Pharmaton Capsules: Package Leaflet: Information For The User

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Package leaflet: Information for the user  You are allergic to any of the ingredients listed in Section 6

of this leaflet
Pharmaton® Capsules  You have severe problems with your kidneys
 You have high iron levels, or a condition such as
Read all of this leaflet carefully before you start taking “haemochromatosis”, which is caused by a problem that
Pharmaton Capsules because it contains important may run in your family
information for you to get the best results.  You have problems with high levels of Vitamin A or D in
– Keep this leaflet. You may need to use it again. your body
– Ask your pharmacist if you need more information or advice.  You have problems with high levels of calcium in your blood
– Talk to your pharmacist or doctor if you develop new or urine
symptoms or if your symptoms get much worse or have not Do not take this medicine if any of the above applies to you. If
shown any sign of improvement over 4 weeks. you are not sure, talk to your pharmacist or doctor before taking
– If a side effect occurs and gets troublesome, or seems this medicine.
serious to you, or if you experience a side effect not listed in
this leaflet, please tell your pharmacist or doctor. Taking other medicines
The following medicines should not be taken with Pharmaton
In this leaflet: Capsules:
1. What Pharmaton Capsules are and what they are used for.  Vitamin A derivatives called “retinoids” (prescribed to treat
2. Before you take Pharmaton Capsules. acne), or Vitamin D treatment
3. How to take Pharmaton Capsules.
Before taking Pharmaton Capsules you should tell your
4. Possible side effects.
pharmacist or doctor if you are taking any of the following
5. How to store Pharmaton Capsules.
medicines:
6. Further information.
 Medicines to thin the blood called “ anticoagulants” such as
warfarin. This is because your doctor will need to monitor
1. WHAT PHARMATON CAPSULES ARE AND WHAT THEY
your blood before you start or stop taking Pharmaton
ARE USED FOR
Capsules
Pharmaton Capsules are a multivitamin, mineral and ginseng
supplement. Each capsule contains standardised Ginseng  Levodopa (used to treat Parkinson’s disease)
extract G115 with Vitamins A, B group, C, D, E, Nicotinamide,  Antihypertensives (medicines used to lower your blood
Folic acid, Biotin, and minerals Iron, Calcium, Copper, pressure)
Magnesium, Zinc, and Selenium.  Depressants or stimulants which act on the central nervous
See Section 6 (Further information) for a complete list of the system
ingredients and quantities in each capsule.  Tetracycline antibiotics such as tetracycline, doxycycline,
minocycline
Pharmaton Capsules are for:
 Relief of daily fatigue associated with a busy, hectic Food, drink, vitamin and mineral supplements
lifestyle. Symptoms of daily fatigue include temporary It is important not to take too much Vitamin A, D, or iron. You
periods of exhaustion (for example caused by stress), should consider your daily intake of all vitamins and minerals
tiredness and a feeling of weakness or lack of vitality. taking into account all sources including food and drinks.
 Ill-balanced or deficient nutrition, where needed to prevent Pregnancy and breast-feeding
or treat symptoms of vitamin and mineral deficiency. Pharmaton Capsules contain Vitamin A.
Pharmaton Capsules contains Ginseng G115 which works by Do not take this medicine if you are pregnant or are likely to
enhancing mental and physical performance and through the become pregnant as large doses of vitamin A may harm the
combined action with vitamins and minerals on the basic baby, especially if used during the first three months of
metabolic processes. pregnancy.
Pharmaton Capsules are suitable for adult men and women but Do not take this medicine if you are breast-feeding
not for children.
Important information about the ingredients
More information about daily fatigue  Pharmaton Capsules contain peanut oil (also known as
Daily fatigue is associated with a busy, hectic lifestyle, and arachis oil). If you are allergic to peanut or soya, do not take
symptoms may include: Pharmaton Capsules
 Lack of energy  Pharmaton Capsules contain a small amount of lactose. If
 Increase in rest requirements you are intolerant to lactose or you cannot digest it, do not
 Energy not restored even after sleep take Pharmaton Capsules
 Decreased mental and physical performance  If you are allergic to any of the other ingredients in
 Lethargy Pharmaton Capsules listed in Section 6, do not take this
 Lack of concentration medicine
Lifestyle changes that may help to overcome daily fatigue
include: 3. HOW TO TAKE PHARMATON CAPSULES
Follow the instructions printed in this leaflet. Talk to your
 Healthy eating
pharmacist or doctor if you develop new symptoms or if your
 Regular exercise, such as a midday stroll
symptoms get much worse or have not shown any sign of
 Take time out to allow for relaxation
improvement over four weeks.
 Prioritise work loads, instead of cramming too much into
one day Adults
 Delegate tasks at work and home  Take one capsule each day
 Find new ways to deal with stress  It is recommended to take the capsule in the morning with
 Learn to say no when there are too many demands on food
personal time  Swallow the capsule whole with water
 Reduce the intake of alcohol, caffeine, and cigarettes Children
Do not give these capsules to children.
How long to take Pharmaton Capsules for
 Start by taking Pharmaton Capsules for 4 weeks.
2. BEFORE YOU TAKE PHARMATON CAPSULES
Do not take Pharmaton Capsules if:
 If, after 4 weeks treatment, you are starting to feel better, 6. FURTHER INFORMATION
you may continue to take Pharmaton Capsules for up to 12 What Pharmaton Capsules contains
weeks. Each soft capsule contains the following active ingredients:
 The usual course of treatment is 8 to 12 weeks. After 12
weeks, talk to a doctor if you would like to continue taking Active ingredient Supplement Amount of RDA
Pharmaton Capsules. The doctor may wish to investigate Name Supplement
your symptoms further. per capsule
If you take more Pharmaton Capsules than you should Panax Ginseng G115 Ginseng 40 mg *
 If you overdose on this medicine you should talk to a doctor extract G115
or go to a hospital straight away. Take the medicine pack Vitamin A palmitate Vitamin A 2667 IU 100%
with you Cholecalciferol Vitamin D 200 IU 100%
If a child accidentally swallows Pharmaton Capsules All-rac-α- Vitamin E 10 mg 83%
Tocopheryl acetate
 Keep out of the reach and sight of children. This product
Ascorbic acid Vitamin C 60 mg 75%
contains iron which could be fatal to a child that takes too
much. Thiamine Vitamin B1 1.4 mg 127%
mononitrate
 If a child accidentally swallows a capsule, talk to a doctor or
go to a hospital straight away. Take the medicine pack with Riboflavin Vitamin B2 1.6 mg 114%
you. Nicotinamide Vitamin B3 18 mg 112%
Pyridoxine Vitamin B6 2 mg 142%
4. POSSIBLE SIDE EFFECTS hydrochloride
Like all medicines, Pharmaton Capsules can cause side effects Folic acid Folic acid 100 50%
in some people, but these are usually mild. micrograms
Cyanocobalamine Vitamin B12 1 microgram 40%
The following side effects may happen with this medicine: Biotin Vitamin B7 150 300%
Common – affects fewer than 1 in 10 people: micrograms
 Nausea (feeling sick), vomiting (being sick) Anhydrous dibasic Calcium 100 mg 12.5%
 Headache calcium phospahte
Uncommon – affects fewer than 1 in 100 people: Dried ferrous Iron 10 mg 71%
sulphate
 Diarrhoea
Dried Magnesium Magnesium 10 mg 2%
Unknown – some side effects are recorded so rarely that sulphate
their frequency is not known: Zinc sulphate Zinc 1 mg 10%
 Hypersensitivity reactions including rash and pruritus monohydrate
(itching) Copper sulphate, Copper 2 mg 200%
 Severe allergic reaction (anaphylactic reaction) dried
 Feeling dizzy Sodium selenite, Selenium 50 91%
 Stomach pains dried micrograms
The side effects nausea, vomiting, stomach pains and diarrhoea Lecithin Lecithin 100 mg *
are less likely to happen if you take the capsules with food. RDA = Recommended Daily Amount
Reporting of side effects * No RDA available
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this The capsules also contain the following ingredients: rapeseed
leaflet. You can also report side effects directly via HPRA oil, arachis (peanut) oil, ethyl vanillin (flavouring), gelatine, hard
Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; fat, triglycerides (medium chain), lactose monohydrate and
Tel: +353 1 6764971; Fax: +353 1 6762517, colloidal anhydrous silica.
Website: www.hpra.ie; E-mail: [email protected]. The capsule shell contains gelatine, glycerol 85% and iron oxide
By reporting side effects you can help provide more information red and black (E172 – colouring).
on the safety of this medicine. Recommended Daily Allowance (RDA) refers to the amount of
each vitamin and mineral that a healthy individual should
5. HOW TO STORE PHARMATON CAPSULES consume each day in order to stay fit. During temporary periods
Do not store above 25° C. Keep the bottle tightly closed to of exhaustion, the daily intake of vitamins and minerals (and
protect from moisture. Ginseng G115) from one capsule of Pharmaton Capsules has
Keep out of the sight and reach of children. been clinically proven to provide relief from tiredness and lack of
Do not use Pharmaton Capsules after the expiry date which is vitality.
stated on the carton and bottle label after EXP.
The expiry date refers to the last day of the month. What Pharmaton Capsules look like and contents of the
pack
Pharmaton Capsules are a dark brown opaque soft gelatin
capsule. They are available in packs of 30 and 100 capsules.
Product Procured from within the EU, repackaged and
distributed by the Parallel Product Authorisation Holder:
PCO Manufacturing, Unit 10, Ashbourne Business Park, Rath,
Ashbourne, Co. Meath, Ireland.
Pharmaton is a registered trademark of PHARMATON S.A.
MANUFACTURER
Pharmaton Capsules are manufactured by Boehringer Ingelheim
Pharma GmbH & Co. KG Binger Strasse 173, 55216
Ingelheim/Rhein, Germany
This leaflet was last approved in: October 2018

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