Ambramicina

Package leaflet: Information for the patient

Ambramicina 250 mg hard capsules

Tetracycline HCl
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 others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ambramicina is and what it is used for

Ambramicina contains the active substance tetraciclina cloridrato, an antibiotic that works by eliminating various
types of bacteria that cause infections.
Ambramicina is indicated in adults and adolescents over 12 years of age for the treatment of
infections caused by bacteria sensitive to tetracycline (bacteria against which tetracycline is effective), particularly:

• bacterial infections of the bronchi and lungs (pneumonia and bronchopneumonia);
• acute and acute-on-chronic infections of the urinary and reproductive systems (those that suddenly reappear);
• post-surgical infections, for example: bone tissue infections (osteomyelitis), soft tissue infections;
• intestinal infections: infectious diarrhoea (bacterial and amoebic dysentery), acute and subacute diarrhoeal syndromes (when infection symptoms develop slowly and gradually, not suddenly);
• acute and subacute heart infections (endocarditis);
• brain infections (typically epidemic cerebrospinal meningitis and purulent meningitis);
• brucellosis (a bacterial infection generally manifesting with fever, sweating, malaise, weight loss, headache, and muscle pain);
• rickettsioses (an infection generally manifesting with fever, headache, general malaise, inflammation of small blood vessels, and often associated with a skin rash);
• ear, nose, and throat infections (tonsillitis, otitis, sinusitis, mastoiditis);
• eye infections, for example: eyelid infections (blepharitis); infections of the conjunctiva, the membrane covering the eye and inner eyelid (conjunctivitis); corneal infections, the transparent front part of the eye, caused by specific bacteria (trachoma);
• female reproductive system infections, for example: uterine infections (metritis, cervicitis), ovarian and fallopian tube infections (annexitis), and vaginal infections (vulvovaginitis);
• bacterial skin infections: localized (for example, furunculosis) or widespread (for example, impetigo: infections manifesting as pus-filled blisters on the skin).

Talk to your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Ambramicina

Do not take Ambramicina

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Ambramicina.

• As with other antibiotics, due to resistant bacteria or bacteria insensitive to tetracycline (bacteria against which tetracycline is ineffective, such as fungi, for example), the use of this medicine may occasionally lead to a new infection superimposed on the existing one (superinfections). Be aware that during treatment, enterocolitis (intestinal infections) due to certain types of resistant bacteria may occur. Given the possible presence of resistant bacteria, when there is no information about the bacteria's sensitivity to the antibiotic, your doctor may prescribe appropriate bacteriological tests (tests that identify the bacteria causing the infection).
• In the treatment of sexually transmitted infections (gonococcal infections), there is a risk of masking symptoms of coexisting syphilis (a sexually transmitted infection); therefore, your doctor will monitor you for at least 4 months.
• Since tetracyclines may reduce blood coagulation capacity (prothrombin activity), your doctor may, if necessary, adjust the dose of anticoagulants (medicines used to thin the blood) that you may be taking during tetracycline administration.
• If you need to undergo long-term treatment cycles, your doctor will periodically request tests to assess blood composition, liver and kidney function.
• If tetracyclines are used in infections caused by Group A beta-hemolytic Streptococcus (a very dangerous type of bacterium causing reactions such as skin redness, rashes, fever, weakness, diarrhea, vomiting, kidney inflammation, throat infections, bruising), treatment must last no less than ten days.
• The use of tetracyclines during the period of tooth development (second half of pregnancy, neonatal period, and early childhood) may cause permanent tooth discoloration (yellow-brown) (see section “Additional undesirable effects in children”).
• If you are prone to photosensitivity reactions (skin rashes appearing after sun exposure), be aware that such reactions may occur during treatment. Therefore, discontinue treatment with Ambramicina as soon as cutaneous erythema (skin irritation) appears (see section 4 “Possible side effects”).
• To avoid esophageal irritation (the organ connecting the throat to the stomach), you must take the product with an adequate amount of water (see section 3 “How to take Ambramicina”).
• If you have kidney problems (renal insufficiency), even at normal doses, accumulation of tetracyclines in the blood may occur, potentially causing liver damage; in such cases, your doctor will adjust the dose according to your kidney function, possibly monitoring blood levels and liver function. Also, be aware that tetracyclines may worsen existing renal insufficiency (see section 3 “How to take Ambramicina”).
• Do not take the medicine after the expiry date stated on the packaging, as it may cause the following effects: polyuria (increased urine volume), glycosuria (sugar in urine), aminoaciduria (amino acids in urine), proteinuria (proteins in urine). Storing tetracyclines in warm and humid conditions may promote the formation of compounds harmful to the kidneys.

Children and adolescents
This medicine is indicated in adolescents over 12 years of age.
In children under 12 years of age, this medicine should be administered only when strictly necessary and under direct medical supervision.
This is particularly important during the neonatal period and childhood (from 0 to 12 years), as this medicine may cause permanent tooth discoloration (yellow-brown) during the period of tooth development (see section “Additional undesirable effects in children”).

Other medicines and Ambramicina
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

• penicillins (a class of antibiotics used to treat infections), as possible interactions may occur between the antibacterial activity of Ambramicina and this class of antibiotics. It is advisable to avoid simultaneous administration of Ambramicina and penicillins.
• antacids containing aluminium, calcium, or magnesium (medicines used for stomach acidity), as they reduce the absorption of orally administered tetracyclines; therefore, simultaneous intake should be avoided.
• anticoagulants (medicines used to thin the blood), as tetracyclines may reduce blood coagulation capacity (prothrombin activity). Your doctor may, if necessary, adjust the dose of anticoagulants you are taking during tetracycline administration.

Ambramicina with food and drink
Avoid consuming milk or dairy products at the same time as this medicine, as these foods reduce the absorption of orally administered tetracyclines.
To avoid esophageal irritation (the organ connecting the throat to the stomach), you must take this medicine with an adequate amount of water (see section 3 “How to take Ambramicina”).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
In pregnant women and during breastfeeding, this product should be administered only when strictly necessary and under direct medical supervision.

Driving and using machines
No effects impairing the ability to drive or use machinery have ever been reported.

3. How to take Ambramicina

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults and adolescents over 12 years of age

• The recommended daily oral dose ranges between 15 and 25 mg/kg of body weight; in particularly severe cases, your doctor may increase the dose. For example, in an adult of average weight, 4-6 capsules of 250 mg per day, i.e. one capsule every 4-6 hours.
• To avoid irritation of the oesophagus, you must take this medicine with an adequate amount of water (see section “Ambramicina with food and drink”).

If you have kidney problems (renal impairment)
If you suffer from renal impairment, your doctor will adjust the dose according to the degree of kidney function
(see section “Warnings and precautions”).
Use in children
In children under 12 years of age, this medicine should be administered only when strictly necessary and under direct medical supervision.
This is particularly important during the neonatal period and childhood (from 0 to 12 years), as this medicine may cause permanent tooth discoloration (yellow-brown) during tooth development
(see section “Additional undesirable effects in children”).
Duration of treatment
The duration of treatment depends on the resolution of fever and improvement in general condition.
Once the fever has subsided, your doctor may advise continuing antibiotic therapy for several more days to prevent possible relapses, possibly reducing the dose.
For certain types of infection, your doctor may prescribe a longer treatment course, even lasting several months, depending on the type of bacteria involved.
In any case, the duration of treatment will be determined by your treating doctor based on your response to therapy.
If you take more Ambramicina than you should
No symptoms have been reported following overdose with Ambramicina.
If you forget to take Ambramicina
Do not take a double dose to make up for the missed capsule.
If you have forgotten one or more doses, consult the doctor who prescribed this medicine before resuming treatment.
After consulting your doctor and resuming treatment, continue following the correct dosing schedule prescribed by your doctor.
If you stop taking Ambramicina
Do not stop treatment without first consulting your doctor.
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 everyone gets them.
If during treatment you experience skin erythema (skin irritation), consult your doctor immediately, who will DISCONTINUE treatment with Ambramicina.

During treatment with tetracyclines, some of the following side effects may occur, according to the frequency listed below:
Very rare (may affect up to 1 in 10,000 patients):

• haemolytic anaemia (destruction of certain blood cells, red blood cells)
• neutropenia (reduction in the number of certain blood cells, neutrophils, a type of white blood cell)
• thrombocytopenia (reduction in the number of platelets in the blood)
• eosinophilia (increase in the number of certain blood cells, eosinophils, a type of white blood cell).

During treatment with tetracyclines, the following side effects affecting the following body systems and organs may also occur:
Intracranial hypertension
Benign intracranial hypertension has been reported in association with tetracyclines, with possible symptoms including headache, vomiting, and visual disturbances such as blurred vision, scotoma, diplopia, or permanent loss of vision. The onset of clinical symptoms, including headache or visual disturbances, should raise suspicion of intracranial hypertension. If increased intracranial pressure is suspected during tetracycline treatment, administration must be discontinued.

Effects affecting mouth, stomach, and intestine

• loss of appetite
• nausea, vomiting, diarrhoea
• infection of the tongue (glossitis and other mucositis)

Effects affecting the skin

• erythematous skin rashes (irritation causing redness of the skin)
• maculopapular skin rashes (irritation characterized by flat or slightly raised small red spots on the skin)

Allergic reactions

• urticarial rashes (rash presenting as finely raised red patches on the skin)
• anaphylactoid purpura (a type of inflammation of small blood vessels usually manifesting with abdominal pain, maculopapular skin lesions, and redness)
• angioneurotic oedema (rapid swelling usually affecting the face, around or inside the mouth, throat, or tongue)

Additional side effects in children
The use of tetracyclines during the neonatal period and in childhood (from 0 to 12 years of age) may cause permanent tooth discolouration (yellow-brown); this occurs especially after prolonged use (at least 1 month) of these antibiotics, but has also been observed after short but repeated treatment courses (see section “Warnings and precautions”).

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 the following website: https://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 Ambramicin

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 pack after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Ambramicina contains

• The active substance is: tetraciclina cloridrato (each capsule contains 250 mg of tetraciclina cloridrato)
• The other components are: magnesium stearate; maize starch; titanium dioxide; indigotine; gelatin.

Description of the appearance of Ambramicina and package contents
Ambramicina is available as 250 mg hard capsules, packaged in a box containing 16 capsules in blisters.
Marketing Authorization Holder
SCHARPER S.p.A. - Viale Ortles, 12 – 20139 Milan
Manufacturer
DOPPEL FARMACEUTICI S.r.l. – Via Volturno, 48 – Quinto Dè Stampi – 20089 Rozzano (MI)