VALEANS 0.50 MG Hard capsule

Содержание инструкции

1. VALEANS 0.25 mg hard capsules, 0.50 mg hard capsules, 1 mg hard capsules, 0.75 mg/ml oral drops, solution
   1. What is Valeans and what is it used for
   2. What you need to know before taking Valeans
   3. How to take Valeans
   4. Possible side effects
   5. How to store Valeans
   6. Contents of the pack and other information

VALEANS 0.25 mg hard capsules, 0.50 mg hard capsules, 1 mg hard capsules, 0.75 mg/ml oral drops, solution

alprazolam

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

1. What is Valeans and what is it used for

Valeans contains the active substance alprazolam. Alprazolam belongs to a group of medicines called
benzodiazepines and works by reducing anxiety, facilitating sleep, decreasing agitation and emotional imbalance (sedative effect).
Valeans is used for the treatment of the following conditions when they are severe and cause discomfort in
normal daily life:

• anxiety
• panic attackswith or without fear/discomfort of frequenting large open spaces (agoraphobia).

2. What you need to know before taking Valeans

Do not take Valeans

• if you are allergicto alprazolam, to benzodiazepines or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from myasthenia gravis, a disease that causes severe muscle weakness;
• if you have severebreathing problems (respiratory failure);
• if you have severeliver problems (hepatic failure);
• if you suffer from sleep apnea, i.e. your breathing is irregular during sleep;
• if you suffer from an eye disease called glaucomaacute angle closure, a problem caused by increased pressure inside the eyes. However, the medicine can be used if you have a form of the disease called open-angle glaucoma and are using appropriate therapy;
• during the first 3 months of pregnancyand if you are breastfeeding(see section “Pregnancy and breastfeeding”).
• children and adolescents

Warnings and precautions
Talk to your doctor or pharmacist beforetaking Valeans if:

• you are elderlyand/or debilitated. Your doctor will prescribe a reduced dose of this medicine;
• you have chronicbreathing problems(chronic respiratory failure), because this medicine may worsen your condition;
• you have problemswith yourkidneys(renal failure) or liver problemsof mild or moderate severity (mild to moderate hepatic failure);
• you suffer from severe depression. Valeans, like other benzodiazepines, should not be used alone to treat depression or anxiety associated with depression because it may worsen the tendency to suicide and cause mood changes;
• you suffer from psychosis, a serious mental illness that alters behavior and causes difficulty relating to other people. Valeans is not recommended as the primary treatment for this condition;
• you are being treated with other medicinesthat act on the brain and mind, because Valeans may increase the effects of these medicines (see section “Other medicines and Valeans”);
• you have or have had in the past problems of abuse and dependenceon alcohol, drugs or other medicines that act on the central nervous system, because there is a greater risk of developing dependence on Valeans (see section “Development of dependence”).

Memory disorders
A few hours after taking Valeans you may have difficulty remembering what happened after
taking the medicine.
Paradoxical disorders
Valeans can cause effects opposite to those expected (paradoxical effects) (see section 4 “Possible
side effects”). These effects are more common in children and the elderly.
If you experience these effects, contact your doctor because treatment with Valeans must be discontinued.
Development of tolerance
If after a few weeks you feel that the medicine is not working as well as it did at the beginning of treatment
contact your doctor.
Development of dependence
Valeans causes dependence(i.e. you may develop an increasing desire to take the medicine or you may
develop physical disorders that decrease or disappear only after taking the medicine). The
probability of developing dependence increases with increasing dose and duration of treatment or
with the combined use of different benzodiazepines. It is greater if you have previously abused drugs or alcohol. Once
physical dependence has developed, abrupt discontinuation of treatment will be accompanied by
withdrawalsymptoms (see section “If you stop taking Valeans”).
Children and adolescents
The use of Valeans is not recommended in children and adolescents under the age of 18.

Elderly patients
Benzodiazepines and similar products should be used with extreme caution in the elderly due to the
risk of sedation and/or musculoskeletal weakness that can cause falls, often with serious
consequences in this population

Other medicines and Valeans
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Caution is needed when Valeans is taken together with the following medicines:

medicinesthat act on the brainand the mindsuch as:

• antipsychotics, medicines for the treatment of some mental illnesses;
• hypnotics, sleep aids;
• sedatives, tranquilizers;
• anxiolytics, medicines for the treatment of anxiety;
• antidepressants, (e.g. nefazodone, fluvoxamine, fluoxetine, imipramine and desipramine) medicines for the treatment of depression;
• narcotic analgesics, opioids (including propoxyphene): medicines for the treatment of severe pain; when administered together with Valeans, they can cause euphoria with an increased probability of developing dependence on Valeans;
• antiepileptics, medicines for the treatment of seizures;
• anesthetics;
• sedating antihistamines, medicines used to treat allergic reactions;
• analgesicsand cough suppressants,based on opium and its derivatives. The concomitant use of Valeans with opioids increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered when alternative therapeutic options are not possible. However, if your doctor prescribes Valeans in combination with opioids, the dose and duration of concomitant treatment must be limited by your doctor. Tell your doctor if you are taking opioids and carefully follow the dose that has been recommended to you. It may be helpful to inform friends and family to observe the possible appearance of signs and symptoms as described above. If these symptoms appear, contact your doctor.

Other medicines

• cimetidine, a medicine used to reduce stomach acidity oral contraceptives
• diltiazem,a medicine used to lower blood pressure
• digoxin(a medicine used to increase the force of heart contraction). If you are elderly, taking Valeans may increase the likelihood of developing the toxic effects of digoxin.

The following medicines can increase the effects of Valeans:

• ketoconazole, itraconazole, posaconazoleand voriconazole, medicines for the treatment of fungal infections;
• erythromycin, clarithromycinand telithromycin and troleandomycin(antibiotics);
• protease inhibitors, (e.g. ritonavir) medicines for the treatment of HIV infection. If you are being treated with protease inhibitors, your doctor may advise you to discontinue treatment with Valeans due to interaction with these medicines.

Valeans with alcohol
Donot drink alcohol while taking Valeans because alcohol increases the effects of this medicine.

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

This medicine should not be taken during the first 3 months of pregnancybecause it can cause birth defects
in the fetus. Your doctor will assess whether you can take this medicine during the second and third
trimesters of pregnancy.
If you take this medicine in the last months of pregnancyor during labor, the newborn may
manifest the following symptoms:

• poor muscle tone (axial hypotonia);
• difficulty breathing (respiratory depression or apnea) and taking milk;
• low body temperature (hypothermia);
• withdrawal symptoms (see section 3 “If you stop taking Valeans”). These effects are reversible and may last from a few days to 1-3 weeks after the baby is born.

Breastfeeding

Donot breastfeed while taking Valeans because this medicine passes into breast milk.

Driving and operating machinery
Donot drive or operate machinery if you experience loss of concentration,
memory or muscle control while being treated with Valeans, or if you feel sleepy or dizzy. These effects may be
increased if you have not slept enough or if you have consumed alcoholic beverages.

Valeans 0.50 mg hard capsules contains E110 yellow orange S
The hard capsules of Valeans 0.50 mg contain the yellow orange S dye which may cause allergic
reactions.

Valeans contains sodium
Valeans capsules and Valeans drops contain less than 1 mmol (23 mg) of sodium per dose from:
0.25 mg per capsule; - 0.50 mg per capsule - 1 mg per capsule – 40 drops (equivalent to 1 mg – maximum
dose for adult), i.e. essentially “sodium-free”

Valeans 0.75 mg/ml oral drops, solution contains ethanol and propylene glycol
This medicine contains 0.24 g of ethanol per maximum dose for adult (equivalent to 40 drops equivalent to 1
mg), equivalent to 6 ml of beer and 3 ml of wine.
It may be harmful to alcoholics. The small amount of alcohol present in this medicine will not produce
significant effects.
To be taken into consideration in pregnant or breastfeeding women, in children and in high-risk groups such as people suffering from liver or epilepsy diseases.
This medicine contains 933 mg of propylene glycol per dose equal to 40 drops (equivalent to 1 mg – maximum
dose for adult) equivalent to 13.2 mg/kg in adults (70 Kg)

3. How to take Valeans

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

• Treatment of anxietyThe recommended initial dose is from 0.25 mg to 0.5 mg 3 times a day. If you prefer the dropsformulation, the recommended initial dose is from 10 to 20 drops 3 times a day (one notch on the graduated dropper scale corresponds to one drop of Valeans oral drops, solution and to 0.025 mg of Alprazolam). The dose may be gradually increased, up to a maximum of 4 mg per day, to be divided into several doses. You should first increase the dose to be taken in the evening and then the dose to be taken during the day.

If you are elderly, have liver or kidney problems and/or are debilitated
The recommended initial dose is 0.25 mg (corresponding to 10 drops) 2-3 times a day.

• Treatment of panic attacks and agoraphobiaThe recommended initial dose is from 0.5 mg to 1 mg to be taken just beforegoing to bed for 1-2 days. Subsequently, the dose may be gradually increased by 1 mg every 3 or 4 days. You should first increase the dose you take at noon, then the morning dose and finally the dose to be taken in the afternoon or evening, until you take Valeans 3 or 4 times a day. You can also use the drops formulation: 20 drops (20 notches) correspond to 0.50 mg - 40 drops (40 notches) correspond to 1 mg.

The duration of treatment with Valeans should be as short as possible.The recommended duration of therapy
should not exceed 8-12 weeks for the treatment of anxiety and 8 months for the treatment of panic
attacks. This period also includes the time needed to gradually reduce the dose of Valeans until
discontinuation. The doctor will decide whether the treatment can be continued beyond the maximum
recommended period.
Instructions for use Valeans 0.25 mg – 0.5 mg – 1 mg hard capsules
To administer half a dose, open the hard capsule by slightly rotating one end and take
one of the two tablets contained therein.
Store the other tablet in the closed capsule and swallow it, including the shell, next time.

Valeans oral solution drops

Using the dropper bottle

• a. Hold the bottle vertically, slowly draw the solution by raising the graduated dropper scale to the notch corresponding to the desired number of drops
• b. Unscrew the bottle cap by pressing simultaneously on the non-serrated opposite sides
• c. Empty the dropper, possibly into a glass containing water, by slowly pushing the head of the scale to the end of its stroke.
• d. Screw the cap back onto the bottle

If you take more Valeans than you should
If you have taken an excessive dose of Valeans, contact your doctor immediately or go to the nearest
emergency room.

• In mild cases, the symptoms may be: mental confusion, drowsiness, difficulty speaking.
• In more severe cases, the symptoms may be: loss of coordination, poor muscle tone, low blood pressure, breathing problems, coma, death.

If you forget to take Valeans
If you forget to take a dose, take it as soon as you remember unless it is almost time to take
the next dose. Do not take a double dose to make up for the missed dose.

If you stop taking Valeans
Donot stop taking Valeans suddenly. Always consult your doctor before stopping
taking Valeans. You must reduce the doses gradually to avoid experiencing:

• withdrawal symptomssuch as:
• severe symptoms: feeling detached from oneself or from the outside world, numbness and tingling in the legs or arms, increased sensitivity to light, sounds and physical contact, hallucinations, seizures, muscle and abdominal cramps, vomiting, sweating, tremors, convulsions;
• other symptoms: headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, mild depression, insomnia;
• rebound symptoms, e.g. panic attacks and anxiety. These symptoms are the same for which you were advised to take Valeans and may reappear temporarily in a more intense way after abrupt discontinuation of treatment.

If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediatelyif you experience any of the following side effects as they may be

serious:

• swelling of the face, tongue and throat with resulting inability to swallow and breathe (angioedema)
• difficulty remembering what happened after taking the medicine (see section 2 “Memory problems”)
• unmasking of pre-existing depression
• dependence(see section 2 “Development of dependence”)
• withdrawal symptomsand rebound symptoms(see section 3 “If you stop taking Valeans”)

Contact your doctor if you experience any of the following side effects:

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

• sedation
• drowsiness
• loss of coordination of movements (dysarthria)
• dizziness
• headache

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

• muscle weakness (asthenia)
• blurred vision
• irritability
• decreased appetite
• confusion
• depression
• problems with coordination of movements
• vertigo
• nausea
• constipation
• memory problems
• difficulty speaking
• difficulty concentrating

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

• vomiting
• muscle weakness
• incontinence
• inability to completely empty the bladder
• irregular menstrual cycle
• increased levels of prolactin (a natural hormone) in the blood
• impaired liver function
• yellowing/yellowish discoloration of the skin and mucous membranes (jaundice)
• decrease or increase in body weight
• increased pressure inside the eye
• hallucinations
• rage
• aggression
• hostile behavior
• anxiety
• agitation
• changes in sexual desire
• insomnia
• abnormal thoughts
• nervousness
• impulsivity and motor hyperactivity
• changes in intellectual ability
• mood variations
• amnesia
• involuntary muscle contractions that force you to assume unnatural positions (dystonia)
• tremor
• sexual dysfunction
• dermatitis

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

• double vision
• excitement

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

• alterations of the nervous system responsible for functions of the body that cannot be voluntarily controlled (e.g. functions of internal organs and glands)
• inflammatory diseases of the liver (hepatitis)
• swelling of the hands and feet due to fluid accumulation (peripheral edema)
• reduction of emotional responses and vigilance
• anorexia
• inability to remember recent life events (anterograde amnesia)
• dry mouth
• mania, hypomania
• drug abuse
• continuous daytime drowsiness
• lethargy
• photosensitivity reactions

Contact your doctor immediatelyif you experience any of the following side effects because the intake of
Valeans must be stopped:
effects opposite to those expected from therapy (paradoxical effects) (see section 2 “Paradoxical
problems”) such as:

• restlessness
• agitation
• irritability
• aggression
• feeling of frustration
• rage
• nightmares
• hallucinations
• thought disorders
• changes in behavior

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national
reporting system at http://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 Valeans

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package, blister and bottle after
“Expires on”. The expiry date refers to the last day of that month.
Store at a temperature below 25°C.
Drops
Validity after first opening: 45 days. You can write the date of first opening in the appropriate space
on the package.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Valeans contains
The active ingredient is alprazolam.
Capsules
Each 0.25 mg Valeans hard capsule contains 0.25 mg of alprazolam (in two 0.125 mg alprazolam tablets each).
The other ingredients are: silica, talc, dibasic calcium phosphate dihydrate, sodium starch glycolate type A,
microcrystalline cellulose, magnesium stearate, erythrosine (E 127), indigotine (E 132), hydrated aluminum oxide,
gelatin.
Each 0.50 mg Valeans hard capsule contains 0.50 mg of alprazolam (in two 0.25 mg alprazolam tablets each).
The other ingredients are: silica, talc, dibasic calcium phosphate dihydrate, sodium starch glycolate type A,
microcrystalline cellulose, magnesium stearate, E 110 yellow orange S, hydrated aluminum oxide, gelatin.
Each 1 mg Valeans hard capsule contains 1 mg of alprazolam (in two 0.5 mg alprazolam tablets each).
The other ingredients are: silica, talc, dibasic calcium phosphate dihydrate, sodium starch glycolate type A,
microcrystalline cellulose, magnesium stearate, gelatin.
Drops
1 ml of Valeans oral drops, solution contains 0.75 mg of alprazolam (10 drops contain 0.25 mg of
alprazolam).
The other ingredients are: sodium saccharin, peppermint essence, propylene glycol, ethanol (96%), purified
water.

Description of the appearance of Valeans and contents of the packs
Valeans 0.25 mg hard capsules are transparent hard capsules containing 2 round, violet tablets.
The hard capsules are available in opaque blisters in packs of 24 hard capsules.
Valeans 0.50 mg hard capsules are transparent hard capsules containing 2 round, orange tablets.
The hard capsules are available in opaque blisters in packs of 24 hard capsules.
Valeans 1 mg hard capsules are transparent hard capsules containing 2 round, white tablets.
The hard capsules are available in opaque blisters in packs of 24 hard capsules.
Valeans oral drops solution is a clear solution. The oral drops are available in 30 ml polyethylene bottles
with a graduated dropper and child-resistant closure.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
NEOPHARMED GENTILI S.p.A – Via San Giuseppe Cottolengo 15 – 20143 Milano

Manufacturer
Valeas SPA - Industria Chimica e Farmaceutica
Via Vallisneri, 10
20133 Milano