In this leaflet:

1. What Dalparan is and what it is used for
2. Before you take Dalparan
3. How to take Dalparan
4. Possible side effects
5. Storing Dalparan

Dalparan 10 mg, comprimidos recubiertos ranurados
Zolpidem

The active substance is zolpidem (DOE) hemitartrate. Each tablet contains 10 mg.
The other ingredients are:
Core: lactose, microcrystalline cellulose, hypromellose, carboxymethyl sodium starch, magnesium stearate.
Coating: hypromellose, titanium dioxide, polyethylene glycol 400.

Marketing authorisation holder: FARMA-LEPORI, S.A. C. Osi, 7 - 08034 Barcelona (Spain)

Manufacturer: SANOFI WINTHROP INDUSTRIE. 6, Boulevard de l’Europe. 21800 Quetigny (France)

1. WHAT DALPARAN IS AND WHAT IT IS USED FOR
Scored coated tablets with the lettering SN 10: box with 30 tablets of 10 mg.
It is classified in the group of other hypnotic and sedative agents alone.
Doctors prescribe Dalparan for sleep rhythm disorders and for all forms of insomnia, particularly when it is difficult to get to sleep, either initially or after an early awakening.
In most cases only a short course of treatment with Dalparan is required (generally speaking it should not be more than two weeks).
Treatment should begin with the lowest doses. The maximum dose should not be surpassed.

2. BEFORE YOU TAKE DALPARAN
Before starting treatment make sure that your doctor knows if you:
• have any liver disorder
• suffer muscular weakness
• have other sleep disorders
• have allergies

Do not take Dalparan in the following cases:
You should not take Dalparan if you know that you have an allergy or excessive reaction against any of the substances contained in these tablets or the group of the benzodiazepines in general.
Neither should you take Dalparan if you have severe respiratory difficulties related or not to sleep for some time or if you have serious muscular or hepatic problems.
If you suffer drug or alcohol dependence you should not take Dalparan unless your doctor tells you to do so formally. If in doubt see your doctor.

Dalparan should not be given to children.

Be particularly careful with Dalparan, since:
Risk of dependence

The use of benzodiazepines may lead to dependence. This occurs mainly after the medicine is taken uninterruptedly for a long time. The following precautions should be taken to minimise the risk of dependence:
- These drugs should only be taken on medical prescription (never because they have worked in other patients) and should never be recommended to other people.
- On no account should the doses prescribed by the physician be increased or treatment be prolonged beyond the time recommended.
- See the doctor regularly for him to decide whether you should continue with treatment.
When the treatment is stopped, restlessness, anxiety, insomnia, lack of concentration, headache and hot flash may appear. Generally speaking, the medication should not be abruptly stopped, but rather the dose should be reduced gradually in accordance with the doctor's instructions.
After taking Dalparan you should sleep all night or rest.
If you have a liver disorder or muscular weakness, your doctor will decide whether you should take a lower dose of Dalparan or not take it at all.

Take Dalparan with food and drink:
Avoid alcoholic drinks during treatment. The effect of alcohol may boost sedation, and it may affect the ability to drive or use machines. If you need additional information on this point check with your doctor.

Pregnancy:
Ask your doctor or pharmacist for advice before taking any medicine.
Before starting the treatment, your doctor should know if you are pregnant or suspect that you may be, or if you wish to get pregnant. The physician will decide whether you should take Dalparan.

Lactation:
Ask your doctor or pharmacist for advice before taking any medicine.
This medicine is excreted in the mother's milk, whereby you should check with your doctor about taking Dalparan while you are breastfeeding your child.

Driving and using machines:
Depending on your individual response, your capacity to drive or use machinery may be affected; therefore, before doing these activities check your reaction to Dalparan.

Use of other medicines:
Before you begin the treatment, your doctor must be informed if you take others medicines (including non-prescription drugs). This is extremely important because the simultaneous use of more than one medicine may increase or reduce their effect.
Therefore, do not take other medicines at the same time as Dalparan unless your doctor is informed and has approved it first. For example, tranquilisers, sleeping pills and similar medicines act on the brain and the nerve, and may reinforce the effect of Dalparan.
With a view to avoiding possible interactions with other medicines, tell your doctor or pharmacist if you are taking, or have recently taken, any other medicine, even non-prescription drugs, and particularly those that act on the Central Nervous System, such as: other hypnotics, anxiolytics/sedatives, antidepressants, antipsychotics, narcotic analgesics, antiepileptics, anaesthetics and sedative antihistamines.
Remember that these instructions may also be applicable to medicines taken previously or subsequently.

3. HOW TO TAKE DALPARAN
Always take Dalparan exactly as your doctor has instructed you. Depending on the nature of your disease, age and weight, your doctor will prescribe the suitable dose.
Follow these instructions unless told to do otherwise by your doctor.
Remember to take your medicine.
If you have the impression that the effect of Dalparan is too strong or too weak, talk to your doctor or pharmacist.
In adults, the daily recommended dose is 1 tablet, in other words 10 mg.
In the elderly or weak patients with some type of liver disorder, or muscular weakness, the physician will prescribe a lower dose. The recommended dose is half a tablet, in other words 5 mg.
The daily dose of zolpidem is not greater than 10 mg in any patient.
Each individual dose should not surpass the limits indicated or the total daily dose, unless your doctor prescribes a higher dose for you.
Take Dalparan just before going to bed and swallow the tablet whole with water or any other non-alcoholic drink.
In normal conditions, you will not take more than 20 minutes to get to sleep after taking Dalparan and you should make sure that you will be allowed to sleep without being disturbed for least 7 hours. Otherwise, although this rarely occurs, you may not remember what had happened while you were awake.
Do not take a double dose to make up for forgotten individual doses, you should continue with the next normal dose.
To avoid withdrawal symptoms do not stop taking Dalparan abruptly, particularly if you have been taking it for a long time.

If you take more Dalparan than you should:
If you have taken more Dalparan than you should, see your doctor or pharmacist immediately.
In case of overdose or accidental intake, go to a medical centre or call the Toxicology Information Service, Tel. 91 562 04 20, indicating the medicine and the amount taken.

If you forgot to take Dalparan:
Do not take a double dose to make up for the doses you forgot to take.

Effects that occur on interruption of Dalparan:
The abrupt interruption of treatment may produce withdrawal syndrome, characterised by headache or muscular pain, anxiety, tension, nervousness, confusion and irritability (see “Be particularly careful with Dalparan”).

4. POSSIBLE SIDE EFFECTS
As occurs with all medicines, Dalparan may have adverse effects.
Most patients tolerate Dalparan well, but some, particularly at the beginning of treatment, feel a little tired or drowsy during the day.
You may develop anterograde amnesia, which means that you do not remember what happened even when you were awake after taking the medicine, so you should make sure that you will be allowed to sleep without being disturbed for least 7 hours.
Very rarely, Dalparan may produce sudden anxiety, hallucinations, excitation and worsening of insomnia. If this happens, check with your doctor immediately.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

5. STORING DALPARAN
No special storage conditions are required.
Keep Dalparan out of the reach and sight of children.

Expiry
Do not use Dalparan after the expiry date indicated on the box or label.

This leaflet was revised in March 2004.

Farma-Lepori
C. Osi, 7 - 08034 Barcelona

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