Amoxicillin and clavulanic acid Tecnigen Italia: detailed information

Package leaflet: Information for the user

Amoxicillin and Clavulanic Acid TecniGen Italia 875 mg/125 mg film-coated tablets
Amoxicillin and Clavulanic Acid TecniGen Italia 875 mg/125 mg powder for oral suspension
in sachets
Equivalent 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, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

What Amoxicillin and Clavulanic Acid TecniGen Italia is and what it is used for
What you need to know before taking Amoxicillin and Clavulanic Acid TecniGen Italia
How to take Amoxicillin and Clavulanic Acid TecniGen Italia
Possible side effects
How to store Amoxicillin and Clavulanic Acid TecniGen Italia
Contents of the pack and other information

1. What Amoxicillin and Clavulanic Acid TecniGen Italia is and what it is used for

Amoxicillin and Clavulanic Acid TecniGen Italia is an antibiotic that works by killing bacteria causing infections. It contains two different active substances called amoxicillin and clavulanic acid.
Amoxicillin belongs to a group of medicines known as "penicillins", whose activity can sometimes be blocked (i.e. rendered inactive). The other active component (clavulanic acid) prevents this from happening.
Amoxicillin and Clavulanic Acid TecniGen Italia is used in adults and children weighing 40 kg or more to treat the following infections:

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 TecniGen Italia

Do not take Amoxicillin and Clavulanic Acid TecniGen Italia

If you are allergic to amoxicillin, clavulanic acid, penicillins, or any of the other ingredients of this medicine (listed in section 6).
If you have had severe allergic reactions to any other antibiotic. These may include skin rashes and swelling of the face or neck.
If you have previously experienced liver problems or jaundice (yellowing of the skin) while taking antibiotics.

Do not take Amoxicillin and Clavulanic Acid TecniGen Italia if any of these cases apply to you.
If you have any doubts, speak with your doctor or pharmacist before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid TecniGen Italia if:

You have infectious mononucleosis
You have previously been treated for liver or kidney problems
You 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 TecniGen Italia.

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 TecniGen Italia or a different medicine.
Conditions you should monitor
Amoxicillin and Clavulanic Acid TecniGen Italia may worsen certain pre-existing conditions or cause serious adverse effects. These may include allergic reactions, seizures, and intestinal inflammation. You should be alert to certain symptoms while taking Amoxicillin and Clavulanic Acid TecniGen Italia in order to minimize any risks. See “Conditions you should monitor” 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 TecniGen Italia. This is because Amoxicillin and Clavulanic Acid TecniGen Italia may affect the results of these tests.
Other medicines and Amoxicillin and Clavulanic Acid TecniGen Italia
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
If you are taking allopurinol (used for gout) together with Amoxicillin and Clavulanic Acid TecniGen Italia, you are much more 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 TecniGen Italia.
If you are taking medicines that help prevent blood clotting (such as warfarin) together with Amoxicillin and Clavulanic Acid TecniGen Italia, additional blood tests may be required.
Amoxicillin and Clavulanic Acid TecniGen Italia may affect the action of methotrexate (a medicine used to treat tumours or rheumatic disorders).
Amoxicillin and Clavulanic Acid TecniGen Italia 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, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Amoxicillin and Clavulanic Acid TecniGen Italia may cause adverse effects, and symptoms may make you unfit to drive.
Do not drive or operate machinery unless you feel well.
Amoxicillin and Clavulanic Acid TecniGen Italia 875 mg/125 mg film-coated tablets
contain less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially 'sodium-free'.
Amoxicillin and Clavulanic Acid TecniGen Italia 875 mg/125 mg powder for oral suspension in sachets contains aspartame (E951) (20 mg per sachet). Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing phenylalanine to accumulate in the body because it cannot be properly metabolized.
The strawberry flavour included in Amoxicillin and Clavulanic Acid TecniGen Italia 875 mg/125 mg powder for oral suspension in sachets contains maltodextrins (glucose). If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.
The strawberry flavour included in Amoxicillin and Clavulanic Acid TecniGen Italia 875 mg/125 mg powder for oral suspension in sachets contains 0.024% benzyl alcohol per dose, equivalent to 0.0031 mg per sachet. Benzyl alcohol may cause allergic reactions.
Ask your doctor or pharmacist for advice if you have liver or kidney disease, are pregnant, or are breastfeeding. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).

3. How to take Amoxicillin and Clavulanic Acid TecniGen Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Tablets
Adults and children weighing 40 kg or more

Usual dose: 1 tablet or sachet twice daily
Higher dose: 1 tablet or sachet three times daily

Sachets
Adults and children weighing 40 kg or more

Usual dose: 1 sachet twice daily
Higher dose: 1 sachet three times daily

Children weighing less than 40 kg
Amoxicillin and Clavulanic Acid TecniGen Italia is not recommended in children weighing less than 40
kg. Please consult your doctor or pharmacist for advice on amoxicillin/clavulanic acid formulations suitable for treating children weighing less than 40 kg.
Patients with kidney or liver problems

If you have kidney problems, your dose may be adjusted. Your doctor may choose a different dosage or a different medicine.
If you have liver problems, you should have blood tests more frequently to monitor your liver function.

How to take Amoxicillin and Clavulanic Acid TecniGen Italia
Tablets:

Take with food
Swallow the tablet whole with a glass of water.
Tablets may be divided along the score line to make swallowing easier. Both parts of the tablet should be taken at the same time.
Space doses evenly throughout the day, at intervals of at least 4 hours. Do not take 2 doses within one hour.
Do not take Amoxicillin and Clavulanic Acid TecniGen Italia for longer than 2 weeks. If you continue to feel unwell, you should see your doctor again.

Sachets:

Just before taking the dose, open the sachet and mix the contents with half a glass of water.
Take with food
Space doses evenly throughout the day, at intervals of at least 4 hours. Do not take 2 doses within one hour.
Do not take Amoxicillin and Clavulanic Acid TecniGen Italia for longer than 2 weeks. If you continue to feel unwell, you should see your doctor again.

If you take more Amoxicillin and Clavulanic Acid TecniGen Italia than you should
If you take more Amoxicillin and Clavulanic Acid TecniGen Italia than prescribed, symptoms may include
stomach problems (nausea, vomiting, and diarrhoea) or seizures. Contact your doctor as soon as possible.
Take the medicine package or bottle with you to show to the doctor.
If you forget to take Amoxicillin and Clavulanic Acid TecniGen Italia
If you forget to take a dose, take it as soon as you remember. Do not take the next dose too early, but wait approximately 4 hours before taking the next dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Amoxicillin and Clavulanic Acid TecniGen Italia
Continue taking Amoxicillin and Clavulanic Acid TecniGen Italia until the treatment is complete, even if you feel better. You need every dose to 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 side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The following side effects may occur with this medicine.

Conditions to 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 breathing
Collapse

Contact your doctor immediately if you experience any of these symptoms. Stop taking Amoxicillin and Clavulanic Acid TecniGen Italia.

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 affected, take Amoxicillin and Clavulanic Acid TecniGen Italia with food.
Vomiting
Diarrhoea (in children)

Uncommon side effects
May affect up to 1 in 100 people:

Skin rash, itching
Raised, itchy skin rash (urticaria)
Indigestion
Dizziness
Headache

Uncommon side effects may be detected through blood tests:

Increased levels of 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 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 side effects may be detected through blood tests:

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

Other side effects with unknown frequency
(frequency cannot be estimated from the available data)

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 body surface – toxic epidermal necrolysis)
- Widespread red rash with small pus-filled blisters (exfoliative bullous dermatitis)
- 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 cell count (eosinophilia) and elevated 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 bilirubin levels in the blood (a substance produced by the liver), 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 TecniGen Italia or who have kidney problems)
Black, hairy-looking tongue

Side effects that may be detected through blood or urine tests:

Severe reduction in white blood cell count
Low red blood cell count (haemolytic anaemia)
Crystals in the urine

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: www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amoxicillin and Clavulanic Acid TecniGen Italia

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Store in the original packaging to protect the medicine from moisture.
Do not use this medicine after the expiry date stated on the blister or sachet and on the box 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 no longer in use. This will help protect the environment.

6. Package contents and other information

What Amoxicillin and Clavulanic Acid TecniGen Italia contains
Amoxicillin and Clavulanic Acid TecniGen Italia 875 mg/125 mg film-coated tablets:

The active substances are amoxicillin and clavulanic acid. Each film-coated tablet contains amoxicillin trihydrate equivalent to 875 mg of amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid.
Other components are: Tablet core: microcrystalline cellulose (E460), crospovidone (E1202), sodium croscarmellose, anhydrous colloidal silica (E551), magnesium stearate (E470b). Tablet coating: basic butyl methacrylate copolymer (Eudragit E 12.5), titanium dioxide (E171), talc, macrogol 6000.

Amoxicillin and Clavulanic Acid TecniGen Italia 875 mg/125 mg oral suspension powder in sachets:

The active substances are amoxicillin and clavulanic acid. Each sachet contains amoxicillin trihydrate equivalent to 875 mg of amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid.
Other components are: aspartame (E951), crospovidone (E1202), anhydrous colloidal silica (E551), magnesium stearate (E470b), strawberry flavour (containing maize maltodextrins and benzyl alcohol).

Description of the appearance of Amoxicillin and Clavulanic Acid TecniGen Italia and pack contents
Amoxicillin and Clavulanic Acid TecniGen Italia 875 mg/125 mg film-coated tablets:
White or almost white, oval, film-coated tablets with a score line.
Packaged in blisters made of OPA/Al/PVC/Al containing 12 film-coated tablets.
Amoxicillin and Clavulanic Acid TecniGen Italia 875 mg/125 mg oral suspension powder in sachets:
Powder ranging from whitish to yellowish in polyethylene terephthalate/aluminium/polyethylene (PET/Al/PE) sachets.
Each package contains 12 sachets in a cardboard box.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Tecnigen srl
via Galileo Galilei 40
20092 Cinisello Balsamo (MI), Italy.
Responsible manufacturer for batch release
PenCef Pharma GmbH
Breitenbachstrasse 13-14
13509 Berlin, Germany

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 bacteria survive and multiply despite the antibiotic.
Bacteria become resistant to antibiotics for various reasons. Using antibiotics appropriately can reduce the emergence of bacterial resistance.
When your doctor prescribes you an antibiotic, it is intended only for the illness you currently have.
Please pay attention to the following advice to help prevent the emergence of bacterial resistance, which leads to loss of antibiotic effectiveness.

It is very important that you take the antibiotic at the correct dose, at the prescribed times, and for the correct number of days. Read the instructions in the package leaflet 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 prescribed for other people, even if you have a similar infection.
Do not give your antibiotics to other people, even if they have a similar infection.
If you have leftover antibiotics after completing your treatment, return them to your pharmacist so they can be disposed of appropriately.