Clamoxyl 1g dispersible tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Clamoxyl 1g dispersible tablets

amoxicillin

Read the entire 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 (or your child) only, and you should not give it to other people, even if they have the same symptoms as you, because it may 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.

Leaflet contents

1. What Clamoxyl is and what it is used for
2. What you need to know before taking Clamoxyl
3. How to take Clamoxyl
4. Possible side effects
5. How to store Clamoxyl
6. Contents of the pack and other information

1. What Clamoxyl is and what it is used for

What Clamoxyl is

Clamoxyl is an antibiotic. The active substance is amoxicillin. This belongs to a group of medicines called "penicillins".

What Clamoxyl is used for

Clamoxyl is used to treat bacterial infections in various parts of the body. Clamoxyl may also be used in combination with other medicines to treat stomach ulcers.

2. What you need to know before taking Clamoxyl

Do not take Clamoxyl

• 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 antibiotic. This may include a skin rash or swelling of the face or throat.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Clamoxyl 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 symptoms apply to you, consult your doctor or pharmacist before taking Clamoxyl.

Blood and urine tests

If you are undergoing:

• urine tests (for glucose in urine) 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 Clamoxyl. This is because Clamoxyl may alter the results of these types of tests.

Other medicines and Clamoxyl

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

• If you are taking allopurinol (used for gout) with Clamoxyl, you may be more likely to experience 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 your dose of Clamoxyl.
• If you are taking anticoagulants (such as warfarin), you may require more frequent blood tests.
• If you are taking other antibiotics (such as tetracycline), Clamoxyl may be less effective.
• If you are taking methotrexate (a medicine used to treat cancer and severe psoriasis), penicillins may reduce methotrexate excretion and potentially increase adverse 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 use of machines

Clamoxyl may cause adverse effects, and symptoms (such as allergic reactions, dizziness, and seizures) may impair your ability to drive.

Do not drive or operate machinery unless you feel well.

Clamoxyl 1g dispersible tablets contain 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 properly eliminate it.

3. How to take Clamoxyl

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

• Add the tablet to a glass of water and stir well until it is uniformly mixed. 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 your 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 calculated based on the child's body weight in kilograms.

• Your doctor will tell you how much Clamoxyl to give 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 recommended dose is 100 mg per kilogram of body weight per day.

Adults and children weighing 40 kg or more

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 infection: 3 g twice a day for one day.
• Lyme disease (an infection transmitted by parasites called ticks): isolated erythema migrans (early stages – single 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: 750 mg or 1 g twice a day for 7 days, in combination 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 daily dose is 6 g per day.

Kidney problems

If you have kidney problems, your 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, symptoms may include stomach upset (nausea, vomiting, or diarrhea), or crystals in the urine, which may appear as cloudy urine, or problems urinating. Contact your doctor as soon as possible. Take the medicine with you so you can show it to the doctor.

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

If you forget 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 make up for a missed dose.

How long you should take Clamoxyl

• Continue taking Clamoxyl for as long as your doctor has instructed, even if you start to feel better. You need to take all the doses to completely eliminate the infection. If some bacteria survive, the infection may return.
• After completing treatment, if you still feel unwell, you should see your doctor again.

Candidiasis (a fungal infection in moist areas of the body that may cause pain, itching, and white discharge) may occur if Clamoxyl is taken for a prolonged period. If this happens, consult your doctor.

If you take Clamoxyl for a prolonged period, your doctor may perform additional blood tests to check that your kidneys, liver, and blood are functioning normally.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

Stop taking Clamoxyl and go 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 resulted in death
• skin rash or flat red pinpoint spots under the skin surface or skin bruising. 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, usually 7 to 12 days after taking Clamoxyl; 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: purple or reddish itchy spots on the skin, especially on the palms of the hands or soles of the feet, swollen raised areas on the skin, soft tissue lesions on the surface of 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, skin peeling, redness, pain, itching. These may be associated with fever, headache, and body aches
• flu-like symptoms, with rash, fever, swollen glands, 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 easy bruising. These may be signs of a problem with your blood cells
• inflammation of the large intestine (colon) with diarrhoea (sometimes with blood), 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 urgently inform your doctor if you have:
  • severe diarrhoea 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 anaemia below, which may lead to jaundice.

These may occur during treatment or up to several weeks afterwards.

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

• Jarish-Herxheimer reaction occurring during treatment with Clamoxyl for Lyme disease and causing fever, chills, headache, muscle pain, and skin rash
• chest pain in the context of allergic reactions, which may be a symptom of an allergic-triggered heart attack (Kounis syndrome)
• red rash typically observed on both sides of the buttocks, upper inner thighs, armpits, and neck [symmetric drug-related intertriginous and flexural exanthema (SDRIFE)]
• drug-induced enterocolitis syndrome (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, diarrhoea, and low blood pressure.

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

Sometimes you may experience less severe skin reactions, such as:

• a rash with mild itching (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 with your doctor, as you may need to stop your treatment with Clamoxyl.

Other possible adverse effects are:

Frequent (may affect up to 1 in 10 people)

• skin rash
• nausea
• diarrhoea.

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
• epileptic seizures (convulsions), observed in patients treated with high doses or with kidney problems
• dizziness
• hyperactivity
• change in tooth colour, which usually disappears 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 anaemia. Signs include: tiredness, 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. You may notice this if you have nosebleeds or cuts that bleed excessively.

Not known (frequency cannot be estimated from available data)

• inflammation of the membranes covering the brain and spinal cord (aseptic meningitis)
• blistering rash arranged in circles with central crusts or resembling a string of pearls (linear IgA disease)
• crystals in the urine causing acute kidney injury, 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.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Clamoxyl

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

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25 °C.

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

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

6. Contents of the pack and other information

Composition of Clamoxyl

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

Nature of the product and pack contents

Clamoxyl 1 g dispersible tablets are oval, white to off-white tablets with a score line, and engraved with “1 g”. The score line is intended only to facilitate breaking the tablet for ease of swallowing and does not allow for division into equal doses.

They are packaged in blisters, within a carton. Available in pack sizes of 6, 8, 12, 14, 16, 18, 20, 24, 30 tablets and clinical pack of 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

GlaxoSmithKline, S.A.

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

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Manufacturer

Glaxo Wellcome Production

Z.I. de la Peyennière

53100 Mayenne, France

This medicinal product is authorized in the European Economic Area member states under the following names:

Belgium – Clamoxyl

France – Clamoxyl, Amoxiciline Biogaran

Greece – Amoxil

Luxembourg – Clamoxyl

Portugal – Clamoxyl

Spain – Clamoxyl

Date of the most recent revision of this leaflet: July 2025

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/)