Amoxicillin Pensapharma

Package leaflet: Information for the user

Amoxicillina PENSA PHARMA 1000 mg dispersible 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 (or your child) 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 adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Amoxicillina PENSA PHARMA is and what it is used for
2. What you need to know before taking Amoxicillina PENSA PHARMA
3. How to take Amoxicillina PENSA PHARMA
4. Possible side effects
5. How to store Amoxicillina PENSA PHARMA
6. Contents of the pack and other information

1. What Amoxicillina PENSA PHARMA is and what it is used for

Amoxicillina PENSA PHARMA is an antibiotic. Its active ingredient, called amoxicillin, belongs to a group of medicines known as "penicillins".
Amoxicillina PENSA PHARMA is used to treat bacterial infections affecting various parts of the body.
Amoxicillina PENSA PHARMA may also be used in combination with other medicines for the treatment of gastric ulcers.

2. What you need to know before taking Amoxicillin PENSA PHARMA

Do not take Amoxicillin PENSA PHARMA:

• if you are allergic to amoxicillin, penicillin, or any of the other ingredients of this medicine (listed in section 6).
• if you have previously had an allergic reaction to any antibiotic. This also includes skin rash or development of facial or throat swelling.

Do not take Amoxicillin PENSA PHARMA if any of the above situations apply to you.
If you have any doubts, consult your doctor or pharmacist before taking Amoxicillin PENSA PHARMA.

Warnings and precautions
Talk to your doctor or pharmacist before taking Amoxicillin PENSA PHARMA if:

• you have glandular fever (fever, sore throat, swollen glands, and extreme tiredness)
• you have kidney problems
• you do not urinate regularly.

If you are unsure whether any of the points listed above apply to you, consult your doctor or pharmacist before taking Amoxicillin PENSA PHARMA.

Blood and urine tests
If you are undergoing:

• urine tests (for glucose) or blood tests to assess liver function
• tests for estriol (used during pregnancy to monitor normal fetal development), inform your doctor or pharmacist that you are taking Amoxicillin, as this medicine may alter the results of these tests.

Other medicines and Amoxicillin PENSA PHARMA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• If you are taking allopurinol (a medicine used to treat gout) together with Amoxicillin PENSA PHARMA, you may have a higher risk of developing an allergic skin reaction.
• If you are taking probenecid (a medicine used to treat gout), your doctor may need to adjust the dose of Amoxicillin PENSA PHARMA.
• If you are taking medicines to prevent blood clots (e.g., warfarin), you may need additional blood tests.
• If you are taking other antibiotics (e.g., tetracyclines), the effectiveness of Amoxicillin PENSA PHARMA may be reduced.
• If you are taking methotrexate (a medicine used to treat cancer and severe psoriasis), Amoxicillin PENSA PHARMA may cause an increase in side effects.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Driving and using machines
Amoxicillin PENSA PHARMA may cause side effects whose symptoms (such as allergic reactions, dizziness, and seizures) may affect your ability to drive.
Do not drive or operate machinery if you do not feel well.

Amoxicillin PENSA PHARMA dispersible tablets contain aspartame
Aspartame (E951) is a source of phenylalanine, a substance that may be harmful to patients with a condition called "phenylketonuria".

Amoxicillin PENSA PHARMA contains maltodextrin
Maltodextrin is absorbed as glucose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

Amoxicillin PENSA PHARMA contains benzyl alcohol
This medicine contains 0.003 mg of benzyl alcohol per dispersible tablet, equivalent to 0.003 mg/1000 mg.
Benzyl alcohol may cause allergic reactions.

3. How to take Amoxicillina PENSA PHARMA

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The tablets can be taken in the following ways:

• Swallow the tablets whole, with a glass of water. To facilitate swallowing, the tablet may be divided along the score line.
• Add the tablet to a glass of water and stir until completely dissolved. Then drink immediately. Take doses at regular intervals throughout the day, spaced at least 4 hours apart.

Recommended dose:

Children weighing less than 40 kg
All doses are calculated according to the child's body weight in kilograms. Your doctor will tell you how much Amoxicillina PENSA PHARMA to give your child.

• The usual dose is 40 mg to 90 mg per kilogram of body weight per day, divided into two or three separate doses.
• The maximum dose is 100 mg per kilogram of body weight per day.

Adults, elderly patients, and children weighing 40 kg or more
The usual dose of Amoxicillina PENSA PHARMA is 250–500 mg three times daily or 750 mg–1 g every 12 hours, depending on the severity and type of infection.

• Severe infections: 750 mg to 1 g three times daily.
• Urinary tract infections: 3 g twice daily for one day.
• Lyme disease (an infection caused by a parasite called tick): isolated erythema migrans (early stage – circular reddish or rosy skin rash): 4 g per day; systemic manifestations (late stage – more severe symptoms or when the disease spreads to other parts of the body): up to 6 g per day.
• Gastric ulcers: a dose of 750 mg or a dose of 1 g twice daily for 7 days, together with other antibiotics and medicines for treating gastric ulcers.
• Prevention of heart infections during surgical procedures: the dose will vary depending on the type of surgery. Other medicines may also be administered simultaneously. Your doctor, pharmacist, or nurse will provide more detailed information. The maximum recommended dose is 6 g per day.

Renal impairment
If you have kidney problems, your dose may be lower than usual.

If you take more Amoxicillina PENSA PHARMA than you should
If you take too much Amoxicillina PENSA PHARMA, symptoms such as gastrointestinal disturbances (nausea, vomiting, diarrhoea) or the presence of crystals in the urine, possibly causing cloudy urine or difficulty urinating, may occur. Contact your doctor as soon as possible, and bring the medicine with you to show it to them.

If you forget to take Amoxicillina PENSA PHARMA

• If you forget a dose, take it as soon as you remember.
• Do not take the next dose too early; wait approximately 4 hours before taking the next dose.
• Do not take a double dose to make up for the missed dose.

How long should you take Amoxicillina PENSA PHARMA?

• Continue taking Amoxicillina PENSA PHARMA for the length of time prescribed by your doctor, even if you start feeling better. It is necessary to take all prescribed doses to fully eliminate the infection. The infection may return if some bacteria survive.
• If, after completing the treatment, you still do not feel well, consult your doctor again.

Prolonged use of Amoxicillina PENSA PHARMA may lead to the development of candidiasis (a yeast infection affecting moist areas of the body, causing irritation, itching, and whitish discharge). If this occurs, consult your doctor.
If you take Amoxicillina PENSA PHARMA for a prolonged period, your doctor may carry out additional tests to ensure that your kidneys, liver, and blood are functioning normally.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Stop taking Amoxicillina PENSA PHARMA and consult a doctor immediately if you notice any of the following serious side effects, as urgent medical treatment may be required:
The following side effects are very rare (may affect up to 1 in 10,000 people):

• allergic reactions, accompanied by signs such as skin itching or rash, swelling of the face, lips, tongue or body, or difficulty breathing. These effects can be severe and, in some cases, have been fatal.
• skin rash or appearance of small, round, flat, reddish spots under the skin surface, or skin bruising. This is due to inflammation of the walls of blood vessels caused by an allergic reaction. It may be accompanied by joint pain (arthritis) and kidney problems;
• a delayed allergic reaction, usually occurring 7–12 days after taking Amoxicillina PENSA PHARMA, accompanied by signs such as skin rash, fever, joint pain, and swollen lymph nodes, particularly those under the arm.
• a skin reaction known as “erythema multiforme”, with itchy, reddish-purple patches on the skin, particularly on the palms of the hands or soles of the feet, areas of skin swelling similar to hives, or painful areas on the surface of the mouth, eyes, and genitals. This may be accompanied by fever and a feeling of extreme fatigue;
• other serious skin reactions may include changes in skin colour, formation of lumps under the skin, appearance of blisters, pustules, peeling, redness, pain, itching and flaking, and may be associated with fever, headache and widespread pain;
• fever, chills, sore throat or other signs of infection, or a tendency to bruise easily. These may be signs of a blood cell disorder;
• the Jarisch-Herxheimer reaction, which may occur during treatment of Lyme disease with Amoxicillina PENSA PHARMA, causing fever, chills, headache, muscle pain and skin rash;
• inflammation of the large intestine (colon) with diarrhoea (sometimes containing blood), abdominal pain and fever;
• severe side effects affecting the liver may occur, mainly observed in patients treated for long periods, in men and in elderly people. Contact your doctor urgently if you notice:
• severe diarrhoea with bleeding;
• blisters, redness or bruising of the skin;
• dark urine or pale stools;
• yellowing of the skin or the white part of the eye (jaundice). See also the section on anaemia below as a possible cause of jaundice.

These effects may occur during treatment with the medicine or even several weeks later.
If any of the above effects occur, stop taking the medicine and contact your doctor immediately.
Sometimes less severe skin reactions may occur, such as:

• a slightly itchy rash (roundish pinkish-red patches), localized swelling similar to hives on the forearms, legs, palms of the hands, hands or feet. This is an uncommon effect (may affect up to 1 in 100 people). If any of these side effects occur, contact your doctor, as it will be necessary to stop treatment with Amoxicillina PENSA PHARMA. Other possible side effects are:
  Common (may affect up to 1 in 10 people)

• skin rash

• nausea

• diarrhoea

Uncommon (may affect up to 1 in 100 people)

• vomiting

Very rare (may affect up to 1 in 10,000 people)

• candidiasis (yeast infection of the vagina, mouth or skin folds); your doctor or pharmacist will prescribe appropriate treatment;
• kidney problems
• seizures, observed in patients treated with high doses or who have kidney problems
• dizziness
• hyperactivity
• presence of crystals in the urine, possibly causing cloudy urine, difficulty urinating or discomfort during urination. Make sure you drink plenty of fluids to reduce the risk of developing these symptoms
• teeth may appear stained, but usually return to their normal appearance with brushing (this effect has been reported in children)
• the tongue may become yellowish, brownish or blackish in colour and have a hairy appearance
• excessive destruction of red blood cells, leading to a type of anaemia. Signs include: fatigue, headache, shortness of breath, dizziness, paleness and yellowing of the skin and the white part of the eye
• reduction in the number of white blood cells
• reduction in the number of cells involved in blood clotting
• prolonged blood clotting time compared to normal. This effect may be noticed with nosebleeds or when sustaining a cut.

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 PENSA PHARMA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Exp”. The expiry date refers to the last day of that month.
Do not store this medicine above 25°C. Store in the original container to protect it from moisture.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of medicines 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 PENSA PHARMA contains
The active substance is amoxicillin trihydrate.
Each dispersible tablet contains amoxicillin trihydrate equivalent to 1 g of amoxicillin.
The other components are: magnesium stearate, microcrystalline cellulose, crospovidone, strawberry flavour, aspartame.
Components of the strawberry flavour are: maize maltodextrin, triethyl citrate (E1505), flavours, propylene glycol and benzyl alcohol.

Description of the appearance of Amoxicillina PENSA PHARMA and package contents
Amoxicillina PENSA PHARMA 1 g dispersible tablets
Oblong tablets, white to off-white in colour, 22 mm x 10 mm, with a score line on both sides.
The tablets are packaged in PVC/PVDC/Aluminium or PVC/TE/PVDC/Aluminium blisters.
Amoxicillina PENSA PHARMA 1 g dispersible tablets are available in packs of 12 dispersible tablets.

Marketing Authorization Holder
PENSA PHARMA S.p.A.
Via Ippolito Rosellini, 12
20124 Milan - Italy

Manufacturer
PenCef Pharma Berlin GmbH
Breitenbachstrasse 13-14
13509 Berlin – GERMANY
Haupt Pharma Latina s.r.l
S.S. 156 Monti Lepini km. 47,600
04100 BORGO SAN MICHELE (LATINA) - ITALY

General recommendation on the use of antibiotics
Antibiotics are used to treat bacterial infections and have no effect against infections caused by viruses.
It may happen that a bacterial infection does not respond to a course of antibiotic therapy. Most often, this is due to the bacteria causing the infection being resistant to the administered antibiotic, thus surviving and multiplying despite treatment.
There are several reasons why bacteria may become resistant to antibiotics. Correct use of antibiotics can help reduce the likelihood of bacteria developing resistance.
An antibiotic prescription is intended solely to treat the current illness. By following the recommendations below, you can help prevent the development of resistant bacteria, which could render antibiotic therapy ineffective.

1. It is very important that antibiotics are taken at the correct dose, at the correct times, and for the prescribed number of days. It is important to read the instructions accompanying the medicine and, if difficult to understand, to ask your doctor or pharmacist for clarification.
2. Antibiotics should not be taken if they have not been specifically prescribed for you and should only be used to treat the infection for which they were prescribed.
3. Do not take antibiotics prescribed for other people, even if the infection appears similar.
4. Do not give antibiotics prescribed for you to other people.
5. If, after completing the treatment course as directed by your doctor, there are any unused antibiotics remaining, these should be returned to a pharmacy for proper disposal.