Valtrax

Package leaflet: Information for the user

Valtrax 5 mg + 5 mg tablets

Isopropamide iodide + Diazepam
Equivalent medicine
Please read all of this leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact 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 taking 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 Valtrax is and what it is used for

Valtrax contains the active substances diazepam (a benzodiazepine used to treat anxiety disorders) and isopropamide iodide (an anticholinergic used to treat stomach and intestinal pain and spasms).
This medicine is used to treat gastrointestinal pain and spasms arising from anxiety.

2. What you should know before taking Valtrax

Do not take Valtrax

• if you are allergic to isopropamide iodide, diazepam, or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a disease causing severe muscle weakness (myasthenia gravis);
• if you have a narrowing of the pylorus, the passage connecting the stomach and the small intestine (pyloric stenosis);
• if you have severe liver problems (severe hepatic insufficiency);
• if you have a serious condition caused by increased pressure inside the eye (glaucoma);
• if you have an enlarged prostate (prostatic hypertrophy);
• if you have bladder problems that prevent normal urine flow (benign bladder neck obstruction);
• if you have intestinal obstruction (arrested movement of intestinal contents);
• if you are elderly and suffer from intestinal atony (arrested movement of intestinal contents due to inadequate intestinal contractions)

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

Development of dependence and withdrawal symptoms
When taking Valtrax, as with other medicines containing benzodiazepines, there is a risk of developing physical and psychological dependence on the medicine.
The likelihood of dependence increases with higher doses and longer duration of treatment, and is greater if you have previously abused drugs or alcohol.
If you develop physical dependence and abruptly stop treatment, you may experience withdrawal symptoms such as headache, muscle pain, severe anxiety, tension, restlessness, confusion, and irritability. In severe cases, the following may occur: distorted perception of the external world (derealization), feelings of detachment from reality (depersonalization), tingling sensations in hands and feet, increased sensitivity to light, noise, sounds, and physical contact, hallucinations, or epileptic seizures.
Since the risk of withdrawal symptoms is higher after abrupt discontinuation of treatment, your doctor will advise you on how to gradually reduce the dose before stopping treatment completely, to minimize the risk of such symptoms.
Your doctor will also inform you about the possibility of experiencing rebound symptoms (recurrence of the symptoms for which you were being treated) upon stopping the medicine, to help minimize anxiety should these symptoms occur.
If treatment is prolonged, your doctor may recommend periodic blood tests and monitoring of liver, kidney function, and blood pressure.

Duration of treatment
Treatment duration should be as short as possible and must not exceed eight to twelve weeks, including a gradual withdrawal period (see "How to take Valtrax"). Your doctor will decide whether to extend treatment based on your individual health condition.

Memory disturbances
Valtrax may cause difficulty in memorizing new information (anterograde amnesia). This usually occurs several hours after taking the medicine. To reduce this risk, ensure you have an uninterrupted sleep of 7–8 hours (see "Possible side effects").

Paradoxical reactions
Valtrax may cause side effects such as restlessness, agitation, irritability, aggression, delusions, anger, nightmares, hallucinations, psychosis, and behavioral changes (see "Possible side effects"). If this occurs, consult your doctor immediately, as treatment must be discontinued (see "If you stop taking Valtrax"). These reactions are more common in elderly patients.

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

Elderly patients
If you are elderly, your doctor will prescribe a reduced dose of Valtrax (see "How to take Valtrax"). You must exercise extreme caution during treatment due to the risk of sedation and/or muscle weakness, which may lead to falls, often with serious consequences.
If you suffer from respiratory problems (chronic respiratory insufficiency), your doctor will prescribe a reduced dose of Valtrax (see "How to take Valtrax").

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

• antipsychotics (medicines used to treat mental disorders or certain forms of depression);
• hypnotics (medicines capable of inducing and maintaining sleep);
• anxiolytics/sedatives (medicines used to treat anxiety and distress);
• antidepressants (medicines used to treat depression);
• narcotic analgesics (potent painkillers acting on the central nervous system - CNS). In this case, euphoria may increase, leading to higher psychological dependence.
• antiepileptics (medicines used to treat seizures caused by epileptic fits);
• anesthetics (medicines capable of inducing temporary loss of sensation);
• sedative antihistamines (medicines used for allergies that cause drowsiness);
• compounds that inhibit certain liver enzymes (especially cytochrome P450), as they may increase the activity of benzodiazepines.

Valtrax and alcohol
Avoid taking Valtrax with alcoholic beverages, as the calming effect of the medicine may be enhanced or other unexpected reactions may occur. This may negatively affect your ability to drive or operate machinery (see "Driving and using machines").

Valtrax with opioids
Combining Valtrax with opioids (potent analgesics, medicines for substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should be avoided.
However, if your doctor prescribes Valtrax together with opioids, the dose and duration of combined treatment must be strictly limited and supervised by your doctor.
Inform your doctor if you are taking opioids and carefully follow the prescribed dosage. It may be helpful to inform family and friends to watch for signs and symptoms such as those listed above. If these symptoms occur, contact your doctor immediately.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not take this medicine during the first three months of pregnancy. In the later stages of pregnancy, take this medicine only if clearly needed and under direct medical supervision.
If, for serious medical reasons, you take this medicine during the last stage of pregnancy or during labor at high doses, the newborn may show the following symptoms: body temperature below 35°C (hypothermia), poor muscle tone (hypotonia), and breathing difficulties.
Moreover, if you take benzodiazepine-containing medicines such as Valtrax for a prolonged period during late pregnancy, the newborn may develop physical dependence and experience withdrawal symptoms after birth.
If you plan to become pregnant or suspect pregnancy, consult your doctor, who will advise you on how to discontinue treatment.
Do not take Valtrax if you are breastfeeding, as this medicine passes into breast milk. If continuing treatment is necessary, discontinue breastfeeding.

Driving and using machines
Valtrax has a calming (sedative) effect, may cause temporary memory loss (amnesia), may affect concentration, and may impair muscle function. Therefore, taking this medicine may negatively affect your ability to drive vehicles or operate machinery. If you have not had sufficient sleep, your attention threshold is more likely to be impaired.

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

3. How to take Valtrax

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
It is recommended to start treatment with the lowest recommended dose and not to exceed the maximum dose.
Your doctor will prescribe the dose appropriate for you to achieve the optimal effect and will periodically reassess your health condition in order to possibly reduce the dose or frequency of administration.

Recommended doses:
Adults: Half a tablet or one tablet 1 to 3 times daily, before meals and in the evening before bedtime.
In acute cases, take 2 tablets simultaneously, if prescribed by the doctor.

Use in children and adolescents: Since Valtrax has not been studied in the pediatric population, its use in children and adolescents is not recommended.

Elderly patients: If you are elderly, your doctor will carefully determine the dose, possibly reducing the above-mentioned doses; initially, the lowest doses will be used.
Your doctor will pay particular attention when determining the dose, especially in patients with:

• cerebral disorders, particularly arteriosclerosis;
• heart and respiratory system problems (cardiorespiratory insufficiency);
• kidney function problems (renal insufficiency);
• liver function problems (hepatic insufficiency).

Duration of treatment
Treatment should be as short as possible. The duration of treatment generally ranges from a minimum of 8 weeks to a maximum of 12 weeks, including a gradual withdrawal period.
If treatment extends beyond the maximum period (12 weeks), your doctor will reassess your health condition.
Regular monitoring is recommended, especially at the beginning of treatment, to reduce, if necessary, the dose or frequency of administration of the medicine, thus avoiding excessive accumulation of the drug 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 appropriate emergency measures will be taken according to the severity of the ingested dose. Symptoms of an overdose of Valtrax may include central nervous system (CNS) depression, breathing difficulties, and cardiovascular problems.

If you forget to take Valtrax
Do not take a double dose to make up for the forgotten dose.

If you stop taking Valtrax
Do not stop taking Valtrax suddenly. Always consult your doctor before stopping treatment (see "Development of dependence and withdrawal symptoms").

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects may occur especially if the dose is not adjusted to individual needs. Therefore, it is recommended to start treatment with a low dosage.
The following side effects have been reported:
Frequency not known (frequency cannot be estimated from the available data)

• drowsiness;
• reduced emotions;
• reduced level of alertness;
• 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 used in combination with other antispastic medicines;
• vomiting;

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

• stomach and intestinal (gastrointestinal) disturbances;
• disturbances in sexual desire (libido);
• skin reactions;
• yellowing of the skin (jaundice);
• reduced blood pressure (hypotension);
• menstrual cycle irregularities;
• liver function problems (hepatic failure);
• reduced number of a specific group of blood cells (bone marrow depression);
• limited ability to memorize new information (anterograde amnesia), sometimes associated with behavioral changes (see “Memory disturbances” in section 2);

The use of Valtrax may unmask pre-existing depression.
The use of this medicine may cause reactions such as restlessness, agitation, irritability, aggressiveness, delusion, anger, nightmares, hallucinations, mental disorders (psychosis), and behavioral changes. These reactions can be serious and are more likely in elderly patients (see “Paradoxical reactions” in section 2).
The use of Valtrax, even at recommended doses, may lead to physical or psychological dependence on the medicine.
Stopping treatment may cause side effects (rebound phenomena) or withdrawal symptoms (see “Development of dependence and withdrawal symptoms” in section 2).
Following the instructions provided in this leaflet reduces the risk of side effects.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following address:
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 stated on the packaging after "EXP". The expiry date refers to the last day of that month.
The stated expiry date applies to the product in its original, unopened packaging and stored correctly.
Store at a temperature not exceeding 25°C.
Do not dispose of any medicine via 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 substances are: isopropamide iodide, diazepam. Each tablet contains 5 mg of isopropamide iodide and 5 inflammable diazepam.
• The other components are: lactose, microcrystalline cellulose, hydrogenated castor oil, talc, colloidal silicon dioxide, magnesium stearate.

Description of the appearance of Valtrax and contents of the pack
Valtrax is available as tablets.
The pack contains one blister with 25 tablets.
Marketing Authorization Holder
NEOPHARMED GENTILI S.p.A. – Via San Giuseppe Cottolengo 15 – 20143 Milan
Manufacturer
Valeas SPA - Chemical and Pharmaceutical Industry - Via Vallisneri, 10, 20133 Milan
VAMFARMA S.r.l. - Via Kennedy, 5 - Comazzo (Lodi)