VALTRAX 5 mg/5 mg Coated Tablet

Зміст інструкції

1. Valtrax 5 mg + 5 mg tablets
   1. What is Valtrax and what is it used for
   2. What you need to know before you take Valtrax
   3. How to take Valtrax
   4. Possible side effects
   5. How to store Valtrax
   6. Package contents and other information

Valtrax 5 mg + 5 mg tablets

Isopropamide iodide + Diazepam
Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Valtrax and what is it used for

Valtrax contains the active ingredients diazepam (a benzodiazepine used to treat anxiety disorders) and isopropyl iodide (an anticholinergic used to treat pain and spasms of the stomach and intestines).
This medicine is used for the treatment of pain and spasms of the gastrointestinal tract developed on an anxious basis.

2. What you need to know before you take Valtrax

Do not take Valtrax

• if you are allergic to isopropyl iodide, diazepam or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a disease that causes severe muscle weakness (myasthenia gravis);
• if you have a narrowing of the pylorus that connects the stomach and the small intestine (pyloric stenosis);
• if you suffer from severe liver problems (severe hepatic insufficiency);
• if you are affected by a serious illness due to an increase in pressure inside the eye (glaucoma);
• if you have an enlarged prostate (prostatic hypertrophy);
• if you have problems with the bladder that prevent the normal flow of urine (benign obstruction of the bladder neck);
• if you suffer from intestinal obstruction (arrest of the passage of contents in the intestine);
• if you are elderly and suffer from intestinal atony (arrest of the passage of contents in the intestine that fails to contract as it should)

Warnings and precautions
Talk to your doctor or pharmacist before taking Valtrax.
If you are being treated with Valtrax, or with any other medicine containing substances that act on the mind (psychotropic medicines), do not consume alcoholic beverages as you may experience unexpected reactions (see “Valtrax with alcohol”).

Development of dependence and withdrawal symptoms
When you take Valtrax, like other drugs containing benzodiazepines, you may be at risk of developing physical and psychological dependence on the medicine.
The likelihood of you developing dependence increases with increasing dose and duration of treatment and is greater if you have previously abused drugs or alcohol.
If you have developed physical dependence and suddenly stop treatment, you may experience withdrawal symptoms such as headache, muscle pain, severe anxiety, tension, restlessness, confusion and irritability. In severe cases, you may experience: distorted perception of the external world (derealization), a feeling of detachment from reality (depersonalization), tingling of hands and feet, excessive sensitivity to light, noise, sounds and physical contact, hallucinations or seizures.
Because the likelihood of withdrawal symptoms appearing is greater after abrupt discontinuation of treatment, your doctor will indicate the procedures to follow to gradually reduce the dose until treatment is stopped to reduce the risk of these symptoms appearing.
Your doctor will also inform you of the possibility that you may experience rebound symptoms (the reappearance of the symptoms for which you were being treated) when treatment is stopped to minimize anxiety should these symptoms occur.
In case of prolonged treatment, your doctor may advise you to have blood tests and check liver, kidney and blood pressure values.

Duration of treatment
The duration of treatment should be as short as possible and should not exceed eight to twelve weeks, including a period of gradual discontinuation (see “How to take Valtrax”). The doctor will decide whether to prolong the treatment based on your health conditions.

Memory disorders
Valtrax may cause you an inability to remember new information (anterograde amnesia). This usually happens several hours after taking the medicine and, therefore, to reduce this risk, make sure you have 7-8 hours of uninterrupted sleep (see “Possible side effects”).

Paradoxical reactions
Valtrax may cause you undesirable effects such as restlessness, agitation, irritability, aggression, delusion, anger, nightmares, hallucinations, psychosis, behavioral changes (see “Possible side effects”). If this should happen, see your doctor because the treatment must be discontinued (see “If you stop taking Valtrax”). These reactions are more common in the elderly.

Children and adolescents
Since Valtrax has not been studied in the pediatric population, it is recommended not to use it in children and adolescents.

Elderly patients
If you are elderly, your doctor will prescribe a reduced dose of Valtrax (see “How to take Valtrax”). You must be extremely careful during treatment with Valtrax due to the risk of sedation and/or muscle weakness that can cause falls, often with serious consequences.
If you suffer from breathing problems (chronic respiratory insufficiency), your doctor will prescribe a reduced dose of Valtrax (see “How to take Valtrax”).

Other medicines and Valtrax
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pay particular attention and consult your doctor or pharmacist if you have taken or are taking one or more of the following medicines:

• antipsychotics (medicines used to treat mental disorders or some forms of depression);
• hypnotics (medicines that can induce and maintain sleep);
• anxiolytics/sedatives (medicines used to treat states of anxiety and distress);
• antidepressants (medicines used to treat depression);
• narcotic analgesics (powerful pain relievers that act on the central nervous system - CNS). In this case, an increase in euphoria may occur, which causes an increase in psychological dependence.
• antiepileptics (medicines used to treat seizures caused by epileptic seizures);
• anesthetics (medicines that have the ability to induce temporary loss of sensation);
• sedating antihistamines (medicines used in case of allergies that cause drowsiness);
• compounds that inhibit certain liver enzymes (especially cytochrome P450), as they may increase the activity of benzodiazepines.

Valtrax with alcohol
Avoid taking Valtrax with alcoholic beverages as the calming effect of the medicine may be increased or you may experience other unexpected reactions. This has negative effects on the ability to drive vehicles or operate machinery (see “Driving and using machines”).
Valtrax with opioids
The combination of Valtrax with opioids (powerful analgesics, medicines for substitution therapy and some medicines for cough) increases the risk of drowsiness, causes difficulty in breathing (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should be avoided.
However, if your doctor prescribes Valtrax in conjunction with opioids, the dose and duration of concomitant treatment must be limited by your doctor.
Tell your doctor if you are taking opioids and carefully follow the dose that has been recommended to you. It may be helpful to inform friends and family to observe the possible appearance of signs and symptoms as described above. If these symptoms occur, contact your doctor

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Do not take this medicine during the first three months of pregnancy. In the subsequent period of pregnancy, take this medicine only if absolutely necessary and under the direct supervision of your doctor.
If, for serious medical reasons, you take this medicine during the last period of pregnancy or during labor at high doses, the newborn may experience the following symptoms: reduction of body temperature below 35°C (hypothermia), poor muscle tone (hypotonia) and difficulty breathing.
Furthermore, if you take medicines containing benzodiazepines, such as Valtrax, for a long time during the advanced stages of pregnancy, the newborn may develop physical dependence on the medicine and experience withdrawal symptoms in the period following birth.
If you intend to become pregnant or suspect you are pregnant, consult your doctor who will tell you how to stop treatment.
Do not take Valtrax if you are breastfeeding as this medicine passes into breast milk.
If it is necessary to continue therapy, discontinue breastfeeding.

Driving and using machines
Valtrax has a calming effect (sedation), can cause a temporary loss of memory (amnesia), can affect concentration and alter muscle function.
Therefore, taking this medicine may have adverse effects on the ability to drive vehicles and operate machinery. If you have not been able to sleep enough, there is a greater likelihood that the attention threshold has been altered.

Valtrax contains lactose
If your doctor has diagnosed you with intolerance to some sugars, contact him before taking this medicine.

3. How to take Valtrax

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
It is recommended to start treatment with the minimum recommended dose and not to exceed the maximum dose.
Your doctor will prescribe the appropriate dose for you to achieve an optimal effect and will periodically reassess your health conditions to eventually reduce the dose or frequency of intake.

The recommended doses are:
Adults:half a tablet or one tablet 1 to 3 times a day, before meals and in the evening before going to bed.
In acute forms, take 2 tablets simultaneously, if prescribed by your doctor.

Use in children and adolescents:since Valtrax has not been studied in the pediatric population, it is recommended not to use it in children and adolescents.

Elderly:if you are elderly, your doctor will carefully determine the dose, evaluating a possible reduction of the above doses and, in any case, will initially adhere to the minimum doses.
The doctor will carefully evaluate the dose, particularly in the case of people with:

• cerebral alterations, in particular arteriosclerosis;
• problems with the functioning of the heart and respiratory system (cardiorespiratory insufficiency);
• problems with the functioning of the kidneys (renal insufficiency);
• problems with the functioning of the liver (hepatic insufficiency).

Duration of treatment
The treatment should be as short as possible. The duration of treatment, generally, varies from a minimum of 8 weeks to a maximum of 12, including a gradual suspension period.
In case of treatment beyond the maximum period (12 weeks), your doctor will reassess your health conditions.
Undergo regular check-ups, especially at the beginning of treatment, to decrease, if necessary, the dose or frequency of taking the medicine in order to avoid excessive accumulation of doses of the medicine in the body.

If you take more Valtrax than you should
If you have taken an excessive dose of Valtrax, contact your doctor immediately or go to the nearest emergency room, where you will be subjected to appropriate emergency measures in relation to the severity of the ingested dose. Symptoms of an excessive dose of Valtrax may manifest as depression of the central nervous system (CNS), and respiratory and cardiovascular problems.

If you forget to take Valtrax
Do not take a double dose to compensate for forgetting the previous dose.

If you stop taking Valtrax
Do not suddenly stop taking Valtrax. Always consult your doctor before stopping intake (see “Development of dependence and withdrawal symptoms”).
If you have any 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.
Side effects can occur especially if the dose is not adjusted to individual needs. For this reason, it is recommended to start treatment with a low dosage.
The following side effects have been reported:

Frequency not known(the frequency cannot be estimated from the available data)

• drowsiness;
• reduction of emotions;
• reduction of the level of attention;
• confusion;
• fatigue;
• headache;
• dizziness;
• muscle weakness;
• loss of muscle coordination (ataxia);
• double vision and visual disturbances;
• dry mouth;
• difficulty in urination;
• constipation, usually when Valtrax is combined with other antispastic medicines;
• vomiting;

These side effects mainly occur at the beginning of treatment and usually
disappear with the continuation of treatment or after dose adjustment.
Other side effects observed with frequency not known are:

• stomach and intestinal disorders (gastrointestinal);
• sexual desire disorders (libido);
• skin reactions;
• yellowing of the skin (jaundice);
• reduction of blood pressure (hypotension);
• irregularities of the menstrual cycle;
• problems with liver function (hepatic insufficiency);
• reduction of the number of a specific group of blood cells (bone marrow depression);
• limited ability of the person to memorize new information (anterograde amnesia) also associated with changes in behavior (see “Memory disorders” in paragraph 2);

The use of Valtrax may reveal an existing state of depression.
The use of the medicine can cause reactions such as restlessness, agitation, irritability,
aggressiveness, delusion, anger, nightmares, hallucinations, mental disorders (psychosis), changes in
behavior. Such reactions can be quite serious and are more likely in
elderly people (see “paradoxical reactions” in paragraph 2).
The use of Valtrax even at the recommended doses can determine physical or psychological dependence on
the medicine.
Discontinuation of therapy may cause side effects (rebound phenomena) or withdrawal crises (see “Development of dependence and withdrawal symptoms” in paragraph 2).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects you can help provide more information on
the safety of this medicine.

5. How to store Valtrax

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
“EXPIRY DATE”. The expiry date refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging, correctly
stored.
Store at a temperature not exceeding 25°C.
Do not dispose of any medicine in 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 Valtrax contains

• The active ingredients are: isopropamide iodide, diazepam. Each tablet contains 5 mg of isopropamide iodide and 5 mg of diazepam.
• The other ingredients are: lactose, microcrystalline cellulose, hydrogenated castor oil, talc, colloidal silicon dioxide, magnesium stearate.

Description of the appearance of Valtrax and package contents
Valtrax is presented as tablets.
The package contains a blister of 25 tablets.

Marketing Authorisation Holder
NEOPHARMED GENTILI S.p.A – Via San Giuseppe Cottolengo 15 – 20143 Milano

Manufacturer
Valeas SPA - Chemical and Pharmaceutical Industry - Via Vallisneri, 10, 20133 Milano
VAMFARMA S.r.l. - Via Kennedy, 5 - Comazzo (Lodi)