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Thiamine Hydrochloride 50 mg Tablets

Active Ingredient:
thiamine hydrochloride
Company:  
Flamingo Pharma (UK) Ltd See contact details
ATC code: 
A11DA01
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL) HCP Med Info
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 04 Apr 2022
{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet are: PL43461/0037, PL43461/0038.

{printer} Print patient leaflet as text only

Thiamine Hydrochloride 50 mg and 100 mg Tablets 28's and 100's (P) (PL 43461/0037)/(PL 43461/0038)

PACKAGE LEAFLET: INFORMATION FOR THE USER

Thiamine Hydrochloride 50mg and 100mg Tablets

Thiamine Hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

  • Keep this leaflet. You may need to read it again.
  • Ask your pharmacist if you need more information or advice.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
  • You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet:

1. What Thiamine Hydrochloride Tablets is and what it is used for
2. What you need to know before you take Thiamine Hydrochloride Tablets
3. How to take Thiamine Hydrochloride Tablets
4. Possible side effects
5. How to store Thiamine Hydrochloride Tablets
6. Content of the pack and other information

1. WHAT THIAMINE HYDROCHLORIDE TABLETS IS AND WHAT IT IS USED FOR

Thiamine Hydrochloride Tablets are vitamin tablets and you have been given them because your body does not have enough thiamine (Vitamin B1). Although this vitamin occurs naturally in nearly all living tissues, and some is obtained from almost all foods - particularly yeast, wholegrain cereals, meat and beans - unpleasant physical symptoms can develop if you do not get enough thiamine in your diet. Taking Thiamine Hydrochloride Tablets - a synthetic version of natural Vitamin B1 - helps to make up for any lack of thiamine in your diet.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIAMINE HYDROCHLORIDE TABLETS
Do not take Thiamine Hydrochloride Tablets

If you are allergic to thiamine hydrochloride or any of the other ingredients of Thiamine Hydrochloride Tablets (see section 6). An allergic reaction may be recognised as a rash, itching, swollen face or lips, shortness of breath.

Warnings and precautions

Talk to your doctor or pharmacist before taking Thiamine Hydrochloride Tablets.

Other medicines and Thiamine Hydrochloride Tablets

Tell your doctor or pharmacist if you are taking any other medicines, including those obtained without a prescription, such as vitamins or herbal preparations which you have bought yourself.

Certain medicines can reduce the effect of your Thiamine Hydrochloride Tablets.

Tell your doctor if you are taking the following medicine because he/she may need to adjust your Thiamine hydrochloride tablets dose:

  • fluorouracil (used to treat certain cancers and viral infections)

Having blood tests or other medical tests:

High concentrations of thiamine in the blood can affect certain medical tests. If you are having a blood test, scan, or any other medical test, tell your doctor that you are taking Thiamine hydrochloride tablets.

Pregnancy, breastfeeding and fertility

Do not take Thiamine Hydrochloride Tablets if you are pregnant or breast-feeding unless under the direction of your doctor

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Thiamine Hydrochloride is not known to affect the ability to drive or use machines.

However, if you feel you may be affected, do not drive or use machines and speak to your doctor.

Thiamine Hydrochloride Tablets contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE THIAMINE HYDROCHLORIDE TABLETS

Always take this medicine exactly as described in this leaflet or as your doctor or Pharmacist has told you.

Check with your doctor or pharmacist if you are not sure.

Take the tablets by mouth. Swallow whole with water. If you find a whole tablet too big to swallow, break it first along the break-line.

The usual dose is as follows:

If you are taking Thiamine Hydrochloride 50mg Tablets:

Adults, the Elderly and Children over 3 years

Mild chronic deficiency: One tablet a day.

Severe thiamine deficiency: Two tablets three times a day.

Children: Not recommended for those under 3 years of age.

If you are taking Thiamine Hydrochloride 100mg Tablets:

Adults, the Elderly and Children over 3 years

Severe thiamine deficiency: One tablet three times a day.

Children: Not recommended for those under 3 years of age.

If you take more Thiamine Hydrochloride Tablets than you should:

This is unlikely to be harmful, but contact your doctor or pharmacist if you are worried or develop a reaction such as a skin rash.

If you forget to take Thiamine Hydrochloride Tablets:

Take your dose as soon as you remember, then carry on taking your tablets as usual.

Do not take a double dose to make up for a forgotten dose.

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.

These tablets are unlikely to cause side effects unless you are overly sensitive (hypersensitive) to thiamine or one of the other ingredients in Thiamine Hydrochloride Tablets. Hypersensitivity reactions to thiamine have been reported, but mostly when it has been given by injection.

Very few people may experience an allergic reaction after taking this medicine, symptoms of this could be:

rash or skin irritation; swelling of face, lips, throat or tongue; stomach pain; difficulty in breathing or swallowing; rapid pulse; heart pain.

Some people may experience a mild stomach upset after taking this medicine, symptoms of this include:

nausea; vomiting; stomach pain: diarrhoea.

If you notice any unusual feelings or symptoms, stop taking the tablets and contact your doctor or pharmacist as soon as you can.

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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE THIAMINE HYDROCHLORIDE TABLETS

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

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENT OF THE PACK AND OTHER INFORMATION
What Thiamine Hydrochloride Tablets contains

The active substance is Thiamine hydrochloride.

Each tablet contains 50 mg or 100 mg of thiamine hydrochloride.

The other ingredients are lactose monohydrate, maize starch, pregelatinised starch, magnesium stearate and talc.

What Thiamine Hydrochloride Tablets looks like and contents of the pack

Thiamine Hydrochloride 50 mg Tablets are white to off white, circular biconvex uncoated tablets embossed with "THT" and "50" separated by break line on one side and plain on other side.

Thiamine Hydrochloride 100 mg Tablets are white to off white, circular biconvex uncoated beveled edges tablets embossed with "THT" and "100" separated by break line on one side and plain on other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Thiamine Hydrochloride Tablets are available in white opaque HDPE bottle with white polypropylene child resistant cap containing a polyester coil and desiccant container: Pack 100's and 250's Tablets.

Thiamine Hydrochloride Tablets are available in blisters of Aluminium-PVC/PVDC containing pack of 28 tablets along with leaflet inside.

Not all pack sizes may be marketed.

Marketing Authorization Holder
Flamingo Pharma (UK) Ltd.
1st Floor
Kirkland House
11-15 Peterborough Road
Harrow
Middlesex
HA1 2AX
United Kingdom

Manufacturers
Flamingo Pharma (UK) Limited
The Bloc
38 Springfield Way
Anlaby
Hull
HU10 6RJ
United Kingdom

This leaflet was last revised in 03/2020.

P

PL 43461/0037

PL 43461/0038

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Flamingo Pharma (UK) Ltd
Company image
Address
The BLOC, 38 Springfield Way, Kingston Upon Hull, HU10 6RJ, UK
Telephone
+44 (0) 7784240228
Medical Information Direct Line
00 800 890 13370
WWW
http://www.flamingopharma.co.uk
Stock Availability
[email protected]