Triazolam Mylan Generics

Patient Information Leaflet

Triazolam Mylan Generics 0.125 mg tablets, 0.25 mg tablets

Equivalent medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Triazolam Mylan Generics is and what it is used for

This medicine contains the active substance triazolam, which belongs to a group of medicines called benzodiazepines, used to treat sleep disorders (insomnia) only when they are severe, disabling, or cause severe distress.
Triazolam Mylan Generics is indicated for the short-term treatment of insomnia for short periods, when the disorder is severe and causes distress in normal daily life.

2. What you need to know before taking Triazolam Mylan Generics

Do not take Triazolam Mylan Generics if:

• you are allergic to triazolam, to medicines of similar type (benzodiazepines), or to any of the other ingredients of this medicine listed in section 6;
• you suffer from myasthenia gravis, a disease causing muscle weakness and fatigue;
• you have severe respiratory problems or suffer from sleep apnoea;
• you have severe liver problems;
• the person to take the medicine is a child;
• you are taking ketoconazole or itraconazole (antifungal medicines used for fungal infections), nefazodone (an antidepressant), efavirenz (used in the treatment of AIDS), or other medicines used against HIV infection (see also section “Other medicines and Triazolam Mylan Generics”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Triazolam Mylan Generics.
Take this medicine with caution if:

• you have mild or moderate liver problems;
• you have respiratory problems, as this medicine may worsen your condition;
• you have or have previously had problems with alcohol or drug abuse or dependence, because you may have a higher risk of developing dependence on Triazolam Mylan Generics (see “Development of dependence”);
• you are taking other medicines that cause drowsiness or act on the brain and mind (see section “Other medicines and Triazolam Mylan Generics”);
• you suffer from depression. Triazolam Mylan Generics, like other benzodiazepines, should not be used alone to treat depression or anxiety associated with depression, as it may worsen suicidal tendencies;
• you suffer from psychosis, a mental illness altering behaviour and causing difficulties in social interaction. Triazolam Mylan Generics is not recommended as the main treatment for this condition;
• you are elderly or debilitated. In this case, your doctor should initially prescribe a lower dose.

Because triazolam may cause sedation (drowsiness, dizziness, loss of coordination and/or difficulty in coordinating movements), patients, especially the elderly, are at increased risk of falls.

Memory disturbances
You may experience difficulty remembering events that occurred after taking Triazolam Mylan Generics, especially if you have not slept long enough (approximately 7–8 hours).

Paradoxical reactions
Triazolam Mylan Generics may cause effects opposite to those expected (paradoxical reactions) (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 Triazolam Mylan Generics should be discontinued.

Tolerance
If after a few weeks you feel the medicine is not working as well as at the beginning of treatment, talk to your doctor.

Dependence
This medicine may cause dependence (i.e. you may feel an increasing desire to take the medicine, or you may develop physical symptoms that decrease or disappear only after taking the medicine). The likelihood of developing dependence increases with higher doses and longer duration of treatment.

Children and adolescents
The safety and efficacy of Triazolam Mylan Generics in children and adolescents under 18 years of age have not been established. Your doctor will decide whether Triazolam Mylan Generics can be given to children and adolescents based on their individual condition.

Other medicines and Triazolam Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The concomitant use of the following medicines is contraindicated (see also section “Do not take Triazolam Mylan Generics”):

• ketoconazole, itraconazole (antifungal medicines used for fungal infections)
• nefazodone (antidepressant)
• efavirenz and other medicines used to treat HIV infection (e.g. ritonavir)

Be especially careful and inform your doctor if you are taking the following medicines:

• other antifungal medicines. Their concomitant use with Triazolam Mylan Generics is not recommended;
• cimetidine, a medicine used to reduce stomach acidity;
• erythromycin, clarithromycin, troleandomycin, isoniazid and rifampicin (antibiotics);
• diltiazem and verapamil (medicines for high blood pressure);
• oral contraceptives;
• imatinib, a medicine used to treat certain types of cancer;
• aprepitant, a medicine for nausea and vomiting;
• medicines acting on the brain and mind, such as:
  o antipsychotics, medicines for treating certain mental illnesses, or hypnotics, sedatives, tranquilizers and sleep-inducing agents, or anxiolytics, medicines for treating anxiety, or antidepressants (e.g. fluvoxamine, sertraline and paroxetine), medicines for treating depression, or narcotic analgesics, medicines for treating severe pain, which, when taken together with Triazolam Mylan Generics, may cause euphoria and increase the risk of dependence.
  o antiepileptics (e.g. carbamazepine), medicines for treating epileptic seizures, or anaesthetics, medicines inducing anaesthesia, i.e. reversible loss of sensation.
  o sedating antihistamines, medicines for treating allergic symptoms.

The concomitant use of Triazolam Mylan Generics and opioids (strong painkillers, medicines for opioid dependence treatment, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes Triazolam Mylan Generics together with opioids, the dose and duration of concomitant treatment must be strictly limited by your doctor.
Inform your doctor about all opioid medicines you are taking and follow your doctor’s dosage recommendations carefully. It may be helpful to inform family members or friends to watch for the signs and symptoms listed above.
Contact your doctor if you experience such symptoms.

Triazolam Mylan Generics with beverages and alcohol
It is not recommended to drink alcohol or grapefruit juice while taking Triazolam Mylan Generics, as the effects of this medicine may be increased.
Avoid drinking grapefruit juice during treatment with this medicine, as grapefruit juice may increase the effects of triazolam and its blood levels.

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

Pregnancy
Using Triazolam Mylan Generics during pregnancy may cause harm to the unborn baby.
If you take this medicine during the last 3 months of pregnancy or during labour, the newborn baby may show low muscle tone (floppy infant syndrome) and withdrawal symptoms (see section 3 “If you stop taking Triazolam Mylan Generics”).

Breastfeeding
Triazolam Mylan Generics must not be used by breastfeeding mothers, as this medicine may pass into breast milk.

Driving and using machines
Triazolam Mylan Generics may significantly impair your ability to drive or operate machinery.
Do not drive or operate machinery if you experience drowsiness or dizziness during treatment with Triazolam Mylan Generics. Triazolam Mylan Generics may also cause a condition called “sleep-driving”, meaning you may not be fully alert while driving and may not remember having driven. These effects may be increased if you have not slept enough or if you have consumed alcoholic beverages.

Triazolam Mylan Generics contains lactose and sodium benzoate
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains 0.13 mg of benzoic acid per tablet. Benzoic acid may increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age (see section “Pregnancy and breastfeeding”).
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How to take Triazolam Mylan Generics

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is 1 tablet (0.125 mg or 0.250 mg) to be taken once daily just before
going to bed.
Your doctor will advise you on the lowest possible dose.
It is recommended not to exceed the maximum daily dose.
Take this medicine for the shortest time possible.
Triazolam Mylan Generics should be taken for short periods only. The maximum recommended duration of
treatment should not exceed 4 weeks. This period includes the time needed to gradually reduce the dose of
Triazolam Mylan Generics before stopping. Your doctor will decide, based on your condition, whether you can take this medicine for a longer period.
Swallow the Triazolam Mylan Generics tablets whole, without chewing, with a little water or other liquid
before going to bed.
Use in children and adolescents
The use of triazolam is not recommended in children and adolescents under 18 years of age.
Elderly patients and patients with liver and/or kidney problems
The recommended dose is one 0.125 mg tablet per day in elderly patients or in patients with liver and/or kidney problems.
If you take more Triazolam Mylan Generics than you should
If you have taken an excessive dose of Triazolam Mylan Generics or if you think a child may have taken
this medicine, contact your doctor immediately or go to the nearest hospital Emergency Department.
Symptoms of overdose may include drowsiness, difficulty speaking, problems with motor coordination, confusion, lethargy, muscle problems (ataxia, hypotonia), low blood pressure, breathing difficulties, rarely coma, and very rarely death. These symptoms may be worsened by concomitant administration of other medicines or alcohol.
If you forget to take Triazolam Mylan Generics
If you forget to take a dose, take it as soon as you remember, but only if you are able to rest immediately afterwards for a sufficient length of time. Do not take a double dose to make up for the missed tablet.
If you stop taking Triazolam Mylan Generics
Do not stop treatment with Triazolam Mylan Generics suddenly or without first discussing it with your doctor, as withdrawal symptoms may occur (see section “Warnings and precautions”).
If your doctor decides to discontinue treatment, they will gradually reduce your dose to minimize:

• withdrawal symptoms such as: severe symptoms: feeling detached from yourself or the external world, numbness and tingling in the arms or legs, increased sensitivity to light, sounds and physical contact, hallucinations, epileptic seizures; or other symptoms: headache, muscle pain, anxiety, tension, restlessness, confusion, irritability;
• rebound insomnia. You may temporarily develop insomnia that is worse than the one you had before starting treatment with this medicine. If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
STOP taking this medicine immediately and contact your doctor if you experience
any of the following side effects, as they are serious:

• severe allergic reaction (anaphylactic shock, anaphylactoid reactions)
• swelling of the face, tongue and throat leading to difficulty swallowing and breathing ( angioedema )

Contact your doctor immediately if you experience any of the following side effects, as treatment with Triazolam Mylan Generics must be discontinued:

• effects opposite to those expected ( paradoxical effects ) (see section 2 “Paradoxical reactions”) such as:
• aggression
• hallucinations
• restlessness
• agitation
• irritability
• delusion
• anger
• nightmares
• disturbances in thinking
• behavioural disturbances

Contact your doctor immediately if you experience any of the following side effects, as they may be serious:

• depression or worsening of pre-existing depression
• dependence (see section 2 “Development of dependence”)
• withdrawal symptoms and rebound symptoms (see section 3 “If you stop taking Triazolam Mylan Generics”)
• “ sleepiness while driving ”, a sleep-related behavioural disorder (see section 2 “Driving and use of machines”)
• difficulty remembering events that occurred after taking the medicine (see section 2 “Memory disturbances”)
• reduced breathing

Contact your doctor if you experience any of the following side effects:
Common side effects (may affect up to 1 in 10 people):

• drowsiness
• dizziness
• headache
• loss of ability to coordinate movements

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

• confusion
• insomnia
• memory loss
• visual disturbances

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

• skin rash
• severe muscle weakness

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

• allergic reactions, swelling due to allergy, hypersensitivity
• sleepwalking
• fainting
• sedation, reduced level of consciousness
• difficulty speaking
• loss of attention
• altered sense of taste
• changes in sexual desire
• falling down

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Triazolam Mylan Generics

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 special storage conditions.
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 Triazolam Mylan Generics contains

• The active substance is triazolam.
• The other components are: maize starch, lactose, microcrystalline cellulose, colloidal silicon dioxide, sodium docusate, sodium benzoate, magnesium stearate, sodium croscarmellose. Tablets of 0.25 mg contain indigo carmine (E132). Tablets of 0.125 mg contain erythrosine (E127).

Description of the appearance of Triazolam Mylan Generics and package contents
Box containing 20 tablets.
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturer
Doppel Farmaceutici S.r.l., Via Volturno 48, Quinto de’ Stampi, Rozzano (MI)
ABC Farmaceutici S.p.A., Canton Moretti 29, 10090 Località S. Bernardo, Ivrea (TO)