BASSADO 100 mg Tablets

Зміст інструкції

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

BASSADO 100 mg tablets

Doxycycline

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 only for you or for your child. Do not give it to other people, even if they have the same symptoms as you, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Bassado and what is it used for?

Bassado contains the active ingredient doxycycline. Doxycycline is an antibiotic of the tetracycline class which belongs to a group of medicines called “antibacterial for systemic use”. Bassado is used in adultsand childrenfor the treatment of infections caused by bacteria sensitive to tetracyclines.

2. What you need to know before using Bassado

Do not use Bassado:

• if you are allergic to doxycycline or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other antibiotics that belong to the tetracycline class;
• if you have difficulty swallowing food and/or drinks;
• if you are pregnant or breastfeeding (see section 2 “Children” and “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before using Bassado.
Tell your doctor beforeusing Bassado if:

• you suffer from a condition in which food from the stomach comes back up into the esophagus, with symptoms such as heartburn, acidity and regurgitation (gastroesophageal reflux). Bassado may worsen these symptoms and in this case your doctor will advise you on a different treatment;
• you have kidney problems (renal insufficiency). In this case, your doctor will advise a lower dose of Bassado than normally recommended, to avoid worsening of kidney problems and to avoid the development of liver problems. See your doctor if any of the following conditions occur or worsen duringtreatment with Bassado (see also section 4 “Possible side effects”):
• diarrhea, which may be mild, but in some cases can be fatal (fatal colitis). Diarrhea can occur with the use of almost all antibiotics, including Bassado, and is due to the alteration of the normal bacterial flora of the intestine which allows the excessive growth of a bacterium called Clostridium difficile. If you experience diarrhea, your doctor will subject you to careful monitoring because infection with Clostridium difficilecan occur even two months after the end of treatment with this medicine;
• inflammation of the esophagus (esophagitis) and injury to the inner wall of the esophagus (esophageal ulcer), which may also be severe. When taking Bassado, you must follow the instructions given in section 3 “How to use Bassado”. If you suddenly experience difficulty swallowing or pain localized behind the sternum (retrosternal pain), immediatelystop treatment with Bassado and see your doctor;
• redness or other skin reactions similar to a sunburn (photosensitization reactions) when exposed to sunlight or ultraviolet rays (e.g., in a solarium). You should avoid direct exposure to the sun or ultraviolet rays (e.g., solarium) during treatment with Bassado, 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 peeling (exfoliative dermatitis), a near-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 an increase in the blood of the 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, immediatelystop treatment with Bassado and see your doctor;
• increased pressure of the fluid inside the skull (benign intracranial hypertension) associated with possible vision loss, sometimes permanent. If you experience visual disturbances during treatment, immediatelystop treatment with Bassado and see your doctor;
• infections caused by microorganisms resistant to doxycycline (superinfection). In this case, treatment with Bassado must be stopped immediatelyand therapy with other medicines must be started;
• liver problems. If you experience liver dysfunction, immediatelystop treatment with Bassado;
• muscle weakness, caused by an abnormal reaction of the immune system (myasthenia gravis).

During treatment with Bassado, your doctor will subject you to frequent checks to assess the function of your liver, kidneys and bone marrow.
If you are being treated with Bassado because you have contracted an infection from bacteria through sexual intercourse, this medicine may mask the presence of syphilis. To rule this out, your doctor will subject you to repeated blood tests for at least 4 months from the start of treatment with Bassado.
While taking Bassado, you may experience an increase in vaginal infections (candidiasis).

Children
Bassado should not be given to children under 8 years of age because:

• it may reduce the growth of babies born between the 22nd and 37th week of pregnancy (premature infants), but this effect is reversible if treatment is stopped;
• it may cause a permanent darkening or yellowing of children's teeth (yellow-gray-brown discoloration) if taken during the period of tooth development (i.e., from the second half of pregnancy to 8 years of age);
• it may produce an increase in the pressure of the fluid inside the skull in newborns,

with swelling of the soft areas of the skull called “fontanelles”. This effect is reversible if treatment is stopped.
There may be circumstances (e.g., serious or potentially life-threatening conditions) in which the doctor may decide that the benefits outweigh these risks, particularly when there are no alternative therapies, in children under 8 years of age and Bassado must be prescribed.

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

• retinoids(medicines for some skin diseases), because co-administration may cause an increase in the pressure of the fluid inside the skull (benign intracranial hypertension);
• methoxyflurane(a medicine used in anesthesia), because co-administration may cause serious kidney problems, which in some cases can be fatal. Tell your doctor or pharmacist if you are taking any of the following medicines:
• warfarin(a medicine that slows down or stops the blood clotting process). Bassado may increase the action of warfarin and increase the risk of bleeding. In this case, the dose of warfarin may need to be reduced;
• penicillins(a class of antibiotics), because taking Bassado together with a penicillin reduces the effectiveness of both medicines against infections;
• phenobarbital, primidone, carbamazepine, phenytoin(medicines for seizures). These medicines reduce the effectiveness of Bassado;
• oral contraceptives. Taking Bassado may decrease the effectiveness of oral contraceptives and may therefore cause unwanted pregnancies or abnormal bleeding from the vagina. In this case, it is recommended to use alternative or additional contraceptive measures;
• cyclosporine(a medicine against organ rejection after a transplant). Taking Bassado may increase the toxic effects of cyclosporine;
• medicines or preparations for stomach acidity containing aluminum salts, calcium salts,magnesium saltsor medicines or products containing iron and bismuth saltsorally.Bassado must be taken at least 2 hours before or 2 hours after taking any of these medicines or preparations, because they reduce the effectiveness of Bassado;
• lithium(a medicine to stabilize mood), methotrexate(a medicine against tumors and autoimmune diseases), digoxin(a medicine against some heart diseases), ergot-based medicines(used against depression). Bassado may increase the toxic effects of these medicines.

Bassado with food, drinks and alcohol
Bassado should not be taken with:

• milk, milk-based foods or dairy products. Bassado should be taken at least 2 hours before or 2 hours after eating or drinking these foods, because they reduce the effectiveness of the medicine;
• alcohol. The effectiveness of Bassado may be reduced by the simultaneous consumption of alcoholic beverages.

Laboratory tests
Bassado may alter the result of some laboratory tests. If you or your child are going to undergo laboratory tests (e.g., urine tests), you must inform your doctor of the treatment with Bassado.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Do nottake Bassado if you are pregnant (see sections “Do not use Bassado” and “Children”).

Do nottake Bassado if you are breastfeeding, as this medicine passes into breast milk.

Driving and using machines
There are no known adverse effects of Bassado on the ability to drive vehicles or operate machinery.

Bassado contains lactose
Bassado contains lactose, a type of sugar. If your doctor has diagnosed you with lactose intolerance, contact him before using this medicine.

3. How to use Bassado

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.
Take Bassado during meals with a plentiful amount of water (a full glass).
You must remain upright after taking this medicine and must not go to bed or lie
down for at least 1 hour.
The recommended daily dose is as follows:

Adults and children aged between 12 years and less than 18 years:
200 mg on the first day (to be taken together), then 100 mg per day. The duration of
treatment depends on the infection to be treated.

Children aged between 8 years and less than 12 years:
Doxycycline for the treatment of acute infections in children aged between 8 years and less than 12
years should be used in situations where other medicines are not available or are not
likely to be effective. In such circumstances, the normal doses are:

For children weighing 45 kg or less:
First day: 4.4 mg per each kg of body weight (in a single dose or in 2 separate doses),
then 2.2 mg per each kg of body weight (in a single dose or in 2 separate doses) from
the second day. 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 should be administered during the entire treatment.

For children weighing more than 45 kg:
The dose administered for adults should be used; 200 mg on the first day (to be taken
together) and then 100 mg per day. The duration of treatment depends on the infection to
be treated.

Duration of treatment
The doctor will decide the duration of treatment with Bassado based on the severity and course
of the infection.
If the infection is caused by a bacterium called Group A beta-hemolytic Streptococcus
(also known as Streptococcus pyogenes), treatment with Bassado must be
continued for at least 10 days.

If you take more Bassado than you should
It is important that you never take more medicine than prescribed. However, if an
excessive dose of Bassado has been taken, go to the nearest hospital to have gastric lavage performed.

If you stop taking Bassado
If you prematurely interrupt the treatment with Bassado, the outcome of the therapy may be
compromised. It is recommended not to suspend treatment with this medicine before the
disappearance of fever and other symptoms of infection. Consult your doctor before interrupting or
terminating treatment with Bassado.
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 Bassado immediately if you experience any of the following side effects
because they may be serious:

• severe allergic reaction (anaphylactic shock)
• swelling of the face, 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 redness of the skin, fever, inflammation of various organs, enlargement of the 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) (see section 2 “Warnings and precautions”)
• severe inflammation of the last part of the intestine called the colon (colitis) caused by excessive growth of a bacterium called Clostridium difficile(pseudomembranous colitis) (see section 2 “Warnings and precautions”)
• injury to the inner wall of the esophagus (esophageal ulcer) (see section 2 “Warnings and precautions”)
• 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 peeling of the skin (exfoliative dermatitis)
• anemia due to excessive destruction of red blood cells (hemolytic anemia).

If you experience any of the side effects listed below, contact your doctor as soon as possible:

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

• redness or other skin reactions similar to a sunburn (photosensitivity reactions) when exposed to sunlight or ultraviolet rays (for example, in a solarium)
• allergy (hypersensitivity) to the medicine
• lowering of blood pressure (hypotension)
• inflammation of the pericardium, a thin membrane surrounding the heart (pericarditis)
• difficulty breathing (dyspnea)
• autoimmune-type allergic reaction with fever, skin redness, joint pain and other symptoms (serum sickness)
• swelling in various parts of the body, especially the ankles and/or legs (edema)
• increased heart rate (tachycardia)
• hives
• headache
• nausea
• vomiting
• redness or rashes on the skin with the formation of small bumps and reddish spots (maculopapular eruptions)

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

• pain or discomfort in the stomach, with a feeling of fullness (dyspepsia)
• burning in the stomach or esophagus (pyrosis)
• inflammation of the stomach (gastritis)

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

• reduction in the number of platelets in the blood (thrombocytopenia)
• reduction in the number of a type of white blood cells called neutrophils (neutropenia)
• increase in the number of a type of white blood cells called eosinophils (eosinophilia)
• microscopic lesions of the thyroid gland
• loss of appetite
• a disease originating from an altered metabolism of porphyrins, substances that are part of the blood and other tissues (porphyria)
• abnormal perception in the ear of ringing, whistling, rustling, pulsations or other sounds in the absence of external noises
• redness
• inflammation of the esophagus (esophagitis)
• inflammation of the entire intestine (small intestine and colon) (enterocolitis)
• inflammation of the skin of the anal region and external genitalia, with infection by Candida(a fungus)
• abdominal pain
• diarrhea
• difficulty swallowing food and/or drinks (dysphagia)
• inflammation of the tongue (glossitis)
• liver damage (hepatic toxicity)
• inflammation of the liver (hepatitis)
• alterations in liver function
• yellowing of the skin and the 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 (for example, in a solarium)
• joint pain (arthralgia)
• muscle pain (myalgia)
• worsening of the symptoms of myasthenia gravis, characterized by muscle weakness
• increased nitrogen in the blood, a substance normally produced by the liver
• 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 by spirochetes such as Lyme disease.
• darker spots on the skin (skin hyperpigmentation).

Not known: frequency cannot be estimated from available data

• alteration of the color and/or failure of tooth growth.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly through the national
reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects helps provide more information on the safety
of this medicine.

5. How to store Bassado

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 package and on the blister 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 wastewater 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 Bassado contains
The active ingredient is doxycycline (as doxycycline hyclate).
Each tablet contains 100 mg of doxycycline (corresponding to 115.4 mg of doxycycline hyclate).
The other ingredients are: starch, sodium lauryl sulfate, lactose, alginic acid, magnesium stearate.

Description of the appearance of Bassado and contents of the pack
Bassado 100 mg tablets are available in aluminium/PVC blisters in packs of 10
tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Italia S.r.l.
via Isonzo 71
04100 Latina

Manufacturer
Doppel Farmaceutici S.r.l.
Via Volturno 48
Quinto de’ Stampi – Rozzano (MI)