AMOXICILLIN/CLAVULANIC ACID TARBIS FARMA 500 mg/125 mg FILM-COATED TABLETS
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Introduction
Package Leaflet: Information for the Patient
Amoxicillin/Clavulanic Acid Tarbis Farma 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 Package Leaflet
- What is Amoxicillin/Clavulanic Acid Tarbis Farma and what is it used for
- What you need to know before you take Amoxicillin/Clavulanic Acid Tarbis Farma
- How to take Amoxicillin/Clavulanic Acid Tarbis Farma
- Possible side effects
- Storage of Amoxicillin/Clavulanic Acid Tarbis Farma
- Package Contents and Further Information
1. What is Amoxicillin/Clavulanic Acid Tarbis Farma and what is it used for
Amoxicillin/Clavulanic Acid Tarbis Farma 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" which can sometimes lose their effectiveness (become inactivated). The other component (clavulanic acid) prevents this from happening.
Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or the common cold. It is essential to follow the dosage instructions, administration intervals, and treatment duration indicated by your doctor. Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medications down the drain or in the trash. |
Amoxicillin/Clavulanic Acid Tarbis Farma 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 Tarbis Farma
Do not take amoxicillin/clavulanic acid:
- if you are allergic to amoxicillin, clavulanic acid, 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 a skin rash or swelling of the face or throat.
- if you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.
Do not take amoxicillin/clavulanic acid 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 unsure whether 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 medication.
Symptoms to be Aware of
Amoxicillin/Clavulanic Acid Tarbis Farma 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 medication 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.
Using Amoxicillin/Clavulanic Acid 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 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, more frequent blood tests will be needed.
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.
This medicine may affect the action of mycophenolate mofetil (a medicine used to prevent organ rejection after transplantation).
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 Tarbis Farma can have side effects and the symptoms may make you unfit to drive.
Do not drive or operate machinery unless you are feeling well.
3. How to Take Amoxicillin/Clavulanic Acid Tarbis Farma
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
The usual 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. The 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 Tarbis Farma
- Take with meals
- Swallow the tablets whole with a glass of water. The tablets can be broken along the score line to make them easier to swallow. Both parts of the tablet should be taken at the same time.
- Space the doses out 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 Than You Should
If you take too much amoxicillin/clavulanic acid, 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.
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
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 forgotten doses.
If You Stop Taking Amoxicillin/Clavulanic Acid
Continue taking amoxicillin/clavulanic acid 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 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) which 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 throat (angioedema), which can cause difficulty breathing
- collapse.
Contact your doctor immediatelyif 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.
Contact your doctor immediatelyif you experience any of 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 in the vagina, mouth, or mucous membranes)
- nausea, especially when taking high doses
- vomiting
- diarrhea (in children).
Uncommon Side Effects(may affect up to 1 in 100 patients)
- skin rash, itching
- increased pruritic rash (urticarial rash)
- 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 patients)
- 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 experience any of these symptoms, consult a doctor urgently.
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
Frequency Not Known
Frequency cannot be estimated from the available data.
- Allergic reactions (see above)
- Inflammation of the large intestine (see above)
- Inflammation of the membrane surrounding the brain and spinal cord (aseptic meningitis).
- Chest pain in the context of allergic reactions, which can be a symptom of allergy-induced heart attack (Kounis syndrome).
- 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.
- Crystals in the urine that cause acute kidney injury.
- Rash with blisters arranged in a circle with a central crust or like a string of pearls (linear IgA disease).
- Acute inflammation of the pancreas (acute pancreatitis). If you have severe and persistent stomach pain, this could be a sign of acute pancreatitis.
- 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 rash)
- flu-like symptoms with skin rash, fever, swollen glands, and abnormal blood test results (such as elevated white blood cell count (eosinophilia) and liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)).
Contact your doctor immediately if you experience any of these symptoms.
- inflammation of the liver (hepatitis)
- jaundice, caused by increased bilirubin in the blood (a substance produced by the liver) which 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
Side effects that may appear in your blood or urine tests:
- significant reduction in the number of white blood cells
- low red blood cell count (hemolytic anemia)
- crystals in the urine.
Reporting of 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 Medicines and Healthcare Products Agency (AEMPS) website: 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 Tarbis Farma
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Keep in the original packaging to protect from moisture.
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 shown.
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. Package Contents and Further Information
Composition of Amoxicillin/Clavulanic Acid Tarbis Farma
- The active substances are: amoxicillin and clavulanic acid.
- Each tablet contains amoxicillin trihydrate equivalent to 500 mg of amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid.
- The other ingredients are:
Core: microcrystalline cellulose, crospovidone, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.
Coating: basic butyl methacrylate copolymer, titanium dioxide, talc, macrogol 6000.
Appearance of the Product and Package Contents
White or almost white, oval, film-coated tablets with a score line.
Amoxicillin/Clavulanic Acid Tarbis Farma is available in blister packs containing 30 film-coated tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Tarbis Farma S.L.
Av. Carlos III 94
08028 Barcelona - Spain
Manufacturer:
PenCef Pharma GmbH
Breitenbachstrasse 13-14
13509 Berlin - Germany
Date of Last Revision of this Leaflet: January 2023
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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