SPAZMOBLOK 20 tablets

What is Spazmoblok and what it is used
Spazmoblok combined medicine that combined analgesic and relaxing smooth muscle action.
Spazmoblok apply for the symptomatic treatment of mild or moderate pain syndrome expressed in spasms of smooth muscles of internal organs in stomach or intestinal colic; biliary colic, renal colic kidney stone disease in painful menstruation (dysmenorrhea).

2. Before you take Spazmoblok
Do not take Spazmoblok in the following cases:
if you are allergic (hypersensitive) to any of the active substances and / or any of the excipients;
in case of hypersensitivity to pyrazolone derivatives or other NSAIDs;
in the gastro-intestinal obstruction and megacolon (enlarged colon);
difficulty in emptying due to weakness of the muscles (atony) and gall bladder;
in severe hepatic and renal failure;
in some hereditary diseases (glucose-b-phosphate dehydrogenase and porphyria);
some blood diseases - leukopenia (reduction in the total number of leukocytes), agranulocytosis (severe reduction or complete absence of certain white blood cells - granulocytes), aplastic anemia (anemia caused damage to the hematopoietic function of bone marrow);
glaucoma (acute glaucoma characterized in that the intraocular pressure increases very quickly);
Pregnancy and lactation.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before taking Spazmoblok.
The product is used with caution in patients with impaired renal and / or hepatic function, diseases associated with narrowing of the gastrointestinal tract and difficulty in passing the gastro-intestinal contents (achalasia, pyloroduodenal stenosis), gastroesophageal reflux disease, intestinal agony, paralytic ileus , glaucoma (increased eye pressure), myasthenia gravis (muscle weakness), heart disease (arrhythmias, ischemic heart disease, congestive heart failure), with known hypersensitivity to NSAIDs, analgesic and antirheumatic drugs (intolerance to analgesics), and and other medications or food or other allergy (hay fever, asthma).
With prolonged acceptance of the product (more than 7 days) is necessary to control the peripheral blood count and functional status of the liver.
Metabolites of Metamizole can color the urine in red, which has no clinical significance.

Other medicines and Spazmoblok
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines.
Concomitant use of Spazmoblok with other medicinal products can strengthen or weaken their effects:
Metamizole increases the content of antiparasitic chloroquine in the blood, reduces the effects of coumarin anticoagulants (products reduce blood clotting) and cyclosporine;
tricyclic antidepressants, oral contraceptives and allopurinol, slow metabolism Metamizole and increase its toxicity;
barbiturates, glutethimide, phenylbutazone (products that enhance the decomposing function of the liver) may reduce the effects of Metamizole;
soothing nervous system drugs (sedatives and tranquilizers) enhance the analgesic effect of Spazmoblok;
concomitant use of Spazmoblok other antipyretic, analgesic and anti-inflammatory drugs increases the risk of allergic reactions;
with concomitant Spazmoblok with chloramphenicol and other myelotoxic products there is a risk of inhibiting the function of bone marrow;
with concomitant administration of metamizole with chlorpromazine and other phenothiazine derivatives have an increased risk of decreased body temperature.
Spazmoblok food, beverages and alcohol:
It should avoid alcohol during treatment with the product.

Pregnancy, lactation and fertility
Please ask your doctor or pharmacist before taking any medicine.

pregnancy
Spazmoblok not be used during pregnancy.

breastfeeding
The product passes into breast milk and is not recommended during lactation.

Driving and using machines
It should be used with caution in people who drive or operate machines as prolonged adoption of Spazmoblok can occur dizziness and infringement accommodative (ability of the eye for seeing close and far away).

Spazmoblok contains wheat starch and lactose
In the composition of the medicinal product contains, as excipient, wheat starch, which makes it unsuitable for patients with celiac disease (a congenital disorder of the small intestine, manifested by diarrhea with the use of wheat products).
This medicinal product contains lactose as an excipient, which makes it unsuitable for patients with lactose intolerance.

3. How to take Spazmoblok
Always take this medicine exactly as described in this leaflet or as you told your doctor, pharmacist or nurse. If you're not sure, ask your doctor, pharmacist or nurse.

Recommended daily doses:
Adults and children over 15 years:
1-2 tablets, 3-4 times daily.
Maximum daily dose - 6 tablets.

Children and adolescents under the age of 15
from 12 to 15 years old - 1 tablet 2-3 times a day. Maximum daily dose - 3 tablets;
from 9 to 12 years of age - 1/2 tablet 2-3 times a day. Maximum daily dose - 2 tablets.
The tablets are taken orally with water after eating.
Treatment duration should not exceed H days.

If you take more than the amount Spazmoblok
When taking a higher dose than prescribed, immediately contact a doctor! Your doctor will decide what measures should be taken if necessary.
Overdose most commonly observed allergic reactions, nausea, vomiting, dizziness, tinnitus, shock, acute renal and liver failure, seizures. The first measures overdose are vomiting, gastric lavage, followed by symptomatic treatment. There is no specific antidote.

If you forget to take Spazmoblok
If you miss a dose, take the medicine at the next regular intake without increasing the dose.
Do not take a double dose to make up for a missed tablet.

If you stop taking Spazmoblok
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS
Like all medicines Spazmoblok can cause side effects, although not everybody gets them.
Adverse reactions are divided into groups according to the terminology of the Medical Dictionary for Regulatory Activities (MedDRA) together with the frequency:
Very common (> = 1/10); Common (> = 1/100, <1/10); Uncommon (> = 1/1000, <1/100); Rare (> = 1 / 10,000 to <1/1 000); Very rare (<1/10 000); Not known (from the available data can not be estimated).

Adverse reactions when using Spazmoblok are most often temporary and resolved with discontinuation of treatment. Some patients can be observed:
Blood and lymphatic system - changes in the number of blood cells (agranulocytosis, thrombocytopenia, leukopenia - a decrease in platelets or leukocytes);

Immune system disorders - rashes, urticaria, pruritus, rarely severe allergic reactions - bronchospasm (reduction of smooth muscles of the bronchial walls), angioedema (swelling of face, lips, eyelids and some mucous membranes); very rarely anaphylactic shock.

Nervous system - dizziness.

Eye disorders - visual disturbances.

Cardiac disorders - a rare sense of palpitations, rapid pulse, heart rhythm disturbances.

Vascular disorders - lower blood pressure.

Respiratory, thoracic and mediastinal disorders - bronchospasm.

Gastrointestinal disorders - discomfort, dry mouth, constipation, exacerbation of gastritis or peptic ulcer disease.

Skin and subcutaneous tissue disorders - are rare skin allergies and rashes, Lyle syndrome or Stevens-Johnson (severe blisters on the skin).

Renal and urinary disorders - difficulty urinating, decreased or increased amount of urine, inflammation of the kidneys.

If any of the side effects gets serious, or if you notice any not mentioned in this leaflet, please tell your doctor or pharmacist.

5. How to store Spazmoblok
Keep out of reach of children.
Do not store above 25 ° C.
Keep your tablets in the original package to protect from light and moisture.
Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of that month.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information
What Spazmoblok
The active substances in one tablet are: Metamizole sodium / (Metamizole sodium) 500 mg, Pitofenon hydrochloride (Pitofenone hydrochloride) 5 mg, Fenpiverin bromide (Fenpiverinium bromide) 0,1 mg.
The other ingredients (excipients) are: corn starch, lactose monohydrate, gelatin, microcrystalline cellulose, talc, sodium hydrogencarbonate, magnesium stearate.

Spazmoblok looks like and contents of the pack
description
Spazmoblok is a white or almost white, round, flat tablets scored on one side. The tablets can be divided into two equal halves.

Package
10 tablets in blister PVC / Al.
2 blisters with leaflet in a carton.