FARMODOXI 100 mg Таблетки

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1. Farmodoxi 100 mg tablets
   1. What is Farmodoxi and what is it used for
   2. What you need to know before taking Farmodoxi
   3. How to use Farmodoxi
   4. Possible side effects
   5. How to store Farmodoxi
   6. Contents of the pack and other information

Farmodoxi 100 mg tablets

doxycycline

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

1. What is Farmodoxi and what is it used for

Farmodoxi contains doxycycline, a substance belonging to a group of antibiotics called
tetracyclines which are used in the treatment of some infections.
Farmodoxi is used for the treatment of infections caused by Gram-positive and Gram-negative germs sensitive to
tetracyclines.

2. What you need to know before taking Farmodoxi

Do not take Farmodoxi

• if you are allergic to doxycycline or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from obstructive disorders of the esophagus, such as narrowing or achalasia;
• if you are pregnant or planning a pregnancy (see “Pregnancy and breastfeeding”);
• if you are breastfeeding (see “Pregnancy and breastfeeding”).

Do not take this medicine if any of the conditions listed above apply to you.
If you have any doubts, talk to your doctor or pharmacist before taking Farmodoxi.
Do not take Farmodoxi during tooth development (pregnancy, infancy, children under 8 years of age) as its use may cause permanent alteration of tooth color (yellow-
gray-brown) or compromise proper tooth growth.
In some circumstances (e.g., serious or life-threatening conditions), your doctor may
decide that the benefits outweigh this risk in children under 8 years of age and may prescribe
Farmodoxi.

Warnings and precautions
Talk to your doctor or pharmacist before taking Farmodoxi.
During treatment with this medicine:

• Avoid excessive exposure to sunlight or artificial UV rays and stop therapy in case of allergic reactions (phototoxicity), such as skin rashes (see “Possible side effects”). Use sunscreens with partial or total protection.
• Take the tablets with plenty of water to reduce the risk of esophageal irritation and ulcers (see “Esophagitis” and “How to take Farmodoxi”).
• Keep in mind that the drug's absorption capacity by the body is reduced if you are taking bismuth subsalicylate-containing medicines (used for temporary gastrointestinal disorders) at the same time (see “Other medicines and Farmodoxi tablets”).
• Keep in mind that taking Farmodoxi may increase the incidence of vaginal candidiasis.

Long-term treatment cycles require periodic checks of the ratio between the various elements of
the blood (hematological parameters) and the function of the kidneys and liver.
Take particular care with Farmodoxi:

• If you suffer from impaired liver function, as the administration of doxycycline at high doses and for periods of time longer than two weeks can cause liver dysfunction which should therefore be monitored, suspending treatment in case of abnormal reactions.
• If you suffer from impaired kidney function; your doctor may in this case decide to reduce the amount of doses;
• If you suffer from renal insufficiency, as even normal doses of tetracycline can lead to an accumulation of medicine in the body with possible liver damage. In this case, the dosage must be adjusted according to the degree of kidney function, resorting, if necessary, to checks of the levels of tetracycline in the blood (which should never exceed 15 mcg/mL) and liver function. Also, keep in mind that tetracyclines have an antianabolic action that can worsen states of renal insufficiency.
• If diarrhea occurs during treatment with Farmodoxi or in the subsequent period (even after more than two months). Cases of diarrhea associated with the bacterium Clostridium difficile(CDAD) have in fact been reported with the use of antibiotics, including doxycycline, the severity of which can range from mild diarrhea to inflammation of the colon (colitis). Antibiotic treatment alters the normal flora of the colon and leads to an overgrowth of Clostridium difficile. If you suspect you have CDAD, contact your doctor immediately.
• If you suffer from myasthenia gravis (a progressive muscle disease characterized by severe muscle weakness).

Cases of bulging fontanelles in newborns and benign intracranial hypertension in adults have been reported in the case of taking the medicine at full dosage. These effects are rapidly
reversible upon discontinuation of treatment.

Esophagitis
Cases of inflammation of the esophagus (esophagitis) and esophageal ulcers, sometimes severe, have been reported.
Take the medicine with plenty of water, even during meals, and remain in an upright position for at least
one hour after taking it. It is not recommended to take the medicine before going to bed.
If symptoms such as difficulty swallowing or chest pain occur during therapy, immediately stop taking the medicine and consult your doctor to assess
together if it is necessary to carry out instrumental investigations.
If you suffer from gastroesophageal reflux (backflow of stomach acid into the esophagus) confirmed, the
doctor may also consider other therapeutic alternatives.

Gonococcal infections
Taking the medicine in the treatment of gonococcal infections may mask the
symptoms of syphilis, which may coexist. In these cases, it is appropriate to perform blood tests for at least 4 months.

Superinfections
As with other antibiotics, treatment with tetracyclines can lead to superinfections from resistant bacterial agents or fungi (for example, a possible manifestation of staphylococcal enterocolitis). Constant monitoring is essential during treatment and, if
a resistant microorganism appears, treatment should be discontinued and appropriate therapy should be started.

Children and adolescents
Farmodoxi should not be taken by children and adolescents under 8 years of age (see “Do not take Farmodoxi”).
Doxycycline, like other tetracyclines, gives rise to a stable calcium complex in the forming bone tissue.
A decrease in the growth rate of the fibula has been observed in premature infants who were given tetracycline orally at a dose of 25 mg/kg every six hours.
In addition, cases of bulging fontanelles in newborns have been reported with full-dose administration.
These reactions are reversible upon discontinuation of treatment.
The use of tetracyclines during the period of tooth formation (second half of pregnancy,
neonatal period and early childhood up to eight years of age) can cause permanent alteration of
tooth color (yellow-gray-brown); this occurs especially after prolonged use of these
antibiotics, but has also been observed after short but repeated treatment periods. Alteration of the enamel has also been
reported, so doxycycline should not be administered to this
patient group unless other alternative medicines are not available or may be
ineffective or contraindicated.

Other medicines and Farmodoxi
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Farmodoxi can affect the functioning of some medicines and, conversely, some medicines
can affect the functioning of Farmodoxi.
Rare cases of increased concentration in the blood of the following medicines have been reported during the concomitant administration of tetracyclines:

• lithium (used for mental disorders),
• methotrexate (used in the treatment of some autoimmune diseases and some tumors),
• digoxin (used for some heart disorders),
• ergot derivatives (used in the treatment of headaches).

Talk to your doctor or pharmacist if you are taking one or more of the following medicines:

• Oral anticoagulants(e.g. warfarin), for the risk of prolongation of blood coagulation time. Since tetracyclines can reduce blood coagulation, your doctor may reduce the dosages of anticoagulant medicines taken simultaneously.
• Penicillins, for the possible occurrence of interference between the antibacterial activities of the two medicines.
• Anticonvulsants, such as barbiturates (phenobarbital, primidone), carbamazepine or phenytoin;
• Oral contraceptives, as taking tetracyclines may decrease the effectiveness of oral contraceptive treatments;
• Cyclosporine(used after organ transplants), as doxycycline may increase the concentrations of cyclosporine in the blood. Any co-administration should therefore be carefully monitored. Interactions related to other medicines:
• Systemic retinoids, for the risk of increased pressure inside the skull (benign intracranial hypertension);
• Methoxyflurane(medicine used in general anesthesia), for the risk of kidney damage (nephrotoxicity), with possible fatal outcome.

In addition, the oral absorption of tetracyclines is reduced by:

• anti-acid preparations containing aluminum, calcium and magnesium;
• foods based on milk or dairy products;
• products containing iron salts and preparations containing zinc and bismuth orally. Avoid concomitant intake and allow at least 2 hours to pass, if possible, between the administration of the aforementioned products and that of tetracyclines.

Interactions with laboratory investigations
False increases in urinary catecholamine levels (tests for the diagnosis or monitoring of pheochromocytoma, a tumor of the adrenal gland) may occur due to interference with the
fluorescence test.

Farmodoxi with food, drinks and alcohol
The oral absorption of tetracyclines is reduced by foods based on milk or dairy products, so
avoid concomitant intake and allow at least 2 hours to pass, if possible, between the administration
of foods based on milk or dairy products and that of tetracyclines.
Avoid drinking alcohol during treatment with Farmodoxi

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Farmodoxi during pregnancy or breastfeeding (see “Do not take
Farmodoxi”).

Driving and operating machinery
Farmodoxi does not impair the ability to drive vehicles or operate machinery.

Farmodoxi contains Sodium
Farmodoxi contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
“sodium-free”.

3. How to use Farmodoxi

Take this medicine following the instructions of your doctor or pharmacist exactly. If you have any
doubts, ask your doctor or pharmacist.
The recommended doses are listed below. Your doctor may prescribe different doses depending on
the infection to be treated.
Usual dose (chest, lung or nasal infections, urinary tract, eye and other
infections):
Children aged between 8 and 12 years:
Farmodoxi should be used in the treatment of acute infections in children aged between 8 and
12 years only in situations where other medicines are not available or are considered potentially
ineffective.
In these circumstances, the usual doses are:

For children weighing up to 45 kg:
first day: 4.4 mg per each kg of body weight (in a single dose or divided into two doses) then
2.2 mg per each kg of body weight (in a single dose or divided into two doses) from the second day
onwards.
The duration of treatment depends on the infection to be treated. In more severe infections, up to
4.4 mg per each kg of body weight, for the entire duration of treatment.

For children weighing more than 45 kg:
the dose provided for adults must be administered: 200 mg on the first day, then 100 mg per day.
The duration of treatment depends on the infection to be treated.
Adults and children aged between 12 and 18 years:
200 mg on the first day, then 100 mg per day. The duration of treatment depends on the infection that
needs to be treated.
Take the tablets during meals with plenty of water (a full glass).
Take the medicine in an upright position, at least one hour before going to bed (see
“Warnings and precautions”).
In case of severe infections, follow the doctor’s instructions carefully.
In all infections caused by group A beta-hemolytic streptococcus, treatment must last at least
ten days.
The duration of treatment will depend on the evolution of the infection; however, it is still advisable not
to stop therapy until the fever and clinical symptoms have disappeared.
In order to obtain maximum therapeutic safety, it is advisable, in any case, to perform tests (antibiogram) to
ascertain that the strain of germs responsible for the condition to be treated is
sensitive to the action of tetracyclines.

If you take more Farmodoxi than you should
If you accidentally take an excessive dose of Farmodoxi, call a doctor or go to the
nearest hospital, taking the package of the medicine with you. This way, the doctor
will immediately know what you have taken.
Gastric lavage (gastric emptying) may be necessary in case of overdose. Blood dialysis
(hemodialysis) is not indicated in case of overdose as it does not change the times of
stay of the medicine in the blood.

If you forget to take Farmodoxi
If you forget to take Farmodoxi, take it as soon as you remember. However, if it is almost
time to take the next dose, skip the one you forgot. Do not take a double dose to make up for the missed dose.

If you stop taking Farmodoxi
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 any of the side effects listed below, contact your doctor immediately:

Very common(may affect more than 1 in 10 people):

• skin reactions of allergy to the sun (photosensitization).

Common(may affect up to 1 in 10 people):

• anaphylactic reactions, including hypersensitivity, Schönlein-Henoch purpura (a disease that manifests with inflammation of the small blood vessels), low blood pressure (hypotension), inflammation of the membrane surrounding the heart (pericarditis), swelling of the skin and mucous membranes (angioedema), exacerbation of systemic lupus erythematosus (a chronic autoimmune disease that causes disorders in various parts of the body, especially the skin), difficulty breathing (dyspnea), serum sickness reaction, fluid accumulation in the body (peripheral edema), increased heart rate (tachycardia) and hives;
• headache;
• nausea;
• vomiting;
• rashes with redness or pustules (erythematous or maculopapular).

Uncommon(may affect up to 1 in 100 people):

• digestive disorders (dyspepsia), such as heartburn (pyrosis) or gastritis.

Rare(may affect up to 1 in 1,000 people):

• blood changes: reduction in the number of platelets (thrombocytopenia), destruction of red blood cells (hemolytic anemia), reduction in the number of neutrophils (neutropenia), increase in the number of eosinophils (eosinophilia);
• drug rash with increased number of eosinophils (eosinophilia) and systemic symptoms (DRESS syndrome);
• microscopic brown pigmentation of the thyroid;
• loss of appetite (anorexia);
• porphyria (a rare metabolic disease);
• increased pressure inside the skull (benign intracranial hypertension) in adults, with possible symptoms such as headache, vomiting, visual disturbances including blurred vision, the appearance of a blind spot, partial or complete within the visual field (scotoma), double vision (diplopia) or permanent vision loss; the manifestation of clinical symptoms, including headache or visual disturbances, should suggest the possibility of a diagnosis of intracranial hypertension; if an increase in

pressure inside the skull is suspected during treatment with tetracyclines, administration should be
stopped;

• ringing in the ear (tinnitus);
• flushing;
• antibiotic-associated colitis (pseudomembranous colitis);
• Clostridium difficilediarrhea (see “Warnings and precautions”);
• inflammation of the esophagus (esophagitis), esophageal ulcers;
• enterocolitis;
• inflammatory lesions (with candidiasis) in the anal and genital area;
• abdominal pain;
• diarrhea;
• difficulty swallowing (dysphagia);
• inflammation of the tongue (glossitis);
• liver damage (hepatotoxicity), hepatitis, changes in liver function, yellowish discoloration of the skin and mucous membranes (jaundice);
• inflammation of the pancreas (pancreatitis);
• severe skin reactions (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme);
• exfoliative dermatitis;
• nail condition (photo-onycholysis);
• joint pain (arthralgia);
• muscle pain (myalgia);
• exacerbation of symptoms of myasthenia gravis, a progressive disease of the muscles characterized by severe muscle weakness;
• increased concentration of nitrogen in the blood (azotemia) (BUN).

Frequency not known(the frequency cannot be estimated from the available data):

• alteration of tooth color and/or failure of tooth growth;
• the Jarisch-Herxheimer reaction which causes fever, chills, headache, muscle pain and rash is usually self-limiting. It occurs shortly after the start of treatment with doxycycline for infections with spirochetes such as Lyme disease.

Additional side effects in children
Rare(may affect up to 1 in 1,000 people)

• bulging fontanelles in newborns.

Side effects can be minimized by using the minimum effective dose for the shortest possible duration needed to control the symptoms.

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 Farmodoxi

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date that is stated on the pack after “Scad”.
The expiry date refers to the last day of that month.
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 Farmodoxi contains

• The active ingredient is doxycycline. Each tablet contains 115.4 mg of doxycycline hyclate (equivalent to 100 mg of anhydrous doxycycline base).
• The other ingredients are: microcrystalline cellulose, dibasic calcium phosphate, crospovidone, magnesium stearate, corn starch, sodium carboxymethylcellulose, talc, sodium lauryl sulfate, colloidal silicon dioxide.

Description of the appearance of Farmodoxi and contents of the pack
Farmodoxi is presented as tablets.
The pack contains 10 tablets of 100 mg.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:
Italfarmaco S.p.A. - V.le F. Testi, 330 Milano

Manufacturer:
Laboratorio Farmacologico Milanese S.r.l. – Caronno Pertusella VA