AMOXICILLIN/CLAVULANIC ACID STADA 500 mg/125 mg FILM-COATED TABLETS

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

Do not take Amoxicillin/Clavulanic Acid Stada:

• if you are allergic to amoxicillin, clavulanic acid, penicillins, or any of the other ingredients of this medicine (listed in 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) when taking an antibiotic.

Do not take Amoxicillin/Clavulanic Acid Stada if you are included in any of the above points.Before starting treatment with amoxicillin/clavulanic acid, 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 not sure if any of the above symptoms affect you, inform your doctor or pharmacist before taking this medicine.

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 or another medicine.

Symptoms to be aware of

Amoxicillin/Clavulanic Acid Stada 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 this medicine 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 this medicine. This is because this medicine can alter the results of these types of tests.

Use of Amoxicillin/Clavulanic Acid Stada with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription and herbal medicines.

If you are taking allopurinol (used for gout) with amoxicillin/clavulanic acid, you may be more likely to suffer a skin allergic reaction.

If you are taking probenecid (used for gout), your doctor may adjust the dose of amoxicillin/clavulanic acid.

If you are taking anticoagulants (such as warfarin) with amoxicillin/clavulanic acid, more blood tests will be needed.

This medicine may affect the action of methotrexate (a medicine used to treat cancer or rheumatic diseases).

This medicine may affect the action of mycophenolate mofetil (a medicine used to prevent organ transplant rejection).

Pregnancy, breastfeeding, and fertility

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

Amoxicillin/Clavulanic Acid Stada may have side effects, and the symptoms may make you unfit to drive.

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

Amoxicillin/Clavulanic Acid Stada contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

3. How to take Amoxicillin/Clavulanic Acid Stada

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

Adults and children over 40 kg

The recommended dose is:

• 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 tablets to children who weigh less than 40 kg.

Patient 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 Stada

• Swallow the tablets whole with a glass of water at the start of meals or a little before.
• Space out the doses during the day, at least 4 hours apart. Do not take 2 doses in 1 hour.
• Do not take amoxicillin/clavulanic acid for more than 2 weeks. If you are still feeling unwell, consult your doctor.

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

If you take too much amoxicillin/clavulanic acid, symptoms such as stomach upset (nausea, vomiting, or diarrhea) or seizures may occur.

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. It is recommended to bring the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to take Amoxicillin/Clavulanic Acid Stada

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.

If you stop taking Amoxicillin/Clavulanic Acid Stada

Continue taking amoxicillin/clavulanic acid until you finish 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 the infection to return.

If you have any further questions on 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.

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 lymph nodes in the 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 an allergic myocardial infarction (Kounis syndrome).

Contact your doctor immediately if you experience any of these symptoms. Stop taking this medicine.

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 pancreatitis

If you have had severe and persistent stomach pain, it may be a sign of acute pancreatitis.

Drug-Induced Enterocolitis Syndrome (DIES)

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 may include abdominal pain, lethargy, diarrhea, and low blood pressure.

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

Very common side effects(may affect more than 1 in 10 people)

• diarrhea (in adults).

Common side effects(may affect up to 1 in 10 people)

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

→ if this happens, take amoxicillin/clavulanic acid before meals

• vomiting
• diarrhea (in children).

Uncommon side effects(may affect up to 1 in 100 people)

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

Uncommon side effects that may appear in your blood tests:

• increase in some substances (enzymes) produced by the liver.

Rare side effects(may affect up to 1 in 1,000 people)

• skin rash, which can form blisters that look like small targets (central dark spot surrounded by a paler area, with a dark ring around the edge - erythema multiforme)

Consult a doctor urgently if you have any of these symptoms.

Rare side effects that may appear in your blood tests:

• low count of blood 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 (cannot be estimated from the available data):

• Allergic reactions (see above)
• Inflammation of the large intestine (see above)
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• Rash with blisters arranged in a circle with a central crust or like a string of pearls (linear IgA disease)
• 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 exfoliative rash, with bumps under the skin and hives (pustular exanthematous)
• 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 your doctor immediately if you have any of these symptoms.

• inflammation of the liver (hepatitis)

• jaundice, caused by an increase in bilirubin in the blood (a substance produced by the liver) that can make the skin and the 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 or with kidney problems)
• black hairy tongue
• stained teeth (in children), which usually disappears with brushing.

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

• significant decrease 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 of side effects

If you experience any side effects, talk to your doctor or pharmacist,even if it is a side effect not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://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 Stada

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

Do not use this medicine after the expiry datethat appears on the packaging and on the blister. The expiry date is the last day of the month indicated.

Do not store above 25°C.

Keep in the original packaging to protect from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amoxicillin/Clavulanic Acid Stada

• The active substances are: amoxicillin and clavulanic acid. Each tablet contains 500 mg of amoxicillin and 125 mg of clavulanic acid.

• The other ingredients are:

Core of the tablet

Colloidal anhydrous silica, magnesium stearate, sodium carboxymethyl starch (type A) (from potato), microcrystalline cellulose

Coating of the tablet

Triethyl citrate, hypromellose, talc, ethylcellulose, cetyl alcohol, sodium lauryl sulfate, titanium dioxide (E171).

Appearance of the product and contents of the pack

Amoxicillin/Clavulanic Acid Stada are film-coated tablets, oblong, white or slightly yellow (10 mm x 21 mm), marked on one side (GG N6).

Amoxicillin/Clavulanic Acid Stada is available in Al/Al blisters containing 10, 12, 20, 21, 24, or 30 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer:STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

Sandoz Gesellschaft m.b.H.

Biochemiestrasse 10

A-6250 Kundl

Austria

or

Clonmel Healthcare Ltd.

Waterford Road, Clonmel, Co. Tipperary

Ireland

Date of last revision of this leaflet: January 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.