2.5 mg and 5 mg tablets
of dihydroergotamine mesylate
What Orstanorm is and what it is used for
Orstanorm contains the active substance dihydroergotamine mesylate. Dihydroergotamine belongs to a group of medicines known as ergot alkaloids. These drugs have an astringent effect on the blood vessels ( vessels become narrower).
Orstanorm counteracts an excessive dilation of certain blood vessels.
Orstanorm is used to treat migraines with or without warning (eg visual disturbances that some people experience just before an attack).
Dihydroergotamine mesylate contained in Orstanorm may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Orstanorm
Do not take Orstanorm:
- if you are allergic to dihydroergotamine mesylate or any of the other ingredients of this medicine (listed in section 6)
- if you are pregnant or breast-feeding (see section ” Pregnancy and breast-feeding “)
- in case of decreased blood circulation in the hands and feet (which may cause a feeling of cold, numbness or tingling in the fingers and toes) or in case of impaired blood circulation caused by vascular disease, with a tendency to cramps or blockage of arteries , or a coronary heart disease (e.g. angina pectoris )
- in untreated high blood pressure
- in case of severe infection you are in the blood
- in case of shock
- diseases that constrict the blood vessels (eg Raynaud’s syndrome)
- if you suffer from inflammation of an artery on the side of the head (temporal arteritis)
- if you have severe liver disease
- at the same time as medicines for fungal infections (eg imidazole and triazole derivatives), some medicines for infection you like macrolide antibiotics with the exception of azithromycin (eg erythromycin) or medicines for HIV / AIDS (so-called protease inhibitors ) (see section ” Other medicines and Orstanorm ”)
- concomitant use of other anti- migraine drugs , which have an astringent effect on the blood vessels, e.g. medicines containing sumatriptan (Imigran) and also those containing nicotine (in heavy smokers) (see section “ Other medicines and Orstanorm ”). If sumatriptan is taken, it should take 6 hours before Orstanorm is used. Conversely, sumatriptan should not be taken until 24 hours after Orstanorm (see section “ Other medicines and Orstanorm ”).
If any of these apply to you, tell your doctor before taking Orstanorm.
Warnings and cautions
Talk to your doctor or pharmacist before taking Orstanorm.
- Orstanorm can cause serious side effects , called fibrosis , [a thickening of the membrane that covers the lungs and covers the walls of the chest (lung and pleural fibrosis ) or a thickening of the inner surface of the abdomen which can cause obstruction of the urinary tract (retroperitoneal fibrosis )] and ergotism (the effect of long-term poisoning by ergot), including severe cases with symptoms such as severe vasoconstriction with possible fatal outcome.
- Signs that the dose is too high are numbness and tingling in the fingers or toes as well as non-migraine-related nausea and vomiting. If any of these are observed, treatment should be stopped immediately and a doctor consulted.
- Prolonged use or overconsumption of painkillers for headaches can aggravate the headache. Talk to your doctor if you think it has affected you. It may be necessary to discontinue treatment with Orstanorm to resolve the issue
Children and youth
The safety and efficacy of Orstanorm in children and adolescents below 18 years of age have not been established, and therefore Orstanorm is not recommended for use in these patients.
Other medicines and Orstanorm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Orstanorm if you are taking any of the following medicines:
The following drugs, as well as heavy smoking, can cause interaction (mainly blood vessel spasms) and concomitant use should be avoided:
- Some medicines for infection , such as macrolide antibiotics (eg erythromycin, troleandomycin, clarithromycin), medicines for HIV / AIDS (such as ritonavir, indinavir, nelfinavir) and medicines for fungal infections (eg ketoconazole , itraconazole, voriconazole) because drugs cause an increased level of dihydroergotamine and thus ergotamine toxicity (signs and symptoms include narrowing of the blood vessels and decreased blood circulation)
- Cimetidine (medicines for heartburn and stomach ulcers ), fluvoxamine (for depression), verapamil, diltiazem (blood pressure lowering), ciclosporin (immunosuppressive – stops the body from repelling a transplanted organ), glyceryl trinitrate (used to treat angina) can result in an expulsion of Orstanorm in the body and this in turn will give a long-term exposure to the drug (overexposure), which can lead to side effects . Therefore, it is recommended not to take the above medicines with Orstanorm
- Medicines for migraines that have an astringent effect on the blood vessels, for example medicines that contain sumatriptan (Imigran), and also nicotine (in heavy smokers). The dosing interval between these medicines must be followed carefully (see section ” Do not take Orstanorm “)
- Patients with poor blood circulation should be careful to combine Orstanorm with beta-blockers (eg propranolol)
- Glyceryl trinitrate ( nitroglycerin ) as this agent increases the effect of Orstanorm.
Orstanorm with food, drink and alcohol
Taking this medicine at the same time as grapefruit juice may lead to increased effects due to increased exposure to dihydroergotamine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There is a risk that the fetus may be affected and dihydroergotamine may cause premature birth. Orstanorm should therefore not be used during pregnancy (see section ” Do not take Orstanorm “).
Breast-feeding
There is a risk that children who are breastfed may be affected. Orstanorm should therefore not be used during breastfeeding (see section “ Do not take Orstanorm ”).
Driving and using machines
Do not drive or use any tools or machines if you experience dizziness during treatment with Orstanorm.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Orstanorm contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Orstanorm
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is:
Adults: During interval treatment (ie periodic treatment with intermittent breaks) of migraine and migraine-like headache, 1-2 tablets (2.5 mg each) twice daily. The maximum daily dose of 10 mg dihydroergotamine mesylate should not be exceeded.
The tablets should be taken by mouth. The tablets should be swallowed with liquid.
Use for children and adolescents
The safety and efficacy of Orstanorm tablets in children and adolescents below the age of 18 years have not been established and it is therefore not recommended to give Orstanorm to these patients.
Use for the elderly
Orstanorm is not recommended for use in elderly patients due to the risk of heart disease.
Impaired renal function
Tell your doctor if you have kidney problems.
Your doctor may want to take special precautions during your treatment. Your doctor may do regular tests to monitor your kidney function and reduce the dose accordingly.
Hepatic impairment
Tell your doctor if you have liver problems.
Your doctor may want to take regular blood tests to monitor your liver function. This medicine is not recommended for patients with severe liver problems.
If you take more Orstanorm than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine, contact a doctor or hospital for assessment of the risk and advice.
Signs of acute overdose include: nausea, vomiting, increased heart rate, dizziness, signs, and symptoms of narrowing of blood vessels such as tingling or numbness, decreased blood circulation to hands and feet, local cell and tissue death (gangrene), pain in the arms and coma.
If you forget to take Orstanorm
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Orstanorm
You must continue to take Orstanorm throughout the time prescribed by your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor immediately, or seek emergency care at a nearby hospital if you experience any of the following side effects:
- Hypersensitivity reactions: redness of the skin, swelling of the face, hives, difficulty breathing. (Rare: may affect up to 1 in 1,000 people)
- Signs of “ergotism” (sharp contraction and spasm in the blood vessels) such as a tingling or stinging sensation in the fingers and toes, chest pain, impaired blood supply to the heart, pain in the heart area, pain and weakness in the arms and legs, cold hands and feet (not related to low temperatures) due to reduced blood supply. (Has been reported: occurs in an unknown number of users)
- Pain in the lower back or side, associated with difficulty urinating or pain when urinating, which may be a sign of retroperitoneal fibrosis , a thickening of the abdominal connective tissue that may cause contraction of the urinary tract. (Rare: may affect up to 1 in 1,000 people)
Additional side effects reported are as follows:
Uncommon (may affect up to 1 in 100 people):
- Nausea and vomiting
Rare (may affect up to 1 in 1,000 people):
- High blood pressure
- Dizziness
- Headache
- Stomach pain, diarrhea
In a few patients treated with Orstanorm regularly for several years, scarring (fibrotic changes) has been observed, especially in the alveoli (signs include shortness of breath, dry cough, pain in the chest or ribs) behind the peritoneum and in the heart valves.
In isolated cases, Orstanorm may increase the risk of a heart attack.
Has been reported: occurs in an unknown number of users:
Muscle cramps have also been reported during use after product approval.
How to store Orstanorm
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. and on the print packaging and the can label after EXP. The expiration date is the last day of the specified month.
Do not use this medicine if the package is damaged or shows signs of opening.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is dihydroergotamine mesylate
- The other ingredients are tartaric acid, gelatin, magnesium stearate, stearic acid, talc, corn starch, lactose monohydrate .
What the medicine looks like and contents of the pack
The 2.5 mg tablet is whitish and round. One side is notched and marked with the code ZI.
The 5 mg tablet is whitish and round. One side is notched and marked with the code BU.
The tablets are delivered in pressure packs containing 100 tablets and in glass jars containing 200 tablets.
Marketing Authorisation Holder
Amdipharm Limited
Temple Chambers
3 Burlington Road
Dublin 4
Ireland
Tel. +44 1268 82 3049
Manufacturer
CENEX SAS
52, rue Marcel and Jacques Gaucher
94120 Fontenay-sous-Bois
France
Amdipharm UK Limited
Capital House, 85 King William Street,
London EC4N 7BL
UK