Label: information for the user

Amoxicillin/Clavulanate Alter 875 mg/125 mg film-coated tablets

EFG-coated

Read the entire label carefully before starting to take the medication.

• Keep this label, as you may need to refer to it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label.See section 4.

1. What isAmoxicillin/Clavulanate Alterand what it is used for

2. What you need to know before starting to takeAmoxicillin/Clavulanate Alter

3. How to takeAmoxicillin/Clavulanate Alter

4. Possible adverse effects

5. Storage ofAmoxicillin/Clavulanate Alter

6. Contents of the package and additional information

Amoxicilina/Ácido clavulánico Alter is an antibiotic that eliminates the bacteria that cause infections. It contains two different medications called amoxicilina and ácido clavulánico. Amoxicilina belongs to a group of medications known as “penicilinas” that sometimes may lose its effectiveness (become inactivated). The other component (ácido clavulánico) prevents this from happening.

Amoxicilina/Ácido clavulánico Alter is used in children and adults to treat the following infections:

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

Do not take Amoxicilina/Ácido clavulánico Alter :

Do not take Amoxicilina/Ácido clavulánico Alter if you are included in any of the above points

before. Before starting treatment with Amoxicilina/Ácido clavulánico Alter, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Inform your doctor or pharmacist before taking this medication if:

If you are unsure whether any of the above symptoms affect you, inform your doctor or pharmacist before taking Amoxicilina/Ácido clavulánico Alter.

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

Depending on the results, your doctor may prescribe a different presentation of Amoxicilina/Ácido clavulánico Alter or another medication.

Symptoms to be aware of

Amoxicilina/Ácido clavulánico Alter may worsen existing conditions or cause serious side effects. These include allergic reactions, convulsions and inflammation of the large intestine. Be aware of certain symptoms while taking Amoxicilina/Ácido clavulánico Alter to reduce the risk of problems. See “Symptoms to be aware of” in section 4.

Blood and urine tests

If you are having blood tests (such as red blood cell studies or liver function studies) or urine tests (to control glucose levels), inform your doctor or nurse that you are taking Amoxicilina/Ácido clavulánico Alter. This is because Amoxicilina/Ácido clavulánico Alter may affect the results of these types of tests.

Use of Amoxicilina/Ácido clavulánico Alter with other medications

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

If you are taking allopurinol (used for gout) with Amoxicilina/Ácido clavulánico Alter, you may be more likely to suffer a skin allergic reaction.

If you are taking methotrexate (medication used to treat cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate and cause a potential increase in side effects.

If you are taking probenecid (used for gout), the concomitant use of probenecid may reduce the excretion of amoxicilina and is not recommended.

If you are taking probenecid (used for gout) your doctor may adjust the dose of Amoxicilina/Ácido clavulánico Alter.

If you are taking anticoagulants (such as warfarin) with Amoxicilina/Ácido clavulánico Alter, more blood tests will be needed.

Amoxicilina/Ácido clavulánico Alter may affect the action of methotrexate (medication used to treat cancer or rheumatic diseases).

Amoxicilina/Ácido clavulánico Alter may affect the way micofenolato de mofetilo (a medication used to prevent organ rejection in transplant patients) works.

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Amoxicilina/Ácido clavulánico Alter may cause side effects and symptoms that may make you unable to drive. Do not drive or operate machinery unless you feel well.

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

Adults and children 40 kg or more

Children under 40 kg of weight

It is preferable to treat children 6 years or less with oral suspension of Amoxicillin/Clavulanic acid or the sachets.

Ask your doctor or pharmacist for advice when administering Amoxicillin/Clavulanic acid Alter to children weighing less than 40 kg.The tablets are not suitable for children weighing less than 25 kg.

Patients with kidney and liver problems

How to take Amoxicillin/Clavulanic acid Alter

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

If you take too much Amoxicillin/Clavulanic acid Alter, you may experience symptoms such as stomach discomfort (nausea, vomiting, or diarrhea) or convulsions. Consult your doctor as soon as possible. Bring the packaging with you to show the doctor.

You can also call the Toxicology Information Service, phone91 562 04 20indicating the medication 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 the missed dose.

If you stop taking Amoxicillin/Clavulanic acid Alter

Continue taking Amoxicillin/Clavulanic acid Alter until you complete the treatment, even if you feel better. You need to take the complete treatment to cure the infection. If you do not, the surviving bacteria may cause you to get the infection again.

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

Like all medicines, Amoxicilina/Ácido clavulánico Alter may cause side effects, although not everyone will experience them.

Symptoms to be aware of

Allergic reactions:

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

Contact your doctor immediately if you experience any of these symptoms. Stop taking Amoxicilina/Ácido clavulánico Alter.

Colitis

Colitis, which causes watery diarrhea, usually with blood and mucus, stomach pain, and/or fever.

Acute pancreatitis

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

Drug-induced enterocolitis syndrome (DIES):

DIES has been mainly reported in children taking amoxicillin/clavulanic acid. 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.

Contact your doctor as soon as possibleto advise you, if you experience these symptoms.

Very common side effects

May affect more than 1 in 10 patients

• diarrhea (in adults).

Common side effects

May affect up to 1 in 10 patients

• mouth ulcers (candida infection in the vagina, mouth, or mucous membranes)
• nausea, especially when taking high doses

Take Amoxicilina/Ácido clavulánico Alter before meals if this happens

• vomiting
• diarrhea (in children).

Uncommon side effects

May affect 1 in 100 patients

• skin rash, itching
• increased pruritic rash (urticarial)
• indigestion
• dizziness
• headache.

Side effects that may appear in blood tests:

Increased levels of certain substances (enzymes) produced by the liver.

Rare side effects

May affect up to 1 in 1,000 patients

• skin rash, which may form blisters that resemble small darts (erythema multiforme)

if you experience any of these symptoms, consult a doctor urgently

Side effects that may appear in blood tests:

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

Other side effects

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

• Allergic reactions (see above)
• Colitis (see above)
• Severe skin reactions:
• • generalized rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and in its most severe form, causing widespread skin peeling (toxic epidermal necrolysis)
  • generalized rash with small blisters with pus (exfoliative bullous dermatitis)
  • red rash, with bumps under the skin and blisters (pustular exanthem)
  • flu-like symptoms with skin rash, fever, swollen lymph nodes, and abnormal blood test results (such as increased eosinophils and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)).

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

• inflammation of the liver (hepatitis)
• jaundice, caused by increased bilirubin in the blood (a substance produced by the liver) that may turn the skin and the white of the eyes yellow
• inflammation of the kidney tubules
• delayed blood clotting
• hyperactivity
• seizures (in patients taking high doses of Amoxicilina/Ácido clavulánico Alter or with kidney problems)
• black tongue that appears hairy
• stained teeth (in children), which usually disappears with brushing
• eruption with blisters arranged in a circle with a central crust or as a pearl necklace (IgA linear disease)

inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).

Side effects that may appear in blood or urine tests:

• significant reduction in the number of white blood cells
• low count of red blood cells (hemolytic anemia)
• crystals in the urine that cause acute kidney injury.

Reporting 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 Pharmacovigilance of Medicines for Human Use: http://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, after CAD that appears on the packaging. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Store in the original packaging to protect it from light.

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.

Composition of Amoxicillin/Clavulanic Acid Alter

The active ingredients are amoxicillin and clavulanic acid. A film-coated tablet contains 1.004,3 mg of Amoxicillin trihydrate equivalent to 875 mg of Amoxicillin and 148.9 mg of Clavulanate potassium equivalent to 125 mg of clavulanic acid.

The other components (excipients) are: Microcrystalline cellulose, Sodium starch glycolate, Colloidal anhydrous silica, Povidone, Eudragit 100, Magnesium stearate, Hypromellose, Titanium dioxide (E171), Macrogol 400 and Talc.

Appearance of the product and contents of the package

Amoxicillin/Clavulanic Acid Alter are capsule-shaped tablets, white to off-white in color, bearing the imprint “RX509” on one face and a notch on the other face.

Packages of 8, 10, 12, 14, 16, 20, 21, 24, 28, 30, 60 and 100 tablets in PVC/PVdC/Alu blisters within a carton (Polyester/aluminium/polyester/polyethylene), containing a desiccant bag.

Do not eat the desiccant bag contained in the inner carton.

Not all package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Alter Laboratories, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Responsible for manufacturing:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87,

2132JH Hoofddorp,

Netherlands

or

Terapia SA

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

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

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

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

Last review date of this leaflet:September 2017

Medical advice/counseling

Antibiotics are used for the treatment of bacterial infections. They are not effective against viral infections.

Occasionally, 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 properly can reduce the likelihood of bacteria becoming resistant to them.

When your doctor prescribes an antibiotic, it is only for the course of your illness. Paying attention to the following advice will help prevent the emergence of resistant bacteria that may make the antibiotic ineffective.

1. It is very important to take the antibiotic in the correct dose, at the indicated hours, and for the correct number of days. Read the label instructions and if you do not understand something, ask your doctor or pharmacist.

2. Do not take an antibiotic unless you have been prescribed it specifically for you and use it only for the infection for which it has been prescribed.

3. Do not take antibiotics that have been prescribed for other people, even if they have the same or a similar infection to yours.

4. Do not give antibiotics that have been prescribed for you to other people.

5. If you still have antibiotics left over after completing treatment, hand over all unused medications to your pharmacy to ensure that the disposal requirements are met.

The detailed information of this medicinal product is available on the website of the Spanish Agency for Medicines: http://www.aemps.gob.es