Amoxicillin Combix 1000 mg dispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amoxicilina Combix 1000 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, as you may need to read it again.

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

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

2. What you need to know before taking Amoxicilina Combix

3. How to take Amoxicilina Combix

4. Possible adverse effects

   1. How to store Amoxicilina Combix

5. Contents of the pack and other information

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

Amoxicilina Combix is an antibiotic. It belongs to a group of antibiotics called penicillins. It is used to treat infections caused by bacteria that are sensitive to amoxicillin.

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 your doctor's instructions regarding dose, frequency, and duration of treatment.

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

What Amoxicilina Combix is used for

Amoxicilina Combix is used to treat bacterial infections in different parts of the body.

Amoxicilina Combix may also be used in combination with other medicines to treat stomach ulcers.

2. What you need to know before taking Amoxicilina Combix

Do not take Amoxicilina Combix:

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Amoxicilina Combix 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 Combix.

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 Combix. This is because Amoxicilina Combix may alter the results of these types of tests.

Taking Amoxicilina Combix 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 Combix, you may be more likely to experience a skin allergic reaction.
• If you are taking probenecid (used to treat gout), your doctor may adjust your dose of Amoxicilina Combix. Concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.
• If you are taking anticoagulants (such as warfarin) with Amoxicilina Combix, more blood tests may be required.
• If you are taking other antibiotics (such as tetracyclines), Amoxicilina Combix may be less effective.
• If you are taking methotrexate (used to treat cancer and severe psoriasis), Amoxicilina Combix may cause an increase in adverse effects. Penicillins may reduce methotrexate excretion and potentially increase its 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

Amoxicillin 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 Combix contains aspartame

This medicine contains 20 mg of aspartame per dispersible tablet.

Aspartame 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 Combix contains glucose

This medicine contains glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Amoxicilina Combix

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

• The tablets may 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 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 Amoxicilina Combix to give 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 weighing 40 kg or more

The usual dose of Amoxicilina Combix 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 through 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 Amoxicilina Combix than you should

If you have taken more Amoxicilina 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 to show them.

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

If you forget to take Amoxicilina Combix

• 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 should you take Amoxicilina Combix

• Continue taking Amoxicilina Combix for as long as your doctor has instructed, even if you feel better. You need to take all doses to overcome the infection. If some bacteria survive, they may cause the infection to 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 Amoxicilina Combix for a prolonged period. If this occurs, consult your doctor.

If you take Amoxicilina Combix 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 experiences them.

Stop taking Amoxicilina Combix 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 pinpoint spots under the skin surface or bruising on 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 Amoxicilina Combix; 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 in 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. 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 treatment with Amoxicilina Combix 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
• 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 have:
  • severe diarrhea with bleeding
  • blisters, redness, or bruising on 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 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 Combix.

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
• 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
• changes in tooth coloration, 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 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 a heart attack triggered by allergy (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 covering the brain and spinal cord (aseptic meningitis)

Reporting of adverse effects

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

5. Storage of Amoxicillin Combix

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

Do not use this medicine after the expiry date which is stated on the carton or blister pack after EXP. The expiry date refers to the last day of the month indicated.

Store below 25 °C. Keep in the original packaging to protect from moisture.

Do not use this medicine if you notice that the tablet or the tablet coating is damaged.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amoxicilina Combix

• The active substance is amoxicillin. Each dispersible tablet contains amoxicillin trihydrate equivalent to 1000 mg of amoxicillin.
• The other components are: aspartame (E951), crospovidone, microcrystalline cellulose (460i), magnesium stearate (E470b), and strawberry flavouring (corn maltodextrin, triethyl citrate (E1505), flavouring components, and propylene glycol (E1520)).

Appearance of Amoxicilina Combix and contents of the pack

White to yellowish-white, oblong tablet, scored on both sides.

Pack sizes of 20 and 30 tablets in PVC/TE/PVDC-aluminum blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Haupt Pharma Latina s.r.l

• 156 Strada Stale km.

47,600, Monti Lepini

04100- Borgo San Michele (LATINA)

Italy

Date of latest review of this leaflet: April 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/