Diertine 2 mg/ml oral drops in solution
SpainTable of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Diertine 2 mg/ml oral drops solution
Dihydroergocristine mesylate
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet as 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Diertine is and what it is used for
- What you need to know before taking Diertine
- How to take Diertine
- Possible adverse effects
- How to store Diertine
- Contents of the pack and other information
1. What Diertine is and what it is used for
Diertine contains the active substance dihydroergocristine mesylate, a semisynthetic derivative of ergocristine, an alkaloid of ergot (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 ergot alkaloids, or to any of the other components 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
Consult your doctor or pharmacist before taking Diertine if:
- You have liver or kidney problems.
- You suffer from severe bradycardia (slow heart rate).
- You have low blood pressure or are taking medications 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 certain organs) and ergotism (characterized, among others, 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 lack of information on the use of this medicine in this age group.
Other medicines and Diertine
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
In particular, inform your doctor if you are being treated with:
- Macrolide antibiotics (e.g. erythromycin, clarithromycin), tetracyclines, medicines for the treatment of HIV infection, the virus causing AIDS (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 blood concentration of dihydroergocristine.
- Other ergot derivatives (such as ergotamine), as this increases the risk of toxicity (fibrosis and ergotism).
- Medicines for treating high blood pressure, because dihydroergocristine may lower blood pressure.
- Medicines that reduce heart rate (e.g. beta-blockers), because dihydroergocristine may cause bradycardia (slowing of the heart rate).
Taking Diertine with food, drinks and alcohol
No incompatibility with food, drinks or alcohol is known.
Pregnancy and breastfeeding If you are pregnant or breastfeeding, do not take Diertine.
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine.
Driving and using machines
The influence of Diertine on the ability to drive and operate machinery is none or negligible.
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 instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Your doctor will decide the most appropriate dose 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 night).
It should be taken after meals.
Duration of treatment
The duration of this treatment is limited. Your doctor will indicate how long you should take Diertine. Take exactly the prescribed dose and do not change it without first speaking to your doctor.
If you take more Diertine than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.
If you take more Diertine than recommended, you may experience decreased blood pressure, reduced heart rate, and confusion. Blood vessel spasms may also occur, leading to increased blood pressure followed by coldness and tingling sensations 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 missed doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
Frequent adverse effects: (may affect up to 1 in 10 people)
-
Nausea, vomiting, loss of appetite, diarrhoea.
-
Orthostatic hypotension (decrease in blood pressure upon changing posture).
-
Skin exanthema (rash).
Uncommon adverse effects (may affect up to 1 in 100 people)
- Blurred vision.
- Nasal congestion.
- Headache, dizziness.
- Bradycardia (slow heart rate).
- Hot flushes.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines at https://www.notificaram.es. By reporting adverse 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 refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater drains or household waste. Unused medicines and their containers should be taken to the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Diertine
The active substance is dihydroergocristine mesylate. Each millilitre of oral solution (20 drops) contains 2 mg of dihydroergocristine mesylate.
The other components (excipients) are: propylene glycol (E-1520).
Appearance of the product and contents of the pack
Topaz-coloured glass bottle containing 50 ml of a clear, colourless oral solution.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Tora Laboratories, S.L.U.
Avenida de Oporto, 60
28019 Madrid, Spain
Manufacturer
Farmasierra Manufacturing, S.L.
Carretera de Irún km 26,200
San Sebastián de los Reyes
28706 Madrid, Spain
Date of the most recent review of this leaflet: February 2021
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/