AMOXICILLIN COMBIX 1000 mg DISPERSIBLE TABLETS

2. What you need to know before you take Amoxicillin Combix

Do not take Amoxicillin 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 a skin rash or swelling of the face or throat.

Do not take Amoxicillin Combix if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking Amoxicillin Combix.

Warnings and precautions

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

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 Combix. This is because Amoxicillin Combix may affect the results of these types of tests.

Using Amoxicillin Combix 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 Combix, you may be more likely to suffer a skin allergic reaction.
• If you are taking probenecid (used to treat gout), your doctor may adjust the dose of Amoxicillin Combix. Concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.
• If you are taking anticoagulants (such as warfarin) with Amoxicillin Combix, more blood tests may be needed.
• If you are taking other antibiotics (such as tetracycline), Amoxicillin Combix may be less effective.
• If you are taking methotrexate (used to treat cancer and severe psoriasis), Amoxicillin Combix may increase the adverse effects. 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Amoxicillin may have side effects such as allergic reactions, dizziness and convulsions, which may make you unfit to drive.

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

Amoxicillin Combix contains aspartame

This medicine contains 20 mg of aspartame in each dispersible 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 is unable to eliminate it properly.

Amoxicillin Combix contains glucose

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

3. How to take Amoxicillin Combix

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 body weight

All doses are based on the child's body weight in kilograms.

• Your doctor will tell you how much Amoxicillin Combix to give to 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 over 40 kg of body weight

The usual dose of Amoxicillin 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 - 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 given at the same time. Your doctor, pharmacist or nurse will be able to give you 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 Combix 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 difficulty urinating. Talk to your doctor as soon as possible. Take the medicine with you to show them.

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

If you forget to take Amoxicillin 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 to take Amoxicillin Combix

• Continue taking Amoxicillin Combix 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 come back.
• Once you finish the treatment, if you continue to feel unwell, you should go back to see your doctor.

Thrush (a yeast infection of the moist parts of the body that can cause pain, itching and white discharge) may appear if you take Amoxicillin Combix for a long time. If this happens, consult your doctor.

If you take Amoxicillin Combix 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 further questions on 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 Combix 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 can 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 Combix, 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 on the skin, soft tissues on the surface of the mouth, eyes or genitals. You may have fever and be very tired
• other serious skin reactions may include: change in skin color, lumps under the skin, blisters, pimples with pus, peeling, redness, pain, itching. 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 Combix 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 tell 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 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 on the skin, especially on the forearms, legs, palms, hands or feet. This is uncommon (may affect up to 1 in 100 people).

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

Other possible side 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)

• thrush (yeast 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, which 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
• discoloration of the teeth, 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
• excessive breakdown of red blood cells that causes a type of anemia. The signs include: tiredness, 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.

Frequency not known(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.
• crystals in the urine that cause acute kidney injury.
• a rash with blisters arranged in a circle with a central crust or like a string of pearls (linear IgA disease).
• inflammation of the membranes that surround the brain and spinal cord (aseptic meningitis).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 after EXP. The expiry date is the last day of the month shown.

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

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Composition of Amoxicilina Combix

• The active ingredient 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 flavoring (corn maltodextrin, triethyl citrate (E1505), flavoring components, and propylene glycol (E1520)).

Appearance of Amoxicilina Combix and Container Content

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

Package size of 20 and 30 tablets in PVC/TE/PVDC-aluminum blisters.

Only some package 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 the Last Revision of this Leaflet: April 2023

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