AMPICILLIN TILLOMED 1 g POWDER FOR INJECTION AND INFUSION SOLUTION

2. What you need to know before you use Ampicilina Tillomed

Do not use Ampicilina Tillomed

• if you are allergic to ampicillin or other penicillins.

Do not use ampicillin if the above circumstance applies to you. If you are unsure, consult your doctor, pharmacist, or nurse before using ampicillin.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use ampicillin:

Hypersensitivity reactions

If you are allergic to cephalosporins (another group of antibacterial medicines). Caution is recommended if you have had allergies in the past.

If an allergic reaction occurs (e.g., hives, anaphylaxis, asthma, allergic rhinitis), treatment with ampicillin should be discontinued and alternative treatment should be initiated.

Colitis

Pay attention to symptoms of watery diarrhea, often with blood and mucus, abdominal pain, and/or fever.

This may be a sign of colitis. See section 4. This also applies if diarrhea occurs several months after ampicillin administration.

Infectious mononucleosis, chronic lymphocytic leukemia

A significant proportion (up to 90%) of patients with infectious mononucleosis or chronic lymphocytic leukemia who receive ampicillin develop skin rashes. The rash usually begins between 7 and 10 days after starting ampicillin treatment and continues for several days or a week after discontinuation.

Severe renal impairment

If you have severe renal impairment, your doctor will adjust the recommended dose of antibiotics and monitor renal function during treatment.

Treatment with anticoagulants

If you are being treated with anticoagulants, there may be a prolongation of prothrombin time. When ampicillin is prescribed concomitantly with anticoagulants, adequate monitoring should be performed. It may be necessary to adjust the dose of oral anticoagulants.

Urine test

Ampicillin may alter the results of some tests. If you provide urine samples for glucose measurement, inform your doctor or nurse that you are taking ampicillin.

Intramuscular administration of solutions may cause pain at the injection site.

Other medicines and Ampicilina Tillomed

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Ampicillin affects or is affected by other medicines, such as:

• Allopurinol (medicine used to treat gout). May increase the risk of allergic rash.
• Methotrexate (medicine used to treat cancer or rheumatism). The adverse effects of methotrexate may increase.
• Probenecid (medicine used to treat gout). Your doctor may decide to adjust the dose of ampicillin.
• Anticoagulants (medicines used to thin the blood). Concomitant administration of anticoagulants may increase the tendency to bleed. Your doctor may decide to perform regular blood tests.
• Live oral typhoid vaccine. There should be an interval of 3 days between the administration of a live oral typhoid vaccine and the administration of antibiotics such as ampicillin.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

Ampicillin may be used during pregnancy if your doctor considers it necessary.

Breastfeeding

Ampicillin is excreted in breast milk in small amounts. Therefore, breastfed infants may experience hypersensitivity reactions, diarrhea, or colonization of the mucosa by yeast, which may make it necessary to discontinue breastfeeding.

Fertility

In animal studies, ampicillin had no effects on fertility.

Driving and using machines

Ampicillin is not known to affect the ability to drive or use machines.

You are responsible for evaluating whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that may affect your ability in these aspects is the use of medicines due to their effects and/or side effects. You will find these effects and side effects described in other sections. Read all the information in this leaflet.

If you are unsure, consult your doctor or pharmacist.

Ampicilina Tillomed contains sodium

Ampicilina Tillomed 500 mg powder for solution for injection and infusion:

This medicine contains approximately 33 mg of sodium (main component of table/cooking salt) per vial. This is equivalent to 1.65% of the maximum recommended daily sodium intake for an adult.

Ampicilina Tillomed 1 g powder for solution for injection and infusion EFG:

This medicine contains approximately 66 mg of sodium (main component of table/cooking salt) per vial. This is equivalent to 3.30% of the maximum recommended daily sodium intake for an adult.

The maximum recommended daily dose is equivalent to 39.48% of the maximum recommended daily sodium intake by the WHO.

Consult your doctor or pharmacist if you need ampicillin daily for a prolonged period, especially if you have been advised to follow a low-salt (sodium) diet.

3. How to use Ampicilina Tillomed

This medicine will be administered to you by healthcare professionals by injection into a muscle or into a blood vessel or by infusion (drip) into a blood vessel.

Your doctor will determine the most suitable dose for you or your child. The dose depends on the type of infection, the location of the body, and its severity.

If you use more Ampicilina Tillomed than you should

If you suspect that you have received an excessive dose, inform your doctor, nurse, or pharmacist.

If you have taken too much of the medicine or if, for example, a child has accidentally ingested it, contact your doctor or the emergency department of the nearest hospital.

Signs of excessive ampicillin administration may include: nausea, vomiting, diarrhea, loss of consciousness, involuntary muscle contractions, cramps, convulsions, coma, renal failure.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Ampicilina Tillomed

Do not take a double dose to make up for a forgotten dose.

If you stop using Ampicilina Tillomed

Do not stop treatment even if symptoms disappear, unless your doctor recommends it, due to the risk of symptom recurrence.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Ampicilina Tillomed and consult your doctor or go to the emergency department of the nearest hospital immediately if you experience any of the following:

• Severe acute allergic reaction (anaphylactic reaction). This type of reaction can be life-threatening. One or more of the following symptoms may appear: skin redness, itchy rash, similar to hives, difficulty breathing, and dizziness (rare, may affect up to 1 in 1000 people).
• Ampicillin may affect white blood cells, impairing defenses against infection. If you contract an infection with symptoms such as fever with severe general deterioration, or fever with symptoms of local infection such as sore throat, pharynx, mouth, or difficulty urinating, you should see your doctor as soon as possible to rule out a lack of white blood cells (agranulocytosis) through a blood test. It is important that you inform about your medication (less frequent, may occur in up to 1 in 100 users).
• Colitis with symptoms such as watery diarrhea, often with blood and mucus, abdominal pain, and/or fever (uncommon, may affect up to 1 in 100 people).

Other possible side effects are:

Frequent (may affect up to 1 in 10 people)

• Skin rash, itching
• Soft stools

Uncommon (may affect up to 1 in 100 people)

• Reduction of red blood cells that can cause paleness, weakness, and difficulty breathing (anemia)
• Decrease in platelet count (thrombocytopenia)
• Decrease or increase in white blood cell count (leukopenia, eosinophilia)
• Inflammation of the tongue and oral mucosa
• Stomatitis, glossitis, abdominal pain
• Nausea and vomiting
• Colitis
• Diarrhea
• Hives
• Cristalluria (presence of crystals in the urine indicating renal irritation)

Rare (may affect up to 1 in 1000 people)

• Severe skin inflammation with peeling (exfoliative dermatitis)

• Skin disorders, sometimes severe (erythema multiforme, Stevens-Johnson syndrome, Lyell syndrome)
• Dizziness, headaches, myoclonus, and convulsions
• Hepatitis (liver inflammation) and cholestatic jaundice; elevated liver values may occur.
• Acute interstitial nephritis (kidney inflammation)
• Pain and swelling at the injection site
• Fungal overgrowth may occur in the oral cavity and abdomen.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ampicilina Tillomed

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and on the carton after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

After reconstitution:

• The reconstituted solution should be used immediately.
• Solutions should be prepared just before use and their transparency should be checked. Only use clear solutions. Do not use cloudy or precipitated solutions.
• For instructions on the storage of this medicine after reconstitution, see the section "This information is intended only for healthcare professionals".
• The unused solution should be discarded.

After dilution:

• The diluted solution should be used immediately.

Medicines should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medicine in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Ampicilina Tillomed Composition

• The active ingredient is ampicillin.
• It does not contain other ingredients.

Ampicilina Tillomed 500 mg powder for solution for injection and infusion:

Each vial contains ampicillin sodium equivalent to 500 mg of ampicillin.

Ampicilina Tillomed 1 g powder for solution for injection and infusion EFG:

Each vial contains ampicillin sodium equivalent to 1 g of ampicillin.

Product Appearance and Container Content

White or almost white powder.

Ampicilina Tillomed 500 mg powder for solution for injection and infusion:

500 mg of powder for solution for injection/infusion in type III colorless glass vials, closed with bromobutyl rubber stoppers and sealed with aluminum flip-off caps in boxes of 1, 5, and 10 units.

Ampicilina Tillomed 1 g powder for solution for injection and infusion EFG

1 g of powder for solution for injection/infusion in type III colorless glass vials, closed with bromobutyl rubber stoppers and sealed with aluminum flip-off caps in boxes of 1, 5, 10, and 50 units.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Tillomed Spain, S.L.U.

c/ Cardenal Marcelo Spínola, 8

28016 Madrid (Spain)

Manufacturer

Antibiotice, S.A.

Str Valea Lupului, 1

Iasi, Judet Iasi - 707410 Romania

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Norway Amroliv 500 mg, 1g, 2g powder for solution for injection/infusion

Sweden Amroliv 1g, 2g powder for solution for injection/infusion

Denmark Amroliv 500 mg, 1g, 2g powder for solution for injection/infusion

Germany Kampyl 500 mg, 1g, 2g powder for the preparation of an injection/infusion solution

Poland Ampicillin Antibiotice

Hungary Ampicillin Antibiotice 1g powder for solution for injection or infusion

Italy Ampicillina Tillomed 1g powder for solution for injection/infusion

Spain Ampicilina Tillomed 500 mg, 1g powder for solution for injection and infusion

Date of the last revision of this leaflet:December 2022

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended only for healthcare professionals:

Incompatibilities

This medicinal product must not be mixed with other solutions except those mentioned in this section.

If ampicillin and an aminoglycoside are prescribed concomitantly, the antibiotics must not be mixed in the syringe or in the container for intravenous fluid, as this may result in a loss of activity of the aminoglycosides.

Reconstitution of the Injection Solution

Ampicillin 500 mg and 1 g can be used for intramuscular and intravenous administration.

Intramuscular Injection

Ampicilina Tillomed 500 mg powder for solution for injection and infusion

To reconstitute the injection solution, dissolve the contents of one vial with 1.8 ml of water for injectable preparations to obtain a concentration of 250 mg/ml of injection solution. Shake well until the solution becomes transparent.

Ampicilina Tillomed 1 g powder for solution for injection and infusion EFG

To reconstitute the injection solution, dissolve the contents of one vial with 4 ml of water for injectable preparations to obtain a concentration of 250 mg/ml of injection solution. Shake well until the solution becomes transparent.

After reconstitution, the solution should be used immediately, and any remainder should be discarded.

The solution should be administered by deep intramuscular injection.

Intravenous Injection

Ampicilina Tillomed 500 mg powder for solution for injection and infusion

To reconstitute the injection solution, dissolve the contents of one vial with 5 ml of water for injectable preparations to obtain a concentration of 100 mg/ml.

Ampicilina Tillomed 1 g powder for solution for injection and infusion EFG

To reconstitute the injection solution, dissolve the contents of one vial with 7.4 ml of water for injectable preparations to obtain a concentration of 125 mg/ml.

After reconstitution, administer the intravenous injection slowly over 5-10 minutes. Rapid administration may cause convulsions.

Intravenous Infusion

First, reconstitute as specified in the "intravenous injection" paragraph before diluting with a 9 mg/ml (0.9%) sodium chloride injection solution.

The concentrations of the diluted solution should not exceed 30 mg/ml. The rate and volume of the infusion should be set so that the medicinal product does not lose its stability in the solution used.

Only the solutions listed above can be used for intravenous infusion of ampicillin.

The solutions should always be freshly prepared before use and their transparency should be checked.

Ampicillin can be administered by intravenous infusion over 20-30 minutes. For continuous infusion, a infusion pump should be used if possible.

Use only clear and practically particle-free solutions.

Do not use cloudy or precipitated solutions.

Disposal of unused medicinal products and all materials that have come into contact with them should be carried out in accordance with local regulations.

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