4 g powder for oral suspension, sachet
cholestyramine

What Cholestyramine Alternova is and what it is used for

Cholestyramine Alternova is used:

  • To lower elevated blood fat levels when diet therapy has not had sufficient effect.
  • In case of skin itching caused by obstruction in the bile ducts.
  • In case of diarrhea caused by too much bile acids in the intestine.


In the small intestine, Cholestyramine Alternova binds bile acids, which are formed from cholesterol. In the new formation of bile acids, cholesterol is taken from the blood, the content of which thereby decreases.

Cholestyramine contained in Cholestyramine Alternova may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Cholestyramine Alternova

Do not use Cholestyramine Alternova

  • If you are allergic to cholestyramine or any of the other ingredients of this medicine (listed in section 6).
  • At complete stop in the bile ducts.
  • In phenylketonuria (a congenital disease of the phenylalanine metabolism).

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Cholestyramine Alternova:

  • If you have inflammatory bowel disease.
  • If you have easy constipation, talk to your doctor. Your doctor may reduce your dose and also recommend a suitable diet and medication to prevent constipation.
  • For very long-term treatment: The use of Cholestyramine Alternova can reduce the uptake of fat-soluble vitamins and a lack of vitamin K increases the tendency to bleed. Vitamins A, D and K may in some cases need to be given prophylactically.

Other medicines and Cholestyramine Alternova

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

  • Other medicines should be taken 1 hour before or 4-6 hours after Cholestyramine Alternova to prevent the absorption of the medicines being affected.
  • The effect of certain other medicines may be affected if Cholestyramine Alternova is taken at the same time. Therefore, consult your doctor before using the following medicines at the same time.
  • Benzylpenicillin, tetracycline (used against bacterial infections)
  • Bezafibrate, ezetimibe, fluvastatin, nicotinic acid , pravastatin (for high blood fats)
  • Digitoxin, digoxin (used in heart diseases such as heart fibrillation )
  • Diclofenac , meloxicam, piroxicam, tenoxicam (used to relieve pain such as joint and muscle inflammation )
  • Mycophenolic acid (used to prevent the body’s immune system from rejecting a transplanted kidney)
  • Phenobarbital (for epileptic seizures)
  • Raloxifene (used to treat and prevent osteoporosis in women after menopause )
  • Thyroid hormones (used to treat hypothyroidism ( hypothyroidism ))
  • Thiazides ( diuretics )
  • Warfarin (used to thin the blood).
  • Combination with ursodeoxycholic acid (used to dissolve small gallstones and in liver disease) should be avoided.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.


Pregnancy

Experience with the use of Cholestyramine Alternova during pregnancy is limited. Therefore, always consult a doctor before using Cholestyramine Alternova during pregnancy.


Breast-feeding

Cholestyramine Alternova does not pass into breast milk.

Driving and using machines

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Cholestyramine Alternova contains the sweetener aspartame (E951)

This medicine contains 30 mg aspartame per sachet equivalent to 3 mg / kg / day.

Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare, inherited disease that leads to the accumulation of high levels of phenylalanine in your body.

Cholestyramine Alternova contains propylene glycol (E1520)

This medicine contains 32.49 mg propylene glycol per sachet equivalent to 3.24 mg / kg / day.

How to use Cholestyramine Alternova

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.


The recommended dose is:

Adults: 1-2 dose bags 2-3 times daily.

Children: The dose is determined by the doctor, who adjusts it individually to the child’s weight or age.


To avoid a sluggish stomach and constipation, it is recommended to start with only ½ dose bag daily during the first week and then increase the dose one week until the prescribed dose is reached. Other medicines should be taken 1 hour before or 4-6 hours after Cholestyramine Alternova to prevent the absorption of the medicines from being affected.


The powder is mixed in at least ½ glass (150 ml) water, juice, juice, or other beverage. It may be appropriate to vary the drinks used. It is also possible to mix in easily flowing soups or finely chopped fruit, such as. apple puree or crushed pineapple. The solution must be taken immediately. Discard any remaining powder.

If you use more Cholestyramine Alternova than you should  

If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center (tel. 112) for risk assessment and advice.


If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.


Very common 
 (may affect more than 1 user in 10):

  • Constipation.


The following side effects have been reported (affects an unknown number of users):

  • Predisposition to bleeding, decreased protein content in the blood, anemia , lymph node disease, large bruises.
  • Vitamin A deficiency, vitamin K deficiency, vitamin D deficiency, low levels of folic acid in the body (in children), excess chlorine in the blood (in children), decreased appetite.
  • Increased sexual desire, anxiety.
  • Headache, dizziness, fainting, drowsiness, nerve pain, tingling, taste disturbances.
  • Night blindness (with vitamin A deficiency), inflammation of the grape membrane of the eye.
  • Tinnitus , dizziness.
  • Asthma , wheezing, labored breathing, hiccups.
  • Inflammation of the pancreas, discomfort in the stomach, flatulence, nausea, vomiting, diarrhea, symptoms of gastrointestinal tract such as heartburn and acid regurgitation, fatty diarrhea, inflammation of the tongue, rectal problems, bleeding in the gastrointestinal tract, bleeding from discoloration, bleeding , bleeding from hemorrhoids , bleeding ulcers in the duodenum , difficulty swallowing, pain in the rectum, belching, acute abdominal pain, caries , bleeding in the mouth, blockage in the flow of intestines, inflammation of the colon.
  • Gallstones , storage of calcium in the gallbladder, bile pains, abnormal liver function values.
  • Redness , skin irritation, hives .
  • Osteoporosis, back pain, muscle pain, joint pain, joint inflammation.
  • Blood in the urine, difficulty urinating, abnormal urine odor, increased urine output.
  • Fatigue, swelling due to fluid accumulation in the tissues .
  • Altered prothrombin values, weight gain, weight loss.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects that are not mentioned in this information. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address

How to store Cholestyramine Alternova

Keep this medicine out of the sight and reach of children.

No special storage instructions.


Do not use this medicine after the expiry date which is stated on the carton and the sachets after “EXP.”. The expiration date is the last day of the specified month.


Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

  • The active substance is cholestyramine 4 g per sachet .
  • The other ingredients are: Flavor (orange): maltodextrin, acacia gum (E414), natural flavorings, butylhydroxyanisole (E320). Propylene glycol alginate (E1520); xanthan gum (E415); aspartame (E951); citric acid (E330); colloidal anhydrous silica.

What the medicine looks like and contents of the pack

White to almost white powder, aroma, and taste of orange.

Packaging: 50 and 56 sachets in cardboard (paper / polyethylene / aluminum / polyethylene).

Marketing Authorisation Holder

Alternova A / S

Energivej 15

5260 Odense S

Denmark


Manufacturer

Laboratorios Rubió SA

Industria 29 Pol. Ind. Count of Sert

08755 Catellbisbal, Barcelona

Spain


Or


Orifarm Generics A / S

Energivej 15

5260 Odense S

Denmark


Local representative:

Orifarm Generics AB,

Box 56048

102 17 Stockholm 

info@orifarm.com

Muhammad Nadeem

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