DRO SPAZ 80 mg. 10 tablets

What DRO Spaz tablets are and what it is used for
Dro Spaz tablets are an antispasmodic (soothing or spasmodic) product.

It applies in the following cases:
Spasms of smooth muscles associated with diseases of the bile ducts and gall bladder of different origins: bile stones, cholecystitis (inflammation of the gall bladder);
Spasms of smooth muscles in urinary tract diseases: kidney stones, urinary stones, inflammation of the renal pelvis, cystitis (bladder inflammation), bladder spasms.
As an adjunct therapy:
In spasms of smooth stomach and intestinal muscles: stomach and duodenal ulcer, gastritis (gastric mucosal inflammation), stomach spasm, enteritis (inflammation of the intestinal mucosa), hypersensitivity and irritability of the colon accompanied by constipation or flatulence Formation of gases in the digestive tract, mainly in the intestine);
Tension-like headache;
For gynecological diseases: painful menstruation.
If after 3 days you do not feel better or your condition gets worse, you should seek medical attention.

2. What you need to know before taking Dro Spaz tablets
Do not take Dro Spaz tablets:
If you are allergic to drotaverine or any of the other ingredients of this medicine (listed in section 6);
If you have severe liver, kidney or heart failure (low-grade syndrome;
In children under 1 year of age.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Dro Spaz.

You need to know that:
Dro Spaz tablets are taken with caution when:
Patients with low blood pressure and especially with a shock (systolic blood pressure below 90 mm Hg);
In patients sensitive to lactose, administration of this product may cause gastrointestinal complaints due to the lactose content of the tablets.
Children and adolescents
The use of Drotaverin has not been studied in children.
Other Drugs and Drug Rescue
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The effect of medicinal products that are used to treat Parkinson's disease (eg levodopa) is reduced with concomitant administration of Drospaz tablets (skeletal muscle stiffness and tremor may worsen).

Dro Food, drink, and alcohol
No restrictions.

Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Animal data and human observations do not indicate the presence of harmful effects during pregnancy. Fetal involvement has not been established. However, during pregnancy, especially during the first trimester, the product should be used with caution.

Breastfeeding
Due to the lack of sufficient results from studies, the use of Dro Spas tablets during breast-feeding is not recommended unless it is prescribed by your doctor.

Fertility
Fertility data are not available.

Driving and using machines
Taken at usual doses, drotaverine does not affect the ability to drive and use machines. However, in the event of dizziness after taking it, avoid dangerous situations and refrain from driving and operating machinery.

Dro Spaz contains the excipient lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product.

3. How to take DRO Spaz tablets
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose is:
Adults:
The usual daily dose is 120-240 mg (1 1/2 - 3 tablets) divided into 2-3 administrations.

Use in children and adolescents:
The use of Drotaverin in children has not been evaluated in clinical trials.
The medicinal product should not be used for more than 7 days without consulting a doctor.

Method of administration:
It is taken by mouth with sufficient fluid.

If you take more Drop Tablets than you should
No overdoses have been reported.
In the event of an overdose, you should contact your doctor or your nearest emergency department immediately.

If you forget to take DRO Spaz tablets
Do not take a double dose to make up for the missed dose. Do this at the time of the next regular intake.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.

Adverse reactions are classified according to the frequency of their occurrence and are divided into:
Very common: may affect more than 1 in 10 people;
Common: may affect up to 1 in 10 people;
Uncommon: may affect up to 1 in 100 people;
Rare: may affect up to 1 in 1,000 people;
Very rare: may affect up to 1 in 10,000 people;
Not known (can not be estimated from the available data).
The side effects with Dro Spaz tablets are rare. They are usually mild, resolute and reversible when discontinuing the product.

Rare: headache, vertigo, insomnia, nausea and palpitations, constipation, low blood pressure.

Rarely: severe allergic reaction that causes swelling of the face or throat, urticaria, rash, pruritus.
 How to store Dro Spaz tablets
Keep out of the reach and sight of children.
Store in the original package at temperatures below 25 ° C.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not dispose of medicines in the sewers or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Package Contents and Additional Information
What Dro Spaz contains
The active substance in 1 tablet: is drotaverine hydrochloride (80 mg).
The other ingredients (excipients) are: lactose monohydrate, povidone, microcrystalline cellulose, croscarmellose sodium, magnesium stearate.

What Dro Spaz looks like and what the package contains
The tablets are yellow with a faint greenish tinge, oval with a convex surface and a dividing line on one side. A slight mosaic is possible.
The pack contains 10 tablets in a PVC / AL blister.
2 blister cards x 10 tablets with a leaflet in a folding carton.

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