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Drug No Spa have composition drotaverine hydrochloride 40 mg, is a smooth muscle spasmolytic medecine : Indicated for Colic biliary pain due to smooth muscle spasm  in connection with biliary tract diseases cholecystolithiasis. cholangiolithiasis, cholecystitis …

MEPRAZ treat of for Gastric ulcer, Gastroesophageal Reflux Disease

Phosphalugel treatment of pain, acidity or burning in the stomach or oesophagus

Maalox treatment of Gastritis,  Dyspepsia, Peptic ulcer, Hiatal hernia

FORM AND PRESENTATION: Tablet

Blister of 10 tablets, box of 2 blisters and box of 5 blisters.

COMPOSITION

Drotaverine hydrochloride 40 mg

Excipients qs. for 1 tablet: lactose monohydrate, maize starch, talc, magnesium stearate.

No Spa 40 mg - Drotaverine hydrochloride 40 mg

PHARMACOLOGICAL PROPERTIES

Pharmacodynamic properties ATC A03A 002

Pharmacotherapeutic group: smooth muscle spasmolytic agent indicated tor treatment of pain syndromes of various organs: gastrointestinal, biliary, urogenital and vascular systems.

No Spa 40 mg ( Drotaverine ) is an isoquinoline derivative, having smooth muscle spasmolytic due to inhibit PDE IV (c AMP specific phosphodiesterases) in vitro without inhibiting the PDE III and PDE V isoenzymes.

PDE4 inhibitors have myorelaxant properties and anti-inflammatory activity. As a consequence of inhibiting the PDE IV enzyme it results in the increase of the intracellular cAMP concentration which by inactivating the myosin light chain kinase enzyme (MICK) and the intracellular calcium ion (Ca++) concentration declines, thus leading to the relaxation of the smooth muscle. Functionally, PDE IV appears to be very important in reducing smooth muscle contractile activity, suggesting that selective PDE IV inhibitors might be useful in the treatment of hypermotility disorders and various diseases associated with spastic conditions of the gastrointestinal, urogenital system.

The enzyme that hydrolyses cAMP in myocardial and vascular smooth muscle cells is mainly the PDE III isoenzyme, this explains, that drotaverine is an effective spasmolytic agent without serious cardiovascular adverse effects and strong cardiovascular therapeutic activity.

It is effective in case of smooth muscle spasms of both neural- and muscular origin.

Independently from the type of autonomous innervation, drotaverine acts on the smooth muscles found in the gastrointestinal, biliary, urogenital and the vascular system.

Due to its vasodilatator effect it increases the tissue circulation.

Droatevrine’s effect is stronger than papaverine’s, its absorption is more rapid and more complete, and it bonds less to the serum proteins.

Drotaverine free of anticholinergic effects.

Pharmacokinetic properties

Drotaverine is rapidly absorbed after oral administration. Volume of distribution = 200 litres.

It is highly bound to human plasma proteins (95-98%). especially to albumin, gamma and beta globulins. Drotaverine might cross the placental barrier.

is reached within 45-60 min after oral administration and after its first pass metabolism the 65% of the administered dose reaches the circulation unchanged.

It is metabolized in the liver. Its biological half-life is 16-22 hours.

Practically within 72 hours it disappears from the body. More than 50% of it is excreted in the urine and about 30% in the faeces. It is mainly excreted in the form of main metabolites: its unchanged form cannot be detected in the urine.

THERAPEUTIC INDICATIONS

No Spa 40 mg is a smooth muscle spasmolytic medecine.

Colic biliary pain due to smooth muscle spasm in connection with biliary tract diseases cholecystolithiasis. cholangiolithiasis, cholecystitis, pericholecyctitis, cholangitis and papillitis.

Colic renal pain due to smooth muscle spasm in urinary tract diseases: nephrolithiasis, ureterolithiasis. pyelitis, cystitis and cramp of urinary bladder.

As adjuvant treatment:

– Abdomen pain oi colic abdomen pain due to smooth muscle spasm of gastrointestinal origins: gastric and duodenal ulcer, gastritis, cardia and pylorus spasm, enteritis and colitis, spastic colitis with constipation and meteoristic forms of irritable colon syndrome. Drotaverin improves quickly and effectively anti-spasmolytic adbomen pain but not faints the emergency abdomen symptoms.

– In gynaecological diseases: dysmenorrhoea.

Adults:

Adults; the usual average daily dose is 120-240 mg/day (in 2-3 divided doses). Similar dosage: 1-2 tablets, 3 times/day.

Children:

For the children, the usual average daily dose is:

– Children between 1 and 6 years old: 40-120 mg/day (in 2-3 divided doses). Similar dosage: 1/2 = 1 tablet. 2-3 times/day.

– Children over 6 years of age: 80-200 mg/day (in 2 5 divided doses). Similar dosage: 1 tablet. 2-5 times/day.

CONTRA-INDICATIONS

DO NOT USE No Spa 40 mg in the following cases:

  1. Hypersensitivity to the active substance or to any of the excipients.
  2. Severe renal, hepatic or cardiac insufficientcy flow EF syndrome)
  3. A-V block of ll-HI degree.

– Tablet forms should not be administered to babies under 1 year old.

PRECAUTIONS

Special warnings and precautions for use Drotaverine’s administration requires increased caution in case of low blood pressure.

When taken according to the recommended dose regimen, the total daily dose intake of lactose is unsuitable for people with lactase insufficiency, galactosaemia or glucose-galactose malabsorption syndrome.( No-spa 40mg tablet contains 50mg of lactose).

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

Together with levodopa, as the antiparkinson effect may decreases, and tremor, rigidity become aggravated.

PREGNANCY AND LACTION

Before to apply any medicine, consult at your medical doctor or pharmacist.

Pregnancy:

There is no evidence of teratogenicity and embryotoxicity from retrospective human and animal studies by oral route. Nevertheless, caution should be taken when prescribed during pregnancy.

Lactation:

There are no adequate data on the use of drotaverine in lactaction women, this medicine should not recommended for prescribing in these subjects.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

In therapeutic doses, drotaverine has no effect on ability to drive or operate machinery during oral treatment.

Patients should be instructed that if they experience vertigo, they should avoid potentially hazardous tasks such as driving or operating machines.

UNDESIRABLE EFFECTS

The following related drotaverine adverse reactions from clinical investigations were listed below by frequency grouping Very common (>1/10), common (>1/100. <1/10), uncommon (>1/1000, <1/100), rare (>1/10.000, <1/1000) and very rare (<1/10.0001 and system organ class:

– Gastrointestinal disorders:

Rare: nausea, constipation.

– Central and peripheral nervous system disorders:

Rare: headaches, dizziness, insomnia.

– Cardiovascular system disorders:

Rare: palpitation, hypotension.

Inform your medical doctor about the above mentioned adverse effects It besides the adverse reactions listed here you notice other unusal symptoms, inform on it to your doctor or pharmacist.

OVER – DOSAGE

No data concerning overdose are available. In over-dosage case, patient needed tightly critical care supervision, and symptomatic treatment and adjuvant care.

Suggested measures include emesis and/or gastric lavage.

STORAGE: Store at 250C – 300C.

Keep out of the reach of children.

SPECIFICATION: Manufacturer specification.

SHELF LIFE: 24 months from the manufacturing date.

DO NOT USE LATER THAN THE DATE OF EXPIRY

Read carefully  all of this package insert before using No Spa. keep this leaflet. You may need read it again. If you have any further questions, ask your doctor or your pharmacist, No Spa has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. It any of the safe effects gets serious,  listed in this leaflet, please tell your doctors or if you notice any side effects not  pharmacists.

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