FARGANESSE 25 mg Coated Tablet

Содержание инструкции

1. FARGANESSE
   1. WHAT FARGANESSE IS AND WHAT IT IS USED FOR
   2. What you need to know before using FARGANESSE
   3. How to use FARGANESSE
   4. Possible side effects
   5. How to store FARGANESSE
   6. Contents of the pack and other information
2. FARGANESSE
   1. What is FARGANESSE and what is it used for
   2. What you need to know before you take FARGANESSE
   3. How to take FARGANESSE
   4. Possible side effects
   5. How to store FARGANESSE
   6. Contents of the pack and other information

FARGANESSE

50 mg/2 ml injectable solution
prometazine hydrochloride

Read this leaflet carefully before using 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, pharmacist or nurse.
• This medicine has been prescribed for you only. 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, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. WHAT FARGANESSE IS AND WHAT IT IS USED FOR

FARGANESSE contains the active ingredient prometazine and belongs to the group of medicines
called phenothiazines (general use antihistamines).
It works by blocking histamine, a substance naturally present in the body, which causes
itching during an allergic reaction. Like many antihistamine agents, it has a sedative
effect.
FARGANESSE is used:

• to treat allergic reactions of various origins affecting the respiratory system, mucous membranes and skin;
• to treat allergic reactions to medicines and blood transfusions or blood products;
• for the treatment of anaphylactic reactions (severe allergic reactions);
• to treat mild emotional disturbances such as nervous anxiety and states of tension.

2. What you need to know before using FARGANESSE

Do not use FARGANESSE

• If you are allergic to promethazine hydrochloride, to other antihistamines or to any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or suspect you may be pregnant.
• If you are breastfeeding.
• In children under two years of age, in premature babies and in newborns.
• If you are taking a medicine for depression belonging to a group of medicines called monoamine oxidase inhibitors (MAOIs).
• If you are undergoing treatment for lower respiratory tract disorders, including bronchial asthma.
• If you have glaucoma (an eye disease), prostatic hypertrophy (enlargement of the prostate), obstruction of the bladder neck, pyloric and duodenal stenosis or of other tracts of the gastrointestinal and urogenital system (narrowing of some parts of the digestive tract or urinary tract).
• Warnings and precautions Do not inject FARGANESSE accidentally intra-arterially orsubcutaneously.

Consult your doctor, pharmacist or nurse before using/before you are
administered FARGANESSE. This is particularly important if you:

• have experienced Reye's syndrome (reaction to the use of aspirin, with problems with the brain and liver)
• have liver problems
• have serious heart problems
• have a personal or family history of heart disease
• have an irregular heartbeat
• are elderly
• the patient is a child.

The use of antihistamine medicines can mask early signs of toxicity to the ear of certain
antibiotics.
The antiemetic effect (which inhibits vomiting) of promethazine can mask the symptoms of
an unrecognized illness and hinder diagnosis.
If you are not sure whether any of the above applies to you, consult your doctor or pharmacist before
using FARGANESSE.

Children
Promethazine should not be used in children under 2 years of age.
It should not be used in children who present signs indicative of Reye's syndrome or
of another hepatic condition.

Other medicines and FARGANESSE
Tell your doctor or pharmacist or nurse if you are taking, have recently taken or
may take any other medicines.

Do not take this medicine and inform your doctor or pharmacist and nurse if you are
taking or have taken the following medicines:some medicines for depression (called
monoamine oxidase inhibitors (MAOIs)). If in doubt, consult your doctor or pharmacist

Inform your doctor or pharmacist or nurse if you are taking, have recently taken or
may take any of the following medicines:
medicines that can affect the heart rhythm.
In addition, it is particularly important to inform your doctor or pharmacist if you are taking the
following medicines:

• hypnotics, sedatives, tranquilizers and other drugs with a depressive effect on the Central Nervous System (CNS);
• medicines that block the functionality of the bone marrow (myelosuppressants). Such association should be avoided.

FARGANESSE with alcohol.
The effects of antihistamines are accentuated if you consume alcohol at the same time.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
You should not use FARGANESSE if you are pregnant or breastfeeding. The doctor may
decide to prescribe this medicine during pregnancy and breastfeeding onlyin
case of actual necessity.

Driving and operating machinery
Because drowsiness may occur, you must be careful if you intend to drive vehicles or
operate machinery. Treatment with FARGANESSE may impair your ability to
react. This must be taken into account in cases where promptness is required, for
example when driving vehicles. Make sure you are not affected by these effects before
driving vehicles or using machinery.

FARGANESSE contains:

• Potassium metabisulfite, anhydrous sodium sulfite. Rarely they can cause severe hypersensitivity reactions and bronchospasm (closure of the bronchi).
• Potassium. this medicine contains less than 1 mmol (39 mg) of potassium per dose, i.e. essentially ‘potassium-free’.
• Sodium. This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How to use FARGANESSE

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

The dose will be established by the doctor who will personalize it for you. The lowest effective dose must be used for the shortest necessary duration. Always take the dose prescribed by the doctor.
If you experience burning or pain during or immediately after application, inform your doctor or nurse immediately.

Adults
The recommended dose is generally 25-50 mg (1-2 ml) for deep intramuscular injection or, in case of urgency, the same doses for slow intravenous injection.
The dose of 100 mg via parenteral route must not be exceeded.

Use in children
Do not use in children under 2 years of age.

From 2 to 5 years
The recommended dose is 5 - 7.5 mg per day, via deep intramuscular injection.

From 5 to 10 years
The recommended dose is 7.5 - 12.5 mg per day, via deep intramuscular injection.
To achieve a sedative (hypnotic sedative) effect, an evening dose of 2.5 - 5 mg is sufficient.

Elderly
If you are an elderly patient, the dosage must be carefully established by the doctor who will have to evaluate a possible reduction of the dosages indicated above.

If you use more FARGANESSE than you should
If you or the child is administered more FARGANESSE than due, contact your doctor immediately or go to the emergency room of the nearest hospital. Bring with you the packaging of the medicine, so that the doctor knows what you have taken or been administered.
In case of overdose, depressive or stimulating effects on the Central Nervous System are generally observed:

• dilated and fixed pupils
• strongly flushed faces
• fever
• coma and cardiovascular collapse (in the most severe cases), and in children: tremors, insomnia, excitement, involuntary movements (athetosis), disturbance of coordination (ataxia) and convulsions. If you have any doubts about the use of this medicine, consult your doctor or pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
At common therapeutic doses, the most frequent side effects consist of:

• sedation and drowsiness
• easy fatigue, asthenia
• difficulty in motor coordination
• blurred vision
• double vision (diplopia)
• dizziness
• ringing in the ears.

Extrapyramidal reactions (painful, involuntary tonic contractions of some muscle groups) are rare and occur with the use of high doses for parenteral administration.
The following are also frequent due to the anticholinergic effects of the medicine:

• dryness of the mouth, throat and nose
• constipation
• difficulty urinating and urinary retention
• reduction and thickening of bronchial secretions accompanied by a feeling of chest tightness and difficult breathing.

Frequency not known (cannot be estimated based on available data):

• abnormal electrical activity of the heart that affects its rhythm, including potentially life-threatening rhythm disturbances
• a severe reaction with fever, stiff muscles, altered blood pressure and coma (malignant neuroleptic syndrome)
• low levels of blood platelets (which can lead to bleeding and bruising)
• restlessness
• hallucinations
• aggressiveness.

The onset of stomach disorders, anorexia, nausea, vomiting and diarrhea can be avoided
by taking antihistamines with meals.
The medicine may cause photosensitization reactions and allergic manifestations up to
and including anaphylactic shock.
At common doses, the medicine does not manifest effects on the cardiovascular system. However,
it is possible, especially if you are elderly or if you are a hypersensitive subject, to experience headache, low blood pressure, tachycardia and heart rhythm disturbances (extrasystoles).
Cases of thrombocytopenic purpura (a disease caused by a low number of
platelets), leukopenia, agranulocytosis (decrease in the number of certain blood cells)
and obstructive jaundice (yellowing of the skin and eyes) have been reported.

Additional side effects in children
Signs of excitation are possible, with the appearance of euphoria, nervousness, tremors and insomnia
and, at high doses, convulsions.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor, pharmacist or nurse.
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 FARGANESSE

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 packaging after
“Exp.”.
The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light.
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 FARGANESSE contains

• The active ingredient is promethazine. Each vial contains promethazine hydrochloride 56.40 mg equivalent to 50 mg of promethazine.
• The other ingredients are: potassium metabisulfite, anhydrous sodium sulfite, sodium citrate, water for injections, anhydrous citric acid.

Description of the appearance of FARGANESSE and contents of the pack
5 vials of 50 mg/2 ml.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
ANSERIS FARMA SRL
Corso Genova 23,

• 20123 – Milan

Italy

Manufacturer
LABORATORIO FARMACEUTICO C.T. S.R.L.
Via Dante Alighieri, 71

• 18038 – Sanremo (IM) – Italy

FARGANESSE

25 mg coated tablets
prometazine hydrochloride

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 experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
• 1. What is FARGANESSE and what it is used for
• 2. What you need to know before you take FARGANESSE
• 3. How to take FARGANESSE
• 4. Possible side effects
• 5. How to store FARGANESSE
• 6. Contents of the pack and other information

1. What is FARGANESSE and what is it used for

FARGANESSE contains the active ingredient prometazine and belongs to the group of medicines
called phenothiazines (general antihistamines). It works by blocking histamine, a
substance naturally present in the body, which causes itching during an allergic
reaction. Like many antihistamine agents, it has a sedative effect.
FARGANESSE is used:

• to treat allergic reactions of various origins affecting the respiratory system, mucous membranes and skin;
• to treat allergic reactions to medicines and blood transfusions or blood derivatives; for the treatment of anaphylactic reactions (severe allergic reactions);
• to treat mild emotional disorders such as nervous anxiety and states of tension.

2. What you need to know before you take FARGANESSE

Do not take FARGANESSE

• If you are allergic to promethazine hydrochloride, to other antihistamines or to any of the other

ingredients of this medicine (listed in section 6).

• If you are or suspect you are pregnant.
• If you are breastfeeding.
• In children under two years of age, in premature babies and in newborns.
• If you are taking a medicine for depression belonging to a group of medicines called monoamine oxidase inhibitors (MAOIs).
• If you are undergoing therapy for lower respiratory tract disorders, including bronchial asthma.
• If you have glaucoma (an eye disease), prostatic hypertrophy (enlargement of the prostate), obstruction of the bladder neck, pyloric and duodenal stenosis or of other tracts of the gastrointestinal and urogenital system (narrowing of some parts of the digestive tract or urinary tract).

Warnings and precautions
Talk to your doctor or pharmacist before taking FARGANESSE. This is particularly
important if you:

• have experienced Reye's syndrome (reaction to the use of aspirin, with problems with the brain and liver)
• have problems with your liver
• have serious heart problems
• have a personal or family history of heart disease
• have an irregular heartbeat
• are elderly
• the patient is a child.

The use of antihistamine medicines can mask the early signs of toxicity to the ear of certain
antibiotics.
The antiemetic effect (which inhibits vomiting) of promethazine can mask the symptoms of
an unrecognized illness and hinder diagnosis.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before
taking FARGANESSE.

Children
FARGANESSE 25 mg coated tablets are NOT indicated in children.

Other medicines and FARGANESSE
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.

Do not take this medicine and tell your doctor or pharmacist if you are taking or have taken
the following medicines:

• some medicines for depression (called monoamine oxidase inhibitors (MAOIs)). If in doubt, talk to your doctor or pharmacist. Tell your doctor or pharmacist if you are taking, have recently taken or might take any of the following medicines:
• hypnotics, sedatives, tranquillizers and other drugs with a depressive effect on the Central Nervous System (CNS)
• medicines that block the functionality of the bone marrow (myelosuppressants). This combination should be avoided
• medicines that can affect the heart rhythm. FARGANESSE with alcoholThe effects of antihistamines are accentuated if you take alcohol at the same time.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this
medicine.
You should not take FARGANESSE if you are pregnant or breastfeeding. The doctor may
decide to prescribe this medicine during pregnancy and breastfeeding onlyin
case of actual necessity.

Driving and using machines
As drowsiness may occur, you must be careful if you intend to drive vehicles or
use machines. Treatment with FARGANESSE may impair your ability to
react. This must be taken into account in cases where promptness is required, for
example when driving vehicles. Make sure you are not affected by these effects before
driving vehicles or using machines.

FARGANESSE contains

• Lactose. If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine.
• Sodium. This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, i.e. essentially ‘sodium-free’.
• Sucrose. If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine.

3. How to take FARGANESSE

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The dose will be established by the doctor who will personalize it for you. The lowest effective dose should be used for the shortest duration necessary. Always take the dose prescribed by your doctor.

Adults:
The recommended dose is 1-4 tablets in 24 hours, divided into multiple administrations with
meals.
Take the highest dose in the evening.

Elderly:
If you are an elderly patient, the dosage must be carefully established by the doctor who
will have to evaluate a possible reduction of the dosages mentioned above.

If you take more FARGANESSE than you should
If you take more FARGANESSE than you should, contact your doctor immediately or go to the
emergency room of the nearest hospital. Bring the package of the medicine with you, so
that the doctor knows what you have taken.
In case of accidental overdose, symptoms may include:

• dilated and fixed pupils
• strongly flushed faces
• fever
• coma and cardiovascular collapse (in the most severe cases).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
At common therapeutic doses, the most frequent side effects consist of:

• sedation and drowsiness
• fatigue
• easy fatigability
• difficulty in motor coordination
• blurred vision
• double vision (diplopia)
• dizziness
• ringing in the ears.

Extrapyramidal reactions (painful, involuntary tonic contractions of some muscle groups) are rare and occur with the use of high doses via the parenteral route.
The following are also frequent due to the anticholinergic effects of the medicine:

• dryness of the mouth, throat and nose
• constipation
• difficulty urinating and urinary retention
• reduction and thickening of bronchial secretions accompanied by a feeling of chest tightness and difficult breathing.

Frequency not known (cannot be estimated based on available data):

• abnormal electrical activity of the heart that affects its rhythm, including potentially life-threatening rhythm disturbances
• a severe reaction with fever, stiff muscles, altered blood pressure and coma (malignant neuroleptic syndrome)
• low levels of blood platelets (which can lead to bleeding and bruising)
• restlessness
• hallucinations
• aggression.

The onset of stomach disorders, anorexia, nausea, vomiting and diarrhea can be avoided
by taking antihistamines with meals.
The medicine may determine photosensitization reactions and allergic manifestations
up to anaphylactic shock.
At common usage doses, the medicine does not manifest effects on the cardiovascular system. However,
it is possible, especially if you are elderly or if you are a hypersensitive subject, headache,
low blood pressure, tachycardia and heart rhythm disturbances (extrasystoles).
Cases of thrombocytopenic purpura (a disease caused by a low number
of platelets), a decrease in the number of some blood cells (leukopenia and
agranulocytosis), a yellowish discoloration of the skin and eyes (obstructive jaundice) have been reported.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet,
consult your doctor, pharmacist or nurse. 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 FARGANESSE

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 packaging after
“Exp.”.
The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light.
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 FARGANESSE contains

• The active ingredient is promethazine. Each coated tablet contains promethazine hydrochloride 28 mg equivalent to 25 mg of promethazine.
• The other ingredients are: lactose, corn starch, polyvinylpyrrolidone, sodium carboxymethylcellulose, magnesium stearate, sandarac gum, rosin, talc, magnesium carbonate, titanium dioxide, iron oxide (E 172), gum arabic, carnauba wax, sucrose.
• Description of the appearance of FARGANESSE and pack contents“25 mg coated tablets” - 20 tablets in blister packs made of AL/PVDC and PVC/PVDC.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
ANSERIS FARMA S.R.L.
Corso Genova 23,

• 20123 – Milan Italy

Manufacturer
Pfizer Italia S.R.L.
Via del Commercio, 25
Marino del Tronto, Ascoli Piceno – Italy