Package Leaflet: Information for the User

Clamoxyl 1 g Dispersible Tablets

amoxicillin

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you (or your child) only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

What is Clamoxyl

Clamoxyl is an antibiotic. The active ingredient is amoxicillin. This belongs to a group of medicines called “penicillins”.

What is Clamoxyl used for

Clamoxyl is used to treat bacterial infections in different parts of the body. Clamoxyl can also be used in combination with other medications to treat stomach ulcers.

Do not take Clamoxyl

• if you are allergic to amoxicillin, penicillin, or any of the other components of this medication (listed in section 6)
• if you have ever had an allergic reaction to any antibiotic. This may include a skin rash or swelling of the face or throat.

Do not take Clamoxyl if any of the above points apply to you. If you are unsure, consult your doctor or pharmacist before taking Clamoxyl.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Clamoxyl if:

• you have infectious mononucleosis (fever, sore throat, swollen lymph nodes, and extreme fatigue)
• you have kidney problems
• you do not urinate regularly.

If you are unsure whether any of the above symptoms apply to you, consult your doctor or pharmacist before taking Clamoxyl.

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)

Inform your doctor or pharmacist that you are taking Clamoxyl. This is because Clamoxyl may affect the results of these types of tests.

Other medications and Clamoxyl

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

• If you are taking allopurinol (used for gout) with Clamoxyl, you may be more likely to have a skin allergic reaction.
• If you are taking probenecid (used to treat gout), it may reduce the excretion of amoxicillin and is not recommended. Your doctor may need to adjust the dose of Clamoxyl.
• If you are taking anticoagulants (such as warfarin), you may need more blood tests.
• If you are taking other antibiotics (such as tetracycline), Clamoxyl may be less effective.
• If you are taking methotrexate (a medication used to treat cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate and cause a potential increase in adverse effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Clamoxyl may have adverse effects and symptoms (such as allergic reactions, dizziness, and seizures) that may make you unfit to drive.

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

Clamoxyl 1 g dispersible tablets contain aspartame

This medication contains 20 mg of aspartame in each dispersible tablet. Aspartame contains a source of phenylalanine that may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

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

• Add the tablet to a glass of water and stir well until it dissolves

uniformly. Swallow the mixture immediately.

• This oral formulation may be suitable for patients who cannot swallow capsules. Other presentations are available, depending on the dose.

• Space the doses uniformly throughout the day, with at least a 4-hour interval.

The usual dose is:

Children under 40 kg in weight

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

• Your doctor will tell you how much Clamoxyl to administer 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 and children 40 kg or more in weight

The usual dose of Clamoxyl 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 infections:3 g twice a day, for one day.
• Lyme disease (a disease transmitted by ticks):erythema migrans (early stages – circular pink or red 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:dose of 750 mg or 1 g, twice a day, for 7 days, with other antibiotics and medications to treat 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 more details.
• The maximum recommended daily dose is 6 g per day.

Renal problems

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

If you take more Clamoxyl than you should

If you have taken more Clamoxyl than you should, the signs may be stomach discomfort (nausea, vomiting, or diarrhea) or crystals in the urine, which may be observed as cloudy urine, or difficulty urinating. Talk to your doctor as soon as possible. Bring the medication to show it to your doctor.

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

If you forgot to take Clamoxyl

• 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 compensate for the missed doses.

How long should you take Clamoxyl

• Continue taking Clamoxyl 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 recur.
• Once you have finished the treatment, if you continue to feel unwell, you should go back to see your doctor.

Candidiasis (a fungal infection of the moist parts of the body that can cause pain, itching, and white discharge) may appear if you take Clamoxyl for a prolonged period. If this happens, consult your doctor.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Clamoxyl and see a doctor immediately if you experience any of the following severe 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, symptoms may include: skin itching or rash, facial swelling, lip, tongue, body, or difficulty breathing. These can be severe and, in some cases, have been fatal
• Rash or flat, round, red spots like the tip of a needle under the skin's surface or skin bruises. This is due to the inflammation of blood vessel walls due to an allergic reaction. It may be associated with joint pain (arthritis) and kidney problems
• You may experience a delayed allergic reaction, usually within 7 to 12 days after taking Clamoxyl, some symptoms include: rashes, fever, joint pain, and lymph node enlargement, 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, and genitals.You may have a fever and feel very tired
• Other severe skin reactions may include: skin color change, lumps under the skin, blisters, pustules with pus, skin peeling, redness, pain, itching. These may be associated with fever, headaches, and body aches
• Symptoms similar to the flu, with rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
• Fever, chills, sore throat, or other signs of infection, or the appearance of bruises easily. These may be signs of a problem with your blood cells
• Colitis, an inflammation of the large intestine, with diarrhea (sometimes with blood), pain, and fever
• You may experience severe liver side effects. These are mainly associated with prolonged treatment, men, and advanced age.You should inform your doctor urgently if you have:
• • Severe diarrhea with bleeding
  • Blisters, redness, or bruises on the skin
  • Dark urine or pale stools
  • Skin and white of the eyes turning yellow (jaundice). See anemia below, which may cause jaundice.

These may occur during treatment or several weeks after.

The following side effects are not known (frequency cannot be estimated from available data)

• Jarish Herxheimer reaction that occurs during Clamoxyl treatment for Lyme disease and causesfever, chills, headache, muscle pain, and skin rash

• Chest pain in the context of allergic reactions, which may be a symptom of an allergy-induced heart attack (Kounis syndrome)
• Medication-induced enterocolitis (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 medication). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

If any of the above symptoms appear, stop taking the medication and see your doctor immediately.

Occasionally, you may experience milder skin reactions, such as:

• A rash with moderate itching (round, pink-red spots), swollen areas with blister-like appearance on forearms, legs, palms, hands, or feet. This is rare (may affect up to 1 in 100 people).

If you experience any of them, talk to your doctor as you may need to interrupt your Clamoxyl treatment.

Other possible side effects are:

Frequent(may affect up to 1 in 10 people)

• skin rash
• Nausea
• Diarrhea

Rare(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), you can get treatment from your doctor or pharmacist for candidiasis
• Kidney problems
• Seizures (convulsions), observed in patients treated with high doses or kidney problems
• Dizziness
• Hypersensitivity
• Alteration in tooth color, which usually disappears with brushing (this has been reported in children)
• The tongue may change color to yellow, brown, or black and may appear hairy
• Excessive red blood cell breakdown, causing a type of anemia. Symptoms include: fatigue, headache, difficulty breathing, dizziness, paleness, and yellowing of the skin and white of the eyes
• Low white blood cell count
• Low count of cells involved in blood clotting
• Blood may take longer than usual to clot. You may notice this if you bleed from the nose or cut yourself.

Not known(frequency cannot be estimated from available data)

• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• Rash with blisters arranged in a circle with a central crust or like a pearl necklace (IgA linear disease)
• Crystals in the urine that cause acute kidney damage,which may appear as cloudy urine or difficulty or discomfort urinating.Make sure to drink plenty of fluids to reduce the risk of these symptoms.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Do not store at a temperature above 25°C.

Do not use this medication if you observe visible signs of deterioration.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need.By doing so, you will help protect the environment.

C omposition of Clamoxyl

• The active ingredient is amoxicillin. Each dispersible tablet contains 1 g of amoxicillin.
• The other components are: crospovidone, aspartame (E-951), peppermint flavoring, magnesium stearate.

Appearance of the product and content of the packaging

Clamoxyl 1 g dispersible tablets are oval-shaped, white to off-white tablets with a notch, and marked with “1 g”. The notch is only for breaking the tablet, to make it easier to swallow, but not for dividing into equal doses.

They are packaged in blisters, in a case. It is available in packaging sizes of 6, 8, 12, 14, 16, 18, 20, 24, 30, and in a clinical pack of 100 tablets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Responsible for manufacturing

Glaxo Wellcome Production

Z.I. de la Peyennière

53100 Mayenne, France

This medicine is authorized in the member states of the European Economic Area with the following names:

Belgium – Clamoxyl

France – Clamoxyl, Amoxiciline Biogaran

Greece – Amoxil

Luxembourg – Clamoxyl

Portugal – Clamoxyl

Spain – Clamoxyl

Date of the last review of this leaflet : April 2024

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)