CLAMOXYL 1g DISPERSIBLE TABLETS

Introduction

Package Leaflet: Information for the User

Clamoxyl 1g Dispersible Tablets

amoxicillin

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Clamoxyl is and what it is used for
2. What you need to know before you take Clamoxyl
3. How to take Clamoxyl
4. Possible side effects
5. Storing 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 infections caused by bacteria in different parts of the body. Clamoxyl can also be used in combination with other medicines to treat stomach ulcers.

2. What you need to know before you take 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 can include a skin rash or swelling of the face or throat.

Do not take Clamoxyl if any of the above applies to you. If you are not sure, 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 glands, and extreme tiredness)
• you have kidney problems
• you do not urinate regularly.

If you are not sure if 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).

Tell your doctor or pharmacist that you are taking Clamoxyl. This is because Clamoxyl can affect 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 use any other medicines.

• If you are taking allopurinol (used for gout) with Clamoxyl, you may be more likely to suffer 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 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 medicine used to treat cancer and severe psoriasis), penicillins can 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

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

Clamoxyl 1g Dispersible Tablets contain aspartame

This medicine contains 20 mg of aspartame in each 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 eliminate it properly.

3. How to take Clamoxyl

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

• Add the tablet to a glass of water and stir well until it is evenly mixed. Swallow the mixture immediately.

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

• Space the doses evenly throughout the day, at least 4 hours apart.

The usual dose is:

Children under 40kg of body weight

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

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

Adults and children over 40kg of body 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 infection:3 g twice a day, for one day.
• Lyme disease (an infection transmitted by parasites called ticks):isolated erythema migrans (early stages - circular pink or red rash): 4 g per day; systemic manifestations (later stages - with 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, 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 can give you more details.
• The maximum recommended daily 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 Clamoxyl than you should

If you have taken more Clamoxyl 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 problems urinating. Talk to your doctor as soon as possible. Take the medicine with you to show the 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 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 forgotten doses.

How long to 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 can cause the infection to come back.
• Once you have finished 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 appear if you take Clamoxyl for a long time. If this happens, consult your doctor.

If you take Clamoxyl 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 Clamoxyl and see a doctor immediately if you get 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 appear, usually 7 to 12 days after taking Clamoxyl, 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 can develop: purple or reddish patches 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 be very tired
• other serious skin reactions can include: change in skin color, lumps under the skin, blisters, pimples with pus, skin peeling, redness, pain, itching. These can 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 can be signs of a problem with your blood cells
• inflammation of the large intestine (colon) with diarrhea (sometimes with blood), pain, and fever
• serious liver effects can occur. These are mainly associated with prolonged treatments, males, and the elderly. You should urgently tell your doctor 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.

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

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

• chest pain in the context of allergic reactions, which can be a symptom of allergy-induced heart attack (Kounis syndrome)
• a skin rash called ‘symmetrical drug-related intertriginous and flexural exanthema’ (SDRIFE) which is normally seen on both sides of the buttocks, in the upper inner thighs, in the armpits, in the neck
• 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 of repeated vomiting (1-4 hours after taking the medicine). Other symptoms can include abdominal pain, lethargy, diarrhea, and low blood pressure.

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

Sometimes you may get less serious skin reactions, such as:

• a rash with moderate itching (round pink-red patches), 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 get any of these, talk to your doctor as you may need to stop your treatment with Clamoxyl.

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), seen in patients treated with high doses or with kidney problems
• dizziness
• hyperactivity
• 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 normal to clot. You may notice this if you have a nosebleed or cut yourself.

Not known(frequency cannot be estimated from the available data)

• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• a rash with blisters arranged in a circle with a central crust or like a string of pearls (linear IgA disease)
• crystals in the urine that cause acute kidney injury, 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.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Clamoxyl

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 refers to the last day of the month shown.

Do not store above 25°C.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Composition of Clamoxyl

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

Appearance of the Product and Container Content

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 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 box. It is available in packs of 6, 8, 12, 14, 16, 18, 20, 24, 30 and in a clinical pack of 100 tablets.

Only some 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

es-ci@gsk.com

Manufacturer

Glaxo Wellcome Production

Z.I. de la Peyennière

53100 Mayenne, France

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

Belgium – Clamoxyl

France – Clamoxyl, Amoxiciline Biogaran

Greece – Amoxil

Luxembourg – Clamoxyl

Portugal – Clamoxyl

Spain – Clamoxyl

Date of the last revision of this leaflet: April 2024

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/)