AMBRAMICINA 250 mg Hard Capsules

Зміст інструкції

1. Ambramicina 250 mg hard capsules
   1. What is Ambramicina and what is it 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

Ambramicina 250 mg hard capsules

Tetracycline HCl

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Ambramicina and what is it used for

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

• infections of the bronchi and lungs of bacterial origin (pneumonia and bronchopneumonia);
• acute and recurrent infections of the urinary and reproductive system (which reappear suddenly);
• infections after surgery, for example: infections of bone tissue (osteomyelitis), infections of soft tissues;
• infections of the intestine: infectious diarrhea (bacterial and amoebic dysentery), acute and subacute diarrheal syndromes (when the symptoms of the infection manifest slowly and gradually, not suddenly);
• infections of the heart (endocarditis) acute and subacute;
• infections of the brain (usually epidemic cerebrospinal meningitis and purulent meningitis);
• brucellosis (bacterial infection that generally manifests with fever, sweating, malaise, weight loss, headache, muscle pain);
• rickettsiosis (infection that generally manifests with fever, headache, general malaise, inflammation of small blood vessels and often associated with a skin rash);
• infections of the ear, nose, throat (tonsillitis, otitis, sinusitis, mastoiditis);
• infections of the eye, for example: infections of the eyelids (blepharitis); infections of the conjunctiva, the membrane that covers the eye and the inside of the eyelid (conjunctivitis); infections of the cornea, the transparent front part of the eye, caused by specific bacteria (trachoma);
• infections of the female reproductive system, for example: infections of the uterus (metritis, cervicitis), of the ovary and fallopian tubes (annexitis), and of the vagina (vulvovaginitis);
• bacterial skin infections: localized (e.g. furuncles) or widespread (e.g. impetigo: infections that manifest with pustules on the skin).

See 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 ingredient 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 bacteria resistantor insensitive to tetracycline (bacteria against which tetracycline is not effective, such as fungi), the use of this medicine may occasionally lead to a new infection that overlaps with the existing one (superinfections). Keep in mind that enterocolitis (intestinal infections) due to the presence of certain types of resistant bacteria may occur during treatment. Taking into account the possible presence of resistant bacteria, when there is no information about the sensitivity of the bacterium to the antibiotic, your doctor will prescribe appropriate bacteriological tests (tests that allow the identification of the bacteria that cause the infection).
• In the treatment of sexually transmitted infections (gonococcal infections), there is a risk of masking the symptoms of a coexisting syphilis (sexually transmitted infection), therefore your doctor will monitor you for at least 4 months.
• Since tetracyclines can reduce the ability of blood to clot(prothrombin activity), your doctor may, if necessary, adjust the dose of anticoagulants (medicines to thin the blood) that you are taking during the administration of tetracyclines.
• If you need to undergo long-term treatmentcycles, your doctor will periodically ask you to undergo tests to evaluate 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 that causes reactions such as skin redness, skin rashes, fever, weakness, diarrhea, vomiting, kidney inflammation, throat infections, bruises), the treatment must last for at least ten days.
• The use of tetracyclines during the period of tooth formation(second half of pregnancy, neonatal period and early childhood) can cause permanent tooth discoloration (yellow-brown) (see section “Additional undesirable effects in children”).
• If you are prone to photosensitization reactions(skin rashesthat appear after exposure to the sun), keep in mind that you may experience these reactions during treatment. Therefore, stop treatment with Ambramicina as soon as skin erythema (skin irritation) appears (see section 4 “Possible side effects”).
• To avoid esophageal irritation(the organ that connects 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 suffer from kidney disorders (renal insufficiency), even at normal doses, accumulation of tetracyclines in the blood with possible liver damage may occur; in these cases, the doctor will adjust the dose to the degree of kidney function, resorting, if necessary, to checks of blood levels and liver function. Also keep in mind that tetracyclines can worsen states of renal insufficiency (see section 3 “How to take Ambramicina”).
• Do not take the medicine after the expiry dateindicated on the packaging, as it may have the following effects: polyuria (increased urine output), glycosuria (presence of sugar in the urine), aminoaciduria (presence of amino acids in the urine), proteinuria (presence of proteins in the urine). Storing tetracyclines in a warm, humid environment can promote the formation of compounds harmful to the kidneys.

Children and adolescents
This medicine is indicated in adolescents over the age of 12 years.
In children under 12 years of age, this medicine should only be administered in cases of actual need
under the direct control of the doctor.
This is especially true in the neonatal period and in early childhood (from 0 to 12 years), as this medicine
during the period of tooth formation can cause permanent tooth discoloration (yellow-brown)
(see section “Additional undesirable effects in children”).

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

• penicillins (a class of antibiotics used to treat infections), as there is a possibility of interference between the antibacterial activities of Ambramicina and this class of antibiotics. It is advisable to avoid taking Ambramicina and penicillins at the same time.
• antacids containing aluminum, calcium or magnesium (medicines used for stomach acidity), as they reduce the absorption of tetracyclines taken orally, so it is advisable to avoid taking them at the same time.
• anticoagulants (medicines to thin the blood), as tetracyclines can reduce the ability of the blood to clot (prothrombin activity). Your doctor may, if necessary, adjust the dose of anticoagulants that you are taking during the administration of tetracyclines.

Ambramicina with food and drink
Avoid consuming milk or dairy products at the same time as taking this
medicine, as these foods reduce the absorption of tetracyclines taken orally.
To avoid esophageal irritation (the organ that connects 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, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with milk
mother, ask your doctor or pharmacist for advice before using this medicine.
In pregnant women and during breastfeeding, the product should only be administered in cases of
actual need under the direct control of the doctor.

Driving and operating machinery
No effects have ever been reported that determine danger for those who drive or use machinery
dangerous.

3. How to take Ambramicina

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.

Adults and adolescents over the age of 12

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

If you have kidney problems (renal insufficiency)
If you suffer from renal insufficiency, the doctor will adjust the dose based on the degree of your kidney function
(see section “Warnings and precautions”).

Use in children
In children under 12 years of age, this medicine should only be administered in cases of actual need
under the direct supervision of the doctor.
This is especially true in the neonatal period and in early childhood (from 0 to 12 years), as this medicine
during the period of tooth formation can cause permanent tooth discoloration (yellow-brown)
(see section “Additional undesirable effects in children”).

Duration of treatment
The duration of treatment is related to the disappearance of fever and the improvement of the general condition.
Once the fever has subsided, to avoid possible relapses, the doctor may have you continue the therapy
with the antibiotic for a few more days, possibly reducing the doses.
For some types of infections, the doctor may prescribe a longer treatment, even for several months, in
based on the type of bacteria.
In any case, the duration of treatment will be established by the attending physician based on how you respond to therapy.

If you take more Ambramicina than you should
No symptoms have been reported following the intake of an excessive dose of Ambramicina.

If you forget to take Ambramicina
Do not take a double dose to make up for forgetting the capsule.
If you have forgotten one or more doses, consult the doctor who prescribed this medicine before
resuming therapy.
Once you have consulted the doctor and resumed therapy, continue according to the correct dosage schedule prescribed
by the doctor.

If you stop the treatment with Ambramicina
Do not interrupt the treatment without first consulting your doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience cutaneous erythema (skin irritation)during treatment, contact your doctor immediately, who will STOPtreatment with Ambramicina.
During treatment with tetracyclines, some of the following side effects may occur with the following frequency:

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

• hemolytic anemia (destruction of some blood cells, red blood cells)
• neutropenia (decrease in the number of some blood cells, neutrophils, a type of white blood cells)
• thrombocytopenia (reduction in the number of platelets in the blood)
• eosinophilia (increase in the number of some blood cells, eosinophils, a type of white blood cells).

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

Effects on mouth, stomach and intestines

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

Effects on the skin

• erythematous skin rashes (irritation that causes redness of the skin)
• maculo-papular skin rashes (irritation characterized by small, flat or raised red spots on the skin)

Allergic reactions

• urticarial rashes (rash that appears with finely raised and reddened patches on the skin)
• anafilactoid purpura (a type of inflammation of small blood vessels that generally manifests with abdominal pain, the presence of maculo-papules on the skin, redness)
• angioedema (rapid swelling that usually occurs on the face, around or inside the mouth, throat or tongue).

Additional side effects in children
The use of tetracyclines in the neonatal period and in childhood (from 0 to 12 years) can cause permanent tooth discoloration (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 periods (see section “Warnings and precautions”).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 Ambramicina

Keep this medicine out of 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 particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ambramicina contains

• the active ingredient is: tetracycline hydrochloride (each capsule contains 250 mg of tetracycline hydrochloride)
• the other ingredients are: magnesium stearate; corn starch; titanium dioxide; indigotine; gelatin.

Description of the appearance of Ambramicina and contents of the pack
Ambramicina is presented in 250 mg hard capsules, packaged in a blister pack of 16 capsules in a carton.

Marketing Authorisation Holder
SCHARPER S.p.A. - Viale Ortles, 12 – 20139 Milano

Manufacturer
DOPPEL FARMACEUTICI S.r.l. – Via Volturno, 48 – Quinto Dè Stampi – 20089 Rozzano (MI)