Amoxicillin/clavulanic acid Alter 875 mg/125 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amoxicillin/Clavulanic acid Alter 875 mg/125 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

• 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 and must not be given to other people, even if they have the same symptoms as you, because it could be harmful to them.
• If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Amoxicillin/Clavulanic Acid Alter is and what it is used for

Amoxicillin/Clavulanic Acid Alter is an antibiotic that kills bacteria causing infections. It contains two different active substances called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins," which can sometimes lose their effectiveness (become inactivated). The other component (clavulanic acid) prevents this from happening.

Amoxicillin/Clavulanic acid Alter is used in children and adults to treat the following infections:

• Middle ear and sinus infections
• Respiratory tract infections
• Urinary tract infections
• Skin and soft tissue infections including dental infections
• Bone and joint infections.

2. What you need to know before starting to take Amoxicillin/Clavulanic Acid Alter

Do not take Amoxicillin/Clavulanic Acid Alter:

• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillins, or any of the other components of this medicine (see section 6)
• if you have ever had a severe allergic reaction (hypersensitivity) to any other antibiotic. This could include skin rash or swelling of the face or neck
• if you have ever had liver problems or jaundice (yellowing of the skin) while taking an antibiotic.

Do not take Amoxicillin/Clavulanic Acid Alter if any of the above apply to you. Before starting treatment with Amoxicillin/Clavulanic Acid Alter, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Tell your doctor or pharmacist before taking this medicine if:

• you have infectious mononucleosis
• you are receiving treatment for liver or kidney problems
• you do not urinate regularly.

If you are unsure whether any of the above conditions apply to you, inform your doctor or pharmacist before taking Amoxicillin/Clavulanic Acid Alter.

In some cases, your doctor may investigate the type of bacteria causing your infection.

Depending on the results, you may be prescribed a different formulation of Amoxicillin/Clavulanic Acid Alter or another medicine.

Symptoms to watch out for

Amoxicillin/Clavulanic Acid Alter may worsen certain existing conditions or cause serious adverse effects. These include allergic reactions, seizures, and inflammation of the large intestine. You should be aware of certain symptoms while taking Amoxicillin/Clavulanic Acid Alter to reduce the risk of complications. See “Symptoms to watch out for” in section 4.

Blood and urine tests

If you are having blood tests (such as studies of red blood cell status or liver function tests) or urine tests (to monitor glucose levels), inform your doctor or nurse that you are taking Amoxicillin/Clavulanic Acid Alter. This is because Amoxicillin/Clavulanic Acid Alter may alter the results of these types of tests.

Use of Amoxicillin/Clavulanic Acid Alter with other medicines

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 Amoxicillin/Clavulanic Acid Alter, you may be more likely to experience a skin allergic reaction.

If you are taking methotrexate (a medicine used to treat cancer and severe psoriasis), penicillins may reduce methotrexate excretion and potentially increase its adverse effects.

If you are taking probenecid (used to treat gout), concomitant use with probenecid may reduce amoxicillin excretion and is not recommended.

If you are taking probenecid (used for gout), your doctor may adjust your dose of Amoxicillin/Clavulanic Acid Alter.

If anticoagulants (such as warfarin) are taken with Amoxicillin/Clavulanic Acid Alter, additional blood tests will be required.

Amoxicillin/Clavulanic Acid Alter may affect the action of methotrexate (a medicine used to treat cancer or rheumatic diseases).

Amoxicillin/Clavulanic Acid Alter may affect how mycophenolate mofetil (a medicine used to prevent organ rejection in transplant patients) works.

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.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Amoxicillin/Clavulanic Acid Alter may cause adverse effects, and the symptoms may mean you should not drive. Do not drive or operate machinery unless you feel well.

3. How to take Amoxicillin/Clavulanic Acid Alter

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Adults and children weighing 40 kg or more

• Usual dose – 1 tablet twice a day
• Higher dose – 1 tablet three times a day

Children weighing less than 40 kg

It is preferable to treat children aged 6 years or younger with oral suspension of Amoxicillin/Clavulanic Acid or sachets.

Seek advice from your doctor or pharmacist when administering Amoxicillin/Clavulanic Acid Alter to children weighing less than 40 kg. Tablets are not suitable for children weighing less than 25 kg.

Patients with kidney or liver problems

• If you have kidney problems, your dose may be adjusted. Your doctor may choose a different formulation or another medicine.
• If you have liver problems, you will have blood tests more frequently to monitor liver function.

How to take Amoxicillin/Clavulanic Acid Alter

• Swallow the tablets whole with a glass of water at the beginning of a meal or slightly before. The tablets can be broken along the score line to make swallowing easier. Both halves of the tablet should be taken at the same time.
• Space your doses evenly throughout the day, at least 4 hours apart. Do not take two doses within one hour.
• Do not take Amoxicillin/Clavulanic Acid Alter for longer than 2 weeks. If you continue to feel unwell, consult your doctor.

If you take more Amoxicillin/Clavulanic Acid Alter than you should

If you take too much Amoxicillin/Clavulanic Acid Alter, symptoms such as stomach upset (nausea, vomiting, or diarrhea) or seizures may occur. Contact your doctor as soon as possible. Take the packaging with you to show the doctor.

You can also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Amoxicillin/Clavulanic Acid Alter

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.

If you stop taking Amoxicillin/Clavulanic Acid Alter

Continue taking Amoxicillin/Clavulanic Acid Alter until the end of the treatment, even if you feel better. You need to complete the full course of treatment to cure the infection. If you do not, surviving bacteria may cause the infection to return.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Amoxicillin/Clavulanic acid Alter may cause adverse effects, although not everyone will experience them.

Symptoms to watch for

Allergic reactions:

• skin rash
• inflammation of blood vessels (vasculitis), which may appear as red or purple spots on the skin, but may affect other parts of the body
• fever, joint pain, swollen glands in the neck, armpits, or groin
• swelling, sometimes of the face or mouth (angioedema), causing difficulty breathing
• collapse
• chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by allergy (Kounis syndrome).

Contact your doctor immediately if you experience any of these symptoms. Stop taking Amoxicillin/Clavulanic acid Alter.

Inflammation of the large intestine

Inflammation of the large intestine, causing watery diarrhoea, usually with blood and mucus, stomach pain and/or fever.

Acute inflammation of the pancreas (acute pancreatitis)

If you have severe and persistent pain in the stomach area, this could be a sign of acute pancreatitis.

Drug-induced enterocolitis syndrome (DIES):

DIES has mainly been reported in children receiving amoxicillin/clavulanate. 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.

Contact your doctor as soon as possible for advice if you have these symptoms.

Very common adverse effects

May affect more than 1 in 10 patients

• diarrhoea (in adults)

Common adverse effects

May affect up to 1 in 10 patients

• thrush (Candida – fungal infection in the vagina, mouth, or mucous membranes)
• nausea, especially when taking high doses

If this happens, take Amoxicillin/Clavulanic acid Alter before meals

• vomiting
• diarrhoea (in children)

Uncommon adverse effects

May affect up to 1 in 100 patients

• skin rash, itching
• increased itchy rash (urticarial wheals)
• indigestion
• dizziness
• headache

Uncommon adverse effects that may appear in your blood tests:

Increase in certain substances (enzymes) produced by the liver.

Rare adverse effects

May affect up to 1 in 1,000 patients

• skin rash, which may blister and resemble small targets (central dark spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme)

If you have any of these symptoms, consult a doctor urgently.

Rare adverse effects that may appear in your blood tests:

• low count of cells involved in blood clotting
• low white blood cell count

Other adverse effects

Other adverse effects that have occurred in a very small number of patients and whose exact frequency is unknown:

• Allergic reactions (see above)
• Inflammation of the large intestine (see above)
• Severe skin reactions:
  • widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and in its most severe form, causing widespread skin peeling (more than 30% of body surface – toxic epidermal necrolysis)
  • widespread rash with small pustule-filled blisters (exfoliative bullous dermatitis)
  • red rash with bumps under the skin and blisters (pustular exanthem)
  • flu-like symptoms with skin rash, fever, swollen glands, and abnormal blood test results (such as increased white blood cells (eosinophilia) and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)).

Contact a doctor immediately if you have any of these symptoms.

• inflammation of the liver (hepatitis)
• jaundice, caused by increased bilirubin in the blood (a substance produced by the liver), which may cause the skin and whites of the eyes to turn yellow
• inflammation of the kidney tubules
• delayed blood clotting
• hyperactivity
• seizures (in patients taking high doses of Amoxicillin/Clavulanic acid Alter or who have kidney problems)
• black, hairy-looking tongue
• stained teeth (in children), which usually disappears with brushing
• blistering rash arranged in a ring with central crusting or resembling a "necklace" (linear IgA disease)
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)

Adverse effects that may appear in your blood or urine tests:

• significant decrease in white blood cell count
• low red blood cell count (haemolytic anaemia)
• crystals in the urine causing acute kidney injury

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Amoxicillin/Clavulanic Acid Alter

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

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

Do not store above 25°C.

Keep in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and any empty containers to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This helps protect the environment.

6. Package contents and other information

Composition of Amoxicillin/Clavulanic Acid Alter

The active substances are amoxicillin and clavulanic acid. One film-coated tablet contains 1,004.3 mg of amoxicillin trihydrate, equivalent to 875 mg of amoxicillin, and 148.9 mg of potassium clavulanate, equivalent to 125 mg of clavulanic acid.

The other components (excipients) are: microcrystalline cellulose, sodium starch glycolate from potato, colloidal anhydrous silica, povidone, Eudragit 100, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 400, and talc.

Appearance of the medicine and contents of the pack

Amoxicillin/Clavulanic Acid Alter are capsule-shaped, white to off-white film-coated tablets, marked with "RX509" on one side and with a score line on the other side.

Packs of 8, 10, 12, 14, 16, 20, 21, 24, 28, 30, 60, and 100 tablets in PVC/PVdC/Alu blisters within an outer pouch (polyester/aluminum/polyester/polyethylene), containing a desiccant sachet.

Do not eat the desiccant sachet contained inside the pouch.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Alter, S.A.
Mateo Inurria, 30
28036 Madrid, Spain

Manufacturer:

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp, Netherlands

or

Terapia SA
Str. Fabricii nr. 124, Cluj Napoca, 400 632, Romania

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

Spain – Amoxicillin/Clavulanic Acid Alter 875 mg/125 mg film-coated tablets EFG

Portugal – Amoxicillin+Clavulanic Acid Alter, 875 mg+125 mg, film-coated tablet MG

Date of the most recent revision of this leaflet: September 2017

Advice/Medical education

Antibiotics are used to treat bacterial infections. They are not effective against viral infections.

Sometimes a bacterial infection does not respond to antibiotic treatment. One of the most common reasons for this is that the bacteria causing the infection are resistant to the antibiotic being taken. This means that the bacteria can survive or grow despite the antibiotic.

Bacteria can become resistant to antibiotics for many reasons. Using antibiotics appropriately can reduce the likelihood of bacteria becoming resistant.

When your doctor prescribes an antibiotic, it is intended solely for the treatment of your current illness. Following the advice below will help prevent the development of resistant bacteria, which could make antibiotics ineffective.

1. It is very important to take the antibiotic at the correct dose, at the prescribed times, and for the full duration of treatment. Read the labeling instructions carefully and, if you do not understand something, ask your doctor or pharmacist.
2. Do not take an antibiotic unless it has been specifically prescribed for you, and use it only for the infection for which it was prescribed.
3. Do not take antibiotics prescribed for other people, even if they have the same or a similar infection to yours.
4. Do not give your prescribed antibiotics to other people.
5. If you have leftover antibiotics after completing your treatment, return all unused medicines to your pharmacy to ensure proper disposal.

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines: http://www.aemps.gob.es