Patient Information Leaflet

DINEZA 5 mg modified-release hard capsules

Dihydroergotamine
Please read 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, consult 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 side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What DINEZA is and what it is used for
What you need to know before taking DINEZA
How to take DINEZA
Possible side effects
How to store DINEZA
Contents of the pack and other information

1. What DINEZA is and what it is used for

DINEZA contains the active substance dihydroergotamine, which belongs to a group of medicines called antimigraine agents that relieve headache symptoms by acting directly on blood circulation in the brain.
This medicine is indicated for the treatment of headache (cephalalgia), recurrent attacks of severe headache (migraine), and vertigo.

2. What you need to know before taking DINEZA

Do not take DINEZA

if you are allergic to dihydroergotamine mesylate or to any of the other ingredients of this medicine (listed in section 6);
if you suffer from blood circulation problems (peripheral arterial diseases such as occlusive angiopathies, coronary disorders);
if you have severe liver or kidney problems (hepatic or renal insufficiency);
if you have a systemic blood infection (septic states);
if you have high blood pressure (hypertension);
if you are pregnant or breastfeeding;
if you are taking triacetyloleandomycin (TAO) or monoamine oxidase inhibitors (MAOIs).

Warnings and precautions
Talk to your doctor or pharmacist before taking DINEZA.
Take this medicine with food to avoid stomach disturbances such as nausea and vomiting (see section “Possible side effects”).
Stop treatment with DINEZA and inform your doctor if you experience tingling in the fingers of your hands or feet.
Do not exceed the recommended doses and take the medicine for the shortest possible time, because prolonged use of DINEZA may cause a serious intoxication called ergotism (see section “If you take more DINEZA than you should”).

Other medicines and DINEZA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take DINEZA if you are taking the following medicines:

triacetyloleandomycin (TAO), used to treat infections;
monoamine oxidase inhibitors (MAOIs), used to treat depression.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take DINEZA if you are pregnant or breastfeeding.

Driving and using machines
This medicine does not impair the ability to drive or operate machinery.

DINEZA contains lactose and sucrose
This medicine contains lactose and sucrose, two types of sugars. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take DINEZA

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose is 2 capsules per day: 1 capsule in the morning and 1 capsule in the evening, taken
during meals.
Do not exceed the recommended doses.
If you take more DINEZA than you should
Taking an excessive dose of this medicine may cause a serious poisoning called ergotism,
characterized by loss of consciousness, seizures, low blood pressure, and numbness of the hands and feet (See section “Warnings and precautions”).
In case of accidental ingestion/overdose of DINEZA, contact your doctor immediately or go to the nearest hospital.
If you forget to take DINEZA
Do not take a double dose to make up for the missed capsule.
Take only the next dose at your usual time.
If you have any questions 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 everyone experiences them.
The following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data):

nausea and vomiting, if you take this medicine on an empty stomach;
tingling sensation (paraesthesia), pain, weakness in the arms and legs (limb weakness), and reduced blood circulation to the hands and feet (peripheral vasoconstriction).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DINEZA

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.
This medicine does not require any special storage conditions.
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 DINEZA contains

The active substance is dihydroergotamine mesilate. Each capsule contains:
• 1.5 mg of immediate-release dihydroergotamine mesilate;
• 3.5 mg of prolonged-release dihydroergotamine mesilate.
The other ingredients are:
• Inner core: sucrose, polyvinylpyrrolidone, starch, lactose, talc, methacrylic polymers, diethyl phthalate;
• Outer shell: gelatin; indigotine (E132).

Description of the appearance of DINEZA and contents of the pack
5 mg hard capsules. Box containing 30 capsules.

Marketing Authorization Holder
DMG ITALIA SRL
via Laurentina Km 26.700
00071 Pomezia (RM), Italy

Manufacturers
Osmopharm SA
Via alle Fornaci
6930 Bedano
Switzerland
Complete production, primary and secondary packaging, batch control

CIT S.r.l.
Via Primo Villa, 17
20875 Burago Molgora (MB)
Italy
Batch release