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Forceval Capsules

15-017 Forceval Adult Capsules PIL V2 23/02/2015 14:25 Page

PATIENT INFORMATION LEAFLET


The functions of the vitamins found in Forceval Capsules are:1,2,3'1


FORCEVAL

CAPSULES


Read all of this leaflet carefully because it contains important

information for you.

This medicine is available without prescription. However, you still need

to take Forceval Capsules carefully to get the best results from them.

•    Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need more information or advice.

•    You must contact a doctor, dietician or pharmacist if your symptoms worsen or do not improve.

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


Vitamin A (^-Carotene).........Is essential for growth, maintenance of skin and mucous membranes

such as the linings of the mouth, nose, lungs, digestive system, colon and for vision, particularly at night

Vitamin D2............................Vitamin D2 helps the body absorb calcium, potassium and

phosphorous, all of which are vital for healthy bones and teeth

Vitamin B] (Thiamin)............Is involved in the proper functioning of the heart muscles and for the

release of energy from protein, fat and carbohydrate, needed for growth, normal appetite and digestion.Thiamin has also been shown to play a vital role in the normal functioning of the nervous system


Vitamin B2 (Riboflavin).........Vitamin B2 plays a key role in energy metabolism, and is required for

the metabolism of fats, carbohydrates, and proteins

Vitamin B6(Pyridoxine).........Vitamin B6helps protein metabolism, along with the maintenance of

the nervous and immune systems

Vitamin B^...........................Vitamin B^ is often called the'red vitamin'because it is required for

regulating blood cells

Vitamin C..............................Vitamin C is an essential vitamin that plays an important role in


The information in this leaflet has been divided into the following sections:

1.    What Forceval Capsules are and what they are taken for

2.    Check before you take Forceval Capsules

3.    How to take Forceval Capsules

4.    Possible side effects

5.    How to store Forceval Capsules

6.    Further information


maintaining the health of our cells, blood vessels and our resistance to infection. Vitamin C also helps bones, teeth, gums, skin and assists the absorption of iron from the blood


| 1. What Forceval Capsules are and what they are taken for

Forceval Capsules are a multivitamin and mineral supplement. They contain a combination of 24 essential vitamins, minerals and trace elements.


The human body requires a wide variety of vitamins, minerals and trace elements to perform crucial daily tasks such as releasing energy from food and repairing cell damage. During certain illnesses, your body either cannot get or cannot efficiently use all of the vitamins, minerals and trace elements it needs.


Vitamin E..............................Vitamin E is a highly effective antioxidant, helping to protect the body

from the effects of free radicals. It also helps to maintain healthy skin and blood cells

Biotin....................................Biotin is needed for normal growth and development of the skin and

hair, the maintenance of a healthy nervous system and the healthy functioning of bone marrow

Nicotinamide........................Nicotinamide (also known as vitamin B3) is essential for a healthy

nervous system

Pantothenic acid...................Pantothenic acid plays a vital role in the process of releasing energy

from foods, the role of fat metabolism and the provision of the immune system with antibodies

Folic acid...............................Folic acid is required to regulate the growth of cells including red

blood cells and protein synthesis


The main functions of the minerals and trace elements are:1,2,3,4



Your doctor, dietician or pharmacist will give you Forceval Capsules if your diet has not provided you with enough vitamins, minerals and trace elements.


Each capsule contains the following 24 essential vitamins, minerals and trace elements, each of which plays a vital role in the efficient daily maintenance of many body processes:


There are 12 vitamins in Forceval Capsules:

Vitamin A (as (3-Carotene).................... 2500    iu

(Retinol Equivalent) (750 micrograms)

Vitamin D2...................400 iu (10 micrograms)

Vitamin B1 (Thiamin).............................1.2    mg

Vitamin B2 (Riboflavin)..........................1.6    mg

Vitamin B6 (Pyridoxine)........................2.0    mg

Vitamin B12..............................3.0    micrograms

Vitamin C...............................................60    mg

Vitamin E ................................................10    mg

Biotin......................................100    micrograms

Nicotinamide..........................................18    mg

Pantothenic Acid .................................. 4.0    mg

Folic Acid..................................400    micrograms


There are 12 minerals and trace elements in Forceval Capsules:


Calcium ........

Iron................

Copper...........

Phosphorous Magnesium ...

Potassium.....

Zinc...............

Iodine ...........

Manganese ..

Selenium.....

Chromium ....

Molybdenum


..............108 mg

................12 mg

.............. 2.0 mg

............... 83 mg

............... 30 mg

.............. 4.0 mg

............... 15 mg

140 micrograms

.............. 3.0 mg

.. 50 micrograms 200 micrograms .250 micrograms


Calcium.................................Calcium is necessary for the formation of bones and teeth and plays a

vital role in cell function, muscle contraction and in the nervous system

Iron.......................................Iron forms part of red blood cells which carry oxygen round the body

Copper..................................Is required for growth and forms part of enzymes involved in blood

and bone formation

Phosphorus...........................Phosphorus is necessary for the formation of bones and has an

important role in many varied chemical reactions in the body

Potassium.............................Potassium is essential in muscle function and in the transmission of

nerve impulses

Magnesium...........................Magnesium is essential for the formation of bones and teeth, and for

the release of energy from food

Zinc.......................................Zinc is required for growth and cell function, bone metabolism, taste,

insulin production and the body's immune system which fights infection

Iodine...................................Involved in functioning of the thyroid gland which regulates many of

the metabolic processes in the body

Manganese...........................Manganese helps the body to utilise calcium and potassium and

maintain the structure of cells

Selenium...............................Selenium helps to protect the cells and lipids from free radical damage

Chromium.............................Helps the body to use glucose by its action on insulin

Molybdenum ........................Is involved in the enzyme processes for protein metabolism.


2. Check before you take Forceval Capsules

4. Possible side effects

Do not take Forceval Capsules:

•    if you are allergic (hypersensitive) to any of the ingredients of Forceval Capsules (see Section 6 Further information)

•    if you suffer from hypercalcaemia (high level of calcium in the blood)

•    if you suffer from iron storage disorders such as bronzed diabetes (haemochromatosis).

•    if you are allergic to peanut or soya.

Do not give Forceval Capsules to children aged under 12.

Take special care with Forceval Capsules

Before you are given Forceval Capsules tell your doctor, dietician or pharmacist if:

•    you are pregnant or thinking of becoming pregnant

•    you are a smoker

•    you have an asbestos related illness such as asbestosis

•    you suffer from thyroid problems.

If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist before taking Forceval Capsules.

Taking other medicines

Tell your doctor if you are taking or have recently taken/used any of the following medicines as they may interfere with Forceval Capsules:

• Phenytoin (used to treat epilepsy)

• Tetracycline antibiotics (used to treat infections) such as doxycycline and minocycline.

Please tell your doctor if you are taking or have recently taken/used any other medicines including other vitamin or mineral products obtained without a prescription.

Pregnancy and breast-feeding

Forceval Capsules contain vitamin A, check with your doctor, dietician or pharmacist for advice before taking this medicine during pregnancy.

Check with your doctor or pharmacist for advice before taking this medicine whilst breast-feeding.

Important information about some of the ingredients of Forceval Capsules

This medicine contains amaranth (E123) and Ponceau 4R (E124), which may cause allergic reactions.

Forceval Capsules contain soya bean oil. If you are allergic to peanut or soya, do not take this medicinal product.

Forceval Capsules contain iron, an overdose could be fatal in children under 12 years.

| 3. How to take Forceval Capsules_

Adults and Elderly: One capsule per day or as prescribed by the doctor. The capsules should be swallowed whole with a glass of water. Children: Do not give Forceval Capsules to children aged under 12. What to do if you take more Forceval Capsules than you should If you (or someone else) accidentally take too many tablets, you should tell your doctor at once or contact the nearest accident and emergency department. Show any left over medicines or the empty packet to the doctor.

If you forget to take Forceval Capsules

Do not worry. If you forget to take a dose, take it as soon as possible, unless it is almost time to take the next dose (within 1-2 hours). Do not take a double dose. Then go on as before.

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

Forceval Capsules may cause allergic reactions (such as rash), and problems related to your stomach and intestines (such as feeling or being sick and stomach pains).

Reporting 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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Forceval Capsules

Keep out of the reach and sight of children.

Do not take Forceval Capsules after the expiry date which is stated on the carton. The expiry date refers to the last day of that month after EXP. Do not store above 25°C. Keep the blister in the outer carton in order to protect from light.

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

6. Further information 2 3 4 5 1


1

   The Pharmacological basis ofTherapeutics, 7th Edition (1985), Goodman and Gilman.

Forceval is a registered trademark of Alliance Pharmaceuticals Limited. Alliance, Alliance Pharmaceuticals and associated devices are registered Trademarks.

© Alliance Pharmaceuticals Limited 2015.

XXXXX

2

What is in Forceval Capsules?

The active ingredients in this medicine are: Vitamin A (as p-Carotene), Vitamin D2, Vitamin Bv Vitamin B2, Vitamin B^ Vitamin B^, Vitamin C, Vitamin E, Biotin, Nicotinamide, Pantothenic acid, Folic acid, Calcium, Iron, Copper, Phosphorous, Magnesium, Potassium, Zinc, Iodine, Manganese, Selenium, Chromium, Molybdenum.

The other ingredients are Soya Bean Oil, Soya Lecithin, Hard Vegetable Fat (Biscuitine 621), Yellow Beeswax, Purified Water, Maize Oil, Gelatin, Glycerine, Ponceau 4R (E124), Amaranth (E123), Titanium Dioxide (E171), Red Iron Oxide Paste (E172), Vegetable Black Paste (E153)

What Forceval Capsules look like and contents of the pack

Forceval Capsules are brown and maroon, soft gelatin capsules printed with FORCEVAL in white on one side . They come in cartons containing 15, 30, 45 or 90 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The product licence holder is: Alliance Pharmaceuticals Limited, Avonbridge House, Chippenham, Wiltshire, SN15 2BB, UK.

Forceval capsules are manufactured by: Pharmapac (UK) Limited,

Valley Road Business Park, Bidston, Merseyside, CH41 7EL, UK.

The information in this leaflet applies only to Forceval Capsules. If you have any questions or you are not sure about anything, ask your doctor. This leaflet was last revised in: February 2015.

REFERENCES

3

   Dietary ReferenceValues for Food Energy and Nutrients for the United Kingdom (1991), H.M.S.O

4

   Recommended Dietary Allowances 10th edition, (1989), Subcommittee on the 10th edition of RDA's. Food and Nutrition Board Commission of Life Sciences. National Research Committee

5

   Manual of NutritionalTherapeutics (1983). David H. Alpers, Ray E. Clouse,William F. Stenson, Fourth Printing December 1986.