AMOXICILLIN/CLAVULANIC ACID ALTER 875 mg/125 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Amoxicillin/Clavulanic Acid Alter 875 mg/125 mg Film-Coated Tablets

Read all of this leaflet carefully before you start taking this medicine.

• 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, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience 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 Package Leaflet:

1. What Amoxicillin/Clavulanic Acid Alter is and what it is used for
2. What you need to know before you take Amoxicillin/Clavulanic Acid Alter
3. How to take Amoxicillin/Clavulanic Acid Alter
4. Possible side effects
5. Storage of Amoxicillin/Clavulanic Acid Alter
6. Package Contents and Further Information

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

Amoxicillin/Clavulanic Acid Alter is an antibiotic that eliminates the bacteria that cause infections. It contains two different active substances called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins" that 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 you 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 a skin rash or swelling of the face or neck
• if you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

Do not take Amoxicillin/Clavulanic Acid Alter if you are included in any of the above points.

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 symptoms affect 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 medication.

Symptoms to be Aware of

Amoxicillin/Clavulanic Acid Alter can worsen certain existing conditions or cause serious side 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 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 status or liver function studies) or urine tests (to check glucose levels), inform your doctor or nurse that you are taking Amoxicillin/Clavulanic Acid Alter. This is because Amoxicillin/Clavulanic Acid Alter can alter the results of these types of tests.

Using Amoxicillin/Clavulanic Acid Alter with Other Medicines

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 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 the excretion of methotrexate and cause a potential increase in side effects.

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

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

If you are taking anticoagulants (such as warfarin) with Amoxicillin/Clavulanic Acid Alter, more blood tests will be needed.

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 have side effects, and the symptoms can make you unfit to drive. Do not drive or operate machinery unless you feel well.

3. How to Take Amoxicillin/Clavulanic Acid Alter

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

Adults and Children Over 40 kg

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

Children Under 40 kg

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

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

Patients with Kidney and Liver Problems

• If you have kidney problems, your dose may be changed. Your doctor may choose a different formulation or another medicine.
• If you have liver problems, you will have more frequent blood tests to check how your liver is working.

How to Take Amoxicillin/Clavulanic Acid Alter

• Swallow the tablets whole with a glass of water at the start of meals or a little before. The tablets can be broken along the score line to make them easier to swallow. You should take both halves of the tablet at the same time.
• Space the doses out during the day, at least 4 hours apart. Do not take two doses in one hour.
• Do not take Amoxicillin/Clavulanic Acid Alter for more than 2 weeks. If you are still feeling unwell, consult your doctor.

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 upset (nausea, vomiting, or diarrhea) or seizures. Consult your doctor as soon as possible. Take the package with you to show the doctor.

You can also call the Toxicology Information Service, phone 91 562 04 20, stating 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 forgotten dose.

If You Stop Taking Amoxicillin/Clavulanic Acid Alter

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

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

4. Possible Side Effects

Like all medicines, Amoxicillin/Clavulanic Acid Alter can cause side effects, although not everybody gets them.

Symptoms to be Aware of

Allergic Reactions:

• skin rash
• inflammation of blood vessels (vasculitis) that can appear as red or purple spots on the skin but can 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), which can cause difficulty breathing
• collapse
• chest pain in the context of allergic reactions, which can be a symptom of allergy-induced heart attack (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, which causes watery diarrhea, usually with blood and mucus, stomach pain, and/or fever.

Acute Inflammation of the Pancreas (Acute Pancreatitis)

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

Drug-Induced Enterocolitis Syndrome (DIES):

DIES has been reported mainly in children receiving amoxicillin/clavulanic acid. It is a certain type of allergic reaction with the main symptom of repeated vomiting (1-4 hours after taking the medicine). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

Contact your doctor as soon as possiblefor advice if you have 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

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

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

• vomiting
• diarrhea (in children).

Uncommon Side Effects

May affect up to 1 in 100 patients

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

Uncommon side effects that may appear in your 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 that can form blisters, which look like 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 side effects that may appear in your 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 not known:

• 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 peeling of the skin (more than 30% of the body surface – toxic epidermal necrolysis)
  • widespread rash with small blisters containing pus (bullous exfoliative dermatitis)
  • red rash with bumps under the skin and blisters (pustular exanthematous eruption)
  • flu-like symptoms with skin rash, fever, gland inflammation, 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) that can make the skin and whites of the eyes turn yellow
• inflammation of the kidney ducts
• delayed blood clotting
• hyperactivity
• seizures (in patients taking high doses of Amoxicillin/Clavulanic Acid Alter or with kidney problems)
• black hairy tongue
• stained teeth (in children), which usually disappears with brushing
• rash with blisters arranged in a circle with a central crust or like a string of pearls (linear IgA disease)

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

Side effects that may appear in your 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 side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side 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, which is stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not store above 25°C.

Store in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Composition of Amoxicillin/Clavulanic Acid Alter

The active ingredients 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 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.

Product Appearance and Container Content

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

Packaging of 8, 10, 12, 14, 16, 20, 21, 24, 28, 30, 60, and 100 tablets in PVC/PVdC/Alu blisters, inside a pouch (Polyester/aluminum/polyester/polyethylene), which contains a desiccant bag.

Do not eat the desiccant bag contained inside the pouch.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder:

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036- Madrid

Spain

Manufacturer:

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 under 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

Date of the last revision of this leaflet:September 2017

Medical Advice/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 properly can reduce the chances 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 you prevent the appearance of resistant bacteria that can make the antibiotic not work.

1. You should not take an antibiotic unless it has been specifically prescribed for you, and you should only use it for the infection for which it was prescribed.
2. You should not take antibiotics that have been prescribed for other people, even if they have the same or a similar infection to yours.
3. You should not give antibiotics that have been prescribed for you to other people.
4. If you still have antibiotic left over after completing the treatment, return all unused medication to your pharmacy to ensure that disposal requirements are met.

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