Amoxicilina/acido clavulanico viatris 125 mg/5 mg +31,25 mg/5 ml polvo para suspension oral efg
Introduction
Prospect: information for parents or caregivers of children
Amoxicillin/Clavulanate Viatris 125 mg/5 ml + 31.25 mg/5 ml powder for oral suspension EFG
Read this prospect carefully before starting to take the medicine, because it contains important information for you.
- Keep this prospect, as you may need to read it again.
- If you have any doubts, consult your doctor, pharmacist, or nurse.
- This medicine is usually prescribed only for babies or children and should not be given to others, even if they have the same symptoms as your child, as it may harm them.
- If your child experiences any adverse effect, consult your doctor, pharmacist, or nurse, even if it is an adverse effect not listed in this prospect. See section 4.
1. What is Amoxicilina/Ácido clavulánico Viatris and what is it used for
Amoxicilina/Ácido clavulánico Viatrisis an antibiotic that eliminates bacteria that cause infections. It contains two active ingredients called amoxicilina and ácido clavulánico. Amoxicilina belongs to a group of medicines known as “penicilinas” that may sometimes lose its effectiveness (become inactivated). The other component (ácido clavulánico) prevents this from happening.
Antibiotics are used to treat bacterial infections and do not work for viral infections, such as the flu or a cold.
It is essential to follow the instructions regarding the dose, administration interval, and treatment duration indicated by your doctor.
Do not store or reuse this medication. If you have leftover antibiotic after treatment, return it to the pharmacy for proper disposal. Do not dispose of the medication through the drain or in the trash.
Amoxicilina/ácido clavulánicois used in babies and children to treat the following infections:
- Middle ear infections 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 starting to take Amoxicillin/Clavulanate Viatris
Do not administerAmoxicilina/Ácido clavulánico Viatris to your child:
- If your child is allergic to amoxicilina, ácido clavulánico, penicilina or any of the other components of this medication (see section 6).
- If your child has ever had a severe allergic reaction to any other antibiotic. This could include skin rash or rapid swelling in the face, lips, mouth, tongue or throat.
- If your child has ever had liver problems or jaundice (yellow discoloration of the skin) when taking this antibiotic.
→Do not giveamoxicilina/ácido clavulánicoto your child if any of the above points apply.Before starting treatment if you are unsure, consult with your child's doctor or pharmacist.
Warnings and precautions
Inform your child's doctor, pharmacist or nurse before starting to administer this medication to your child if:
- Your child has infectious mononucleosis.
- Your child is receiving treatment for liver or kidney problems.
- Your child does not urinate regularly.
If you are unsure whether any of the above symptoms affect your child, inform your child's doctor or pharmacist before giving amoxicilina/ácido clavulánico.
Your child's doctor may investigate the type of bacteria causing the infection. Depending on the results, your child may receive a different presentation of amoxicilina/ácido clavulánico 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 your child is taking amoxicilina/ácido clavulánico to reduce the risk of problems. See section 4.
Blood and urine tests
If your child is having blood tests (such as studies of red blood cell status or liver function tests) or urine tests (to control glucose levels), inform your child's doctor or nurse that your child is taking amoxicilina/ácido clavulánico. This is because amoxicilina/ácido clavulánico may alter the results of these types of tests.
Other medications and Amoxicilina/Ácido clavulánico Viatris
Inform your child's doctor or pharmacist if your child is taking, has taken recently or may need to take other medications, including those acquired without a prescription and herbal medications.
If your child is taking allopurinol (used for gout) with amoxicilina/ácido clavulánico, it may be more likely to have a skin allergic reaction.
If your child is taking probenecid (used for gout), your child's doctor may adjust the dose of amoxicilina/ácido clavulánico. Concomitant use of probenecid may reduce amoxicilina excretion and is not recommended.
If your child is taking anticoagulants (such as warfarin) with amoxicilina/ácido clavulánico, more blood tests will be needed.
Amoxicilina/ácido clavulánico may affect the mechanism of action of methotrexate (a medication for cancer, severe psoriasis or rheumatic diseases). Penicillins may reduce methotrexate excretion and cause a potential increase in side effects.
Amoxicilina/ácido clavulánico may affect the functioning of micofenolato de mofetilo (a medication used to prevent organ transplant rejection).
Pregnancy and breastfeeding
If your daughter is to take this medication and is pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.
Driving and operating machinery
Amoxicilina/ácido clavulánico may cause side effects, such as allergic reactions, dizziness and convulsions. If this happens to your child, they should not drive or ride a bicycle and should not use tools or machinery.
Amoxicilina/Ácido clavulánico Viatris contains aspartamo (E-951), glucose (dextrosa), maltodextrina de maíz, sorbitol (E-420), alcohol bencílico, dióxido de azufre (E-220), benzoato de benciloand sodium
Aspartamo is a source of phenylalanine. This may be harmful if your child has phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it correctly.
If your child's doctor has told you that your child has an intolerance to certain sugars (such as glucose, dextrosa and maltodextrina), consult with them before taking this medication.
Benzyl alcohol may cause allergic reactions. Benzyl alcohol has been associated with the risk of serious side effects, including respiratory problems (called "breathing difficulty") in young children. Do not give it to your newborn baby (up to 4 weeks old), unless your doctor recommends it. Do not use for more than a week in young children (under 3 years old), unless your doctor or pharmacist recommends it. Ask your doctor or pharmacist if you are pregnant, breastfeeding, have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause side effects (called "metabolic acidosis").
In rare cases, sulfur dioxide may cause severe hypersensitivity reactions and bronchospasm.
Benzyl benzoate may increase jaundice (yellow discoloration of the skin and eyes) in newborns (up to 4 weeks old).
This medication contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially "sodium-free".
3. How to Administer Amoxicillin/Clavulanate Viatris
Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have doubts.
Use in adults and children weighing 40 kg or more
- It is not usually recommended for adults and children who weigh more than 40 kg.
Ask your doctor or pharmacist for advice.
Use in children weighing less than 40 kg
All doses are expressed in relation to the child's body weight in kilograms.
- Your doctor will advise you how much Amoxicilina/Ácido clavulánico Viatris to give to your baby or child.
- You will be provided with a plastic dosing spoon. You must use it to give the correct dose to your baby or child.
- Recommended dose – 20 mg/5 mg to 60 mg/15 mg per kilogram of body weight and day, administered in three divided doses.
Patients with kidney and liver problems
- If your child has kidney problems, the dose may be reduced. Your doctor may choose a different presentation or another medication.
- If your child has liver problems, blood tests will be performed more frequently to check how their liver is functioning.
How to administer Amoxicilina/Ácido clavulánico Viatris
- Always shake the bottle well before each dose.
- Administer with meals.
- Space doses throughout the day, at least 4 hours apart. Do not take 2 doses in 1 hour.
- Do not administer Amoxicilina/Ácido clavulánico Viatris to your child for more than two weeks. If your child continues to feel unwell, they should return to see the doctor.
If you administer more Amoxicilina/Ácido clavulánico Viatris than you should
If you administer too much amoxicilina/ácido clavulánico to your child, symptoms such as stomach upset (nausea, vomiting, or diarrhea), fluid and electrolyte imbalance (muscle tremors or spasms, numbness or irregular heartbeats, or seizures) or amoxicilina crystalluria (crystals found in urine during urine tests) may appear. Consult your doctor as soon as possible. Bring the bottle to show the doctor. You can also call the Toxicology Information Service, phone 915620420, indicating the medication and the amount ingested.
If you forgot to administer Amoxicilina/Ácido clavulánico Viatris
If you forget to administer a dose, give it as soon as you remember. Do not give your child the next dose too soon, wait at least 4 hours before giving the next dose.
Do not give a double dose to compensate for the missed doses.
If your child stops taking Amoxicilina/Ácido clavulánico Viatris
Continue administering amoxicilina/ácido clavulánico to your child until the treatment is completed, even if they feel better.
Your child needs to complete the treatment to help them fight the infection. If bacteria survive, they will get the infection again.
If you have any other doubts about the use of this medication, consult your doctor, pharmacist, or nurse.
4. Possible Adverse Effects
Contact a doctor immediately if your child experiences any of these symptoms. Stop giving amoxicillin/clavulanic acid:
Allergic reactions:
- Skin rash.
- Swelling of blood vessels (vasculitis), which 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.
- Quick swelling of the face, lips, mouth, tongue, or throat, which can cause difficulty swallowing or breathing (angioedema).
- Collapsing.
- Chest pain in the context of allergic reactions, which can be a symptom of an allergic-induced heart attack (Kounis syndrome).
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 rash with small blisters with pus (exfoliative bullous dermatitis).
- Red rash, with lumps under the skin and blisters (pustular exanthema).
- Symptoms similar to the flu with skin rash, fever, swollen lymph nodes, and abnormal blood test results (including an increase in white blood cells (eosinophilia) and elevated liver enzymes (drug-induced eosinophilia and systemic symptoms (DRESS)).
Other possible severe side effects:
- Colitis, which causes watery diarrhea, usually with blood and mucus, stomach pain, and/or fever.
Inflammation of the pancreas (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 mainly been reported in children taking amoxicillin/clavulanic acid. 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.
- Liver inflammation (hepatitis).
- Jaundice, caused by an increase in bilirubin in the blood (a substance produced by the liver), which can make the skin and the white part of the eyes turn yellow.
- Seizures (in patients taking high doses of amoxicillin/clavulanic acid or those with kidney problems).
- Severe headache, neck stiffness, abnormal sensitivity to light, feeling and being sick, which can be caused by inflammation of the protective covering of the brain and spinal cord (aseptic meningitis).
- Feeling tired and short of breath with pale skin, which can be caused by a low number of red blood cells (hemolytic anemia).
- Inflammation of the kidney tubules.
- Increased number of infections, such as sore throat, mouth ulcers, fever, which can be caused by a severe reduction in the number of white blood cells.
Contact your doctor as soon as possibleso that they can advise you if your child experiences these symptoms.
Other possible side effects
Very common(may affect more than 1 in 10 people)
- Diarhea (in adults).
Common(may affect up to 1 in 10 people)
- Thrush (Candida infection) – fungal infection in the vagina, mouth, or mucous membranes.
- Nausea, especially when taking high doses.
→ if this happens, take amoxicillin/clavulanic acid with meals
- Vomiting.
- Diarhea (in children).
Uncommon(may affect up to 1 in 100 people)
- Skin rash, itching.
- Increased pruritic rash (urticarial hives).
- Indigestion.
- Dizziness.
- Headache.
Side effects that may appear in blood tests:
- Increased levels of certain substances (enzymes) produced by the liver.
Rare(may affect up to 1 in 1,000 people)
- Skin rash, which may form blisters that look like small darts (erythema multiforme).
Side effects that may appear in blood tests:
- Low count of cells involved in blood clotting.
Unknown frequency (cannot be estimated from available data)
Other side effects that have occurred in a very small number of patients and whose exact frequency is unknown.
- Delayed blood clotting.
- Hypervigilance.
- Black tongue that looks hairy.
- Stained teeth (in children), which usually disappears with brushing.
Generalized rash with blisters arranged in a circle with a central crust or as a pearl necklace (IgA linear disease).
Side effects that may appear in blood or urine tests:
- Crystals in the urinethat cause acute kidney injury.
Reporting of side effects:
If you experience any type of side effect, consult your doctor or pharmacist even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Conservation of Amoxicilina/Clavulanic Acid Viatris
Keep this medication out of the sight and reach of children.
Before reconstitution: Do not store at a temperature above 25°C.
After reconstitution: Store in the refrigerator (between 2°C and 8°C). Use within 7 days following reconstitution. Indicate the date of reconstitution on the box and the label of the bottle.
Do not use this medication after the expiration date that appears on the box after CAD or EXP. The expiration date is the last day of the month indicated.
Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.
6. Contents of the packaging and additional information
Composition of Amoxicillin/Clavulanic Acid Viatris
The active ingredients are amoxicillin and clavulanic acid
- 5 ml contain 125 mg of amoxicillin corresponding to 143.5 mg of amoxicillin trihydrate and 31.25 mg of clavulanic acid corresponding to 37.23 mg of potassium clavulanate.
- The other components are: anhydrous citric acid , anhydrous trisodium citrate , aspartame (E-951), talc, guar gum, anhydrous silicon dioxide, lemon flavor (contains glucose (dextrose), sorbitol (E-420), benzyl alcohol, sulfur dioxide (E-220) and sodium), peach-apricot flavor (contains sorbitol (E-420), benzyl benzoate, sulfur dioxide (E-220), benzyl alcohol and sodium) and orange flavor (contains cornstarch).
See section 2, "Amoxicillin/Clavulanic Acid contains aspartame (E-951), glucose (dextrose), cornstarch, sorbitol (E-420), benzyl alcohol, sulfur dioxide (E-220), benzyl benzoate and sodium".
Appearance of the product and contents of the package
White powder for oral suspension.
Bottle with powder to prepare 60 ml of oral suspension.
2 Bottles with powder to prepare 2 x 60 ml of oral suspension.
Bottle with powder to prepare 100 ml of oral suspension.
Bottle with powder to prepare 120 ml of oral suspension.
Only some package sizes may be marketed.
Marketing authorization holder and manufacturer responsible
Marketing authorization holder:
Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland
Manufacturer responsible:
Sandoz GmbH,
Biochemiestrasse 10,
A-6250 Kundl,
Austria.
or
McDermott Laboratories Ltd, t/a Gerard Laboratories,
35/36 Baldoyle Industrial Estate,
Grange Road,
Dublin – 13,
Ireland.
For more information about this medicine, please contact the local representative of the marketing authorization holder:
Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain
This medicine is authorized in the EEA Member States with the following names:
Germany Amoxidura Plus Saft 125/31.25mg
Belgium Amoxiclav Mylan 125 mg/ 5 ml, poeder voor orale suspensie
Spain Amoxicillin/Clavulanic Acid Viatris 125 mg/5 ml + 31,25 mg/5 ml powder for oral suspension EFG
Netherlands Amoxicilline/Clavulaanzuur Mylan (powder for preparation of) 125 mg/31,25 mg per 5 ml
Last review date of this leaflet: December 2023
The detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/
Reconstitution instructions
After opening the screw cap, make sure the seal of the bottle cap is intact and firmly attached to the edge of the bottle. Do not use it if it is not intact. Shake the bottle to loosen the powder adhering to it. Add the volume of water (as indicated below), invert the contents and shake well. Do not use the reconstituted suspension if the color is not white.
Another option is to shake the bottle to loosen the powder adhering to it and then fill it with water up to just below the line of the bottle or the label. Invert the contents and shake well and then add water up to exactly the line. Invert the contents and shake well again.
| Concentration | Volume of water to be added to the reconstitution (ml) | Final volume of the reconstituted oral suspension (ml) |
| 125 mg/31,25 mg per 5 ml | 57 | 60 |
| 95 | 100 | |
| 114 | 120 |
Shake the bottle well before administering each dose.
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