ADDOFIX 10 mg Coated Tablet

Зміст інструкції

1. Addofix 10 mg coated tablets
   1. What is Addofix and what is it used for
   2. What you need to know before you take Addofix
   3. How to take Addofix
   4. Possible side effects
   5. How to store Addofix
   6. Contents of the pack and other information
2. ADDOFIX 20 mg/ml injectable solution
   1. What is Addofix and what is it used for
   2. What you need to know before using Addofix
   3. How to use Addofix
   4. Possible side effects
   5. How to store Addofix
   6. Contents of the pack and other information

Addofix 10 mg coated tablets

N-butylscopolammonium bromide

Read this leaflet carefully before taking this medicine as it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist
has told you to do.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

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

1. What is Addofix and what is it used for

Addofix contains the active ingredient N-butylscopolamine bromide which belongs to a group of medicines
called semisynthetic belladonna alkaloids used for disorders of the motility of the stomach, intestines and
biliary tract (gastrointestinal tract).
This medicine is indicated in adults and children over 6 years of age for:

• pain and spasms in the stomach and intestines
• pain and spasms due to obstructions in the flow of the biliary tract (where bile flows, a substance involved in some digestive processes). Consult your doctor if you do not notice any improvement or if you notice a worsening of symptoms after a short period of treatment.

2. What you need to know before you take Addofix

Do not take Addofix

• if you are allergic to joscine N-butyl bromide or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a severe form of glaucoma, i.e. an eye disease caused by an increase in the pressure of the fluid contained within it (acute angle-closure glaucoma);
• if you suffer from an enlargement of the prostate gland (prostatic hypertrophy);
• if you suffer from an inability of the bladder to empty completely (urinary retention);
• if you have a narrowing of the stomach or intestine (pyloric or gastrointestinal tract stenosis);
• in case of intestinal obstruction or if you suspect you have an intestinal obstruction;
• if you suffer from a disease of the intestine, associated with disorders of the movements of the intestine (paralytic or obstructive ileus) or chronic inflammatory bowel disease (ulcerative colitis) and colon dilation (megacolon);
• if you suffer from a disorder caused by frequent regurgitation of stomach contents into the esophagus, the duct through which food reaches the stomach (reflux esophagitis);
• if you suffer from loss of muscle tone of the intestine (intestinal atony), especially if you are an elderly or debilitated person;
• if you suffer from a disease characterized by muscle weakness and fatigue (myasthenia gravis);
• in children under 6 years of age;
• in case of rare hereditary conditions that may be incompatible with an excipient of the product (see “Addofix coated tablets contains sucrose”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Addofix.
Immediately inform your doctor if you experience severe abdominal pain of unknown cause, which
persists or worsens or is accompanied by symptoms such as:

• fever;
• nausea;
• vomiting;
• alteration of bowel movements;
• abdominal tenderness;
• decreased blood pressure;
• fainting;
• blood in the stool.

Take this medicine with caution and inform your doctor if any of the following conditions apply to you:

• if you suffer from breathing problems (chronic obstructive inflammatory respiratory diseases), as Addofix reduces the volume of substances produced by the bronchi (bronchial secretions);
• if you are an elderly person;
• if you suffer from disorders of the autonomic nervous system;
• if you suffer from or are predisposed to heart rhythm disorders (cardiac tachyarrhythmias);
• if you have high blood pressure (arterial hypertension);
• if you suffer from severe heart problems (congestive heart failure);
• if you suffer from a dysfunction of the thyroid gland that can lead to weight loss, fatigue, and weakness (hyperthyroidism);
• if you have problems with the liver or kidneys (patients with hepatic and renal diseases);
• if you suffer from a disease caused by an increase in pressure inside the eye (acute angle-closure glaucoma);
• if you suffer from blockage or slowing of digestion or the need to urinate (intestinal or urinary stasis);
• if you have a fever (pyrexia), as this medicine reduces sweating.

If you experience eye pain and redness with loss of vision after the injection of Addofix, contact your
eye doctor urgently as you may have a severe form of glaucoma, i.e. an eye disease caused by an increase in the pressure of the fluid contained within it (acute angle
closure glaucoma), which has not been diagnosed or, consequently, treated.
Medicines like Addofix can prolong the time of stomach emptying with stagnation of
substances.
If you are taking high doses of this medicine, do not abruptly stop treatment (See the
section “If you stop taking Addofix”). If you experience side effects, inform your doctor
who will assess whether to reduce the dose to control mild side effects or stop treatment in case
of severe side effects.

Children
Addofix should not be given to children under 6 years of age.

Elderly
If you are elderly, consult your doctor before starting treatment with Addofix.

Other medicines and Addofix
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Take this medicine with caution and only under strict medical supervision in the following situations:

• if you are taking medicines such as antidepressants (especially tricyclic and tetracyclic antidepressants), phenothiazines (medicines used for allergies or mental disorders), butyrophenones (medicines used for mental disorders and vomiting), antihistamines (medicines used for allergies), antipsychotics (medicines used for mental disorders), quinidine (medicinal for the heart), amantadine (medicinal for central nervous system diseases involving a loss of movement control, such as Parkinson's disease), disopyramide (medicinal for the heart) and other medicines for respiratory diseases (such as tiotropium, ipratropium), substances similar to atropine (substance that acts at the nervous system level), because their effect may be increased by Addofix,
• if you are taking medicines against vomiting and nausea, such as metoclopramide, because both their effect and that of Addofix may decrease,
• if you are taking beta-adrenergic drugs (medicines used to treat asthma) because the tachycardia (increased heart rate) induced by these drugs may be increased by Addofix.

Avoid taking this medicine together with antacids, medicines used to reduce stomach acidity, as they may reduce the absorption of this medicine in the intestine.

Addofix and alcohol
Do not consume alcoholic beverages during treatment with this medicine.

Pregnancy, breastfeeding and fertility
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.
If you are pregnant or breastfeeding, it is preferable to avoid using Addofix.
The doctor will assess whether the use of this medicine is strictly necessary.

Driving and operating machinery
Medicines like Addofix can cause visual disturbances (visual accommodation disorders) and
drowsiness that can affect your ability to drive vehicles and operate machinery. If you experience these
symptoms, avoid driving or using machinery.

Addofix contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this
medicine.

3. How to take Addofix

Take this medicine following exactly the instructions in this leaflet or as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose for adults and adolescents over 14 years of age is 1-2 tablets, 3 times a day.
If necessary, your doctor may increase the dose.
Swallow the tablets whole with an adequate amount of water.
Take this medicine only for short periods of treatment.
Do not exceed the recommended doses without consulting your doctor. Do not take Addofix regularly or for prolonged periods without consulting your doctor and undergoing investigations to identify the
cause of abdominal pain.
If the contractions (spasms) recur repeatedly or if you notice a change in them, consult your doctor.

Use in children aged between 6 and 14 years
Consult your doctor and carefully follow their instructions before starting treatment with Addofix.

If you take more Addofix than you should
Following the intake of high doses of this medicine, the following effects may occur:

• difficulty urinating (urinary retention);
• dry mouth;
• redness of the skin;
• increased heart rate (tachycardia);
• altered bowel activity (inhibition of intestinal motility);
• temporary visual disturbances;

In case of accidental ingestion/intake of an excessive dose of Addofix, immediately inform your
doctor or go to the nearest hospital.
Treatment
Your doctor will prescribe the appropriate therapy.

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

If you stop taking Addofix
If you are taking high doses of this medicine, do not abruptly stop treatment with Addofix
but consult your doctor as a gradual discontinuation of treatment is recommended.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Addofix can cause side effects, although not everybody gets them.
The following side effects may occur, usually of mild intensity:

Uncommon(may affect up to 1 in 100 people)

• skin reactions, skin irritation, appearance of hives accompanied by itching (urticaria),
• itching;
• increased heart rate (tachycardia);
• dry mouth (xerostomia);
• changes in sweating.

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

• difficulty urinating (urinary retention).

Frequency not known(the frequency cannot be estimated on the basis of the available data)

• severe allergic reactions (anaphylactic reactions up to anaphylactic shock),
• difficulty breathing (dyspnea),
• skin rash (rash),
• skin irritation (erythema) and other allergic manifestations.

The following side effects have also been observed:

• pupil dilation (mydriasis),
• difficulty focusing images (accommodation disorders),
• increased pressure of the fluid contained in the eye (intraocular tension),
• drowsiness,
• constipation.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform 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 Addofix

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.
This medicine does not require any particular storage conditions.
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 Addofix contains

• The active ingredient is hyoscine butylbromide. Each tablet contains 10 mg of hyoscine butylbromide.
• The other ingredients are: o tablet core: anhydrous calcium hydrogen phosphate, corn starch, pregelatinized starch, silicon dioxide, tartaric acid, stearic acid; o coating: povidone, sucrose, talc, titanium dioxide, macrogol 6000, carnauba wax, spray-dried acacia.

Description of the appearance of Addofix and contents of the pack
Pack of 30 coated tablets.

Marketing Authorisation Holder
So.Se.PHARM S.r.l.- Via dei Castelli Romani, 22, 00071 Pomezia (RM) - Italy

Manufacturer
Special Product'sLine S.p.A. – Via Frattarotonda Vado Largo, 1, 03012 Anagni (FR) – Italy

ADDOFIX 20 mg/ml injectable solution

N-butylscopolamine bromide

Generic medicine
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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Addofix and what is it used for

Addofix contains the active ingredient N-butylscopolamine bromide which belongs to a group of medicines
called semisynthetic belladonna alkaloids used for disorders of the motility of the stomach, intestines and
the biliary tract (gastrointestinal tract) and the genitourinary tract.
This medicine is indicated in adults in cases of:

• pain and spasms in the stomach and intestines
• pain and spasms due to obstructions in the flow of the urinary tract and the biliary tract (where bile flows, a substance involved in some digestive processes). See your doctor if you do not feel better or if you feel worse after using the medicine.

2. What you need to know before using Addofix

Do not use Addofix

• if you are allergic to joscine N-butyl bromide, to similar substances or to any of the other components of this medicine (listed in section 6);
• if you suffer from a disease caused by an increase in pressure in the eye and are not taking medications to treat this condition (untreated acute angle-closure glaucoma);
• if you suffer from an enlarged prostate or have difficulty urinating (prostatic hypertrophy or other causes of urinary retention);
• if you have a narrowing of the stomach or intestine (pyloric or gastrointestinal tract stenosis);
• if you have a reduction in intestinal activity (paralytic ileus) or have a severe inflammation of the stomach or intestine (ulcerative colitis, megacolon);
• if you suffer from inflammation of the esophagus caused by the reflux of undigested material (reflux esophagitis);
• if you suffer from loss of muscle tone in the intestine (intestinal atony), especially if you are elderly or debilitated;
• if you suffer from a disease characterized by muscle weakness and fatigue (myasthenia gravis);
• if you suffer from heart rhythm disorders (cardiac tachyarrhythmias);
• if you suffer from an increased heart rate (tachycardia).

If you are taking medications used to reduce or block the formation of blood clots
(anticoagulants), do not use Addofix for injection into the muscle but consult your doctor, who will administer the
medicine intravenously or subcutaneously to avoid the formation of bruises (hematoma).

Warnings and precautions
Consult your doctor, pharmacist or nurse before using Addofix.
Immediately inform your doctor if you experience severe abdominal pain of unknown cause, which
persists or worsens or is accompanied by symptoms such as:

• fever;
• nausea;
• vomiting;
• alteration of bowel movements;
• abdominal tenderness;
• decreased blood pressure;
• fainting;
• blood in the stool. The doctor will perform appropriate tests to determine the cause of your symptoms.

Use this medicine with caution if any of the following conditions apply to you:

• if you suffer from breathing problems (chronic obstructive inflammatory respiratory diseases), as Addofix reduces the volume of substances produced by the bronchi (bronchial secretions);
• if you are an elderly person;
• if you suffer from disorders of the autonomic nervous system;
• if you have high blood pressure (arterial hypertension);
• if you suffer from severe heart problems (congestive heart failure);
• if your thyroid is overactive (hyperthyroidism);
• if you have problems with your liver or kidneys (patients with hepatic and renal impairments);
• if you suffer from a disease caused by an increase in pressure inside the eye (acute angle-closure glaucoma);
• if you suffer from blockage or slowing of digestion or the need to urinate (intestinal or urinary stasis);
• if you are prone to heart rhythm disorders (tachyarrhythmias);
• if you have a fever (pyrexia), as this medicine reduces sweating.

If you experience eye pain and redness with loss of vision after the injection of Addofix, consult
your ophthalmologist urgently as you may have a severe form of glaucoma, i.e. a disease
of the eye caused by an increase in the pressure of the liquid contained within it (acute angle
glaucoma), which has not been diagnosed or, consequently, treated.
Medicines like Addofix can prolong the time of stomach emptying with stagnation of
substances.
If you are using high doses of this medicine, do not suddenly stop treatment (See section “If you stop treatment with Addofix”). If you experience undesirable effects, inform your doctor
who will assess whether to reduce the dose to control mild undesirable effects or stop treatment in case
of severe undesirable effects.
Addofix can cause severe allergic reactions (anaphylaxis, including shock) after administration by
injection (injectable route). Therefore, after the injection, the doctor will keep you under observation.
If you have heart problems and are undergoing parenteral therapy with Addofix, the doctor will keep you
under observation.

Children
Addofix should not be administered to children.

Elderly
If you are elderly, consult your doctor before starting treatment with Addofix.

Other medicines and Addofix
Inform your doctor, pharmacist or nurse if you are taking, have recently taken or might take any
other medicine.
Use this medicine with caution and only under strict medical supervision in the following situations:

• if you are taking medicines such as antidepressants (particularly tricyclic and tetracyclic antidepressants), phenothiazines (medicines used for allergies or mental disorders), butyrophenones (medicines used for mental disorders and vomiting), antihistamines (medicines used for allergies), antipsychotics (medicines used for mental disorders), quinidine (medicinal for the heart), amantadine (medicinal for central nervous system diseases involving a loss of movement control, such as Parkinson's disease), disopyramide (medicinal for the heart) and other medicines for respiratory diseases (such as tiotropium, ipratropium), substances similar to atropine (substance that acts at the nervous system level), because their effect may be increased by Addofix,
• if you are taking medicines against vomiting and nausea, such as metoclopramide, because both their effect and that of Addofix may decrease,
• if you are taking beta-adrenergic drugs (medicines used to treat asthma) because the tachycardia (increased heart rate per minute) induced by these drugs may be increased by Addofix.

Avoid using this medicine together with antacids, medicines used to reduce stomach acidity.

Addofix with alcohol
Do not consume alcoholic beverages during treatment with this medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding
ask your doctor, pharmacist or nurse for advice before using this medicine.
There is not enough data to establish the effect of this medicine in pregnant or
breastfeeding women. Therefore, if you are pregnant or breastfeeding, avoid using Addofix.

Driving and operating machinery
This medicine can cause visual disturbances (visual accommodation disorders), dizziness and
drowsiness that can affect your ability to drive and operate machinery. If you experience these
symptoms, avoid driving or using machinery.

Addofix contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. it is practically ‘sodium-free’.

3. How to use Addofix

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

Adults
The recommended dose is:

• 1 vial several times a day by injection into a muscle or vein.

The Addofix solution must be injected slowly.

Donot use Addofix daily and regularly or for prolonged periods without undergoing investigations for the
cause of abdominal pain.
Instructions for opening the vial
The vial has a line to facilitate breakage (breakaway vial) and therefore a file is not necessary.

If you use more Addofix than you should
Following the administration of high doses of this medicine, the following effects may occur:

• difficulty urinating (urinary retention);
• dry mouth;
• increased heart rate (tachycardia);
• mild feeling of fatigue (torpor);
• temporary visual disturbances;

In case of accidental ingestion/intake of an excessive dose of Addofix, immediately inform your
doctor or go to the nearest hospital.

If you forget to use Addofix
Do not use a double dose to make up for a missed dose.

If you stop using Addofix
If you are using high doses of this medicine, do not abruptly stop treatment with Addofix but
consult your doctor as a gradual discontinuation of treatment is recommended.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, Addofix can cause side effects, although not everybody gets them.
The following side effects may occur, usually of mild intensity:

Common(may affect up to 1 in 10 people)

• visual disturbances (accommodation disorders);
• increased heart rate (tachycardia);
• dizziness;
• dry mouth (xerostomia).

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

• serious allergic reactions (anaphylactic shock, including fatal outcome, anaphylactic reactions), difficulty breathing (dyspnea), skin irritations (urticaria, skin rash, erythema), itching and other allergic manifestations (hypersensitivity);
• vision problems (mydriasis, increased intraocular pressure);
• decreased blood pressure, skin flushing;
• altered sweating;
• difficulty urinating (urinary retention); The following side effects have also been reported:
• drowsiness,
• constipation,
• difficulty urinating.

High doses can lead to signs of stimulation of the central nervous system, and interference with the state
of consciousness and the function of the heart and lungs.
Pain at the injection site occurs rarely, especially after intramuscular administration.

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 Addofix

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 at a temperature not exceeding 30 °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 Addofix contains

• The active ingredient is N-butylscopolamine bromide. Each vial (1 ml) contains 20 mg of N-butylscopolamine bromide.
• The other ingredients are: sodium chloride, water for injections.

Description of the appearance of Addofix and contents of the pack
Pack of 6 vials of 1ml.

Marketing Authorisation Holder
So.Se.PHARM S.r.l.- Via dei Castelli Romani, 22, 00071 Pomezia (RM) - Italy

Manufacturer
DOPPEL FARMACEUTICI S.r.l. – Via Volturno, 48 – Quinto de’ Stampi – 20089 Rozzano (MI) – Italy