PRESINEX 0.1 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

PRESINEX 0.1 mg tablets

Desmopressin

Read all of this leaflet carefully before you start taking this medicine.

• Keep this 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 leaflet.

Contents of the pack:

1. What PRESINEX 0.1 mg tablets are and what they are used for
2. Before you take PRESINEX 0.1 mg tablets
3. How to take PRESINEX 0.1 mg tablets
4. Possible side effects
5. Storing PRESINEX 0.1 mg tablets
6. Further information

1. What PRESINEX 0.1 mg tablets are and what they are used for

Presinex tablets work at the level of the kidneys. The kidneys control the body's fluid balance. Presinex tablets are similar to a natural hormone called vasopressin. Vasopressin is secreted in the pituitary gland (an organ in the brain) and regulates the amount of urine produced by the kidneys.

Presinex 0.1 mg tablets are indicated for:

• Treatment of central diabetes insipidus due to insufficient production of vasopressin, as a result of a primary or acquired alteration in the pituitary gland
• Treatment of urinary incontinence (nocturnal enuresis) after excluding any physical cause, in patients over 5 years of age with normal urine concentration capacity.

2. BEFORE YOU TAKE PRESINEX 0.1 mg tablets

Do not take PRESINEX 0.1 mg tablets

• If you are allergic (hypersensitive) to desmopressin or any of the other ingredients of Presinex 0.1 mg tablets
• If you have habitual or psychogenic polydipsia (excessive thirst)
• If you have known hyponatremia (low sodium levels)
• If you have severe heart failure, as Presinex may cause vasodilation, especially at high doses.

Take special care with PRESINEX 0.1 mg tablets

If you have primary nocturnal enuresis, be careful to restrict fluid intake by not drinking between 1 hour before administration and until the next morning (at least 8 hours).

In elderly patients or those with heart problems, special precautions should be taken with Presinex 0.1 mg tablets.

If you have chronic kidney disease, the effect of Presinex 0.1 mg tablets is reduced.

If you experience diarrhea or vomiting, please stop treatment with Presinex 0.1 mg tablets and inform your doctor.

Treatment without reducing fluid intake may cause water retention and/or decreased sodium levels in the blood, accompanied by symptoms and signs of alarm (headache, nausea/vomiting, weight gain, and in severe cases, convulsions). See section 4. Possible Side Effects

Special care should be taken to avoid decreased sodium levels in the blood in the following cases:

• Generalized infections, fever, and diabetes insipidus (inappropriate ADH secretion syndrome)
• Diseases where diuretic medications are used to increase urine production
• Treatment with medications that may cause diabetes insipidus on their own, such as antidepressant medications: tricyclic antidepressants, for example, amitriptyline, selective serotonin reuptake inhibitors, for example, fluoxetine, chlorpromazine, and carbamazepine.
• Treatment with non-steroidal anti-inflammatory drugs (NSAIDs) such as acetylsalicylic acid.

Consult your doctor if you experience any of these symptoms or have experienced them before.

Using other medicines:

Please inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Please inform your doctor if you are taking:

• Any pain or anti-inflammatory medication containing non-steroidal anti-inflammatory drugs (also known as NSAIDs), for example, indomethacin.
• Oral hypoglycemic agents
• Medications for the treatment of depression
• Medications to reduce blood cholesterol levels (clofibrate).

Taking PRESINEX 0.1 mg tablets with food and drinks:

PRESINEX 0.1 mg tablets can be taken before or during meals with a glass of water.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medication. During pregnancy, Presinex 0.1 mg tablets should be administered with caution.

Children:

Presinex 0.1 mg tablets are indicated in children over 5 years of age.

Driving and using machines:

Presinex 0.1 mg tablets have no effects that may affect the ability to drive and use machinery.

Important information about some of the ingredients of PRESINEX 0.1 mg tablets

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

3. HOW TO TAKE PRESINEX 0.1 mg tablets

Always take Presinex 0.1 mg tablets exactly as your doctor has told you. Check with them if you are unsure.

Central diabetes insipidus

Your doctor will indicate the most suitable individual dose. Generally, a dose of 0.1 mg to 1.2 mg per day is used. Therefore, in most cases, a treatment program of 1 tablet of Presinex 0.1 mg three times a day would be sufficient. To facilitate swallowing, the tablet can be broken before administration. Both parts should be taken.

Depending on the result, your doctor may adjust the treatment program.

If symptoms of water retention/hyponatremia appear, treatment should be interrupted and the dose adjusted again.

Primary nocturnal enuresis

In the case of using Presinex 0.1 mg tablets for the treatment of urinary incontinence, the full dose should be taken before going to bed.

Your doctor will determine the suitable individual dose. The initial suitable dose is 0.2 mg at bedtime. The dose can be increased to 0.4 mg if the lower dose is not sufficiently active.

Fluid intake should be controlled.

If symptoms or signs of water retention and/or hyponatremia (headache, nausea/vomiting, weight gain, and in severe cases, convulsions) appear, treatment should be interrupted until the patient has recovered. Once treatment is restarted, fluid intake should be strictly controlled.

After 3 months of treatment, the need for continuation is assessed by interrupting it for at least 1 week.

If you take more PRESINEX 0.1 mg tablets than you should:

Consult your doctor or pharmacist immediately or the Toxicology Information Service, telephone: 91 562 04 20, indicating the medication and the amount used.

If you forget to take PRESINEX 0.1 mg tablets

If you forget to take your tablets, please consult your doctor or pharmacist for advice. Do not take a double dose to make up for the forgotten dose.

4. Possible side effects

Like all medicines, Presinex 0.1 mg tablets can cause side effects, although not everybody gets them.

Frequent, between 1 and 10 patients in every 100 patients treated:headache, stomach pain, nausea

Very rare, less than 1 in every 10,000 patients treated:decreased sodium levels in the blood, emotional disorders in children, and occasionally allergic reactions on the skin or more severe generalized reactions.

Due to decreased sodium levels in the blood due to water retention as a consequence of treatment along with reduced fluid intake, headache, nausea, vomiting, decreased sodium, weight gain, and in severe cases, convulsions may occur.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. Storing PRESINEX 0.1 mg tablets

Keep out of the reach and sight of children.

No special storage conditions are required.

Expiry date:

Do not use PRESINEX 0.1 mg tablets after the expiry date stated on the carton.

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

6. FURTHER INFORMATION

Composition of PRESINEX 0.1 mg tablets:

• The active substance is desmopressin acetate. Each tablet contains 0.1 mg of desmopressin acetate, equivalent to 0.89 mg of desmopressin base.
• The other ingredients (excipients) are: lactose monohydrate, corn starch, povidone 25, and magnesium stearate.

Appearance and packaging of the product:

PRESINEX 0.1 mg tablets are presented in the form of tablets. The tablets are round, white, and scored. The score line on the Presinex tablet makes it possible to break the tablet before ingestion to facilitate swallowing. Once the tablet is broken, both parts should be taken.

Each bottle of Presinex 0.1 mg contains 100 tablets.

Marketing authorization holder:

CANTABRIA PHARMA S.L

C/ Ribera del Loira, 46 edificio 2

-28042- Madrid

Manufacturer:

Kern Pharma, S.L.

Poligono Industrial Colón II

C/.Venus, 72 08228 Terrasa

Barcelona

This leaflet was approved in: February 2007.