MIRACLIN 100 mg Таблетки

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1. MIRACLIN 100 mg tablets
   1. What is MIRACLIN and what is it used for
   2. What you need to know before taking MIRACLIN
2. MIRACLIN must be taken at least 2 hours before or 2 hours after having eaten or drunk
   1. How to take MIRACLIN
   2. Possible side effects
   3. How to store MIRACLIN
   4. Contents of the pack and other information
3. MIRACLIN is available in tablet form of 100 mg in a pack containing 10

MIRACLIN 100 mg tablets

Doxycycline
Generic medicine

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

1. What is MIRACLIN and what is it used for

MIRACLIN contains the active ingredient doxycycline, which belongs to a group of antibiotics called tetracyclines, used against infections caused by bacteria.
MIRACLIN is indicated for the treatment of infections caused by certain types of bacteria against which tetracyclines are effective.

2. What you need to know before taking MIRACLIN

Do not take MIRACLIN

• if you are allergic to doxycycline or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other medicines of the same family as MIRACLIN (tetracyclines);
• if you suffer from disorders of obstruction of the esophagus (the organ that connects the throat to the stomach) such as narrowing or a disease called achalasia characterized by failure of the esophagus to relax during swallowing and therefore involves pain and difficulty swallowing food and/or drinks;
• if you are pregnant or breastfeeding.

The medicine is not indicated for children under twelve years of age (see sections “Warnings and precautions” and “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking MIRACLIN.
Tell your doctor beforeusing MIRACLIN:

• if you have liver problems, the doctor will prescribe MIRACLIN with caution as the administration of this medicine at high doses and for periods longer than 2 weeks can cause liver problems. If this should occur, the doctor will stop the treatment;
• if you have kidney problems, even serious (renal insufficiency). An accumulation of tetracycline antibiotics such as MIRACLIN in the blood may occur, which may worsen renal insufficiency and also cause liver problems. In this case, the doctor will reduce the dose of MIRACLIN to avoid worsening kidney problems and to prevent liver problems from occurring, and will monitor the amount of doxycycline in your blood and liver function;
• if you suffer from a disorder in which food in the stomach returns into the esophagus, with symptoms such as heartburn, acidity and regurgitation (gastroesophageal reflux). In this case, the doctor will evaluate treatments as an alternative to MIRACLIN as MIRACLIN may exacerbate these symptoms;
• if you suffer from a muscle disease characterized by severe muscle weakness (myasthenia gravis);
• if you suffer from an immune system disorder that causes joint pain, skin rashes and fever (systemic lupus erythematosus). The condition may worsen with the assumption of MIRACLIN.

Talk to your doctor if any of the following conditions occur or worsen

during treatment with MIRACLIN (see also section 4):

• diarrhea, which may be mild, but in some cases can cause death (fatal colitis). Diarrhea can occur with the use of almost all antibiotics, including MIRACLIN, and is due to the alteration of the normal bacterial flora of the intestine, thus allowing the excessive growth of a bacterium called Clostridium difficile. In case of diarrhea, the doctor will subject you to careful checks because Clostridium difficile infection can occur even two months after the end of treatment with this medicine;
• if you experience difficulty swallowing or pain behind the sternum during treatment, stop treatment immediatelyand see your doctor. In fact, cases of inflammation of the mucous membrane of the esophagus (esophagitis) and lesions of the esophagus (esophageal ulcers) even severe have occurred with the use of MIRACLIN. Take MIRACLIN with plenty of water, even during meals, and remain in an upright position for at least 1 hour after taking it. Do not take this medicine before bedtime;
• redness or other skin reactions similar to a sunburn (photosensitization reactions) following exposure to sunlight and UV rays (e.g. solarium). Avoid exposure to excessive sunlight or UV rays (e.g. solarium) during treatment with MIRACLIN, especially if you are prone to this type of reaction. Sometimes, with the use of this medicine, severe skin reactions can occur, such as widespread skin desquamation (exfoliative dermatitis), a nearly total necrosis (death of tissues) of the skin and mucous membranes (toxic epidermal necrolysis), reddish patches or circular spots, often with central blisters, mainly on the trunk (Stevens-Johnson Syndrome); redness of the skin, fever, inflammation of various organs,

enlargement of the lymph nodes and increased number of a type of white blood cells
called “eosinophils” (DRESS syndrome). Ulcers may also be present in the mouth,
throat, nose, limbs, genitals and conjunctivitis (red and swollen eyes). If you experience skin reactions during treatment
stop immediatelythe treatment and see your
doctor;

• increased pressure of the fluid inside the skull (benign intracranial hypertension) associated with possible loss of vision, sometimes even permanent. If you experience visual disturbances during treatment, stop MIRACLIN treatment immediately and see your doctor;
• infections caused by microorganisms resistant to doxycycline (superinfections) or bacteria insensitive to tetracyclines (i.e. bacteria against which tetracyclines are not effective). If this should occur, treatment with MIRACLIN must be stopped immediatelyand the doctor will start therapy with other medicines,
• liver problems. If you experience liver dysfunction, stop MIRACLIN treatment immediately;
• muscle weakness, caused by an abnormal immune system reaction (myasthenia gravis);
• an immune system disorder that causes joint pain, skin rashes and fever (Systemic Lupus Erythematosus). The condition may worsen with the assumption of MIRACLIN.

During treatment with MIRACLIN, your doctor will subject you to frequent checks to
assess liver, kidney and bone marrow function.
During treatment of sexually transmitted infections (gonococcal infections), there is a
risk of covering up the symptoms of a coexisting syphilis (serious sexually transmitted
infection). To rule out that you also have syphilis, the doctor will subject you to
blood tests for at least 4 months from the start of treatment with MIRACLIN.
If you take this medicine for long periods, your doctor will subject you to periodic checks
of blood values (blood count) and liver and kidney function.
While taking MIRACLIN, you may experience an increase in vaginal infections (candidiasis).

Children
In children under 12 years of age MIRACLIN, like other tetracyclines, should not be
administered. MIRACLIN may reduce the growth of children born between the 22nd and 37th week
of pregnancy (premature babies), but this effect is reversible if treatment is
interrupted.
In newborns and children up to 12 years of age, this medicine can cause reduced growth
of the leg bones (fibula), reversible with discontinuation of treatment; permanent discoloration of
teeth (yellow-brown) or reduced enamel formation of teeth (enamel hypoplasia).
In addition, with high doses, cases of increased pressure of the fluid have occurred
inside the skull with swelling of the membranes covering the unsealed skull in newborns (bulging fontanelles), resolved rapidly with discontinuation of
treatment.

Other medicines and MIRACLIN
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
The following medicines must notbe taken together with MIRACLIN:

• methoxyflurane, a medicine used during anesthesia or against pain (analgesic). Serious kidney damage, even fatal, may occur;
• systemic retinoids, medicines used to treat psoriasis, a skin inflammatory disease and other skin diseases, as there is a risk of reversible increase in pressure inside the skull (benign intracranial hypertension).

Tell your doctor or pharmacist if you are also taking the following medicines:

• lithium(medicine to stabilize mood), methotrexate(used for tumors and autoimmune diseases), digoxin(used to increase the force of heart contraction) and ergot derivatives(used for headaches): concomitant administration of MIRACLIN may increase the toxic effects of these medicines;
• anticoagulants(medicines used to thin the blood), such as warfarin. MIRACLIN may reduce the blood's ability to clot (prothrombin activity). The doctor, if necessary, will adjust the dose of anticoagulants you are taking together with MIRACLIN;
• penicillins(a type of antibiotics) as there are possible interferences between the antibacterial activities of MIRACLIN and this class of antibiotics. Avoid concomitant use of MIRACLIN and penicillins;
• anticonvulsants, medicines used for seizures such as barbiturates (phenobarbital, primidone), carbamazepine and phenytoin;
• oral contraceptives(medicines used to prevent pregnancy). Taking MIRACLIN may reduce the effectiveness of oral contraceptives and unwanted pregnancies or abnormal vaginal bleeding may therefore occur. In this case, it is recommended to adopt alternative or additional contraceptive measures;
• cyclosporine(medicine used to prevent rejection after an organ transplant). Taking MIRACLIN may increase the toxic effects of cyclosporine;
• medicines or preparations against stomach acidity containing aluminum salts, calcium salts, magnesium saltsor medicines or products containing iron or zinc and bismuth saltsorally.MIRACLIN must be taken at least 2 hours before or 2 hours after taking any of these medicines or preparations, as they reduce the effectiveness of MIRACLIN.

Laboratory tests
If you are going to have urine tests, tell your doctor and healthcare personnel that
you are taking MIRACLIN, as this medicine can alter the results of a laboratory test (false increases in urinary catecholamine levels with fluorescence testing).

MIRACLIN with food, drinks and alcohol
During treatment with MIRACLIN, avoid taking:

• alcoholThe effectiveness of MIRACLIN may be reduced by the simultaneous consumption of alcoholic beverages.
• milk, beverages or foods based on milk or dairy products

MIRACLIN must be taken at least 2 hours before or 2 hours after having eaten or drunk

these foods, because they reduce the effectiveness of the medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be 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.
Pregnancy

Do nottake MIRACLIN during pregnancy as this medicine passes into the placenta
and can cause harm to the fetus.
Breastfeeding
Tetracycline antibiotics, such as MIRACLIN, pass into breast milk. Therefore do not
take MIRACLIN during breastfeeding with breast milk.
Fertility
The impact of using MIRACLIN on fertility is not known.

Driving and operating machinery
There are no reports that treatment with MIRACLIN may interfere with the ability
to drive vehicles and operate machinery.

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

3. How to take MIRACLIN

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The recommended dose is 2 tablets (200 mg) in one single dose for the first day of treatment
and then 1 tablet (100 mg) per day for the following days. For severe infections, your doctor
will establish the appropriate dose.

Duration of treatment
The doctor will decide the duration of treatment with Miraclin based on the severity and course
of the infection.
For infections caused by the bacterium Streptococcus beta-hemolyticus group A, the treatment
must last at least 10 days.
To ensure that the bacteria responsible for the infection are sensitive to MIRACLIN and therefore
that the therapy is effective, before treatment your doctor may subject you to a specific examination
called an antibiogram, which allows to evaluate the sensitivity of the bacteria to various
antibiotics.

Method of administration
Take each dose during meals with plenty of water (a full glass) to
avoid irritation of the esophagus (see “MIRACLIN with food, drinks and alcohol”).
Take the medicine in an upright position and do not lie down for at least one hour after taking
the medicine.

If you take more MIRACLIN than you should
It is important that you never take more medicine than prescribed. In case of
accidental ingestion/intake of an excessive dose of MIRACLIN, immediately inform
your doctor or go to the nearest hospital.

If you forget to take MIRACLIN
Do not take a double dose to make up for a missed dose.

If you stop taking MIRACLIN
If you prematurely interrupt the treatment with MIRACLIN, the outcome of the therapy may be
compromised. It is recommended not to stop treatment with this medicine before
the disappearance of fever and other symptoms of infection.
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.

STOPusing MIRACLIN immediately if you experience any of the following side effects because they may be serious:

• severe allergic reaction (anaphylactic shock)
• swelling of the face, neck, lips, tongue and throat with resulting inability to swallow and breathe (angioedema)
• flare-up of a chronic autoimmune inflammatory condition affecting various organs (systemic lupus erythematosus)
• allergic reaction of an autoimmune type affecting small blood vessels, with the appearance of reddish spots on the skin (Schönlein-Henoch purpura)
• allergic reaction to the medicine with skin redness, fever, inflammation of various organs, enlarged lymph nodes and an increase in the blood of the number of a type of white blood cells called eosinophils (DRESS syndrome)
• increased pressure of the fluid contained within the skull (benign intracranial hypertension in adults) or swelling of the soft areas of the skull called “fontanelles” (in newborns). Possible symptoms of benign intracranial hypertension are headache, vomiting, visual disturbances including blurred vision, a visual field defect limited to an area with normal vision (scotoma), double vision (diplopia) and possible vision loss, in some cases, even permanent (see section 2 “Warnings and precautions”)
• severe inflammation of the last part of the intestine called the colon (colitis) caused by the excessive growth of a bacterium called Clostridium difficile (pseudomembranous colitis) (see section 2)
• injury to the inner wall of the esophagus (esophageal ulcer) (see section 2)
• severe acute hypersensitivity with almost total necrosis of the skin and mucous membranes (toxic epidermal necrolysis)
• severe acute hypersensitivity of the skin and mucous membranes to substances and medicines (Stevens-Johnson syndrome)
• severe and widespread redness with skin peeling (exfoliative dermatitis)
• anemia due to excessive destruction of red blood cells (hemolytic anemia).

The following side effects may occur during treatment with MIRACLIN:

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

• redness or other skin reactions similar to a sunburn due to sensitivity to light (photosensitization) when exposed to sunlight or ultraviolet rays (e.g. solarium).

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

• severe allergic reactions with rapid onset (anaphylactic reactions, anaphylactoid reactions),
• allergy (hypersensitivity) to the medicine,
• low blood pressure (hypotension),
• inflammation of the membrane surrounding the heart (pericarditis),
• difficulty breathing (dyspnea),
• autoimmune-type allergic reaction with fever, skin redness, joint pain and other symptoms (serum sickness),
• fluid retention with swelling in various parts of the body, especially the ankles and/or legs (peripheral edema),
• increased heart rate (tachycardia),
• urticaria,
• headache;
• nausea and vomiting;
• redness (skin eruptions with the formation of small bumps and reddish spots on the skin (maculopapular eruptions).

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

• stomach pain or discomfort, with a feeling of fullness (dyspepsia),
• heartburn or esophageal burning (pyrosis),
• inflammation of the stomach lining (gastritis).

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

• abnormal perception of ringing in the ears (tinnitus) whistles, rustling, pulsations or other in the absence of external noises,
• flushing,
• lesions of the esophagus (esophageal ulcers) and inflammation of the esophageal lining (esophagitis),
• inflammation of the small intestine and colon (enterocolitis),
• inflammation of the skin and lesions of the anus or external genitalia, with infection by Candida(a fungus),
• abdominal pain,
• diarrhea,
• difficulty swallowing (dysphagia),
• inflammation of the tongue (glossitis),
• liver damage (hepatotoxicity),
• inflammation of the liver (hepatitis),
• alterations in liver function,
• yellowing of the skin and whites of the eyes (jaundice),
• inflammation of the pancreas (pancreatitis),
• inflammation of blood vessels with skin necrosis and hypersensitivity reactions (erythema multiforme),
• total or partial detachment of one or more nails following exposure to sunlight or ultraviolet rays (e.g. in a solarium) (photo-onycholysis),
• joint pain (arthralgia),
• muscle pain (myalgia),
• worsening of symptoms of a disease that causes severe muscle weakness called myasthenia gravis,
• increased levels of nitrogen in the blood,
• reduction in the number of platelets in the blood (thrombocytopenia),
• increase in a type of white blood cells called eosinophils (eosinophilia),
• decrease in the number of a type of white blood cells called neutrophils (neutropenia),
• disease originating from an altered metabolism of porphyrins, substances that are part of the blood and other tissues (porphyria),
• loss of appetite,
• microscopic lesions of the thyroid gland,
• the Jarisch-Herxheimer reaction, which causes fever, chills, headache, muscle pain and rash, is usually self-limiting. It occurs shortly after starting treatment with doxycycline for infections by spirochetes such as Lyme disease,
• darker spots on the skin (skin hyperpigmentation).

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

• alteration of the color and/or failure to grow teeth.

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 MIRACLIN

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.
Do not store at a temperature above 25 °C.
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 MIRACLIN contains

• The active ingredient is doxycycline hyclate. Each tablet contains 115.4 mg of doxycycline hyclate, equivalent to 100 mg of doxycycline anhydrous 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 MIRACLIN and contents of the pack

MIRACLIN is available in tablet form of 100 mg in a pack containing 10

tablets of 100 mg in blisters.

Marketing Authorisation Holder and Manufacturer
Laboratorio Farmacologico Milanese S.r.l. – Via Monterosso, 273 -21042 Caronno Pertusella
(VA)