Somnovit 1 mg tablets
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Somnovit 1 mg tablets
Loprazolam
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if these are effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Somnovit is and what it is used for.
- What you need to know before taking Somnovit.
- How to take Somnovit.
- Possible side effects.
- How to store Somnovit.
- Contents of the pack and other 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 preserves the natural sleep cycle.
Loprazolam is also a drug with sedative properties, anxiolytic effects, anticonvulsant capacity, and muscle relaxant effects.
Doctors prescribe Somnovit for sleep rhythm disorders and for all forms of insomnia, especially when there is difficulty falling asleep, either initially or after early awakening.
In most cases, only short-term treatment with Somnovit is required (generally not exceeding two weeks).
Treatment should begin with the lowest dose. The maximum dose must not be exceeded.
2. What you need to know before taking 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 benzodiazepines in general, or to any of the other ingredients of this medicine (listed in section 6).
- if you have long-standing respiratory difficulties whether related to sleep or not, or suffer from severe muscular or liver problems.
- if you have drug or alcohol dependence, you should not take Somnovit unless your doctor specifically instructs you to do so. If you have any doubts about this, consult your doctor.
- if you have increased intraocular pressure (glaucoma).
- and remember that Somnovit must not be given to children.
Warnings and precautions
Talk to 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 illnesses
- have allergies
The use of benzodiazepines may lead to dependence. This occurs mainly after prolonged, uninterrupted use of the medicine. To minimize the risk of dependence, the following precautions should be observed:
- benzodiazepines should only be taken on a doctor's prescription (never because they have worked for other patients), and you should never recommend them to others.
- under no circumstances should you increase the dose prescribed by your doctor, or extend the treatment beyond the recommended duration.
- consult your doctor regularly so they can decide whether treatment should continue.
When stopping the medication, symptoms such as restlessness, anxiety, insomnia, difficulty concentrating, headache, and hot flushes may occur. Generally, it is not recommended to stop the medication abruptly; instead, the dose should be gradually reduced according to your doctor's instructions.
After taking Somnovit, make sure you can rest undisturbed for at least 7 hours.
Elderly patients may be more affected by Somnovit than younger patients. If you are elderly, your doctor may prescribe a lower dose and monitor 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 you should take a lower dose of Somnovit or not take it at all.
Other medicines and Somnovit
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. This is extremely important because taking more than one medicine at the same time may increase or decrease their effects.
Therefore, you should not take other medicines at the same time as Somnovit unless your doctor is aware and has approved it beforehand. For example, tranquilizers, sleep-inducing medicines, and similar drugs act on the brain and nerves and may enhance the effect of Somnovit.
Taking Somnovit with food, drinks, and alcohol
During treatment, avoid alcoholic beverages. Alcohol may enhance the sedative effect, which could affect your ability to drive or operate machinery. If you need further information on this point, consult your doctor.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine.
If you are pregnant or breastfeeding, think you might 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 discuss with your doctor whether it is advisable to take Somnovit while nursing your baby.
Driving and using machines
Somnovit is a medicine that causes drowsiness. Do not drive or operate machinery if you feel sleepy or notice that your attention and reaction ability are reduced. Pay special attention at the beginning of treatment or when the dose is increased.
Somnovit contains lactose
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.
3. How to take Somnovit
Follow exactly the instructions for use of this medicine as given by your doctor. If in 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 patients or those with liver or kidney disorders, or muscle weakness, your doctor will prescribe a lower dose.
Take Somnovit just before going to bed, swallowing the tablet without chewing it, with water or another non-alcoholic drink.
Under normal conditions, you should fall asleep within 20 minutes after taking Somnovit, and it is advisable to ensure that you can rest undisturbed for at least 7 hours. Otherwise, although this occurs only rarely, you may not remember what happened while you were awake.
To avoid withdrawal symptoms, you must not stop taking Somnovit abruptly, especially if you have been taking it for a long time.
Remember to take your medicine.
Each individual dose must not exceed the stated limits, nor must the total daily dose, unless your doctor prescribes a higher dose.
The normal dose is:
-
in adults: 1 tablet (1 mg of loprazolam) per day. In case of resistant insomnia, your doctor may increase the dose to 2 mg daily.
-
in elderly patients 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 for you on your own. 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Somnovit
Do not take a double dose to make up for missed doses. Instead, continue with your normal dose.
If you stop taking Somnovit
When stopping treatment, symptoms such as restlessness, anxiety, insomnia, difficulty concentrating, headache, and hot flushes may occur. Abruptly stopping the medication is generally not recommended; instead, the dose should be gradually reduced according to your doctor's instructions.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences 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, meaning you do not remember events that occurred while you were awake after taking the medicine. Therefore, you must ensure that you can rest for at least 7 hours without interruption.
Very rarely, Somnovit may cause sudden anxiety, hallucinations, excitement, and sleep disorders. If this occurs, consult your doctor immediately.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of 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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of 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 stated on the packaging after EXP.
The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Somnovit 1 mg tablets
- The active substance is loprazolam. Each tablet contains 1.245 mg of loprazolam methanesulfonate monohydrate, equivalent to 1 mg of loprazolam.
- The other components are colloidal silicon dioxide, corn starch, povidone, cellulose, magnesium stearate (E572), and lactose.
Appearance of the product and contents of the pack
Somnovit is light yellow, round, biconvex, scored tablets. It is supplied 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 the most recent review of this leaflet: May 2011
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)