Farganesse

Package leaflet: Information for the user

FARGANESSE

50 mg/2 ml injectable solution
promethazine hydrochloride
Please read this leaflet carefully before using 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, 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, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 using 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 substance promethazine and belongs to a group of medicines known as phenothiazines (antihistamines for general use).
It works by blocking histamine, a naturally occurring substance in the body that 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 to blood transfusions or blood products;
• for the treatment of anaphylactic reactions (severe allergic reactions);
• to treat mild emotional disturbances such as nervous anxiety and tension states.

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 definitely or possibly pregnant.
• If you are breastfeeding.
• In children under two years of age, in premature infants, 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 being treated for lower respiratory tract disorders, including bronchial asthma.
• If you have glaucoma (an eye disease), prostatic hypertrophy (enlarged prostate), bladder neck obstruction, pyloric or duodenal stenosis, or other gastrointestinal or urogenital tract strictures (narrowing of certain parts of the digestive or urinary tracts).

Warnings and precautions
Do not accidentally inject FARGANESSE intra-arterially or subcutaneously.

Talk to your doctor, pharmacist, or nurse before using/having FARGANESSE administered to you. This is particularly important if you:

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

The use of antihistamine medicines may mask the early signs of ototoxicity (ear toxicity) caused by certain antibiotics.
The antiemetic effect (vomiting inhibition) of promethazine may mask symptoms of an undiagnosed illness and interfere with diagnosis.
If you are unsure whether any of the above situations apply to you, consult your doctor or pharmacist before using FARGANESSE.

Children
Promethazine must not be used in children under 2 years of age.
It should not be used in children showing signs suggestive of Reye's syndrome or other liver disorders.

Other medicines and FARGANESSE
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Do not take this medicine and inform your doctor, pharmacist, or nurse if you are taking or have taken the following medicines: certain antidepressants (called monoamine oxidase inhibitors (MAOIs)). If in doubt, consult your doctor or pharmacist.
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any of the following medicines:
medicines that may affect heart rhythm.
Moreover, it is particularly important to inform your doctor or pharmacist if you are taking any of the following medicines:

• hypnotics, sedatives, tranquillisers, and other medicines with central nervous system (CNS) depressant effects;
• medicines that suppress bone marrow function (myelosuppressants). Such combinations should be avoided.

FARGANESSE and alcohol
The effects of antihistamines are enhanced if alcohol is consumed at the same time.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
You must not use FARGANESSE if you are pregnant or breastfeeding. Your doctor may decide to prescribe this medicine during pregnancy or breastfeeding only if clearly necessary.

Driving and using machines
As drowsiness may occur, you should be cautious if you intend to drive or operate machinery. Treatment with FARGANESSE may impair reaction capability. This should be taken into account whenever alertness is required, for example when driving vehicles. Make sure you are not affected by these side effects before driving or using machinery.

FARGANESSE contains:

• Potassium metabisulfite, anhydrous sodium sulfite. Rarely, these may cause severe hypersensitivity reactions and bronchospasm (bronchial constriction).
• 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 exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The dose will be determined by the doctor, who will tailor it to your individual needs. The lowest effective dose for the shortest necessary duration should always be used. Always take the dose prescribed by your doctor.
If you experience burning or pain during or immediately after administration, inform your doctor or nurse immediately.

Adults
The recommended dose is generally 25–50 mg (1–2 ml) administered by deep intramuscular injection, or, in emergency situations, the same doses given by slow intravenous injection.
The parenteral dose must not exceed 100 mg.

Use in children
Do not use in children under 2 years of age.
From 2 to 5 years of age
The recommended dose is 5–7.5 mg per day, administered by deep intramuscular injection.
From 5 to 10 years of age
The recommended dose is 7.5–12.5 mg per day, administered by deep intramuscular injection.
For a sedative effect (hypnotic-sedative), a single evening dose of 2.5–5 mg is sufficient.

Elderly patients
If you are an elderly patient, the dosage must be carefully determined by the doctor, who may consider reducing the doses indicated above.

If you use more FARGANESSE than you should
If you or the child receive more FARGANESSE than prescribed, contact your doctor immediately or go to the nearest hospital emergency department. Take the medicine package with you so the doctor knows what has been taken or administered.
In case of overdose, central nervous system depression or stimulation is generally observed, including:

• dilated and fixed pupils
• markedly flushed face
• fever
• coma and cardiocirculatory collapse (in severe cases)
• in children: tremors, insomnia, agitation, involuntary movements (athetosis), coordination disturbances (ataxia), and convulsions.

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everyone experiences them.
At usual therapeutic doses, the most common side effects include:

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

Extrapyramidal reactions (painful, involuntary tonic muscle contractions) are rare and occur mainly with high doses administered parenterally.
Due to the anticholinergic effects of the medicine, the following are also common:

• dryness of the mouth, throat, and nose
• constipation
• difficulty urinating and urinary retention
• reduced and thickened bronchial secretions, accompanied by a sensation of chest tightness and difficulty breathing.

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

• abnormal electrical activity of the heart affecting its rhythm, including potentially life-threatening arrhythmias
• a serious reaction with fever, muscle rigidity, altered blood pressure, and coma (neuroleptic malignant syndrome)
• low levels of blood platelets (which may lead to bleeding and bruising)
• restlessness
• hallucinations
• aggression.

Stomach disturbances, anorexia, nausea, vomiting, and diarrhoea may be avoided by taking antihistamines with meals.
The medicine may cause photosensitization reactions and allergic manifestations up to anaphylactic shock.
At usual doses, the medicine does not show effects on the cardiovascular system. However, especially if you are elderly or hypersensitive, you may experience headache, low blood pressure, tachycardia, and cardiac rhythm disturbances (extrasystoles).
Cases of thrombocytopenic purpura (a condition caused by low platelet count), leucopenia, agranulocytosis (reduced 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 may occur, including euphoria, nervousness, tremors, and insomnia; at high doses, seizures may also occur.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via 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 sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What FARGANESSE contains

• The active substance is promethazine. Each ampoule contains promethazine hydrochloride 56.40 mg, equivalent to 50 mg of promethazine.
• The other components 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 ampoules of 50 mg/2 ml.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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

Package leaflet: information for the user

FARGANESSE

25 mg coated tablets
promethazine hydrochloride
Please 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 for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
  Contents of this leaflet:

1. What FARGANESSE is and what it is used for
2. What you need to know before taking FARGANESSE
3. How to take FARGANESSE
4. Possible side effects
5. How to store FARGANESSE
6. Package contents and other information

1. What FARGANESSE is and what it is used for

FARGANESSE contains the active substance promethazine and belongs to a group of medicines
called phenothiazines (antihistamines for general use). It works by blocking histamine, a
naturally occurring substance in the body that 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 caused by medicines and by blood transfusions or blood products; for the treatment of anaphylactic reactions (severe allergic reactions);
• to treat mild emotional disturbances such as nervous anxiety and tension states.

2. What you need to know before taking 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 pregnant or suspect you might be pregnant.
• If you are breastfeeding.
• In children under two years of age, in premature infants, 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 being treated for lower respiratory tract disorders, including bronchial asthma.
• If you have glaucoma (an eye disease), prostatic hypertrophy (enlarged prostate), bladder neck obstruction, pyloric or duodenal stenosis, or other gastrointestinal or urogenital tract strictures (narrowing of certain parts of the digestive 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 (a reaction to aspirin use, involving brain and liver problems)
• have liver problems
• have severe heart problems
• have a personal or family history of heart disease
• have irregular heartbeat
• are elderly
• the patient is a child.

The use of antihistamines may mask the early signs of ototoxicity (ear toxicity) caused by certain
antibiotics.
The antiemetic effect (vomiting inhibition) of promethazine may mask symptoms of an undiagnosed
illness and interfere with diagnosis.
If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before
taking FARGANESSE.

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

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

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

• certain antidepressants called monoamine oxidase inhibitors (MAOIs). If in doubt, consult your doctor or pharmacist. Inform your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines:
• hypnotics, sedatives, tranquilizers, and other drugs with central nervous system (CNS) depressant effects
• medicines that suppress bone marrow function (myelosuppressive agents). Such combination should be avoided
• medicines that may affect heart rhythm.

FARGANESSE and alcohol
The effects of antihistamines are increased if alcohol is taken at the same time.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, plan to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
You must not take FARGANESSE if you are pregnant or breastfeeding. Your doctor may decide to
prescribe this medicine during pregnancy or breastfeeding only if clearly necessary.

Driving and using machines
As drowsiness may occur, you should exercise caution if you intend to drive or operate machinery.
Treatment with FARGANESSE may impair reaction ability. This should be taken into account in
situations requiring alertness, such as driving. Make sure you are not affected by these effects before
driving or operating machinery.

FARGANESSE contains

• Lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her 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 an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take FARGANESSE

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The dose will be determined by your doctor, who will tailor it to your individual needs. The lowest effective dose for the shortest necessary duration should be used. Always take the dose prescribed by your doctor.

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

Elderly patients:
If you are an elderly patient, the dosage must be carefully determined by your doctor, who may consider reducing the doses indicated above.

If you take more FARGANESSE than you should
If you take more FARGANESSE than prescribed, contact your doctor immediately or go to the nearest hospital emergency department.
Take the medicine’s packaging with you, so the doctor knows what you have taken.
In case of accidental overdose, symptoms may include:

• dilated and fixed pupils
• strongly flushed face
• fever
• coma and cardiocirculatory collapse (in more severe cases).

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 are:

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

Extrapyramidal reactions (painful involuntary tonic contractions of certain muscle groups) are rare and occur with high doses administered parenterally.
Moreover, due to the anticholinergic effects of the medicine, the following are common:

• dryness of the mouth, throat, and nose
• constipation
• difficulty in urination and urinary retention
• reduced and thickened bronchial secretion, accompanied by a feeling of chest tightness and difficulty breathing.

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

• abnormal electrical activity of the heart affecting its rhythm, including potentially life-threatening rhythm disturbances
• a serious reaction with fever, muscle rigidity, changes in blood pressure, and coma (neuroleptic malignant syndrome)
• low levels of blood platelets (which may lead to bleeding and bruising)
• restlessness
• hallucinations
• aggression.

Stomach disturbances, loss of appetite, nausea, vomiting, and diarrhoea can be avoided by taking antihistamines with meals.
The medicine may cause photosensitization reactions and allergic manifestations up to anaphylactic shock.
At common dosage levels, the medicine does not show effects on the cardiovascular system. However, especially if you are elderly or hypersensitive, headache, low blood pressure, tachycardia, and heart rhythm disturbances (extrasystoles) may occur.
Cases of thrombocytopenic purpura (a condition caused by a low number of platelets), reduced numbers of certain blood cells (leucopenia and agranulocytosis), and 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, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the website
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 packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What FARGANESSE contains

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

Marketing Authorization Holder and Manufacturer
Marketing Authorization 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