Package Leaflet: Information for the user

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

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

• 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 only. Do not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet. See section 4.

Amoxicilina/Ácido clavulánico Almus is an antibiotic that eliminates 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 Almus is used in adults and children 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 Almus:

• if you are allergic (hypersensitive) to amoxicilina, ácido clavulánico, penicilinas, or any of the other components of this medication (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 (yellow discoloration of the skin) when taking an antibiotic.

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

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

Warnings and precautions

Inform your doctor or pharmacist before taking this medication 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 Amoxicilina/Ácido clavulánico Almus.

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

Depending on the results, you may be prescribed a different presentation of Amoxicilina/Ácido clavulánico Almus or another medication.

Symptoms to be aware of

Amoxicilina/Ácido clavulánico 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 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 liver function (liver function tests) or urine tests (to control glucose levels), inform your doctor or nurse that you are taking Amoxicilina/Ácido clavulánico Almus. This is because amoxicilina/ácido clavulánico may alter the results of these types of tests.

Use of Amoxicilina/Ácido clavulánico Almus with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use other medications, including those obtained without a prescription and herbal medications.

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

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

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

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

Amoxicilina/Ácido clavulánico may affect the functioning of micofenolato de mofetilo (a medication used to prevent organ transplant rejection).

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Amoxicilina/Ácido clavulánico Almus contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially “sodium-free”.

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

• Usual dose: 1 tablet three times a day

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 Almus to children weighing less than 40 kg. These tablets are not indicated for children weighing 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 presentation or another medication.
• 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 beginning of meals or a little before. The groove is only for breaking the tablet if it is difficult to swallow it whole. You must take both parts of the tablet at the same time.
• Space the doses throughout 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 continue to feel 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. Bring the packaging or bottle with you to show the doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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 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 have 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 Almus can 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
• Loss of consciousness
• Chest pain in the context of allergic reactions, which can be a symptom of an allergic-induced heart attack (Kounis syndrome)

• Contact your doctor immediatelyif you experience any of these symptoms.
• Stop taking Amoxicilina/Ácido clavulánico Almus.

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. 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 possibleso they can advise you if you experience these symptoms

Very common side effects

May affect more than 1 in 10 patients

• Diarhea (in adults).

Common side 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

• Take Amoxicilina/Ácido clavulánico Almus before meals if you experience this.

• Vomiting
• Diarhea (in children).

Uncommon side effects

May affect 1 in 100 patients

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

Serious 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 eruption, which may form blisters that resemble small darts (a dark center surrounded by a lighter area, with a dark ring around the edge –erythema multiforme)

• Seek medical attention immediately if you experience any of these symptoms

Serious side effects that may appear in blood tests:

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

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)
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• 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 (more than 30% of the body surface –toxic epidermal necrolysis)
  • Generalized red rash with small blisters containing pus (vesiculobullous dermatitis)
  • Red exfoliative rash, with lumps under the skin and urticaria (pustular exanthema).
  • Symptoms similar to the flu, with skin rash, fever, swollen lymph nodes, and abnormal blood test results (such as increased eosinophils and elevated liver enzymes) (eosinophilic drug reaction with systemic symptoms (DRESS)).

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

• Inflammation of the liver (hepatitis)
• Icterus, caused by increased bilirubin in the blood (a substance produced by the liver) that can turn the skin and white of the eyes yellow
• Inflammation of the kidney tubules
• Delayed blood clotting
• Hypervigilance
• Seizures (in patients taking high doses of this medication or with kidney problems)
• Black tongue that appears hairy
• Stained teeth (in children), which usually disappears with brushing
• Rash with blisters arranged in a circle with a central crust or as a pearl necklace (IgA linear disease)

Serious side effects that may appear in blood or urine tests:

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

If you experience side effects

• If you consider any of the side effects you experience to be severe or if you notice any side effects not mentioned in this leafletinform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Do not store this medication at a temperature above 25°C. Store in the original packaging to protect it from humidity.

Keep out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging or blister, after "CAD". The expiration date is the last day of the month indicated.

“Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.”

Composition of Amoxicillin/Clavulanic Acid Almus

• The active principles 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), croscarmellose sodium, 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 packaging content

Film-coated, oblong, white or almost white tablets with a notch.

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 package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Responsible manufacturer

PenCef Pharma GmbH

Breitenbachstrasse 13

13509 Berlin, Germany

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

NetherlandsAmoxicilline/Clavulaanzuur Centrient 500 mg/125 mg filmomhulde

tablets

SpainAmoxicilina/Ácido clavulánico Almus 500 mg/125 mg film-coated tablets

Last review date of this leaflet: March 2023

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/