Farma is used for

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

2. What you need to know before starting Amoxicilina Tarbis Farma

Do not take Amoxicilina Tarbis Farma:

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Amoxicilina Tarbis Farma 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 symptoms apply to you, inform your doctor or pharmacist before taking Amoxicilina Tarbis Farma.

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

Taking Amoxicilina Tarbis Farma with other medicines

Tell 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) together with Amoxicilina Tarbis Farma, you may be more likely to experience a skin allergic reaction.
• If you are taking probenecid (used to treat gout), concomitant use may reduce the excretion of amoxicillin and is not recommended.
• If you are taking anticoagulants (such as warfarin) with Amoxicilina Tarbis Farma, more blood tests may be needed.
• If you are taking other antibiotics (such as tetracyclines), Amoxicilina Tarbis Farma 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Amoxicilina Tarbis Farma 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.

3. How to take Amoxicilina Tarbis Farma

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

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

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 Amoxicilina Tarbis Farma 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 recommended 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 Amoxicilina Tarbis Farma 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 – single red or pink circular rash): 4 g per day; systemic manifestations (late stages – 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 1 g twice a day for 7 days, together with other antibiotics and medicines for treating stomach ulcers.
• To prevent heart infection during surgery: the dose will vary depending on the type of surgery. Other medicines may be given at the same time. Your doctor, pharmacist, or nurse can provide further 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 Amoxicilina Tarbis Farma 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 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Amoxicilina Tarbis Farma

• 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 should you take Amoxicilina Tarbis Farma

• Continue taking amoxicillin for as long as your doctor has told you, even if you start to feel better. You need to take all the doses to overcome 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 in moist areas of the body that may cause pain, itching, and white discharge) may occur if Amoxicilina Tarbis Farma 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 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 everyone will experience them.

Stop taking Amoxicilina Tarbis Farma 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 resulted in 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 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: 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 on the surface of the mouth, eyes, and genitals. You may also 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. 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, which 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 bloody), pain, and fever
• severe adverse effects in the liver may occur. These are mainly associated with patients undergoing prolonged treatment, males, and older age. You should inform 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 whites of the eyes (jaundice). See also anemia below, which may lead to jaundice.

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

If any of the above symptoms appear, 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 with a blister-like appearance 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 with your doctor, as you will need to discontinue treatment with Amoxicilina Tarbis Farma.

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 can be obtained from your doctor or pharmacist for candidiasis
• kidney problems
• epileptic 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 to drink plenty of fluids to reduce the likelihood of these symptoms
• the tongue may change color to 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. You may notice this if you have nosebleeds or cuts that bleed excessively.

Frequency 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 been reported mainly in children receiving amoxicillin. It is a certain 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.
• crystals in the urine causing acute kidney injury.
• blistering rash arranged in circles with central crusts or resembling a string of pearls (linear IgA disease).
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://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 sight and reach of children.

Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

Store below 25°C.

Do not use this medicine if you notice any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. 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 capsule contains 500 mg of amoxicillin (as amoxicillin trihydrate).
• The other components are: Core: talc, magnesium stearate (E572). Capsule shell: gelatin, quinoline yellow (E104), allura red (E129) and titanium dioxide.

Appearance of the product and contents of the pack

Amoxicilina Tarbis Farma 500 mg hard capsules are presented as opaque gelatin capsules with a red cap and white body.

The capsules are packed in PVC/aluminum blisters, in pack sizes of 20 and 30 capsules.

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Tarbis Farma S.L.

Gran Via Carlos III 94

08028 Barcelona - Spain

Manufacturer:

Antibiotice

1 Valea Lupului

Iasi 707410 - Romania

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 for Medicines and Health Products (AEMPS) http://www.aemps.gob.es