Clamoxyl 500 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Clamoxyl 500 mg hard capsules

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.

  1. 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 could 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.

Contents of this leaflet

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 known as "penicillins".

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow the instructions regarding dose, dosing interval, and duration of treatment as given by your doctor.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

What Clamoxyl is used for

Clamoxyl is used to treat bacterial infections in different 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 tiredness)
• 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 (urine glucose) 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 taking, have recently taken, or might need to take 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 Clamoxyl dose.
• If you are taking anticoagulants (such as warfarin), you may need more frequent blood tests.
• If you are taking other antibiotics (such as tetracycline), Clamoxyl may be less effective.
• If you are taking metotrexate (a medicine used to treat cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate and potentially increase adverse effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using 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.

3. How to take Clamoxyl

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

• Swallow the capsules with water, without opening them.
• If you cannot swallow the capsule, inform your doctor, who may prescribe another formulation more suitable for you. Capsules are not suitable for treating patients who cannot swallow capsules due to the risk of choking. Alternative formulations are available, depending on the dose, including oral formulations that can be used specifically in patients who cannot swallow capsules.
• Space the 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 – circular pink or red rash): 4 g per day; systemic manifestations (late stages – more severe symptoms or when the disease spreads through the body): up to 6 g per day.
• Stomach ulcers: 750 mg or 1 g twice a day for 7 days, together 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 given 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 difficulty 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, stating 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 the length of time prescribed by your doctor, 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.
• If you still feel unwell after completing the treatment, you should see your doctor again.

Prolonged use of Clamoxyl may lead to candidiasis (a fungal infection in moist areas of the body that may cause pain, itching, and white discharge). If this occurs, consult your doctor.

If you take Clamoxyl for a prolonged period, your doctor may perform additional blood tests to monitor the normal function of your kidneys, liver, and blood.

If you have any further questions about the use of 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 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 may be severe and, in some cases, have resulted in death
• skin rash or flat, round red spots like pinpricks 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 enlarged lymph nodes, especially under the arms
• a skin reaction called 'erythema multiforme' in which you may develop: itchy purple or reddish 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 also 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 patients undergoing prolonged treatment, males, and advanced age. You must contact your doctor urgently if you experience:
  • severe diarrhoea with bleeding
  • blisters, redness, or bruising of 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, causing fever, chills, headache, muscle pain, and skin rash
• chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by allergy (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 primarily 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 see your doctor immediately.

Sometimes you may experience less serious 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 to 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 is available from your doctor or pharmacist for candidiasis
• kidney problems
• seizures (convulsions), observed in patients treated with high doses or with kidney problems
• dizziness
• hyperactivity
• the tongue may change color to 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. This may be noticed as nosebleeds or prolonged bleeding from cuts.

Not known (frequency cannot be estimated from available data)

• inflammation of the membranes surrounding 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 Medicines: 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 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 drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Clamoxyl

• The active substance is amoxicillin. Each capsule contains 500 mg of amoxicillin (as amoxicillin trihydrate).
• The other components are: magnesium stearate (E-572), gelatin, erythrosine (E-127), titanium dioxide (E-171), indigo carmine (E-132), yellow iron oxide (E-172), and shellac (E-904).

Appearance of the product and contents of the pack

Clamoxyl 500 mg capsules are yellow and red capsules printed with “GS JVL”. They are packaged in blisters, contained in a carton box. Available pack sizes are 10, 12, 16, 20, 21, 24, 30 and 100 capsules.

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

Cyprus – Amoxil

France – Clamoxyl, Amoxicilline Biogaran

Greece – Amoxil

Luxembourg – Clamoxyl

Malta – Amoxil

Portugal – Clamoxyl

Spain – Clamoxyl

Date of the most recent review of this leaflet: December 2024

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.es/