SOMNOVIT 1 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Somnovit 1 mg Tablets

Loprazolam

Read this package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What Somnovit is and what it is used for.
2. What you need to know before you take Somnovit.
3. How to take Somnovit.
4. Possible side effects.
5. Storing Somnovit.
6. Contents of the pack and further information

1. What Somnovit is and what it is used for

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

Loprazolam is also a drug with sedative properties, reducing anxiety, with the ability to combat convulsions and with muscle relaxant effects.

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

In most cases, only short-term treatment with Somnovit is needed (generally not exceeding two weeks).

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

2. What you need to know before you take Somnovit

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

Do not take Somnovit

• if you are allergic to the active substance, to the group of benzodiazepines in general, or to any of the other components of this medicine (listed in section 6).
• if you have breathing difficulties related or not to sleepfor a long time or suffer from severe muscle or liver problems.
• if you suffer from drug or alcohol dependence, you should not take Somnovit unless your doctor has formally indicated it. 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

Talk to your doctor or pharmacist before you start taking Somnovit.

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

• have any liver or kidney disorder
• suffer from muscle weakness
• have other illnesses
• have allergies

The use of benzodiazepines can lead to dependence. This occurs mainly after uninterrupted use of the medicine for a long time. To minimize the risk of dependence, the following precautions should be taken:

• the use of benzodiazepines will only be done under medical prescription (never because they have worked for other patients) and will never be recommended to other people.
• do not increase the prescribed doses in any way, nor prolong the treatment for longer than recommended.
• consult your doctor regularly so that he can decide if treatment should be continued.

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

After taking Somnovit, it is advisable to make sure you can rest without being awakened for 7 hours.

Elderly people may be more affected by Somnovit than younger patients. If you are an elderly 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 disorder, or suffer from muscle weakness, your doctor will decide whether it is convenient for you to take a lower dose of Somnovit or not to take it at all.

Other medicines and Somnovit

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, even those bought without a prescription. This is extremely important because the simultaneous use of more than one medicine can increase or decrease its effect.

Therefore, you should not take other medicines at the same time as Somnovit unless your doctor is informed and approves it beforehand. For example, tranquilizers, sleep inducers, and similar medicines act on the brain and nerves and can reinforce the effect of Somnovit.

Taking Somnovit with food, drinks, and alcohol

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

Pregnancy and breastfeeding

Talk to your doctor or pharmacist before using any medicine.

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

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

Driving and using machines

Somnovit is a sleep-inducing medicine. Do not drive or use machines if you feel drowsy or if you notice that your attention and reaction capacity are reduced. Pay special attention when starting treatment or if the dose is increased.

Somnovit contains lactose

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

3. How to take Somnovit

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

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

In elderly people or those who suffer from liver or kidney disorders, or muscle weakness, the doctor will prescribe a lower dose.

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

Under normal conditions, you will not take more than 20 minutes to fall asleep after taking Somnovit, and it is advisable to make sure you can rest without being awakened for at least 7 hours. Otherwise, although this happens rarely, it is possible that you will not remember what happened while you were awake.

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

Remember to take your medicine.

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

The normal dose is:

• in adults: 1 tablet (1 mg of loprazolam) per day. In case of severe 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 failure, 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 effect of the medicine 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 medicine and the amount taken.

If you forget to take Somnovit

Do not take a double dose to make up for forgotten doses, but continue with the normal dose.

If you stop taking Somnovit

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

If you have any other 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.

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

You may develop anterograde amnesia, i.e., you do not remember what happened while you were awake after taking the medicine. Therefore, you should make sure you can rest for at least 7 hours without being disturbed.

Very rarely, Somnovit can cause sudden anxiety, hallucinations, excitement, and sleep disorders. If this happens, consult your doctor immediately.

If you think any of the side effects you are suffering from is serious, or if you notice any side effect not mentioned in this package leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Somnovit

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

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the packaging after EXP.

The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Somnovit 1 mg tablets

• The active substance is loprazolam. Each tablet contains 1.245 mg of loprazolam methansulfonate monohydrate, which corresponds to 1 mg of loprazolam.
• The other ingredients are colloidal silicon dioxide, corn starch, povidone, cellulose, magnesium stearate (E572), and lactose.

Appearance of the product and pack contents

Somnovit are light yellow, round, biconvex, and scored tablets. They are available in packs containing 30 tablets.

Marketing authorization holder and manufacturer

Teofarma S.r.l.

Via Fratelli Cervi, 8

27010 Valle Salimbene (PV) – Italy

Date of last revision of this package leaflet:May 2011

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)