APPROVED
Order of the Ministry of
Health of Ukraine
571 № 06.09.2011
Registration certificate
№UA/6289/01/01
INSTRUCTION FOR USE
of medicinal preparation
DROTAVERINЕ
General characteristic:
International nonproprietary and chemical names: drotaverinе;
1-[(3,4-Diethoxyphenyl)methylene]-6,7-diethoxy-1,2,3,4-tetrahydroisoquinoline hydrochloride;
main physicochemical properties: round, plain tablets of light-yellow, light yellow with greenish
shade, yellow or yellow with greenish shade colour with beveled edge. The surface of tablets can
be marble.
composition: 1 tablet contains drotaverinе hydrochloride 0.04 g (40 mg) calculated as 100%
substance;
excipients: potato starch, GranuLac-70 (lactose monohydrate), medicinal low molecular
polyvinylpyrrolidone, calcium stearate.
Pharmaceutical form. Tablets.
Pharmacotherapeutic group. Synthetic antispasmodic and anticholinergic agents.
АТС Code А03А D02.
Pharmacological properties
Pharmacodynamics. Myotropic spasmolytic. Its chemical structure and pharmacological properties
are close to those of papaverine, but the effect is stronger and more durable. It decreases the influx
of active calcium into smooth muscles due to inhibiting of phosphodiesterase and intracellular
increase of cAMP level. The preparation decreases the tone of smooth muscles in visceral organs,
reduces intestinal peristalsis, dilatates blood vessels. It does not have an impact on vegetative
nervous system, does not cross blood-brain barrier. The preparation increases minute blood
volume.
Pharmacokinetics. Rapidly and completely is absorbed in gastro-intestinal tract. Following oral
administration bioavailability of drotaverine is close to 100%, elimination half-life is 12 minutes.
Drotaverine is uniformly distributed in tissues, penetrates smooth muscles. The preparation is
excreted in the urine.
Indications for use. Spasm of smooth muscles in visceral organs (cardio- and pyloric spasm),
chronic gastroduodenitis, gastric and duodenal ulcers, cholelithiasis, nephrolithiasis (colics),
chronic cholecystitis, postcholecystectomy syndrome, hypermotor biliary dyskinesia, spasmodic
intestinal dyskinesia, intestinal colic associated with postoperative flatulence, colitis, proctitis,
tenesmus, flatulence, pyelitis, headache associated with cerebral vasospasm, spasms of the
coronary and peripheral arteries (obliterating endarteritis, Raynaud's disease), to weaken uterine
contractions when needed and to relieve cervical spasm in labor, spasm of smooth muscles during
instrumentation.
Posology and Method of Administration. Drotaverine is intended for oral use.
Adults are prescribed 1 - 2 tablets 2 - 3 times daily. The duration of treatment depends on the
nature of the disease and should be determined by a physician.
Since no reliable information on the use of the medication in children is available, Drotaverine
should only be used on prescription and under a physician's supervision, having weighed the
potential risks and benefits.
Children of 1 to 6 years of age are prescribed 1/2 tablet 1 - 2 times daily; children of 6 to 12 years
of age - 1 tablet 2 - 3 times daily; over 12 years of age- 1-2 tablets 2 - 3 times daily. When used in
children, a tablet should be crushed and taken with a small volume of water.
Undesirable effect. Drotaverine is usually well tolerated. Occasionally arrhythmia, arterial
hypotension, palpitations, allergic dermatitis, constipation, sweating, flushing may occur.
Contraindications. Hypersensitivity to drotaverine; significant hepatic, renal, and cardiac
insuffiency, II - III degree atrioventricular block, cardiogenic shock, arterial hypotension, children
under 1 year of age..
Overdose. In case of overdose atrioventricular block, cardiac arrest, paralysis of respiratory center
may occur. The treatment is symptomatic.
Special warnings and precautions for use. The preparation should be used with caution in
pregnant, in patients with marked coronary atherosclerosis.
Drotaverine may be used as a part of combined treatment in management of hypertonic crisis.
Drotaverine as well as papaverin has no anticholinergic effect, and therefore, unlike cholinolytic
antispasmodic, may be administered in patients with glaucoma. Coincidently, the preparation
should be administered with caution in patients with prostatic hypertrophy (prostate adenoma)
since due to detrusor muscle relaxation urine retention may occur.
Interaction with other medicaments. Intensifies the effect of other spasmolytics (including Mcholinoblockers), increases hypotension caused by tricyclic antidepressants, quinidine, and
novocainamid. Concurrent use of phenobarbital has additive beneficial effect on spasm. The
preparation reduces spasmogenic morphine activity, antiparkinsonian levodopa activity.
Shelf-life and conditions for storage. Store in protected from the light place at the temperature
15 - 25 °С. Shelf-life 3 years.
Keep out of reach of children.
Dispensing category Non-prescription medicine.
Nature and content of container. Tablets 0.04 g №10 in blister, 1 or 3 blisters in pack.
Manufacturer OJSC «Kyivmedpreparat».
Location. Ukraine, 01032, Kyiv, Saksaganskogo str, 139.
Phone (044) 490 7522.
APPROVED
Order of the Ministry of
Health of Ukraine
________ № _____
Registration certificate
№ _________________
DROTAVERINЕ
40 mg tablets
PACKAGE LEAFLET. INFORMATION FOR THE PATIENT.
Read all of this leaflet carefully before you start using this medicine! Keep this leaflet. You may
need to read it again. If you have further questions, ask your doctor or pharmacist. This medicine
has been prescribed for you, do not recommend it to others without doctor’s consultation. It may
harm them, even if their symptoms are the same as yours.
Composition:
Active substance: 1 tablet contains drotaverinе hydrochloride 0.04 g (40 mg) calculated as 100%
substance;
Excipients: potato starch, GranuLac-70 (lactose monohydrate), medicinal low molecular
polyvinylpyrrolidone, calcium stearate.
Pharmaceutical form. Tablets.
Pharmacotherapeutic group. Antispasmodic agent. Its chemical structure and pharmacological
properties are close to those of papaverine, but the effect is stronger and more durable. The
preparation decreases the tone of smooth muscles in visceral organs, reduces intestinal motility,
dilatates blood vessels. It does not have an impact on vegetative nervous system, does not cross
blood-brain barrier. Rapidly and completely is absorbed in gastro-intestinal tract. Drotaverine is
uniformly distributed in tissues, penetrates smooth muscles. The preparation is excreted in the
urine.
Indications for use. Drotaverine is used for abdominal pain management, caused by spasm of
smooth muscles in visceral organs: chronic gastroduodenitis, gastric and duodenal ulcers,
cholelithiasis, nephrolithiasis (colics), chronic cholecystitis, postcholecystectomy syndrome,
hypermotor biliary dyskinesia, spasmodic intestinal dyskinesia, intestinal colic associated with
postoperative flatulence, colitis, proctitis, tenesmus, flatulence, pyelitis, headache associated with
cerebral vasospasm, spasms of the coronary and peripheral arteries (obliterating endarteritis,
Raynaud's disease), to weaken uterine contractions when needed and to relieve cervical spasm in
labor, spasm of smooth muscles during instrumentation.
Contraindications. Significant hepatic, renal, and cardiac insuffiency; II - III degree
atrioventricular block; cardiogenic shock; pediatric age up to 1 year; arterial hypotension. Known
hypersensitivity to components of the preparation.
Precautions for use. Without doctor’s consultation the preparation should not be used longer than
indicated, dosage must not exceed recommended!
Please pay your attention to the possible risk of administration of the preparation in pregnant, in
patients with marked coronary atherosclerosis.
If symptoms are not reducing or you feel worse, or you noticed any of side effects, please consult
your doctor about further taking your medicine!
Interaction with other medicaments.
Please tell your doctor if you are taking or have recently taken any other medicine. Drotaverinе
intensifies the effect of other spasmolytics, increases hypotension caused by tricyclic
antidepressants, quinidine, and novocainamid. Concurrent use of phenobarbital has additive
beneficial effect on spasm. The preparation reduces spasmogenic morphine activity,
antiparkinsonian levodopa activity
Special warnings. In consultation with doctor, Drotaverinе may be used as a part of combined
treatment in management of hypertonic crisis. Drotaverinе, unlike other (cholinolytic)
antispasmodic, may be administered in patients with glaucoma. Coincidently, the preparation
should be administered with caution in patients with prostatic hypertrophy (prostate adenoma)
because urine retention may occur.
Posology and Method of Administration. Drotaverine is intended for oral use.
Adults are prescribed 1 - 2 tablets 2 - 3 times daily. The duration of treatment depends on the
nature of the disease and should be determined by a physician.
Since no reliable information on the use of the medication in children is available, Drotaverine
should only be used on prescription and under a physician's supervision, having weighed the
potential risks and benefits.
Children of 1 to 6 years of age are prescribed 1/2 tablet 1 - 2 times daily; children of 6 to 12 years
of age - 1 tablet 2 - 3 times daily; over 12 years of age- 1-2 tablets 2 - 3 times daily. When used in
children, a tablet should be crushed and taken with a small volume of water.
In case of overdose atrioventricular block, cardiac arrest, paralysis of respiratory center may occur.
In order to maintain the function of vital organs, an ambulance should be called in.
підтримки функцій життєво важливих органів необхідно викликати швидку допомогу.
Undesirable effect. Drotaverine is usually well tolerated. Occasionally arrhythmia, arterial
hypotension, palpitations, allergic dermatitis (cutaneous flushing, edema), constipation, sweating,
flushing may occur.
If any of the side effects occur, or if you notice any side effects not listed in this leaflet, please
consult your doctor about further taking your medicine.
Shelf-life. Do not use the medication after the expiry date!
Shelf-life is 3 years.
Visual signs that preparation got out of use: change of the colour.
Conditions for storage. Store in protected from the light place at the temperature 15 - 25 °С. .
Keep out of reach of children!
Nature and content of container. Tablets 0.04 g №10 in blister, 1 or 3 blisters in pack.
Dispensing category Non-prescription medicine.
Name and address of manufacturer OJSC «Kyivmedpreparat».
Ukraine, 01032, Kyiv, Saksaganskogo str, 139.
Phone (044) 490 7522.