CONTROL 1 mg Tablet

Зміст інструкції

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

Control 1 mg tablets

Control 2.5 mg tablets
lorazepam

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

1. What is Control and what is it used for

Control contains the active ingredient lorazepam which belongs to a group of medicines
called benzodiazepines and acts on the central nervous system reducing anxiety (anxiolytic effect), facilitating a sleep entirely comparable to normal sleep (hypnotic effect),
improving mood and decreasing the intensity of emotional reactions to psychic stress
(sedative effect).
Benzodiazepines are indicated only when the disorder is severe, disabling or
subjects the individual to severe discomfort and only for short-term treatment.
This medicine is prescribed to treat:

• anxiety and symptoms related to the anxious state;
• insomnia.

2. What you need to know before taking Control

Do not take Control

• if you are allergic to lorazepam, to benzodiazepines or to any of the other ingredients of this medicine (listed in section 6);
• if your muscles are consistently very weak or tired (myasthenia gravis);
• if you have severe breathing problems (respiratory failure);
• if you suffer from episodes of interrupted breathing for several seconds during sleep (sleep apnea syndrome); P a g . 1 | 13
• if you have severe liver problems (hepatic failure);
• if you have an eye condition characterized by high eye pressure and visual impairment (narrow-angle glaucoma);
• if you are pregnant, intend to become pregnant or suspect you may be pregnant (see “Pregnancy, breastfeeding and fertility”);
• if you are breastfeeding (see “Pregnancy, breastfeeding and fertility”).

Warnings and precautions
The duration of treatment with Control should be as short as possible. It is recommended not
to
exceed 4 weeks for the treatment of insomnia and 8-12 weeks for the
treatment of anxiety. The recommended duration of treatment also includes the
period necessary for the gradual reduction of the dosage(see section 3 “How
to take Control”).
Consult your doctor or pharmacist before taking Control if:

• you have or have ever had breathing problems (chronic respiratory failure, COPD - Chronic Obstructive Pulmonary Disease - or sleep apnea syndrome) because this medicine can decrease your spontaneous breathing capacity. Breathing problems may also be associated with the following conditions:
• you suffer from heart problems (heart failure);
• you suffer from low blood pressure;
• you suffer from general breathing problems, chronic inability to breathe adequately and regularly, during exertion or at rest;
• you suffer from episodes of interrupted breathing for several seconds during sleep (sleep apnea).

If you experience any of these conditions and need to start treatment with Control,
your doctor will subject you to regular medical check-ups.

• you suffer from or have ever suffered from allergic reactions to benzodiazepines. This medicine can cause severe and rapid allergic reactions (anaphylactic reactions) or swelling of the face, tongue and throat with inability to swallow and breathe (angioedema). Sometimes, these reactions can be fatal. As soon as one or more symptoms appear, go to the nearest emergency room. In these cases, your doctor will advise you not to take any more medicines containing lorazepam and to continue treating your condition with other medicines;
• you have or have had problems with alcohol, drug or medicine abuse, because Control can also cause dependence (see “Development of dependence”) or personality disorders;
• you have respiratory problems, or suffer from heart problems (heart failure) or if you have low blood pressure;
• you have or have ever had liver problems (hepatic failure) because this medicine could worsen your condition. The doctor will advise you on the most suitable dosage for your condition;
• you have or have ever had kidney problems (renal failure). The doctor will advise you on the most suitable dosage for your condition;
• you have a severe brain disease (hepatic encephalopathy);
• you suffer from or have ever suffered from depression, because this medicine can worsen your condition and increase suicidal thoughts;
• you suffer from or have ever suffered from difficulty relating to others or to various life situations, even if you have not always been aware of these difficulties. Control is not recommended as the primary treatment for this condition.

Memory disorders
After taking Control you may have difficulty remembering what happened after
taking the medicine. Therefore, it is advisable that you can sleep for 7-8 hours after
taking this medicine.
Paradoxical reactions
Control can cause mental reactions and effects opposite to those expected (paradoxical
effects) (see section 4 “Possible side effects”). These effects are more
frequent in children and the elderly.
If you experience these effects, consult your doctor who will advise you on how to
stop taking this medicine.
Development of tolerance
Following repeated use of this medicine for several weeks, a decrease in its effectiveness (tolerance) may occur. Control is recommended for short-term treatments.
In addition, treatment with this medicine increases sensitivity to the effects of alcohol and
other medicines that depress brain function. Therefore, when taking Control,
the simultaneous intake of alcohol and these types of medicines should be avoided or
reduced.
Development of dependence
The use of benzodiazepines, including Control, can cause dependence, which can manifest
as a growing need, desire or exaggerated search for wanting to take the medicine
(psychic dependence) or the development of physical disorders that decrease or disappear only
after taking the medicine (physical dependence). The likelihood of developing psychic and physical dependence on this medicine increases with increasing dose and duration
of treatment.
You are more likely to develop a dependence on Control if:

• you have taken drugs in the past or are currently taking drugs;
• you have drunk alcohol in the past or currently drink alcohol frequently and/or in large quantities;
• you have had a desire to take medicines in excessive quantities in the past or currently have such a desire;
• you suffer from or have ever suffered from difficulty relating to others or to various life situations, even if you have not always been aware of these difficulties.

In case of abrupt discontinuation of treatment with Control after the development of dependence, you
may experience withdrawalsymptoms such as:

• severesymptoms (more likely after taking Control at high doses for a long period of time): feeling of detachment or estrangement from oneself or from the external world, increased sensitivity to sounds, numbness and tingling in the legs or

arms, hypersensitivity to light, noise and physical contact, hallucinations,
delirium, seizures, convulsions.
Seizures and convulsions are more likely to occur if you are
taking antidepressants (antidepressants) simultaneously with
Control;

• other symptoms: headache, muscle pain, extreme anxiety, emotional tension, restlessness, confusion, irritability, dizziness, nausea, diarrhea, loss of appetite, mood alteration with a tendency to sadness, depression, insomnia, sweating, persistent ringing in the ears, involuntary body movements, vomiting, tingling sensation, altered perceptions, abdominal and muscle cramps, tremor, agitation, accentuated perception of heartbeat (palpitations), increased heart rate (tachycardia), panic attacks, vertigo, increased reflexes, loss of the ability to remember recent events, strong increase in body temperature;
• rebound symptoms: insomnia and anxiety. These symptoms are the same for which you were advised to take treatment with Control but, in case of abrupt discontinuation of the treatment, they may temporarily reappear in a more severe form than before starting treatment with this medicine. In addition, you may experience mood changes, restlessness, anxiety and sleep disturbances.

Do not stop taking Control suddenly. Consult your doctor or pharmacist who
will advise you on the correct way to stop treatment with this
medicine(see section 3 “If you stop taking Control”).

If you are elderly, debilitated and/or suffer from particular health conditions
If you are elderly, debilitated (your general health conditions are very weak) because the
effects of benzodiazepines, such as lorazepam contained in this medicine, can
increase the risk of falls due to inability to make coordinated movements (ataxia),
muscle weakness, feeling of instability, drowsiness, fatigue (see “Use in
the elderly or debilitated”).
If you suffer from significant brain diseases (you have vascular lesions especially cerebral arteriosclerosis)
you are more sensitive to the effect of Control.
If you suffer from low blood pressure, this medicine may cause
an increase in episodes of low blood pressure.
Therefore, it is recommended to use this medicine at the lowest possible dosage or
to avoid its use.
If you have severeliver problems.
If you suffer from severe liver problems associated or not with brain symptoms such as mental confusion,
altered level of consciousness or coma, Control should not be used
because it could worsen your condition (see also section 2 “Do not take
Control”).

Children and adolescents
The efficacy and safety of Control in children under 12 years of age are not known.
This medicine should not be used in children unless strictly necessary and
under the control of the doctor. The duration of treatment is established by the doctor and must be the
shortest possible.

Other medicines and Control
Inform your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Do not take Control with the following medicines unless prescribed by your doctor:

• Medicines that cause a strong reduction of all brain functions, such as:
• other medicines that act on the central nervous system such as neuroleptics (used to treat psychiatric disorders), hypnotics (used to treat insomnia), anxiolytics/sedatives or barbiturates (used to treat anxiety), antidepressants (used to treat depression), antiepileptics such as phenobarbital or hydantoin (used to treat epilepsy), anesthetics (used for anesthesia), because they can increase the effects of this medicine, the intake of these substances together with lorazepam should be avoided;
• antihistamines (used to treat allergies), because they can increase the effects of this medicine;
• narcotic analgesics (used for pain relief), because they can cause euphoria and increase the risk of dependence;
• Control, administered together with anesthetic medicines, can cause euphoria, with an increased probability of developing psychic dependence;
• the concomitant use of Control and opioids (strong painkillers, medicines for substitution therapy and some medicines for cough) increases the risk of drowsiness, difficulty in breathing (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible. However, if your doctor has prescribed Control together with opioids, the dose and duration of concomitant therapy must be limited by the doctor. It may be helpful to inform friends or relatives to pay attention to the signs and symptoms listed above. Consult your doctor when these symptoms occur;
• clozapine (used to treat schizophrenia), because it can cause strong sedation, excessive production of saliva and loss of coordination of movements (ataxia);
• valproate (used to treat epilepsy), because it increases the amount of Control in the blood. If necessary to take them together, the doctor will reduce the dose of lorazepam you need to take by half;
• probenecid (used to treat gout), because it can increase the effects of this medicine. If necessary to take them together, the doctor will reduce the dose of lorazepam you need to take by half;
• cisapride (used to treat gastroesophageal reflux), because it can increase the effects of this medicine;
• lofexidine (used to control withdrawal symptoms from opioids), because it can increase the effects of this medicine;
• nabilone (used to treat nausea and vomiting in chemotherapy), because it can increase the effects of this medicine;
• disulfiram (used in the treatment of alcoholism), because it can increase the effects of this medicine;
• muscle relaxants, such as baclofen or tizanidine, (used to reduce muscle spasms that cause pain), because they can increase the effects of this medicine;
• sodium oxybate (used to treat narcolepsy), because its effect may be increased by the simultaneous intake of lorazepam;
• theophylline or aminophylline (used to treat asthma), because they reduce the effects of this medicine;
• loxapine (mainly used in the treatment of schizophrenia), because together with Control it may cause an excessive loss of cognitive functions (stupor), a state characterized by excessive passivity and inertia towards events and people (e.g. inability to move and mutism) reduction in the number of breaths and lowering of blood pressure (hypotension).
• caffeine (a substance contained mainly in coffee, but also in numerous energy drinks), because it can reduce the effects of Control.

Even compounds that influence liver enzymes (in particular cytochrome P450) can
increase the activity of benzodiazepines; however, unlike what has been observed with
many other benzodiazepines, pharmacokinetic interactions between the
P450 system and Control have not been demonstrated.

Interaction with food, beverages and alcohol
Do not drink alcohol while taking Control because alcohol increases the drowsiness and
reduced state of consciousness induced by this medicine.
This can also lead to a serious impairment of the ability to drive vehicles and
operate machinery (see section “Driving and using machines”).

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.
Pregnancy

This medicine should not be taken during pregnancy, especially during the first 3
months,because it can cause congenital malformations in the fetus.
If you take this medicine during the last period of pregnancy or during labour,
the baby, once born, may have a lower body temperature (hypothermia)
with resulting metabolic alterations, muscle weakness (hypotonia), excessive
decrease in motor activity and difficulty breathing (moderate respiratory depression),
suspension of breathing for a period of several seconds (apnea), feeding problems
or present a yellowish discoloration of the skin and eyes due to increased
bilirubin (neonatal jaundice).
If you have taken this medicine regularly during the last period of pregnancy, your
baby may develop physical dependence symptoms or withdrawal symptoms after
birth (see section “Development of dependence”).
Breastfeeding
Do not take this medicine if you are breastfeeding. The lorazepam contained in this
medicine passes into breast milk and can cause sedation and inability to
suck milk from the breast in the newborn.
Fertility
If you are a woman of childbearing age, you should contact your doctor, whether you intend
to become pregnant or suspect you are pregnant, regarding stopping
the medicine.

Driving and using machines
This medicine can make you feel deeply relaxed (sedation), memory loss (amnesia), can alter your ability to concentrate and control your muscles
and cause you dizziness and visual disturbances. All these effects can compromise your
ability to drive vehicles or operate machinery.
Avoid driving even if the duration of your sleep is insufficient (less than 7-8 hours of uninterrupted sleep) because you are likely to be less attentive.

Control contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact them before
taking this medicine.

3. How to take Control

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Based on your condition and illness, your doctor will advise you on the dose, how many times a day to take the medicine and the duration of treatment with Control, to ensure that
you take the lowest possible dose for the shortest possible time.
If you need to increase the dose of this medicine, your doctor will suggest
how to proceed gradually to avoid unwanted effects. In case of
an increase in the dose of Control, it is necessary to first increase the evening dose and then
possibly increase the morning dose as well.

Treatment of anxiety
Treatment should be as short as possible. The doctor will regularly check your
condition.
The recommended dose is 1 mg tablet, or ½ - 1 tablet of 2.5 mg, 1 - 3
times a day.
The duration of treatment generally should not exceed 8 - 12 weeks, including
a period of gradual discontinuation. In certain cases, the doctor may decide to extend
the treatment, after evaluating your health conditions.

Treatment of insomnia
The duration of treatment should be as short as possible.
The recommended dose is 1 - 2.5 mg.
It is advisable to take the medicine in the evening, before going to bed.
Treatment should be started with the lowest recommended dose. The maximum dose should not
be exceeded.
The duration of treatment generally varies from a few days to 2 weeks, up to a
maximum of 4 weeks, including a period of gradual discontinuation.
In certain cases, the doctor may decide to extend the treatment, after evaluating your
health conditions.

Method of administration
The tablets can be taken at any time of the day
regardless of meals.
The evening dose should be increased before the daytime dose.

Use in elderly or debilitated people
In elderly and debilitated patients, the doctor will evaluate the administration of a reduced
dose.

Use in people with kidney or liver problems
In patients with severe kidney or liver problems (renal or hepatic insufficiency), the doctor
will evaluate the administration of a reduced dose and subject them to frequent checks.

If you take more Control than you should
If you take a dose of Control, higher than that prescribed immediately inform your
doctoror go to the nearest hospital. Bring this leaflet and the packaging of
this medicine with you even if it is empty.
The symptoms of overdose may be, in mild cases:

• blurred vision, drowsiness, disorientation and weakening of sensory functions;
• difficulty in articulating speech;
• mental confusion;
• continuous sleep and reduced response to normal stimuli;
• inability to completely empty the bladder;
• changes in sexual desire.

In more severe cases, when large quantities of medicine are taken for suicidal purposes or
when this medicine is taken together with alcoholic beverages or other medicines
that reduce the state of consciousness and the main brain functions, the symptoms may be:

• loss of coordination ability;
• poor muscle tone;
• low blood pressure;
• excessive drowsiness;
• symptoms opposite to those expected from the effects of this medicine (paradoxical symptoms);
• reduction of all functions of the central nervous system;
• reduction of heart function;
• reduction of breathing;
• coma;
• death.

Contact your doctor immediately or go to the nearest emergency room if you take more
Control than prescribed by your doctor. If you are conscious, you will be induced to vomit within
one hour of taking the medicine; if you are unconscious, you will undergo
gastric lavage. If these procedures are not sufficient, you may be given
activated charcoal to reduce the absorption of Control, or flumazenil, a medicine that
counteracts the effects of Control.

If you forget to take Control
Do not take a double dose to make up for the missed tablet.
If you forget to take a dose, take it as soon as you remember, but make sure to
be able to rest immediately afterwards and for long enough (7-8 hours).
If you think you have forgotten more than one dose, consult your doctor.

If you stop taking Control

• At the end of treatment with this medicine, the doctor will decide whether you need to continue therapy.
• The dose and frequency of taking this medicine must be reduced slowly before stopping treatment. This allows the body to get used to the lack of medicine, and reduces the risk of unpleasant effects when stopping treatment. Your doctor will tell you how to do it.
• Do not stop treatment abruptlyotherwise the symptoms for which you were being treated may reappear even more intensely than before (rebound insomnia and anxiety) (see also “Development of dependence”). When stopping treatment, you may experience withdrawal symptoms such as headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, depressed mood and nervousness, dizziness, nausea, diarrhea and loss of appetite. In more severe cases, the following symptoms may manifest: loss of sense of reality (derealization), altered self-perception (depersonalization), hypersensitivity to sounds (hyperacusis), sensation of numbness or tingling in hands and feet, hypersensitivity to light, noise and physical contact, hallucinations up to delirium, seizures or convulsions (violent and involuntary muscle contractions). Other symptoms are: depression, insomnia, sweating, ringing in the ears (tinnitus), involuntary movements, vomiting, diffuse tingling (paresthesia), altered perceptions (perceptual alterations), abdominal and muscle pain (abdominal and muscle cramps), tremor, muscle suffering (myalgia), agitation, sensation of heartbeat (palpitations), accelerated heartbeat (tachycardia), panic attacks, balance disorders (vertigo), accentuated muscle reflexes (hyper-reflexia), short-term memory loss, increased body temperature (hyperthermia).
• Even the insomnia or anxiety that required treatment with this medicine may reappear in a more severe form (rebound phenomena with mood changes, anxiety, restlessness or sleep disturbances). If you suffer from these symptoms, ask your doctor for advice.
• If you suffer from epilepsy or seizures or are taking medications for depression (antidepressants), be careful, because the risk of seizures when stopping treatment with this medicine is greater for you.

If you have any further questions on 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 everyone will experience them.

Normally, side effects are observed at the beginning of treatment and generally decrease in intensity or disappear with the continuation of treatment or by reducing the dose.
Contact your doctor immediatelyif you experience any of the following side effects because the intake of Control must be stopped:

• opposite effects to those expected (paradoxical effects) (see section 2 “Paradoxical reactions”) such as:
• depression or unmasking of existing depression
• restlessness
• agitation
• irritability
• aggression
• feeling of disappointment
• anger
• nightmares
• hallucinations
• difficulty in correctly interpreting reality and thought disorders
• behavioral changes
• drowsiness, even during the day
• dizziness
• loss of coordination
• sleep disorders, insomnia
• confusion
• changes in sexual desire
• anxiety
• feelings of hostility
• a general state of excitement
• sexual excitement
• decreased ability to reach the climax of sexual excitement (orgasm)
• fatigue
• impotence

Contact your doctor immediatelyif you experience any of the following side effects because they can be serious:

• severe allergic reaction (anaphylactic shock)
• swelling of the face, tongue and throat resulting in an inability to swallow and breathe
• difficulty remembering what happened after taking the medicine (anterograde amnesia). This may also be accompanied by behavioral changes (see section 2 “Memory disorders”)
• physical dependence on the medicine (see section 2 “Development of dependence”)
• psychological dependence on the medicine (see section 2 “Development of dependence”)
• withdrawal symptoms (see section 2 “Development of dependence”)
• rebound symptoms (see section 2 “Development of dependence”)
• coma
• thoughts of suicide, suicide attempts
• excessive use of Control (abuse) or other similar medicines (benzodiazepines)
• severe decrease in the number of white blood cells in the blood, which may increase susceptibility to infections.

If the dose is not correct, an excessive state of “calm” (sedation) and excessive muscle relaxation can be obtained, which manifest with the following side effects:

• drowsiness, loss of emotions, reduced state of alertness, confusion, fatigue, headache, dizziness, muscle weakness, inability to make coordinated movements (ataxia), double vision (diplopia). These are effects that appear more frequently at the beginning of treatment and tend to disappear as therapy progresses.

Side effects may be:

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

• daytime drowsiness and excessive calm (sedation), fatigue.

Common (may affect up to 1 in 10 people)

• tremors, dizziness, confusion
• muscle weakness, loss of energy (asthenia)
• loss of coordination
• depression and unmasking of a pre-existing depressive state

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

• nausea
• change in libido including alterations

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

• loss of emotions, disinhibition, euphoria, sleep disorders, decreased orgasm;
• headache, reduced alertness, difficulty in articulating speech (dysarthria), transient recent memory loss (anterograde amnesia) or memory disorders;
• visual disturbances, double vision (diplopia), blurred vision;
• reduction in blood pressure (hypotension);
• breathing problems (respiratory depression, apnea, worsening of nocturnal apnea, worsening of obstructive pulmonary disease);
• constipation, alteration of salivation;
• increased bilirubin, yellowing of the skin and eyes (jaundice), increased levels of certain liver enzymes (transaminases and alkaline phosphatase);
• allergic skin reactions (allergic dermatitis), hair loss (alopecia);
• decreased sexual potency in men (impotence).

Very rare (may affect up to 1 in 10,000 people)

• alteration in the number of certain cells present in the blood (thrombocytopenia, leukopenia, agranulocytosis, pancytopenia);
• generalized allergic reactions (hypersensitivity including anaphylaxis and anaphylactoid reactions);
• hormonal disease called SIADH (syndrome of inappropriate secretion of antidiuretic hormone);
• decrease in the amount of sodium present in the blood (hyponatremia);
• extrapyramidal symptoms, coma;
• excessive decrease in body temperature (hypothermia).

Not known (frequency cannot be estimated based on available data)

• dependence, withdrawal syndrome, suicide attempts, behavioral changes;
• agitation, aggression, anger, nightmares, hallucinations, delusion, irritability, restlessness;
• disorientation;
• decreased ability to experience emotions;
• convulsions/seizures;
• changes in skin color, blood pressure, heart rate, salivation and other functions not controlled by will, such as manifestations that may accompany a seizure;
• decreased attention and/or reduced ability to concentrate;
• balance disorders;
• feeling of instability;
• problems with the stomach and intestines;
• inability to completely empty the bladder of urine (urinary retention);
• changes in appetite
• Angioedema, dermatological symptoms including very serious reactions.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist.
You can also report side effects directly through the website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can contribute to providing more information on the safety of this medicine.

5. How to store Control

Store at a temperature below 25°C.
Keep this medicine out of 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 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 Control contains
Control 1 mg tablets

• The active ingredient is lorazepam. Each tablet contains 1 mg of lorazepam.
• The other ingredients are microcrystalline cellulose, lactose monohydrate, corn starch, magnesium stearate, amberlite IRP 88.

Control 2.5 mg tablets

• The active ingredient is lorazepam. Each tablet contains 2.5 mg of lorazepam.
• The other ingredients are microcrystalline cellulose, lactose monohydrate, corn starch, magnesium stearate, amberlite IRP 88.

Description of the appearance of Control and contents of the pack
Control 1 mg tablets are presented in a pack containing two blisters in
PVC/Aluminum with 15 tablets each. Pack of 30 tablets.
Control 2.5 mg tablets are presented in a pack containing two blisters in
PVC/Aluminum with 10 tablets each. Pack of 20 tablets.

Marketing authorisation holder and manufacturer
Laboratorio Farmaceutico SIT S.r.l. – via Cavour, 70 – 27035 Mede (PV)