Active ingredients: Cholestyramine
QUESTRAN 4 g powder for oral suspension
Indications Why is Questran used? What is it for?
Questran contains cholestyramine, which belongs to a group of drugs known as bile acid sequestrants.
Questran is indicated for lowering blood cholesterol levels in patients:
- with an excess of cholesterol not associated with any other disease (primary hypercholesterolemia)
- with an excess of cholesterol associated with an excess of triglycerides in the blood (hypercholesterolemia associated with hypertriglyceridemia), when hypercholesterolemia represents the main therapeutic problem. Therefore Questran is not indicated if the primary alteration is the only hypertriglyceridemia
- with an excess of cholesterol that cannot be controlled by a proper diet alone.
Questran is also indicated to reduce itching associated with partial blockage of the biliary tract (the transport system of the bile produced by the liver).
Contraindications When Questran should not be used
Do not take Questran
- If you are allergic to cholestyramine or any of the other ingredients of this medicine
- If you have a complete blockage of the biliary tract, as Questran cannot perform any activity if the bile is not poured into the intestine.
- If you suffer from phenylketonuria, a disease characterized by the 'accumulation of phenylaniline in the body's tissues and fluids', as Questran contains aspartame which is a source of phenylaniline (see section 'Questran contains aspartame').
- If you are pregnant, if you think you are pregnant or if you are breast-feeding (see section "Pregnancy and breast-feeding").
Precautions for use What you need to know before taking Questran
Talk to your doctor or pharmacist before taking Questran.
Tell your doctor:
- if you suffer from excess cholesterol in the blood resulting from the following diseases (secondary hypercholesterolemia):
- hypothyroidism (dysfunction of the thyroid gland that produces less thyroid hormones than it should),
- diabetes mellitus (changes in blood sugar levels),
- nephrotic syndrome (changes in the kidneys resulting in a loss of protein in the urine),
- dysproteinemia (alteration in the quantity and quality of proteins in the blood)
- obstruction of the hepatic passages (bile transport system).
In these cases, the doctor will adopt the appropriate therapies and will recommend you to follow an adequate diet, control your body weight and treat any other problems that can lead to hypercholesterolemia;
- if you suffer from constipation, as cholestyramine could make it worse; in case of constipation your doctor may reduce your cholestyramine dose due to the risk of stool blockage (faecal wedging);
- if you have signs of coronary heart disease (vessels that carry blood to the heart), in the presence of which the effort of defecation must be avoided. In these cases, your doctor will adjust the dose of Questran to prevent constipation.
During the first months of therapy, your doctor will frequently evaluate your blood cholesterol levels; it could subsequently subject it to periodic checks. It will also check blood triglyceride levels for any significant changes.
If you have been taking Questran for a long time:
- your doctor will consider supplementing your diet with Vitamins A, D and K, as the medicine can interfere with the digestion and absorption of fats and fat-soluble vitamins (Vitamin A, D, K and K1) and increase the risk of blood loss caused by a Vitamin K deficiency;
- your doctor will consider giving you folic acid as a decrease in folate (vitamin B) can be observed in serum or red blood cells;
- high amounts of Questran (cholesteramine) can lead to hyperchloraemic acidosis (accumulation of acids in the body caused by the loss of a lot of fluids) particularly in children and young patients;
- Questran may increase the urinary excretion of calcium and therefore also due to the possible interference with the absorption of Vitamin D may increase the risk of osteoporosis (reduction in bone mass and deterioration of bone tissue).
Possible consequences of hypercholesterolemia
People with high blood cholesterol levels (hypercholesterolemia) can experience at any time:
- xanthomas (accumulations of fatty substances in the skin),
- arteritis (inflammation of the arteries),
- thrombophlebitis (inflammation of the superficial veins with consequent thrombus formation),
- myocardial infarction (death of part of the heart muscle),
- myocardial ischaemia (lack of adequate blood supply to the heart muscle),
- edema (accumulations of fluid in the tissues),
- uveitis (inflammation of the eyes),
- paraesthesia (changes in the sensitivity of the limbs or other parts of the body),
- claudications (limping),
- muscle aches,
- dyspnea (shortness of breath),
- dizziness,
- drowsiness,
- fatigue.
These manifestations may also appear during Questran therapy and are not related to taking the medicine.
Children and adolescents
Your doctor will use caution when prescribing Questran to patients under the age of 18, as the long-term effects in this age group are not known. The possible effects of Questran on the absorption of vitamins and electrolytes should be considered (see Warnings and precautions)
Interactions Which drugs or foods may change the effect of Questran
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor if you are taking:
- phenylbutazone (medicine used to treat pain and inflammation),
- warfarin (medicine used to prevent blood clots),
- chlorothiazide (diuretic medicine),
- tetracyclines (antibacterial medicine),
- penicillin G (an antibiotic),
- phenobarbital (medicine used in the treatment of epilepsy due to its ability to control uncontrolled body movements, seizures),
- thyroid and thyroxine preparations (medicines used to treat thyroid dysfunction),
- digitalis (medicine used to treat heart failure).
Questran may delay or reduce the absorption of these medicines. Your doctor will advise you to take the medicines listed above 1 hour before taking Questran, or 4-6 hours after, and in any case as long as possible.
Also, if you take digitalis and stop treatment with Questran and then resume or stop it, there may be an increase in digitalis absorption which is a health hazard.
In addition, tell your doctor if you are taking:
- oral anticoagulants (medicines used to prevent blood clotting),
- medicines that pass from the liver to the intestine and back to the liver (such as estrogen for example) in your body as Questran can interfere with the way these medicines work.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breast-feeding do not take Questran.
If taken during pregnancy, Questran may be harmful to an unborn baby. If taken while breastfeeding, interference with the absorption of fat-soluble vitamins in the mother could also affect the infant.
Driving and using machines
Questran does not appear to have a negative effect on driving and using machines.
Questran contains aspartame
This medicine contains a source of phenylalanine (aspartame). It may be harmful to you if you have phenylketonuria (see section "Do not take Questran").
Dose, Method and Time of Administration How to use Questran: Posology
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
There recommended dose to decrease blood cholesterol levels it varies from 1 to 6 sachets per day. The optimal dose will be determined by your doctor based on the severity of your disease.
There recommended dose to reduce itching associated with partial blockage of the biliary tract is 1-2 sachets per day.
Take Questran before meals.
If you are taking other medicines, the timing of Questran may be changed as needed to avoid interference (see section "Other medicines and Questran").
In the first months of treatment and if your doctor increases your dose, you will be asked to undergo periodic tests to check your blood levels of cholesterol, triglycerides, fats and lipoproteins (combinations of proteins and fats).
Use in children and adolescents
Your doctor will use caution when prescribing Questran to patients under the age of 18, as the long-term effects in this age group are not known.
The dose will be determined by the doctor based on the health of the child. It usually starts with just one dose per day. Your doctor will increase the dose every 5 to 6 days until the appropriate dose for your child is reached
Method of administration
- Do not take Questran in its powder form.
- Combine the contents of the Questran sachet with water, full skim milk or fruit juice in a glass.
- Shake well with a teaspoon.
- Wait 10 minutes before drinking so that the powder absorbs the water and a homogeneous suspension is obtained.
Duration of treatment
The doctor will determine the duration of the treatment.
Overdose What to do if you have taken too much Questran
If you take more Questran than you should
If you accidentally take an overdose of Questran contact your doctor or the nearest hospital immediately.
The greatest risk of taking too much Questran could be a possible blockage of the intestinal tract.
If you forget to take Questran
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Questran
Like all medicines, this medicine can cause side effects, although not everybody gets them
The most common side effects are limited to the gastrointestinal tract (stomach and intestines).
Constipation is the most frequent effect. If you are elderly (over 60 years old), and if you are being treated with high doses, you are more prone to constipation. Many cases of constipation are mild, transient and controllable with conventional therapies. in case of constipation, contact your doctor who will evaluate the possible reduction of the dosage or the interruption of the treatment, to avoid the worsening of haemorrhoid disorders (dilation of the rectal and anus veins) or intestinal blockage phenomena.
If you suffer from coronary artery disease (vessels that carry blood to the heart) you will need to avoid the problems associated with severe constipation.
Other side effects that may be observed, the frequency of which is not known, are:
Effects affecting the mouth, stomach and intestines
- Pain and distension in the abdomen
- Excessive gas formation in the stomach or intestines (flatulence)
- Nausea
- He retched
- Diarrhea
- Burning sensation felt behind the breastbone (heartburn)
- Difficulty digesting (dyspepsia) and passing stools with excessive undigested fat content (steatorrhea)
- Acute disorders in the abdomen due to the formation of a pasty mass in the transverse colon
- Loss of blood from the stomach and intestines
- Dark stools
- Blood loss due to hemorrhoids and / or lesions of the inner walls of the stomach and duodenum (gastroduodenal ulcers)
- Difficult or painful swallowing (dysphagia)
- Hiccup
- Exacerbation of the gastroduodenal ulcer
- Alteration of taste
- Inflammation of the pancreas (pancreatitis)
- Pain and bleeding in the rectum (terminal part of the intestine)
- Inflammation of one or more diverticula, small pockets that form in the terminal part of the intestine (diverticulitis)
- Blowing out of the mouth (belching)
- Bleeding of the gums
- Caries
Effects affecting the metabolism and glands
- Lack or reduced appetite (anorexia)
- Tendency to bleed due to decreased prothrombin content in the blood (Vitamin K deficiency)
- Vitamin A deficiency (reduction of visual acuity during the night) and Vitamin D
- Body weight changes
- Syndrome causing fluid retention resulting in swelling (edema)
- Increased sexual desire
- Enlargement of the glands (glandular swelling)
- Accumulation of acids in the body caused by the loss of a lot of fluids (hyperchloraemic acidosis)
Effects affecting the liver and bile
- Formation of calcium-rich clumps, with gallbladder calcification (however this may not be related to the use of Questran, but to pre-existing liver damage)
- Intense pain in the abdomen caused by the presence of solid aggregates (stones) in the biliary tract (biliary colic)
Effects affecting the skin
- Irritation and lesions of the skin, tongue and the area around the anus.
Effects affecting diagnostic tests
- Abnormalities in the functioning of the liver
Effects affecting the blood
- Increase or decrease in prothrombin time (time it takes for the blood to clot)
- Hemorrhages of the subcutaneous tissues due to bruises (bruising)
- Reduction in the amount of hemoglobin in the blood (anemia)
Effects that affect the immune system, the body's defense system
- Appearance of red or white bumps of various sizes, which may be accompanied by itching (hives)
- Asthma
- Shortness of breath (dyspnoea)
- Contraction of the muscles that line the airways and make breathing difficult (bronchospasm)
Effects affecting the muscles and bones
- Back pain (low back pain)
- Pain in the muscles and joints
- Chronic inflammation of the joints resulting in pain and swelling (arthritis)
- Decreased bone mass and deterioration of bone tissue (osteoporosis)
Effects affecting the nervous system
- Headache
- Anxiety
- Dizziness
- Balance disorders
- Lack or loss of muscle strength (asthenia)
- Annoying sensation of ringing in the ears (tinnitus)
- Temporary loss of consciousness (syncope)
- Drowsiness
- Severe pain caused by inflammation of one or more nerves in the femur (femoral neuralgia)
- Altered feeling in the limbs or other parts of the body (paraesthesia)
Effects affecting the eyes
- Inflammation of the eye (uveitis)
Effects affecting the kidneys and urinary tract
- Presence of blood in the urine (haematuria)
- Difficulty passing urine (dysuria)
- "Burnt" smell in the urine
- Urine excretion (diuresis)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Store in the original packaging. Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP.
The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
What Questran contains
- The active ingredient is cholestyramine hydrochloride. Each sachet contains 4 g of cholestyramine
- The other ingredients are: propylene glycol alginate, anhydrous citric acid, orange flavor, xanthan gum, aspartame (see section "Questran contains aspartame") and anhydrous colloidal silica.
What Questran looks like and contents of the pack
Powder for oral suspension packed in sachets. Each box contains 12 sachets.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
QUESTRAN 4 G POWDER FOR ORAL SUSPENSION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One sachet contains:
Active ingredient: cholestyramine hydrochloride equal to 4 g cholestyramine.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Powder for oral suspension.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
QUESTRAN is indicated:
- in patients with primary hypercholesterolemia, with hypercholesterolemia associated with hypertriglyceridemia when the former represents the major therapeutic problem, in all cases that do not respond to dietary treatment alone.
- in patients with partial obstruction of the biliary tract: for the relief of itching associated with the obstruction.
Questran may also be useful for lowering cholesterol levels in patients with hypercholesterolemia and hypertriglyceridaemia, but is not indicated if the primary alteration is hypertriglyceridaemia alone.
04.2 Posology and method of administration
Adults: the recommended dose for adults varies from 1 to 6 sachets per day before meals. The optimal posology will be established in the opinion of the doctor and according to the severity of the cases.
In the treatment of pruritus associated with partial obstruction of the biliary tract the dose is 1-2 sachets per day. The suggested time for administration is at meal but it can be modified according to the need to avoid interference with other medicines. it is recommended to increase the dosage progressively and carry out periodic checks of the levels of lipids and lipoproteins.
Children: Caution is needed as a precise dosage in children has not been established. The posology should be determined on a case-by-case basis bearing in mind that the long-term effects of the medicinal product in pediatric patients are not yet known.
To reduce gastrointestinal side effects it is useful to start therapy in children with only 1 daily dose of QUESTRAN. The dosage will then be increased every 5/6 days until the desired therapeutic effect is achieved. The possible effects of cholestyramine on the absorption of vitamins and electrolytes should always be considered.
04.3 Contraindications
QUESTRAN is contraindicated in patients with complete obstruction of the biliary tract as it cannot exert any activity if bile is not secreted in the intestine. It is also contraindicated in patients with hypersensitivity to the active substance or to any of the excipients.
Due to the presence of aspartame (30 mg in each sachet), a source of phenylalanine, the drug is contraindicated in phenylketonuria.
Contraindicated in pregnancy and lactation (see section 4.6).
04.4 Special warnings and appropriate precautions for use
Hypercholesterolemia, at any time, can be subject to manifestations such as: xanthomas, arteritis, thrombophlebitis, myocardial infarcts, myocardial ischemias, edema, uveitis, paraesthesia, claudication, muscle pain, dyspnoea, dizziness, drowsiness, fatigue.
These manifestations may also arise during therapy with QUESTRAN, and are not correlated with the intake of the drug.
Before starting treatment with QUESTRAN it is advisable to ascertain the existence of any secondary hypercholesterolemia to: hypothyroidism, diabetes mellitus, nephrotic syndrome, dysproteinemia and obstruction of the hepatic tract, and to institute appropriate therapies. Also, before starting treatment with QUESTRAN, it is advisable to resort to an appropriate dietary regimen, control of body weight, and the treatment of any other disorders that may cause hypercholesterolemia. During the first months of therapy, serum cholesterol levels should be checked frequently; subsequently, periodic checks would be desirable which will allow to establish the variations in serum cholesterol levels, according to which the dosage schedule can be appropriately varied. Triglyceride levels should also be checked periodically to detect any significant changes. Dosages higher than 24 g of cholestyramine per day can interfere with normal fat absorption. With QUESTRAN, appreciable results can be obtained from the first month of therapy; to maintain the results achieved, the treatment must be continued. Chronic use of QUESTRAN can interfere with digestion, the absorption of fats and fat-soluble vitamins (Vit. A, D, K, K1) and cause an increased tendency to bleed due to Vit. K. This type of symptomatology responds promptly to parenteral administration of Vit. K, and relapses can be prevented by oral intake of Vit. K to be taken at least 1 hour before or 4-6 hours after cholestyramine administration. In cases of prolonged administration it is advisable to consider an adequate integration of Vit. A and D. After long periods of administration, a reduction in serum or erythrocyte folate was also observed. In these cases it is necessary to evaluate the possibility of administering folic acid. Due to the effect of the hydrochloride radical, high quantities of cholestyramine can lead to hyperchloraemic acidosis, particularly in children and young patients. The drug can increase the urinary excretion of calcium and therefore, also due to the possible interference with the absorption of Vit. D, can increase the risk of osteoporosis. Cholestyramine can induce or aggravate pre-existing constipation or a related condition such as hemorrhoids. In patients with constipation the dosage of cholestyramine should be reduced due to the possibility of wedging. In patients with symptomatic coronary artery disease, in whom effort to defecate should be avoided, the dosage of QUESTRAN should be adjusted to prevent constipation.
04.5 Interactions with other medicinal products and other forms of interaction
QUESTRAN may delay or reduce the absorption of some medicines (phenylbutazone, warfarin, chlorothiazide, tetracyclines, penicillin G, phenobarbital, thyroid and thyroxine preparations and digitalis). It is therefore advisable to administer these medicines 1 hour before taking QUESTRAN, or 4-6 hours later, in any case at the maximum distance of time possible. In the event of discontinuous treatment or discontinuation of cholestyramine treatment, consider the health risk of patients taking toxic medicines such as digitalis, as there would be an increase in digitalis absorption. Particular precautions should be taken in case of simultaneous use of cholestyramine and oral anticoagulants Furthermore, QUESTRAN can interfere with drugs (eg: estrogens) which, like bile acids, are subject to entero-hepatic circulation.
04.6 Pregnancy and lactation
Pregnancy: do not use in case of known or suspected pregnancy. Although QUESTRAN is not absorbed into the circulation and therefore there are no grounds for fetal harm, no controlled studies have been performed on pregnant women. Due to the known interference on the absorption of fat-soluble vitamins, QUESTRAN can be harmful to the fetus even if vitamin supplements are administered simultaneously.
Breastfeeding: Do not use QUESTRAN while breastfeeding. Interference with the absorption of fat-soluble vitamins in the mother could also affect the infant.
04.7 Effects on ability to drive and use machines
Not relevant.
04.8 Undesirable effects
The most common adverse reactions are limited to the gastrointestinal tract. Constipation is the phenomenon that recurs most frequently. Predisposing factors are very high dosage and advanced age (over 60 years).
Many cases of constipation are mild, transient and easily controlled with conventional therapies. In some patients, a temporary reduction of the dosage may be required and, in the most resistant cases, the interruption of treatment, in order to prevent intestinal obstruction or aggravation of haemorrhoidal disorders.
Problems associated with severe constipation should be avoided in patients with clinical evidence of coronary artery disease. Other less frequent adverse reactions are: abdominal pain and distension, flatulence, nausea, vomiting, diarrhea, heartburn, anorexia, dyspepsia and steatorrhea, pancreatitis, bleeding tendency due to hypoprothrombinemia (Vitamin K deficiency), Vitamin A deficiency (decreased blood visus during the night) and Vitamin D, hyperchloremic acidosis in children and osteoporosis. Irritation and rashes on the skin, tongue and perianal area. Rare cases of post-marketing intestinal obstruction have been reported, including two pediatric deaths.
In patients on cholestyramine therapy, small calcific agglomerates have been found in the biliary tract, with calcification of the gallbladder. However, this may not be related to drug use but to pre-existing liver damage.
One patient experienced biliary colic each of the three times he took cholestyramine. Another diagnosed with acute abdominal discomfort showed a pasty mass in the transverse colon on radiographic examination.
Other side effects, not necessarily related to the drug, are:
Gastrointestinal disorders: gastrointestinal and rectal bleeding, dark stools, haemorrhoidal and / or gastroduodenal ulcer bleeding, dysphagia, hiccups, exacerbation of peptic ulcer, taste disturbance, pancreatitis, rectal pain, diverticulitis, belching, hyperchloraemic acidosis.
Investigations: liver function abnormality;
Disorders of the blood and lymphatic system: increase or decrease in prothrombin time, ecchymosis, anemia;
Immune system disorders: hives, asthma, dyspnoea, bronchospasm;
Musculoskeletal and connective tissue disorders: low back pain, muscle and joint pain, arthritis;
Nervous system disorders: headache, anxiety, dizziness, balance disturbances, asthenia, tinnitus, syncope, somnolence,
femoral neuralgia, paraesthesia.
Eye disorders: uveitis;
Renal and urinary disorders: hematuria, dysuria, "burning" smell in the urine, diuresis;
Miscellaneous: weight loss and weight gain, libido increase, glandular swelling, edema, gum bleeding, tooth decay.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
Should cases of overdose occur, the greatest risk would be constituted by possible obstruction of the intestinal tract. In these cases the therapy to be instituted will be determined by the location, the degree of this potential obstruction and the presence or absence of normal motility.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: hypocholesterolemics and hypotiglyceridemics. Sequestrants of bile acids. ATC code: C10AC01.
Cholesterol is the most important and probably the only precursor of bile acids. During normal digestion, the bile acids are secreted in the intestine, for the most part reabsorbed, and through the portal circulation they return to the liver.
Cholestyramine, anionic exchange resin in hydrochloride form, absorbs and combines with bile acids in the intestine forming an insoluble complex that is excreted in the faeces. This leads to a continuous, even if partial, removal of bile acids from the enterohepatic circulation, preventing them their reabsorption. The increased fecal loss of bile acids due to the administration of QUESTRAN leads to a greater oxidation of cholesterol to bile acids, a decrease in beta-lipoproteins, LDL, serum cholesterol levels. Despite the fact that QUESTRAN induces an increase in hepatic synthesis of cholesterol, there is a lowering of the latter in plasma levels.
05.2 Pharmacokinetic properties
Cholestyramine is not absorbed from the gastrointestinal tract.
In patients with partial biliary obstruction, the reduction in serum bile acid levels due to Questran reduces the deposition of bile acids in the dermis resulting in a decrease in pruritus.
05.3 Preclinical safety data
Studies in laboratory animals (rats) were conducted in which cholestyramine was used as a means to detect the role of various factors (fats, bile, microbiological flora) in the development of intestinal tumors experimentally induced by potent carcinogens; the observed incidence of these tumors was higher in rats taking cholestyramine resin associated with the experimental factors than in controls.
The correspondence of these laboratory tests performed on rats with the clinical use of QUESTRAN is not known.
Long-term and large case studies in humans showed no evidence or difference in toxicity including incidence of tumors between subjects treated with QUESTRAN and those treated with placebo.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Propylene glycol alginate, anhydrous citric acid, orange flavor, xanthan gum, aspartame, anhydrous colloidal silica.
06.2 Incompatibility
None known.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
Store in the original container.
06.5 Nature of the immediate packaging and contents of the package
Box containing 12 sachets.
06.6 Instructions for use and handling
Do not take QUESTRAN in its powdered form: combine water, skimmed milk or fruit juice in a glass with the contents of a QUESTRAN sachet. Shake well with a teaspoon.
Wait 10 minutes before drinking to allow the powder to absorb the water and thus obtain a homogeneous suspension.
07.0 MARKETING AUTHORIZATION HOLDER
BRISTOL-MYERS SQUIBB S.r.l. Via Virgilio Maroso, 50 - Rome
08.0 MARKETING AUTHORIZATION NUMBER
Questran 4 g powder for oral suspension - 12 sachets AIC No. 023014018.
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
May 2010.
10.0 DATE OF REVISION OF THE TEXT
October 2012
