Amoxicillin/clavulanic acid Almus 500 mg/125 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

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

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Amoxicillin/Clavulanic acid Almus is and what it is used for
2. What you need to know before taking Amoxicillin/Clavulanic acid Almus
3. How to take Amoxicillin/Clavulanic acid Almus
4. Possible side effects
5. How to store 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 kills bacteria causing infections. It contains two different active substances 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 taking Amoxicillin/Clavulanic Acid Almus

Do not take Amoxicillin/Clavulanic Acid Almus:

• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillins, or 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 skin rash or swelling of the face or neck

• if you have ever had liver problems or jaundice (yellowing of the skin) while taking an antibiotic.

• Do not take Amoxicillin/Clavulanic Acid Almus if any of the above apply to you.

If you are unsure, consult your doctor or pharmacist before starting treatment with Amoxicillin/Clavulanic Acid Almus.

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 conditions apply to you, inform your doctor or pharmacist before taking Amoxicillin/Clavulanic Acid 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 formulation of Amoxicillin/Clavulanic Acid Almus or another medicine.

Symptoms to watch for

Amoxicillin/clavulanic acid may worsen certain existing conditions or cause serious adverse 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 complications. See "Symptoms to watch for" 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 monitor glucose levels), inform your doctor or nurse that you are taking Amoxicillin/Clavulanic Acid Almus. This is because amoxicillin/clavulanic acid may alter the results of these types of tests.

Use of Amoxicillin/Clavulanic Acid Almus with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to 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 Almus, you may be more likely to develop a skin allergic reaction.

If you are taking methotrexate (a medicine used to treat cancer and severe psoriasis), penicillins may reduce methotrexate excretion and potentially increase its adverse effects.

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

If anticoagulants (such as warfarin) are taken with Amoxicillin/Clavulanic Acid Almus, additional blood tests will be required.

Amoxicillin/clavulanic acid may affect the effectiveness of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).

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 taking this medicine.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Amoxicillin/clavulanic acid may cause adverse effects, and symptoms may make it unsafe for you to drive. Do not drive or operate machinery unless you feel well.

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

3. How to take Amoxicillin/Clavulanic Acid Almus

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Adults and children weighing 40 kg or more

• Usual dose: 1 tablet three times a day

Children weighing less than 40 kg

• It is preferable to treat children aged 6 years or younger with amoxicillin/clavulanic acid oral suspension or sachets.
• Seek advice from your doctor or pharmacist before 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 or liver problems

• If you have kidney problems, your dose may need to be adjusted. Your doctor may choose a different formulation or another medicine.
• If you have liver problems, you will have blood tests more frequently to monitor liver function.

How to take Amoxicillin/Clavulanic Acid Almus

• Swallow the tablets whole with a glass of water at the beginning of a meal or shortly before. The score line is only intended for splitting the tablet if you find it difficult to swallow whole. You must take both parts of the tablet at the same time.
• Space your doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
• Do not take Amoxicillin/Clavulanic Acid Almus for longer than 2 weeks. If you still feel unwell, consult your doctor.

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

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine 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 for the full duration of treatment, even if you feel better. You need to complete the full course to cure the infection. If you do not, surviving bacteria may cause the infection to return.

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

4. Possible adverse effects

Like all medicines, Amoxicillin/Clavulanic Acid Almus may cause adverse effects, although not everyone experiences them.

Symptoms you should watch for

Allergic reactions:

• Skin rash

• Inflammation of blood vessels (vasculitis), which may appear as red or purple spots on the skin, but may 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), causing difficulty breathing

• Collapse

• Chest pain during allergic reactions, which may be a symptom of an allergic-triggered heart attack (Kounis syndrome)

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

• Stop taking Amoxicillin/Clavulanic Acid Almus.

Inflammation of the large intestine

Inflammation of the large intestine, causing 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 pain in the stomach area, this could be a sign of acute pancreatitis.

Drug-induced enterocolitis syndrome (DIES)

DIES has been reported mainly in children receiving amoxicillin. It is a type of allergic reaction with the main symptom being 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 adverse effects

May affect more than 1 in 10 patients

• Diarrhea (in adults).

Common adverse 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

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

• Vomiting

• Diarrhea (in children).

Uncommon adverse effects

May affect 1 in 100 patients

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

Rare side effects that may appear in blood tests:

• Increase in certain substances (enzymes) produced by the liver.

Rare adverse effects

May affect up to 1 in 1,000 patients:

• Skin rash that may form blisters resembling small targets (a dark central 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 adverse effects that may appear in blood tests:

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

Other adverse effects

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

• 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 skin peeling (more than 30% of body surface – toxic epidermal necrolysis)
  • Widespread red rash with small pus-filled blisters (exfoliative bullous or vesicular dermatitis)
  • Exfoliative red rash, with lumps under the skin and hives (exanthematous pustulosis)
  • 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), which may cause the skin and whites of the eyes to turn yellow

• Inflammation of the kidney tubules

• Delayed blood clotting

• Hyperactivity

• Seizures (in patients taking high doses of this medicine or who have kidney problems)

• Black, hairy-looking tongue

• Tooth staining (in children), which usually disappears with brushing

• Blistering rash arranged in circles with a crusted center or resembling a "necklace of pearls" (linear IgA disease)

Adverse 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 causing acute kidney injury

If you experience adverse effects

• If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 above 25°C. Keep 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 stated on the container or blister pack, following "EXP". The expiry date refers to the last day of the month indicated.

“Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This helps protect the environment.”

6. Package Contents and Additional Information

Composition of Amoxicillin/Clavulanic Acid Almus

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

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

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

Appearance of Amoxicillin/Clavulanic Acid Almus and Pack Contents

Film-coated tablets, white or almost white, oblong, 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 certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Holder

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 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 filmomhulde tabletten

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

Date of most recent review of this leaflet: March 2023

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