How to use AMPICILLIN TILLOMED 1 g POWDER FOR INJECTION AND INFUSION SOLUTION
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the User
Ampicilina Tillomed 500mgpowder for solution for injection and infusion
Ampicilina Tillomed 1gpowder for solution for injection and infusion EFG
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet, you may need to read it again. If you have any further questions, ask your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of the pack
- What is Ampicilina Tillomed and what is it used for
- What you need to know before you use Ampicilina Tillomed
- How to use Ampicilina Tillomed
- Possible side effects
- Storage of Ampicilina Tillomed
- Contents of the pack and other information
1. What is Ampicilina Tillomed and what is it used for
Ampicilina Tillomed contains the active substance ampicillin, which belongs to a group of medicines called penicillins.
Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or common cold. It is important that you follow the instructions regarding dose, administration interval, and treatment duration as indicated by your doctor. Do not store or reuse this medicine. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste. |
This medicine is used to treat bacterial infections (antibiotics) and works by eliminating the bacteria that cause the infections. Ampicillin is used to treat infections caused by bacteria sensitive to ampicillin.
Ampicillin is used to treat the following diseases:
- Acute exacerbation of chronic bronchitis (infection of the respiratory tract).
- Pyelonephritis (infection of the upper urinary tract).
- Bacterial meningitis (infection of the membranes covering the brain).
- Pneumonia (infection of the lungs) when another penicillin is not effective or is inadequate for other reasons.
- Intra-abdominal infections (infection of the stomach and intestine).
- Bloodstream infection associated with any of the aforementioned infections.
Ampicillin is also used for the treatment and prevention of endocarditis (infection of the heart valves).
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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- Country of registration
- Dosage formINJECTABLE, 1 g
- ATC codeJ01CA01
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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Frequently Asked Questions
AMPICILLIN TILLOMED 1 g POWDER FOR INJECTION AND INFUSION SOLUTION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
The active ingredient in AMPICILLIN TILLOMED 1 g POWDER FOR INJECTION AND INFUSION SOLUTION is ampicillin. This information helps identify medicines with the same composition but different brand names.
AMPICILLIN TILLOMED 1 g POWDER FOR INJECTION AND INFUSION SOLUTION is manufactured by Laboratorios Tillomed Spain S.L.U. Pharmacy brands and packaging may differ depending on the distributor.
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether AMPICILLIN TILLOMED 1 g POWDER FOR INJECTION AND INFUSION SOLUTION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
Spain has a well-developed healthcare infrastructure across major cities such as Madrid, Barcelona, Valencia, and Seville. Pharmacies are widely available and operate under strict regulations, ensuring access to prescribed medications.
You can buy AMPICILLIN TILLOMED 1 g POWDER FOR INJECTION AND INFUSION SOLUTION in Madrid, Barcelona, Seville, or Valencia at any local pharmacy with a valid prescription.
To obtain a prescription, you can use Oladoctor:
Other medicines with the same active substance (ampicillin) include AMPICILLIN TILLOMED 500 mg POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION, GOBEMICINA 1g INJECTABLE, GOBEMICINA 500 mg INJECTABLE. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
