Valeans

Package leaflet: Information for the user

VALEANS 0.25 mg hard capsules, 0.50 mg hard capsules

alprazolam
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 others, even if their symptoms are the same as yours, as it may 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 Valeans is and what it is 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

1. What Valeans is and what it is used for

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

• anxiety
• panic attacks, with or without fear/discomfort of being in open spaces or crowded places (agoraphobia).

2. What you should know before taking Valeans

Do not take Valeans

• if you are allergic to alprazolam, benzodiazepines, or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from myasthenia gravis, a disease causing severe muscle weakness;
• if you have severe breathing problems (respiratory failure);
• if you have severe liver problems (hepatic insufficiency);
• if you suffer from sleep apnea, meaning your breathing is irregular during sleep;
• if you have an eye disease called acute closed-angle glaucoma, a condition caused by increased pressure inside the eyes. However, the medicine may be used if you have a form of the disease called open-angle glaucoma and are receiving appropriate treatment;
• during the first 3 months of pregnancy and if you are breastfeeding (see section “Pregnancy and breastfeeding”);
• children and adolescents

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

• you are elderly and/or debilitated. Your doctor will prescribe a reduced dose of this medicine;
• you have chronic breathing problems (chronic respiratory failure), as this medicine may worsen your condition;
• you have kidney problems (renal insufficiency) or liver problems of mild to moderate severity (mild to moderate hepatic insufficiency);
• you suffer from severe depression. Valeans, like other benzodiazepines, should not be used alone to treat depression or anxiety associated with depression, as it may increase suicidal tendencies and cause mood changes;
• you suffer from psychosis, a serious mental illness affecting behavior and causing difficulties in social interactions. Valeans is not recommended as the primary treatment for this condition;
• you are being treated with other medicines acting on the brain and mind, because Valeans may enhance the effects of these medicines (see section “Other medicines and Valeans”);
• you have or have previously had problems with abuse and dependence on alcohol, drugs, or other medicines acting on the central nervous system, as you have a higher risk of developing dependence on Valeans (see section “Development of dependence”).

Memory disturbances
A few hours after taking Valeans, you may experience difficulty remembering events that occurred after taking the medicine.

Paradoxical reactions
Valeans may cause effects opposite to those expected (paradoxical effects) (see section 4 “Possible side effects”). These effects are more common in children and elderly people.
If you experience these effects, consult your doctor, as treatment with Valeans should be discontinued.

Development of tolerance
If after a few weeks the medicine seems less effective than at the beginning of treatment, consult your doctor.

Development of dependence
Valeans may cause dependence (i.e., you may feel an increasing desire to take the medicine or develop physical symptoms that decrease or disappear only after taking the medicine). The likelihood of developing dependence increases with higher doses, longer treatment duration, or combined use of different benzodiazepines. The risk is higher if you have previously abused drugs or alcohol. Once physical dependence has developed, abruptly stopping treatment may lead to withdrawal symptoms (see section “If you stop taking Valeans”).

Children and adolescents
The use of Valeans is not recommended in children and adolescents under 18 years of age.

Elderly patients
Benzodiazepines and similar products must be used with extreme caution in elderly patients due to the risk of sedation and/or musculoskeletal weakness, which may lead to falls, often with serious consequences in this population.

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

Medicines acting on the brain and mind, such as:

• antipsychotics, medicines used to treat certain mental illnesses;
• hypnotics, sleep-inducing medicines;
• sedatives, tranquillisers;
• anxiolytics, medicines used to treat anxiety;
• antidepressants (e.g. nefazodone, fluvoxamine, fluoxetine, imipramine, and desipramine), medicines used to treat depression;
• narcotic analgesics, opioids (including propoxyphene): medicines used to treat severe pain; when taken together with Valeans, they may cause euphoria and increase the risk of developing dependence on Valeans;
• antiepileptics, medicines used to treat epileptic seizures;
• anaesthetics;
• sedating antihistamines, medicines used to treat allergic symptoms;
• analgesics and cough suppressants containing opium or its derivatives. Concomitant use of Valeans with opioids increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no alternative treatment options are available. However, if your doctor prescribes Valeans together with opioids, the dose and duration of concomitant treatment must be strictly limited. Inform your doctor if you are taking opioids and carefully follow the recommended dosage. It may be helpful to inform friends and family to watch for signs and symptoms such as those listed above. If such symptoms occur, contact your doctor immediately.

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 strength of heart contractions). If you are elderly, taking Valeans may increase the likelihood of developing digoxin-related toxic effects.

The following medicines may increase the effects of Valeans:

• ketoconazole, itraconazole, posaconazole, and voriconazole, medicines used to treat fungal infections;
• erythromycin, clarithromycin, telithromycin, and troleandomycin (antibiotics);
• protease inhibitors (e.g. ritonavir), medicines used to treat HIV infection. If you are being treated with protease inhibitors, your doctor may advise discontinuing Valeans due to potential interactions with these medicines.

Valeans and alcohol
Do not drink alcohol while taking Valeans, as alcohol enhances the effects of this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
This medicine must not be taken during the first 3 months of pregnancy, as it may cause congenital malformations 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 during the last months of pregnancy or during labour, the newborn may show the following symptoms:

• poor muscle tone (axial hypotonia);
• breathing difficulties (respiratory depression or apnea) and difficulty feeding;
• low body temperature (hypothermia);
• withdrawal symptoms (see section 3 “If you stop taking Valeans”). These effects are reversible and may last from several days up to 1–3 weeks after birth.

Breastfeeding
Do not breastfeed while taking Valeans, as this medicine passes into breast milk.

Driving and using machines
Do not drive or operate machinery if, during treatment with Valeans, you experience loss of concentration, memory, or muscle control, or if you feel drowsy 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 contain E110 sunset yellow S
The 0.50 mg hard capsules of Valeans contain the colouring agent sunset yellow S, which may cause allergic reactions.

Valeans contains sodium
Valeans capsules contain less than 1 mmol (23 mg) of sodium per dose of:
0.25 mg per capsule; - 0.50 mg per capsule, i.e. essentially “sodium-free”

3. How to take Valeans

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.

• Treatment of anxiety
  The recommended starting dose is 0.25 mg to 0.5 mg three times a day. The dose may be gradually increased up to a maximum of 4 mg per day, divided into several doses. You should first increase the evening dose, followed by the daytime doses.

If you are elderly, have liver or kidney problems and/or are debilitated
The recommended starting dose is 0.25 mg two to three times a day.

• Treatment of panic attacks and agoraphobia
  The recommended starting dose is 0.5 mg to 1 mg taken for 1–2 days just before going to bed. Afterwards, the dose may be gradually increased by 1 mg every 3 or 4 days. You should first increase the midday dose, then the morning dose, and finally the afternoon or evening dose, until taking Valeans 3 or 4 times a day.

The duration of treatment with Valeans should be as short as possible. The recommended treatment duration should not exceed 8–12 weeks for the treatment of anxiety and 8 months for the treatment of panic attacks. This period includes the time needed to gradually reduce the dose of Valeans before stopping. Your doctor will decide whether treatment may continue beyond the recommended maximum period.

Instructions for use
Valeans 0.25 mg – 0.5 mg hard capsules
To administer a half dose, open the hard capsule by gently twisting one end and take one of the two tablets contained inside.
Store the other tablet in the re-closed capsule and swallow it, including the capsule shell, the next time.

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 department.

• In mild cases, symptoms may include: mental confusion, drowsiness, difficulty speaking.
• In more severe cases, symptoms may include: loss of ability to coordinate movements, reduced muscle tone, low blood pressure, breathing difficulties, 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 for your next dose. Do not take a double dose to make up for the missed dose.

If you stop taking Valeans
Do not stop taking Valeans suddenly. Always consult your doctor before stopping Valeans. You must gradually reduce the dose to avoid experiencing:

• Withdrawal symptoms such as:
  • severe symptoms: feeling detached from yourself or from the outside world, numbness and tingling in arms or legs, increased sensitivity to light, sounds and physical touch, hallucinations, epileptic seizures, muscle and abdominal cramps, vomiting, sweating, tremors, convulsions;
  • other symptoms: headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, mild depression, insomnia;
• Rebound symptoms, for example panic attacks and anxiety. These symptoms are the same ones for which you were prescribed Valeans and may temporarily reappear more intensely after abrupt discontinuation of treatment.

If you have any questions 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.
Seek immediate medical advice if you experience any of the following side effects, as they may be
serious:

• swelling of the face, tongue and throat, leading to difficulty in swallowing and breathing ( angioedema )
• inability to remember events following the intake of the medicine (see section 2 “Memory disturbances”)
• unmasking of pre-existing depression
• dependence (see section 2 “Development of dependence”)
• withdrawal symptoms and 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 ability to coordinate 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 movement coordination
• vertigo
• nausea
• constipation
• memory disturbances
• difficulty in speaking
• difficulty in 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
• altered liver function
• yellowish/yellow discoloration of the skin and mucous membranes (jaundice)
• decrease or increase in body weight
• increased intraocular pressure
• hallucinations
• anger
• aggression
• hostile behaviour
• anxiety
• restlessness
• changes in sexual desire
• insomnia
• unusual thoughts
• nervousness
• impulsiveness and motor hyperactivity
• intellectual disturbances
• mood changes
• amnesia
• involuntary muscle contractions causing unnatural postures (dystonia)
• tremor
• sexual dysfunction
• dermatitis

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

• double vision
• excitement

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

• disturbances of the autonomic nervous system responsible for bodily functions that cannot be voluntarily controlled (e.g. internal organs and glands)
• inflammatory liver diseases (hepatitis)
• swelling of the hands and feet due to fluid retention (peripheral edema)
• reduced emotional responsiveness and alertness
• anorexia
• inability to recall recent events (anterograde amnesia)
• dry mouth
• mania, hypomania
• drug abuse
• persistent drowsiness, even during the day
• lethargy
• photosensitivity reactions

Seek immediate medical advice if you experience any of the following side effects, as treatment with
Valeans must be discontinued :
effects opposite to those expected from therapy ( paradoxical effects ) (see section 2 “Paradoxical
disturbances”), such as:

• restlessness
• agitation
• irritability
• aggression
• feelings of disappointment
• anger
• nightmares
• hallucinations
• disturbances in thought
• behavioural changes

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 stated on the carton and blister pack after "Expires".
The expiry date refers to the last day of that month.
Store below 25°C.
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 Valeans contains
The active substance is alprazolam.
Capsules
One hard capsule of Valeans 0.25 mg contains 0.25 mg of alprazolam (in two tablets of 0.125 mg alprazolam each).
The other components are: silica, talc, calcium dibasic phosphate dihydrate, sodium starch glycolate type A, microcrystalline cellulose, magnesium stearate, erythrosine (E 127), indigo carmine (E 132), hydrated aluminium oxide, gelatin.
One hard capsule of Valeans 0.50 mg contains 0.50 mg of alprazolam (in two tablets of 0.25 mg alprazolam each).
The other components are: silica, talc, calcium dibasic phosphate dihydrate, sodium starch glycolate type A, microcrystalline cellulose, magnesium stearate, E 110 orange yellow S, hydrated aluminium oxide, gelatin.

Description of the appearance of Valeans and contents of the pack
The Valeans 0.25 mg hard capsules are transparent hard capsules containing 2 round purple tablets. The hard capsules are available in opaque blisters, pack size: 24 hard capsules.
The Valeans 0.50 mg hard capsules are transparent hard capsules containing 2 round orange tablets. The hard capsules are available in opaque blisters, pack size: 24 hard capsules.

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

Manufacturer
ICE S.p.A.
Canton Moretti 29
10015 San Bernardo d’Ivrea (TO), Italy