Package Insert: Information for the Patient

Somnovit 1 mg Tablets

Loprazolam

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Loprazolam is a medication belonging to a group of medications known as benzodiazepines. Loprazolam is a sleep-inducing agent that respects the natural sleep phases.

Loprazolam is also a sedative medication, anxiolytic, capable of combating seizures, and with muscle-relaxing effects.

Doctors prescribe Somnovit for sleep rhythm disorders and all forms of insomnia, especially when there are difficulties falling asleep, either initially or after a premature awakening.

In most cases, only a short-term treatment with Somnovit is needed (in general, it should not exceed two weeks).

Treatment should begin with the lowest dose. The maximum dose should not be exceeded..

Read carefully the instructions provided in section 3 (see “How to take Somnovit”).

Do not take Somnovit

• if you are allergic to the active ingredient, to the benzodiazepine group in general, or to any of the other components of this medication (listed in section 6).
• if you have respiratory difficultiesrelated or not to sleepfor a long time or suffer from severe muscle or liver problems.
• if you suffer from drug or alcohol dependence, do not take Somnovit unless your doctor instructs you to do so. If you have any doubts, consult your doctor.
• if you have increased intraocular pressure (glaucoma).
• and remember that Somnovit should not be administered to children.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Somnovit.

Before starting treatment, make sure your doctor knows if you:

• have any liver or kidney disorders
• suffer from muscle weakness
• have other diseases
• have allergies

The use of benzodiazepines can lead to dependence. This occurs mainly after taking the medication continuously for a long time. To minimize the risk of dependence, follow these precautions:

• benezodiazepine use will be made only under medical prescription (never because they have worked in other patients) and never advise others.
• do not increase the prescribed doses at all, or prolong the treatment longer than recommended.
• consult your doctor regularly to decide if treatment should continue.

After stopping administration, restlessness, anxiety, insomnia, lack of concentration, headache, and hot flashes may appear. It is not recommended to stop treatment abruptly, but rather to gradually reduce the dose, according to the doctor's instructions.

After taking Somnovit, it is advisable to ensure that you can rest without being woken up for 7 hours.

Older people may be affected by Somnovit more than young patients. If you are an older person, your doctor may prescribe a lower dose and check your response to treatment. Please follow your doctor's instructions carefully.

If you have any liver or kidney disorders, or suffer from muscle weakness, your doctor will decide whether to take a lower dose of Somnovit or not to take it at all.

Other medications and Somnovit

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription. This is extremely important because the simultaneous use of multiple medications can increase or decrease their effect.

Therefore, do not take other medications at the same time as Somnovit unless your doctor is informed and approves it in advance. For example, tranquilizers, sleep inducers, and similar medications act on the brain and nerves and can enhance the effect of Somnovit.

Taking Somnovit with food, drinks, and alcohol

Avoid alcoholic beverages during treatment. The effect of alcohol can potentiate sedation, and this can affect the ability to drive or operate machinery. If you need additional information on this point, consult your doctor.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Benzodiazepines are excreted in breast milk, so you should consult your doctor about the convenience of taking Somnovit while breastfeeding your child.

Driving and operating machines

Somnovit is a sleep medication. Do not drive or operate machines if you feel drowsy or if you notice that your attention and reaction time are reduced. Pay special attention to the start of treatment or if the dose is increased.

Somnovit contains lactose

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will prescribe the appropriate dose depending on the nature of your illness, your age, and weight.

In elderly people or those with liver or kidney disorders, or muscle weakness, your doctor will prescribe a lower dose.

Take Somnovit just before going to bed and swallow the tablet without chewing it, with water or another non-alcoholic beverage.

Under normal conditions, you should fall asleep within 20 minutes of taking Somnovit, and it is advisable to ensure that you can rest without being woken up for at least 7 hours. Otherwise, although this occurs in rare cases, you may not remember what happened while you were awake.

To avoid withdrawal symptoms, do not stop taking Somnovit abruptly, especially if you have been taking it for a long time.

Remember to take your medication.

Each individual dose should not exceed the indicated limits, and the total daily dose should not be exceeded, unless your doctor prescribes a higher dose.

The usual dose is:

• in adults: 1 tablet (1 mg of loprazolam) per day. In cases of resistant insomnia, your doctor may increase the dose to 2 mg per day.

• in elderly people and patients with liver or kidney disease, or moderate respiratory insufficiency, the recommended dose is half a tablet (0.5 mg of loprazolam) per day.

Never change the dose prescribed by your doctor yourself. If you think the medication's effect is too strong or too weak, consult your doctor.

If you take more Somnovit than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Somnovit

Do not take a double dose to compensate for the missed doses, but rather continue with the normal dose.

If you interrupt treatment with Somnovit

Stopping its administration may cause restlessness, anxiety, insomnia, lack of concentration, headache, and hot flashes. It is generally not recommended to stop the medication abruptly, but rather to gradually reduce the dose according to the doctor's instructions.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Most patients tolerate Somnovit well, but some, especially at the beginning of treatment, may feel somewhat tired or drowsy during the day.

You may developanterograde amnesia, meaning you may not remember what happened while you were awake after taking the medication, so you should ensure you can rest for at least 7 hours without being disturbed.

Somnovit may rarely produce sudden anxiety, hallucinations, excitement, and sleep disorders. If this happens, consult your doctor immediately.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist..

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after CAD.

The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications.This will help protect the environment.

Composition of Somnovit 1 mg tablets

• The active ingredient is loprazolam. Each tablet contains 1,245 mg of loprazolam metansulfonate monohydrate corresponding to 1 mg of loprazolam.
• The other components are colloidal silicon dioxide, cornstarch, polyvidone, cellulose, magnesium stearate (E572), and lactose.

Appearance of the product and contents of the packaging

Somnovit are yellowish clear, round, biconvex, and scored tablets. They are presented in packaging containing 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Teofarma S.r.l.

Via Fratelli Cervi, 8

27010 Valle Salimbene (PV) – Italy

Date of the last review of this leaflet:May 2011

Detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)