500 mg / 800 IU chewable tablet is calcium / cholecalciferol ( vitamin D 3 ) 

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information. You may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Bencium is and what it is used for 
2. What you need to know before you use Bencium 
3. How to use Bencium 
4. Possible side effects 
5. How to store Bencium 
6. Contents of the packaging and other information 

1. What Bencium is and what it is used for

Bencium is a drug that contains supplements of calcium and vitamin D 3.

It is used

  • to prevent and treat calcium and vitamin D deficiency in the elderly.
  • as vitamin D and calcium supplements, adjunctive treatment for osteoporosis(osteoporosis) for patients at increased risk of vitamin D and calcium deficiency.

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

2. What you need to know before using Bencium

Do not use Bencium

  • if you are allergic to calcium, vitamin D, or any of the other ingredients of this medicine (listed in section 6)
  • if you have high levels of calcium in your blood (hypercalcemia)
  • if you have high levels of calcium in your urine ( hypercalciuria )
  • if you have hyperactive parathyroid glands (hyperparathyroidism)
  • if you have bone marrow cancer ( myeloma )
  • if you have cancer that has affected the skeleton (skeletal metastases)
  • if you have limited mobility in the arms/legs (prolonged immobilization), together with hypercalcemia and/or hypercalciuria
  • if you have kidney stones (nephrolithiasis)
  • if you have calcium deposits in your kidneys ( nephrocalcinosis )
  • if you have an excess of vitamin D in your blood (hypervitaminosis D)
  • if you have severe kidney problems.

Warnings and cautions

Talk to your doctor or pharmacist before taking Bencium

  • if you are on long-term treatment, especially if you are also taking diuretics (used to treat high blood pressure or edema ) or cardiac glycosides (used to treat heart disease)
  • if you have impaired kidney function
  • if you have sarcoidosis (a disease of the immune system, which can increase vitamin D levels in the body)
  • if you have osteoporosis and at the same time can not move
  • if you are taking other products that contain vitamin D. Additional doses of calcium and vitamin D should be taken under close medical supervision.

Children and young people

Bencium chewable tablets are not intended for the treatment of children or adolescents.

Other drugs and Bencium

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

  • Other drugs that can affect or be affected by Bencium are:
    • thiazide diuretics (used to treat high blood pressure or edema )
    • cardiac glycosides (used to treat heart disease).
  • In addition, if you are taking tetracycline (a type of antibiotic ), you should take it at least two hours before or four to six hours after taking Bencium. Calcium carbonate may affect the absorption of tetracycline preparations if taken at the same time.
  • Medicines containing bisphosphonates (used to treat osteoporosis ) should be taken at least three hours before taking Bencium.
  • Orlistat (used to treat obesity, cholestyramine (a product used to lower high cholesterol ), or laxatives, such as liquid paraffin, may interfere with absorption and thereby reduce the effect of fat-soluble vitamins, such as vitamin D 3.
  • Phenytoin (a product for the treatment of epilepsy ) or barbiturates (lung agents) can lead to a reduction in the effect of vitamin D.
  • Glucocorticoids (eg cortisone ) can lead to a decrease in the effect of vitamin D and a decrease in calcium levels in the blood.
  • Calcium may reduce the effect of levothyroxine (used to treat hypothyroidism). For this reason, levothyroxine should be taken at least four hours before or four hours after Bencium.
  • The effect of quinolone antibiotics can be reduced if they are taken at the same time as calcium. Take quinolone antibiotics two hours before or six hours after taking Bencium.
  • Calcium salts can reduce the absorption of iron, zinc, and strontium ranelate. Consequently, iron, zinc, or strontium ranelate preparations should be taken at least two hours before or after Bencium.

Bencium with food, drink, and alcohol

You can take Bencium at any time, with or without food.

Pregnancy, breastfeeding, and fertility

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

Bencium is not recommended during pregnancy in patients without vitamin D and calcium deficiency. In the case of vitamin D deficiency, the recommended dose is dependent on national guidelines, but the maximum daily dose should not exceed 2500 mg of calcium and 4000 IU of vitamin D per day.

A prolonged overdose of calcium and vitamin D during pregnancy must be avoided, as this can lead to high levels of calcium in the blood and can have a negative effect on the fetus.

Bencium can be used during breast-feeding. As calcium and vitamin D are excreted in breast milk, you should consult your doctor if your child is receiving any other products that contain vitamin D. This should be considered when giving extra vitamin D to the baby.

Driving and using machines

Bencium has no effect on the ability to drive and use 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.

Bencium contains excipients

  • Benzyl alcohol: This medicine contains 0.0115 mg of benzyl alcohol per chewable tablet. Benzyl alcohol can cause allergic reactions. If you are pregnant or breast-feeding, or if you have impaired liver or kidney function, consult your doctor or pharmacist before using this medicine. Large amounts of benzyl alcohol can be stored in the body and cause side effects (metabolic acidosis ).
  • Sorbitol (E420): This medicine contains 52 mg sorbitol per chewable tablet.
  • Sodium: This medicine contains less than 1 mmol (23 mg) sodium per chewable tablet, ie essentially ‘sodium-free ‘.
  • Aspartame (E951): This medicine contains 0.5 mg aspartame per chewable tablet. Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare, serious disease that leads to the accumulation of high levels of phenylalanine in your body.
  • Isomalt (E953) and sucrose: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to use Bencium

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 1 chewable tablet daily (equivalent to 500 mg calcium and 800 IU [international units] vitamin D 3 ). Dosage one is determined individually for you by your doctor.

The tablet must be chewed before swallowing. It can be taken at any time, with or without food.

You should make sure you get an adequate daily intake of calcium through nutrition (ie dairy products, vegetables, mineral water).

Use for children and adolescents

Bencium is not intended for use by children and adolescents.

Overdose of Bencium can lead to symptoms such as nausea, vomiting, thirst or increased thirst, increased urine production, dehydration, or constipation. In the case of a suspected overdose, contact a doctor or pharmacist immediately.

If you forget to use Bencium

If you forget to take Bencium, take the missed dose as soon as possible. Do not take a double dose to make up for a forgotten tablet.

If you stop using Bencium

If you want to stop treatment prematurely, contact your doctor.

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

4. Possible side effects

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

Uncommon: may affect up to 1 in 100 people

  • high levels of calcium in the blood ( hypercalcemia ) or urine ( hypercalciuria ).

Rare: may affect up to 1 in 1,000 users

  • nausea, diarrhea, abdominal pain, constipation, flatulence, bloating.
  • rash, itching, hives.

Stop taking Bencium and contact a doctor immediately if you experience the following allergic reaction (has been reported, occurs in an unknown number of users):

  • swelling of the face, lips, tongue, or throat with sudden difficulty breathing and severe rash.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. 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. 

5. How to store Bencium

Keep out of sight and reach of children.

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

No special temperature instructions. Close the tablet jar tightly. Moisture sensitive.

The medicine 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.

6. Contents of the packaging and other information

Content declaration

  • The active substances are calcium carbonate and cholecalciferol ( vitamin D 3 ). Each chewable tablet contains calcium carbonate equivalent to 500 mg of calcium and cholecalciferol concentrate (in powder form) equivalent to 800 IU (20 micrograms) cholecalciferol ( vitamin D 3 ).
  • The other ingredients are isomalt (E953), xylitol, sorbitol (E420), anhydrous citric acid, sodium dihydrogen citrate, magnesium stearate, carmellose sodium, the orange flavor “CPB” (containing the flavors, mannitol (E421), maltodextrin, gluconol44actone), benzyl alcohol, propylene glycol, sodium ) the orange flavoring substance “CVT” (containing the flavoring agents, mannitol (E421), maltodextrin, gluconolactone (E575), sorbitol (E420), medium-chain triglycerides ), hydrogenated colloidal silica, silica, dioxide (silica) all- rac -α-Tocopherol, modified corn starch, sucrose, medium-chain triglycerides, and colloidal anhydrous silica.

What the medicine looks like and the contents of the pack

Bencium is white, round chewable tablets with an orange flavor, with a diameter of 18 mm.

The chewable tablets, together with a desiccant, are packaged in a polypropylene capsule-sealed tablet jar and are available in the following pack sizes: 25, 30, 90 (3 x 30), and 100 (4 x 25) chewable tablets .

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Consilient Health Limited,

th Floor, Beaux Lane House,

Mercer Street Lower,

Dublin 2,

Ireland

Manufacturer:

Hermes Arzneimittel GmbH

Hans-Urmiller-Ring 52

82515 Wolfratshausen

Germany 

This medicinal product is authorized under the European Economic Area under the names:

Finland: Bencium 500 mg / 800 IU chewable tablet is

Norway: Bencium 500 mg / 800 IU chewable tablets

Muhammad Nadeem

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