Dear Patient.
Prescription drugs may be prescribed by a doctor.
If you have lost a leaflet from the drug, here you can get a copy of it.
In medical matters concerning dosage, consult your doctor.
Bellergot tablets
Ergotamini tartras + Atropinum + Phenobarbitalum 0.3 mg + 0.1 mg + 20.0 mg coated tablets
Single coated tablet contains:
- Active substances:
- Ergotamine tartrate 0.3 mg
Atropine 0.1 mg (as a class of tropane alkaloids)
Phenobarbital 20.0 mg
- Ergotamine tartrate 0.3 mg
- Excipients: Lactose monohydrate, potato starch, magnesium stearate, gelatine, talc, gum arabic, saccharose, indigotine (E132).
Individual package contains 30 coated tablets.
What are Bellergot tablets and what are they for?
Bellergot tablets contain three active substances: phenobarbital, ergotamine tartrate and tropane alkaloids.
Phenobarbital is a sedative, hypnotic and anticonvulsant. Tropane alkaloids are smooth muscle relaxants for internal organs such as bronchitis, digestive and urinary tract. They also inhibit the secretional activity of skin and mucous membranes glands, such as sweat, salivary and bronchial glands. Tropane alkaloids also exhibit anti-emetic activity. Ergotamine tartrate contained in Bellergot tablets is an antimigraine agent increasing directly vascular wall tension.
Concomitant action of ingredients makes Bellergot tablets a sedative, hypnotic, antimigraine and anticholinergic medicine (i.e. they reduce sympathetic nervous system tension).
Therapeutic indications:
Bellergot tablets are used in nervous excitability which accompanies the symptoms of menopause and in migraine headaches.
Before you take Bellergot tablets
Do not take Bellergot tablets if you:
are hypersensitive to any of the ingredients, suffer from porphyria, myasthenia gravis, myxoedema, Parkinson’s disease, respiratory failure, heart, liver or kidney failures, dependence on alcohol and smoking, peripheral vascular disease (atherosclerosis, Raynaud’s disease), coronary heart disease, hypertension, diabetes, pruritus, sepsis, narrow-angle glaucoma, urinary obstruction, intestinal obstruction, are pregnant or breastfeeding.
Take special care before you take Bellergot tablets:
as they are intended for acute therapy in a short-term treatment.
Long-term use of painkillers can worsen headaches. if you suffer from headaches during regular analgesic use. In this case ask your doctor.
Taking Bellergot tablets with food and drink:
Do not take this medicine with grapefruit juice or eat grapefruit or products containing grapefruit while taking this medicine.
Do not drink alcohol whilst taking this medicine.
Use of Bellergot tablets in children:
Do not use in children.
Pregnancy:
Ask your doctor for advice before taking any medication. Do not use during pregnancy.
Breast-feeding:
Ask your doctor for advice before taking any medication. Do not use during breast-feeding.
Driving and using machines:
This medicine may impair psychomotor performance, hence patients taking Bellergot tablets are advised not to drive or use machines.
Important information about some of the ingredients of Bellergot tablets:
Tell your doctor if you are intolerant to certain sugars.
Taking Bellergot tablets with other drugs:
Consult the concomitant use of Bellergot tablets and other medicines with your doctor each time due to the risk of interactions.
Tell your doctor if you are taking any other medicines, especially OTC medicines you have bought yourself.
How to take Bellergot tablets
This medicine is intended for oral use in adults.
In the treatment of nervous excitability which accompanies the symptoms of menopause: take 1 or 2 coated tablets 2 or 3 times a day.
In the treatment of migraine: take 3 coated tablets at once. If necessary, the dose may be repeated after at least 1 hour.
Do not take more than 12 coated tablets in 24 hours in the treatment of migraine.
This product should be used only when necessary, at an ad hoc basis.
This medicine is not intended for chronic treatment.
Do not take more than 32 coated tablets weekly.
If you feel that the medicine is too strong or too weak, talk to your doctor.
Do not exceed the stated dose of Bellergot tablets.
If you take more than the recommended dose, contact your doctor immediately.
What should you do if you forget to take a dose?
Do not take a double dose to make up for a forgotten dose.
Possible side-effects
Like all medicines, Bellergot tablets can cause side effects, although not everybody gets them.
Recommended doses of Bellergot tablets are well tolerated. Side effects that may occur are moderate. Occurrence of side effects is associated with high doses and long-term therapy.
Side effects were listed by MedDRA body system organ class and by frequency: very common (> 1/10), common (> 1/100 to <1/10), uncommon (> 1/1,000 to <1/100), rare (> 1/10,000 to <1/1000), very rare (<1/10,000), including isolated reports.
Gastrointestinal disorders:
Common: nausea, vomiting. Uncommon: excessive thirst, abdominal pain.
Nervous system disorders:
Common: somnolence. Uncommon: anxiety and agitation, depression.
Skin and subcutaneous tissue disorders:
Common: allergic reactions (hives, skin rash swelling), decreased perspiration. Very rare: exfoliative dermatitis, Stevens-Johnson syndrome, Lyell syndrome.
Heart disorders:
Uncommon: arrhythmia, bradycardia, coronary vasospasm, myocardial ischaemia and retrosternal pain, retroperitoneal fibrosis, cardiac valve fibrosis, pulmonary fibrosis and retroperitoneal fibrosis.
Vascular disorders:
Uncommon: peripheral blood vessels contraction and ischaemic changes, cold feeling in extremities, numbness of fingers and toes, weakness of the lower limbs.
General disorders and administration site conditions:
Common: dryness of mucous membranes in the nose and mouth, decreased salivation, increased body temperature. Uncommon: limb weakness, muscle pain, numbness and tingling of fingers and toes, local swelling and itching.
Blood and lymphatic system disorders:
Very rare: agranulocytosis, thrombocytopoenia, megaloblastic anaemia.
Eye disorders:
Common: slight increase in intraocular pressure, slight mydriasis, photophobia.
Renal and urinary tract disorders:
Very rate: oliguria.
Pregnancy, puerperium and perinatal period:
Common: influence on uterine contractions (increasing the strength and frequency of contractions), which is the risk of miscarriage or premature birth.
Congenital, familial and genetic disorders:
This medicine may be a teratogen.
If any of these effects occur stop taking this medicine and tell your doctor.
How to store Bellergot tablets
Do not store above 25°C.
Do not take this medicine after the expiry date which is stated on packaging. Keep out of the reach and sight of children.
6. Other information
Other information
For more detailed information, please contact the local representative of the Marketing Authorization holder – phone: (+48) 71 321 86 04 ext. 123
Wrocławskie Zakłady Zielarskie „Herbapol” S.A.
Poland, 50-951 Wrocław, ul. Św. Mikołaja 65/68
Before use read the leaflet, which includes indications, contraindications, data on adverse effects and dosage, as well as information about the medicinal product, or consult your doctor or pharmacist, as each drug used improperly threatens your life or health.