CEFIXIME NECLIFE 100 mg/5 ml ORAL SUSPENSION POWDER

1. What is Cefixime Neclife and what is it used for

This medication contains a substance called cefixime, which belongs to the group of antibiotics known as "cephalosporins", used to treat infections caused by bacteria.

This medication is used to treat:

• Acute middle ear infection
• Infection that causes sudden worsening of long-term bronchitis
• Uncomplicated acute bladder infection

• Acute throat infection caused by bacteria
• Uncomplicated acute infections in the urinary tract (uncomplicated acute cystitis)
• Uncomplicated acute gonorrhea

2. What you need to know before taking Cefixime Neclife

Do not take Cefixime Neclife if:

• you are allergic to cefixime or any of the other components of this medication (listed in section 6). An allergic reaction can consist of a skin rash (hives), itching, difficulty swallowing or breathing, or swelling of the face, lips, throat, and tongue.
• you are allergic to any other type of cephalosporin antibiotic.
• you have had a severe allergic reaction to penicillin or any other type of beta-lactam antibiotic.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

Before taking cefixime, you must inform your doctor if:

• you are allergic to penicillin or any other beta-lactam antibiotic.

Not everyone who is allergic to penicillins is also allergic to cephalosporins. However, you should be especially cautious if you have ever had an allergic reaction to any penicillin, as you may also be allergic to this medication.

If a patient experiences a severe allergic reaction or anaphylaxis (severe allergic reaction that causes difficulty breathing or dizziness) after administration of Cefixime Neclife, the administration will be discontinued and the corresponding treatment will be provided.

• You have ever been told that your kidneys do not work very well. Additionally, if you are undergoing any type of treatment (such as dialysis) for kidney failure. You can take cefixime but may need a lower dose. (Children with kidney problems should not receive cefixime).

• You have severe or persistent diarrhea that may be bloody and may be associated with stomach pain or cramps: these symptoms can occur during or shortly after treatment and are rare but can present potentially fatal adverse reactions. Stop taking cefixime and contact your doctor immediately. Medications that can decrease or stop intestinal movements should not be taken.

Treatment with a cycle of cefixime may transiently increase the likelihood of developing infections caused by other types of germs that cefixime does not affect. For example, you may develop oral candidiasis (infection caused by a yeast-like fungus called Candida).

Other medications and Cefixime Neclife

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

In particular, inform your doctor or pharmacist if you are taking:

• Anticoagulants (medications that prevent blood clotting)

• Interference with laboratory tests

• If you have a blood or urine test, inform your doctor that you are taking this medication, as cefixime may alter the results of some of these tests.

• This medication may alter the results of some urine sugar tests, such as Benedict's test, Fehling's test, or copper sulfate test. As with other cephalosporins, cefixime may alter the results of a blood test to detect antibodies called the direct Coombs test.

Pregnancy, breastfeeding, and fertility

This medication is specifically made for children. However, if you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and using machines

Cefixime may cause dizziness. If you are affected, do not drive or operate machinery.

Taking Cefixime Neclife with food and drinks

Cefixime can be taken with or without food.

Important information about some of the ingredients of Cefixime Neclife

Cefixime Neclife contains:

Sucrose:this medication contains approximately 2.33 g of sucrose in each 5 ml after reconstitution. This should be taken into account in patients with diabetes mellitus. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medication. It may be harmful to teeth when the medication is used for chronic use, e.g., for two weeks or more.Sodium benzoate:this medication contains 10.0 mg of sodium benzoate in each 5 ml after reconstitution. Sodium benzoate may increase jaundice (yellow color of the skin and eyes) in newborn babies (up to 4 weeks of age).

3. How to take Cefixime Neclife

Follow the administration instructions of this medication exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Usual dose for adults and adolescents (12 years and older)The usual dose in adults is 400 mg per day, either as a single dose or in two divided doses. If your doctor has prescribed a dose per day, it should be taken every 24 hours. If your doctor has prescribed two doses per day, each dose should be taken every 12 hours. The medication should always be taken at the same time every day.

Children over 6 months and up to 11 years. Children receive cefixime as an oral suspension (liquid taken orally). The daily dose is calculated according to the child's weight. Generally, the total amount per day is 8 mg per kilogram of body weight in a single dose or divided into 2 doses according to weight. For exact dose administration, the package is supplied with a 5 ml plastic oral syringe marked every 0.25 ml. As a general guideline for usual doses, see the following table.

Children under 6 years

The use of this medication is not recommended in children under 6 months of age.

Elderly patients

No dose adjustment is necessary in elderly patients, provided the kidneys are functioning properly.

Renal impairment

If you have severe kidney problems or are undergoing dialysis, your doctor will reduce your dose. There is not enough data on the use of this medication in children with kidney problems. Therefore, the use of Cefixime Neclife is not recommended in these patients.

Preparation of Cefixime Neclife

50 ml of oral suspension:Shake to loosen the powder. Add 35 ml of water in two portions to the dry mixture in the bottle. Shake well after each addition. No further dilution is recommended.

100 ml of oral suspension:Shake to loosen the powder. Add 69 ml of water in two portions to the dry mixture in the bottle. Shake well after each addition. No further dilution is recommended.

If you take more Cefixime Neclife than you should

If you take more of this medication than you should, contact the emergency department of the nearest hospital or your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service (Tel. 91 562 04 20), indicating the medication and the amount ingested.

If you forget to take Cefixime Neclife

If you forget to take a dose, take it as soon as you remember. However, if the next dose is due in less than 6 hours, skip the missed dose and return to your regular dosing schedule. Do not take a double dose to make up for a missed dose.

If you interrupt treatment with Cefixime Neclife

It is important that you take this medication until you complete the entire treatment prescribed by your doctor. If you stop taking it too soon, the infection may recur.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Allergic reactionsAll medications can cause allergic reactions, although severe allergic reactions are generally rare (may affect up to 1 in 1,000 people). These can include: • Sudden breathing and chest tightness • Swelling of the eyelids, face, or lips. • Severe skin rashes that can lead to blisters and can affect the eyes, mouth, throat, and genitals.

All these allergic reactions require urgent medical attention. If you think you are having any of these types of reactions, stop taking this medication and contact your doctor or the emergency department of the nearest hospital.

The following side effects have been reported:

Frequent(may affect up to 1 in 10 people):

• Diarrhea (If you have severe diarrhea or see blood in your stool, you should stop taking this medication and talk to your doctor immediately, as you may have a rare intestinal infection that requires special treatment)

Uncommon(may affect up to 1 in 100 people):

• Headache
• Nausea
• Vomiting
• Abdominal pain (in the stomach),
• Skin rash
• Changes in blood tests that measure liver function

Rare(may affect up to 1 in 1,000 people):

• Severe allergic reaction that causes swelling of the face or throat (angioedema)
• Hypersensitivity reactions (these are skin rashes that are less severe allergic reactions than those mentioned above, irregular rash [hives], itching)
• Dizziness
• Lack of appetite (anorexia)
• Flatulence (gas)
• Itching of the skin
• Fever
• Increased number of a type of white blood cell called eosinophils
• Inflammation of the mucous membranes
• Recurrent infections caused by bacteria.
• Recurrent infections caused by fungi.
• Changes in special blood tests that show how your kidneys are working

Very rare(may affect up to 1 in 10,000 people):

• Blisters or bleeding of the skin around the lips, eyes, mouth, nose, and genitals. Also, flu-like symptoms and fever (Stevens-Johnson syndrome) • Severe rash with blisters where the layers of the skin can peel off, leaving large areas of raw and exposed skin on the body. Also, a feeling of discomfort, fever, chills, and muscle pain (toxic epidermal necrolysis) • Hypersensitivity reaction that causes symptoms such as rash, joint pain, fever, and shock (serum sickness) • A feeling of restlessness associated with increased activity (psychomotor hyperactivity) • Severe allergic reaction that causes difficulty breathing or shock (anaphylactic shock) inflammation of the intestines that sometimes occurs after antibiotic treatment (antibiotic-associated colitis) • Severe reduction in the number of white blood cells, making infections more likely (agranulocytosis)
• Severe reduction in blood cells that can cause weakness, bruising, or make infections more likely (pancytopenia) • Decrease in the number of small cells needed for blood clotting, increasing the risk of bleeding or bruising (thrombocytopenia) (if you have a blood test for any reason, tell the person taking your blood sample that you are taking this medication, as it may affect the result) • Reduction in red blood cells that can make the skin pale and cause weakness or difficulty breathing (hemolytic anemia) • Low white blood cell count (leukopenia) • Reversible inflammation of the kidney that affects its structure and function. • Inflammation of the liver (hepatitis) • Bile disorder (cholestatic jaundice) • Changes in special blood tests that show how your kidney is working (increased creatinine in the blood)

Frequency not known(cannot be estimated from the available data):

• Increased platelet count (thrombocytosis)
• Decreased number of a type of white blood cell (neutropenia)
• Indigestion
• Skin rash or skin lesions with a pink/red ring and a pale center, which can itch, scale, or be filled with fluid. The rash appears especially on the palms of the hands or soles of the feet. They can be signs of a severe allergy to the medication, called "erythema multiforme".
• A brain condition with symptoms including seizures (convulsions), feeling confused, feeling less alert or aware than usual, unusual muscle movements, or stiffness. This can be something called encephalopathy. This side effect is more likely if you have taken an overdose or if you already have a kidney problem.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Cefixime Neclife

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

Do not use this medication after the expiration date that appears on the box after {CAD}. The expiration date is the last day of the month indicated.

Unopened: Store below 25 °C. Do not refrigerate or freeze.

After reconstitution, the suspension can be stored below 25 °C for 14 days. Do not refrigerate or freeze. Keep the bottles well closed and shake them well before use. Discard any unused portion after 14 days. Dilution of the suspension is not recommended.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the Sigre Point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Cefixima Neclife

The active ingredient is cefixime.

• The other components are: xanthan gum, sodium benzoate, anhydrous colloidal silica, sucrose, guarana strawberry flavor (which contains nature-identical aromas, natural flavors, corn maltodextrin, and propylene glycol)

Appearance of the product and packaging content

Cefixima Neclife is a granular powder with a white to pale yellow color and a guarana strawberry flavor. Each 5 ml of reconstituted suspension contains cefixime trihydrate equivalent to 100 mg of cefixime. Cefixima Neclife is presented in a Type III amber glass bottle with a white CR Pilfer Proof closure containing 25 g or 50 g of powder for the preparation of 50 ml or 100 ml of oral suspension, respectively. The bottles are supplied with a measuring cup marked "35 ml" and "69 ml"; which can measure 35 ml and 69 ml of water for reconstitution. The bottles are supplied with a 5 ml plastic oral syringe graduated in 0.25 ml divisions. Only some package sizes may be marketed

Marketing authorization holder and manufacturer

Marketing authorization holder

Nectlife PT, Unipessoal LDA

Rua Brito Pais, 8C

1495-028 Alges

Portugal

Manufacturer

PHARMADOX HEALTHCARE LIMITED

KW20A Kordin Industrial Park

PLA 3000 Paola

Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Portugal:Cefixime Nectar

Germany:Cefixime Nectar

Spain:Cefixime Neclife

Croatia:Cefiksim Nectar

Hungary:Cefixime Nectar

Ireland:Cefixime Nectar Lifesciences

Italy:Cefixime Nectar

Date of the last revision of this leaflet: October2018

Detailed and updated 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/