AMOXICILLIN ARDINE 250 mg/5 ml ORAL SUSPENSION POWDER

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

Do not take Amoxicillin Ardine:

• if you are allergic to amoxicillin, penicillin, 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 Ardine if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking Amoxicillin Ardine.

Warnings and precautions

Consult your doctor or pharmacist before taking Amoxicillin Ardine 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 Ardine.

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

Using Amoxicillin Ardine with other medicines

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

• If you are taking allopurinol (used for gout) with Amoxicillin Ardine, 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 Ardine. Concomitant use of probenecid may reduce the excretion of Amoxicillin and is not recommended.
• If you are taking anticoagulants (such as warfarin) with Amoxicillin Ardine, more blood tests may be needed.
• If you are taking other antibiotics (such as tetracycline), Amoxicillin Ardine may be less effective.
• If you are taking methotrexate (a medicine used to treat cancer and severe psoriasis), Amoxicillin Ardine may increase the risk of side effects. Penicillins may reduce the excretion of methotrexate and cause a potential increase in side 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 Ardine may have side effects, and the symptoms (such as allergic reactions, dizziness, and convulsions) may make you unfit to drive.

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

Amoxicillin Ardine contains glucose, sucrose, and sodium

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

Patients with diabetes mellitus should note that this medicine contains 1.6 g of sucrose per 5 ml (320 mg per ml).

It may cause tooth decay.

Patient on a low-sodium diet should note that this medicine contains 16.43 mg (0.71 mmol) of sodium per 5 ml of reconstituted suspension.

3. How to take Amoxicillin Ardine

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

• Shake the bottle well before each intake.
• Space out the intakes 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 Ardine 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 recommended dose is 100 mg per kilogram of body weight per day.

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

This suspension is not normally recommended for adults and children who weigh more than 40 kg. Ask your doctor or pharmacist for advice.

Kidney problems

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

If you take more Amoxicillin Ardine 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. Bring the medicine to show them. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Amoxicillin Ardine

• 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 Ardine

• Continue taking Amoxicillin Ardine 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 cause the infection to come back.
• Once you finish the treatment, if you are still feeling 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 occur if you take Amoxicillin Ardine for a long time. If this happens, consult your doctor.

If you take Amoxicillin Ardine 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 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 Ardine 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 can be associated with joint pain (arthritis) and kidney problems
• a delayed allergic reaction may occur 7 to 12 days after taking Amoxicillin Ardine, some signs include: rash, 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 spots 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 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. These can 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 can be signs of a blood cell problem
• Jarisch-Herxheimer reaction that occurs during treatment with Amoxicillin Ardine 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 occur. 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 cause jaundice.
• 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 skin eruption with blisters arranged in a circle with a central crust or like a string of pearls (linear IgA disease)
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)

These can occur during treatment or up to several weeks after.

If any of the above symptoms occur, stop taking the medicine and see a doctor immediately.

You may sometimes experience less serious skin reactions such as:

• a moderate rash with itching (round, pink-red spots), swollen areas with a blister-like appearance on 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 Ardine.

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 (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, 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
• a severe 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 normal to clot. You may notice this if you have a nosebleed or cut yourself.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Amoxicillin Ardine

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 after EXP. The expiry date is the last day of the month shown.

Dry powder

Store in the original packaging to protect from moisture.

Liquid suspension

Once the suspension is reconstituted, it must be used within 14 days in the refrigerator.

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

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

6. Container Content and Additional Information

Composition of Amoxicilina Ardine

• The active ingredient is amoxicillin. In each 5 ml of suspension, the amoxicillin content is 250 mg.
• The other components are: Anhydrous citric acid (E330), Sodium citrate dihydrate (E331) (sodium), Sodium benzoate (E211), Microcrystalline cellulose (E460)/carboxymethyl cellulose sodium (E466), Raspberry flavor (contains glucose and corn starch), Aerosil, Magnesium stearate, Sodium lauryl sulfate (sodium), and Sucrose.

Appearance of the Product and Container Content

Amoxicilina Ardine 250 mg/5 ml powder for oral suspension is a white powder in type II amber glass bottles with a nominal volume of 114 ml (for 40 ml presentations) or 158 ml (for 120 ml presentations). These bottles are packaged in a box with a graduated dosing syringe for a medium dose of 30 mg/kg of weight and day, with the equivalence in weight of the child and milliliters per intake.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Reig Jofré Laboratory, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Manufacturer:

Reig Jofré Laboratory, S.A.

Jarama, 111 (Industrial Estate)

45007 (Toledo)

Date of the Last Revision of this Prospectus: January 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/

General Advice Regarding the Use of Antibiotics

Antibiotics are used to treat bacterial infections. They are not effective against viral infections.

Sometimes a bacterial infection does not respond to antibiotic treatment. One of the most common reasons for this is that the bacteria causing the infection are resistant to the antibiotic being taken. This means that the bacteria can survive or grow despite the antibiotic.

Bacteria can become resistant to antibiotics for many reasons. Using antibiotics properly can reduce the chances of bacteria becoming resistant to them.

When your doctor prescribes an antibiotic, it is only to treat your current illness. Paying attention to the following tips will help you prevent the appearance of resistant bacteria that can make the antibiotic not work:

2. You should not take an antibiotic unless it has been specifically prescribed for you, and you should only use it for the infection for which it was prescribed.
3. You should not take antibiotics that have been prescribed for other people, even if they had a similar infection to yours.
4. You should not give antibiotics that have been prescribed for you to other people.
5. If you still have antibiotic left after completing the treatment, return all unused medication to your pharmacy to ensure that disposal requirements are met.

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Reconstitution Instructions

Check that the cap is intact before use.

Invert and shake the bottle to loosen the powder stuck to the bottom.

Fill the bottle with water just up to the mark on the label of the bottle, indicated by an arrow.

Invert and shake well, refill with water up to the mark. Invert and shake again.

Shake well before taking each dose.