Amoxicillin and clavulanic acid Almus Pharma
Italy
Table of Contents
Package leaflet: Information for the patient
Amoxicillin and Clavulanic Acid Almus Pharma 875 mg/125 mg film-coated tablets
Generic medicine
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 only. Do not give it 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, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Amoxicillin and Clavulanic Acid Almus Pharma is and what it is used for
- What you need to know before taking Amoxicillin and Clavulanic Acid Almus Pharma
- How to take Amoxicillin and Clavulanic Acid Almus Pharma
- Possible side effects
- How to store Amoxicillin and Clavulanic Acid Almus Pharma
- Contents of the pack and other information
1. What Amoxicillin and Clavulanic Acid Almus Pharma is and what it is used for
Amoxicillin and Clavulanic Acid Almus Pharma 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 called "penicillins", whose activity can sometimes be blocked (rendered inactive). The other active ingredient (clavulanic acid) prevents this from happening.
Amoxicillin and Clavulanic Acid Almus Pharma 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 Almus Pharma
Do not take Amoxicillin and Clavulanic Acid Almus Pharma
- if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillins, or to any of the other ingredients of this medicine (listed in section 6).
- if you have had a severe allergic reaction (hypersensitivity) to any other antibiotic. This may include a skin rash or swelling of the face or neck.
- if you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.
Do not take Amoxicillin and Clavulanic Acid Almus Pharma if any of these situations apply to you.
If you have any doubts, speak with your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid Almus Pharma.
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, discuss them with your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid Almus Pharma.
In some cases, your doctor may perform tests to identify the type of bacteria causing your infection. Based on the results, they may prescribe a different dosage of Amoxicillin and Clavulanic Acid Almus Pharma or a different medicine.
Conditions to which you should pay attention
Amoxicillin/clavulanic acid may worsen certain pre-existing conditions or cause serious side effects. These may include allergic reactions, seizures, and inflammation of the bowel. You should be aware of certain symptoms while taking amoxicillin/clavulanic acid in order to minimize any risks. See "Conditions to which you should pay attention" in section 4.
Blood and urine tests
If you are scheduled for blood tests (such as checks for red blood cells or liver function tests) or urine tests (for glucose), inform your doctor or nurse that you are taking Amoxicillin and Clavulanic Acid Almus Pharma. This is because amoxicillin/clavulanic acid may affect the results of these tests.
Other medicines and Amoxicillin and Clavulanic Acid Almus Pharma
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are taking allopurinol (used for gout) together with Amoxicillin and Clavulanic Acid Almus Pharma, you are at increased risk of developing a skin allergic reaction.
If you are taking probenecid (used for gout), your doctor may decide to adjust the dose of Amoxicillin and Clavulanic Acid Almus Pharma.
If you are taking medicines that help prevent blood clots (such as warfarin) together with Amoxicillin and Clavulanic Acid Almus Pharma, additional blood tests may be required.
Amoxicillin and Clavulanic Acid Almus Pharma may affect the action of methotrexate (a medicine used to treat cancers or rheumatic diseases).
Amoxicillin and Clavulanic Acid Almus Pharma may affect the action of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Amoxicillin and Clavulanic Acid Almus Pharma may cause side effects, and symptoms may make you unfit to drive. Do not drive or operate machinery if you do not feel well.
3. How to take Amoxicillin and Clavulanic Acid Almus Pharma
Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Adults and children weighing 40 kg or more
- Usual dose – 1 tablet twice a day
- Higher dose – 1 tablet three times a day
Children weighing less than 40 kg
- Children aged 6 years or younger should preferably be treated with amoxicillin/clavulanic acid oral suspension or sachets.
- Ask your doctor or pharmacist for advice when administering Amoxicillin and Clavulanic Acid Almus Pharma tablets to children weighing less than 40 kg. The tablets are not suitable 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 dosage or an alternative medicine.
- If you have liver problems, more frequent blood tests may be required to monitor how well your liver is functioning.
How to take Amoxicillin and Clavulanic Acid Almus Pharma
- Swallow the tablet whole with a glass of water at the beginning of a meal or just before. The tablets may be broken along the score line to make swallowing easier. You must take both parts of the tablet at the same time.
- Space your doses evenly throughout the day, at intervals of at least 4 hours. Do not take 2 doses within 1 hour.
- Do not take Amoxicillin and Clavulanic Acid Almus Pharma for longer than two weeks. If you continue to feel unwell, you should return to your doctor.
If you take more Amoxicillin and Clavulanic Acid Almus Pharma than you should
If you take more than the prescribed amount, symptoms may include stomach disturbances (nausea, vomiting or diarrhoea) or seizures. Speak to your doctor as soon as possible. Take the medicine pack or bottle with you to show the doctor.
If you forget to take Amoxicillin and Clavulanic Acid Almus Pharma
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.
If you stop taking Amoxicillin and Clavulanic Acid Almus Pharma
Continue taking Amoxicillin and Clavulanic Acid Almus Pharma for the full duration of treatment, 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 doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions:
- Skin rashes
- Inflammation of blood vessels (vasculitis), which may appear as red or purple spots on the skin, but which can 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 Almus Pharma
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 side effects
May affect more than 1 in 10 people
- Diarrhoea (in adults)
Common side effects
May affect up to 1 in 10 people
- Thrush (candidiasis – a fungal infection of the vagina, mouth or skin folds)
- Nausea, especially when taking high doses – if you are affected, take Amoxicillin and Clavulanic Acid Almus Pharma before food
- Vomiting
- Diarrhoea (in children)
Uncommon side effects
May affect up to 1 in 100 people
- Skin rash, itching
- Raised itchy rash (urticaria)
- Indigestion
- Dizziness
- Headache
Uncommon side effects may be detected in blood tests:
- Increase in certain proteins (enzymes) produced by the liver
Rare side effects
May affect up to 1 in 1,000 people
- Skin rashes, which may appear as blisters and look like 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 side effects may be detected in blood tests:
- Low number of cells involved in blood clotting
- Low number of white blood cells
Other side effects
Other side effects 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 skin detachment (more than 30% of the body surface – toxic epidermal necrolysis)
- Widespread red rash with small pus-filled blisters (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 white blood cells (eosinophilia) and liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
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 the skin and whites of the eyes to appear yellow
- Inflammation of the kidney tubules
- Blood takes longer to clot
- Hyperactivity
- Seizures (in people taking high doses of Amoxicillin and Clavulanic Acid Almus Pharma or who have kidney problems)
- Black, hairy-looking tongue
- Staining of teeth (in children), usually removable by brushing
Side effects that may be detected in 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 side effects
If any of the side effects worsen or become troublesome, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Amoxicillin and Clavulanic Acid Almus Pharma
Do not store above 25°C. Keep in the original packaging to protect
the medicine from moisture.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after
“Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Amoxicillina e Acido Clavulanico Almus Pharma contains
- The active substances are amoxicillin and clavulanic acid.
- Each tablet contains amoxicillin trihydrate equivalent to 875 mg of amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid.
- The other components are: Tablet core: Microcrystalline cellulose (E460), crospovidone (E1202), sodium croscarmellose, anhydrous colloidal silica (E551), magnesium stearate (E470b). Film coating: Basic butylated methacrylate copolymer, titanium dioxide (E171), talc (E553b), macrogol 6000.
Description of the appearance of Amoxicillina e Acido Clavulanico Almus Pharma and contents of the pack
Film-coated tablet, white to off-white, with a score line.
OPA/AL/PVC-AL: 12, 20 and 30 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Almus S.r.l.
Via Cesarea 11/10
16121 Genoa, Italy
Manufacturer
PenCef Pharma GmbH
Breitenbachstrasse 13-14
13509 Berlin, Germany
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy: Amoxicillina e Acido Clavulanico Almus Pharma 875 mg/125 mg film-coated tablets
Netherlands: Amoxicilline/Clavulaanzuur DSM Sinochem 875 mg/125 mg filmomhulde tabletten
Spain: Amoxicilina/Ácido Clavulánico Almus 875 mg/125 mg comprimidos recubiertos con película EFG
Behavioural hygiene
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
Sometimes, a bacterial infection does 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 the 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, 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 exact number of days indicated. 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 someone else, even if you believe 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.