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

Introduction

Package Leaflet: Information for the User

Amoxicillin/Clavulanic Acid Almus 500 mg/125 mg Film-Coated Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get 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 pack:

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

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

Amoxicillin/Clavulanic Acid Almus is an antibiotic that eliminates the bacteria that cause infections. It contains two different drugs 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 Almus is used in adults and children 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 Almus

Do not take Amoxicillin/Clavulanic Acid Almus:

• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, to penicillins or to any of the other ingredients 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 Almus if you are included in any of the above points.

Before starting treatment with Amoxicillin/Clavulanic Acid Almus, if you are not sure, consult your doctor or pharmacist.

Warnings and precautions

Tell your doctor or pharmacist before taking this medicine if:

• you have infectious mononucleosis
• you are being treated 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 Amoxicillin/Clavulanic Acid Almus.

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

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

Symptoms to be aware of

Amoxicillin/Clavulanic Acid 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 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 to check your liver function (liver function tests) or urine tests (to check glucose levels), inform your doctor or nurse that you are taking Amoxicillin/Clavulanic Acid Almus. This is because amoxicillin/clavulanic acid can alter the results of these types of tests.

Using Amoxicillin/Clavulanic Acid Almus with other medicines

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

If you are taking allopurinol (used for gout) with Amoxicillin/Clavulanic Acid Almus, you may be more likely to suffer 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 anticoagulants (such as warfarin) with Amoxicillin/Clavulanic Acid Almus, more blood tests will be needed.

Amoxicillin/Clavulanic Acid may affect the functioning of mycophenolate mofetil (a medicine used to prevent organ transplant rejection).

Pregnancy and breastfeeding

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.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Amoxicillin/Clavulanic Acid may have side effects, and the symptoms can make you unfit to drive. Do not drive or operate machinery unless you are feeling well.

Amoxicillin/Clavulanic Acid Almus contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially “sodium-free”.

3. How to take Amoxicillin/Clavulanic Acid Almus

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Adults and children over 40 kg

• Usual 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 Almus to children who weigh less than 40 kg. These tablets are not indicated for children under 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 Almus

• Swallow the tablets whole with a glass of water at the start of meals or a little before. The score line is only to facilitate breaking the tablet if you have difficulty swallowing it whole. You should take both halves of the tablet at the same time.
• 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 Almus for more than 2 weeks. If you are still feeling unwell, consult your doctor.

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

If you take too much Amoxicillin/Clavulanic Acid, you may experience symptoms such as stomach upset (nausea, vomiting, or diarrhea). Consult your doctor as soon as possible. Take the pack or bottle with you to show the doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Amoxicillin/Clavulanic Acid Almus

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 Almus

Continue taking Amoxicillin/Clavulanic Acid Almus until you finish the treatment, even if you feel better. You need to take the full treatment to cure the infection. If you do not, the bacteria that survive may cause you to become infected again.

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

4. Possible side effects

Like all medicines, Amoxicillin/Clavulanic Acid Almus 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 immediatelyif you experience any of these symptoms.
• Stop taking Amoxicillin/Clavulanic Acid Almus.

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 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 who receive 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 possiblefor 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 of the vagina, mouth, or mucous membranes)
• Nausea, especially when taking high doses

• if this happens, take Amoxicillin/Clavulanic Acid Almus before meals

• Vomiting
• Diarrhea (in children).

Uncommon side effects

May affect up to 1 in 100 people

• Skin rash, itching
• Increased itchy rash (urticarial rash)
• Indigestion
• Dizziness
• Headache.

Rare 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 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)

• If you have any of these symptoms, consult your doctor urgently

Rare side effects that may appear in your blood or urine 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)
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• 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 red rash with small blisters containing pus (exfoliative dermatitis or vesicular dermatitis)
  • Red exfoliative rash with bumps under the skin and hives (pustular exanthematous eruption).
  • 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) 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 this medicine 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)

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

• Significant decrease in the number of white blood cells
• Low red blood cell count (hemolytic anemia)
• Crystals in the urine that cause acute kidney injury

If you experience side effects

• If you think any of the side effects you are experiencing are serious or if you notice any side effects not listed in this leaflet tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: 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 Almus

Do not store this medicine at a temperature above 25°C. Keep it in the original packaging to protect it from moisture.

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton or blister after "EXP". The expiry date is the last day of the month shown.

"Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.”

6. Container Content and Additional Information

Composition of Amoxicillin/Clavulanic Acid Almus

• The active ingredients are amoxicillin and clavulanic acid.
• A film-coated tablet contains amoxicillin trihydrate equivalent to 500 mg of amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid.
• The other components are:

Core:Microcrystalline cellulose (E460), crospovidone type A (E1202), sodium croscarmellose, anhydrous colloidal silica (E551), magnesium stearate (E470b).

Coating:Basic butyl methacrylate copolymer, titanium dioxide (E171), talc (E553b), macrogol 6000.

Appearance of Amoxicillin/Clavulanic Acid Almus and Container Content

Film-coated tablets, oblong, white or almost white, and scored.

OPA/Al/PVC-Al: 4/5/6/10/12/14/15/16/18/20/21/24/30/36/42/48/54/60/66/72/78/84/90/96/100/500 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder

Almus Pharmaceutical, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Manufacturer

PenCef Pharma GmbH

Breitenbachstrasse 13

13509 Berlin, Germany

This medicinal product is authorized in the EEA Member States under the following names:

Netherlands Amoxicilline/Clavulaanzuur Centrient 500 mg/125 mg film-coated tablets

Spain Amoxicillin/Clavulanic Acid Almus 500 mg/125 mg film-coated tablets EFG

Date of the last revision of this prospectus: March 2023

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