DIERTINE 2 mg/ml ORAL DROPS IN SOLUTION

Introduction

Package Leaflet: Information for the User

Diertine 2 mg/ml Oral Drops in Solution

Dihydroergocristine, mesylate

Read this package leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this package leaflet, as 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 only. Do not pass it on to others, as 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, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Diertine and what is it used for
2. What you need to know before taking Diertine
3. How to take Diertine
4. Possible side effects
5. Storage of Diertine
6. Contents of the pack and further information

1. What is Diertine and what is it used for

Diertine contains the active substance dihydroergocristine mesylate, a semi-synthetic derivative of ergocristine, an alkaloid of the ergot of rye (Claviceps purpurea).

Diertine is used in adults for the treatment of symptoms of circulatory disorders in otorhinolaryngology (vertiginous syndrome).

2. What you need to know before taking Diertine

Do not take Diertine

• If you are allergic to dihydroergocristine mesylate, to the alkaloids of the ergot of rye, or to any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or breastfeeding.
• If you have a history of and/or symptoms of severe psychotic disorder.
• If you have a history of fibrotic disorders (cardiac, pulmonary, pleural, peritoneal, retroperitoneal).

Warnings and precautions

Talk to your doctor or pharmacist before taking Diertine if:

• You have liver or kidney problems.
• You have severe bradycardia (slow heart rate).
• You have low blood pressure or are taking medicines to lower blood pressure.

This medicine should not be used continuously or at doses higher than recommended, as it may cause fibrotic reactions (formation of fibrous tissue in some organs) and ergotism (characterized by symptoms such as tingling, spasms, cramps, or coldness in the extremities).

Children and adolescents

Diertine is not recommended for use in children and adolescents (under 18 years of age) due to the lack of information on the use of this medicine in this age group.

Other medicines and Diertine

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, tell your doctor if you are being treated with:

• Macrolide antibiotics (e.g., erythromycin, clarithromycin), tetracycline, medicines for the treatment of HIV infection (e.g., ritonavir, indinavir, nelfinavir, amprenavir, delavirdine, saquinavir, atazanavir, and efavirenz), or medicines for treating fungal infections (e.g., ketoconazole, itraconazole, voriconazole), as they may increase the concentration of dihydroergocristine in the blood.
• Other ergot derivatives (such as ergotamine), as they increase the risk of toxicity (fibrosis and ergotism).
• Medicines for treating high blood pressure, as dihydroergocristine may lower blood pressure.
• Medicines that slow down the heart rate (e.g., beta-blockers), as dihydroergocristine may cause bradycardia (slow heart rate).

Taking Diertine with food, drinks, and alcohol

No incompatibilities with food, drinks, or alcohol are known.

Pregnancy and breastfeedingIf you are pregnant or breastfeeding, you should not take Diertine.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Driving and using machines

Diertine has no or negligible influence on the ability to drive and use machines.

Diertine contains propylene glycol (E-1520)

This medicine contains 1037 mg of propylene glycol in each 20 drops of oral solution, equivalent to 1037 mg/ml.

3. How to take Diertine

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will decide what dose is most suitable for you.

The recommended dose in adults is 2 mg (20 drops) three times a day, or 3 mg (30 drops) twice a day (morning and evening).

It should be administered after meals.

Duration of treatment

The duration of this treatment is limited. Your doctor will indicate the duration of your treatment with Diertine. Take exactly the prescribed dose and do not modify it without talking to your doctor first.

If you take more Diertine than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you take more Diertine than recommended, you may experience a decrease in blood pressure, a decrease in heart rate, and confusion. You may also experience spasms of the blood vessels, with an increase in blood pressure and a subsequent feeling of coldness and tingling in the extremities.

If you forget to take Diertine

If you forget to take a dose of Diertine, take the next scheduled dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you have any other questions 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.

Common side effects:(may affect up to 1 in 10 people)

• Nausea, vomiting, loss of appetite, diarrhea.

• Orthostatic hypotension (decrease in blood pressure when changing posture).
• Exanthematous eruptions on the skin.

Uncommon side effects(may affect up to 1 in 100 people)

• Blurred vision.
• Nasal congestion.
• Headache, dizziness.
• Bradycardia (slow heart rate).
• Hot flashes.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Diertine

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 is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Diertine

The active substance is dihydroergocristine mesylate. Each milliliter of oral solution (20 drops) contains 2 mg of dihydroergocristine mesylate.

The other ingredients (excipients) are: propylene glycol (E-1520).

Appearance of the product and packaging contents

Ambert-colored glass bottle containing 50 ml of clear and colorless oral solution.

Marketing authorization holder and manufacturer

Marketing authorization holder

Tora Laboratories, S.L.U.

Avenida de Oporto, 60

28019 Madrid, Spain

Manufacturer

Farmasierra

Carretera de Irún km 26,200

San Sebastián de los Reyes

28700 Madrid

Spain

Date of last revision of this package leaflet:February 2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/