Amoxicillin and clavulanic acid PensA
Italy
Table of Contents
PATIENT LEAFLET: INFORMATION FOR THE USER
Amoxicillin and Clavulanic Acid Pensa 875 mg + 125 mg
Film-coated tablets
Amoxicillin and Clavulanic Acid Pensa 875 mg + 125 mg
Oral suspension powder
amoxicillin + clavulanic acid
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you (or your child) only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Amoxicillin and Clavulanic Acid Pensa is and what it is used for
- What you need to know before taking Amoxicillin and Clavulanic Acid Pensa
- How to take Amoxicillin and Clavulanic Acid Pensa
- Possible side effects
- How to store Amoxicillin and Clavulanic Acid Pensa
- Contents of the pack and other information
1. WHAT AMOXICILLIN AND CLAVULANIC ACID PENSA IS AND WHAT IT IS USED FOR
Amoxicillin and Clavulanic Acid Pensa is an antibiotic that works by killing bacteria that cause infections. It contains two different active ingredients called amoxicillin and clavulanic acid.
Amoxicillin belongs to a group of medicines known as "penicillins", whose activity can sometimes be blocked (rendered inactive). The other active component (clavulanic acid) prevents this from happening.
Amoxicillin and Clavulanic Acid Pensa 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 SHOULD KNOW BEFORE TAKING AMOXICILLIN AND CLAVULANIC ACID PENSA
Do not take Amoxicillin and Clavulanic Acid Pensa if:
- you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillins, or to any of the excipients in Amoxicillin and Clavulanic Acid Pensa (listed in section 6)
- you have had a serious allergic reaction (hypersensitivity) to any other antibiotic. This may include a skin rash or swelling of the face or neck
- you have had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.
→ Do not take Amoxicillin and Clavulanic Acid Pensa if any of the above apply to you.
If you are in doubt, speak to your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid Pensa.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if you:
- have infectious mononucleosis
- have previously been treated for liver or kidney problems
- do not urinate regularly.
If you are unsure whether any of the above conditions apply to you, consult your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid Pensa.
In some cases, your doctor may carry out tests to identify the type of bacteria causing your infection.
Based on the results, your doctor may prescribe a different dose of Amoxicillin and Clavulanic Acid Pensa or a different medicine.
Conditions to which you should pay attention
Amoxicillin and Clavulanic Acid Pensa may worsen certain pre-existing conditions or cause serious side effects. These may include allergic reactions, seizures, and inflammation of the intestine. You should be aware of certain symptoms while taking Amoxicillin and Clavulanic Acid Pensa, in order to reduce any risk. See "Conditions to which you should pay attention" in section 4.
Blood and urine tests
If you are scheduled for blood tests (such as red blood cell counts or liver function tests) or urine tests (for glucose), inform your doctor or nurse that you are taking Amoxicillin and Clavulanic Acid Pensa. This is because Amoxicillin and Clavulanic Acid Pensa may affect the results of these tests.
Taking with other medicines
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines, including those obtained without a prescription and herbal products.
If you are taking allopurinol (used for gout) together with Amoxicillin and Clavulanic Acid Pensa, you are very likely to develop a skin allergic reaction.
If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of Amoxicillin and Clavulanic Acid Pensa.
If you are taking medications (such as warfarin) that help prevent blood clots together with Amoxicillin and Clavulanic Acid Pensa, additional blood tests may be required.
Amoxicillin and Clavulanic Acid Pensa may affect how methotrexate (a medicine used to treat cancers or rheumatic diseases) works.
Amoxicillin and Clavulanic Acid Pensa may affect the action of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, inform your doctor or pharmacist. Seek advice from your doctor or pharmacist before taking any medicine.
Driving and using machines
Amoxicillin and Clavulanic Acid Pensa may cause side effects, and symptoms may make you unfit to drive.
Do not drive or operate machinery unless you feel better.
Amoxicillin and Clavulanic Acid Pensa 875 mg + 125 mg Oral Powder for Suspension contains aspartame
- Amoxicillin and Clavulanic Acid Pensa contains 12.50 mg of aspartame (E951) per sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder that causes phenylalanine to accumulate because the body cannot eliminate it properly.
Amoxicillin and Clavulanic Acid Pensa 875 mg + 125 mg Film-coated Tablets contain sodium
- This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.
3. HOW TO TAKE AMOXICILLIN AND CLAVULANIC ACID PENSA
Always take Amoxicillin and Clavulanic Acid Pensa exactly as prescribed by your
doctor. If you have any doubts, consult your doctor or pharmacist.
Adults and children weighing 40 kg or more
875 mg/125 mg film-coated tablets
- Usual dose – 1 tablet twice daily
- Higher dose – 1 tablet three times daily
875 mg/125 mg powder for oral suspension in sachets
- Usual dose – 1 sachet twice daily
- Higher dose – 1 sachet three times daily
Children weighing less than 40 kg
Children aged 6 years or younger should preferably be treated with Amoxicillin and
Clavulanic Acid oral suspension or sachets.
Amoxicillin and Clavulanic Acid Pensa 875 mg/125 mg film-coated tablets
Consult your doctor or pharmacist for advice on administering Amoxicillin and
Clavulanic Acid Pensa tablets to children weighing less than 40 kg. The tablets are not
suitable for children weighing less than 25 kg.
Amoxicillin and Clavulanic Acid Pensa 875 mg/125 mg sachets are not recommended.
Patients with kidney or liver problems
- If you have kidney problems, your dose may need to be adjusted. Your doctor may choose a different dosage or a different medicine.
- If you have liver problems, you may require more frequent blood tests to monitor liver function.
How to take Amoxicillin and Clavulanic Acid Pensa
875 mg/125 mg film-coated tablets
- Swallow the tablet whole with a glass of water at the beginning of a meal or immediately before. The tablets may be split in half if you have difficulty swallowing them whole. Both halves of the tablet should be taken at the same time.
- Space your doses evenly throughout the day, with at least 4 hours between doses. Do not take 2 doses within 1 hour.
- Do not take Amoxicillin and Clavulanic Acid Pensa for longer than 2 weeks. If you continue to feel unwell, you should return to your doctor.
875 mg/125 mg powder for oral suspension in sachets
- Immediately before taking Amoxicillin and Clavulanic Acid Pensa, open the sachet and mix the contents with half a glass of water.
- Take at the beginning of a meal or immediately before.
- Space your doses evenly throughout the day, with at least 4 hours between doses. Do not take 2 doses within 1 hour.
- Do not take Amoxicillin and Clavulanic Acid Pensa for longer than 2 weeks. If you continue to feel unwell, you should return to your doctor.
If you take more Amoxicillin and Clavulanic Acid Pensa than you should
If you take too much Amoxicillin and Clavulanic Acid Pensa, symptoms may include gastrointestinal
disturbances (nausea, vomiting, or diarrhea) or seizures. Contact your doctor as soon as possible.
Bring the medicine package or container to show your doctor.
If you forget to take Amoxicillin and Clavulanic Acid Pensa
If you forget to take a dose, take it as soon as you remember. Do not take the next dose too early; instead, wait approximately 4 hours before taking the next dose. Do not take a double dose to make up for a missed dose.
If you stop treatment with Amoxicillin and Clavulanic Acid Pensa
Continue taking Amoxicillin and Clavulanic Acid Pensa until the treatment course is complete,
even if you feel better. You need every dose to help fight the infection. If some bacteria survive, they may cause the infection to return.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
4. POSSIBLE ADVERSE REACTIONS
Like all medicines, Amoxicillin and Clavulanic Acid Pensa can cause adverse reactions,
although not everyone experiences them.
Conditions you should pay attention to
Allergic reactions:
- skin rashes
- inflammation of blood vessels (vasculitis), which may appear as red or purple spots on the skin, but may also affect other parts of the body
- fever, joint pain, swelling of the glands in the neck, armpits, or groin
- swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing
- collapse.
→ Contact your doctor immediately if you experience any of these symptoms. Stop taking
Amoxicillin and Clavulanic Acid Pensa.
Intestinal inflammation
Intestinal inflammation, causing watery diarrhoea usually with blood and mucus, stomach pain and/or fever.
→ If you experience these symptoms, contact your doctor as soon as possible for advice.
Very common adverse reactions
May affect more than 1 in 10 people
- diarrhoea (in adults).
Common adverse reactions
May affect up to 1 in 10 people
- thrush (candida – a fungal infection of the vagina, mouth or skin folds)
- nausea, especially when taking high doses: if affected, take Amoxicillin and Clavulanic Acid Pensa before food
- vomiting
- diarrhoea (in children).
Uncommon adverse reactions
May affect up to 1 in 100 people
- skin rash, itching
- raised itchy skin rash (urticaria)
- indigestion
- dizziness
- headache. Uncommon adverse reactions may be detected through blood tests:
- increased levels of certain proteins (enzymes) produced by the liver.
Rare adverse reactions
May affect up to 1 in 1,000 people
- skin rashes, which may appear as blisters and resemble small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme). If you notice any of these symptoms, contact your doctor urgently. Rare adverse reactions may be detected through blood tests:
- low number of cells involved in blood clotting
- low number of white blood cells.
Other adverse reactions
Other adverse reactions occur in a very limited number of people, but their exact frequency is unknown.
- Allergic reactions (see above)
- Intestinal inflammation (see above)
- Inflammation of the protective membrane surrounding the brain (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 a more severe form causing extensive peeling of the skin (more than 30% of body surface – toxic epidermal necrolysis)
- widespread red rash with small blisters containing pus (exfoliative bullous dermatitis)
- a red rash with crusts, swellings under the skin and blisters (pustular exanthema)
- flu-like symptoms with rash, fever, swollen glands and abnormal blood test results (including increased number of white blood cells (eosinophilia) and elevated liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms)
→ If you experience any of these symptoms, contact your doctor immediately.
- inflammation of the liver (hepatitis)
- jaundice, caused by increased levels of bilirubin (a substance produced in the liver) in the blood, which may cause yellowing of the skin and whites of the eyes
- inflammation of the kidney tubules
- blood takes longer to clot
- hyperactivity
- seizures (in people taking high doses of Amoxicillin and Clavulanic Acid Pensa or who have kidney problems)
- black hairy tongue
Adverse reactions that may be detected through blood or urine tests:
- severe reduction in the number of white blood cells
- low number of red blood cells (haemolytic anaemia)
- crystals in the urine.
If you experience adverse reactions
→ If any of the adverse reactions worsen or become bothersome, or if you notice any adverse reaction not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
- avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.
5. HOW TO STORE AMOXICILLIN AND CLAVULANIC ACID PENSA
Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the product from light and moisture at a temperature not exceeding 25°C.
Do not use Amoxicillin and Clavulanic Acid Pensa after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Do not use Amoxicillin and Clavulanic Acid Pensa 875 mg + 125 mg Powder for oral suspension if the sachet is torn or damaged.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. PACKAGING CONTENTS AND OTHER INFORMATION
What Amoxicillina e Acido Clavulanico Pensa contains
Amoxicillina e Acido Clavulanico Pensa 875 mg + 125 mg Film-coated tablets
Each tablet contains:
Active substances:
amoxicillin trihydrate corresponding to 875 mg amoxicillin
potassium clavulanate corresponding to 125 mg clavulanic acid.
Excipients: Anhydrous colloidal silica, magnesium stearate, sodium starch glycolate, microcrystalline cellulose, hydroxypropylmethylcellulose, talc, titanium dioxide, diethyl phthalate, dimethicone.
Amoxicillina e Acido Clavulanico Pensa 875 mg + 125 mg Powder for oral suspension
Each sachet contains:
Active substances:
amoxicillin trihydrate corresponding to 875 mg amoxicillin
potassium clavulanate corresponding to 125 mg clavulanic acid.
Excipients: Hydrated colloidal silica, orange flavour, aspartame.
Description of the appearance of Amoxicillina e Acido Clavulanico Pensa and pack contents
Film-coated tablets: Carton pack containing 12 tablets
Powder for oral suspension: Carton pack containing 12 sachets
Marketing Authorization Holder
Pensa Pharma S.p.A. – Via Ippolito Rosellini, 12 – 20124 Milano, Italy
Manufacturers and final quality controllers
Elpen SA – 95 Marathonos Avenue – 19009 Pikermi Attika (Greece)
Laboratorio Reig Jofrè S.A. – Calle Jarama s/n – Polígono Industrial – 45007 Toledo (Spain)
This patient information leaflet was last approved on
Behavioural hygiene
Antibiotics are used to treat bacterial infections and are not effective against viral infections. Sometimes, bacterial infections do not respond to antibiotic treatment. The most common reason for this is that the bacteria causing the infection are resistant to the antibiotic being used. This means that bacteria survive and multiply despite the presence of the antibiotic.
Bacteria can become resistant to antibiotics for various reasons. By using antibiotics appropriately, you can help reduce the development of bacterial resistance.
When your doctor prescribes you an antibiotic treatment, it is intended solely for the illness you currently have. Please follow the advice below to help prevent the emergence of bacterial resistance, which can lead to antibiotics becoming ineffective.
It is very important that you take the antibiotic at the correct dose, at the prescribed times, and for the full duration of treatment. Read the instructions in this leaflet carefully and, if anything is unclear, ask your doctor or pharmacist for clarification.
Do not take antibiotics unless they have been specifically prescribed for you, and use them only for the infection for which they were prescribed.
Do not use antibiotics that have been prescribed for other people, even if you think your infection is similar.
Do not give your prescribed antibiotics to other people.
If you have leftover antibiotics after completing your treatment, return them to your pharmacist for proper disposal.